Analysis reveals poor outcomes in refractory DLBCL

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Analysis reveals poor outcomes in refractory DLBCL

 

Micrograph showing DLBCL

 

Results from the SCHOLAR-1 study revealed poor outcomes of salvage therapy in patients with refractory diffuse large B-cell lymphoma (DLBCL).

 

This retrospective study included data on patients enrolled in 2 randomized trials and 2 academic databases.

 

The patients had primary refractory disease, were refractory to second-line or later therapy, or had relapsed within 12 months of autologous stem cell transplant (ASCT).

 

Twenty-six percent of patients responded to salvage therapy, with 7% achieving a complete response (CR).

 

The median overall survival (OS) was 6.3 months, and 20% of patients were still alive at 2 years’ follow-up.

 

Christian Gisselbrecht, MD, of Saint Louis Hospital in Paris, France, and his colleagues reported these findings in Blood. SCHOLAR-1 was funded through an unrestricted grant from Kite Pharma.

 

“SCHOLAR-1 demonstrates the uniformly poor treatment outcomes for patients with aggressive non-Hodgkin lymphoma and emphasizes the need for breakthrough therapies for these refractory patients,” Dr Gisselbrecht said.

 

Patient characteristics

 

The study included pooled, patient-level data from 2 phase 3 trials and 2 databases:

 

 

 

 

 

 

  • The Canadian Cancer Trials Group study LY.12 (n=219)
  • The Lymphoma Academic Research Organization’s CORAL study  (n=170)
  • A cohort from MD Anderson Cancer Center (n=165)
  • A cohort from the Molecular Epidemiology Resource of the University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence (n=82).

There were a total of 636 patients who met criteria for refractory DLBCL, which included primary mediastinal B-cell lymphoma and transformed follicular lymphoma.

 

Twenty-eight percent of patients were primary refractory, 50% were refractory to second-line or later therapy, and 22% had relapsed within 12 months of transplant.

 

The patients’ median age was 55 (range, 19-81), and 64% were male. Seventy-three percent had an ECOG performance status of 0-1, 14% had a status of 2-4, and 13% were missing this data. Seventy-two percent of patients had stage III-IV disease, 27% had stage I-II disease, and less than 1% were missing this data.

 

Treatments

 

The MD Anderson cohort included patients who were relapsed/refractory to initial rituximab-containing chemotherapy, had failed salvage platinum-containing chemotherapy, and received a second salvage therapy at MD Anderson.

 

The University of Iowa/Mayo Clinic cohort included unselected, newly diagnosed patients with lymphoma who entered prospective documentation of primary and subsequent treatments and outcomes.

 

In the LY.12 study, patients were enrolled upon relapse after anthracycline-containing therapy and randomized to 1 of 2 salvage regimens, with a goal of consolidative ASCT.

 

The CORAL study enrolled patients in their first relapse or whose lymphoma was refractory to first-line therapy. They were randomized to 1 of 2 salvage regimens, with a goal of consolidative ASCT.

 

In the LY.12 and CORAL studies, eligible patients with CD20+ lymphoma were randomized to rituximab maintenance or observation post-ASCT.

 

Response

 

In all, 523 patients were evaluated for response. The overall response rate (ORR) was 26%, with a 7% CR rate and an 18% partial response rate.

 

Among patients with primary refractory disease, the ORR was 20%, and the CR rate was 3%.

 

Among patients who were refractory to second-line or later therapy, the ORR was 26%, and the CR rate was 10%.

 

Among patients who relapsed after transplant, the ORR was 34%, and the CR rate was 15%.

 

Survival

 

A total of 603 patients were evaluated for survival.

 

The median OS from the start of salvage therapy was 6.3 months (range, 5.9-7.0). The 1-year OS rate was 28%, and the 2-year OS was 20%.

 

Among primary refractory patients, the median OS was 7.1 months (range, 6.0-8.1), 1-year OS was 29%, and 2-year OS was 24%.

 

 

 

Among patient who were refractory to second-line or later therapy, the median OS was 6.1 months (range, 5.2-7.0), 1-year OS was 26%, and 2-year OS was 17%.

 

Among patients who relapsed after transplant, the median OS was 6.2 months (range, 5.2-7.6), 1-year OS was 32%, and 2-year OS was 19%.

 

“Although 60% to 70% of non-Hodgkin lymphoma patients survive 5 years after rituximab-based chemotherapy and autologous stem cell transplant, nearly half of them either do not respond or relapse shortly after transplant,” Dr Gisselbrecht noted.

 

“SCHOLAR-1 provides a rigorous measure of outcomes for these patients who do not benefit from currently available therapies, and this landmark study will serve as an important historical control for evaluating new therapeutic candidates in the field of non-Hodgkin lymphoma.”

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Micrograph showing DLBCL

 

Results from the SCHOLAR-1 study revealed poor outcomes of salvage therapy in patients with refractory diffuse large B-cell lymphoma (DLBCL).

 

This retrospective study included data on patients enrolled in 2 randomized trials and 2 academic databases.

 

The patients had primary refractory disease, were refractory to second-line or later therapy, or had relapsed within 12 months of autologous stem cell transplant (ASCT).

 

Twenty-six percent of patients responded to salvage therapy, with 7% achieving a complete response (CR).

 

The median overall survival (OS) was 6.3 months, and 20% of patients were still alive at 2 years’ follow-up.

 

Christian Gisselbrecht, MD, of Saint Louis Hospital in Paris, France, and his colleagues reported these findings in Blood. SCHOLAR-1 was funded through an unrestricted grant from Kite Pharma.

 

“SCHOLAR-1 demonstrates the uniformly poor treatment outcomes for patients with aggressive non-Hodgkin lymphoma and emphasizes the need for breakthrough therapies for these refractory patients,” Dr Gisselbrecht said.

 

Patient characteristics

 

The study included pooled, patient-level data from 2 phase 3 trials and 2 databases:

 

 

 

 

 

 

  • The Canadian Cancer Trials Group study LY.12 (n=219)
  • The Lymphoma Academic Research Organization’s CORAL study  (n=170)
  • A cohort from MD Anderson Cancer Center (n=165)
  • A cohort from the Molecular Epidemiology Resource of the University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence (n=82).

There were a total of 636 patients who met criteria for refractory DLBCL, which included primary mediastinal B-cell lymphoma and transformed follicular lymphoma.

 

Twenty-eight percent of patients were primary refractory, 50% were refractory to second-line or later therapy, and 22% had relapsed within 12 months of transplant.

 

The patients’ median age was 55 (range, 19-81), and 64% were male. Seventy-three percent had an ECOG performance status of 0-1, 14% had a status of 2-4, and 13% were missing this data. Seventy-two percent of patients had stage III-IV disease, 27% had stage I-II disease, and less than 1% were missing this data.

 

Treatments

 

The MD Anderson cohort included patients who were relapsed/refractory to initial rituximab-containing chemotherapy, had failed salvage platinum-containing chemotherapy, and received a second salvage therapy at MD Anderson.

 

The University of Iowa/Mayo Clinic cohort included unselected, newly diagnosed patients with lymphoma who entered prospective documentation of primary and subsequent treatments and outcomes.

 

In the LY.12 study, patients were enrolled upon relapse after anthracycline-containing therapy and randomized to 1 of 2 salvage regimens, with a goal of consolidative ASCT.

 

The CORAL study enrolled patients in their first relapse or whose lymphoma was refractory to first-line therapy. They were randomized to 1 of 2 salvage regimens, with a goal of consolidative ASCT.

 

In the LY.12 and CORAL studies, eligible patients with CD20+ lymphoma were randomized to rituximab maintenance or observation post-ASCT.

 

Response

 

In all, 523 patients were evaluated for response. The overall response rate (ORR) was 26%, with a 7% CR rate and an 18% partial response rate.

 

Among patients with primary refractory disease, the ORR was 20%, and the CR rate was 3%.

 

Among patients who were refractory to second-line or later therapy, the ORR was 26%, and the CR rate was 10%.

 

Among patients who relapsed after transplant, the ORR was 34%, and the CR rate was 15%.

 

Survival

 

A total of 603 patients were evaluated for survival.

 

The median OS from the start of salvage therapy was 6.3 months (range, 5.9-7.0). The 1-year OS rate was 28%, and the 2-year OS was 20%.

 

Among primary refractory patients, the median OS was 7.1 months (range, 6.0-8.1), 1-year OS was 29%, and 2-year OS was 24%.

 

 

 

Among patient who were refractory to second-line or later therapy, the median OS was 6.1 months (range, 5.2-7.0), 1-year OS was 26%, and 2-year OS was 17%.

 

Among patients who relapsed after transplant, the median OS was 6.2 months (range, 5.2-7.6), 1-year OS was 32%, and 2-year OS was 19%.

