A score incorporating clinical and biological markers could help predict the risk of death in patients with malignant pleural effusion and their likelihood of responding well to pleurodesis, according to a study published online in The Lancet Oncology.

The researchers used five separate and independent datasets from three previous multicenter randomized controlled trials – TIME-1, TIME-2, and TIME-3 – to identify 17 candidates for biomarkers of survival at 3 months and 7 candidates for biomarkers of pleurodesis success at 3 months.

They combined these with clinical, radiological, and biological variables to develop the clinical PROMISE model, which included relative protein expression of tissue inhibitor of metalloproteinases 1, platelet-derived growth factor, vascular endothelial growth factor, cadherin 1 and interleukin 4. The pleurodesis dataset included tumour necrosis factor alpha, TNF-beta, interleukin 6, and fibroblast growth factor 2.

The model was then externally validated using complete case data from 162 individuals with malignant pleural effusion, just over one-third of whom had died before 3 months.

The researchers also developed a biological model based on prognostic factors for survival, including use of previous chemotherapy and radiotherapy, baseline ECOG performance status, cancer type, hemoglobin, and white blood cell count.

The researchers found that the PROMISE scores showed “good discrimination,” and based on that, they came up with four categories – A, B, C, and D, representing less than 25% risk, 25%-49% risk, 50%-74% risk, and 75% or more risk of death by 3 months. However, none of the biomarkers associated with pleurodesis outcomes could be validated.

“All parameters included in the PROMISE score are independently associated with survival, and thus the identified markers permit some speculation as to their biological role in survival in malignant pleural effusion,” wrote Ioannis Psallidas, MD, of the Oxford Centre for Respiratory Medicine at Oxford (England) University Hospital, and his coauthors.

For example, they noted that patients who had previously been treated with chemotherapy and radiotherapy may have a poorer prognosis because of the development of more aggressive cancer after treatment. Similarly, white blood cell counts and C-reactive protein are markers of inflammation and are linked to poor tumor-specific immunity.

“Evidence suggests that clinical judgment alone is imprecise for estimation of patient survival, highlighted by the fact that physicians are ineffective in excluding study participants with poor prognosis from large clinical trials,” the authors wrote. “Although future confirmatory studies are required, the PROMISE score (either clinical or biological) could potentially be used in everyday clinical practice as a method to improve patient management and reduce associated health-care costs, and as an enrichment strategy for future clinical trials.”

The study was supported by the Oxford Respiratory Trials Unit, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. No conflicts of interest were declared.

SOURCE: Psallidas I et al. Lancet Oncol. 2018 Jun 13. doi: 10.1016/S1470-2045(18)30294-8.

A score incorporating clinical and biological markers could help predict the risk of death in patients with malignant pleural effusion and their likelihood of responding well to pleurodesis, according to a study published online in The Lancet Oncology.

The researchers used five separate and independent datasets from three previous multicenter randomized controlled trials – TIME-1, TIME-2, and TIME-3 – to identify 17 candidates for biomarkers of survival at 3 months and 7 candidates for biomarkers of pleurodesis success at 3 months.

They combined these with clinical, radiological, and biological variables to develop the clinical PROMISE model, which included relative protein expression of tissue inhibitor of metalloproteinases 1, platelet-derived growth factor, vascular endothelial growth factor, cadherin 1 and interleukin 4. The pleurodesis dataset included tumour necrosis factor alpha, TNF-beta, interleukin 6, and fibroblast growth factor 2.

The model was then externally validated using complete case data from 162 individuals with malignant pleural effusion, just over one-third of whom had died before 3 months.

The researchers also developed a biological model based on prognostic factors for survival, including use of previous chemotherapy and radiotherapy, baseline ECOG performance status, cancer type, hemoglobin, and white blood cell count.

The researchers found that the PROMISE scores showed “good discrimination,” and based on that, they came up with four categories – A, B, C, and D, representing less than 25% risk, 25%-49% risk, 50%-74% risk, and 75% or more risk of death by 3 months. However, none of the biomarkers associated with pleurodesis outcomes could be validated.

