COVID-19: What's new in heme/onc

Patients who are profoundly immunosuppressed after extensive cancer treatment, and who fall ill with COVID-19, can shed viable SARS-CoV-2 virus for at least 2 months after symptom onset and may need extended periods of isolation.

Live-virus shedding was detected in 18 patients who had undergone hematopoietic stem cell transplants or chimeric antigen receptor (CAR) T-cell therapy and in 2 patients with lymphoma. 

The finding was reported Dec. 1 in a research letter in the New England Journal of Medicine. 

Individuals who are otherwise healthy when they get COVID-19 are “no longer infectious after the first week of illness,” said lead author Mini Kamboj, MD, chief medical epidemiologist, Memorial Sloan Kettering Cancer Center, New York. 

“We need to keep an open mind about how [much] longer immunocompromised patients could pose an infection risk to others,” she added.

Dr. Kamboj said in an interview that her team’s previous experience with stem cell transplant recipients had suggested that severely immunocompromised patients shed other viruses (such as respiratory syncytial virus, parainfluenza, and influenza) for longer periods of time than do healthy controls.

Based on their latest findings, the investigators suggest that current guidelines for COVID-19 isolation precautions may need to be revised for immunocompromised patients. Even if only a small proportion of patients with cancer who have COVID-19 remain contagious for prolonged periods of time, “it’s a residual risk that we need to address,” Dr. Kamboj said. 

Dr. Kamboj also suggested that physicians follow test-based criteria to determine when a patient undergoing transplant can be released from isolation.
 

Shedding of viable virus

For this study, the investigators used cell cultures to detect viable virus in serially collected nasopharyngeal and sputum samples from 20 immunocompromised patients who had COVID-19 (diagnosed with COVID-19 between March 10 and April 20).  

Patients had lymphoma (n = 8), multiple myeloma (n= 7), acute leukemia/myelodysplastic syndrome (n = 4), and chronic leukemia (n = 1). There were 16 patients who had undergone transplant, 2 who had received CAR T-cell therapy, and 2 who had received other therapy.

There were 15 patients receiving active treatment or chemotherapy, and 11 developed severe COVID-19 infection. 

In total, 78 respiratory samples were collected.

“Viral RNA was detected for up to 78 days after the onset of symptoms,” the researchers reported, “[and] viable virus was detected in 10 of 14 nasopharyngeal samples (71%) that were available from the first day of laboratory testing.”

Five patients were followed up, and from these patients, the team grew virus in culture for up to 61 days after symptom onset. Two among this small group of five patients had received allogenic hematopoietic stem cell transplantation and one patient had been treated with CAR T-cell therapy within the previous 6 months. This patient remained seronegative for antibodies to the coronavirus.

For 11 patients, the team obtained serial sample genomes and found that  “each patient was infected by a distinct virus and there were no major changes in the consensus sequences of the original serial specimens or cultured isolates.” These findings were consistent with persistent infection, they noted.

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients who are profoundly immunosuppressed after extensive cancer treatment, and who fall ill with COVID-19, can shed viable SARS-CoV-2 virus for at least 2 months after symptom onset and may need extended periods of isolation.

Live-virus shedding was detected in 18 patients who had undergone hematopoietic stem cell transplants or chimeric antigen receptor (CAR) T-cell therapy and in 2 patients with lymphoma. 

The finding was reported Dec. 1 in a research letter in the New England Journal of Medicine. 

Individuals who are otherwise healthy when they get COVID-19 are “no longer infectious after the first week of illness,” said lead author Mini Kamboj, MD, chief medical epidemiologist, Memorial Sloan Kettering Cancer Center, New York. 

“We need to keep an open mind about how [much] longer immunocompromised patients could pose an infection risk to others,” she added.

Dr. Kamboj said in an interview that her team’s previous experience with stem cell transplant recipients had suggested that severely immunocompromised patients shed other viruses (such as respiratory syncytial virus, parainfluenza, and influenza) for longer periods of time than do healthy controls.

Based on their latest findings, the investigators suggest that current guidelines for COVID-19 isolation precautions may need to be revised for immunocompromised patients. Even if only a small proportion of patients with cancer who have COVID-19 remain contagious for prolonged periods of time, “it’s a residual risk that we need to address,” Dr. Kamboj said. 

Dr. Kamboj also suggested that physicians follow test-based criteria to determine when a patient undergoing transplant can be released from isolation.
 

Shedding of viable virus

For this study, the investigators used cell cultures to detect viable virus in serially collected nasopharyngeal and sputum samples from 20 immunocompromised patients who had COVID-19 (diagnosed with COVID-19 between March 10 and April 20).  

Patients had lymphoma (n = 8), multiple myeloma (n= 7), acute leukemia/myelodysplastic syndrome (n = 4), and chronic leukemia (n = 1). There were 16 patients who had undergone transplant, 2 who had received CAR T-cell therapy, and 2 who had received other therapy.

There were 15 patients receiving active treatment or chemotherapy, and 11 developed severe COVID-19 infection. 

In total, 78 respiratory samples were collected.

“Viral RNA was detected for up to 78 days after the onset of symptoms,” the researchers reported, “[and] viable virus was detected in 10 of 14 nasopharyngeal samples (71%) that were available from the first day of laboratory testing.”

Five patients were followed up, and from these patients, the team grew virus in culture for up to 61 days after symptom onset. Two among this small group of five patients had received allogenic hematopoietic stem cell transplantation and one patient had been treated with CAR T-cell therapy within the previous 6 months. This patient remained seronegative for antibodies to the coronavirus.

For 11 patients, the team obtained serial sample genomes and found that  “each patient was infected by a distinct virus and there were no major changes in the consensus sequences of the original serial specimens or cultured isolates.” These findings were consistent with persistent infection, they noted.

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Patients who are profoundly immunosuppressed after extensive cancer treatment, and who fall ill with COVID-19, can shed viable SARS-CoV-2 virus for at least 2 months after symptom onset and may need extended periods of isolation.

Live-virus shedding was detected in 18 patients who had undergone hematopoietic stem cell transplants or chimeric antigen receptor (CAR) T-cell therapy and in 2 patients with lymphoma. 

The finding was reported Dec. 1 in a research letter in the New England Journal of Medicine. 

Individuals who are otherwise healthy when they get COVID-19 are “no longer infectious after the first week of illness,” said lead author Mini Kamboj, MD, chief medical epidemiologist, Memorial Sloan Kettering Cancer Center, New York. 

“We need to keep an open mind about how [much] longer immunocompromised patients could pose an infection risk to others,” she added.

Dr. Kamboj said in an interview that her team’s previous experience with stem cell transplant recipients had suggested that severely immunocompromised patients shed other viruses (such as respiratory syncytial virus, parainfluenza, and influenza) for longer periods of time than do healthy controls.

Based on their latest findings, the investigators suggest that current guidelines for COVID-19 isolation precautions may need to be revised for immunocompromised patients. Even if only a small proportion of patients with cancer who have COVID-19 remain contagious for prolonged periods of time, “it’s a residual risk that we need to address,” Dr. Kamboj said. 

Dr. Kamboj also suggested that physicians follow test-based criteria to determine when a patient undergoing transplant can be released from isolation.
 

Shedding of viable virus

For this study, the investigators used cell cultures to detect viable virus in serially collected nasopharyngeal and sputum samples from 20 immunocompromised patients who had COVID-19 (diagnosed with COVID-19 between March 10 and April 20).  

Patients had lymphoma (n = 8), multiple myeloma (n= 7), acute leukemia/myelodysplastic syndrome (n = 4), and chronic leukemia (n = 1). There were 16 patients who had undergone transplant, 2 who had received CAR T-cell therapy, and 2 who had received other therapy.

There were 15 patients receiving active treatment or chemotherapy, and 11 developed severe COVID-19 infection. 

In total, 78 respiratory samples were collected.

“Viral RNA was detected for up to 78 days after the onset of symptoms,” the researchers reported, “[and] viable virus was detected in 10 of 14 nasopharyngeal samples (71%) that were available from the first day of laboratory testing.”

Five patients were followed up, and from these patients, the team grew virus in culture for up to 61 days after symptom onset. Two among this small group of five patients had received allogenic hematopoietic stem cell transplantation and one patient had been treated with CAR T-cell therapy within the previous 6 months. This patient remained seronegative for antibodies to the coronavirus.

For 11 patients, the team obtained serial sample genomes and found that  “each patient was infected by a distinct virus and there were no major changes in the consensus sequences of the original serial specimens or cultured isolates.” These findings were consistent with persistent infection, they noted.

The authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The risk of arterial and venous thrombosis in patients with COVID-19 has been a major issue throughout the pandemic, and how best to manage this risk is the subject of a new review article.

The article, by Gregory Dr. Piazza, MD, and David A. Morrow, MD, Brigham and Women’s Hospital, Boston, was published online in JAMA on Nov. 23.

“Basically we’re saying: ‘Be proactive about prevention,’” Dr. Piazza told this news organization.

There is growing recognition among those on the frontline that there is an increased risk of thrombosis in COVID-19 patients, Dr. Piazza said. The risk is highest in patients in the intensive care unit, but the risk is also increased in patients hospitalized with COVID-19, even those not in ICU.

“We don’t really know what the risk is in nonhospitalized COVID-19 patients, but we think it’s much lower than in those who are hospitalized,” he said. “We are waiting for data on the optimal way of managing this increased risk of thrombosis in COVID patients, but for the time being, we believe a systematic way of addressing this risk is best, with every patient hospitalized with COVID-19 receiving some type of thromboprophylaxis. This would mainly be with anticoagulation, but in patients in whom anticoagulation is contraindicated, then mechanical methods could be used, such as pneumatic compression boots or compression stockings.”

The authors report thrombotic complication rates of 2.6% in noncritically ill hospitalized patients with COVID-19 and 35.3% in critically ill patients from a recent U.S. registry study.

Autopsy findings of microthrombi in multiple organ systems, including the lungs, heart, and kidneys, suggest that thrombosis may contribute to multisystem organ dysfunction in severe COVID-19, they note. Although the pathophysiology is not fully defined, prothrombotic abnormalities have been identified in patients with COVID-19, including elevated levels of D-dimer, fibrinogen, and factor VIII, they add.

“There are several major questions about which COVID-19 patients to treat with thromboprophylaxis, how to treat them in term of levels of anticoagulation, and there are many ongoing clinical trials to try and answer these questions,” Dr. Piazza commented. “We need results from these randomized trials to provide a better compass for COVID-19 patients at risk of clotting.”

At present, clinicians can follow two different sets of guidelines on the issue, one from the American College of Chest Physicians and the other from the International Society on Thrombosis and Hemostasis, the authors note.

“The ACCP guidelines are very conservative and basically follow the evidence base for medical patients, while the ISTH guidelines are more aggressive and recommend increased levels of anticoagulation in both ICU and hospitalized non-ICU patients and also extend prophylaxis after discharge,” Dr. Piazza said.

“There is quite a difference between the two sets of guidelines, which can be a point of confusion,” he added.

Dr. Piazza notes that at his center every hospitalized COVID patient who does not have a contraindication to anticoagulation receives a standard prophylactic dose of a once-daily low-molecular-weight heparin (for example, enoxaparin 40 mg). A once-daily product is used to minimize infection risk to staff.

While all COVID patients in the ICU should automatically receive some anticoagulation, the optimal dose is an area of active investigation, he explained. “There were several early reports of ICU patients developing blood clots despite receiving standard thromboprophylaxis so perhaps we need to use higher doses. There are trials underway looking at this, and we would advise enrolling patients into these trials.”

If patients can’t be enrolled into trials, and clinicians feel higher anticoagulation levels are needed, Dr. Piazza advises following the ISTH guidance, which allows an intermediate dose of low-molecular-weight heparin (up to 1 mg/kg enoxaparin).

“Some experts are suggesting even higher doses may be needed in some ICU patients, such as the full therapeutic dose, but I worry about the risk of bleeding with such a strategy,” he said.

Dr. Piazza says they do not routinely give anticoagulation after discharge, but if this is desired then patients could be switched to an oral agent, and some of the direct-acting oral anticoagulants are approved for prophylactic use in medically ill patients.

Dr. Piazza points out that whether thromboprophylaxis should be used for nonhospitalized COVID patients who have risk factors for clotting such as a prior history of thrombosis or obesity is a pressing question, and he encourages clinicians to enroll these patients in clinical trials evaluating this issue, such as the PREVENT-HD trial.

“If they can’t enroll patents in a trial, then they have to make a decision whether the patient is high-enough risk to justify off-label use of anticoagulant. There is a case to be made for this, but there is no evidence for or against such action at present,” he noted.

At this time, neither the ISTH nor ACCP recommend measuring D-dimer to screen for venous thromboembolism or to determine intensity of prophylaxis or treatment, the authors note.

“Ongoing investigation will determine optimal preventive regimens in COVID-19 in the intensive care unit, at hospital discharge, and in nonhospitalized patients at high risk for thrombosis,” they conclude.

Dr. Piazza reported grants from Bayer, Bristol Myers Squibb, Boston Scientific, Janssen, and Portola, and personal fees from Agile, Amgen, Pfizer, and the Prairie Education and Research Cooperative outside the submitted work. Dr. Morrow reported grants from Abbott Laboratories, Amgen, Anthos Therapeutics, Esai, GlaxoSmithKline, Takeda, and The Medicines Company; grants and personal fees from AstraZeneca, Merck, Novartis, and Roche Diagnostics; and personal fees from Bayer Pharma and InCarda outside the submitted work.

A version of this article originally appeared on Medscape.com.

The risk of arterial and venous thrombosis in patients with COVID-19 has been a major issue throughout the pandemic, and how best to manage this risk is the subject of a new review article.

The article, by Gregory Dr. Piazza, MD, and David A. Morrow, MD, Brigham and Women’s Hospital, Boston, was published online in JAMA on Nov. 23.

“Basically we’re saying: ‘Be proactive about prevention,’” Dr. Piazza told this news organization.

There is growing recognition among those on the frontline that there is an increased risk of thrombosis in COVID-19 patients, Dr. Piazza said. The risk is highest in patients in the intensive care unit, but the risk is also increased in patients hospitalized with COVID-19, even those not in ICU.

“We don’t really know what the risk is in nonhospitalized COVID-19 patients, but we think it’s much lower than in those who are hospitalized,” he said. “We are waiting for data on the optimal way of managing this increased risk of thrombosis in COVID patients, but for the time being, we believe a systematic way of addressing this risk is best, with every patient hospitalized with COVID-19 receiving some type of thromboprophylaxis. This would mainly be with anticoagulation, but in patients in whom anticoagulation is contraindicated, then mechanical methods could be used, such as pneumatic compression boots or compression stockings.”

The authors report thrombotic complication rates of 2.6% in noncritically ill hospitalized patients with COVID-19 and 35.3% in critically ill patients from a recent U.S. registry study.

Autopsy findings of microthrombi in multiple organ systems, including the lungs, heart, and kidneys, suggest that thrombosis may contribute to multisystem organ dysfunction in severe COVID-19, they note. Although the pathophysiology is not fully defined, prothrombotic abnormalities have been identified in patients with COVID-19, including elevated levels of D-dimer, fibrinogen, and factor VIII, they add.

“There are several major questions about which COVID-19 patients to treat with thromboprophylaxis, how to treat them in term of levels of anticoagulation, and there are many ongoing clinical trials to try and answer these questions,” Dr. Piazza commented. “We need results from these randomized trials to provide a better compass for COVID-19 patients at risk of clotting.”

At present, clinicians can follow two different sets of guidelines on the issue, one from the American College of Chest Physicians and the other from the International Society on Thrombosis and Hemostasis, the authors note.

“The ACCP guidelines are very conservative and basically follow the evidence base for medical patients, while the ISTH guidelines are more aggressive and recommend increased levels of anticoagulation in both ICU and hospitalized non-ICU patients and also extend prophylaxis after discharge,” Dr. Piazza said.

“There is quite a difference between the two sets of guidelines, which can be a point of confusion,” he added.

Dr. Piazza notes that at his center every hospitalized COVID patient who does not have a contraindication to anticoagulation receives a standard prophylactic dose of a once-daily low-molecular-weight heparin (for example, enoxaparin 40 mg). A once-daily product is used to minimize infection risk to staff.

While all COVID patients in the ICU should automatically receive some anticoagulation, the optimal dose is an area of active investigation, he explained. “There were several early reports of ICU patients developing blood clots despite receiving standard thromboprophylaxis so perhaps we need to use higher doses. There are trials underway looking at this, and we would advise enrolling patients into these trials.”

If patients can’t be enrolled into trials, and clinicians feel higher anticoagulation levels are needed, Dr. Piazza advises following the ISTH guidance, which allows an intermediate dose of low-molecular-weight heparin (up to 1 mg/kg enoxaparin).

“Some experts are suggesting even higher doses may be needed in some ICU patients, such as the full therapeutic dose, but I worry about the risk of bleeding with such a strategy,” he said.

Dr. Piazza says they do not routinely give anticoagulation after discharge, but if this is desired then patients could be switched to an oral agent, and some of the direct-acting oral anticoagulants are approved for prophylactic use in medically ill patients.

Dr. Piazza points out that whether thromboprophylaxis should be used for nonhospitalized COVID patients who have risk factors for clotting such as a prior history of thrombosis or obesity is a pressing question, and he encourages clinicians to enroll these patients in clinical trials evaluating this issue, such as the PREVENT-HD trial.

“If they can’t enroll patents in a trial, then they have to make a decision whether the patient is high-enough risk to justify off-label use of anticoagulant. There is a case to be made for this, but there is no evidence for or against such action at present,” he noted.

At this time, neither the ISTH nor ACCP recommend measuring D-dimer to screen for venous thromboembolism or to determine intensity of prophylaxis or treatment, the authors note.

“Ongoing investigation will determine optimal preventive regimens in COVID-19 in the intensive care unit, at hospital discharge, and in nonhospitalized patients at high risk for thrombosis,” they conclude.

Dr. Piazza reported grants from Bayer, Bristol Myers Squibb, Boston Scientific, Janssen, and Portola, and personal fees from Agile, Amgen, Pfizer, and the Prairie Education and Research Cooperative outside the submitted work. Dr. Morrow reported grants from Abbott Laboratories, Amgen, Anthos Therapeutics, Esai, GlaxoSmithKline, Takeda, and The Medicines Company; grants and personal fees from AstraZeneca, Merck, Novartis, and Roche Diagnostics; and personal fees from Bayer Pharma and InCarda outside the submitted work.

