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Women Living Longer With Metastatic Breast Cancer
More women are living longer with distant metastatic breast cancer (MBC), according to a National Cancer Institute study. Between 1992-1994 and 2005-2012, 5-year relative survival among women who were diagnosed with MBC at ages 15 to 49 doubled, from 18% to 36%.
Researchers also found that relative survival time increased from 22.3 months to 38.7 months for women diagnosed aged 15 -49 years, and from 19.1 months to 29.7 months for those aged 50 – 64 years.
Moreover, a “small but meaningful” number of women are living years after an initial diagnosis of MBC, the study found. More than 11% of women diagnosed between 2000-2004 aged < 64 years survived ≥ 10 years. Although nearly half of women with MBC have had it for ≤ 2 , one third have lived with it for ≥ 5 years.
The study findings “make clear that the majority of MBC patients, those who are diagnosed with non-metastatic cancer but progress to distant disease, have never been properly documented,” said Angela Mariotto, PhD, chief of the NCI Data Analytics Branch of the Division of Cancer Control and Population Sciences. By including women with recurrence, the study provides a more accurate number of women in the U.S. living with MBC, which can help with health care planning.
More women are living longer with distant metastatic breast cancer (MBC), according to a National Cancer Institute study. Between 1992-1994 and 2005-2012, 5-year relative survival among women who were diagnosed with MBC at ages 15 to 49 doubled, from 18% to 36%.
Researchers also found that relative survival time increased from 22.3 months to 38.7 months for women diagnosed aged 15 -49 years, and from 19.1 months to 29.7 months for those aged 50 – 64 years.
Moreover, a “small but meaningful” number of women are living years after an initial diagnosis of MBC, the study found. More than 11% of women diagnosed between 2000-2004 aged < 64 years survived ≥ 10 years. Although nearly half of women with MBC have had it for ≤ 2 , one third have lived with it for ≥ 5 years.
The study findings “make clear that the majority of MBC patients, those who are diagnosed with non-metastatic cancer but progress to distant disease, have never been properly documented,” said Angela Mariotto, PhD, chief of the NCI Data Analytics Branch of the Division of Cancer Control and Population Sciences. By including women with recurrence, the study provides a more accurate number of women in the U.S. living with MBC, which can help with health care planning.
More women are living longer with distant metastatic breast cancer (MBC), according to a National Cancer Institute study. Between 1992-1994 and 2005-2012, 5-year relative survival among women who were diagnosed with MBC at ages 15 to 49 doubled, from 18% to 36%.
Researchers also found that relative survival time increased from 22.3 months to 38.7 months for women diagnosed aged 15 -49 years, and from 19.1 months to 29.7 months for those aged 50 – 64 years.
Moreover, a “small but meaningful” number of women are living years after an initial diagnosis of MBC, the study found. More than 11% of women diagnosed between 2000-2004 aged < 64 years survived ≥ 10 years. Although nearly half of women with MBC have had it for ≤ 2 , one third have lived with it for ≥ 5 years.
The study findings “make clear that the majority of MBC patients, those who are diagnosed with non-metastatic cancer but progress to distant disease, have never been properly documented,” said Angela Mariotto, PhD, chief of the NCI Data Analytics Branch of the Division of Cancer Control and Population Sciences. By including women with recurrence, the study provides a more accurate number of women in the U.S. living with MBC, which can help with health care planning.
Statins for the Physically Fit: Do They Help or Hurt?
Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”
It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.
The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.
Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.
Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”
Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.
Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”
It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.
The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.
Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.
Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”
Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.
Statins may not be the best choice for physically active people, even short term. A study by researchers from VA North Texas Health Care System in Dallas, University of Texas in Austin, and Joint Base Antonio-Fort Sam in Houston, Texas, found higher risks of diabetes and diabetic complications—“without any of the hoped-for cardiovascular benefits.”
It is already established that statins can raise the risk of diabetes. But the military health researchers say there has been no primary prevention clinical trial to examine the overall adverse events (AEs) of statins in physically active people. In a previous study of TRICARE enrollees, the researchers found that short-term statin therapy was not associated with reduced cardiovascular morbidity but was associated with increased risk of AEs. To follow up on those findings, the researchers conducted another study to examine the short- and long-term AEs of statins in active-duty military—chosen precisely because of their physical fitness.
The study, which involved 837 statin users and 2,488 nonusers, covered 2001-2011. The researchers captured 3 intervals: short-term outcomes, 2006; intermediate outcomes, 2006-2009; and long-term outcomes, 2006-2011.
Statin users had nearly twice the risk of diabetes compared with nonusers: 12.5% vs 5.8%. They also had a higher incidence of diabetes with complications: 1.7% vs 0.7%. However, the overall incidence of major acute cardiovascular events was low: 2.58 events per 1,000 person-years in users, and 2.63 events in nonusers. That small number meant the researchers could not show beneficial cardiovascular effects due to statins.
Their findings help fill a gap in the literature, the researchers say, and highlight the possibility that some healthy and active individuals may be receiving statins unnecessarily, putting them at risk for AEs. Moreover, those risks persist long after statins are discontinued, the researchers note. Their study suggests that “we may need to adjust our approach and priorities to primary prevention.”
Source:
Mansi IA, English JL, Morris MJ, Zhang S, Mortensen EM, Halm EA. J Sci Med Sport. 2017;20(7):627-632.
doi: 10.1016/j.jsams.2016.12.075.
Statewide QI learning collaboratives improve asthma care
Care of children with asthma can be improved using statewide quality improvement (QI) learning collaboratives, said Judith C. Dolins, of the American Academy of Pediatrics (AAP), Elk Grove Village, Ill., and her associates.
AAP chapters demonstrated this through their implementation of the Chapter Quality Network (CQN) project, which was supported by the national organization. This project sought to encourage practice changes in asthma care in a number of states using statewide QI learning collaboratives and lead practices to implement the National Heart, Lung, and Blood Institute’s (NHLBI) 2007 asthma guidelines over the course of four time periods, which the researchers referred to as waves. In nine states, 19 AAP chapters engaged 180 practices to participate, and involved 749 pediatricians treating 45,431 patients (Pediatrics. 2017. doi: 10.1542/peds.2016-1612).
Across all waves, practices had reasonably high baseline use of the stepwise approach (81%-89%) and a controller medication for patients with persistent asthma (74%-88%). The patients with a current written asthma action plan increased from 49%-57% to 75%-91%. Physicians’ and parents’ ratings of asthma in children as “well controlled” rose modestly from 58%-63% to 71%-74% and from 67%-73% to 78%-87%, respectively. Patients receiving self-management materials increased from 57%-62% to 62%-88%.
Here’s how the project worked. The CQN had three linked frameworks.: One provided a methodology for spreading practice changes, another outlined the elements of care, and a third provided a framework so the practices could test, implement, and adapt changes.
A national AAP leadership team of experts in asthma care, QI, and primary care practice systems developed a set of key drivers and interventions, and an implementation guide that included resources, tools and methods, and a set of measures for the chapters. They also designed reporting tools and a curriculum fostering QI learning by chapter leaders. Then, in a state chapter leadership learning network and a practice collaborative model in each state, there were “multiple in-person learning sessions and defined action periods, best practices, and tests of change that were spread and incorporated” for the chapters to use, according to the study report.
Chapters in each state had monthly webinars and two in-person learning sessions for participating practices. They also reviewed data reports at the state and practice level and provided coaching for practices.
Practices were asked to “incorporate optimal NHLBI asthma care practices, including assessment of control, a stepwise approach to treatment, appropriate use of controller medication, and an updated asthma action plan for self-management.” Other interventions included use of an asthma encounter form (which collected 16 measures, including outcome and process measures that were entered into a national database at least monthly); introduction of population registries; workflow assessment; motivational interviews; plan-do-study-act cycles for QI; and review of data for QI.
All the physicians were eligible to earn MOC part 4 credit and continuing medical education credit, and 80% of the physicians did get MOC credit across the 4 waves.