“All parameters included in the PROMISE score are independently associated with survival, and thus the identified markers permit some speculation as to their biological role in survival in malignant pleural effusion,” wrote Ioannis Psallidas, MD, of the Oxford Centre for Respiratory Medicine at Oxford (England) University Hospital, and his coauthors.

For example, they noted that patients who had previously been treated with chemotherapy and radiotherapy may have a poorer prognosis because of the development of more aggressive cancer after treatment. Similarly, white blood cell counts and C-reactive protein are markers of inflammation and are linked to poor tumor-specific immunity.

“Evidence suggests that clinical judgment alone is imprecise for estimation of patient survival, highlighted by the fact that physicians are ineffective in excluding study participants with poor prognosis from large clinical trials,” the authors wrote. “Although future confirmatory studies are required, the PROMISE score (either clinical or biological) could potentially be used in everyday clinical practice as a method to improve patient management and reduce associated health-care costs, and as an enrichment strategy for future clinical trials.”

The study was supported by the Oxford Respiratory Trials Unit, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. No conflicts of interest were declared.

SOURCE: Psallidas I et al. Lancet Oncol. 2018 Jun 13. doi: 10.1016/S1470-2045(18)30294-8.

A score incorporating clinical and biological markers could help predict the risk of death in patients with malignant pleural effusion and their likelihood of responding well to pleurodesis, according to a study published online in The Lancet Oncology.

The researchers used five separate and independent datasets from three previous multicenter randomized controlled trials – TIME-1, TIME-2, and TIME-3 – to identify 17 candidates for biomarkers of survival at 3 months and 7 candidates for biomarkers of pleurodesis success at 3 months.

They combined these with clinical, radiological, and biological variables to develop the clinical PROMISE model, which included relative protein expression of tissue inhibitor of metalloproteinases 1, platelet-derived growth factor, vascular endothelial growth factor, cadherin 1 and interleukin 4. The pleurodesis dataset included tumour necrosis factor alpha, TNF-beta, interleukin 6, and fibroblast growth factor 2.

The model was then externally validated using complete case data from 162 individuals with malignant pleural effusion, just over one-third of whom had died before 3 months.

The researchers also developed a biological model based on prognostic factors for survival, including use of previous chemotherapy and radiotherapy, baseline ECOG performance status, cancer type, hemoglobin, and white blood cell count.

The researchers found that the PROMISE scores showed “good discrimination,” and based on that, they came up with four categories – A, B, C, and D, representing less than 25% risk, 25%-49% risk, 50%-74% risk, and 75% or more risk of death by 3 months. However, none of the biomarkers associated with pleurodesis outcomes could be validated.

“All parameters included in the PROMISE score are independently associated with survival, and thus the identified markers permit some speculation as to their biological role in survival in malignant pleural effusion,” wrote Ioannis Psallidas, MD, of the Oxford Centre for Respiratory Medicine at Oxford (England) University Hospital, and his coauthors.

For example, they noted that patients who had previously been treated with chemotherapy and radiotherapy may have a poorer prognosis because of the development of more aggressive cancer after treatment. Similarly, white blood cell counts and C-reactive protein are markers of inflammation and are linked to poor tumor-specific immunity.

“Evidence suggests that clinical judgment alone is imprecise for estimation of patient survival, highlighted by the fact that physicians are ineffective in excluding study participants with poor prognosis from large clinical trials,” the authors wrote. “Although future confirmatory studies are required, the PROMISE score (either clinical or biological) could potentially be used in everyday clinical practice as a method to improve patient management and reduce associated health-care costs, and as an enrichment strategy for future clinical trials.”

The study was supported by the Oxford Respiratory Trials Unit, Medical Research Funding-University of Oxford, Slater & Gordon Research Fund, and Oxfordshire Health Services Research Committee Research Grants. No conflicts of interest were declared.

SOURCE: Psallidas I et al. Lancet Oncol. 2018 Jun 13. doi: 10.1016/S1470-2045(18)30294-8.

Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.

The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.

Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.

While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.

Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.

All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.

With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”

Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.

“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.

Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.

The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.

In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.

The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.

SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.

Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.

The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.

Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.

While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.

Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.

All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.

With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”

Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.

“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.

Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.

The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.

In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.

The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.

SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.

Fludarabine, cyclophosphamide, and rituximab are recommended as initial therapy for patients with chronic lymphocytic leukemia who do not have TP53 disruption, according to new guidelines from the British Society for Haematology.

The guidelines update the 2012 recommendations on chronic lymphocytic leukemia (CLL) to include “significant” developments in treatment. They were published in the British Journal of Haematology.

Anna H. Schuh, MD, of the department of oncology at the University of Oxford (England), and her coauthors noted that, while these guidelines apply to treatments available outside clinical trials, wherever possible patients with CLL should be treated within the clinical trial setting.

While recommending fludarabine, cyclophosphamide, and rituximab as first-line therapy, the guideline authors acknowledged that the combination of bendamustine and rituximab is an acceptable alternative for patients who could not take the triple therapy because of comorbidities such as advanced age, renal impairment, or issues with marrow capacity.

Similarly, less-fit patients could also be considered for chlorambucil-obinutuzumab or chlorambucil-ofatumumab combinations.

All patients diagnosed with CLL should be tested for TP53 deletions and mutations before each line of therapy, the guideline committee recommended. TP53 disruption makes chemoimmunotherapy ineffective because of either a deletion of chromosome 17p or a mutation in the TP53 gene. However, there is compelling evidence for the efficacy of ibrutinib in these patients, or idelalisib and rituximab for those with cardiac disease or receiving vitamin K antagonists.

With respect to maintenance therapy, the guidelines noted that this was not routinely recommended in CLL as “it is unclear to what extent the progression-free survival benefit is offset by long-term toxicity.”

Patients who are refractory to chemoimmunotherapy, who have relapsed, or who cannot be retreated with chemoimmunotherapy should be treated with idelalisib with rituximab or ibrutinib monotherapy, the guidelines suggested.

“Deciding whether ibrutinib or idelalisib with rituximab is most appropriate for an individual patient depends on a range of factors, including toxicity profile and convenience of delivery,” the authors wrote. However, they noted that the value of adding bendamustine to either option was unclear as research had not shown significant, associated gains in median progression-free survival.

Allogeneic stem cell transplantation should be considered as a treatment option for patients who have either failed chemotherapy, have a TP53 disruption and have not responded to B-cell receptor signaling pathway inhibitors such as ibrutinib, or have a Richter transformation.

The guidelines also addressed the issue of autoimmune cytopenias, which occur in 5%-10% of patients with CLL and can actually precede the diagnosis of CLL in about 9% of cases.

In patients where autoimmune cytopenia is the dominant clinical feature, they should be treated with corticosteroids, intravenous immunoglobulin, or rituximab. However, for patients where the cytopenia is triggered by CLL therapy, the guidelines recommended halting treatment and beginning immunosuppression.

The guideline development was supported by the British Society for Haematology. The UK CLL Forum is a registered charity that receives funding from a number of pharmaceutical companies.

SOURCE: Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460.

mycosis fungoides

The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.

Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.

Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.

The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.

The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.

MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.

Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.

Baseline characteristics were similar between the treatment arms.

The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).

The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).

For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.

After crossover, the ORR in the mogamulizumab arm was 30% (41/136).

The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.

For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.

The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:

• Infusion-related reactions (33.2% vs 0.5%)
• Drug eruptions (23.9% vs 0.5%)
• Diarrhea (23.4% vs 61.8%)
• Nausea (15.2% vs 42.5%)
• Thrombocytopenia (11.4% vs 30.6%)
• Dysgeusia (3.3% vs 28.0%)
• Increased blood creatinine (3.3% vs 28.0%)
• Decreased appetite (7.6% vs 24.7%).

There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).

mycosis fungoides

The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.

Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.

Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.

The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.

The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.

MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.

Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.

Baseline characteristics were similar between the treatment arms.

The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).

The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).

For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.

After crossover, the ORR in the mogamulizumab arm was 30% (41/136).

The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.

For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.