A version of this article originally appeared on Medscape.com.

The risk of arterial and venous thrombosis in patients with COVID-19 has been a major issue throughout the pandemic, and how best to manage this risk is the subject of a new review article.

The article, by Gregory Dr. Piazza, MD, and David A. Morrow, MD, Brigham and Women’s Hospital, Boston, was published online in JAMA on Nov. 23.

“Basically we’re saying: ‘Be proactive about prevention,’” Dr. Piazza told this news organization.

There is growing recognition among those on the frontline that there is an increased risk of thrombosis in COVID-19 patients, Dr. Piazza said. The risk is highest in patients in the intensive care unit, but the risk is also increased in patients hospitalized with COVID-19, even those not in ICU.

“We don’t really know what the risk is in nonhospitalized COVID-19 patients, but we think it’s much lower than in those who are hospitalized,” he said. “We are waiting for data on the optimal way of managing this increased risk of thrombosis in COVID patients, but for the time being, we believe a systematic way of addressing this risk is best, with every patient hospitalized with COVID-19 receiving some type of thromboprophylaxis. This would mainly be with anticoagulation, but in patients in whom anticoagulation is contraindicated, then mechanical methods could be used, such as pneumatic compression boots or compression stockings.”

The authors report thrombotic complication rates of 2.6% in noncritically ill hospitalized patients with COVID-19 and 35.3% in critically ill patients from a recent U.S. registry study.

Autopsy findings of microthrombi in multiple organ systems, including the lungs, heart, and kidneys, suggest that thrombosis may contribute to multisystem organ dysfunction in severe COVID-19, they note. Although the pathophysiology is not fully defined, prothrombotic abnormalities have been identified in patients with COVID-19, including elevated levels of D-dimer, fibrinogen, and factor VIII, they add.

“There are several major questions about which COVID-19 patients to treat with thromboprophylaxis, how to treat them in term of levels of anticoagulation, and there are many ongoing clinical trials to try and answer these questions,” Dr. Piazza commented. “We need results from these randomized trials to provide a better compass for COVID-19 patients at risk of clotting.”

At present, clinicians can follow two different sets of guidelines on the issue, one from the American College of Chest Physicians and the other from the International Society on Thrombosis and Hemostasis, the authors note.

“The ACCP guidelines are very conservative and basically follow the evidence base for medical patients, while the ISTH guidelines are more aggressive and recommend increased levels of anticoagulation in both ICU and hospitalized non-ICU patients and also extend prophylaxis after discharge,” Dr. Piazza said.

“There is quite a difference between the two sets of guidelines, which can be a point of confusion,” he added.

Dr. Piazza notes that at his center every hospitalized COVID patient who does not have a contraindication to anticoagulation receives a standard prophylactic dose of a once-daily low-molecular-weight heparin (for example, enoxaparin 40 mg). A once-daily product is used to minimize infection risk to staff.

While all COVID patients in the ICU should automatically receive some anticoagulation, the optimal dose is an area of active investigation, he explained. “There were several early reports of ICU patients developing blood clots despite receiving standard thromboprophylaxis so perhaps we need to use higher doses. There are trials underway looking at this, and we would advise enrolling patients into these trials.”

If patients can’t be enrolled into trials, and clinicians feel higher anticoagulation levels are needed, Dr. Piazza advises following the ISTH guidance, which allows an intermediate dose of low-molecular-weight heparin (up to 1 mg/kg enoxaparin).

“Some experts are suggesting even higher doses may be needed in some ICU patients, such as the full therapeutic dose, but I worry about the risk of bleeding with such a strategy,” he said.

Dr. Piazza says they do not routinely give anticoagulation after discharge, but if this is desired then patients could be switched to an oral agent, and some of the direct-acting oral anticoagulants are approved for prophylactic use in medically ill patients.

Dr. Piazza points out that whether thromboprophylaxis should be used for nonhospitalized COVID patients who have risk factors for clotting such as a prior history of thrombosis or obesity is a pressing question, and he encourages clinicians to enroll these patients in clinical trials evaluating this issue, such as the PREVENT-HD trial.

“If they can’t enroll patents in a trial, then they have to make a decision whether the patient is high-enough risk to justify off-label use of anticoagulant. There is a case to be made for this, but there is no evidence for or against such action at present,” he noted.

At this time, neither the ISTH nor ACCP recommend measuring D-dimer to screen for venous thromboembolism or to determine intensity of prophylaxis or treatment, the authors note.

“Ongoing investigation will determine optimal preventive regimens in COVID-19 in the intensive care unit, at hospital discharge, and in nonhospitalized patients at high risk for thrombosis,” they conclude.

Dr. Piazza reported grants from Bayer, Bristol Myers Squibb, Boston Scientific, Janssen, and Portola, and personal fees from Agile, Amgen, Pfizer, and the Prairie Education and Research Cooperative outside the submitted work. Dr. Morrow reported grants from Abbott Laboratories, Amgen, Anthos Therapeutics, Esai, GlaxoSmithKline, Takeda, and The Medicines Company; grants and personal fees from AstraZeneca, Merck, Novartis, and Roche Diagnostics; and personal fees from Bayer Pharma and InCarda outside the submitted work.

A version of this article originally appeared on Medscape.com.

Patients with hematologic disease who develop COVID-19 may experience substantial morbidity and mortality related to SARS-CoV-2 infection, according to recent registry data reported at the all-virtual annual meeting of the American Society of Hematology.

Overall mortality was 28% for the first 250 patients entered into the ASH Research Collaborative COVID-19 Registry for Hematology, researchers reported in an abstract of their study findings.

However, the burden of death and moderate-to-severe COVID-19 outcomes was highest in patients with poorer prognosis and those with relapsed/refractory hematological disease, they added.

The most commonly represented malignancies were acute leukemia, non-Hodgkin lymphoma, and myeloma or amyloidosis, according to the report.

Taken together, the findings do support an “emerging consensus” that COVID-19 related morbidity and mortality is significant in these patients, authors said – however, the current findings may not be reason enough to support a change in treatment course for the underlying disease.

“We see no reason, based on our data, to withhold intensive therapies from patients with underlying hematologic malignancies and favorable prognoses, if aggressive supportive care is consistent with patient preferences,” wrote the researchers.

ASH President Stephanie Lee, MD, MPH, said these registry findings are important to better understand how SARS-CoV-2 is affecting not only patients with hematologic diseases, but also individuals who experience COVID-19-related hematologic complications.

However, the findings are limited due to the heterogeneity of diseases, symptoms, and treatments represented in the registry, said Dr. Lee, associate director of the clinical research division at Fred Hutchinson Cancer Center in Seattle.

“More data will be coming in, but I think this is an example of trying to harness real-world information to try to learn things until we get more controlled studies,” Dr. Lee said in a media briefing held in advance of the ASH meeting.
 

Comorbidities and more

Patients with blood cancers are often older and may have comorbidities such as diabetes or hypertension that have been linked to poor COVID-19 outcomes, according to the authors of the report, led by William A. Wood, MD, MPH, associate professor of medicine with the UNC Lineberger Comprehensive Cancer Center in Chapel Hill, N.C.

Moreover, these patients may have underlying immune dysfunction and may receive chemotherapy or immunotherapy that is “profoundly immunosuppressive,” Dr. Wood and coauthors said in their report.

To date, however, risks of morbidity and mortality related to SARS-CoV-2 infection have not been well defined in this patient population, authors said.

More data is emerging now from the ASH Research Collaborative COVID-19 Registry for Hematology, which includes data on patients positive for COVID-19 who have a past or present hematologic condition or have experienced a hematologic complication related to COVID-19.

All data from the registry is being made available through a dashboard on the ASH Research Collaborative website, which as of Dec. 1, 2020, included 693 complete cases.

The data cut in the ASH abstract includes the first 250 patients enrolled at 74 sites around the world, the authors said. The most common malignancies included acute leukemia in 33%, non-Hodgkin lymphoma in 27%, and myeloma or amyloidosis in 16%.

The most frequently reported symptoms included fever in 73%, cough in 67%, dyspnea in 50%, and fatigue in 40%, according to that report.

At the time of this data snapshot, treatment with COVID-19-directed therapies including hydroxychloroquine or azithromycin were common, reported in 76 and 59 patients, respectively, in the cohort.

Batch submissions from sites with high incidence of COVID-19 infection are ongoing. The registry has been expanded to include nonmalignant hematologic diseases, and the registry will continue to accumulate data as a resource for the hematology community.

Overall mortality was 28% at the time, according to the abstract, with nearly all of the deaths occurring in patients classified as having COVID-19 that was moderate (i.e., requiring hospitalization) or severe (i.e., requiring ICU admission).

“In some instances, death occurred after a decision was made to forgo ICU admission in favor of a palliative approach,” said Dr. Wood and coauthors in their report.

Dr. Wood reported research funding from Pfizer, consultancy with Teladoc/Best Doctors, and honoraria from the ASH Research Collaborative. Coauthors provided disclosures related to Celgene, Madrigal Pharmaceuticals, Pharmacyclics, and Amgen, among others.

SOURCE: Wood WA et al. ASH 2020, Abstract 215.

Patients with hematologic disease who develop COVID-19 may experience substantial morbidity and mortality related to SARS-CoV-2 infection, according to recent registry data reported at the all-virtual annual meeting of the American Society of Hematology.

Overall mortality was 28% for the first 250 patients entered into the ASH Research Collaborative COVID-19 Registry for Hematology, researchers reported in an abstract of their study findings.

However, the burden of death and moderate-to-severe COVID-19 outcomes was highest in patients with poorer prognosis and those with relapsed/refractory hematological disease, they added.

The most commonly represented malignancies were acute leukemia, non-Hodgkin lymphoma, and myeloma or amyloidosis, according to the report.

Taken together, the findings do support an “emerging consensus” that COVID-19 related morbidity and mortality is significant in these patients, authors said – however, the current findings may not be reason enough to support a change in treatment course for the underlying disease.

“We see no reason, based on our data, to withhold intensive therapies from patients with underlying hematologic malignancies and favorable prognoses, if aggressive supportive care is consistent with patient preferences,” wrote the researchers.

ASH President Stephanie Lee, MD, MPH, said these registry findings are important to better understand how SARS-CoV-2 is affecting not only patients with hematologic diseases, but also individuals who experience COVID-19-related hematologic complications.

However, the findings are limited due to the heterogeneity of diseases, symptoms, and treatments represented in the registry, said Dr. Lee, associate director of the clinical research division at Fred Hutchinson Cancer Center in Seattle.

“More data will be coming in, but I think this is an example of trying to harness real-world information to try to learn things until we get more controlled studies,” Dr. Lee said in a media briefing held in advance of the ASH meeting.
 

Comorbidities and more

Patients with blood cancers are often older and may have comorbidities such as diabetes or hypertension that have been linked to poor COVID-19 outcomes, according to the authors of the report, led by William A. Wood, MD, MPH, associate professor of medicine with the UNC Lineberger Comprehensive Cancer Center in Chapel Hill, N.C.

Moreover, these patients may have underlying immune dysfunction and may receive chemotherapy or immunotherapy that is “profoundly immunosuppressive,” Dr. Wood and coauthors said in their report.

To date, however, risks of morbidity and mortality related to SARS-CoV-2 infection have not been well defined in this patient population, authors said.

More data is emerging now from the ASH Research Collaborative COVID-19 Registry for Hematology, which includes data on patients positive for COVID-19 who have a past or present hematologic condition or have experienced a hematologic complication related to COVID-19.

All data from the registry is being made available through a dashboard on the ASH Research Collaborative website, which as of Dec. 1, 2020, included 693 complete cases.

The data cut in the ASH abstract includes the first 250 patients enrolled at 74 sites around the world, the authors said. The most common malignancies included acute leukemia in 33%, non-Hodgkin lymphoma in 27%, and myeloma or amyloidosis in 16%.

The most frequently reported symptoms included fever in 73%, cough in 67%, dyspnea in 50%, and fatigue in 40%, according to that report.

At the time of this data snapshot, treatment with COVID-19-directed therapies including hydroxychloroquine or azithromycin were common, reported in 76 and 59 patients, respectively, in the cohort.

Batch submissions from sites with high incidence of COVID-19 infection are ongoing. The registry has been expanded to include nonmalignant hematologic diseases, and the registry will continue to accumulate data as a resource for the hematology community.

Overall mortality was 28% at the time, according to the abstract, with nearly all of the deaths occurring in patients classified as having COVID-19 that was moderate (i.e., requiring hospitalization) or severe (i.e., requiring ICU admission).

“In some instances, death occurred after a decision was made to forgo ICU admission in favor of a palliative approach,” said Dr. Wood and coauthors in their report.

Dr. Wood reported research funding from Pfizer, consultancy with Teladoc/Best Doctors, and honoraria from the ASH Research Collaborative. Coauthors provided disclosures related to Celgene, Madrigal Pharmaceuticals, Pharmacyclics, and Amgen, among others.

SOURCE: Wood WA et al. ASH 2020, Abstract 215.

Patients with hematologic disease who develop COVID-19 may experience substantial morbidity and mortality related to SARS-CoV-2 infection, according to recent registry data reported at the all-virtual annual meeting of the American Society of Hematology.

Overall mortality was 28% for the first 250 patients entered into the ASH Research Collaborative COVID-19 Registry for Hematology, researchers reported in an abstract of their study findings.

However, the burden of death and moderate-to-severe COVID-19 outcomes was highest in patients with poorer prognosis and those with relapsed/refractory hematological disease, they added.

The most commonly represented malignancies were acute leukemia, non-Hodgkin lymphoma, and myeloma or amyloidosis, according to the report.

Taken together, the findings do support an “emerging consensus” that COVID-19 related morbidity and mortality is significant in these patients, authors said – however, the current findings may not be reason enough to support a change in treatment course for the underlying disease.

“We see no reason, based on our data, to withhold intensive therapies from patients with underlying hematologic malignancies and favorable prognoses, if aggressive supportive care is consistent with patient preferences,” wrote the researchers.

ASH President Stephanie Lee, MD, MPH, said these registry findings are important to better understand how SARS-CoV-2 is affecting not only patients with hematologic diseases, but also individuals who experience COVID-19-related hematologic complications.

However, the findings are limited due to the heterogeneity of diseases, symptoms, and treatments represented in the registry, said Dr. Lee, associate director of the clinical research division at Fred Hutchinson Cancer Center in Seattle.

“More data will be coming in, but I think this is an example of trying to harness real-world information to try to learn things until we get more controlled studies,” Dr. Lee said in a media briefing held in advance of the ASH meeting.
 

Comorbidities and more

Patients with blood cancers are often older and may have comorbidities such as diabetes or hypertension that have been linked to poor COVID-19 outcomes, according to the authors of the report, led by William A. Wood, MD, MPH, associate professor of medicine with the UNC Lineberger Comprehensive Cancer Center in Chapel Hill, N.C.

Moreover, these patients may have underlying immune dysfunction and may receive chemotherapy or immunotherapy that is “profoundly immunosuppressive,” Dr. Wood and coauthors said in their report.

To date, however, risks of morbidity and mortality related to SARS-CoV-2 infection have not been well defined in this patient population, authors said.

More data is emerging now from the ASH Research Collaborative COVID-19 Registry for Hematology, which includes data on patients positive for COVID-19 who have a past or present hematologic condition or have experienced a hematologic complication related to COVID-19.

All data from the registry is being made available through a dashboard on the ASH Research Collaborative website, which as of Dec. 1, 2020, included 693 complete cases.

The data cut in the ASH abstract includes the first 250 patients enrolled at 74 sites around the world, the authors said. The most common malignancies included acute leukemia in 33%, non-Hodgkin lymphoma in 27%, and myeloma or amyloidosis in 16%.

The most frequently reported symptoms included fever in 73%, cough in 67%, dyspnea in 50%, and fatigue in 40%, according to that report.

At the time of this data snapshot, treatment with COVID-19-directed therapies including hydroxychloroquine or azithromycin were common, reported in 76 and 59 patients, respectively, in the cohort.

Batch submissions from sites with high incidence of COVID-19 infection are ongoing. The registry has been expanded to include nonmalignant hematologic diseases, and the registry will continue to accumulate data as a resource for the hematology community.

Overall mortality was 28% at the time, according to the abstract, with nearly all of the deaths occurring in patients classified as having COVID-19 that was moderate (i.e., requiring hospitalization) or severe (i.e., requiring ICU admission).

“In some instances, death occurred after a decision was made to forgo ICU admission in favor of a palliative approach,” said Dr. Wood and coauthors in their report.

Dr. Wood reported research funding from Pfizer, consultancy with Teladoc/Best Doctors, and honoraria from the ASH Research Collaborative. Coauthors provided disclosures related to Celgene, Madrigal Pharmaceuticals, Pharmacyclics, and Amgen, among others.

SOURCE: Wood WA et al. ASH 2020, Abstract 215.

Immune checkpoint inhibitor (ICI) therapy does not increase the risk of developing or dying from COVID-19, according to a pair of studies presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

Cytokine storm plays a major role in the pathogenesis of COVID-19, according to research published in The Lancet Respiratory Medicine. This has generated concern about using ICIs during the pandemic, given their immunostimulatory activity and the risk of immune-related adverse effects.

However, two retrospective studies suggest ICIs do not increase the risk of developing COVID-19 or dying from the disease.

In a study of 1,545 cancer patients prescribed ICIs and 20,418 matched controls, the incidence of COVID-19 was 1.4% with ICI therapy and 1.0% without it (odds ratio, 1.38; P = .15).

In a case-control study of 50 patients with cancer and COVID-19, 28% of patients who had received ICIs died from COVID-19, compared with 36% of patients who had not received ICIs (OR, 0.36; P = .23).

Vartan Pahalyants and Kevin Tyan, both students in Harvard University’s joint MD/MBA program in Boston, presented these studies at the meeting.
 

COVID-19 incidence with ICIs

Mr. Pahalyants and colleagues analyzed data from cancer patients treated in the Mass General Brigham health care system. The researchers compared 1,545 patients with at least one ICI prescription between July 1, 2019, and Feb. 29, 2020, with 20,418 matched cancer patients not prescribed ICIs. The team assessed COVID-19 incidence based on positive test results through June 19, 2020, from public health data.