 

“Although 60% to 70% of non-Hodgkin lymphoma patients survive 5 years after rituximab-based chemotherapy and autologous stem cell transplant, nearly half of them either do not respond or relapse shortly after transplant,” Dr Gisselbrecht noted.

 

“SCHOLAR-1 provides a rigorous measure of outcomes for these patients who do not benefit from currently available therapies, and this landmark study will serve as an important historical control for evaluating new therapeutic candidates in the field of non-Hodgkin lymphoma.”

 

Micrograph showing DLBCL

 

Results from the SCHOLAR-1 study revealed poor outcomes of salvage therapy in patients with refractory diffuse large B-cell lymphoma (DLBCL).

 

This retrospective study included data on patients enrolled in 2 randomized trials and 2 academic databases.

 

The patients had primary refractory disease, were refractory to second-line or later therapy, or had relapsed within 12 months of autologous stem cell transplant (ASCT).

 

Twenty-six percent of patients responded to salvage therapy, with 7% achieving a complete response (CR).

 

The median overall survival (OS) was 6.3 months, and 20% of patients were still alive at 2 years’ follow-up.

 

Christian Gisselbrecht, MD, of Saint Louis Hospital in Paris, France, and his colleagues reported these findings in Blood. SCHOLAR-1 was funded through an unrestricted grant from Kite Pharma.

 

“SCHOLAR-1 demonstrates the uniformly poor treatment outcomes for patients with aggressive non-Hodgkin lymphoma and emphasizes the need for breakthrough therapies for these refractory patients,” Dr Gisselbrecht said.

 

Patient characteristics

 

The study included pooled, patient-level data from 2 phase 3 trials and 2 databases:

 

 

 

 

 

 

  • The Canadian Cancer Trials Group study LY.12 (n=219)
  • The Lymphoma Academic Research Organization’s CORAL study  (n=170)
  • A cohort from MD Anderson Cancer Center (n=165)
  • A cohort from the Molecular Epidemiology Resource of the University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence (n=82).

There were a total of 636 patients who met criteria for refractory DLBCL, which included primary mediastinal B-cell lymphoma and transformed follicular lymphoma.

 

Twenty-eight percent of patients were primary refractory, 50% were refractory to second-line or later therapy, and 22% had relapsed within 12 months of transplant.

 

The patients’ median age was 55 (range, 19-81), and 64% were male. Seventy-three percent had an ECOG performance status of 0-1, 14% had a status of 2-4, and 13% were missing this data. Seventy-two percent of patients had stage III-IV disease, 27% had stage I-II disease, and less than 1% were missing this data.

 

Treatments

 

The MD Anderson cohort included patients who were relapsed/refractory to initial rituximab-containing chemotherapy, had failed salvage platinum-containing chemotherapy, and received a second salvage therapy at MD Anderson.

 

The University of Iowa/Mayo Clinic cohort included unselected, newly diagnosed patients with lymphoma who entered prospective documentation of primary and subsequent treatments and outcomes.

 

In the LY.12 study, patients were enrolled upon relapse after anthracycline-containing therapy and randomized to 1 of 2 salvage regimens, with a goal of consolidative ASCT.

 

The CORAL study enrolled patients in their first relapse or whose lymphoma was refractory to first-line therapy. They were randomized to 1 of 2 salvage regimens, with a goal of consolidative ASCT.

 

In the LY.12 and CORAL studies, eligible patients with CD20+ lymphoma were randomized to rituximab maintenance or observation post-ASCT.

 

Response

 

In all, 523 patients were evaluated for response. The overall response rate (ORR) was 26%, with a 7% CR rate and an 18% partial response rate.

 

Among patients with primary refractory disease, the ORR was 20%, and the CR rate was 3%.

 

Among patients who were refractory to second-line or later therapy, the ORR was 26%, and the CR rate was 10%.

 

Among patients who relapsed after transplant, the ORR was 34%, and the CR rate was 15%.

 

Survival

 

A total of 603 patients were evaluated for survival.

 

The median OS from the start of salvage therapy was 6.3 months (range, 5.9-7.0). The 1-year OS rate was 28%, and the 2-year OS was 20%.

 

Among primary refractory patients, the median OS was 7.1 months (range, 6.0-8.1), 1-year OS was 29%, and 2-year OS was 24%.

 

 

 

Among patient who were refractory to second-line or later therapy, the median OS was 6.1 months (range, 5.2-7.0), 1-year OS was 26%, and 2-year OS was 17%.

 

Among patients who relapsed after transplant, the median OS was 6.2 months (range, 5.2-7.6), 1-year OS was 32%, and 2-year OS was 19%.

 

“Although 60% to 70% of non-Hodgkin lymphoma patients survive 5 years after rituximab-based chemotherapy and autologous stem cell transplant, nearly half of them either do not respond or relapse shortly after transplant,” Dr Gisselbrecht noted.

 

“SCHOLAR-1 provides a rigorous measure of outcomes for these patients who do not benefit from currently available therapies, and this landmark study will serve as an important historical control for evaluating new therapeutic candidates in the field of non-Hodgkin lymphoma.”

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Insured cancer patients report ‘overwhelming’ financial distress

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Cancer patient receiving chemotherapy

A study of 300 US cancer patients showed that paying for care can cause “overwhelming” financial distress, even when patients have health insurance.

Sixteen percent of the patients studied reported “high or overwhelming” financial distress, spending a median of 31% of their monthly household income on healthcare, not including insurance premiums.

They had a median monthly out-of-pocket cost of $728 (range, $6 to $47,250).

Fumiko Chino, MD, of Duke University Medical Center in Durham, North Carolina, and her colleagues reported these findings in a letter to JAMA Oncology.

The researchers interviewed 300 insured cancer patients for this study. They had a median age of 59.6, and 68.3% were married.

Fifty-six percent of patients had private insurance, 35.7% had Medicare, and 7.3% had Medicaid.

Annual household incomes were as follows:

  • 45.7%, $60,000 or greater
  • 15.7%, $40,000 to $59,999
  • 17.7%, $20,000 to 39,999
  • 13.7%, lower than $20,000
  • 7.3%, unknown.

The median monthly out-of-pocket cost for care was $592 (range, $3-$47,250), not including insurance premiums. The median relative cost of care was 11% of a patient’s monthly household income.

“Those who spend more than 10% of their income on healthcare costs are considered underinsured,” Dr Chino said. “Learning about the cost-sharing burden on some insured patients is important right now, given the uncertainty in health insurance.”

Most of the patients studied (83.7%, n=251) reported no, low, or average financial distress. Their median relative cost of care was 10% of their monthly household income, and their median monthly out-of-pocket cost was $565 (range, $3 to $26,756). Six percent of these patients had Medicaid, 39% had Medicare, and 53.8% had private insurance.

For the 16.3% of patients (n=49) who reported high or overwhelming financial distress, 67.3% had private insurance, 18.4% had Medicare, and 14.3% had Medicaid. As stated above, their median relative cost of care was 31% of their monthly household income, and their median monthly out-of-pocket cost was $728 (range, $6 to $47,250).

“This study adds to the growing evidence that we need to intervene,” said study author Yousuf Zafar, MD, of Duke Cancer Institute.

“We know there are a lot of barriers that prevent patients from talking about cost with their providers. We need to create tools for patients at risk of financial toxicity and connect them with resources in a timely fashion so they can afford their care.”

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Photo by Rhoda Baer
Cancer patient receiving chemotherapy

A study of 300 US cancer patients showed that paying for care can cause “overwhelming” financial distress, even when patients have health insurance.

Sixteen percent of the patients studied reported “high or overwhelming” financial distress, spending a median of 31% of their monthly household income on healthcare, not including insurance premiums.

They had a median monthly out-of-pocket cost of $728 (range, $6 to $47,250).

Fumiko Chino, MD, of Duke University Medical Center in Durham, North Carolina, and her colleagues reported these findings in a letter to JAMA Oncology.

The researchers interviewed 300 insured cancer patients for this study. They had a median age of 59.6, and 68.3% were married.

Fifty-six percent of patients had private insurance, 35.7% had Medicare, and 7.3% had Medicaid.

Annual household incomes were as follows:

  • 45.7%, $60,000 or greater
  • 15.7%, $40,000 to $59,999
  • 17.7%, $20,000 to 39,999
  • 13.7%, lower than $20,000
  • 7.3%, unknown.

The median monthly out-of-pocket cost for care was $592 (range, $3-$47,250), not including insurance premiums. The median relative cost of care was 11% of a patient’s monthly household income.

“Those who spend more than 10% of their income on healthcare costs are considered underinsured,” Dr Chino said. “Learning about the cost-sharing burden on some insured patients is important right now, given the uncertainty in health insurance.”