The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:

• Infusion-related reactions (33.2% vs 0.5%)
• Drug eruptions (23.9% vs 0.5%)
• Diarrhea (23.4% vs 61.8%)
• Nausea (15.2% vs 42.5%)
• Thrombocytopenia (11.4% vs 30.6%)
• Dysgeusia (3.3% vs 28.0%)
• Increased blood creatinine (3.3% vs 28.0%)
• Decreased appetite (7.6% vs 24.7%).

There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).

mycosis fungoides

The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.

Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.

Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.

The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.

The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.

MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.

Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.

Baseline characteristics were similar between the treatment arms.

The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).

The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).

For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.

After crossover, the ORR in the mogamulizumab arm was 30% (41/136).

The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.

For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.

The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:

• Infusion-related reactions (33.2% vs 0.5%)
• Drug eruptions (23.9% vs 0.5%)
• Diarrhea (23.4% vs 61.8%)
• Nausea (15.2% vs 42.5%)
• Thrombocytopenia (11.4% vs 30.6%)
• Dysgeusia (3.3% vs 28.0%)
• Increased blood creatinine (3.3% vs 28.0%)
• Decreased appetite (7.6% vs 24.7%).

There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).

Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.

Courtesy Judge Steve Leifman

“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.

Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.

In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.

“We joke, but it’s true. It would have been cheaper and more effective to send them to Harvard,” Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”

Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.

The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.

Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).

Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.

Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.

Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.

Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.

Courtesy Judge Steve Leifman

“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.

Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.

In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.

“We joke, but it’s true. It would have been cheaper and more effective to send them to Harvard,” Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”

Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.

The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.

Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).

Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.

Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.

Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.

Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.

Courtesy Judge Steve Leifman

“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.

Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.

In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.

“We joke, but it’s true. It would have been cheaper and more effective to send them to Harvard,” Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”

Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.

The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.

Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).

Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.

Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.

Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.

Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.

Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.

Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.

Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.

Artfoliophoto/Thinkstock

“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.

Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.

The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.

Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.

“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.

Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. On average, drugs seized west of the Mississippi River are about 40% more pure than those seized east of the river. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.

Click here to read the Forbes article.

Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.

Artfoliophoto/Thinkstock

“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.

Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.

The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.

Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.

“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.

Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. On average, drugs seized west of the Mississippi River are about 40% more pure than those seized east of the river. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.

Click here to read the Forbes article.

Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.

Artfoliophoto/Thinkstock

“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.

Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.

The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.

Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.

“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.

Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. On average, drugs seized west of the Mississippi River are about 40% more pure than those seized east of the river. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.

Click here to read the Forbes article.

WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.

In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”

She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”

Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.

More information on CUBE-C is available on the NEA website.

The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
 

emechcatie@mdedge.com

WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.

In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”

She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”

Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.

More information on CUBE-C is available on the NEA website.

The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
 

emechcatie@mdedge.com

WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.

In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”

She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”

Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.

More information on CUBE-C is available on the NEA website.

The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
 

emechcatie@mdedge.com

Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.

Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.

The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).

A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.

“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.

Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.

“Our data suggest there may be alternative and additional ways to help children and adolescents at highest risk for suicidal behavior,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”

Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
 

lfranki@mdedge.com

SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.

Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.

Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.

The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).

A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.

“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.

Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.

“Our data suggest there may be alternative and additional ways to help children and adolescents at highest risk for suicidal behavior,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”

Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
 

lfranki@mdedge.com

SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.

Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.

Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.

The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).

A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.

“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.

Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.

“Our data suggest there may be alternative and additional ways to help children and adolescents at highest risk for suicidal behavior,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”

Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
 

lfranki@mdedge.com

SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.

Presenter

Elisabeth Schainker, MD, MSc
 

Session title

Making the referral and navigating “A Whole New World” of care
 

Session summary

By describing different types of post-acute care clinical services, Dr. Schainker empowered the HM18 audience to rethink how to best identify patients and conditions appropriate for transitions of care, from short-term acute care environments to long-term acute care places, inpatient rehabs, or skilled nursing facilities.