The incidence of COVID-19 was low in both groups – 1.4% in the ICI group and 1.0% in the matched control group (P = .16). Among COVID-19–positive patients, the all-cause death rate was 40.9% in the ICI group and 28.6% in the control group (P = .23).

In multivariate analysis, patients prescribed ICIs did not have a significantly elevated risk for COVID-19 relative to peers not prescribed ICIs (OR, 1.38; P = .15). However, risk was significantly increased for female patients (OR, 1.74; P < .001), those living in a town or county with higher COVID-19 positivity rate (OR, 1.59; P < .001), and those with severe comorbidity (vs. mild or moderate; OR, 9.77; P = .02).

Among COVID-19–positive patients, those prescribed ICIs did not have a significantly elevated risk for all-cause mortality (OR, 1.60; P = .71), but male sex and lower income were associated with an increased risk of death.

“We did not identify an increased risk of [COVID-19] diagnosis among patients prescribed ICIs compared to the controls,” Mr. Pahalyants said. “This information may assist patients and their providers in decision-making around continuation of therapy during this protracted pandemic. However, more research needs to be conducted to determine potential behavioral and testing factors that may have affected COVID-19 diagnosis susceptibility among patients included in the study.”

COVID-19 mortality with ICIs

For their study, Mr. Tyan and colleagues identified 25 cancer patients who had received ICIs in the year before a COVID-19 diagnosis between March 20, 2020, and June 3, 2020, at the Dana-Farber Cancer Institute and Mass General Brigham network. The researchers then matched each patient with a cancer patient having a COVID-19 diagnosis who had not received ICIs during the preceding year.

Overall, 28% of patients who had received ICIs before their COVID-19 diagnosis died from COVID-19, compared with 36% of those who had not received ICIs.

In multivariate analysis, ICI therapy did not predict COVID-19 mortality (OR, 0.36; P = .23). However, the risk of death from COVID-19 increased with age (OR, 1.14; P = .01) and for patients with chronic obstructive pulmonary disease (OR, 12.26; P = .01), and risk was lower for statin users (OR, 0.08; P = .02). Findings were similar in an analysis restricted to hospitalized patients in the ICI group and their matched controls.

Two ICI-treated patients with COVID-19 had persistent immune-related adverse events (hypophysitis in both cases), and one ICI-treated patient developed a new immune-related adverse event (hypothyroidism).

At COVID-19 presentation, relative to counterparts who had not received ICIs, patients who had received ICIs had higher platelet counts (P = .017) and higher D-dimer levels (P = .037). In the context of similar levels of other biomarkers, this finding is “of unclear significance, as all deaths in the cohort were due to respiratory failure as opposed to hypercoagulability,” Mr. Tyan said.

The patients treated with ICIs were more likely to die from COVID-19 if they had elevated troponin levels (P = .01), whereas no such association was seen for those not treated with ICIs.

“We found that ICI therapy is not associated with greater risk for COVID-19 mortality. Our period of follow-up was relatively short, but we did not observe a high incidence of new or persistent immune-related adverse events among our patients taking ICIs,” Mr. Tyan said.

“While larger prospective trials are needed to evaluate long-term safety in the context of COVID-19 infection, our findings support the continuation of ICI therapy during the pandemic as it does not appear to worsen outcomes for cancer patients,” he concluded.
 

ICI therapy can continue, with precautions

“The question of susceptibility to COVID-19 has been unclear as ICIs do not necessarily cause immunosuppression but certainly result in modulation of a patient’s immune system,” said Deborah Doroshow, MD, PhD, assistant professor at the Tisch Cancer Institute Icahn School of Medicine at Mount Sinai, New York. She was not involved in these studies.

“The findings of the study by Pahalyants and colleagues, which used a very large sample size, appear to convincingly demonstrate that ICI receipt is not associated with an increased susceptibility to COVID-19,” Dr. Doroshow said in an interview.

SOURCE: Pahalyants V et al. SITC 2020, Abstract 826. Tyan K et al. SITC 2020, Abstract 481.

Immune checkpoint inhibitor (ICI) therapy does not increase the risk of developing or dying from COVID-19, according to a pair of studies presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

Cytokine storm plays a major role in the pathogenesis of COVID-19, according to research published in The Lancet Respiratory Medicine. This has generated concern about using ICIs during the pandemic, given their immunostimulatory activity and the risk of immune-related adverse effects.

However, two retrospective studies suggest ICIs do not increase the risk of developing COVID-19 or dying from the disease.

In a study of 1,545 cancer patients prescribed ICIs and 20,418 matched controls, the incidence of COVID-19 was 1.4% with ICI therapy and 1.0% without it (odds ratio, 1.38; P = .15).

In a case-control study of 50 patients with cancer and COVID-19, 28% of patients who had received ICIs died from COVID-19, compared with 36% of patients who had not received ICIs (OR, 0.36; P = .23).

Vartan Pahalyants and Kevin Tyan, both students in Harvard University’s joint MD/MBA program in Boston, presented these studies at the meeting.
 

COVID-19 incidence with ICIs

Mr. Pahalyants and colleagues analyzed data from cancer patients treated in the Mass General Brigham health care system. The researchers compared 1,545 patients with at least one ICI prescription between July 1, 2019, and Feb. 29, 2020, with 20,418 matched cancer patients not prescribed ICIs. The team assessed COVID-19 incidence based on positive test results through June 19, 2020, from public health data.

The incidence of COVID-19 was low in both groups – 1.4% in the ICI group and 1.0% in the matched control group (P = .16). Among COVID-19–positive patients, the all-cause death rate was 40.9% in the ICI group and 28.6% in the control group (P = .23).

In multivariate analysis, patients prescribed ICIs did not have a significantly elevated risk for COVID-19 relative to peers not prescribed ICIs (OR, 1.38; P = .15). However, risk was significantly increased for female patients (OR, 1.74; P < .001), those living in a town or county with higher COVID-19 positivity rate (OR, 1.59; P < .001), and those with severe comorbidity (vs. mild or moderate; OR, 9.77; P = .02).

Among COVID-19–positive patients, those prescribed ICIs did not have a significantly elevated risk for all-cause mortality (OR, 1.60; P = .71), but male sex and lower income were associated with an increased risk of death.

“We did not identify an increased risk of [COVID-19] diagnosis among patients prescribed ICIs compared to the controls,” Mr. Pahalyants said. “This information may assist patients and their providers in decision-making around continuation of therapy during this protracted pandemic. However, more research needs to be conducted to determine potential behavioral and testing factors that may have affected COVID-19 diagnosis susceptibility among patients included in the study.”

COVID-19 mortality with ICIs

For their study, Mr. Tyan and colleagues identified 25 cancer patients who had received ICIs in the year before a COVID-19 diagnosis between March 20, 2020, and June 3, 2020, at the Dana-Farber Cancer Institute and Mass General Brigham network. The researchers then matched each patient with a cancer patient having a COVID-19 diagnosis who had not received ICIs during the preceding year.

Overall, 28% of patients who had received ICIs before their COVID-19 diagnosis died from COVID-19, compared with 36% of those who had not received ICIs.

In multivariate analysis, ICI therapy did not predict COVID-19 mortality (OR, 0.36; P = .23). However, the risk of death from COVID-19 increased with age (OR, 1.14; P = .01) and for patients with chronic obstructive pulmonary disease (OR, 12.26; P = .01), and risk was lower for statin users (OR, 0.08; P = .02). Findings were similar in an analysis restricted to hospitalized patients in the ICI group and their matched controls.

Two ICI-treated patients with COVID-19 had persistent immune-related adverse events (hypophysitis in both cases), and one ICI-treated patient developed a new immune-related adverse event (hypothyroidism).

At COVID-19 presentation, relative to counterparts who had not received ICIs, patients who had received ICIs had higher platelet counts (P = .017) and higher D-dimer levels (P = .037). In the context of similar levels of other biomarkers, this finding is “of unclear significance, as all deaths in the cohort were due to respiratory failure as opposed to hypercoagulability,” Mr. Tyan said.

The patients treated with ICIs were more likely to die from COVID-19 if they had elevated troponin levels (P = .01), whereas no such association was seen for those not treated with ICIs.

“We found that ICI therapy is not associated with greater risk for COVID-19 mortality. Our period of follow-up was relatively short, but we did not observe a high incidence of new or persistent immune-related adverse events among our patients taking ICIs,” Mr. Tyan said.

“While larger prospective trials are needed to evaluate long-term safety in the context of COVID-19 infection, our findings support the continuation of ICI therapy during the pandemic as it does not appear to worsen outcomes for cancer patients,” he concluded.
 

ICI therapy can continue, with precautions

“The question of susceptibility to COVID-19 has been unclear as ICIs do not necessarily cause immunosuppression but certainly result in modulation of a patient’s immune system,” said Deborah Doroshow, MD, PhD, assistant professor at the Tisch Cancer Institute Icahn School of Medicine at Mount Sinai, New York. She was not involved in these studies.

“The findings of the study by Pahalyants and colleagues, which used a very large sample size, appear to convincingly demonstrate that ICI receipt is not associated with an increased susceptibility to COVID-19,” Dr. Doroshow said in an interview.

SOURCE: Pahalyants V et al. SITC 2020, Abstract 826. Tyan K et al. SITC 2020, Abstract 481.

Immune checkpoint inhibitor (ICI) therapy does not increase the risk of developing or dying from COVID-19, according to a pair of studies presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

Cytokine storm plays a major role in the pathogenesis of COVID-19, according to research published in The Lancet Respiratory Medicine. This has generated concern about using ICIs during the pandemic, given their immunostimulatory activity and the risk of immune-related adverse effects.

However, two retrospective studies suggest ICIs do not increase the risk of developing COVID-19 or dying from the disease.

In a study of 1,545 cancer patients prescribed ICIs and 20,418 matched controls, the incidence of COVID-19 was 1.4% with ICI therapy and 1.0% without it (odds ratio, 1.38; P = .15).

In a case-control study of 50 patients with cancer and COVID-19, 28% of patients who had received ICIs died from COVID-19, compared with 36% of patients who had not received ICIs (OR, 0.36; P = .23).

Vartan Pahalyants and Kevin Tyan, both students in Harvard University’s joint MD/MBA program in Boston, presented these studies at the meeting.
 

COVID-19 incidence with ICIs

Mr. Pahalyants and colleagues analyzed data from cancer patients treated in the Mass General Brigham health care system. The researchers compared 1,545 patients with at least one ICI prescription between July 1, 2019, and Feb. 29, 2020, with 20,418 matched cancer patients not prescribed ICIs. The team assessed COVID-19 incidence based on positive test results through June 19, 2020, from public health data.

The incidence of COVID-19 was low in both groups – 1.4% in the ICI group and 1.0% in the matched control group (P = .16). Among COVID-19–positive patients, the all-cause death rate was 40.9% in the ICI group and 28.6% in the control group (P = .23).

In multivariate analysis, patients prescribed ICIs did not have a significantly elevated risk for COVID-19 relative to peers not prescribed ICIs (OR, 1.38; P = .15). However, risk was significantly increased for female patients (OR, 1.74; P < .001), those living in a town or county with higher COVID-19 positivity rate (OR, 1.59; P < .001), and those with severe comorbidity (vs. mild or moderate; OR, 9.77; P = .02).

Among COVID-19–positive patients, those prescribed ICIs did not have a significantly elevated risk for all-cause mortality (OR, 1.60; P = .71), but male sex and lower income were associated with an increased risk of death.

“We did not identify an increased risk of [COVID-19] diagnosis among patients prescribed ICIs compared to the controls,” Mr. Pahalyants said. “This information may assist patients and their providers in decision-making around continuation of therapy during this protracted pandemic. However, more research needs to be conducted to determine potential behavioral and testing factors that may have affected COVID-19 diagnosis susceptibility among patients included in the study.”

COVID-19 mortality with ICIs

For their study, Mr. Tyan and colleagues identified 25 cancer patients who had received ICIs in the year before a COVID-19 diagnosis between March 20, 2020, and June 3, 2020, at the Dana-Farber Cancer Institute and Mass General Brigham network. The researchers then matched each patient with a cancer patient having a COVID-19 diagnosis who had not received ICIs during the preceding year.

Overall, 28% of patients who had received ICIs before their COVID-19 diagnosis died from COVID-19, compared with 36% of those who had not received ICIs.

In multivariate analysis, ICI therapy did not predict COVID-19 mortality (OR, 0.36; P = .23). However, the risk of death from COVID-19 increased with age (OR, 1.14; P = .01) and for patients with chronic obstructive pulmonary disease (OR, 12.26; P = .01), and risk was lower for statin users (OR, 0.08; P = .02). Findings were similar in an analysis restricted to hospitalized patients in the ICI group and their matched controls.

Two ICI-treated patients with COVID-19 had persistent immune-related adverse events (hypophysitis in both cases), and one ICI-treated patient developed a new immune-related adverse event (hypothyroidism).

At COVID-19 presentation, relative to counterparts who had not received ICIs, patients who had received ICIs had higher platelet counts (P = .017) and higher D-dimer levels (P = .037). In the context of similar levels of other biomarkers, this finding is “of unclear significance, as all deaths in the cohort were due to respiratory failure as opposed to hypercoagulability,” Mr. Tyan said.

The patients treated with ICIs were more likely to die from COVID-19 if they had elevated troponin levels (P = .01), whereas no such association was seen for those not treated with ICIs.

“We found that ICI therapy is not associated with greater risk for COVID-19 mortality. Our period of follow-up was relatively short, but we did not observe a high incidence of new or persistent immune-related adverse events among our patients taking ICIs,” Mr. Tyan said.

“While larger prospective trials are needed to evaluate long-term safety in the context of COVID-19 infection, our findings support the continuation of ICI therapy during the pandemic as it does not appear to worsen outcomes for cancer patients,” he concluded.
 

ICI therapy can continue, with precautions

“The question of susceptibility to COVID-19 has been unclear as ICIs do not necessarily cause immunosuppression but certainly result in modulation of a patient’s immune system,” said Deborah Doroshow, MD, PhD, assistant professor at the Tisch Cancer Institute Icahn School of Medicine at Mount Sinai, New York. She was not involved in these studies.

“The findings of the study by Pahalyants and colleagues, which used a very large sample size, appear to convincingly demonstrate that ICI receipt is not associated with an increased susceptibility to COVID-19,” Dr. Doroshow said in an interview.

SOURCE: Pahalyants V et al. SITC 2020, Abstract 826. Tyan K et al. SITC 2020, Abstract 481.

Can receiving all posttransplant care at home improve outcomes for patients undergoing hematopoietic stem cell transplant (HSCT)? Researchers are conducting phase 2 trials to find out.

Anthony D. Sung, MD, of Duke University, Durham, N.C., described this research to David H. Henry, MD, of Penn Medicine in Philadelphia, host of the Blood & Cancer podcast.

On the Nov. 12 episode of Blood & Cancer, Dr. Sung outlined the process of receiving post-HSCT care at home and discussed Duke’s clinical trials assessing the impact of home care on costs, quality of life, the microbiome, graft-versus-host disease (GVHD), and other outcomes. The following transcript of that discussion has been edited for length and clarity.
 

David Henry, MD: Welcome to this podcast. We’re delighted to have you listening today because we’re going to be speaking with Dr. Anthony Sung from Duke University, where he is assistant professor of medicine in the division of hematologic malignancies and cellular therapies.

So let’s get right into it. I’m a generalist at Pennsylvania Hospital in Philadelphia, where we do auto [autologous] transplants at the main university hospital, autos and allos [allogeneic], and these patients are in [hospital] anywhere from a little bit to a long time. And I’ve often thought to try and do some of this as outpatient. But I think you have a project, which I’m going to ask you to describe, where you try and do most [treatment] outpatient. So tell me what this project is all about, and we’ll skip through how it works.
 

Anthony Sung, MD: Absolutely. So this is focused on both autologous as well as allogeneic stem cell transplant patients at Duke and a few other centers around the country. Duke University has actually had a long history of an outpatient transplant program. This program is based in a day hospital, which is basically like a high-functioning clinic that’s open 7 days a week. Patients can come into the hospital and receive blood transfusions, IV infusions, and any other therapies that they would need as part of their stem cell transplant treatment in the outpatient setting, returning to their home or to a furnished apartment, temporary lodging, while they’re receiving their care.

What we have done, however, is to take this a step further and deliver care within the patient’s own home. In a sense, we’re returning to an older form of medicine where doctors would make house calls. Within our home-transplant program, instead of the patients having to be in the hospital or instead of having to come back and forth to the outpatient hospital every day, which places additional stresses and strains upon them, our providers will make house calls to the patient’s homes, will draw their labs right there, do a history and physical exam, assess and attend to any of the needs that they have.

Then in the afternoon, the providers will return, have the labs run in the hospital, as they would normally do, a CBC, CMP [comprehensive metabolic panel], and so forth. And then a nurse would return to the patient’s home if needed to deliver any interventions, such as blood transfusions, intravenous fluids, or electrolytes, right there in the comfort of the patient’s own home.
 

Dr. Henry: So let’s then take it through what happens. Say I am a patient with myeloma. I’ve had various therapies, and it’s time for me to get an autotransplant, let’s say. And so I need to do a couple of things. I need to get my stem cells collected. I need to then get my high-dose [conditioning] therapy, and then follows the stem cell therapy reinfusion. So can you take me through each step? Where is that done?

Dr. Sung: Absolutely. So the collection will occur in the outpatient setting, typically after mobilization with G-CSF [granulocyte colony–stimulating factor] and/or plerixafor. That will occur in our outpatient clinic with one of our leukapheresis machines. And the patient will then return to that same outpatient clinic, which is the same building, the same facility as the hospital, to receive melphalan conditioning. And then, following conditioning, about 24 hours after, day 0, that’s the day of their stem cell transplant infusion, which we do in the hospital setting just because of the potential for reactions associated with that.

But everything after that, from day 1 onwards, we try to keep them at home. And as I said, they will stay in their home. One of our nurse practitioners or physician assistants will visit them in the morning, do the assessment and draw the labs. And nurses will return in the afternoon to deliver any supportive care that they need.
 