Most of the patients studied (83.7%, n=251) reported no, low, or average financial distress. Their median relative cost of care was 10% of their monthly household income, and their median monthly out-of-pocket cost was $565 (range, $3 to $26,756). Six percent of these patients had Medicaid, 39% had Medicare, and 53.8% had private insurance.

For the 16.3% of patients (n=49) who reported high or overwhelming financial distress, 67.3% had private insurance, 18.4% had Medicare, and 14.3% had Medicaid. As stated above, their median relative cost of care was 31% of their monthly household income, and their median monthly out-of-pocket cost was $728 (range, $6 to $47,250).

“This study adds to the growing evidence that we need to intervene,” said study author Yousuf Zafar, MD, of Duke Cancer Institute.

“We know there are a lot of barriers that prevent patients from talking about cost with their providers. We need to create tools for patients at risk of financial toxicity and connect them with resources in a timely fashion so they can afford their care.”

Photo by Rhoda Baer
Cancer patient receiving chemotherapy

A study of 300 US cancer patients showed that paying for care can cause “overwhelming” financial distress, even when patients have health insurance.

Sixteen percent of the patients studied reported “high or overwhelming” financial distress, spending a median of 31% of their monthly household income on healthcare, not including insurance premiums.

They had a median monthly out-of-pocket cost of $728 (range, $6 to $47,250).

Fumiko Chino, MD, of Duke University Medical Center in Durham, North Carolina, and her colleagues reported these findings in a letter to JAMA Oncology.

The researchers interviewed 300 insured cancer patients for this study. They had a median age of 59.6, and 68.3% were married.

Fifty-six percent of patients had private insurance, 35.7% had Medicare, and 7.3% had Medicaid.

Annual household incomes were as follows:

  • 45.7%, $60,000 or greater
  • 15.7%, $40,000 to $59,999
  • 17.7%, $20,000 to 39,999
  • 13.7%, lower than $20,000
  • 7.3%, unknown.

The median monthly out-of-pocket cost for care was $592 (range, $3-$47,250), not including insurance premiums. The median relative cost of care was 11% of a patient’s monthly household income.

“Those who spend more than 10% of their income on healthcare costs are considered underinsured,” Dr Chino said. “Learning about the cost-sharing burden on some insured patients is important right now, given the uncertainty in health insurance.”

Most of the patients studied (83.7%, n=251) reported no, low, or average financial distress. Their median relative cost of care was 10% of their monthly household income, and their median monthly out-of-pocket cost was $565 (range, $3 to $26,756). Six percent of these patients had Medicaid, 39% had Medicare, and 53.8% had private insurance.

For the 16.3% of patients (n=49) who reported high or overwhelming financial distress, 67.3% had private insurance, 18.4% had Medicare, and 14.3% had Medicaid. As stated above, their median relative cost of care was 31% of their monthly household income, and their median monthly out-of-pocket cost was $728 (range, $6 to $47,250).

“This study adds to the growing evidence that we need to intervene,” said study author Yousuf Zafar, MD, of Duke Cancer Institute.

“We know there are a lot of barriers that prevent patients from talking about cost with their providers. We need to create tools for patients at risk of financial toxicity and connect them with resources in a timely fashion so they can afford their care.”

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Advanced cancer patients have lower survival after cardiac arrest

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Hospital room

A new study suggests patients with advanced cancer who suffer cardiac arrest in the hospital have a survival rate of less than 10%, which is about half the rate of patients without cancer who suffer cardiac arrest.

This finding helps to clear up some myths about cardiac arrest survival and can be used as a guidepost when hospitalized cancer patients and their families consider do-not-resuscitate (DNR) orders, said Jeffrey T. Bruckel, MD, of the University of Rochester Medical Center in New York.

“We’re hopeful that our study, in some way, will help doctors and cancer patients make more informed decisions about the end of life,” Dr Bruckel said. “It’s very important to have early, frank discussions around the goals of care.”

Dr Bruckel and his colleagues published their study in the Journal of Oncology Practice.

The researchers used a US-wide resuscitation registry to evaluate survival after cardiac arrest in patients treated at 369 hospitals.

The study excluded patients with implantable defibrillators and those who were admitted for surgery, emergency room treatment, rehabilitation, or treatment from cardiac catheterization labs or interventional radiology.

Of the 47,157 eligible patients who experienced cardiac arrest, 14% (n=6585) had advanced cancer, including hematologic malignancies.

After cardiac arrest, 57.5% of the advanced cancer patients were resuscitated successfully, as were 63% of non-cancer patients (P<0.001).

After resuscitation, 9.6% of the cancer patients survived to be discharged, compared to 19.2% of non-cancer patients (P<0.001).

When the researchers adjusted their analysis for potential confounders, results were similar. The rate of successful resuscitation was 52.3% in advanced cancer patients and 56.6% in non-cancer patients (P<0.001). The rate of survival to discharge was 7.4% and 13.4%, respectively (P<0.001).

Dr Bruckel said there was no evidence to suggest that patients with advanced cancer received less aggressive resuscitation care.

However, there was a significant difference in the mean duration of resuscitation time among non-survivors with cancer—22.5 minutes—and non-survivors without cancer—24.2 minutes (P<0.001). After adjustment, the mean duration of resuscitation was 22.5 minutes and 24.1 minutes, respectively (P<0.001).

Cancer patients were more likely than those without cancer to sign DNR orders after resuscitation—55.6% and 43%, respectively (P<0.001). Results were similar after adjustment—50.4% and 41.6%, respectively (P<0.001).

Dr Bruckel and his colleagues said there were several limitations to this study, including a lack of detailed data on the types of advanced cancer and cancer treatments being given at the time of cardiac arrest.

Therefore, the next step in advancing this work is to gather data on the types of cancer diagnosis and treatment plans of patients who undergo in-hospital cardiac arrest.

Dr Bruckel also believes it is important to know how patients feel about this data and how both patients and physicians are using this data in decision-making.

“A large component of end-of-life care involves patient and family care decision-making, and a lot of that is driven by the routine discussions that we have,” Dr Bruckel said. “Not every patient is going to want detailed information, but for those that do, it’s important to have it. It’s important to tell them what we know.” 

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Photo by Diane Reid
Hospital room

A new study suggests patients with advanced cancer who suffer cardiac arrest in the hospital have a survival rate of less than 10%, which is about half the rate of patients without cancer who suffer cardiac arrest.

This finding helps to clear up some myths about cardiac arrest survival and can be used as a guidepost when hospitalized cancer patients and their families consider do-not-resuscitate (DNR) orders, said Jeffrey T. Bruckel, MD, of the University of Rochester Medical Center in New York.

“We’re hopeful that our study, in some way, will help doctors and cancer patients make more informed decisions about the end of life,” Dr Bruckel said. “It’s very important to have early, frank discussions around the goals of care.”

Dr Bruckel and his colleagues published their study in the Journal of Oncology Practice.

The researchers used a US-wide resuscitation registry to evaluate survival after cardiac arrest in patients treated at 369 hospitals.

The study excluded patients with implantable defibrillators and those who were admitted for surgery, emergency room treatment, rehabilitation, or treatment from cardiac catheterization labs or interventional radiology.

Of the 47,157 eligible patients who experienced cardiac arrest, 14% (n=6585) had advanced cancer, including hematologic malignancies.

After cardiac arrest, 57.5% of the advanced cancer patients were resuscitated successfully, as were 63% of non-cancer patients (P<0.001).

After resuscitation, 9.6% of the cancer patients survived to be discharged, compared to 19.2% of non-cancer patients (P<0.001).

When the researchers adjusted their analysis for potential confounders, results were similar. The rate of successful resuscitation was 52.3% in advanced cancer patients and 56.6% in non-cancer patients (P<0.001). The rate of survival to discharge was 7.4% and 13.4%, respectively (P<0.001).

Dr Bruckel said there was no evidence to suggest that patients with advanced cancer received less aggressive resuscitation care.

However, there was a significant difference in the mean duration of resuscitation time among non-survivors with cancer—22.5 minutes—and non-survivors without cancer—24.2 minutes (P<0.001). After adjustment, the mean duration of resuscitation was 22.5 minutes and 24.1 minutes, respectively (P<0.001).

Cancer patients were more likely than those without cancer to sign DNR orders after resuscitation—55.6% and 43%, respectively (P<0.001). Results were similar after adjustment—50.4% and 41.6%, respectively (P<0.001).

Dr Bruckel and his colleagues said there were several limitations to this study, including a lack of detailed data on the types of advanced cancer and cancer treatments being given at the time of cardiac arrest.

Therefore, the next step in advancing this work is to gather data on the types of cancer diagnosis and treatment plans of patients who undergo in-hospital cardiac arrest.