With increasing numbers of pediatric patients with medical complexity, who are dependent on technology devices and complicated care needs, hospitalists need to be knowledgeable about the rules of engagement for prolonged or enhanced recoveries, families’ needs, and insurance qualifications. The role of the hospitalist is to make sure that things are in place for safe and successful discharges, keeping in mind patients’ complexity, resources available within family and community, and fair assessments of readmission risks.

Whether rehab needs pertain to pulmonary, medical, or post NICU stays – length of stay averaging 70-80 days – hospitalists still need to ensure that patients have a clear potential to do better and transition to home eventually. There are inadequate numbers of such pediatric post-acute care facilities, 36 hospitals to be precise. Franciscan Children’s, where Dr. Schainker practices, was beautifully represented in a short movie played during the session at the annual meeting of the Society of Hospital Medicine. The protagonists in the movie were children: Mae and Luke.

Key takeaways for HM

1. Knowledge: Post-acute care services facilitate safe discharges of complex medical patients that eventually get home.

2. Attitude: Hospitalists need to identify what would benefit their patients and counsel families, as well as make proper and timely referrals.

3. Behavior: Hospitalists should be familiar with local resources and engage with available providers of post-acute care services.
 

Dr. Giordano is a pediatric neurosurgery hospitalist at Columbia University Medical Center in New York.

Presenter

Elisabeth Schainker, MD, MSc
 

Session title

Making the referral and navigating “A Whole New World” of care
 

Session summary

By describing different types of post-acute care clinical services, Dr. Schainker empowered the HM18 audience to rethink how to best identify patients and conditions appropriate for transitions of care, from short-term acute care environments to long-term acute care places, inpatient rehabs, or skilled nursing facilities.

With increasing numbers of pediatric patients with medical complexity, who are dependent on technology devices and complicated care needs, hospitalists need to be knowledgeable about the rules of engagement for prolonged or enhanced recoveries, families’ needs, and insurance qualifications. The role of the hospitalist is to make sure that things are in place for safe and successful discharges, keeping in mind patients’ complexity, resources available within family and community, and fair assessments of readmission risks.

Whether rehab needs pertain to pulmonary, medical, or post NICU stays – length of stay averaging 70-80 days – hospitalists still need to ensure that patients have a clear potential to do better and transition to home eventually. There are inadequate numbers of such pediatric post-acute care facilities, 36 hospitals to be precise. Franciscan Children’s, where Dr. Schainker practices, was beautifully represented in a short movie played during the session at the annual meeting of the Society of Hospital Medicine. The protagonists in the movie were children: Mae and Luke.

Key takeaways for HM

1. Knowledge: Post-acute care services facilitate safe discharges of complex medical patients that eventually get home.

2. Attitude: Hospitalists need to identify what would benefit their patients and counsel families, as well as make proper and timely referrals.

3. Behavior: Hospitalists should be familiar with local resources and engage with available providers of post-acute care services.
 

Dr. Giordano is a pediatric neurosurgery hospitalist at Columbia University Medical Center in New York.

Presenter

Elisabeth Schainker, MD, MSc
 

Session title

Making the referral and navigating “A Whole New World” of care
 

Session summary

By describing different types of post-acute care clinical services, Dr. Schainker empowered the HM18 audience to rethink how to best identify patients and conditions appropriate for transitions of care, from short-term acute care environments to long-term acute care places, inpatient rehabs, or skilled nursing facilities.

With increasing numbers of pediatric patients with medical complexity, who are dependent on technology devices and complicated care needs, hospitalists need to be knowledgeable about the rules of engagement for prolonged or enhanced recoveries, families’ needs, and insurance qualifications. The role of the hospitalist is to make sure that things are in place for safe and successful discharges, keeping in mind patients’ complexity, resources available within family and community, and fair assessments of readmission risks.

Whether rehab needs pertain to pulmonary, medical, or post NICU stays – length of stay averaging 70-80 days – hospitalists still need to ensure that patients have a clear potential to do better and transition to home eventually. There are inadequate numbers of such pediatric post-acute care facilities, 36 hospitals to be precise. Franciscan Children’s, where Dr. Schainker practices, was beautifully represented in a short movie played during the session at the annual meeting of the Society of Hospital Medicine. The protagonists in the movie were children: Mae and Luke.