“Our findings are notable for achieving improvement in asthma care through training multiple state coordinating entities instead of directly leading the learning collaborative itself. Few other projects have achieved this level of results in pediatric practice improvement in asthma care on such a widespread scale across multiple states. This project may serve as a model for other statewide and national organizations attempting to achieve improvements in population health through support and training for statewide organizations that, in turn, support individual health care providers and practices,” Ms. Dolins and her associates said. “Although none of the waves achieved the preset goal of 90%, all showed substantial improvement and remarkable consistency in the rate of improvement. We, therefore, regarded the project as an overall success.”
The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
We can do a better job of taking care of our patients. And in no other area is there more room for quality improvement (QI) than in ambulatory care. In the article by Dolins et al., substantial improvements were reported in outpatient management meeting the standard of care for asthma. In my experience, doing so not only gives children a better functional outcome but also saves costs by avoiding unnecessary ED visits and hospitalization and generates new dollars for pediatric offices through the additional services they provide. We have seen similar improvements in our own work in South Carolina and Tennessee. The practices that have wanted to become involved in our asthma QI are those that are already doing a better than average job. Yet, they still generate substantial additional improvements.
The AAP study relied heavily on national experts and standards. Although their input is valued, the true advantage of QI is the opportunity for pediatricians and their staff at the service delivery level to generate their own changes within the context of a learning collaborative. True improvement and innovation is facilitated by allowing flexibility at the local level and sharing the ideas that result. Those that design the QI efforts of the future need to make sure they allow for local expertise rather than leaning too heavily on centrally predetermined change concepts.
Part IV Maintenance of Certification requirements from the American Board of Pediatrics help provide momentum for successful pediatric QI. The National Improvement Partnership Network has formed pediatric outpatient learning collaboratives to share ideas. As we identify more successes with ambulatory care QI, as more and more organizations like AAP state chapters become involved, as all practices – rather than just the best – recognize the obligation to promote quality, we have a tremendous opportunity to improve the developmental and health outcomes of the children. QI can promote work and cost efficiencies that facilitate our work as pediatricians, making our lives more productive and rewarding.
Francis E. Rushton Jr, MD, is a pediatrician and medical director of South Carolina’s QTIP (Quality Through Innovation in Pediatrics) network and the Quality Director for PHIIT (Pediatric Health Improvement In Tennessee). He reported not having any relevant financial disclosures.
We can do a better job of taking care of our patients. And in no other area is there more room for quality improvement (QI) than in ambulatory care. In the article by Dolins et al., substantial improvements were reported in outpatient management meeting the standard of care for asthma. In my experience, doing so not only gives children a better functional outcome but also saves costs by avoiding unnecessary ED visits and hospitalization and generates new dollars for pediatric offices through the additional services they provide. We have seen similar improvements in our own work in South Carolina and Tennessee. The practices that have wanted to become involved in our asthma QI are those that are already doing a better than average job. Yet, they still generate substantial additional improvements.
The AAP study relied heavily on national experts and standards. Although their input is valued, the true advantage of QI is the opportunity for pediatricians and their staff at the service delivery level to generate their own changes within the context of a learning collaborative. True improvement and innovation is facilitated by allowing flexibility at the local level and sharing the ideas that result. Those that design the QI efforts of the future need to make sure they allow for local expertise rather than leaning too heavily on centrally predetermined change concepts.
Part IV Maintenance of Certification requirements from the American Board of Pediatrics help provide momentum for successful pediatric QI. The National Improvement Partnership Network has formed pediatric outpatient learning collaboratives to share ideas. As we identify more successes with ambulatory care QI, as more and more organizations like AAP state chapters become involved, as all practices – rather than just the best – recognize the obligation to promote quality, we have a tremendous opportunity to improve the developmental and health outcomes of the children. QI can promote work and cost efficiencies that facilitate our work as pediatricians, making our lives more productive and rewarding.
Francis E. Rushton Jr, MD, is a pediatrician and medical director of South Carolina’s QTIP (Quality Through Innovation in Pediatrics) network and the Quality Director for PHIIT (Pediatric Health Improvement In Tennessee). He reported not having any relevant financial disclosures.
We can do a better job of taking care of our patients. And in no other area is there more room for quality improvement (QI) than in ambulatory care. In the article by Dolins et al., substantial improvements were reported in outpatient management meeting the standard of care for asthma. In my experience, doing so not only gives children a better functional outcome but also saves costs by avoiding unnecessary ED visits and hospitalization and generates new dollars for pediatric offices through the additional services they provide. We have seen similar improvements in our own work in South Carolina and Tennessee. The practices that have wanted to become involved in our asthma QI are those that are already doing a better than average job. Yet, they still generate substantial additional improvements.
The AAP study relied heavily on national experts and standards. Although their input is valued, the true advantage of QI is the opportunity for pediatricians and their staff at the service delivery level to generate their own changes within the context of a learning collaborative. True improvement and innovation is facilitated by allowing flexibility at the local level and sharing the ideas that result. Those that design the QI efforts of the future need to make sure they allow for local expertise rather than leaning too heavily on centrally predetermined change concepts.
Part IV Maintenance of Certification requirements from the American Board of Pediatrics help provide momentum for successful pediatric QI. The National Improvement Partnership Network has formed pediatric outpatient learning collaboratives to share ideas. As we identify more successes with ambulatory care QI, as more and more organizations like AAP state chapters become involved, as all practices – rather than just the best – recognize the obligation to promote quality, we have a tremendous opportunity to improve the developmental and health outcomes of the children. QI can promote work and cost efficiencies that facilitate our work as pediatricians, making our lives more productive and rewarding.
Francis E. Rushton Jr, MD, is a pediatrician and medical director of South Carolina’s QTIP (Quality Through Innovation in Pediatrics) network and the Quality Director for PHIIT (Pediatric Health Improvement In Tennessee). He reported not having any relevant financial disclosures.
Care of children with asthma can be improved using statewide quality improvement (QI) learning collaboratives, said Judith C. Dolins, of the American Academy of Pediatrics (AAP), Elk Grove Village, Ill., and her associates.
AAP chapters demonstrated this through their implementation of the Chapter Quality Network (CQN) project, which was supported by the national organization. This project sought to encourage practice changes in asthma care in a number of states using statewide QI learning collaboratives and lead practices to implement the National Heart, Lung, and Blood Institute’s (NHLBI) 2007 asthma guidelines over the course of four time periods, which the researchers referred to as waves. In nine states, 19 AAP chapters engaged 180 practices to participate, and involved 749 pediatricians treating 45,431 patients (Pediatrics. 2017. doi: 10.1542/peds.2016-1612).
Across all waves, practices had reasonably high baseline use of the stepwise approach (81%-89%) and a controller medication for patients with persistent asthma (74%-88%). The patients with a current written asthma action plan increased from 49%-57% to 75%-91%. Physicians’ and parents’ ratings of asthma in children as “well controlled” rose modestly from 58%-63% to 71%-74% and from 67%-73% to 78%-87%, respectively. Patients receiving self-management materials increased from 57%-62% to 62%-88%.
Here’s how the project worked. The CQN had three linked frameworks.: One provided a methodology for spreading practice changes, another outlined the elements of care, and a third provided a framework so the practices could test, implement, and adapt changes.
A national AAP leadership team of experts in asthma care, QI, and primary care practice systems developed a set of key drivers and interventions, and an implementation guide that included resources, tools and methods, and a set of measures for the chapters. They also designed reporting tools and a curriculum fostering QI learning by chapter leaders. Then, in a state chapter leadership learning network and a practice collaborative model in each state, there were “multiple in-person learning sessions and defined action periods, best practices, and tests of change that were spread and incorporated” for the chapters to use, according to the study report.
Chapters in each state had monthly webinars and two in-person learning sessions for participating practices. They also reviewed data reports at the state and practice level and provided coaching for practices.
Practices were asked to “incorporate optimal NHLBI asthma care practices, including assessment of control, a stepwise approach to treatment, appropriate use of controller medication, and an updated asthma action plan for self-management.” Other interventions included use of an asthma encounter form (which collected 16 measures, including outcome and process measures that were entered into a national database at least monthly); introduction of population registries; workflow assessment; motivational interviews; plan-do-study-act cycles for QI; and review of data for QI.
All the physicians were eligible to earn MOC part 4 credit and continuing medical education credit, and 80% of the physicians did get MOC credit across the 4 waves.