Dr Bruckel also believes it is important to know how patients feel about this data and how both patients and physicians are using this data in decision-making.

“A large component of end-of-life care involves patient and family care decision-making, and a lot of that is driven by the routine discussions that we have,” Dr Bruckel said. “Not every patient is going to want detailed information, but for those that do, it’s important to have it. It’s important to tell them what we know.” 

Photo by Diane Reid
Hospital room

A new study suggests patients with advanced cancer who suffer cardiac arrest in the hospital have a survival rate of less than 10%, which is about half the rate of patients without cancer who suffer cardiac arrest.

This finding helps to clear up some myths about cardiac arrest survival and can be used as a guidepost when hospitalized cancer patients and their families consider do-not-resuscitate (DNR) orders, said Jeffrey T. Bruckel, MD, of the University of Rochester Medical Center in New York.

“We’re hopeful that our study, in some way, will help doctors and cancer patients make more informed decisions about the end of life,” Dr Bruckel said. “It’s very important to have early, frank discussions around the goals of care.”

Dr Bruckel and his colleagues published their study in the Journal of Oncology Practice.

The researchers used a US-wide resuscitation registry to evaluate survival after cardiac arrest in patients treated at 369 hospitals.

The study excluded patients with implantable defibrillators and those who were admitted for surgery, emergency room treatment, rehabilitation, or treatment from cardiac catheterization labs or interventional radiology.

Of the 47,157 eligible patients who experienced cardiac arrest, 14% (n=6585) had advanced cancer, including hematologic malignancies.

After cardiac arrest, 57.5% of the advanced cancer patients were resuscitated successfully, as were 63% of non-cancer patients (P<0.001).

After resuscitation, 9.6% of the cancer patients survived to be discharged, compared to 19.2% of non-cancer patients (P<0.001).

When the researchers adjusted their analysis for potential confounders, results were similar. The rate of successful resuscitation was 52.3% in advanced cancer patients and 56.6% in non-cancer patients (P<0.001). The rate of survival to discharge was 7.4% and 13.4%, respectively (P<0.001).

Dr Bruckel said there was no evidence to suggest that patients with advanced cancer received less aggressive resuscitation care.

However, there was a significant difference in the mean duration of resuscitation time among non-survivors with cancer—22.5 minutes—and non-survivors without cancer—24.2 minutes (P<0.001). After adjustment, the mean duration of resuscitation was 22.5 minutes and 24.1 minutes, respectively (P<0.001).

Cancer patients were more likely than those without cancer to sign DNR orders after resuscitation—55.6% and 43%, respectively (P<0.001). Results were similar after adjustment—50.4% and 41.6%, respectively (P<0.001).

Dr Bruckel and his colleagues said there were several limitations to this study, including a lack of detailed data on the types of advanced cancer and cancer treatments being given at the time of cardiac arrest.

Therefore, the next step in advancing this work is to gather data on the types of cancer diagnosis and treatment plans of patients who undergo in-hospital cardiac arrest.

Dr Bruckel also believes it is important to know how patients feel about this data and how both patients and physicians are using this data in decision-making.

“A large component of end-of-life care involves patient and family care decision-making, and a lot of that is driven by the routine discussions that we have,” Dr Bruckel said. “Not every patient is going to want detailed information, but for those that do, it’s important to have it. It’s important to tell them what we know.” 

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Database may provide insight into childhood cancers

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A database containing information on more than 11,000 tumors is now available to researchers studying pediatric cancers.

The database was created as part of UC Santa Cruz Genomics Institute’s Treehouse Childhood Cancer Initiative.

The goal of this initiative is to allow researchers to analyze their patients’ data alongside data from thousands of patients with pediatric and adult cancers, including leukemias and lymphomas.

The intention is to help researchers find hidden causes of cancer that may be missed when they analyze a patient’s data in isolation.

The database, which is available at https://treehouse.xenahubs.net, contains RNA-sequencing gene expression data, as well as information on patients’ age, sex, and disease.

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Photo by Darren Baker
Researcher at a computer

A database containing information on more than 11,000 tumors is now available to researchers studying pediatric cancers.

The database was created as part of UC Santa Cruz Genomics Institute’s Treehouse Childhood Cancer Initiative.

The goal of this initiative is to allow researchers to analyze their patients’ data alongside data from thousands of patients with pediatric and adult cancers, including leukemias and lymphomas.

The intention is to help researchers find hidden causes of cancer that may be missed when they analyze a patient’s data in isolation.

The database, which is available at https://treehouse.xenahubs.net, contains RNA-sequencing gene expression data, as well as information on patients’ age, sex, and disease.

Photo by Darren Baker
Researcher at a computer

A database containing information on more than 11,000 tumors is now available to researchers studying pediatric cancers.

The database was created as part of UC Santa Cruz Genomics Institute’s Treehouse Childhood Cancer Initiative.

The goal of this initiative is to allow researchers to analyze their patients’ data alongside data from thousands of patients with pediatric and adult cancers, including leukemias and lymphomas.

The intention is to help researchers find hidden causes of cancer that may be missed when they analyze a patient’s data in isolation.

The database, which is available at https://treehouse.xenahubs.net, contains RNA-sequencing gene expression data, as well as information on patients’ age, sex, and disease.

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Solid organ transplantation contributes significantly to incidence of NHL among children and adolescents

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Solid organ transplant recipients contribute a disproportionate fraction of pediatric non-Hodgkin lymphoma (NHL) cases, especially diffuse large B-cell lymphoma cases (DLBCL), according to an analysis of data drawn from transplant and cancer registries.

Investigators calculated that the incidence of NHL for the pediatric transplant population was 257 times higher than the general population, after analysis from the U.S. transplant registry and 16 cancer registries from around the country between 1990 and 2012. The incidence of NHL for the pediatric transplant population was 306 cases per 100,000 person-years (95% CI, 271-344), compared to 1.19 cases per 100,000 person-years (95% CI, 1.12-1.27) in the general population. Furthermore, transplant recipients made up a much larger proportion of general population DLBCL cases (7.62%; 95% CI, 6.35%-8.88%).

In the general population, the most common subtypes were DLBCL (25% of cases), Burkitt lymphoma (24%), and precursor cell lymphoblastic lymphoma (20%). Among NHLs diagnosed in transplant recipients, 65% were DLBCL, and 9% were Burkitt lymphoma, whereas there were no cases of precursor cell lymphoblastic lymphoma, reported Elizabeth L. Yanik, PhD, of Washington University, St. Louis, and her associates (Cancer. 2017 Jul 31. doi: 10.1002/cncr.30923).

The increased risk of NHL and other cancers for organ transplant recipients is primarily the result of the immunosuppressant medications administered after transplantation, leading to an increased risk of infection-related cancers, the authors said.

“NHL cases are largely attributable to EBV [Epstein-Barr virus] infections that occur while recipients are immunosuppressed, as evidenced by the high prevalence of EBV detectable in NHL tumors and particularly in cases diagnosed during the heavily immunosuppressed period early after transplantation,” wrote Dr. Yanik and her colleagues. “Patients who experience a primary EBV infection after transplantation are particularly susceptible because transplant recipients have a higher NHL risk if they are seronegative for EBV before transplantation.”

Among those at risk, Dr. Yanik and fellow investigators found transplant patients younger than 5 years were the most susceptible to NHL, making up 19.79% of those diagnosed with DLBCL.

The proportion of NHL in solid organ transplant recipients within the entire pediatric NHL population has risen over time, from 1.66% of the NHL population during 1990-1994 to 3.73% during 2010-2012.

“This trend is driven by the rising prevalence of transplant recipients in the general population and not by increases in NHL risk among transplant recipients,” noted Dr. Yanik and her coauthors. “The proportion of NHL diagnoses attributable to transplant recipients has grown over time, and it is likely that this population will be an important source of pediatric NHL cases in the future.”

This study was partially funded by the National Cancer Institute. One coauthor reported being an employee at GRAIL Inc. No other relevant financial disclosures were reported.

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Solid organ transplant recipients contribute a disproportionate fraction of pediatric non-Hodgkin lymphoma (NHL) cases, especially diffuse large B-cell lymphoma cases (DLBCL), according to an analysis of data drawn from transplant and cancer registries.

Investigators calculated that the incidence of NHL for the pediatric transplant population was 257 times higher than the general population, after analysis from the U.S. transplant registry and 16 cancer registries from around the country between 1990 and 2012. The incidence of NHL for the pediatric transplant population was 306 cases per 100,000 person-years (95% CI, 271-344), compared to 1.19 cases per 100,000 person-years (95% CI, 1.12-1.27) in the general population. Furthermore, transplant recipients made up a much larger proportion of general population DLBCL cases (7.62%; 95% CI, 6.35%-8.88%).