Dr. Henry: So let’s define “home.” So I’m a Philadelphia resident and I say to you, Dr. Sung, I want to go home. You say, well, Philadelphia is too far. What is close enough and not too far, when you say home?

Dr. Sung: Absolutely. So when we originally conceived the program, we focused on patients who lived within an hour of our transplant center. And in part, that was because, as you know, unfortunately, things can sometimes go wrong during transplant. One of the most concerning ones is infections. And if a patient were to develop a neutropenic fever, we would want them to be seen as urgently as possible within an hour. And that’s where our limitation comes from.

So for our patients who live more than an hour away, those are the ones that we will have relocate to temporary lodging near our transplant center. And we’ve worked with several facilities in the area that have clean, furnished units that are available for rent. Many insurances also include lodging benefits for patients during stem cell transplant, recognizing this need. And historically, those [patients] were not considered part of our transplant patient cohorts.

I have not mentioned, but we initially did this in a phase 1 study, and we’re now studying it in a series of randomized, phase 2 studies that I can go into detail later on. And because they were not necessarily in their home, but a temporary lodging environment, those patients who relocated to Durham were not eligible for a home transplant study.

However, in the setting of the COVID-19 pandemic, we’ve actually pivoted our program in many ways. Specifically, if you think about a patient who’s coming into contact with the medical system, they come to the hospital, they meet someone at the door who is screening them for COVID-19. They see someone who checks them in at the front desk. A medical assistant takes them in the back. Someone calls their labs and phlebotomy. They may encounter other patients and environmental services, other individuals in the setting. You’re talking about dozens of different encounters. Who knows how many surfaces that potentially someone with COVID-19 has coughed on or contaminated?

And in contrast, you have house calls, which even if they are located in the temporary lodging, that’s just one or two individuals going into their living environment. They’re not encountering any different surfaces. And so, in the setting of COVID-19, we felt that this platform had the potential to help protect all our transplant patients who are among the most vulnerable patients, the most immunocompromised patients, and so we expanded our program to include those individuals as well.
 

Dr. Henry: So ... what are the actual outcomes of your patients in terms of how they’re doing, engrafting, and getting cured of their malignancy?

Dr. Sung: So as I mentioned, we first did this in a phase 1 safety and feasibility pilot study of both autologous and allo-transplant patients. This was presented at the annual meeting of the American Society of Hematology [Blood. 2017;130:745]. And we’re actually about ready to submit our manuscript on this.

And we found no difference in outcomes between patients who received care in the home transplant setting versus those who received conventional care either in the day hospital or hospital environment. The process appeared safe. Patients did just as well, if not better. Certainly, anecdotally, patients would talk about feeling so much more comfortable and happier being cared for in that home environment.

And we are now in the process of formally studying these outcomes in two NIH [National Institutes of Health]-funded clinical trials, one focused on allogeneic transplant patients [NCT02218151] and the other focused on autologous transplant patients [NCT01725022].
 

Dr. Henry: So of course, I’m waiting for this next question, which is cost. The services are the same, but you have people traveling, people who are highly skilled caregivers. Have you looked at cost differences from hospital versus home?

Dr. Sung: Absolutely. So you do have increased upfront costs because you have travel time for advanced practice providers and nurses. Not only that, but when a nurse is helping to give a patient a blood transfusion in the home environment, they’re 1:1 with that patient as opposed to the day hospital where a nurse could help with transfusions simultaneously for multiple patients. At the same time, by keeping patients out of the hospital, you have drastic, significant cost savings in that way.

In addition, I should mention, part of why we’re conducting these randomized, phase 2 clinical trials is we believe home care actually has the potential to decrease complications. One area of my research is on the impact of the microbiome, the bacteria in the gut, on transplant outcomes. And we’ve done a number of studies, many in collaboration with Memorial Sloan Kettering, showing that disruption of the microbiota, the bacteria in the gut, is associated with increased infections, graft-versus-host disease, and treatment-related mortality if we’re able to keep patients in their home setting.

However, I actually should go back a step. It’s well known that, if you take an individual from their home setting and put them in a foreign environment such as the hospital, that new environment, that new diet, hospital food as opposed to home food, and so forth, can dramatically shift the microbiome. Our hypothesis is that, by keeping patients in the home environment, their familiar environment will be able to help preserve their microbiome, thus decreasing infections, graft-versus-host disease, and other complications. That’s actually the goal of our studies: to see if we can preserve the microbiome and decrease complications.
 

Dr. Henry: So how will you evaluate that? Are you doing fecal studies, patient culture studies? How are you testing that?

Dr. Sung: So we have a very broad biobank program where we collect stool on our transplantations, pretransplant, day 0, weekly for the first month. And then, in the case of our allogeneic transplant patients, day 60, 90, 180, and 365.

And we do that both in our home transplant patients as well as their matched controls on the phase 2 studies. And we also collect it on a lot of our other transplant patients as part of our biobanking programs and our observational studies to try to understand what’s going on during transplant and how to help improve transplant outcomes.
 

Dr. Henry: Do you have any results of that? You’re probably showing a difference.

Dr. Sung: We think so, on some preliminary results, but those were based on small numbers of patients. And we’re really hoping that these randomized clinical trials with the larger numbers of patients enrolled will help show that difference.

But getting back to your earlier question about cost, a case of graft-versus-host disease, grade 2 or higher, can add about $100,000 to the cost of care. So if you prevent one case of bad gut or liver graft-versus-host disease, those are your cost savings right there.

The randomized, phase 2 trial for allogeneic transplant patients, the primary endpoint is graft-versus-host disease. So we’re looking at the microbiome and those associations and the prevention of GVHD. For the randomized clinical trial in autologous transplant patients – with autologous stem cells, you’re not going to get GVHD – but we do hope to improve quality of life and long-term outcomes in those patients as well.
 

Dr. Henry: Wonderful. Well, Tony, I really want to thank you so much for talking with us today.

Dr. Sung: Thank you very much for this opportunity. And again, I also want to just thank everyone who’s been involved in these studies, the advanced practice providers and nurses who are caring for our patients at home, the study staff who have been involved. Particularly, I’d like to highlight the role of both Nelson Chao, who’s our division chief and my mentor who piloted and first developed home transplant, and Kristin Nichols, our research nurse who has really led the drive forward.

Dr. Sung and Dr. Henry have no relevant disclosures. The trials are funded by grants from the National Institutes of Health.

Can receiving all posttransplant care at home improve outcomes for patients undergoing hematopoietic stem cell transplant (HSCT)? Researchers are conducting phase 2 trials to find out.

Anthony D. Sung, MD, of Duke University, Durham, N.C., described this research to David H. Henry, MD, of Penn Medicine in Philadelphia, host of the Blood & Cancer podcast.

On the Nov. 12 episode of Blood & Cancer, Dr. Sung outlined the process of receiving post-HSCT care at home and discussed Duke’s clinical trials assessing the impact of home care on costs, quality of life, the microbiome, graft-versus-host disease (GVHD), and other outcomes. The following transcript of that discussion has been edited for length and clarity.
 

David Henry, MD: Welcome to this podcast. We’re delighted to have you listening today because we’re going to be speaking with Dr. Anthony Sung from Duke University, where he is assistant professor of medicine in the division of hematologic malignancies and cellular therapies.

So let’s get right into it. I’m a generalist at Pennsylvania Hospital in Philadelphia, where we do auto [autologous] transplants at the main university hospital, autos and allos [allogeneic], and these patients are in [hospital] anywhere from a little bit to a long time. And I’ve often thought to try and do some of this as outpatient. But I think you have a project, which I’m going to ask you to describe, where you try and do most [treatment] outpatient. So tell me what this project is all about, and we’ll skip through how it works.
 

Anthony Sung, MD: Absolutely. So this is focused on both autologous as well as allogeneic stem cell transplant patients at Duke and a few other centers around the country. Duke University has actually had a long history of an outpatient transplant program. This program is based in a day hospital, which is basically like a high-functioning clinic that’s open 7 days a week. Patients can come into the hospital and receive blood transfusions, IV infusions, and any other therapies that they would need as part of their stem cell transplant treatment in the outpatient setting, returning to their home or to a furnished apartment, temporary lodging, while they’re receiving their care.

What we have done, however, is to take this a step further and deliver care within the patient’s own home. In a sense, we’re returning to an older form of medicine where doctors would make house calls. Within our home-transplant program, instead of the patients having to be in the hospital or instead of having to come back and forth to the outpatient hospital every day, which places additional stresses and strains upon them, our providers will make house calls to the patient’s homes, will draw their labs right there, do a history and physical exam, assess and attend to any of the needs that they have.

Then in the afternoon, the providers will return, have the labs run in the hospital, as they would normally do, a CBC, CMP [comprehensive metabolic panel], and so forth. And then a nurse would return to the patient’s home if needed to deliver any interventions, such as blood transfusions, intravenous fluids, or electrolytes, right there in the comfort of the patient’s own home.
 

Dr. Henry: So let’s then take it through what happens. Say I am a patient with myeloma. I’ve had various therapies, and it’s time for me to get an autotransplant, let’s say. And so I need to do a couple of things. I need to get my stem cells collected. I need to then get my high-dose [conditioning] therapy, and then follows the stem cell therapy reinfusion. So can you take me through each step? Where is that done?

Dr. Sung: Absolutely. So the collection will occur in the outpatient setting, typically after mobilization with G-CSF [granulocyte colony–stimulating factor] and/or plerixafor. That will occur in our outpatient clinic with one of our leukapheresis machines. And the patient will then return to that same outpatient clinic, which is the same building, the same facility as the hospital, to receive melphalan conditioning. And then, following conditioning, about 24 hours after, day 0, that’s the day of their stem cell transplant infusion, which we do in the hospital setting just because of the potential for reactions associated with that.

But everything after that, from day 1 onwards, we try to keep them at home. And as I said, they will stay in their home. One of our nurse practitioners or physician assistants will visit them in the morning, do the assessment and draw the labs. And nurses will return in the afternoon to deliver any supportive care that they need.
 

Dr. Henry: So let’s define “home.” So I’m a Philadelphia resident and I say to you, Dr. Sung, I want to go home. You say, well, Philadelphia is too far. What is close enough and not too far, when you say home?

Dr. Sung: Absolutely. So when we originally conceived the program, we focused on patients who lived within an hour of our transplant center. And in part, that was because, as you know, unfortunately, things can sometimes go wrong during transplant. One of the most concerning ones is infections. And if a patient were to develop a neutropenic fever, we would want them to be seen as urgently as possible within an hour. And that’s where our limitation comes from.

So for our patients who live more than an hour away, those are the ones that we will have relocate to temporary lodging near our transplant center. And we’ve worked with several facilities in the area that have clean, furnished units that are available for rent. Many insurances also include lodging benefits for patients during stem cell transplant, recognizing this need. And historically, those [patients] were not considered part of our transplant patient cohorts.

I have not mentioned, but we initially did this in a phase 1 study, and we’re now studying it in a series of randomized, phase 2 studies that I can go into detail later on. And because they were not necessarily in their home, but a temporary lodging environment, those patients who relocated to Durham were not eligible for a home transplant study.

However, in the setting of the COVID-19 pandemic, we’ve actually pivoted our program in many ways. Specifically, if you think about a patient who’s coming into contact with the medical system, they come to the hospital, they meet someone at the door who is screening them for COVID-19. They see someone who checks them in at the front desk. A medical assistant takes them in the back. Someone calls their labs and phlebotomy. They may encounter other patients and environmental services, other individuals in the setting. You’re talking about dozens of different encounters. Who knows how many surfaces that potentially someone with COVID-19 has coughed on or contaminated?

And in contrast, you have house calls, which even if they are located in the temporary lodging, that’s just one or two individuals going into their living environment. They’re not encountering any different surfaces. And so, in the setting of COVID-19, we felt that this platform had the potential to help protect all our transplant patients who are among the most vulnerable patients, the most immunocompromised patients, and so we expanded our program to include those individuals as well.
 

Dr. Henry: So ... what are the actual outcomes of your patients in terms of how they’re doing, engrafting, and getting cured of their malignancy?

Dr. Sung: So as I mentioned, we first did this in a phase 1 safety and feasibility pilot study of both autologous and allo-transplant patients. This was presented at the annual meeting of the American Society of Hematology [Blood. 2017;130:745]. And we’re actually about ready to submit our manuscript on this.

And we found no difference in outcomes between patients who received care in the home transplant setting versus those who received conventional care either in the day hospital or hospital environment. The process appeared safe. Patients did just as well, if not better. Certainly, anecdotally, patients would talk about feeling so much more comfortable and happier being cared for in that home environment.

And we are now in the process of formally studying these outcomes in two NIH [National Institutes of Health]-funded clinical trials, one focused on allogeneic transplant patients [NCT02218151] and the other focused on autologous transplant patients [NCT01725022].
 

Dr. Henry: So of course, I’m waiting for this next question, which is cost. The services are the same, but you have people traveling, people who are highly skilled caregivers. Have you looked at cost differences from hospital versus home?

Dr. Sung: Absolutely. So you do have increased upfront costs because you have travel time for advanced practice providers and nurses. Not only that, but when a nurse is helping to give a patient a blood transfusion in the home environment, they’re 1:1 with that patient as opposed to the day hospital where a nurse could help with transfusions simultaneously for multiple patients. At the same time, by keeping patients out of the hospital, you have drastic, significant cost savings in that way.

In addition, I should mention, part of why we’re conducting these randomized, phase 2 clinical trials is we believe home care actually has the potential to decrease complications. One area of my research is on the impact of the microbiome, the bacteria in the gut, on transplant outcomes. And we’ve done a number of studies, many in collaboration with Memorial Sloan Kettering, showing that disruption of the microbiota, the bacteria in the gut, is associated with increased infections, graft-versus-host disease, and treatment-related mortality if we’re able to keep patients in their home setting.

However, I actually should go back a step. It’s well known that, if you take an individual from their home setting and put them in a foreign environment such as the hospital, that new environment, that new diet, hospital food as opposed to home food, and so forth, can dramatically shift the microbiome. Our hypothesis is that, by keeping patients in the home environment, their familiar environment will be able to help preserve their microbiome, thus decreasing infections, graft-versus-host disease, and other complications. That’s actually the goal of our studies: to see if we can preserve the microbiome and decrease complications.
 

Dr. Henry: So how will you evaluate that? Are you doing fecal studies, patient culture studies? How are you testing that?

Dr. Sung: So we have a very broad biobank program where we collect stool on our transplantations, pretransplant, day 0, weekly for the first month. And then, in the case of our allogeneic transplant patients, day 60, 90, 180, and 365.

And we do that both in our home transplant patients as well as their matched controls on the phase 2 studies. And we also collect it on a lot of our other transplant patients as part of our biobanking programs and our observational studies to try to understand what’s going on during transplant and how to help improve transplant outcomes.
 

Dr. Henry: Do you have any results of that? You’re probably showing a difference.

Dr. Sung: We think so, on some preliminary results, but those were based on small numbers of patients. And we’re really hoping that these randomized clinical trials with the larger numbers of patients enrolled will help show that difference.

But getting back to your earlier question about cost, a case of graft-versus-host disease, grade 2 or higher, can add about $100,000 to the cost of care. So if you prevent one case of bad gut or liver graft-versus-host disease, those are your cost savings right there.

The randomized, phase 2 trial for allogeneic transplant patients, the primary endpoint is graft-versus-host disease. So we’re looking at the microbiome and those associations and the prevention of GVHD. For the randomized clinical trial in autologous transplant patients – with autologous stem cells, you’re not going to get GVHD – but we do hope to improve quality of life and long-term outcomes in those patients as well.
 

Dr. Henry: Wonderful. Well, Tony, I really want to thank you so much for talking with us today.

Dr. Sung: Thank you very much for this opportunity. And again, I also want to just thank everyone who’s been involved in these studies, the advanced practice providers and nurses who are caring for our patients at home, the study staff who have been involved. Particularly, I’d like to highlight the role of both Nelson Chao, who’s our division chief and my mentor who piloted and first developed home transplant, and Kristin Nichols, our research nurse who has really led the drive forward.

Dr. Sung and Dr. Henry have no relevant disclosures. The trials are funded by grants from the National Institutes of Health.

Can receiving all posttransplant care at home improve outcomes for patients undergoing hematopoietic stem cell transplant (HSCT)? Researchers are conducting phase 2 trials to find out.

Anthony D. Sung, MD, of Duke University, Durham, N.C., described this research to David H. Henry, MD, of Penn Medicine in Philadelphia, host of the Blood & Cancer podcast.

On the Nov. 12 episode of Blood & Cancer, Dr. Sung outlined the process of receiving post-HSCT care at home and discussed Duke’s clinical trials assessing the impact of home care on costs, quality of life, the microbiome, graft-versus-host disease (GVHD), and other outcomes. The following transcript of that discussion has been edited for length and clarity.
 

David Henry, MD: Welcome to this podcast. We’re delighted to have you listening today because we’re going to be speaking with Dr. Anthony Sung from Duke University, where he is assistant professor of medicine in the division of hematologic malignancies and cellular therapies.

So let’s get right into it. I’m a generalist at Pennsylvania Hospital in Philadelphia, where we do auto [autologous] transplants at the main university hospital, autos and allos [allogeneic], and these patients are in [hospital] anywhere from a little bit to a long time. And I’ve often thought to try and do some of this as outpatient. But I think you have a project, which I’m going to ask you to describe, where you try and do most [treatment] outpatient. So tell me what this project is all about, and we’ll skip through how it works.
 

Anthony Sung, MD: Absolutely. So this is focused on both autologous as well as allogeneic stem cell transplant patients at Duke and a few other centers around the country. Duke University has actually had a long history of an outpatient transplant program. This program is based in a day hospital, which is basically like a high-functioning clinic that’s open 7 days a week. Patients can come into the hospital and receive blood transfusions, IV infusions, and any other therapies that they would need as part of their stem cell transplant treatment in the outpatient setting, returning to their home or to a furnished apartment, temporary lodging, while they’re receiving their care.

What we have done, however, is to take this a step further and deliver care within the patient’s own home. In a sense, we’re returning to an older form of medicine where doctors would make house calls. Within our home-transplant program, instead of the patients having to be in the hospital or instead of having to come back and forth to the outpatient hospital every day, which places additional stresses and strains upon them, our providers will make house calls to the patient’s homes, will draw their labs right there, do a history and physical exam, assess and attend to any of the needs that they have.