“Our findings are notable for achieving improvement in asthma care through training multiple state coordinating entities instead of directly leading the learning collaborative itself. Few other projects have achieved this level of results in pediatric practice improvement in asthma care on such a widespread scale across multiple states. This project may serve as a model for other statewide and national organizations attempting to achieve improvements in population health through support and training for statewide organizations that, in turn, support individual health care providers and practices,” Ms. Dolins and her associates said. “Although none of the waves achieved the preset goal of 90%, all showed substantial improvement and remarkable consistency in the rate of improvement. We, therefore, regarded the project as an overall success.”
The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
Care of children with asthma can be improved using statewide quality improvement (QI) learning collaboratives, said Judith C. Dolins, of the American Academy of Pediatrics (AAP), Elk Grove Village, Ill., and her associates.
AAP chapters demonstrated this through their implementation of the Chapter Quality Network (CQN) project, which was supported by the national organization. This project sought to encourage practice changes in asthma care in a number of states using statewide QI learning collaboratives and lead practices to implement the National Heart, Lung, and Blood Institute’s (NHLBI) 2007 asthma guidelines over the course of four time periods, which the researchers referred to as waves. In nine states, 19 AAP chapters engaged 180 practices to participate, and involved 749 pediatricians treating 45,431 patients (Pediatrics. 2017. doi: 10.1542/peds.2016-1612).
Across all waves, practices had reasonably high baseline use of the stepwise approach (81%-89%) and a controller medication for patients with persistent asthma (74%-88%). The patients with a current written asthma action plan increased from 49%-57% to 75%-91%. Physicians’ and parents’ ratings of asthma in children as “well controlled” rose modestly from 58%-63% to 71%-74% and from 67%-73% to 78%-87%, respectively. Patients receiving self-management materials increased from 57%-62% to 62%-88%.
Here’s how the project worked. The CQN had three linked frameworks.: One provided a methodology for spreading practice changes, another outlined the elements of care, and a third provided a framework so the practices could test, implement, and adapt changes.
A national AAP leadership team of experts in asthma care, QI, and primary care practice systems developed a set of key drivers and interventions, and an implementation guide that included resources, tools and methods, and a set of measures for the chapters. They also designed reporting tools and a curriculum fostering QI learning by chapter leaders. Then, in a state chapter leadership learning network and a practice collaborative model in each state, there were “multiple in-person learning sessions and defined action periods, best practices, and tests of change that were spread and incorporated” for the chapters to use, according to the study report.
Chapters in each state had monthly webinars and two in-person learning sessions for participating practices. They also reviewed data reports at the state and practice level and provided coaching for practices.
Practices were asked to “incorporate optimal NHLBI asthma care practices, including assessment of control, a stepwise approach to treatment, appropriate use of controller medication, and an updated asthma action plan for self-management.” Other interventions included use of an asthma encounter form (which collected 16 measures, including outcome and process measures that were entered into a national database at least monthly); introduction of population registries; workflow assessment; motivational interviews; plan-do-study-act cycles for QI; and review of data for QI.
All the physicians were eligible to earn MOC part 4 credit and continuing medical education credit, and 80% of the physicians did get MOC credit across the 4 waves.
“Our findings are notable for achieving improvement in asthma care through training multiple state coordinating entities instead of directly leading the learning collaborative itself. Few other projects have achieved this level of results in pediatric practice improvement in asthma care on such a widespread scale across multiple states. This project may serve as a model for other statewide and national organizations attempting to achieve improvements in population health through support and training for statewide organizations that, in turn, support individual health care providers and practices,” Ms. Dolins and her associates said. “Although none of the waves achieved the preset goal of 90%, all showed substantial improvement and remarkable consistency in the rate of improvement. We, therefore, regarded the project as an overall success.”
The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
FROM PEDIATRICS
Key clinical point:
Major finding: In wave 4, during which data were collected for 9 months, the rate of optimal asthma care at each encounter improved from 38% to 72%.
Data source: In nine states, 19 AAP chapters engaged 180 practices to participate in quality improvement learning collaboratives, which involved 749 pediatricians treating 45,431 patients.
Disclosures: The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
Pembrolizumab takes on r/r PMBCL
LUGANO, SWITZERLAND – Patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL) have few good therapeutic options, but pembrolizumab (Keytruda) may be one of them, an interim analysis from a phase 2 trial suggests.
Six of 10 patients with relapsed/refractory PMBCL for whom autologous stem cell transplantation (ASCT) had failed had responses to salvage therapy with pembrolizumab, including three complete responses (CR) and three partial responses (PR), reported Pier Luigi Zinzani, MD, PhD, of the University of Bologna, Italy.
“In relapsed/refractory primary mediastinal large B-cell lymphoma including heavily pretreated patients in our series, pembrolizumab showed promising antitumor activity in these preliminary data from a phase 2 study, and a manageable safety profile,” Dr. Zinzani said at the International Conference on Malignant Lymphoma.
Although standard cytotoxic chemotherapy regimens are curative in approximately 80% of patients with PMBCL, those with relapsed/refractory disease have a poor prognosis and limited treatment options. In the United States, about 200 patients are diagnosed with relapsed/refractory PMBCL each year, Dr. Zinzani noted.
The rationale for using a programmed death-1 (PD-1) inhibitor such as pembrolizumab is that PMBCL tumors frequently harbor amplifications and/or translocations in the 9p24.1 locus that lead to overexpression of PD ligand 1 (PD-L1) or PD-L2. Pembrolizumab blocks interactions between PD-1 and its ligands.
In the Keynote-013 PMBCL cohort, the objective response rate (ORR) was 48%, including 24% CR.
Keynote 170 investigators are enrolling adults with relapsed/refractory PMBCL who are either ineligible for ASCT following at least two prior lines of therapy, or who had a relapse following a transplant.
Patients receive pembrolizumab 200 mg every 3 weeks. Those who achieve a complete response are allowed to discontinue after a minimum of 24 weeks on study, those with partial response or stable disease are treated for 35 cycles or until disease progression or intolerable toxicities, and those with disease progression are discontinued, but are allowed to remain on study until progression is confirmed.
Responses are assessed by PET and CT scans according to 2007 International Working Group criteria.
Among the 29 patients assessable for efficacy at the time of Dr. Zinzani’s presentations, the best response by blinded central review was 41% (12 patients: 4 CR and 8 PR). Three patients had stable disease, and eight had disease progression. Six patients died or discontinued participation prior to the first assessment.
In all, 16 of 22 patients had reductions in target lesions, and all but one of these patients had reductions greater than 50%.
After a median follow-up of 6.6 months, 10 patients had ongoing responses. The median time to response was 2.9 months. The median duration of response has not been reached.
Of the 10 patients for whom ASCT had failed, three had a CR, and three had a PR. Among 19 ASCT-ineligible patients, one had a CR and five had a PR.
The interim safety analysis included 49 patients. Of this group, only one discontinued treatment because of adverse events. There were 26 treatment-related adverse events, but no treatment-related deaths.
The most frequent adverse events were neutropenia, asthenia, hypothyroidism, and pyrexia.
The study is supported by Merck. Dr Zinzani disclosed serving on advisory boards for several companies.
LUGANO, SWITZERLAND – Patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL) have few good therapeutic options, but pembrolizumab (Keytruda) may be one of them, an interim analysis from a phase 2 trial suggests.
Six of 10 patients with relapsed/refractory PMBCL for whom autologous stem cell transplantation (ASCT) had failed had responses to salvage therapy with pembrolizumab, including three complete responses (CR) and three partial responses (PR), reported Pier Luigi Zinzani, MD, PhD, of the University of Bologna, Italy.
“In relapsed/refractory primary mediastinal large B-cell lymphoma including heavily pretreated patients in our series, pembrolizumab showed promising antitumor activity in these preliminary data from a phase 2 study, and a manageable safety profile,” Dr. Zinzani said at the International Conference on Malignant Lymphoma.
Although standard cytotoxic chemotherapy regimens are curative in approximately 80% of patients with PMBCL, those with relapsed/refractory disease have a poor prognosis and limited treatment options. In the United States, about 200 patients are diagnosed with relapsed/refractory PMBCL each year, Dr. Zinzani noted.