In the general population, the most common subtypes were DLBCL (25% of cases), Burkitt lymphoma (24%), and precursor cell lymphoblastic lymphoma (20%). Among NHLs diagnosed in transplant recipients, 65% were DLBCL, and 9% were Burkitt lymphoma, whereas there were no cases of precursor cell lymphoblastic lymphoma, reported Elizabeth L. Yanik, PhD, of Washington University, St. Louis, and her associates (Cancer. 2017 Jul 31. doi: 10.1002/cncr.30923).

The increased risk of NHL and other cancers for organ transplant recipients is primarily the result of the immunosuppressant medications administered after transplantation, leading to an increased risk of infection-related cancers, the authors said.

“NHL cases are largely attributable to EBV [Epstein-Barr virus] infections that occur while recipients are immunosuppressed, as evidenced by the high prevalence of EBV detectable in NHL tumors and particularly in cases diagnosed during the heavily immunosuppressed period early after transplantation,” wrote Dr. Yanik and her colleagues. “Patients who experience a primary EBV infection after transplantation are particularly susceptible because transplant recipients have a higher NHL risk if they are seronegative for EBV before transplantation.”

Among those at risk, Dr. Yanik and fellow investigators found transplant patients younger than 5 years were the most susceptible to NHL, making up 19.79% of those diagnosed with DLBCL.

The proportion of NHL in solid organ transplant recipients within the entire pediatric NHL population has risen over time, from 1.66% of the NHL population during 1990-1994 to 3.73% during 2010-2012.

“This trend is driven by the rising prevalence of transplant recipients in the general population and not by increases in NHL risk among transplant recipients,” noted Dr. Yanik and her coauthors. “The proportion of NHL diagnoses attributable to transplant recipients has grown over time, and it is likely that this population will be an important source of pediatric NHL cases in the future.”

This study was partially funded by the National Cancer Institute. One coauthor reported being an employee at GRAIL Inc. No other relevant financial disclosures were reported.

 

Solid organ transplant recipients contribute a disproportionate fraction of pediatric non-Hodgkin lymphoma (NHL) cases, especially diffuse large B-cell lymphoma cases (DLBCL), according to an analysis of data drawn from transplant and cancer registries.

Investigators calculated that the incidence of NHL for the pediatric transplant population was 257 times higher than the general population, after analysis from the U.S. transplant registry and 16 cancer registries from around the country between 1990 and 2012. The incidence of NHL for the pediatric transplant population was 306 cases per 100,000 person-years (95% CI, 271-344), compared to 1.19 cases per 100,000 person-years (95% CI, 1.12-1.27) in the general population. Furthermore, transplant recipients made up a much larger proportion of general population DLBCL cases (7.62%; 95% CI, 6.35%-8.88%).

In the general population, the most common subtypes were DLBCL (25% of cases), Burkitt lymphoma (24%), and precursor cell lymphoblastic lymphoma (20%). Among NHLs diagnosed in transplant recipients, 65% were DLBCL, and 9% were Burkitt lymphoma, whereas there were no cases of precursor cell lymphoblastic lymphoma, reported Elizabeth L. Yanik, PhD, of Washington University, St. Louis, and her associates (Cancer. 2017 Jul 31. doi: 10.1002/cncr.30923).

The increased risk of NHL and other cancers for organ transplant recipients is primarily the result of the immunosuppressant medications administered after transplantation, leading to an increased risk of infection-related cancers, the authors said.

“NHL cases are largely attributable to EBV [Epstein-Barr virus] infections that occur while recipients are immunosuppressed, as evidenced by the high prevalence of EBV detectable in NHL tumors and particularly in cases diagnosed during the heavily immunosuppressed period early after transplantation,” wrote Dr. Yanik and her colleagues. “Patients who experience a primary EBV infection after transplantation are particularly susceptible because transplant recipients have a higher NHL risk if they are seronegative for EBV before transplantation.”

Among those at risk, Dr. Yanik and fellow investigators found transplant patients younger than 5 years were the most susceptible to NHL, making up 19.79% of those diagnosed with DLBCL.

The proportion of NHL in solid organ transplant recipients within the entire pediatric NHL population has risen over time, from 1.66% of the NHL population during 1990-1994 to 3.73% during 2010-2012.

“This trend is driven by the rising prevalence of transplant recipients in the general population and not by increases in NHL risk among transplant recipients,” noted Dr. Yanik and her coauthors. “The proportion of NHL diagnoses attributable to transplant recipients has grown over time, and it is likely that this population will be an important source of pediatric NHL cases in the future.”

This study was partially funded by the National Cancer Institute. One coauthor reported being an employee at GRAIL Inc. No other relevant financial disclosures were reported.

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Key clinical point: Solid organ transplant recipients contribute a disproportionate fraction of pediatric NHL cases, especially DLBCL cases.

Major finding: Incidence of NHL among the pediatric transplant population was 257 times higher at 306 cases per 100,000 person-years (95% CI, 271-344), compared to 1.19 cases per 100,000 person-years (95% CI, 1.12-1.27) in the general pediatric population.

Data source: Retrospective cohort study of children and adolescents in the U.S. transplant registry and 16 cancer registries from around the country between 1990 and 2012.

Disclosures: This study was partially funded by the National Cancer Institute. One coauthor reported being an employee at GRAIL Inc. No other relevant financial disclosures were reported.

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FDA grants priority review of acalabrutinib for second-line treatment of MCL

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The Food and Drug Administration has granted a priority review for acalabrutinib, a Bruton tyrosine kinase inhibitor, for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

The new drug application is based on results from the phase 2 ACE-LY-004 trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory MCL who had received at least one prior therapy.

Results from the trial will be submitted for presentation at a forthcoming medical meeting, makers of the drug AstraZeneca said in a press release announcing the priority review. The company also has a phase 3 trial underway evaluating acalabrutinib as a first-line treatment for patients with MCL.

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The Food and Drug Administration has granted a priority review for acalabrutinib, a Bruton tyrosine kinase inhibitor, for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

The new drug application is based on results from the phase 2 ACE-LY-004 trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory MCL who had received at least one prior therapy.

Results from the trial will be submitted for presentation at a forthcoming medical meeting, makers of the drug AstraZeneca said in a press release announcing the priority review. The company also has a phase 3 trial underway evaluating acalabrutinib as a first-line treatment for patients with MCL.

 

The Food and Drug Administration has granted a priority review for acalabrutinib, a Bruton tyrosine kinase inhibitor, for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

The new drug application is based on results from the phase 2 ACE-LY-004 trial, which evaluated the safety and efficacy of acalabrutinib in patients with relapsed/refractory MCL who had received at least one prior therapy.

Results from the trial will be submitted for presentation at a forthcoming medical meeting, makers of the drug AstraZeneca said in a press release announcing the priority review. The company also has a phase 3 trial underway evaluating acalabrutinib as a first-line treatment for patients with MCL.

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Delirium linked to early death in advanced cancer patients

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Doctor evaluating patient

A diagnosis of delirium during a visit to the emergency department (ED) is a poor prognostic factor for patients with advanced cancer, according to research published in The Oncologist.

The study showed that patients with advanced cancer who were diagnosed with delirium during an ED visit were more likely to be admitted to the hospital or intensive care unit (ICU) and more likely to die earlier than patients without delirium.

This shows the importance of accurately diagnosing delirium in advanced cancer patients, said Ahmed Elsayem, MD, of the University of Texas MD Anderson Cancer Center in Houston.

Previous studies have shown that delirium is associated with poor survival in advanced cancer patients being treated in ICUs or receiving palliative care in hospices, but no one had investigated whether the same was true for patients visiting EDs.

“To the best our knowledge, this is the first study to show the poor survival of advanced cancer patients in the emergency department setting,” Dr Elsayem said.

He and his colleagues previously conducted a study in which they assessed the frequency of delirium in advanced cancer patients visiting the ED at MD Anderson. The researchers tested for delirium using 2 questionnaires—the Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS).

Questioning 243 patients in total, the team found that 44 patients, or 18%, were suffering with delirium according to at least 1 of the questionnaires.

In the current study, Dr Elsayem and his colleagues determined how many of these cancer patients, with and without delirium, were subsequently admitted to hospital and ICUs, as well as how long the patients lived after their visit to the ED.

Results

The rate of hospitalization was 82% among patients with delirium according to CAM and/or MDAS, 77% among patients with delirium according to MDAS only, and 49% among patients without delirium (P=0.0013). Rates of ICU admission were 18%, 14%, and 2%, respectively (P=0.0004).

The median overall survival was 1.23 months for patients with delirium according to CAM and/or MDAS, 4.70 months for patients with delirium according to MDAS only, and 10.45 months for patients without delirium. The difference between the patients with and without delirium was significant (P<0.0001).