Then in the afternoon, the providers will return, have the labs run in the hospital, as they would normally do, a CBC, CMP [comprehensive metabolic panel], and so forth. And then a nurse would return to the patient’s home if needed to deliver any interventions, such as blood transfusions, intravenous fluids, or electrolytes, right there in the comfort of the patient’s own home.
 

Dr. Henry: So let’s then take it through what happens. Say I am a patient with myeloma. I’ve had various therapies, and it’s time for me to get an autotransplant, let’s say. And so I need to do a couple of things. I need to get my stem cells collected. I need to then get my high-dose [conditioning] therapy, and then follows the stem cell therapy reinfusion. So can you take me through each step? Where is that done?

Dr. Sung: Absolutely. So the collection will occur in the outpatient setting, typically after mobilization with G-CSF [granulocyte colony–stimulating factor] and/or plerixafor. That will occur in our outpatient clinic with one of our leukapheresis machines. And the patient will then return to that same outpatient clinic, which is the same building, the same facility as the hospital, to receive melphalan conditioning. And then, following conditioning, about 24 hours after, day 0, that’s the day of their stem cell transplant infusion, which we do in the hospital setting just because of the potential for reactions associated with that.

But everything after that, from day 1 onwards, we try to keep them at home. And as I said, they will stay in their home. One of our nurse practitioners or physician assistants will visit them in the morning, do the assessment and draw the labs. And nurses will return in the afternoon to deliver any supportive care that they need.
 

Dr. Henry: So let’s define “home.” So I’m a Philadelphia resident and I say to you, Dr. Sung, I want to go home. You say, well, Philadelphia is too far. What is close enough and not too far, when you say home?

Dr. Sung: Absolutely. So when we originally conceived the program, we focused on patients who lived within an hour of our transplant center. And in part, that was because, as you know, unfortunately, things can sometimes go wrong during transplant. One of the most concerning ones is infections. And if a patient were to develop a neutropenic fever, we would want them to be seen as urgently as possible within an hour. And that’s where our limitation comes from.

So for our patients who live more than an hour away, those are the ones that we will have relocate to temporary lodging near our transplant center. And we’ve worked with several facilities in the area that have clean, furnished units that are available for rent. Many insurances also include lodging benefits for patients during stem cell transplant, recognizing this need. And historically, those [patients] were not considered part of our transplant patient cohorts.

I have not mentioned, but we initially did this in a phase 1 study, and we’re now studying it in a series of randomized, phase 2 studies that I can go into detail later on. And because they were not necessarily in their home, but a temporary lodging environment, those patients who relocated to Durham were not eligible for a home transplant study.

However, in the setting of the COVID-19 pandemic, we’ve actually pivoted our program in many ways. Specifically, if you think about a patient who’s coming into contact with the medical system, they come to the hospital, they meet someone at the door who is screening them for COVID-19. They see someone who checks them in at the front desk. A medical assistant takes them in the back. Someone calls their labs and phlebotomy. They may encounter other patients and environmental services, other individuals in the setting. You’re talking about dozens of different encounters. Who knows how many surfaces that potentially someone with COVID-19 has coughed on or contaminated?

And in contrast, you have house calls, which even if they are located in the temporary lodging, that’s just one or two individuals going into their living environment. They’re not encountering any different surfaces. And so, in the setting of COVID-19, we felt that this platform had the potential to help protect all our transplant patients who are among the most vulnerable patients, the most immunocompromised patients, and so we expanded our program to include those individuals as well.
 

Dr. Henry: So ... what are the actual outcomes of your patients in terms of how they’re doing, engrafting, and getting cured of their malignancy?

Dr. Sung: So as I mentioned, we first did this in a phase 1 safety and feasibility pilot study of both autologous and allo-transplant patients. This was presented at the annual meeting of the American Society of Hematology [Blood. 2017;130:745]. And we’re actually about ready to submit our manuscript on this.

And we found no difference in outcomes between patients who received care in the home transplant setting versus those who received conventional care either in the day hospital or hospital environment. The process appeared safe. Patients did just as well, if not better. Certainly, anecdotally, patients would talk about feeling so much more comfortable and happier being cared for in that home environment.

And we are now in the process of formally studying these outcomes in two NIH [National Institutes of Health]-funded clinical trials, one focused on allogeneic transplant patients [NCT02218151] and the other focused on autologous transplant patients [NCT01725022].
 

Dr. Henry: So of course, I’m waiting for this next question, which is cost. The services are the same, but you have people traveling, people who are highly skilled caregivers. Have you looked at cost differences from hospital versus home?

Dr. Sung: Absolutely. So you do have increased upfront costs because you have travel time for advanced practice providers and nurses. Not only that, but when a nurse is helping to give a patient a blood transfusion in the home environment, they’re 1:1 with that patient as opposed to the day hospital where a nurse could help with transfusions simultaneously for multiple patients. At the same time, by keeping patients out of the hospital, you have drastic, significant cost savings in that way.

In addition, I should mention, part of why we’re conducting these randomized, phase 2 clinical trials is we believe home care actually has the potential to decrease complications. One area of my research is on the impact of the microbiome, the bacteria in the gut, on transplant outcomes. And we’ve done a number of studies, many in collaboration with Memorial Sloan Kettering, showing that disruption of the microbiota, the bacteria in the gut, is associated with increased infections, graft-versus-host disease, and treatment-related mortality if we’re able to keep patients in their home setting.

However, I actually should go back a step. It’s well known that, if you take an individual from their home setting and put them in a foreign environment such as the hospital, that new environment, that new diet, hospital food as opposed to home food, and so forth, can dramatically shift the microbiome. Our hypothesis is that, by keeping patients in the home environment, their familiar environment will be able to help preserve their microbiome, thus decreasing infections, graft-versus-host disease, and other complications. That’s actually the goal of our studies: to see if we can preserve the microbiome and decrease complications.
 

Dr. Henry: So how will you evaluate that? Are you doing fecal studies, patient culture studies? How are you testing that?

Dr. Sung: So we have a very broad biobank program where we collect stool on our transplantations, pretransplant, day 0, weekly for the first month. And then, in the case of our allogeneic transplant patients, day 60, 90, 180, and 365.

And we do that both in our home transplant patients as well as their matched controls on the phase 2 studies. And we also collect it on a lot of our other transplant patients as part of our biobanking programs and our observational studies to try to understand what’s going on during transplant and how to help improve transplant outcomes.
 

Dr. Henry: Do you have any results of that? You’re probably showing a difference.

Dr. Sung: We think so, on some preliminary results, but those were based on small numbers of patients. And we’re really hoping that these randomized clinical trials with the larger numbers of patients enrolled will help show that difference.

But getting back to your earlier question about cost, a case of graft-versus-host disease, grade 2 or higher, can add about $100,000 to the cost of care. So if you prevent one case of bad gut or liver graft-versus-host disease, those are your cost savings right there.

The randomized, phase 2 trial for allogeneic transplant patients, the primary endpoint is graft-versus-host disease. So we’re looking at the microbiome and those associations and the prevention of GVHD. For the randomized clinical trial in autologous transplant patients – with autologous stem cells, you’re not going to get GVHD – but we do hope to improve quality of life and long-term outcomes in those patients as well.
 

Dr. Henry: Wonderful. Well, Tony, I really want to thank you so much for talking with us today.

Dr. Sung: Thank you very much for this opportunity. And again, I also want to just thank everyone who’s been involved in these studies, the advanced practice providers and nurses who are caring for our patients at home, the study staff who have been involved. Particularly, I’d like to highlight the role of both Nelson Chao, who’s our division chief and my mentor who piloted and first developed home transplant, and Kristin Nichols, our research nurse who has really led the drive forward.

Dr. Sung and Dr. Henry have no relevant disclosures. The trials are funded by grants from the National Institutes of Health.

Initial evidence suggests that the deliberate delays in melanoma care that occurred during the COVID-19 shelter-in-place lockdown last spring had a significant negative impact on patient outcomes, Rebecca I. Hartman, MD, MPH, said at a virtual forum on cutaneous malignancies jointly presented by Postgraduate Institute for Medicine and Global Academy for Medication Education.

This is not what National Comprehensive Cancer Network officials expected when they issued short-term recommendations on how to manage cutaneous melanoma during the first wave of the COVID-19 pandemic. Those recommendations for restriction of care, which Dr. Hartman characterized as “pretty significant changes from how we typically practice melanoma care in the U.S.,” came at a time when there was justifiable concern that the first COVID-19 surge would strain the U.S. health care system beyond the breaking point.

The rationale given for the NCCN recommendations was that most time-to-treat studies have shown no adverse patient outcomes for 90-day delays in treatment, even for thicker melanomas. But those studies, all retrospective, have been called into question. And the first real-world data on the impact of care restrictions during the lockdown, reported by Italian dermatologists, highlights adverse effects with potentially far-reaching consequences, noted Dr. Hartman, director of melanoma epidemiology at Brigham and Women’s Hospital and a dermatologist, Harvard University, Boston.

Analysis of the impact of lockdown-induced delays in melanoma care is not merely an academic exercise, she added. While everyone hopes that the spring 2020 COVID-19 shelter-in-place was a once-in-a-lifetime event, there’s no guarantee that will be the case. Moreover, the lockdown provides a natural experiment addressing the possible consequences of melanoma care delays on patient outcomes, a topic that for ethical reasons could never be addressed in a randomized trial.

The short-term NCCN recommendations included the use of excisional biopsies for melanoma diagnosis whenever possible; and delay of up to 3 months for wide local excision of in situ melanoma, any invasive melanoma with negative margins, and even T1 melanomas with positive margins provided the bulk of the lesion had been excised. The guidance also suggested delaying sentinel lymph node biopsy (SLNB), along with increased use of neoadjuvant therapy in patients with clinically palpable regional lymph nodes in order to delay surgery for up to 8 weeks. Single-agent systemic therapy at the least-frequent dosing was advised in order to minimize toxicity and reduce the need for additional health care resources: for example, nivolumab (Opdivo) at 480 mg every 4 weeks instead of every 2 weeks, and pembrolizumab (Keytruda) at 400 mg every 6 weeks, rather than every 3 weeks.

So, that’s what the NCCN recommended. Here’s what actually happened during shelter-in-place as captured in Dr. Hartman’s survey of 18 U.S. members of the Melanoma Prevention Working Group, all practicing dermatology in centers particularly hard-hit in the first wave of the pandemic: In-person new melanoma patient visits plunged from an average of 4.83 per week per provider to 0.83 per week. Telemedicine visits with new melanoma patients went from zero prepandemic to 0.67 visits per week per provider, which doesn’t come close to making up for the drop in in-person visits. Interestingly, two respondents reported turning to gene-expression profile testing for patient prognostication because of delays in SLNB.

Wide local excision was delayed by an average of 6 weeks in roughly one-third of melanoma patients with early tumor stage disease, regardless of margin status. For patients with stage T1b disease, wide local excision was typically performed on time during shelter-in-place; however, SLNB was delayed by an average of 5 weeks in 22% of patients with positive margins and 28% of those with negative margins. In contrast, 80% of patients with more advanced T2-T4 melanoma underwent on-schedule definitive management with wide local excision and SLNB, Dr. Hartman reported.

Critics have taken issue with the NCCN’s conclusion that most time-to-treatment studies show no harm arising from 90-day treatment delays. A review of the relevant published literature by Dr. Hartman’s Harvard colleagues, published in July, found that the evidence is mixed. “There is insufficient evidence to definitively conclude that delayed wide resection after gross removal of the primary melanoma is without harm,” they concluded in the review.

Spanish dermatologists performed a modeling study in order to estimate the potential impact of COVID-19 lockdowns on 5- and 10-year survival of melanoma patients. Using the growth rate of a random sample of 1,000 melanomas to model estimates of tumor thickness after various delays, coupled with American Joint Committee on Cancer survival data for different T stages, they estimated that 5-year survival would be reduced from 94.2% to 92.3% with a 90-day delay in diagnosis, and that 10-year survival would drop from 90.0% to 87.6%.

But that’s merely modeling. Francesco Ricci, MD, PhD, and colleagues from the melanoma unit at the Istituto Dermopatico dell’Immacolata, Rome, have provided a first look at the real-world impact of the lockdown. In the prelockdown period of January through March 9th, 2020, the referral center averaged 2.3 new melanoma diagnoses per day. During the Rome lockdown, from March 10th through May 3rd, this figure dropped to a mean of 0.6 melanoma diagnoses per day. Postlockdown, from May 4th to June 6th, the average climbed to 1.3 per day. The rate of newly diagnosed nodular melanoma was 5.5-fold greater postlockdown, compared with prelockdown; the rate of ulcerated melanoma was 4.9-fold greater.

“We can hypothesize that this may have been due to delays in diagnosis and care,” Dr. Hartman commented. “This is important because we know that nodular melanoma as well as ulceration tend to have a worse prognosis in terms of mortality.”

The mean Breslow thickness of newly diagnosed melanomas was 0.88 mm prelockdown, 0.66 mm during lockdown, and 1.96 mm postlockdown. The investigators speculated that the reduced Breslow thickness of melanomas diagnosed during lockdown might be explained by a greater willingness of more health-conscious people to defy the shelter-in-place instructions because of their concern about a suspicious skin lesion. “Though it is way too early to gauge the consequences of such diagnostic delay, should this issue be neglected, dermatologists and their patients may pay a higher price later with increased morbidity, mortality, and financial burden,” according to the investigators.

Dr. Hartman observed that it will be important to learn whether similar experiences occurred elsewhere during lockdown.

Another speaker, John M. Kirkwood, MD, said he has seen several melanoma patients referred from outside centers who had delays of up to 3 months in sentinel lymph node management of T2 and T3 tumors during lockdown who now have widespread metastatic disease.

“Now, is that anecdotal? I don’t know, it’s just worrisome to me,” commented Dr. Kirkwood, professor of medicine, dermatology, and translational science at the University of Pittsburgh.

Merrick Ross, MD, professor of surgical oncology at M.D. Anderson Cancer Center, Houston, recalled, “There was a period of time [during the lockdown] when we weren’t allowed to do certain elective procedures, if you want to call cancer surgery elective.”

“It’s too soon to talk about outcomes because a lot of patients are still in the process of being treated after what I would consider a significant delay in diagnosis,” the surgeon added.

An audience member asked if there will be an opportunity to see data on the damage done by delaying melanoma management as compared to lives saved through the lockdown for COVID-19. Dr. Ross replied that M.D. Anderson is in the midst of an institution-wide study analyzing the delay in diagnosis of a range of cancers.

“In our melanoma center it is absolutely clear, although we’re still collecting data, that the median tumor thickness is much higher since the lockdown,” Dr. Ross commented.

Dr. Hartman said she and her coinvestigators in the Melanoma Prevention Working Group are attempting to tally up the damage done via the lockdown by delaying melanoma diagnosis and treatment. But she agreed with the questioner that the most important thing is overall net lives saved through shelter-in-place.

“I’m sure that, separately, nondermatologists – perhaps infectious disease doctors and internists – are looking at how many lives were saved by the lockdown policy. So I do think all that data will come out,” Dr. Hartman predicted.

She reported having no financial conflicts regarding her presentation.

Global Academy for Medical Education and this news organization are owned by the same company.
 

bjancin@mdedge.com

SOURCE: Hartman, R. Cutaneous malignancies forum.

Initial evidence suggests that the deliberate delays in melanoma care that occurred during the COVID-19 shelter-in-place lockdown last spring had a significant negative impact on patient outcomes, Rebecca I. Hartman, MD, MPH, said at a virtual forum on cutaneous malignancies jointly presented by Postgraduate Institute for Medicine and Global Academy for Medication Education.

This is not what National Comprehensive Cancer Network officials expected when they issued short-term recommendations on how to manage cutaneous melanoma during the first wave of the COVID-19 pandemic. Those recommendations for restriction of care, which Dr. Hartman characterized as “pretty significant changes from how we typically practice melanoma care in the U.S.,” came at a time when there was justifiable concern that the first COVID-19 surge would strain the U.S. health care system beyond the breaking point.

The rationale given for the NCCN recommendations was that most time-to-treat studies have shown no adverse patient outcomes for 90-day delays in treatment, even for thicker melanomas. But those studies, all retrospective, have been called into question. And the first real-world data on the impact of care restrictions during the lockdown, reported by Italian dermatologists, highlights adverse effects with potentially far-reaching consequences, noted Dr. Hartman, director of melanoma epidemiology at Brigham and Women’s Hospital and a dermatologist, Harvard University, Boston.

Analysis of the impact of lockdown-induced delays in melanoma care is not merely an academic exercise, she added. While everyone hopes that the spring 2020 COVID-19 shelter-in-place was a once-in-a-lifetime event, there’s no guarantee that will be the case. Moreover, the lockdown provides a natural experiment addressing the possible consequences of melanoma care delays on patient outcomes, a topic that for ethical reasons could never be addressed in a randomized trial.

The short-term NCCN recommendations included the use of excisional biopsies for melanoma diagnosis whenever possible; and delay of up to 3 months for wide local excision of in situ melanoma, any invasive melanoma with negative margins, and even T1 melanomas with positive margins provided the bulk of the lesion had been excised. The guidance also suggested delaying sentinel lymph node biopsy (SLNB), along with increased use of neoadjuvant therapy in patients with clinically palpable regional lymph nodes in order to delay surgery for up to 8 weeks. Single-agent systemic therapy at the least-frequent dosing was advised in order to minimize toxicity and reduce the need for additional health care resources: for example, nivolumab (Opdivo) at 480 mg every 4 weeks instead of every 2 weeks, and pembrolizumab (Keytruda) at 400 mg every 6 weeks, rather than every 3 weeks.

So, that’s what the NCCN recommended. Here’s what actually happened during shelter-in-place as captured in Dr. Hartman’s survey of 18 U.S. members of the Melanoma Prevention Working Group, all practicing dermatology in centers particularly hard-hit in the first wave of the pandemic: In-person new melanoma patient visits plunged from an average of 4.83 per week per provider to 0.83 per week. Telemedicine visits with new melanoma patients went from zero prepandemic to 0.67 visits per week per provider, which doesn’t come close to making up for the drop in in-person visits. Interestingly, two respondents reported turning to gene-expression profile testing for patient prognostication because of delays in SLNB.