The rationale for using a programmed death-1 (PD-1) inhibitor such as pembrolizumab is that PMBCL tumors frequently harbor amplifications and/or translocations in the 9p24.1 locus that lead to overexpression of PD ligand 1 (PD-L1) or PD-L2. Pembrolizumab blocks interactions between PD-1 and its ligands.
In the Keynote-013 PMBCL cohort, the objective response rate (ORR) was 48%, including 24% CR.
Keynote 170 investigators are enrolling adults with relapsed/refractory PMBCL who are either ineligible for ASCT following at least two prior lines of therapy, or who had a relapse following a transplant.
Patients receive pembrolizumab 200 mg every 3 weeks. Those who achieve a complete response are allowed to discontinue after a minimum of 24 weeks on study, those with partial response or stable disease are treated for 35 cycles or until disease progression or intolerable toxicities, and those with disease progression are discontinued, but are allowed to remain on study until progression is confirmed.
Responses are assessed by PET and CT scans according to 2007 International Working Group criteria.
Among the 29 patients assessable for efficacy at the time of Dr. Zinzani’s presentations, the best response by blinded central review was 41% (12 patients: 4 CR and 8 PR). Three patients had stable disease, and eight had disease progression. Six patients died or discontinued participation prior to the first assessment.
In all, 16 of 22 patients had reductions in target lesions, and all but one of these patients had reductions greater than 50%.
After a median follow-up of 6.6 months, 10 patients had ongoing responses. The median time to response was 2.9 months. The median duration of response has not been reached.
Of the 10 patients for whom ASCT had failed, three had a CR, and three had a PR. Among 19 ASCT-ineligible patients, one had a CR and five had a PR.
The interim safety analysis included 49 patients. Of this group, only one discontinued treatment because of adverse events. There were 26 treatment-related adverse events, but no treatment-related deaths.
The most frequent adverse events were neutropenia, asthenia, hypothyroidism, and pyrexia.
The study is supported by Merck. Dr Zinzani disclosed serving on advisory boards for several companies.
LUGANO, SWITZERLAND – Patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL) have few good therapeutic options, but pembrolizumab (Keytruda) may be one of them, an interim analysis from a phase 2 trial suggests.
Six of 10 patients with relapsed/refractory PMBCL for whom autologous stem cell transplantation (ASCT) had failed had responses to salvage therapy with pembrolizumab, including three complete responses (CR) and three partial responses (PR), reported Pier Luigi Zinzani, MD, PhD, of the University of Bologna, Italy.
“In relapsed/refractory primary mediastinal large B-cell lymphoma including heavily pretreated patients in our series, pembrolizumab showed promising antitumor activity in these preliminary data from a phase 2 study, and a manageable safety profile,” Dr. Zinzani said at the International Conference on Malignant Lymphoma.
Although standard cytotoxic chemotherapy regimens are curative in approximately 80% of patients with PMBCL, those with relapsed/refractory disease have a poor prognosis and limited treatment options. In the United States, about 200 patients are diagnosed with relapsed/refractory PMBCL each year, Dr. Zinzani noted.
The rationale for using a programmed death-1 (PD-1) inhibitor such as pembrolizumab is that PMBCL tumors frequently harbor amplifications and/or translocations in the 9p24.1 locus that lead to overexpression of PD ligand 1 (PD-L1) or PD-L2. Pembrolizumab blocks interactions between PD-1 and its ligands.
In the Keynote-013 PMBCL cohort, the objective response rate (ORR) was 48%, including 24% CR.
Keynote 170 investigators are enrolling adults with relapsed/refractory PMBCL who are either ineligible for ASCT following at least two prior lines of therapy, or who had a relapse following a transplant.
Patients receive pembrolizumab 200 mg every 3 weeks. Those who achieve a complete response are allowed to discontinue after a minimum of 24 weeks on study, those with partial response or stable disease are treated for 35 cycles or until disease progression or intolerable toxicities, and those with disease progression are discontinued, but are allowed to remain on study until progression is confirmed.
Responses are assessed by PET and CT scans according to 2007 International Working Group criteria.
Among the 29 patients assessable for efficacy at the time of Dr. Zinzani’s presentations, the best response by blinded central review was 41% (12 patients: 4 CR and 8 PR). Three patients had stable disease, and eight had disease progression. Six patients died or discontinued participation prior to the first assessment.
In all, 16 of 22 patients had reductions in target lesions, and all but one of these patients had reductions greater than 50%.
After a median follow-up of 6.6 months, 10 patients had ongoing responses. The median time to response was 2.9 months. The median duration of response has not been reached.
Of the 10 patients for whom ASCT had failed, three had a CR, and three had a PR. Among 19 ASCT-ineligible patients, one had a CR and five had a PR.
The interim safety analysis included 49 patients. Of this group, only one discontinued treatment because of adverse events. There were 26 treatment-related adverse events, but no treatment-related deaths.
The most frequent adverse events were neutropenia, asthenia, hypothyroidism, and pyrexia.
The study is supported by Merck. Dr Zinzani disclosed serving on advisory boards for several companies.
AT 14-ICML
Key clinical point: Poor-prognosis relapsed/refractory primary mediastinal large B-cell lymphoma may respond to PD-1 inhibition.
Major finding: The best response by blinded central review was 41% (12 patients: 4 complete and 8 partial responses).
Data source: Interim analysis from a phase 2 study with 29 patients evaluable for efficacy, 49 for safety.
Disclosures: Merck supports the study. Dr Zinzani disclosed serving on advisory boards for several companies.
Getting a Better Picture of Skin Cancer
A handheld detector that offers noninvasive real-time imaging can help dermatologic surgeons get a better idea of skin cancer dimensions before committing to surgery, according to researchers from National Skin Centre and Singapore Bioimaging Consortium, both in Singapore, and Technical University of Munich and iThera Medical GmbH, both in Germany.
Current imaging technologies can lead to excessive or incomplete removal of the cancer, the researchers say. The multispectral optoacoustic tomography (MSOT) allows the user to differentiate tissue chromophores (the chromophore is the part of the molecule responsible for its color) and exogenous contrast agents based on their spectral signatures.
The researchers performed MSOT imaging with 2- and 3-dimensional handheld scanners on 21 patients with nonmelanoma skin cancers. All the skin lesions had recognizable images on MSOT with both detectors, visualizing the shape and thickness of the lesions. The 2D and 3D detectors also offered images with well-resolved tissue chromophores. But the volumetric probe gave more accurate tumor dimensions compared with those from histology analysis.
Aggressive types of skin cancers can involve deeper structures, such as predominant deep blood vessels, the researchers note—another reason the MSOT detector could be useful. In one case, the depth of the basal cell carcinoma, which included its underlying vasculature, reached beyond 3 mm, which might have gone undetected by other imaging modalities, they say.
The fact that the device is also noninvasive and offers real-time imaging, the researchers suggest, makes volumetric MSOT “an ideal modality for longitudinal monitoring of skin diseases and treatment responses.”
Source:
Attia ABE, Chuah SY, Razansky D, et al. Photoacoustics. 2017;7:20-26.
doi: 10.1016/j.pacs.2017.05.003.
A handheld detector that offers noninvasive real-time imaging can help dermatologic surgeons get a better idea of skin cancer dimensions before committing to surgery, according to researchers from National Skin Centre and Singapore Bioimaging Consortium, both in Singapore, and Technical University of Munich and iThera Medical GmbH, both in Germany.
Current imaging technologies can lead to excessive or incomplete removal of the cancer, the researchers say. The multispectral optoacoustic tomography (MSOT) allows the user to differentiate tissue chromophores (the chromophore is the part of the molecule responsible for its color) and exogenous contrast agents based on their spectral signatures.
The researchers performed MSOT imaging with 2- and 3-dimensional handheld scanners on 21 patients with nonmelanoma skin cancers. All the skin lesions had recognizable images on MSOT with both detectors, visualizing the shape and thickness of the lesions. The 2D and 3D detectors also offered images with well-resolved tissue chromophores. But the volumetric probe gave more accurate tumor dimensions compared with those from histology analysis.