Given the influence delirium appears to have on survival, Dr Elsayem said prompt diagnosis and management in hospital EDs is essential.

He noted that, in many cases, delirium in advanced cancer patients can be resolved by simply stopping or modifying their medication and treating any associated infections.

“Treating the triggers if known—such as stopping medications—is the main treatment for an episode of delirium,” Dr Elsayem said.

He also suggested that further research needs to be done on this topic, including conducting similar studies on delirium in advanced cancer patients in other EDs and with larger groups of patients.

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Photo courtesy of the CDC
Doctor evaluating patient

A diagnosis of delirium during a visit to the emergency department (ED) is a poor prognostic factor for patients with advanced cancer, according to research published in The Oncologist.

The study showed that patients with advanced cancer who were diagnosed with delirium during an ED visit were more likely to be admitted to the hospital or intensive care unit (ICU) and more likely to die earlier than patients without delirium.

This shows the importance of accurately diagnosing delirium in advanced cancer patients, said Ahmed Elsayem, MD, of the University of Texas MD Anderson Cancer Center in Houston.

Previous studies have shown that delirium is associated with poor survival in advanced cancer patients being treated in ICUs or receiving palliative care in hospices, but no one had investigated whether the same was true for patients visiting EDs.

“To the best our knowledge, this is the first study to show the poor survival of advanced cancer patients in the emergency department setting,” Dr Elsayem said.

He and his colleagues previously conducted a study in which they assessed the frequency of delirium in advanced cancer patients visiting the ED at MD Anderson. The researchers tested for delirium using 2 questionnaires—the Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS).

Questioning 243 patients in total, the team found that 44 patients, or 18%, were suffering with delirium according to at least 1 of the questionnaires.

In the current study, Dr Elsayem and his colleagues determined how many of these cancer patients, with and without delirium, were subsequently admitted to hospital and ICUs, as well as how long the patients lived after their visit to the ED.

Results

The rate of hospitalization was 82% among patients with delirium according to CAM and/or MDAS, 77% among patients with delirium according to MDAS only, and 49% among patients without delirium (P=0.0013). Rates of ICU admission were 18%, 14%, and 2%, respectively (P=0.0004).

The median overall survival was 1.23 months for patients with delirium according to CAM and/or MDAS, 4.70 months for patients with delirium according to MDAS only, and 10.45 months for patients without delirium. The difference between the patients with and without delirium was significant (P<0.0001).

Given the influence delirium appears to have on survival, Dr Elsayem said prompt diagnosis and management in hospital EDs is essential.

He noted that, in many cases, delirium in advanced cancer patients can be resolved by simply stopping or modifying their medication and treating any associated infections.

“Treating the triggers if known—such as stopping medications—is the main treatment for an episode of delirium,” Dr Elsayem said.

He also suggested that further research needs to be done on this topic, including conducting similar studies on delirium in advanced cancer patients in other EDs and with larger groups of patients.

Photo courtesy of the CDC
Doctor evaluating patient

A diagnosis of delirium during a visit to the emergency department (ED) is a poor prognostic factor for patients with advanced cancer, according to research published in The Oncologist.

The study showed that patients with advanced cancer who were diagnosed with delirium during an ED visit were more likely to be admitted to the hospital or intensive care unit (ICU) and more likely to die earlier than patients without delirium.

This shows the importance of accurately diagnosing delirium in advanced cancer patients, said Ahmed Elsayem, MD, of the University of Texas MD Anderson Cancer Center in Houston.

Previous studies have shown that delirium is associated with poor survival in advanced cancer patients being treated in ICUs or receiving palliative care in hospices, but no one had investigated whether the same was true for patients visiting EDs.

“To the best our knowledge, this is the first study to show the poor survival of advanced cancer patients in the emergency department setting,” Dr Elsayem said.

He and his colleagues previously conducted a study in which they assessed the frequency of delirium in advanced cancer patients visiting the ED at MD Anderson. The researchers tested for delirium using 2 questionnaires—the Confusion Assessment Method (CAM) and Memorial Delirium Assessment Scale (MDAS).

Questioning 243 patients in total, the team found that 44 patients, or 18%, were suffering with delirium according to at least 1 of the questionnaires.

In the current study, Dr Elsayem and his colleagues determined how many of these cancer patients, with and without delirium, were subsequently admitted to hospital and ICUs, as well as how long the patients lived after their visit to the ED.

Results

The rate of hospitalization was 82% among patients with delirium according to CAM and/or MDAS, 77% among patients with delirium according to MDAS only, and 49% among patients without delirium (P=0.0013). Rates of ICU admission were 18%, 14%, and 2%, respectively (P=0.0004).

The median overall survival was 1.23 months for patients with delirium according to CAM and/or MDAS, 4.70 months for patients with delirium according to MDAS only, and 10.45 months for patients without delirium. The difference between the patients with and without delirium was significant (P<0.0001).

Given the influence delirium appears to have on survival, Dr Elsayem said prompt diagnosis and management in hospital EDs is essential.

He noted that, in many cases, delirium in advanced cancer patients can be resolved by simply stopping or modifying their medication and treating any associated infections.

“Treating the triggers if known—such as stopping medications—is the main treatment for an episode of delirium,” Dr Elsayem said.

He also suggested that further research needs to be done on this topic, including conducting similar studies on delirium in advanced cancer patients in other EDs and with larger groups of patients.

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FDA grants acalabrutinib breakthrough designation

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Mantle cell lymphoma

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to acalabrutinib, a BTK inhibitor being developed to treat multiple B-cell malignancies.

The breakthrough designation applies to acalabrutinib as a treatment for patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy.

The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

The FDA granted acalabrutinib breakthrough designation based on data from the drug’s development program, which includes data from the phase 2 ACE-LY-004 trial in patients with relapsed or refractory MCL.

Data from this trial have not yet been released to the public but are expected to be presented at an upcoming medical meeting.

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Mantle cell lymphoma

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to acalabrutinib, a BTK inhibitor being developed to treat multiple B-cell malignancies.

The breakthrough designation applies to acalabrutinib as a treatment for patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy.

The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

The FDA granted acalabrutinib breakthrough designation based on data from the drug’s development program, which includes data from the phase 2 ACE-LY-004 trial in patients with relapsed or refractory MCL.

Data from this trial have not yet been released to the public but are expected to be presented at an upcoming medical meeting.

Mantle cell lymphoma

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to acalabrutinib, a BTK inhibitor being developed to treat multiple B-cell malignancies.

The breakthrough designation applies to acalabrutinib as a treatment for patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy.

The FDA’s breakthrough designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

The designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

The FDA granted acalabrutinib breakthrough designation based on data from the drug’s development program, which includes data from the phase 2 ACE-LY-004 trial in patients with relapsed or refractory MCL.

Data from this trial have not yet been released to the public but are expected to be presented at an upcoming medical meeting.

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Clinical Endpoints in PTCL: The Road Less Traveled

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Release Date: August 1, 2017
Expiration Date: July 31, 2018

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Agenda

Developing New Strategic Goals in PTCL (duration 27:00)
Andrei R. Shustov, MD
University of Washington School of Medicine
Fred Hutchinson Cancer Research Center
Seattle, WA, USA

PTCL as a Rare Disease: A Case of Overall Survival (duration 19:00)
Owen A. O’Connor, MD, PhD
Columbia University Medical Center
The New York Presbyterian Hospital
New York, NY, USA

Why Might Response Rates Differ Between the East and West? (duration 17:00)
Kensei Tobinai, MD, PhD
National Cancer Center Hospital
Tokyo, Japan

Provided by:

Original activity supported by an educational grant from:

Spectrum Pharmaceuticals

Learning Objectives

At the end of the activity, participants should be able to:

  • Explain why progression-free survival is important when treating patients with PTCL
  • Determine when overall survival is possible
  • Describe the challenges of using matched control analysis in PTCL clinical trials
  • Discuss why different response rates to therapy for PTCL may be seen in Asian patients versus North American or European patients and define the possible contributing factors

Target Audience

Hematologists, oncologists, and other clinicians and scientists with an interest in T-cell lymphoma

Statement of Need

This activity explores clinical endpoints in PTCL, the importance of choosing the appropriate ones and the possibility of achieving them. Global and regional differences in PTCL are also explored as they relate to response rates. The presentations highlight the challenges physicians face in treating PTCL patients and recent developments are discussed to help practitioners evaluate the utility of these endpoints in choosing appropriate treatments to improve outcomes in their patients with PTCL.