Wide local excision was delayed by an average of 6 weeks in roughly one-third of melanoma patients with early tumor stage disease, regardless of margin status. For patients with stage T1b disease, wide local excision was typically performed on time during shelter-in-place; however, SLNB was delayed by an average of 5 weeks in 22% of patients with positive margins and 28% of those with negative margins. In contrast, 80% of patients with more advanced T2-T4 melanoma underwent on-schedule definitive management with wide local excision and SLNB, Dr. Hartman reported.

Critics have taken issue with the NCCN’s conclusion that most time-to-treatment studies show no harm arising from 90-day treatment delays. A review of the relevant published literature by Dr. Hartman’s Harvard colleagues, published in July, found that the evidence is mixed. “There is insufficient evidence to definitively conclude that delayed wide resection after gross removal of the primary melanoma is without harm,” they concluded in the review.

Spanish dermatologists performed a modeling study in order to estimate the potential impact of COVID-19 lockdowns on 5- and 10-year survival of melanoma patients. Using the growth rate of a random sample of 1,000 melanomas to model estimates of tumor thickness after various delays, coupled with American Joint Committee on Cancer survival data for different T stages, they estimated that 5-year survival would be reduced from 94.2% to 92.3% with a 90-day delay in diagnosis, and that 10-year survival would drop from 90.0% to 87.6%.

But that’s merely modeling. Francesco Ricci, MD, PhD, and colleagues from the melanoma unit at the Istituto Dermopatico dell’Immacolata, Rome, have provided a first look at the real-world impact of the lockdown. In the prelockdown period of January through March 9th, 2020, the referral center averaged 2.3 new melanoma diagnoses per day. During the Rome lockdown, from March 10th through May 3rd, this figure dropped to a mean of 0.6 melanoma diagnoses per day. Postlockdown, from May 4th to June 6th, the average climbed to 1.3 per day. The rate of newly diagnosed nodular melanoma was 5.5-fold greater postlockdown, compared with prelockdown; the rate of ulcerated melanoma was 4.9-fold greater.

“We can hypothesize that this may have been due to delays in diagnosis and care,” Dr. Hartman commented. “This is important because we know that nodular melanoma as well as ulceration tend to have a worse prognosis in terms of mortality.”

The mean Breslow thickness of newly diagnosed melanomas was 0.88 mm prelockdown, 0.66 mm during lockdown, and 1.96 mm postlockdown. The investigators speculated that the reduced Breslow thickness of melanomas diagnosed during lockdown might be explained by a greater willingness of more health-conscious people to defy the shelter-in-place instructions because of their concern about a suspicious skin lesion. “Though it is way too early to gauge the consequences of such diagnostic delay, should this issue be neglected, dermatologists and their patients may pay a higher price later with increased morbidity, mortality, and financial burden,” according to the investigators.

Dr. Hartman observed that it will be important to learn whether similar experiences occurred elsewhere during lockdown.

Another speaker, John M. Kirkwood, MD, said he has seen several melanoma patients referred from outside centers who had delays of up to 3 months in sentinel lymph node management of T2 and T3 tumors during lockdown who now have widespread metastatic disease.

“Now, is that anecdotal? I don’t know, it’s just worrisome to me,” commented Dr. Kirkwood, professor of medicine, dermatology, and translational science at the University of Pittsburgh.

Merrick Ross, MD, professor of surgical oncology at M.D. Anderson Cancer Center, Houston, recalled, “There was a period of time [during the lockdown] when we weren’t allowed to do certain elective procedures, if you want to call cancer surgery elective.”

“It’s too soon to talk about outcomes because a lot of patients are still in the process of being treated after what I would consider a significant delay in diagnosis,” the surgeon added.

An audience member asked if there will be an opportunity to see data on the damage done by delaying melanoma management as compared to lives saved through the lockdown for COVID-19. Dr. Ross replied that M.D. Anderson is in the midst of an institution-wide study analyzing the delay in diagnosis of a range of cancers.

“In our melanoma center it is absolutely clear, although we’re still collecting data, that the median tumor thickness is much higher since the lockdown,” Dr. Ross commented.

Dr. Hartman said she and her coinvestigators in the Melanoma Prevention Working Group are attempting to tally up the damage done via the lockdown by delaying melanoma diagnosis and treatment. But she agreed with the questioner that the most important thing is overall net lives saved through shelter-in-place.

“I’m sure that, separately, nondermatologists – perhaps infectious disease doctors and internists – are looking at how many lives were saved by the lockdown policy. So I do think all that data will come out,” Dr. Hartman predicted.

She reported having no financial conflicts regarding her presentation.

Global Academy for Medical Education and this news organization are owned by the same company.
 

bjancin@mdedge.com

SOURCE: Hartman, R. Cutaneous malignancies forum.

Initial evidence suggests that the deliberate delays in melanoma care that occurred during the COVID-19 shelter-in-place lockdown last spring had a significant negative impact on patient outcomes, Rebecca I. Hartman, MD, MPH, said at a virtual forum on cutaneous malignancies jointly presented by Postgraduate Institute for Medicine and Global Academy for Medication Education.

This is not what National Comprehensive Cancer Network officials expected when they issued short-term recommendations on how to manage cutaneous melanoma during the first wave of the COVID-19 pandemic. Those recommendations for restriction of care, which Dr. Hartman characterized as “pretty significant changes from how we typically practice melanoma care in the U.S.,” came at a time when there was justifiable concern that the first COVID-19 surge would strain the U.S. health care system beyond the breaking point.

The rationale given for the NCCN recommendations was that most time-to-treat studies have shown no adverse patient outcomes for 90-day delays in treatment, even for thicker melanomas. But those studies, all retrospective, have been called into question. And the first real-world data on the impact of care restrictions during the lockdown, reported by Italian dermatologists, highlights adverse effects with potentially far-reaching consequences, noted Dr. Hartman, director of melanoma epidemiology at Brigham and Women’s Hospital and a dermatologist, Harvard University, Boston.

Analysis of the impact of lockdown-induced delays in melanoma care is not merely an academic exercise, she added. While everyone hopes that the spring 2020 COVID-19 shelter-in-place was a once-in-a-lifetime event, there’s no guarantee that will be the case. Moreover, the lockdown provides a natural experiment addressing the possible consequences of melanoma care delays on patient outcomes, a topic that for ethical reasons could never be addressed in a randomized trial.

The short-term NCCN recommendations included the use of excisional biopsies for melanoma diagnosis whenever possible; and delay of up to 3 months for wide local excision of in situ melanoma, any invasive melanoma with negative margins, and even T1 melanomas with positive margins provided the bulk of the lesion had been excised. The guidance also suggested delaying sentinel lymph node biopsy (SLNB), along with increased use of neoadjuvant therapy in patients with clinically palpable regional lymph nodes in order to delay surgery for up to 8 weeks. Single-agent systemic therapy at the least-frequent dosing was advised in order to minimize toxicity and reduce the need for additional health care resources: for example, nivolumab (Opdivo) at 480 mg every 4 weeks instead of every 2 weeks, and pembrolizumab (Keytruda) at 400 mg every 6 weeks, rather than every 3 weeks.

So, that’s what the NCCN recommended. Here’s what actually happened during shelter-in-place as captured in Dr. Hartman’s survey of 18 U.S. members of the Melanoma Prevention Working Group, all practicing dermatology in centers particularly hard-hit in the first wave of the pandemic: In-person new melanoma patient visits plunged from an average of 4.83 per week per provider to 0.83 per week. Telemedicine visits with new melanoma patients went from zero prepandemic to 0.67 visits per week per provider, which doesn’t come close to making up for the drop in in-person visits. Interestingly, two respondents reported turning to gene-expression profile testing for patient prognostication because of delays in SLNB.

Wide local excision was delayed by an average of 6 weeks in roughly one-third of melanoma patients with early tumor stage disease, regardless of margin status. For patients with stage T1b disease, wide local excision was typically performed on time during shelter-in-place; however, SLNB was delayed by an average of 5 weeks in 22% of patients with positive margins and 28% of those with negative margins. In contrast, 80% of patients with more advanced T2-T4 melanoma underwent on-schedule definitive management with wide local excision and SLNB, Dr. Hartman reported.

Critics have taken issue with the NCCN’s conclusion that most time-to-treatment studies show no harm arising from 90-day treatment delays. A review of the relevant published literature by Dr. Hartman’s Harvard colleagues, published in July, found that the evidence is mixed. “There is insufficient evidence to definitively conclude that delayed wide resection after gross removal of the primary melanoma is without harm,” they concluded in the review.

Spanish dermatologists performed a modeling study in order to estimate the potential impact of COVID-19 lockdowns on 5- and 10-year survival of melanoma patients. Using the growth rate of a random sample of 1,000 melanomas to model estimates of tumor thickness after various delays, coupled with American Joint Committee on Cancer survival data for different T stages, they estimated that 5-year survival would be reduced from 94.2% to 92.3% with a 90-day delay in diagnosis, and that 10-year survival would drop from 90.0% to 87.6%.

But that’s merely modeling. Francesco Ricci, MD, PhD, and colleagues from the melanoma unit at the Istituto Dermopatico dell’Immacolata, Rome, have provided a first look at the real-world impact of the lockdown. In the prelockdown period of January through March 9th, 2020, the referral center averaged 2.3 new melanoma diagnoses per day. During the Rome lockdown, from March 10th through May 3rd, this figure dropped to a mean of 0.6 melanoma diagnoses per day. Postlockdown, from May 4th to June 6th, the average climbed to 1.3 per day. The rate of newly diagnosed nodular melanoma was 5.5-fold greater postlockdown, compared with prelockdown; the rate of ulcerated melanoma was 4.9-fold greater.

“We can hypothesize that this may have been due to delays in diagnosis and care,” Dr. Hartman commented. “This is important because we know that nodular melanoma as well as ulceration tend to have a worse prognosis in terms of mortality.”

The mean Breslow thickness of newly diagnosed melanomas was 0.88 mm prelockdown, 0.66 mm during lockdown, and 1.96 mm postlockdown. The investigators speculated that the reduced Breslow thickness of melanomas diagnosed during lockdown might be explained by a greater willingness of more health-conscious people to defy the shelter-in-place instructions because of their concern about a suspicious skin lesion. “Though it is way too early to gauge the consequences of such diagnostic delay, should this issue be neglected, dermatologists and their patients may pay a higher price later with increased morbidity, mortality, and financial burden,” according to the investigators.

Dr. Hartman observed that it will be important to learn whether similar experiences occurred elsewhere during lockdown.

Another speaker, John M. Kirkwood, MD, said he has seen several melanoma patients referred from outside centers who had delays of up to 3 months in sentinel lymph node management of T2 and T3 tumors during lockdown who now have widespread metastatic disease.

“Now, is that anecdotal? I don’t know, it’s just worrisome to me,” commented Dr. Kirkwood, professor of medicine, dermatology, and translational science at the University of Pittsburgh.

Merrick Ross, MD, professor of surgical oncology at M.D. Anderson Cancer Center, Houston, recalled, “There was a period of time [during the lockdown] when we weren’t allowed to do certain elective procedures, if you want to call cancer surgery elective.”

“It’s too soon to talk about outcomes because a lot of patients are still in the process of being treated after what I would consider a significant delay in diagnosis,” the surgeon added.

An audience member asked if there will be an opportunity to see data on the damage done by delaying melanoma management as compared to lives saved through the lockdown for COVID-19. Dr. Ross replied that M.D. Anderson is in the midst of an institution-wide study analyzing the delay in diagnosis of a range of cancers.

“In our melanoma center it is absolutely clear, although we’re still collecting data, that the median tumor thickness is much higher since the lockdown,” Dr. Ross commented.

Dr. Hartman said she and her coinvestigators in the Melanoma Prevention Working Group are attempting to tally up the damage done via the lockdown by delaying melanoma diagnosis and treatment. But she agreed with the questioner that the most important thing is overall net lives saved through shelter-in-place.

“I’m sure that, separately, nondermatologists – perhaps infectious disease doctors and internists – are looking at how many lives were saved by the lockdown policy. So I do think all that data will come out,” Dr. Hartman predicted.

She reported having no financial conflicts regarding her presentation.

Global Academy for Medical Education and this news organization are owned by the same company.
 

bjancin@mdedge.com

SOURCE: Hartman, R. Cutaneous malignancies forum.

People whose treatment for cancer is delayed by even 1 month have a 6%-13% higher risk of dying, suggests research published online in the BMJ.

In light of the treatment delays resulting from the pandemic, Canadian and U.K. researchers carried out a review and analysis of relevant studies published between January 2000 and April 2020.

Included studies examined data on surgical interventions, systemic therapy, or radiotherapy for seven forms of cancer – bladder, breast, colon, rectum, lung, cervix, and head and neck. Delays were measured from diagnosis to the first treatment or from the completion of one treatment to the start of the next.

The search identified 34 suitable studies for 17 indications, with data from more than 1.2 million patients. The analysis identified a significant association between delay and increased mortality for 13 of the 17 indications (P < .05).

For surgery, there was a 6%-8% increase in the risk of death for every 4-week treatment delay. Estimates for systemic treatment varied (hazard ratio range, 1.01-1.28). Four-week delays in radiotherapy were for radical radiotherapy for head and neck cancer (HR, 1.09; 95% confidence interval, 1.05-1.14), adjuvant radiotherapy after breast-conserving surgery (HR, 0.98; 95% CI, 0.88-1.09), and cervical cancer adjuvant radiotherapy (HR, 1.23; 95% CI, 1.00-1.50).

Delays of up to 8 and 12 weeks further increased mortality. An 8-week delay in breast cancer surgery was linked to a 17% increased mortality, and a 12-week delay would increase mortality by 26%.

A surgical delay of 12 weeks for patients with breast cancer continuing for 1 year – which is likely to be the case as the pandemic continues – would lead to 1,400 excess deaths in the United Kingdom.

The authors said the results of this study could be used to guide policy making on the organization of cancer services, particularly as the pandemic continues and further delays are expected.

This article originally appeared on Univadis, part of the Medscape Professional Network.

People whose treatment for cancer is delayed by even 1 month have a 6%-13% higher risk of dying, suggests research published online in the BMJ.

In light of the treatment delays resulting from the pandemic, Canadian and U.K. researchers carried out a review and analysis of relevant studies published between January 2000 and April 2020.

Included studies examined data on surgical interventions, systemic therapy, or radiotherapy for seven forms of cancer – bladder, breast, colon, rectum, lung, cervix, and head and neck. Delays were measured from diagnosis to the first treatment or from the completion of one treatment to the start of the next.

The search identified 34 suitable studies for 17 indications, with data from more than 1.2 million patients. The analysis identified a significant association between delay and increased mortality for 13 of the 17 indications (P < .05).

For surgery, there was a 6%-8% increase in the risk of death for every 4-week treatment delay. Estimates for systemic treatment varied (hazard ratio range, 1.01-1.28). Four-week delays in radiotherapy were for radical radiotherapy for head and neck cancer (HR, 1.09; 95% confidence interval, 1.05-1.14), adjuvant radiotherapy after breast-conserving surgery (HR, 0.98; 95% CI, 0.88-1.09), and cervical cancer adjuvant radiotherapy (HR, 1.23; 95% CI, 1.00-1.50).

Delays of up to 8 and 12 weeks further increased mortality. An 8-week delay in breast cancer surgery was linked to a 17% increased mortality, and a 12-week delay would increase mortality by 26%.

A surgical delay of 12 weeks for patients with breast cancer continuing for 1 year – which is likely to be the case as the pandemic continues – would lead to 1,400 excess deaths in the United Kingdom.

The authors said the results of this study could be used to guide policy making on the organization of cancer services, particularly as the pandemic continues and further delays are expected.

This article originally appeared on Univadis, part of the Medscape Professional Network.

People whose treatment for cancer is delayed by even 1 month have a 6%-13% higher risk of dying, suggests research published online in the BMJ.

In light of the treatment delays resulting from the pandemic, Canadian and U.K. researchers carried out a review and analysis of relevant studies published between January 2000 and April 2020.

Included studies examined data on surgical interventions, systemic therapy, or radiotherapy for seven forms of cancer – bladder, breast, colon, rectum, lung, cervix, and head and neck. Delays were measured from diagnosis to the first treatment or from the completion of one treatment to the start of the next.

The search identified 34 suitable studies for 17 indications, with data from more than 1.2 million patients. The analysis identified a significant association between delay and increased mortality for 13 of the 17 indications (P < .05).

For surgery, there was a 6%-8% increase in the risk of death for every 4-week treatment delay. Estimates for systemic treatment varied (hazard ratio range, 1.01-1.28). Four-week delays in radiotherapy were for radical radiotherapy for head and neck cancer (HR, 1.09; 95% confidence interval, 1.05-1.14), adjuvant radiotherapy after breast-conserving surgery (HR, 0.98; 95% CI, 0.88-1.09), and cervical cancer adjuvant radiotherapy (HR, 1.23; 95% CI, 1.00-1.50).

Delays of up to 8 and 12 weeks further increased mortality. An 8-week delay in breast cancer surgery was linked to a 17% increased mortality, and a 12-week delay would increase mortality by 26%.

A surgical delay of 12 weeks for patients with breast cancer continuing for 1 year – which is likely to be the case as the pandemic continues – would lead to 1,400 excess deaths in the United Kingdom.

The authors said the results of this study could be used to guide policy making on the organization of cancer services, particularly as the pandemic continues and further delays are expected.

This article originally appeared on Univadis, part of the Medscape Professional Network.

Delays in colorectal cancer screening due to the COVID-19 pandemic could lead to higher rates of advanced-stage cancer and death, according to a new study.

When compared with a delay of less than three months, the longer delay seen this year may result in an 11.9% increase in death rates.

“Across the globe, health care systems are facing serious difficulties while dealing with COVID-19, and it is imperative that support is given to the public and patients throughout the crisis, including for high-impact diseases such as colorectal cancer,” Luigi Ricciardiello, the lead study author and a professor at the University of Bologna in Italy, said in a statement.

Ricciardiello and colleagues presented their research on Monday at UEG Week Virtual 2020, an international conference for gastroenterologists. The study will be published in the UEG Journal .

The researchers created a model to forecast the effects of delayed cancer screening during 2020. A “moderate” delay of 7-12 months caused a 3% increase in advanced-stage colon cancer, and a long delay of more than 12 months caused a 7% increase in advanced cancer.