Aggressive types of skin cancers can involve deeper structures, such as predominant deep blood vessels, the researchers note—another reason the MSOT detector could be useful. In one case, the depth of the basal cell carcinoma, which included its underlying vasculature, reached beyond 3 mm, which might have gone undetected by other imaging modalities, they say.
The fact that the device is also noninvasive and offers real-time imaging, the researchers suggest, makes volumetric MSOT “an ideal modality for longitudinal monitoring of skin diseases and treatment responses.”
Source:
Attia ABE, Chuah SY, Razansky D, et al. Photoacoustics. 2017;7:20-26.
doi: 10.1016/j.pacs.2017.05.003.
A handheld detector that offers noninvasive real-time imaging can help dermatologic surgeons get a better idea of skin cancer dimensions before committing to surgery, according to researchers from National Skin Centre and Singapore Bioimaging Consortium, both in Singapore, and Technical University of Munich and iThera Medical GmbH, both in Germany.
Current imaging technologies can lead to excessive or incomplete removal of the cancer, the researchers say. The multispectral optoacoustic tomography (MSOT) allows the user to differentiate tissue chromophores (the chromophore is the part of the molecule responsible for its color) and exogenous contrast agents based on their spectral signatures.
The researchers performed MSOT imaging with 2- and 3-dimensional handheld scanners on 21 patients with nonmelanoma skin cancers. All the skin lesions had recognizable images on MSOT with both detectors, visualizing the shape and thickness of the lesions. The 2D and 3D detectors also offered images with well-resolved tissue chromophores. But the volumetric probe gave more accurate tumor dimensions compared with those from histology analysis.
Aggressive types of skin cancers can involve deeper structures, such as predominant deep blood vessels, the researchers note—another reason the MSOT detector could be useful. In one case, the depth of the basal cell carcinoma, which included its underlying vasculature, reached beyond 3 mm, which might have gone undetected by other imaging modalities, they say.
The fact that the device is also noninvasive and offers real-time imaging, the researchers suggest, makes volumetric MSOT “an ideal modality for longitudinal monitoring of skin diseases and treatment responses.”
Source:
Attia ABE, Chuah SY, Razansky D, et al. Photoacoustics. 2017;7:20-26.
doi: 10.1016/j.pacs.2017.05.003.
FDA Approves First New ALS Drug in Years
A new treatment for amyotrophic lateral sclerosis (ALS), Radicava (edaravone), is on the way for U.S. patients.
“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”
In a 6-month trial, 137 patients were randomly assigned to edaravone or placebo. At week 24, those receiving edaravone had declined less on a clinical assessment of daily functioning.
Edaravon is given intravenously daily for 14 days to start, followed by 14 days drug free. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug free.
The most common adverse reactions are bruising and gait disturbance. Edaravon also contains sodium bisulfite, which can cause serious allergic reactions in patients with sulfite sensitivity.
A new treatment for amyotrophic lateral sclerosis (ALS), Radicava (edaravone), is on the way for U.S. patients.
“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”
In a 6-month trial, 137 patients were randomly assigned to edaravone or placebo. At week 24, those receiving edaravone had declined less on a clinical assessment of daily functioning.
Edaravon is given intravenously daily for 14 days to start, followed by 14 days drug free. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug free.
The most common adverse reactions are bruising and gait disturbance. Edaravon also contains sodium bisulfite, which can cause serious allergic reactions in patients with sulfite sensitivity.
A new treatment for amyotrophic lateral sclerosis (ALS), Radicava (edaravone), is on the way for U.S. patients.
“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”
In a 6-month trial, 137 patients were randomly assigned to edaravone or placebo. At week 24, those receiving edaravone had declined less on a clinical assessment of daily functioning.
Edaravon is given intravenously daily for 14 days to start, followed by 14 days drug free. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug free.
The most common adverse reactions are bruising and gait disturbance. Edaravon also contains sodium bisulfite, which can cause serious allergic reactions in patients with sulfite sensitivity.
Add-on azithromycin cuts asthma exacerbations
Adults with persistent symptomatic asthma who took azithromycin as an add-on therapy experienced fewer exacerbations and had improved quality of life, compared with their peers who took a placebo, a multicenter, randomized trial demonstrated.
“Macrolide antibiotics have antibacterial, antiviral, and anti-inflammatory effects, and are reported to be beneficial in both eosinophilic and noneosinophilic subtypes,” a group of Australian researchers wrote online July 4 in The Lancet (doi: org/10.1016/S0140-6736[17]31281-3). “Systematic reviews of randomized, controlled trials report benefits of macrolides on asthma symptoms but [we] are unable to draw conclusions about the effects on other endpoints, including exacerbations, due to lack of data, heterogeneity of results, and inadequate study design and sample size.”
The researchers observed a significant reduction in the incidence of total asthma exacerbations in the azithromycin-treated group: 1.07/patient-year, compared with 1.86/patient year in the placebo group, which translated into an incidence rate ratio of 0.59 (P less than .0001). Specifically, 127 patients in the placebo group (61%) experienced at least one asthma exacerbation compared with 94 patients in the azithromycin group (44%; P less than .0001). A significant improvement in asthma-related quality of life was also seen among patients in the azithromycin group (adjusted mean difference of 0.36; P = .001).
Though the mechanism of the antiviral effect of macrolides is not yet determined, Dr. Gibson and his associates noted that respiratory viral infection is associated with severe exacerbations in eosinophilic asthma and causes most respiratory infections. “There is a known interaction between eosinophilic airway inflammation, exacerbation rate, and impaired innate antiviral immunity,” they wrote. “Since we observed a benefit of azithromycin on both asthma exacerbations and respiratory infections, we speculate that azithromycin might be acting to prevent viral-induced episodes in asthma.”
“Given the major impact of asthma exacerbations on patients and the community and the ongoing risk posed by these events in patients who remain symptomatic on maintenance therapy, we consider that azithromycin is a valuable addition to existing regimens for treating asthma,” the researchers concluded. “The long-term effects of this therapy on community microbial resistance require further evaluation.”
The overall rates and types of serious adverse events seen in both groups were not significantly different from each other, with serious adverse events having occurred in 16 (8%) patients treated with azithromycin and 26 (13%) patients given the placebo.
The study was funded by the National Health and Medical Research Council of Australia and the John Hunter Hospital Charitable Trust. The authors reported having no financial conflicts directly related to the study.
Since microbial resistance is a well known side effect of antibiotic use, add-on therapy with azithromycin in asthma needs to be restricted to those patients with the highest unmet medical need (for example, frequent exacerbators) and to time periods with the greatest risk of exacerbations (such as winter). Biomarkers that predict the therapeutic response to macrolides might facilitate optimal patient selection. Further research is needed to elucidate the most important mechanism of action of these pleiotropic drugs. Macrolides have anti-inflammatory, antibacterial, and antiviral effects. However, the authors did not observe a reduction in inflammatory cell counts in sputum to support a definite anti-inflammatory effect. Azithromycin also was effective in patients with and without potentially pathogenic microorganisms in sputum cultures at baseline. Since azithromycin reduced both asthma exacerbations and respiratory infections, the benefits of azithromycin might be caused by preventing viral-induced attacks in asthma. Azithromycin stimulates phagocytosis of microbes and dead cells by macrophages (i.e., efferocytosis), an effect that is likely to be independent of the nature of the accompanying neutrophilic or eosinophilic airway inflammation.
Gibson and colleagues have clearly shown that add-on therapy with azithromycin is effective and safe in adult patients with uncontrolled asthma despite treatment with inhaled corticosteroids and long-acting beta-agonists. Azithromycin benefited patients with both eosinophilic and noneosinophilic asthma. However, the effects of long-term therapy with macrolides on community microbial resistance remain a public health concern. Future studies with potentially safer nonantibiotic macrolides in uncontrolled severe asthma are warranted. Since the antimicrobial effects probably contribute to the overall efficacy of macrolides, the beneficial effects of nonantibiotic macrolides might be intermediate between macrolide antibiotics and placebo.