 

FACULTY

Faculty

Andrei R. Shustov, MD
Disclosures: Consulting fee: Celgene; BMS

Owen O’Connor, MD, PhD
Disclosures: Consulting fees: Mundipharma; Celgene; Contracted Research: Mundipharma; Spectrum; Celgene; Seattle Genetics; TG Therapeutics; ADCT; Trillium

Kensei Tobinai, MD, PhD
Disclosures: Honoraria: Eisai; HUYA Bioscience International; Janssen; Mundipharma; Takeda; Zenyaku Kogyo; Contracted research: Abbvie; Celgene; Chugai Pharma; Eisai; GlaxoSmithKline; Janssen; Kyowa Hakko Kirin; Mundipharma; Ono Pharmaceutical; SERVIER; Takeda

Permissions

Andrei Shustov presentation

  • Slide 7: PTCL Prognosis Is Indicative of Diverse Biology
    • Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
  • Slide 8: PTCL: Global Epidemiology
    • Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
  • Slide 9: PTCL: USA Epidemiology (top half)
    • Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
  • Slide 9: PTCL: USA Epidemiology (bottom half)
    • Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
  • Slide 10: PTCL Prognosis: Histology x Race (USA)
    • Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
  • Slide 12: PTCL Prognosis: Clinical Features (top right side)
    • Reprinted with permission. © 2013 American Society of Clinical Oncology. All rights reserved.
  • Slide 14: PTCL Prognosis: Molecular Classifiers (left side)
    • Republished with permission of the American Society of Hematology, from Parilla Castellar ER, et al. Blood 2014;124:1473-1480
  • Slide 14: PTCL Prognosis: Molecular Classifiers (right side)
    • Republished with permission of the American Society of Hematology, from Iqbal J, et al. Blood 2014;123:2915-2923
  • Slide 17: US Epidemiology of PTCL
    • Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
  • Slides 18-19: Romidepsin in Relapsed/Refractory PTCL
    • Reprinted with permission. © 2012 American Society of Clinical Oncology. All rights reserved.
  • Slides 20-22, 25: Romidepsin in Elderly Patients
    • Shustov A, et al. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma 2017 [Epub ahead of print]. Reprinted by permission of Taylor & Francis Ltd, http://www.tandfonline.com
  • Slides 27-28: Belinostat in Relapsed/Refractory PTCL
    • Reprinted with permission. © 2015 American Society of Clinical Oncology. All rights reserved.

Kensei Tobinai presentation

  • Slide 7: Overall Survival of ATL Pts in JCOG 9801
    • Reprinted with permission. © 2007 American Society of Clinical Oncology. All rights reserved.

Disclaimer

The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of Hemedicus, the supporter, or Frontline Medical Communications. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.

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Agenda

Developing New Strategic Goals in PTCL (duration 27:00)
Andrei R. Shustov, MD
University of Washington School of Medicine
Fred Hutchinson Cancer Research Center
Seattle, WA, USA

PTCL as a Rare Disease: A Case of Overall Survival (duration 19:00)
Owen A. O’Connor, MD, PhD
Columbia University Medical Center
The New York Presbyterian Hospital
New York, NY, USA

Why Might Response Rates Differ Between the East and West? (duration 17:00)
Kensei Tobinai, MD, PhD
National Cancer Center Hospital
Tokyo, Japan

Provided by:

Original activity supported by an educational grant from:

Spectrum Pharmaceuticals

Learning Objectives

At the end of the activity, participants should be able to:

  • Explain why progression-free survival is important when treating patients with PTCL
  • Determine when overall survival is possible
  • Describe the challenges of using matched control analysis in PTCL clinical trials
  • Discuss why different response rates to therapy for PTCL may be seen in Asian patients versus North American or European patients and define the possible contributing factors

Target Audience

Hematologists, oncologists, and other clinicians and scientists with an interest in T-cell lymphoma

Statement of Need

This activity explores clinical endpoints in PTCL, the importance of choosing the appropriate ones and the possibility of achieving them. Global and regional differences in PTCL are also explored as they relate to response rates. The presentations highlight the challenges physicians face in treating PTCL patients and recent developments are discussed to help practitioners evaluate the utility of these endpoints in choosing appropriate treatments to improve outcomes in their patients with PTCL.

 

FACULTY

Faculty

Andrei R. Shustov, MD
Disclosures: Consulting fee: Celgene; BMS

Owen O’Connor, MD, PhD
Disclosures: Consulting fees: Mundipharma; Celgene; Contracted Research: Mundipharma; Spectrum; Celgene; Seattle Genetics; TG Therapeutics; ADCT; Trillium

Kensei Tobinai, MD, PhD
Disclosures: Honoraria: Eisai; HUYA Bioscience International; Janssen; Mundipharma; Takeda; Zenyaku Kogyo; Contracted research: Abbvie; Celgene; Chugai Pharma; Eisai; GlaxoSmithKline; Janssen; Kyowa Hakko Kirin; Mundipharma; Ono Pharmaceutical; SERVIER; Takeda

Permissions

Andrei Shustov presentation

  • Slide 7: PTCL Prognosis Is Indicative of Diverse Biology
    • Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
  • Slide 8: PTCL: Global Epidemiology
    • Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
  • Slide 9: PTCL: USA Epidemiology (top half)
    • Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
  • Slide 9: PTCL: USA Epidemiology (bottom half)
    • Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
  • Slide 10: PTCL Prognosis: Histology x Race (USA)
    • Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
  • Slide 12: PTCL Prognosis: Clinical Features (top right side)
    • Reprinted with permission. © 2013 American Society of Clinical Oncology. All rights reserved.
  • Slide 14: PTCL Prognosis: Molecular Classifiers (left side)
    • Republished with permission of the American Society of Hematology, from Parilla Castellar ER, et al. Blood 2014;124:1473-1480
  • Slide 14: PTCL Prognosis: Molecular Classifiers (right side)
    • Republished with permission of the American Society of Hematology, from Iqbal J, et al. Blood 2014;123:2915-2923
  • Slide 17: US Epidemiology of PTCL
    • Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
  • Slides 18-19: Romidepsin in Relapsed/Refractory PTCL
    • Reprinted with permission. © 2012 American Society of Clinical Oncology. All rights reserved.
  • Slides 20-22, 25: Romidepsin in Elderly Patients
    • Shustov A, et al. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma 2017 [Epub ahead of print]. Reprinted by permission of Taylor & Francis Ltd, http://www.tandfonline.com
  • Slides 27-28: Belinostat in Relapsed/Refractory PTCL
    • Reprinted with permission. © 2015 American Society of Clinical Oncology. All rights reserved.

Kensei Tobinai presentation

  • Slide 7: Overall Survival of ATL Pts in JCOG 9801
    • Reprinted with permission. © 2007 American Society of Clinical Oncology. All rights reserved.

Disclaimer

The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of Hemedicus, the supporter, or Frontline Medical Communications. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.

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Vidyard Video
Vidyard Video

Release Date: August 1, 2017
Expiration Date: July 31, 2018

Note: This activity is no longer available for credit.

Agenda

Developing New Strategic Goals in PTCL (duration 27:00)
Andrei R. Shustov, MD
University of Washington School of Medicine
Fred Hutchinson Cancer Research Center
Seattle, WA, USA

PTCL as a Rare Disease: A Case of Overall Survival (duration 19:00)
Owen A. O’Connor, MD, PhD
Columbia University Medical Center
The New York Presbyterian Hospital
New York, NY, USA

Why Might Response Rates Differ Between the East and West? (duration 17:00)
Kensei Tobinai, MD, PhD
National Cancer Center Hospital
Tokyo, Japan

Provided by:

Original activity supported by an educational grant from:

Spectrum Pharmaceuticals

Learning Objectives

At the end of the activity, participants should be able to:

  • Explain why progression-free survival is important when treating patients with PTCL
  • Determine when overall survival is possible
  • Describe the challenges of using matched control analysis in PTCL clinical trials
  • Discuss why different response rates to therapy for PTCL may be seen in Asian patients versus North American or European patients and define the possible contributing factors

Target Audience

Hematologists, oncologists, and other clinicians and scientists with an interest in T-cell lymphoma

Statement of Need

This activity explores clinical endpoints in PTCL, the importance of choosing the appropriate ones and the possibility of achieving them. Global and regional differences in PTCL are also explored as they relate to response rates. The presentations highlight the challenges physicians face in treating PTCL patients and recent developments are discussed to help practitioners evaluate the utility of these endpoints in choosing appropriate treatments to improve outcomes in their patients with PTCL.