Key takeaways for HM

1. Knowledge: Post-acute care services facilitate safe discharges of complex medical patients that eventually get home.

2. Attitude: Hospitalists need to identify what would benefit their patients and counsel families, as well as make proper and timely referrals.

3. Behavior: Hospitalists should be familiar with local resources and engage with available providers of post-acute care services.
 

Dr. Giordano is a pediatric neurosurgery hospitalist at Columbia University Medical Center in New York.

CHICAGO – Trabectedin (Yondelis) was superior to best supportive care at prolonging progression-free survival in patients with heavily pretreated advanced leiomyosarcomas and liposarcomas, investigators in the randomized phase 3 T-SAR trial reported.

Among 103 patients with soft-tissue sarcomas that had progressed after two to four lines of standard chemotherapy, median progression-free survival (PFS) for patients randomized to trabectedin was 3.12 months, compared with 1.51 for patients randomized to best supportive care.

This difference translated into a hazard ratio (HR) favoring trabectedin of 0.39 (P less than .0001), Axel Le Cesne, MD, of Gustave Roussy Cancer Institute in Villejuif, France, reported on behalf of colleagues in the French Sarcoma Group.

All of the benefit was apparently among patients with what he termed “L-sarcomas” – leiomyosarcoma and liposarcoma – compared with other sarcoma histologies.

“The tumor control rate after six courses of trabectedin is similar to previous studies. As already reported, trabectedin is well-tolerated,” he said at the annual meeting of the American Society of Clinical Oncology.

Trabectedin was shown to be superior to best supportive care at delaying disease progression among patients with advanced translocation-related sarcomas in a randomized phase 2 trial in Japan, but had not been studied in this setting against other sarcoma histologies, Dr. Le Cesne said.

The investigators enrolled 103 patients and randomly assigned them to receive either best supportive care or trabectedin in a 1.5 mg/m² infusion over 24 hours every 3 weeks. Patients in the best supportive care arm could be crossed over to the trabectedin arm at the time of progression.

Sarcoma histologies included liposarcoma, leiomyosarcoma, undifferentiated sarcomas, myxofibrosarcoma, synovial sarcoma, and others. The L-sarcomas accounted for 60.2% of the patient population.

Fifty-two patients were randomized to trabectedin and 51 to best supportive care, but 2 patients assigned to best supportive care dropped out soon after randomization, leaving 52 and 49 patients, respectively, for the as-treated analysis. All 103 patients were assessable for efficacy.

After a median follow-up of 26 months, median PFS for all patients, as noted before, was 3.12 months in the trabectedin arm and 1.51 months in the best supportive care arm.

The overall response rate in the trabectedin arm was 13.7%, composed of seven partial responses. There were no responses in the best supportive care arm. In all, 66.7% of patients in the trabectedin arm and 61.2% of patients in the best supportive care arm had stable disease, and 19.6% and 38.8%, respectively, had disease progression.

An analysis of PFS by sarcoma histology showed that all of the benefit appeared to be in patients with L-sarcomas, with a median PFS for trabectedin-treated patients of 5.13 months compared with 1.41 months for controls (HR 0.29, P less than .0001).

In contrast, there was no significant difference between the groups among patients with non–L sarcomas, with respective median PFS of 1.81 and 1.51 months (HR 0.60, P = .16). There were no treatment responses among patients in either treatment arm in this subgroup.

Not surprisingly, there were more grade 3 or 4 adverse events among patients in the trabectedin arm. Neutropenia was seen in 23 patients given trabectedin and 1 given best supportive care; leukopenia in 18 patients vs. 0, thrombocytopenia in 13 vs. 0, and elevated liver transaminases in 17 vs. 1, respectively.

In all, 45 of the 49 patients who were treated in the best supportive care arm were crossed over to trabectedin.

Median overall survival was 13.6 months in the trabectedin arm and 10.8 months in the best supportive care arm. This difference was not statistically significant.

Dr Le Cesne noted that the tumor control rate of 30% with trabectedin was similar to that seen in an earlier French trial (Lancet Oncol. 2015 Mar 1;16[3]:312-19).