This text is excerpted from a commentary published online July 4 in The Lancet (doi. org/10.1016/S0140-6736[17]31547-7). Guy Brusselle, MD, is with the department of respiratory medicine at Ghent (Belgium) University Hospital and Ian Pavord, MD, is with the University of Oxford’s Nuffield Department of Medicine, England. Both authors disclosed having received honoraria and other financial support from numerous pharmaceutical companies.
Since microbial resistance is a well known side effect of antibiotic use, add-on therapy with azithromycin in asthma needs to be restricted to those patients with the highest unmet medical need (for example, frequent exacerbators) and to time periods with the greatest risk of exacerbations (such as winter). Biomarkers that predict the therapeutic response to macrolides might facilitate optimal patient selection. Further research is needed to elucidate the most important mechanism of action of these pleiotropic drugs. Macrolides have anti-inflammatory, antibacterial, and antiviral effects. However, the authors did not observe a reduction in inflammatory cell counts in sputum to support a definite anti-inflammatory effect. Azithromycin also was effective in patients with and without potentially pathogenic microorganisms in sputum cultures at baseline. Since azithromycin reduced both asthma exacerbations and respiratory infections, the benefits of azithromycin might be caused by preventing viral-induced attacks in asthma. Azithromycin stimulates phagocytosis of microbes and dead cells by macrophages (i.e., efferocytosis), an effect that is likely to be independent of the nature of the accompanying neutrophilic or eosinophilic airway inflammation.
Gibson and colleagues have clearly shown that add-on therapy with azithromycin is effective and safe in adult patients with uncontrolled asthma despite treatment with inhaled corticosteroids and long-acting beta-agonists. Azithromycin benefited patients with both eosinophilic and noneosinophilic asthma. However, the effects of long-term therapy with macrolides on community microbial resistance remain a public health concern. Future studies with potentially safer nonantibiotic macrolides in uncontrolled severe asthma are warranted. Since the antimicrobial effects probably contribute to the overall efficacy of macrolides, the beneficial effects of nonantibiotic macrolides might be intermediate between macrolide antibiotics and placebo.
This text is excerpted from a commentary published online July 4 in The Lancet (doi. org/10.1016/S0140-6736[17]31547-7). Guy Brusselle, MD, is with the department of respiratory medicine at Ghent (Belgium) University Hospital and Ian Pavord, MD, is with the University of Oxford’s Nuffield Department of Medicine, England. Both authors disclosed having received honoraria and other financial support from numerous pharmaceutical companies.
Since microbial resistance is a well known side effect of antibiotic use, add-on therapy with azithromycin in asthma needs to be restricted to those patients with the highest unmet medical need (for example, frequent exacerbators) and to time periods with the greatest risk of exacerbations (such as winter). Biomarkers that predict the therapeutic response to macrolides might facilitate optimal patient selection. Further research is needed to elucidate the most important mechanism of action of these pleiotropic drugs. Macrolides have anti-inflammatory, antibacterial, and antiviral effects. However, the authors did not observe a reduction in inflammatory cell counts in sputum to support a definite anti-inflammatory effect. Azithromycin also was effective in patients with and without potentially pathogenic microorganisms in sputum cultures at baseline. Since azithromycin reduced both asthma exacerbations and respiratory infections, the benefits of azithromycin might be caused by preventing viral-induced attacks in asthma. Azithromycin stimulates phagocytosis of microbes and dead cells by macrophages (i.e., efferocytosis), an effect that is likely to be independent of the nature of the accompanying neutrophilic or eosinophilic airway inflammation.
Gibson and colleagues have clearly shown that add-on therapy with azithromycin is effective and safe in adult patients with uncontrolled asthma despite treatment with inhaled corticosteroids and long-acting beta-agonists. Azithromycin benefited patients with both eosinophilic and noneosinophilic asthma. However, the effects of long-term therapy with macrolides on community microbial resistance remain a public health concern. Future studies with potentially safer nonantibiotic macrolides in uncontrolled severe asthma are warranted. Since the antimicrobial effects probably contribute to the overall efficacy of macrolides, the beneficial effects of nonantibiotic macrolides might be intermediate between macrolide antibiotics and placebo.
This text is excerpted from a commentary published online July 4 in The Lancet (doi. org/10.1016/S0140-6736[17]31547-7). Guy Brusselle, MD, is with the department of respiratory medicine at Ghent (Belgium) University Hospital and Ian Pavord, MD, is with the University of Oxford’s Nuffield Department of Medicine, England. Both authors disclosed having received honoraria and other financial support from numerous pharmaceutical companies.
Adults with persistent symptomatic asthma who took azithromycin as an add-on therapy experienced fewer exacerbations and had improved quality of life, compared with their peers who took a placebo, a multicenter, randomized trial demonstrated.
“Macrolide antibiotics have antibacterial, antiviral, and anti-inflammatory effects, and are reported to be beneficial in both eosinophilic and noneosinophilic subtypes,” a group of Australian researchers wrote online July 4 in The Lancet (doi: org/10.1016/S0140-6736[17]31281-3). “Systematic reviews of randomized, controlled trials report benefits of macrolides on asthma symptoms but [we] are unable to draw conclusions about the effects on other endpoints, including exacerbations, due to lack of data, heterogeneity of results, and inadequate study design and sample size.”
The researchers observed a significant reduction in the incidence of total asthma exacerbations in the azithromycin-treated group: 1.07/patient-year, compared with 1.86/patient year in the placebo group, which translated into an incidence rate ratio of 0.59 (P less than .0001). Specifically, 127 patients in the placebo group (61%) experienced at least one asthma exacerbation compared with 94 patients in the azithromycin group (44%; P less than .0001). A significant improvement in asthma-related quality of life was also seen among patients in the azithromycin group (adjusted mean difference of 0.36; P = .001).
Though the mechanism of the antiviral effect of macrolides is not yet determined, Dr. Gibson and his associates noted that respiratory viral infection is associated with severe exacerbations in eosinophilic asthma and causes most respiratory infections. “There is a known interaction between eosinophilic airway inflammation, exacerbation rate, and impaired innate antiviral immunity,” they wrote. “Since we observed a benefit of azithromycin on both asthma exacerbations and respiratory infections, we speculate that azithromycin might be acting to prevent viral-induced episodes in asthma.”
“Given the major impact of asthma exacerbations on patients and the community and the ongoing risk posed by these events in patients who remain symptomatic on maintenance therapy, we consider that azithromycin is a valuable addition to existing regimens for treating asthma,” the researchers concluded. “The long-term effects of this therapy on community microbial resistance require further evaluation.”
The overall rates and types of serious adverse events seen in both groups were not significantly different from each other, with serious adverse events having occurred in 16 (8%) patients treated with azithromycin and 26 (13%) patients given the placebo.
The study was funded by the National Health and Medical Research Council of Australia and the John Hunter Hospital Charitable Trust. The authors reported having no financial conflicts directly related to the study.
Adults with persistent symptomatic asthma who took azithromycin as an add-on therapy experienced fewer exacerbations and had improved quality of life, compared with their peers who took a placebo, a multicenter, randomized trial demonstrated.
“Macrolide antibiotics have antibacterial, antiviral, and anti-inflammatory effects, and are reported to be beneficial in both eosinophilic and noneosinophilic subtypes,” a group of Australian researchers wrote online July 4 in The Lancet (doi: org/10.1016/S0140-6736[17]31281-3). “Systematic reviews of randomized, controlled trials report benefits of macrolides on asthma symptoms but [we] are unable to draw conclusions about the effects on other endpoints, including exacerbations, due to lack of data, heterogeneity of results, and inadequate study design and sample size.”
The researchers observed a significant reduction in the incidence of total asthma exacerbations in the azithromycin-treated group: 1.07/patient-year, compared with 1.86/patient year in the placebo group, which translated into an incidence rate ratio of 0.59 (P less than .0001). Specifically, 127 patients in the placebo group (61%) experienced at least one asthma exacerbation compared with 94 patients in the azithromycin group (44%; P less than .0001). A significant improvement in asthma-related quality of life was also seen among patients in the azithromycin group (adjusted mean difference of 0.36; P = .001).