 

FACULTY

Faculty

Andrei R. Shustov, MD
Disclosures: Consulting fee: Celgene; BMS

Owen O’Connor, MD, PhD
Disclosures: Consulting fees: Mundipharma; Celgene; Contracted Research: Mundipharma; Spectrum; Celgene; Seattle Genetics; TG Therapeutics; ADCT; Trillium

Kensei Tobinai, MD, PhD
Disclosures: Honoraria: Eisai; HUYA Bioscience International; Janssen; Mundipharma; Takeda; Zenyaku Kogyo; Contracted research: Abbvie; Celgene; Chugai Pharma; Eisai; GlaxoSmithKline; Janssen; Kyowa Hakko Kirin; Mundipharma; Ono Pharmaceutical; SERVIER; Takeda

Permissions

Andrei Shustov presentation

  • Slide 7: PTCL Prognosis Is Indicative of Diverse Biology
    • Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
  • Slide 8: PTCL: Global Epidemiology
    • Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
  • Slide 9: PTCL: USA Epidemiology (top half)
    • Reprinted with permission. © 2008 American Society of Clinical Oncology. All rights reserved.
  • Slide 9: PTCL: USA Epidemiology (bottom half)
    • Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
  • Slide 10: PTCL Prognosis: Histology x Race (USA)
    • Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
  • Slide 12: PTCL Prognosis: Clinical Features (top right side)
    • Reprinted with permission. © 2013 American Society of Clinical Oncology. All rights reserved.
  • Slide 14: PTCL Prognosis: Molecular Classifiers (left side)
    • Republished with permission of the American Society of Hematology, from Parilla Castellar ER, et al. Blood 2014;124:1473-1480
  • Slide 14: PTCL Prognosis: Molecular Classifiers (right side)
    • Republished with permission of the American Society of Hematology, from Iqbal J, et al. Blood 2014;123:2915-2923
  • Slide 17: US Epidemiology of PTCL
    • Reprinted with permission. © 2016 American Society of Clinical Oncology. All rights reserved.
  • Slides 18-19: Romidepsin in Relapsed/Refractory PTCL
    • Reprinted with permission. © 2012 American Society of Clinical Oncology. All rights reserved.
  • Slides 20-22, 25: Romidepsin in Elderly Patients
    • Shustov A, et al. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma 2017 [Epub ahead of print]. Reprinted by permission of Taylor & Francis Ltd, http://www.tandfonline.com
  • Slides 27-28: Belinostat in Relapsed/Refractory PTCL
    • Reprinted with permission. © 2015 American Society of Clinical Oncology. All rights reserved.

Kensei Tobinai presentation

  • Slide 7: Overall Survival of ATL Pts in JCOG 9801
    • Reprinted with permission. © 2007 American Society of Clinical Oncology. All rights reserved.

Disclaimer

The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of Hemedicus, the supporter, or Frontline Medical Communications. This material is prepared based upon a review of multiple sources of information, but it is not exhaustive of the subject matter. Therefore, healthcare professionals and other individuals should review and consider other publications and materials on the subject matter before relying solely upon the information contained within this educational activity.

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Evaluation of Fitness, Metabolism, and Quality of Life During Hematopoietic Stem Cell Transplant

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Abstract 30: 2017 AVAHO Meeting

Purpose: The objective of this study is to characterize biochemical and physiologic factors that contribute to changes in patient fitness, body composition, and quality of life (QoL) during hematopoietic stem cell transplantation (HCT).

Background: Though HCT can cure subsets of patients with hematologic malignancies, it carries a high risk of short- and long-term toxicity. Prior work has shown that following both autologous and allogeneic HCT, most patients suffer impairment in QoL for many months after transplant. Efforts to date have inconsistently demonstrated benefit in addressing parameters of nutrition, physical activity, and metabolism.

Methods: This prospective pilot study of 60 patients at VA Puget Sound Marrow Transplant Unit with hematologic malignancy will incorporate multidisciplinary evaluation by endocrinology, nutrition, gastroenterology, and oncology specialties. Assessments before and periodically after HCT include objective measures of fitness by 6-minue walk test, resting energy expenditure, maximum oxygen consumption, handgrip and other muscle group strength, and stair climbing power; body composition by bio-impedance and dual-energy X-ray absorptiometry scans; anabolic and catabolic factors such as insulin growth factor-1, growth hormone, and free and weakly bound testosterone; biochemical markers of inflammatory milieu; and validated questionnaires of nutrition, functional status, and QoL.

Results: The protocol opened to accrual in March 2017. To date, 12 patients have enrolled in study, and posttransplant evaluations (approximately 30 days after transplantation, median = 36) have been performed on 4. Early findings suggest relatively preserved body weight and composition but trends toward decreased QoL and fitness, particularly in aerobic capacity, handgrip strength, and total lower body fitness. Updated findings will be presented at the Association of VA Hematology/Oncology Conference.

Implications: With improving survival outcomes following HCT for hematologic malignancies due to advances in therapeutics and supportive care, increased attention will be directed at optimizing patient-centered quality outcomes. Understanding of the biochemical and physiologic factors underlying these outcomes may lead to refinements in prognostic models and present targets for risk mitigation interventions in the peri-transplant period.

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Abstract 30: 2017 AVAHO Meeting
Abstract 30: 2017 AVAHO Meeting

Purpose: The objective of this study is to characterize biochemical and physiologic factors that contribute to changes in patient fitness, body composition, and quality of life (QoL) during hematopoietic stem cell transplantation (HCT).

Background: Though HCT can cure subsets of patients with hematologic malignancies, it carries a high risk of short- and long-term toxicity. Prior work has shown that following both autologous and allogeneic HCT, most patients suffer impairment in QoL for many months after transplant. Efforts to date have inconsistently demonstrated benefit in addressing parameters of nutrition, physical activity, and metabolism.

Methods: This prospective pilot study of 60 patients at VA Puget Sound Marrow Transplant Unit with hematologic malignancy will incorporate multidisciplinary evaluation by endocrinology, nutrition, gastroenterology, and oncology specialties. Assessments before and periodically after HCT include objective measures of fitness by 6-minue walk test, resting energy expenditure, maximum oxygen consumption, handgrip and other muscle group strength, and stair climbing power; body composition by bio-impedance and dual-energy X-ray absorptiometry scans; anabolic and catabolic factors such as insulin growth factor-1, growth hormone, and free and weakly bound testosterone; biochemical markers of inflammatory milieu; and validated questionnaires of nutrition, functional status, and QoL.

Results: The protocol opened to accrual in March 2017. To date, 12 patients have enrolled in study, and posttransplant evaluations (approximately 30 days after transplantation, median = 36) have been performed on 4. Early findings suggest relatively preserved body weight and composition but trends toward decreased QoL and fitness, particularly in aerobic capacity, handgrip strength, and total lower body fitness. Updated findings will be presented at the Association of VA Hematology/Oncology Conference.

Implications: With improving survival outcomes following HCT for hematologic malignancies due to advances in therapeutics and supportive care, increased attention will be directed at optimizing patient-centered quality outcomes. Understanding of the biochemical and physiologic factors underlying these outcomes may lead to refinements in prognostic models and present targets for risk mitigation interventions in the peri-transplant period.

Purpose: The objective of this study is to characterize biochemical and physiologic factors that contribute to changes in patient fitness, body composition, and quality of life (QoL) during hematopoietic stem cell transplantation (HCT).

Background: Though HCT can cure subsets of patients with hematologic malignancies, it carries a high risk of short- and long-term toxicity. Prior work has shown that following both autologous and allogeneic HCT, most patients suffer impairment in QoL for many months after transplant. Efforts to date have inconsistently demonstrated benefit in addressing parameters of nutrition, physical activity, and metabolism.

Methods: This prospective pilot study of 60 patients at VA Puget Sound Marrow Transplant Unit with hematologic malignancy will incorporate multidisciplinary evaluation by endocrinology, nutrition, gastroenterology, and oncology specialties. Assessments before and periodically after HCT include objective measures of fitness by 6-minue walk test, resting energy expenditure, maximum oxygen consumption, handgrip and other muscle group strength, and stair climbing power; body composition by bio-impedance and dual-energy X-ray absorptiometry scans; anabolic and catabolic factors such as insulin growth factor-1, growth hormone, and free and weakly bound testosterone; biochemical markers of inflammatory milieu; and validated questionnaires of nutrition, functional status, and QoL.

Results: The protocol opened to accrual in March 2017. To date, 12 patients have enrolled in study, and posttransplant evaluations (approximately 30 days after transplantation, median = 36) have been performed on 4. Early findings suggest relatively preserved body weight and composition but trends toward decreased QoL and fitness, particularly in aerobic capacity, handgrip strength, and total lower body fitness. Updated findings will be presented at the Association of VA Hematology/Oncology Conference.

Implications: With improving survival outcomes following HCT for hematologic malignancies due to advances in therapeutics and supportive care, increased attention will be directed at optimizing patient-centered quality outcomes. Understanding of the biochemical and physiologic factors underlying these outcomes may lead to refinements in prognostic models and present targets for risk mitigation interventions in the peri-transplant period.

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