Based on a survival rate of 5 years for stage 3 or stage 4 colorectal cancer, the death rate would increase nearly 12% when screening is delayed for more than a year, as compared with less than three months of delay.

The research team found similar results when forecasting advanced-stage cancer and deaths earlier this year. In a paper published in Clinical Gastroenterology and Hepatology in early September, they projected that deaths could increase 12% if screening is delayed for more than a year.

Throughout the pandemic, screening programs have been delayed in many countries, particularly across Europe.

“Healthcare authorities need to act urgently on how they reorganise activities during COVID-19, without compromising the diagnosis of other high-impact diseases like this research shows,” Ricciardiello said.

United European Gastroenterology, a professional medical organization for digestive health specialists, has called for policymakers to implement colon cancer screening programs across the European Union. Annually, more than 375,000 new cases are diagnosed across the EU, and more than 170,000 people die from colorectal cancer, according to a UEG report.

“Early-stage diagnosis of colorectal cancer is crucial — it’s far easier to treat and enhances optimal patient outcomes,” Ricciardiello said. “It is therefore essential that vital diagnosis tools, like screening programmes, continue and help to prevent mortality rates from rising even further.”
 

This article first appeared on Medscape.com.

Delays in colorectal cancer screening due to the COVID-19 pandemic could lead to higher rates of advanced-stage cancer and death, according to a new study.

When compared with a delay of less than three months, the longer delay seen this year may result in an 11.9% increase in death rates.

“Across the globe, health care systems are facing serious difficulties while dealing with COVID-19, and it is imperative that support is given to the public and patients throughout the crisis, including for high-impact diseases such as colorectal cancer,” Luigi Ricciardiello, the lead study author and a professor at the University of Bologna in Italy, said in a statement.

Ricciardiello and colleagues presented their research on Monday at UEG Week Virtual 2020, an international conference for gastroenterologists. The study will be published in the UEG Journal .

The researchers created a model to forecast the effects of delayed cancer screening during 2020. A “moderate” delay of 7-12 months caused a 3% increase in advanced-stage colon cancer, and a long delay of more than 12 months caused a 7% increase in advanced cancer.

Based on a survival rate of 5 years for stage 3 or stage 4 colorectal cancer, the death rate would increase nearly 12% when screening is delayed for more than a year, as compared with less than three months of delay.

The research team found similar results when forecasting advanced-stage cancer and deaths earlier this year. In a paper published in Clinical Gastroenterology and Hepatology in early September, they projected that deaths could increase 12% if screening is delayed for more than a year.

Throughout the pandemic, screening programs have been delayed in many countries, particularly across Europe.

“Healthcare authorities need to act urgently on how they reorganise activities during COVID-19, without compromising the diagnosis of other high-impact diseases like this research shows,” Ricciardiello said.

United European Gastroenterology, a professional medical organization for digestive health specialists, has called for policymakers to implement colon cancer screening programs across the European Union. Annually, more than 375,000 new cases are diagnosed across the EU, and more than 170,000 people die from colorectal cancer, according to a UEG report.

“Early-stage diagnosis of colorectal cancer is crucial — it’s far easier to treat and enhances optimal patient outcomes,” Ricciardiello said. “It is therefore essential that vital diagnosis tools, like screening programmes, continue and help to prevent mortality rates from rising even further.”
 

This article first appeared on Medscape.com.

Delays in colorectal cancer screening due to the COVID-19 pandemic could lead to higher rates of advanced-stage cancer and death, according to a new study.

When compared with a delay of less than three months, the longer delay seen this year may result in an 11.9% increase in death rates.

“Across the globe, health care systems are facing serious difficulties while dealing with COVID-19, and it is imperative that support is given to the public and patients throughout the crisis, including for high-impact diseases such as colorectal cancer,” Luigi Ricciardiello, the lead study author and a professor at the University of Bologna in Italy, said in a statement.

Ricciardiello and colleagues presented their research on Monday at UEG Week Virtual 2020, an international conference for gastroenterologists. The study will be published in the UEG Journal .

The researchers created a model to forecast the effects of delayed cancer screening during 2020. A “moderate” delay of 7-12 months caused a 3% increase in advanced-stage colon cancer, and a long delay of more than 12 months caused a 7% increase in advanced cancer.

Based on a survival rate of 5 years for stage 3 or stage 4 colorectal cancer, the death rate would increase nearly 12% when screening is delayed for more than a year, as compared with less than three months of delay.

The research team found similar results when forecasting advanced-stage cancer and deaths earlier this year. In a paper published in Clinical Gastroenterology and Hepatology in early September, they projected that deaths could increase 12% if screening is delayed for more than a year.

Throughout the pandemic, screening programs have been delayed in many countries, particularly across Europe.

“Healthcare authorities need to act urgently on how they reorganise activities during COVID-19, without compromising the diagnosis of other high-impact diseases like this research shows,” Ricciardiello said.

United European Gastroenterology, a professional medical organization for digestive health specialists, has called for policymakers to implement colon cancer screening programs across the European Union. Annually, more than 375,000 new cases are diagnosed across the EU, and more than 170,000 people die from colorectal cancer, according to a UEG report.

“Early-stage diagnosis of colorectal cancer is crucial — it’s far easier to treat and enhances optimal patient outcomes,” Ricciardiello said. “It is therefore essential that vital diagnosis tools, like screening programmes, continue and help to prevent mortality rates from rising even further.”
 

This article first appeared on Medscape.com.

Mortality in patients with COVID-19 and cancer is associated with general clinical and demographic factors, cancer-specific factors, cancer treatment variables, and laboratory parameters, according to two presentations at the European Society for Medical Oncology Virtual Congress 2020.

Two analyses of data from the COVID-19 and Cancer Consortium (CCC19) were presented at the meeting.

The data suggest that older age, male sex, more comorbidities, poor performance status, progressive cancer or multiple cancers, hematologic malignancy, and recent cancer therapy are all associated with higher mortality among patients with cancer and COVID-19. Anti-CD20 therapy is associated with an especially high mortality rate, according to an investigator.

Among hospitalized patients, increased absolute neutrophil count as well as abnormal D-dimer, high-sensitivity troponin, and C-reactive protein are associated with a higher risk of mortality.

Prior analyses of CCC19 data pointed to several factors associated with higher COVID-19 death rates, according to Petros Grivas, MD, PhD, of University of Washington, Seattle, who presented some CCC19 data at the meeting. However, the prior analyses were limited by weak statistical power and low event rates, Dr. Grivas said.
 

Clinical and laboratory factors: Abstract LBA72

The aim of Dr. Grivas’s analysis was to validate a priori identified demographic and clinicopathologic factors associated with 30-day all-cause mortality in patients with COVID-19 and cancer. Dr. Grivas and colleagues also explored the potential association between laboratory parameters and 30-day all-cause mortality.

The analysis included 3,899 patients with cancer and COVID-19 from 124 centers. Most centers are in the United States, but 4% are in Canada, and 2% are in Spain. About two-thirds of patients were 60 years of age or younger at baseline, half were men, 79% had solid tumors, and 21% had hematologic malignancies.

Cancer-specific factors associated with an increased risk of 30-day all-cause mortality were having progressive cancer (adjusted odds ratio, 2.9), receiving cancer therapy within 3 months (aOR, 1.2), having a hematologic versus solid tumor (aOR, 1.7), and having multiple malignancies (aOR, 1.5).

Clinical factors associated with an increased risk of 30-day all-cause mortality were Black versus White race (aOR, 1.5), older age (aOR, 1.7 per 10 years), three or more actively treated comorbidities (versus none; aOR, 2.1), and Eastern Cooperative Oncology Group performance status of 2 or more (versus 0; aOR, 4.6).

In hospitalized patients, several laboratory variables were associated with an increased risk of 30-day all-cause mortality. Having an absolute neutrophil count above the upper limit of normal doubled the risk (aOR, 2.0), while abnormal D-dimer, high-sensitivity troponin, and C-reactive protein all more than doubled the risk of mortality (aORs of 2.5, 2.5, and 2.4, respectively).

Further risk modeling with multivariable analysis will be performed after longer follow-up, Dr. Grivas noted.
 

Treatment-related outcomes: Abstract LBA71

An additional analysis of CCC19 data encompassed 3,654 patients. In this analysis, researchers investigated the correlation between timing of cancer treatment and COVID-19–related complications and 30-day mortality.

Mortality was highest among cancer patients treated 1-3 months prior to COVID-19 diagnosis, with all-cause mortality at 28%, said Trisha M. Wise-Draper, MD, PhD, of University of Cincinnati, when presenting the data at the meeting.

Rates for other complications (hospitalization, oxygen required, ICU admission, and mechanical ventilation) were similar regardless of treatment timing.

The unadjusted 30-day mortality rate was highest for patients treated most recently with chemoimmunotherapy (30%), followed by chemotherapy (18%), chemoradiotherapy (18%), and targeted therapy (17%).

The mortality rate was “particularly high,” at 50%, in patients receiving anti-CD20 therapy 1-3 months prior to COVID-19 diagnosis – the time period for which significant B-cell depletion develops, Dr. Wise-Draper observed.

An analysis of disease status among 1,449 patients treated within 3 months of COVID-19 diagnosis showed mortality risk increasing from 6% among patients in remission or with newly emergent disease, to 22% in patients with any active cancer, to 34% in those with progressing disease, Dr. Wise-Draper said.

Discussant Benjamin Solomon, MD, PhD, of Peter MacCallum Cancer Centre in Melbourne, made note of the high 30-day mortality rate seen in patients receiving anti-CD20 therapy as well as the elevated standardized mortality ratios with recent chemoimmunotherapy and targeted therapy.

“Although there are some limitations of this analysis, it provides the best data we have to date about the effects of treatment on early mortality in patients with COVID-19 and cancer. It points to a modest but heterogeneous effect of treatment on outcome, one which is likely to become clearer with larger cohorts and additional analysis,” Dr. Solomon said.

This research was funded by the American Cancer Society, Hope Foundation for Cancer Research, Jim and Carol O’Hare Fund, National Cancer Institute, National Human Genome Research Institute, Vanderbilt Institute for Clinical and Translational Research, and Fonds de Recherche du Quebec-Sante. Dr. Grivas disclosed relationships with many companies, but none are related to this work. Dr. Wise-Draper disclosed relationships with Merck, Bristol-Myers Squibb, Tesaro, GlaxoSmithKline, AstraZeneca, Shattuck Labs, and Rakuten. Dr. Solomon disclosed relationships with Amgen, AstraZeneca, Merck, Bristol-Myers Squibb, Novartis, Pfizer, and Roche-Genentech.

SOURCES: Grivas P et al. ESMO 2020, Abstract LBA72; Wise-Draper TM et al. ESMO 2020, Abstract LBA71.

Mortality in patients with COVID-19 and cancer is associated with general clinical and demographic factors, cancer-specific factors, cancer treatment variables, and laboratory parameters, according to two presentations at the European Society for Medical Oncology Virtual Congress 2020.

Two analyses of data from the COVID-19 and Cancer Consortium (CCC19) were presented at the meeting.

The data suggest that older age, male sex, more comorbidities, poor performance status, progressive cancer or multiple cancers, hematologic malignancy, and recent cancer therapy are all associated with higher mortality among patients with cancer and COVID-19. Anti-CD20 therapy is associated with an especially high mortality rate, according to an investigator.

Among hospitalized patients, increased absolute neutrophil count as well as abnormal D-dimer, high-sensitivity troponin, and C-reactive protein are associated with a higher risk of mortality.

Prior analyses of CCC19 data pointed to several factors associated with higher COVID-19 death rates, according to Petros Grivas, MD, PhD, of University of Washington, Seattle, who presented some CCC19 data at the meeting. However, the prior analyses were limited by weak statistical power and low event rates, Dr. Grivas said.
 

Clinical and laboratory factors: Abstract LBA72

The aim of Dr. Grivas’s analysis was to validate a priori identified demographic and clinicopathologic factors associated with 30-day all-cause mortality in patients with COVID-19 and cancer. Dr. Grivas and colleagues also explored the potential association between laboratory parameters and 30-day all-cause mortality.

The analysis included 3,899 patients with cancer and COVID-19 from 124 centers. Most centers are in the United States, but 4% are in Canada, and 2% are in Spain. About two-thirds of patients were 60 years of age or younger at baseline, half were men, 79% had solid tumors, and 21% had hematologic malignancies.

Cancer-specific factors associated with an increased risk of 30-day all-cause mortality were having progressive cancer (adjusted odds ratio, 2.9), receiving cancer therapy within 3 months (aOR, 1.2), having a hematologic versus solid tumor (aOR, 1.7), and having multiple malignancies (aOR, 1.5).

Clinical factors associated with an increased risk of 30-day all-cause mortality were Black versus White race (aOR, 1.5), older age (aOR, 1.7 per 10 years), three or more actively treated comorbidities (versus none; aOR, 2.1), and Eastern Cooperative Oncology Group performance status of 2 or more (versus 0; aOR, 4.6).

In hospitalized patients, several laboratory variables were associated with an increased risk of 30-day all-cause mortality. Having an absolute neutrophil count above the upper limit of normal doubled the risk (aOR, 2.0), while abnormal D-dimer, high-sensitivity troponin, and C-reactive protein all more than doubled the risk of mortality (aORs of 2.5, 2.5, and 2.4, respectively).

Further risk modeling with multivariable analysis will be performed after longer follow-up, Dr. Grivas noted.
 

Treatment-related outcomes: Abstract LBA71

An additional analysis of CCC19 data encompassed 3,654 patients. In this analysis, researchers investigated the correlation between timing of cancer treatment and COVID-19–related complications and 30-day mortality.

Mortality was highest among cancer patients treated 1-3 months prior to COVID-19 diagnosis, with all-cause mortality at 28%, said Trisha M. Wise-Draper, MD, PhD, of University of Cincinnati, when presenting the data at the meeting.

Rates for other complications (hospitalization, oxygen required, ICU admission, and mechanical ventilation) were similar regardless of treatment timing.

The unadjusted 30-day mortality rate was highest for patients treated most recently with chemoimmunotherapy (30%), followed by chemotherapy (18%), chemoradiotherapy (18%), and targeted therapy (17%).

The mortality rate was “particularly high,” at 50%, in patients receiving anti-CD20 therapy 1-3 months prior to COVID-19 diagnosis – the time period for which significant B-cell depletion develops, Dr. Wise-Draper observed.

An analysis of disease status among 1,449 patients treated within 3 months of COVID-19 diagnosis showed mortality risk increasing from 6% among patients in remission or with newly emergent disease, to 22% in patients with any active cancer, to 34% in those with progressing disease, Dr. Wise-Draper said.

Discussant Benjamin Solomon, MD, PhD, of Peter MacCallum Cancer Centre in Melbourne, made note of the high 30-day mortality rate seen in patients receiving anti-CD20 therapy as well as the elevated standardized mortality ratios with recent chemoimmunotherapy and targeted therapy.

“Although there are some limitations of this analysis, it provides the best data we have to date about the effects of treatment on early mortality in patients with COVID-19 and cancer. It points to a modest but heterogeneous effect of treatment on outcome, one which is likely to become clearer with larger cohorts and additional analysis,” Dr. Solomon said.

This research was funded by the American Cancer Society, Hope Foundation for Cancer Research, Jim and Carol O’Hare Fund, National Cancer Institute, National Human Genome Research Institute, Vanderbilt Institute for Clinical and Translational Research, and Fonds de Recherche du Quebec-Sante. Dr. Grivas disclosed relationships with many companies, but none are related to this work. Dr. Wise-Draper disclosed relationships with Merck, Bristol-Myers Squibb, Tesaro, GlaxoSmithKline, AstraZeneca, Shattuck Labs, and Rakuten. Dr. Solomon disclosed relationships with Amgen, AstraZeneca, Merck, Bristol-Myers Squibb, Novartis, Pfizer, and Roche-Genentech.

SOURCES: Grivas P et al. ESMO 2020, Abstract LBA72; Wise-Draper TM et al. ESMO 2020, Abstract LBA71.

Mortality in patients with COVID-19 and cancer is associated with general clinical and demographic factors, cancer-specific factors, cancer treatment variables, and laboratory parameters, according to two presentations at the European Society for Medical Oncology Virtual Congress 2020.

Two analyses of data from the COVID-19 and Cancer Consortium (CCC19) were presented at the meeting.

The data suggest that older age, male sex, more comorbidities, poor performance status, progressive cancer or multiple cancers, hematologic malignancy, and recent cancer therapy are all associated with higher mortality among patients with cancer and COVID-19. Anti-CD20 therapy is associated with an especially high mortality rate, according to an investigator.

Among hospitalized patients, increased absolute neutrophil count as well as abnormal D-dimer, high-sensitivity troponin, and C-reactive protein are associated with a higher risk of mortality.

Prior analyses of CCC19 data pointed to several factors associated with higher COVID-19 death rates, according to Petros Grivas, MD, PhD, of University of Washington, Seattle, who presented some CCC19 data at the meeting. However, the prior analyses were limited by weak statistical power and low event rates, Dr. Grivas said.
 

Clinical and laboratory factors: Abstract LBA72

The aim of Dr. Grivas’s analysis was to validate a priori identified demographic and clinicopathologic factors associated with 30-day all-cause mortality in patients with COVID-19 and cancer. Dr. Grivas and colleagues also explored the potential association between laboratory parameters and 30-day all-cause mortality.

The analysis included 3,899 patients with cancer and COVID-19 from 124 centers. Most centers are in the United States, but 4% are in Canada, and 2% are in Spain. About two-thirds of patients were 60 years of age or younger at baseline, half were men, 79% had solid tumors, and 21% had hematologic malignancies.

Cancer-specific factors associated with an increased risk of 30-day all-cause mortality were having progressive cancer (adjusted odds ratio, 2.9), receiving cancer therapy within 3 months (aOR, 1.2), having a hematologic versus solid tumor (aOR, 1.7), and having multiple malignancies (aOR, 1.5).

Clinical factors associated with an increased risk of 30-day all-cause mortality were Black versus White race (aOR, 1.5), older age (aOR, 1.7 per 10 years), three or more actively treated comorbidities (versus none; aOR, 2.1), and Eastern Cooperative Oncology Group performance status of 2 or more (versus 0; aOR, 4.6).