Pharmamar supplied trabectedin for the study. Dr. Le Cesne disclosed honoraria from the company and from Amgen, Bayer, Lilly, Novartis, and Pfizer.

SOURCE: Le Cesne A et al. ASCO 2018. Abstract 11508.

CHICAGO – Trabectedin (Yondelis) was superior to best supportive care at prolonging progression-free survival in patients with heavily pretreated advanced leiomyosarcomas and liposarcomas, investigators in the randomized phase 3 T-SAR trial reported.

Among 103 patients with soft-tissue sarcomas that had progressed after two to four lines of standard chemotherapy, median progression-free survival (PFS) for patients randomized to trabectedin was 3.12 months, compared with 1.51 for patients randomized to best supportive care.

This difference translated into a hazard ratio (HR) favoring trabectedin of 0.39 (P less than .0001), Axel Le Cesne, MD, of Gustave Roussy Cancer Institute in Villejuif, France, reported on behalf of colleagues in the French Sarcoma Group.

All of the benefit was apparently among patients with what he termed “L-sarcomas” – leiomyosarcoma and liposarcoma – compared with other sarcoma histologies.

“The tumor control rate after six courses of trabectedin is similar to previous studies. As already reported, trabectedin is well-tolerated,” he said at the annual meeting of the American Society of Clinical Oncology.

Trabectedin was shown to be superior to best supportive care at delaying disease progression among patients with advanced translocation-related sarcomas in a randomized phase 2 trial in Japan, but had not been studied in this setting against other sarcoma histologies, Dr. Le Cesne said.

The investigators enrolled 103 patients and randomly assigned them to receive either best supportive care or trabectedin in a 1.5 mg/m² infusion over 24 hours every 3 weeks. Patients in the best supportive care arm could be crossed over to the trabectedin arm at the time of progression.

Sarcoma histologies included liposarcoma, leiomyosarcoma, undifferentiated sarcomas, myxofibrosarcoma, synovial sarcoma, and others. The L-sarcomas accounted for 60.2% of the patient population.

Fifty-two patients were randomized to trabectedin and 51 to best supportive care, but 2 patients assigned to best supportive care dropped out soon after randomization, leaving 52 and 49 patients, respectively, for the as-treated analysis. All 103 patients were assessable for efficacy.

After a median follow-up of 26 months, median PFS for all patients, as noted before, was 3.12 months in the trabectedin arm and 1.51 months in the best supportive care arm.

The overall response rate in the trabectedin arm was 13.7%, composed of seven partial responses. There were no responses in the best supportive care arm. In all, 66.7% of patients in the trabectedin arm and 61.2% of patients in the best supportive care arm had stable disease, and 19.6% and 38.8%, respectively, had disease progression.

An analysis of PFS by sarcoma histology showed that all of the benefit appeared to be in patients with L-sarcomas, with a median PFS for trabectedin-treated patients of 5.13 months compared with 1.41 months for controls (HR 0.29, P less than .0001).

In contrast, there was no significant difference between the groups among patients with non–L sarcomas, with respective median PFS of 1.81 and 1.51 months (HR 0.60, P = .16). There were no treatment responses among patients in either treatment arm in this subgroup.

Not surprisingly, there were more grade 3 or 4 adverse events among patients in the trabectedin arm. Neutropenia was seen in 23 patients given trabectedin and 1 given best supportive care; leukopenia in 18 patients vs. 0, thrombocytopenia in 13 vs. 0, and elevated liver transaminases in 17 vs. 1, respectively.

In all, 45 of the 49 patients who were treated in the best supportive care arm were crossed over to trabectedin.

Median overall survival was 13.6 months in the trabectedin arm and 10.8 months in the best supportive care arm. This difference was not statistically significant.

Dr Le Cesne noted that the tumor control rate of 30% with trabectedin was similar to that seen in an earlier French trial (Lancet Oncol. 2015 Mar 1;16[3]:312-19).

Pharmamar supplied trabectedin for the study. Dr. Le Cesne disclosed honoraria from the company and from Amgen, Bayer, Lilly, Novartis, and Pfizer.