Though the mechanism of the antiviral effect of macrolides is not yet determined, Dr. Gibson and his associates noted that respiratory viral infection is associated with severe exacerbations in eosinophilic asthma and causes most respiratory infections. “There is a known interaction between eosinophilic airway inflammation, exacerbation rate, and impaired innate antiviral immunity,” they wrote. “Since we observed a benefit of azithromycin on both asthma exacerbations and respiratory infections, we speculate that azithromycin might be acting to prevent viral-induced episodes in asthma.”
“Given the major impact of asthma exacerbations on patients and the community and the ongoing risk posed by these events in patients who remain symptomatic on maintenance therapy, we consider that azithromycin is a valuable addition to existing regimens for treating asthma,” the researchers concluded. “The long-term effects of this therapy on community microbial resistance require further evaluation.”
The overall rates and types of serious adverse events seen in both groups were not significantly different from each other, with serious adverse events having occurred in 16 (8%) patients treated with azithromycin and 26 (13%) patients given the placebo.
The study was funded by the National Health and Medical Research Council of Australia and the John Hunter Hospital Charitable Trust. The authors reported having no financial conflicts directly related to the study.
FROM THE LANCET
Key clinical point:
Major finding: Azithromycin reduced the incidence of total asthma exacerbations, compared with placebo (1.07/patient-year vs. 1.86/patient-year, respectively, for an incidence rate ratio of 0.59; P less than .0001).
Data source: A randomized, placebo-controlled, multicenter trial of 420 adults with persistent, uncontrolled asthma.
Disclosures: The study was funded by the National Health and Medical Research Council of Australia and the John Hunter Hospital Charitable Trust. The authors reported having no financial conflicts directly related to the study.
IMiD/Anti-CD20 combo induces complete responses in r/r NHL
Lugano, Switzerland – A combination of obinutuzumab (Gazyva) and the experimental immunomodulatory agent CC-122 showed “clinically meaningful” activity against relapsed/refractory diffuse large B cell lymphoma (DLBCL) and indolent non-Hodgkin lymphoma (NHL) in a phase 1b study.
Among 38 patients with heavily pretreated, relapsed/refractory DLBCL, follicular lymphoma (FL), or marginal zone lymphoma (MZL), the overall response rate was 66%, including 12 patients (32%) with a complete response (CR), reported Jean-Marie Michot, MD, from the Goustave-Roussy Cancer Center in Villejuif, France.
CC-122 is a thalidomide analog that shares a molecular target with its cousin lenalidomide (Revlimid). Both molecules bind to the protein cereblon to cause degradation of the lymphoid transcription factors Aiolos and Ikaros.
As a single agent, CC-122 has been shown to have immunomodulatory effects on T-cell and natural killer (NK)–cell functions and has shown clinical activity in heavily pretreated patients with relapsed refractory NHL, including various cell-of-origin–based DLBCL subtypes, Dr, Michot said.
In preclinical studies, the combination of CC-122 and obinutuzumab, an anti-CD20 monoclonal antibody, has shown synergistic effects against FL and greater antilymphoma effects against DLBCL than either agent alone, he added.
In a multicenter, open-label, phase 1b dose-escalation and expansion study, investigators enrolled 19 patients with FL or MZL for whom at least one prior regimen had failed and 19 patients with relapsed/refractory DLBCL following at least two prior regimens and failed autologous stem cell transplant.
The patients received oral CC-122 at different dose levels for 5 of 7 days in each 28 day treatment cycle, plus intravenous obinutuzumab 1000 mg on days 2, 8, and 15 of cycle 1 and day 1 of cycles 2 through 8.
Responses were assessed according to International Working Group 2007 revised response criteria for malignant lymphoma.
Among all 38 patients, 25 (66%) had a response. Responses consisted of 12 CR (3 in patients with DLBCL, and 9 in patients with FL/MZL) and 13 partial responses (six and seven patients, respectively),
The median time to best response was 57 days. Responses were seen in 23 of the 30 patients who received CC-122 at dose level of 3 mg or higher.
“To date, patients receiving CC-122 at a dose of 3 mg and higher have the best and more durable responses to CC-122 plus obinutuzumab,” Dr. Michot said.
Patients generally tolerated the combination well. The most common grade 3 or 4 adverse events were hematologic and included grade 4 febrile neutropenia in two patients. Two patients discontinued treatment because of adverse events.
There was a dose-limiting toxicity, grade 4 neutropenia in one patient who received CC-122 at the 3 mg dose level, and one death from a tumor flare reaction in a patient treated at the 4 mg dose level.
The dose-escalation arm of the study has completed, and investigators are enrolling patients in a dose expansion phase at the 3 mg level.
The study was sponsored by Celgene. Hoffman La-Roche contributed obinutuzumab for the study. Dr. Michot reported serving as an advisor to Bristol-Myers Squibb and receiving travel grants from BMS, Pfizer, and Roche. Seven coauthors are Celgene employees and stockholders.
Lugano, Switzerland – A combination of obinutuzumab (Gazyva) and the experimental immunomodulatory agent CC-122 showed “clinically meaningful” activity against relapsed/refractory diffuse large B cell lymphoma (DLBCL) and indolent non-Hodgkin lymphoma (NHL) in a phase 1b study.
Among 38 patients with heavily pretreated, relapsed/refractory DLBCL, follicular lymphoma (FL), or marginal zone lymphoma (MZL), the overall response rate was 66%, including 12 patients (32%) with a complete response (CR), reported Jean-Marie Michot, MD, from the Goustave-Roussy Cancer Center in Villejuif, France.
CC-122 is a thalidomide analog that shares a molecular target with its cousin lenalidomide (Revlimid). Both molecules bind to the protein cereblon to cause degradation of the lymphoid transcription factors Aiolos and Ikaros.
As a single agent, CC-122 has been shown to have immunomodulatory effects on T-cell and natural killer (NK)–cell functions and has shown clinical activity in heavily pretreated patients with relapsed refractory NHL, including various cell-of-origin–based DLBCL subtypes, Dr, Michot said.
In preclinical studies, the combination of CC-122 and obinutuzumab, an anti-CD20 monoclonal antibody, has shown synergistic effects against FL and greater antilymphoma effects against DLBCL than either agent alone, he added.
In a multicenter, open-label, phase 1b dose-escalation and expansion study, investigators enrolled 19 patients with FL or MZL for whom at least one prior regimen had failed and 19 patients with relapsed/refractory DLBCL following at least two prior regimens and failed autologous stem cell transplant.
The patients received oral CC-122 at different dose levels for 5 of 7 days in each 28 day treatment cycle, plus intravenous obinutuzumab 1000 mg on days 2, 8, and 15 of cycle 1 and day 1 of cycles 2 through 8.
Responses were assessed according to International Working Group 2007 revised response criteria for malignant lymphoma.
Among all 38 patients, 25 (66%) had a response. Responses consisted of 12 CR (3 in patients with DLBCL, and 9 in patients with FL/MZL) and 13 partial responses (six and seven patients, respectively),
The median time to best response was 57 days. Responses were seen in 23 of the 30 patients who received CC-122 at dose level of 3 mg or higher.
“To date, patients receiving CC-122 at a dose of 3 mg and higher have the best and more durable responses to CC-122 plus obinutuzumab,” Dr. Michot said.
Patients generally tolerated the combination well. The most common grade 3 or 4 adverse events were hematologic and included grade 4 febrile neutropenia in two patients. Two patients discontinued treatment because of adverse events.
There was a dose-limiting toxicity, grade 4 neutropenia in one patient who received CC-122 at the 3 mg dose level, and one death from a tumor flare reaction in a patient treated at the 4 mg dose level.
The dose-escalation arm of the study has completed, and investigators are enrolling patients in a dose expansion phase at the 3 mg level.
The study was sponsored by Celgene. Hoffman La-Roche contributed obinutuzumab for the study. Dr. Michot reported serving as an advisor to Bristol-Myers Squibb and receiving travel grants from BMS, Pfizer, and Roche. Seven coauthors are Celgene employees and stockholders.
Lugano, Switzerland – A combination of obinutuzumab (Gazyva) and the experimental immunomodulatory agent CC-122 showed “clinically meaningful” activity against relapsed/refractory diffuse large B cell lymphoma (DLBCL) and indolent non-Hodgkin lymphoma (NHL) in a phase 1b study.