In hospitalized patients, several laboratory variables were associated with an increased risk of 30-day all-cause mortality. Having an absolute neutrophil count above the upper limit of normal doubled the risk (aOR, 2.0), while abnormal D-dimer, high-sensitivity troponin, and C-reactive protein all more than doubled the risk of mortality (aORs of 2.5, 2.5, and 2.4, respectively).

Further risk modeling with multivariable analysis will be performed after longer follow-up, Dr. Grivas noted.
 

Treatment-related outcomes: Abstract LBA71

An additional analysis of CCC19 data encompassed 3,654 patients. In this analysis, researchers investigated the correlation between timing of cancer treatment and COVID-19–related complications and 30-day mortality.

Mortality was highest among cancer patients treated 1-3 months prior to COVID-19 diagnosis, with all-cause mortality at 28%, said Trisha M. Wise-Draper, MD, PhD, of University of Cincinnati, when presenting the data at the meeting.

Rates for other complications (hospitalization, oxygen required, ICU admission, and mechanical ventilation) were similar regardless of treatment timing.

The unadjusted 30-day mortality rate was highest for patients treated most recently with chemoimmunotherapy (30%), followed by chemotherapy (18%), chemoradiotherapy (18%), and targeted therapy (17%).

The mortality rate was “particularly high,” at 50%, in patients receiving anti-CD20 therapy 1-3 months prior to COVID-19 diagnosis – the time period for which significant B-cell depletion develops, Dr. Wise-Draper observed.

An analysis of disease status among 1,449 patients treated within 3 months of COVID-19 diagnosis showed mortality risk increasing from 6% among patients in remission or with newly emergent disease, to 22% in patients with any active cancer, to 34% in those with progressing disease, Dr. Wise-Draper said.

Discussant Benjamin Solomon, MD, PhD, of Peter MacCallum Cancer Centre in Melbourne, made note of the high 30-day mortality rate seen in patients receiving anti-CD20 therapy as well as the elevated standardized mortality ratios with recent chemoimmunotherapy and targeted therapy.

“Although there are some limitations of this analysis, it provides the best data we have to date about the effects of treatment on early mortality in patients with COVID-19 and cancer. It points to a modest but heterogeneous effect of treatment on outcome, one which is likely to become clearer with larger cohorts and additional analysis,” Dr. Solomon said.

This research was funded by the American Cancer Society, Hope Foundation for Cancer Research, Jim and Carol O’Hare Fund, National Cancer Institute, National Human Genome Research Institute, Vanderbilt Institute for Clinical and Translational Research, and Fonds de Recherche du Quebec-Sante. Dr. Grivas disclosed relationships with many companies, but none are related to this work. Dr. Wise-Draper disclosed relationships with Merck, Bristol-Myers Squibb, Tesaro, GlaxoSmithKline, AstraZeneca, Shattuck Labs, and Rakuten. Dr. Solomon disclosed relationships with Amgen, AstraZeneca, Merck, Bristol-Myers Squibb, Novartis, Pfizer, and Roche-Genentech.

SOURCES: Grivas P et al. ESMO 2020, Abstract LBA72; Wise-Draper TM et al. ESMO 2020, Abstract LBA71.

Restarting breast cancer screening programs after the COVID-19 disruption will be challenging given a trade-off between minimizing excess mortality from the disease and strain on programs, according to a modeling study reported at the 12th European Breast Cancer Conference.

Fallout of the pandemic has included reductions in cancer screening and diagnosis, said study investigator Lindy M. Kregting, a PhD student in the department of public health at Erasmus Medical Center, University Medical Center Rotterdam (the Netherlands).

In the Netherlands, new breast cancer diagnoses fell dramatically from historical levels starting in February. The number in April was less than half of that expected.

Ms. Kregting and colleagues used modeling to assess the impact of four strategies for restarting breast cancer screening in the Netherlands. The strategies differed regarding the population affected, the duration of the effects, and changes in stopping age. The usual situation, without any disruption, served as the comparator.

Results showed wide variation across strategies with respect to the increase in screening capacity needed during the latter half of this year – from 0% to 100% – and the excess breast cancer mortality occurring during 2020-2030 – from as many as 181 excess breast cancer deaths to as few as 14.

“The effects of the disruption are dependent on the chosen restart strategy,” Ms. Kregting summarized. “It would be preferred to immediately catch up because this minimizes the impact, but it also requires a very high capacity, so it may not always be possible. A proper alternative would be to increase the stopping age, so no screens are omitted, because this requires a rather normal capacity, and it will result in only small effects on incidence and mortality.”

As screening programs restart in some countries, there are still a lot of unknowns that could affect outcomes, including how many women will attend given that some may stay away out of fear, Ms. Kregting cautioned.

“We plan to do further model calculations when we know exactly what has happened. ... For now, we just assumed some reasonable disruption periods, and we assumed that capacity would be back to the original, before COVID-19, but I think we can say this is probably not the case,” she added.
 

Study details

Ms. Kregting and colleagues used Dutch breast cancer screening program parameters (biennial digital mammography for women aged 50-75 years) and a microsimulation screening analysis model to simulate four strategies for restarting breast cancer screening after a 6-month disruption:

• “Everyone delay,” a strategy in which all screening continues in the order planned with no change in the stopping age of 75 years (so that one in four women ultimately miss a screening during their lifetime)
• “First rounds no delay,” in which there is a delay in screening except for women having their first screening
• “Continue after stopping age,” in which there is a delay in screening but temporary increasing of the stopping age (to 76.5 years) to ensure all women get their final screen
• “Catch-up after stop,” in which capacity is increased to ensure full catch-up, with all delayed screens caught up in a 6-month period (the second half of 2020).

Results showed that 5,872 women would be screened in the latter half of 2020 if screening proceeded as usual without disruption. The necessary capacity was essentially the same with all of the restarting strategies, except for the catch-up-after-stop strategy, which would require a doubling of that number.

The temporal pattern of breast cancer incidence varied according to restart strategy early on, but incidence essentially returned to that expected with undisrupted screening by 2025 for all four strategies, with some small fluctuations thereafter.

The impact on breast cancer mortality differed considerably long term. It increased slightly and transiently above the expected level with the catch-up-after-stop strategy, but there were sizable, long-lasting increases with the other strategies, with excess deaths still seen in 2060 for the everyone-delay strategy.

In absolute terms, the excess number of breast cancer deaths during 2020-2030, compared with undisrupted screening, was 181 with the everyone-delay strategy, 155 with the first-rounds-no-delay strategy, 145 with the continue-after-stopping-age strategy, and just 14 with the catch-up-after-stop strategy. Ms. Kregting declined to provide numbers for other countries, given that the model is based on the Dutch population and screening program.
 

Results in context

“The unprecedented burden of COVID-19 on health systems worldwide has important implications for cancer care,” said invited discussant Alessandra Gennari, MD, PhD, of the University of Eastern Piedmont and Maggiore della Carità Hospital, both in Novara, Italy.

“There is a delay in diagnosis due to the fact that screening programs and diagnostic programs have been decreased or suspended in many Western countries where this is standard of care. Patients also are more reluctant to present to health care services, delaying their diagnosis,” Dr. Gennari said.

Findings of this new study add to those of similar studies undertaken in Italy (published in In Vivo) and the United Kingdom (published in The Lancet Oncology) showing the likely marked toll of the pandemic on cancer diagnosis and mortality, Dr. Gennari noted. Taken together, the findings underscore the urgent need for policy interventions to mitigate this impact.

“These interventions should focus on increasing routine diagnostic capacity, through which up to 40% of patients with cancer are diagnosed,” Dr. Gennari recommended. “Public health messaging is needed that accurately conveys the risk of severe illness from COVID-19 versus the risks of not seeking health care advice if patients are symptomatic. Finally, there is a need for provision of evidence-based data on which clinicians can adequately base their decision on how to manage the risks of cancer patients and the risks and benefits of procedures during the pandemic.”

The current study did not have any specific funding, and Ms. Kregting disclosed no conflicts of interest. Dr. Gennari disclosed relationships with Roche, Eisai, Lilly, AstraZeneca, Daiichi Sankyo, Merck, Novartis, and Pfizer.

SOURCE: Kregting L et al. EBCC-12 Virtual Conference, Abstract 24.

Restarting breast cancer screening programs after the COVID-19 disruption will be challenging given a trade-off between minimizing excess mortality from the disease and strain on programs, according to a modeling study reported at the 12th European Breast Cancer Conference.

Fallout of the pandemic has included reductions in cancer screening and diagnosis, said study investigator Lindy M. Kregting, a PhD student in the department of public health at Erasmus Medical Center, University Medical Center Rotterdam (the Netherlands).

In the Netherlands, new breast cancer diagnoses fell dramatically from historical levels starting in February. The number in April was less than half of that expected.

Ms. Kregting and colleagues used modeling to assess the impact of four strategies for restarting breast cancer screening in the Netherlands. The strategies differed regarding the population affected, the duration of the effects, and changes in stopping age. The usual situation, without any disruption, served as the comparator.

Results showed wide variation across strategies with respect to the increase in screening capacity needed during the latter half of this year – from 0% to 100% – and the excess breast cancer mortality occurring during 2020-2030 – from as many as 181 excess breast cancer deaths to as few as 14.

“The effects of the disruption are dependent on the chosen restart strategy,” Ms. Kregting summarized. “It would be preferred to immediately catch up because this minimizes the impact, but it also requires a very high capacity, so it may not always be possible. A proper alternative would be to increase the stopping age, so no screens are omitted, because this requires a rather normal capacity, and it will result in only small effects on incidence and mortality.”

As screening programs restart in some countries, there are still a lot of unknowns that could affect outcomes, including how many women will attend given that some may stay away out of fear, Ms. Kregting cautioned.

“We plan to do further model calculations when we know exactly what has happened. ... For now, we just assumed some reasonable disruption periods, and we assumed that capacity would be back to the original, before COVID-19, but I think we can say this is probably not the case,” she added.
 

Study details

Ms. Kregting and colleagues used Dutch breast cancer screening program parameters (biennial digital mammography for women aged 50-75 years) and a microsimulation screening analysis model to simulate four strategies for restarting breast cancer screening after a 6-month disruption:

• “Everyone delay,” a strategy in which all screening continues in the order planned with no change in the stopping age of 75 years (so that one in four women ultimately miss a screening during their lifetime)
• “First rounds no delay,” in which there is a delay in screening except for women having their first screening
• “Continue after stopping age,” in which there is a delay in screening but temporary increasing of the stopping age (to 76.5 years) to ensure all women get their final screen
• “Catch-up after stop,” in which capacity is increased to ensure full catch-up, with all delayed screens caught up in a 6-month period (the second half of 2020).

Results showed that 5,872 women would be screened in the latter half of 2020 if screening proceeded as usual without disruption. The necessary capacity was essentially the same with all of the restarting strategies, except for the catch-up-after-stop strategy, which would require a doubling of that number.

The temporal pattern of breast cancer incidence varied according to restart strategy early on, but incidence essentially returned to that expected with undisrupted screening by 2025 for all four strategies, with some small fluctuations thereafter.

The impact on breast cancer mortality differed considerably long term. It increased slightly and transiently above the expected level with the catch-up-after-stop strategy, but there were sizable, long-lasting increases with the other strategies, with excess deaths still seen in 2060 for the everyone-delay strategy.

In absolute terms, the excess number of breast cancer deaths during 2020-2030, compared with undisrupted screening, was 181 with the everyone-delay strategy, 155 with the first-rounds-no-delay strategy, 145 with the continue-after-stopping-age strategy, and just 14 with the catch-up-after-stop strategy. Ms. Kregting declined to provide numbers for other countries, given that the model is based on the Dutch population and screening program.
 

Results in context

“The unprecedented burden of COVID-19 on health systems worldwide has important implications for cancer care,” said invited discussant Alessandra Gennari, MD, PhD, of the University of Eastern Piedmont and Maggiore della Carità Hospital, both in Novara, Italy.

“There is a delay in diagnosis due to the fact that screening programs and diagnostic programs have been decreased or suspended in many Western countries where this is standard of care. Patients also are more reluctant to present to health care services, delaying their diagnosis,” Dr. Gennari said.

Findings of this new study add to those of similar studies undertaken in Italy (published in In Vivo) and the United Kingdom (published in The Lancet Oncology) showing the likely marked toll of the pandemic on cancer diagnosis and mortality, Dr. Gennari noted. Taken together, the findings underscore the urgent need for policy interventions to mitigate this impact.

“These interventions should focus on increasing routine diagnostic capacity, through which up to 40% of patients with cancer are diagnosed,” Dr. Gennari recommended. “Public health messaging is needed that accurately conveys the risk of severe illness from COVID-19 versus the risks of not seeking health care advice if patients are symptomatic. Finally, there is a need for provision of evidence-based data on which clinicians can adequately base their decision on how to manage the risks of cancer patients and the risks and benefits of procedures during the pandemic.”

The current study did not have any specific funding, and Ms. Kregting disclosed no conflicts of interest. Dr. Gennari disclosed relationships with Roche, Eisai, Lilly, AstraZeneca, Daiichi Sankyo, Merck, Novartis, and Pfizer.

SOURCE: Kregting L et al. EBCC-12 Virtual Conference, Abstract 24.

Restarting breast cancer screening programs after the COVID-19 disruption will be challenging given a trade-off between minimizing excess mortality from the disease and strain on programs, according to a modeling study reported at the 12th European Breast Cancer Conference.

Fallout of the pandemic has included reductions in cancer screening and diagnosis, said study investigator Lindy M. Kregting, a PhD student in the department of public health at Erasmus Medical Center, University Medical Center Rotterdam (the Netherlands).

In the Netherlands, new breast cancer diagnoses fell dramatically from historical levels starting in February. The number in April was less than half of that expected.

Ms. Kregting and colleagues used modeling to assess the impact of four strategies for restarting breast cancer screening in the Netherlands. The strategies differed regarding the population affected, the duration of the effects, and changes in stopping age. The usual situation, without any disruption, served as the comparator.

Results showed wide variation across strategies with respect to the increase in screening capacity needed during the latter half of this year – from 0% to 100% – and the excess breast cancer mortality occurring during 2020-2030 – from as many as 181 excess breast cancer deaths to as few as 14.

“The effects of the disruption are dependent on the chosen restart strategy,” Ms. Kregting summarized. “It would be preferred to immediately catch up because this minimizes the impact, but it also requires a very high capacity, so it may not always be possible. A proper alternative would be to increase the stopping age, so no screens are omitted, because this requires a rather normal capacity, and it will result in only small effects on incidence and mortality.”

As screening programs restart in some countries, there are still a lot of unknowns that could affect outcomes, including how many women will attend given that some may stay away out of fear, Ms. Kregting cautioned.

“We plan to do further model calculations when we know exactly what has happened. ... For now, we just assumed some reasonable disruption periods, and we assumed that capacity would be back to the original, before COVID-19, but I think we can say this is probably not the case,” she added.
 

Study details

Ms. Kregting and colleagues used Dutch breast cancer screening program parameters (biennial digital mammography for women aged 50-75 years) and a microsimulation screening analysis model to simulate four strategies for restarting breast cancer screening after a 6-month disruption:

• “Everyone delay,” a strategy in which all screening continues in the order planned with no change in the stopping age of 75 years (so that one in four women ultimately miss a screening during their lifetime)
• “First rounds no delay,” in which there is a delay in screening except for women having their first screening
• “Continue after stopping age,” in which there is a delay in screening but temporary increasing of the stopping age (to 76.5 years) to ensure all women get their final screen
• “Catch-up after stop,” in which capacity is increased to ensure full catch-up, with all delayed screens caught up in a 6-month period (the second half of 2020).

Results showed that 5,872 women would be screened in the latter half of 2020 if screening proceeded as usual without disruption. The necessary capacity was essentially the same with all of the restarting strategies, except for the catch-up-after-stop strategy, which would require a doubling of that number.

The temporal pattern of breast cancer incidence varied according to restart strategy early on, but incidence essentially returned to that expected with undisrupted screening by 2025 for all four strategies, with some small fluctuations thereafter.

The impact on breast cancer mortality differed considerably long term. It increased slightly and transiently above the expected level with the catch-up-after-stop strategy, but there were sizable, long-lasting increases with the other strategies, with excess deaths still seen in 2060 for the everyone-delay strategy.

In absolute terms, the excess number of breast cancer deaths during 2020-2030, compared with undisrupted screening, was 181 with the everyone-delay strategy, 155 with the first-rounds-no-delay strategy, 145 with the continue-after-stopping-age strategy, and just 14 with the catch-up-after-stop strategy. Ms. Kregting declined to provide numbers for other countries, given that the model is based on the Dutch population and screening program.
 

Results in context

“The unprecedented burden of COVID-19 on health systems worldwide has important implications for cancer care,” said invited discussant Alessandra Gennari, MD, PhD, of the University of Eastern Piedmont and Maggiore della Carità Hospital, both in Novara, Italy.

“There is a delay in diagnosis due to the fact that screening programs and diagnostic programs have been decreased or suspended in many Western countries where this is standard of care. Patients also are more reluctant to present to health care services, delaying their diagnosis,” Dr. Gennari said.

Findings of this new study add to those of similar studies undertaken in Italy (published in In Vivo) and the United Kingdom (published in The Lancet Oncology) showing the likely marked toll of the pandemic on cancer diagnosis and mortality, Dr. Gennari noted. Taken together, the findings underscore the urgent need for policy interventions to mitigate this impact.

“These interventions should focus on increasing routine diagnostic capacity, through which up to 40% of patients with cancer are diagnosed,” Dr. Gennari recommended. “Public health messaging is needed that accurately conveys the risk of severe illness from COVID-19 versus the risks of not seeking health care advice if patients are symptomatic. Finally, there is a need for provision of evidence-based data on which clinicians can adequately base their decision on how to manage the risks of cancer patients and the risks and benefits of procedures during the pandemic.”

The current study did not have any specific funding, and Ms. Kregting disclosed no conflicts of interest. Dr. Gennari disclosed relationships with Roche, Eisai, Lilly, AstraZeneca, Daiichi Sankyo, Merck, Novartis, and Pfizer.

SOURCE: Kregting L et al. EBCC-12 Virtual Conference, Abstract 24.