SOURCE: Le Cesne A et al. ASCO 2018. Abstract 11508.

CHICAGO – Trabectedin (Yondelis) was superior to best supportive care at prolonging progression-free survival in patients with heavily pretreated advanced leiomyosarcomas and liposarcomas, investigators in the randomized phase 3 T-SAR trial reported.

Among 103 patients with soft-tissue sarcomas that had progressed after two to four lines of standard chemotherapy, median progression-free survival (PFS) for patients randomized to trabectedin was 3.12 months, compared with 1.51 for patients randomized to best supportive care.

This difference translated into a hazard ratio (HR) favoring trabectedin of 0.39 (P less than .0001), Axel Le Cesne, MD, of Gustave Roussy Cancer Institute in Villejuif, France, reported on behalf of colleagues in the French Sarcoma Group.

All of the benefit was apparently among patients with what he termed “L-sarcomas” – leiomyosarcoma and liposarcoma – compared with other sarcoma histologies.

“The tumor control rate after six courses of trabectedin is similar to previous studies. As already reported, trabectedin is well-tolerated,” he said at the annual meeting of the American Society of Clinical Oncology.

Trabectedin was shown to be superior to best supportive care at delaying disease progression among patients with advanced translocation-related sarcomas in a randomized phase 2 trial in Japan, but had not been studied in this setting against other sarcoma histologies, Dr. Le Cesne said.

The investigators enrolled 103 patients and randomly assigned them to receive either best supportive care or trabectedin in a 1.5 mg/m² infusion over 24 hours every 3 weeks. Patients in the best supportive care arm could be crossed over to the trabectedin arm at the time of progression.

Sarcoma histologies included liposarcoma, leiomyosarcoma, undifferentiated sarcomas, myxofibrosarcoma, synovial sarcoma, and others. The L-sarcomas accounted for 60.2% of the patient population.

Fifty-two patients were randomized to trabectedin and 51 to best supportive care, but 2 patients assigned to best supportive care dropped out soon after randomization, leaving 52 and 49 patients, respectively, for the as-treated analysis. All 103 patients were assessable for efficacy.

After a median follow-up of 26 months, median PFS for all patients, as noted before, was 3.12 months in the trabectedin arm and 1.51 months in the best supportive care arm.

The overall response rate in the trabectedin arm was 13.7%, composed of seven partial responses. There were no responses in the best supportive care arm. In all, 66.7% of patients in the trabectedin arm and 61.2% of patients in the best supportive care arm had stable disease, and 19.6% and 38.8%, respectively, had disease progression.

An analysis of PFS by sarcoma histology showed that all of the benefit appeared to be in patients with L-sarcomas, with a median PFS for trabectedin-treated patients of 5.13 months compared with 1.41 months for controls (HR 0.29, P less than .0001).

In contrast, there was no significant difference between the groups among patients with non–L sarcomas, with respective median PFS of 1.81 and 1.51 months (HR 0.60, P = .16). There were no treatment responses among patients in either treatment arm in this subgroup.

Not surprisingly, there were more grade 3 or 4 adverse events among patients in the trabectedin arm. Neutropenia was seen in 23 patients given trabectedin and 1 given best supportive care; leukopenia in 18 patients vs. 0, thrombocytopenia in 13 vs. 0, and elevated liver transaminases in 17 vs. 1, respectively.

In all, 45 of the 49 patients who were treated in the best supportive care arm were crossed over to trabectedin.

Median overall survival was 13.6 months in the trabectedin arm and 10.8 months in the best supportive care arm. This difference was not statistically significant.

Dr Le Cesne noted that the tumor control rate of 30% with trabectedin was similar to that seen in an earlier French trial (Lancet Oncol. 2015 Mar 1;16[3]:312-19).

Pharmamar supplied trabectedin for the study. Dr. Le Cesne disclosed honoraria from the company and from Amgen, Bayer, Lilly, Novartis, and Pfizer.

SOURCE: Le Cesne A et al. ASCO 2018. Abstract 11508.