Among 38 patients with heavily pretreated, relapsed/refractory DLBCL, follicular lymphoma (FL), or marginal zone lymphoma (MZL), the overall response rate was 66%, including 12 patients (32%) with a complete response (CR), reported Jean-Marie Michot, MD, from the Goustave-Roussy Cancer Center in Villejuif, France.
CC-122 is a thalidomide analog that shares a molecular target with its cousin lenalidomide (Revlimid). Both molecules bind to the protein cereblon to cause degradation of the lymphoid transcription factors Aiolos and Ikaros.
As a single agent, CC-122 has been shown to have immunomodulatory effects on T-cell and natural killer (NK)–cell functions and has shown clinical activity in heavily pretreated patients with relapsed refractory NHL, including various cell-of-origin–based DLBCL subtypes, Dr, Michot said.
In preclinical studies, the combination of CC-122 and obinutuzumab, an anti-CD20 monoclonal antibody, has shown synergistic effects against FL and greater antilymphoma effects against DLBCL than either agent alone, he added.
In a multicenter, open-label, phase 1b dose-escalation and expansion study, investigators enrolled 19 patients with FL or MZL for whom at least one prior regimen had failed and 19 patients with relapsed/refractory DLBCL following at least two prior regimens and failed autologous stem cell transplant.
The patients received oral CC-122 at different dose levels for 5 of 7 days in each 28 day treatment cycle, plus intravenous obinutuzumab 1000 mg on days 2, 8, and 15 of cycle 1 and day 1 of cycles 2 through 8.
Responses were assessed according to International Working Group 2007 revised response criteria for malignant lymphoma.
Among all 38 patients, 25 (66%) had a response. Responses consisted of 12 CR (3 in patients with DLBCL, and 9 in patients with FL/MZL) and 13 partial responses (six and seven patients, respectively),
The median time to best response was 57 days. Responses were seen in 23 of the 30 patients who received CC-122 at dose level of 3 mg or higher.
“To date, patients receiving CC-122 at a dose of 3 mg and higher have the best and more durable responses to CC-122 plus obinutuzumab,” Dr. Michot said.
Patients generally tolerated the combination well. The most common grade 3 or 4 adverse events were hematologic and included grade 4 febrile neutropenia in two patients. Two patients discontinued treatment because of adverse events.
There was a dose-limiting toxicity, grade 4 neutropenia in one patient who received CC-122 at the 3 mg dose level, and one death from a tumor flare reaction in a patient treated at the 4 mg dose level.
The dose-escalation arm of the study has completed, and investigators are enrolling patients in a dose expansion phase at the 3 mg level.
The study was sponsored by Celgene. Hoffman La-Roche contributed obinutuzumab for the study. Dr. Michot reported serving as an advisor to Bristol-Myers Squibb and receiving travel grants from BMS, Pfizer, and Roche. Seven coauthors are Celgene employees and stockholders.
AT 14-ICML
Key clinical point: A combination of the experimental immunomodulator CC-122 and obinutuzumab showed significant activity against relapsed/refractory non-Hodgkin lymphoma.
Major finding: The overall response rate was 66%, including 32% complete responses.
Data source: A multicenter open-label phase 1b dose-escalation study in 19 patients with DLBCL and 19 with follicular lymphoma or marginal zone lymphoma.
Disclosures: The study was sponsored by Celgene. Hoffman La-Roche contributed obinutuzumab for the study. Dr. Michot reported serving as an advisor to Bristol-Myers Squibb and receiving travel grants from BMS, Pfizer, and Roche. Seven coauthors are Celgene employees and stockholders.
An Action Plan for Better COPD Care
A “detailed, patient-centered roadmap” for addressing the third leading cause of death in the U.S.—chronic obstructive pulmonary disease (COPD)—will provide a “cohesive tool” for health professionals, according to the National Heart, Lung, and Blood Institute (NHLBI). Together with federal and non-federal partners, NHLBI released the first-ever COPD National Action Plan in May at the American Thoracic Society International Conference in Washington, DC.
The plan was developed from comments shared at a “COPD Town Hall” by patients and their families, health care providers, academics, and industry representatives. It takes a unified approach identifying the specific work doctors, educators, researchers, federal agencies, patients, advocates, and the biomedical industry can do to make a difference, according to official at NHLBI.
An estimated 16 million Americans have COPD—and millions more may have it and not know. However COPD often is preventable and highly treatable, early diagnosis can lead to better outcomes. With that as the goal, the plan’s developers aim to:
- Empower patients, families, and caregivers to recognize and reduce the burden of COPD
- Equip health care professionals to provide comprehensive care to people with COPD
- Collect, analyze, report, and disseminate COPD data
- Increase and sustain COPD research
- Turn COPD recommendations into research and public health care actions
Involving patients and families has been “invaluable,” said James Kiley, PhD, director of NHLBI’s division of Lung Diseases. “The different perspectives brought by those who live these issues every day contributed to making this a clear, coordinated way forward for all stakeholders.”
A “detailed, patient-centered roadmap” for addressing the third leading cause of death in the U.S.—chronic obstructive pulmonary disease (COPD)—will provide a “cohesive tool” for health professionals, according to the National Heart, Lung, and Blood Institute (NHLBI). Together with federal and non-federal partners, NHLBI released the first-ever COPD National Action Plan in May at the American Thoracic Society International Conference in Washington, DC.
The plan was developed from comments shared at a “COPD Town Hall” by patients and their families, health care providers, academics, and industry representatives. It takes a unified approach identifying the specific work doctors, educators, researchers, federal agencies, patients, advocates, and the biomedical industry can do to make a difference, according to official at NHLBI.
An estimated 16 million Americans have COPD—and millions more may have it and not know. However COPD often is preventable and highly treatable, early diagnosis can lead to better outcomes. With that as the goal, the plan’s developers aim to:
- Empower patients, families, and caregivers to recognize and reduce the burden of COPD
- Equip health care professionals to provide comprehensive care to people with COPD
- Collect, analyze, report, and disseminate COPD data
- Increase and sustain COPD research
- Turn COPD recommendations into research and public health care actions
Involving patients and families has been “invaluable,” said James Kiley, PhD, director of NHLBI’s division of Lung Diseases. “The different perspectives brought by those who live these issues every day contributed to making this a clear, coordinated way forward for all stakeholders.”
A “detailed, patient-centered roadmap” for addressing the third leading cause of death in the U.S.—chronic obstructive pulmonary disease (COPD)—will provide a “cohesive tool” for health professionals, according to the National Heart, Lung, and Blood Institute (NHLBI). Together with federal and non-federal partners, NHLBI released the first-ever COPD National Action Plan in May at the American Thoracic Society International Conference in Washington, DC.
The plan was developed from comments shared at a “COPD Town Hall” by patients and their families, health care providers, academics, and industry representatives. It takes a unified approach identifying the specific work doctors, educators, researchers, federal agencies, patients, advocates, and the biomedical industry can do to make a difference, according to official at NHLBI.
An estimated 16 million Americans have COPD—and millions more may have it and not know. However COPD often is preventable and highly treatable, early diagnosis can lead to better outcomes. With that as the goal, the plan’s developers aim to:
- Empower patients, families, and caregivers to recognize and reduce the burden of COPD
- Equip health care professionals to provide comprehensive care to people with COPD
- Collect, analyze, report, and disseminate COPD data
- Increase and sustain COPD research
- Turn COPD recommendations into research and public health care actions
Involving patients and families has been “invaluable,” said James Kiley, PhD, director of NHLBI’s division of Lung Diseases. “The different perspectives brought by those who live these issues every day contributed to making this a clear, coordinated way forward for all stakeholders.”
Study: No increased mortality with ACA-prompted readmission declines
Concerns that efforts to reduce 30-day hospital readmission rates under the Affordable Care Act’s Hospital Readmission Reduction Program might lead to unintended increases in mortality rates appear to be unfounded, according to a review of more than 6.7 million hospitalizations for heart failure, acute myocardial infarction, or pneumonia between 2008 and 2014.
In fact, reductions in 30-day readmission rates among Medicare fee-for-service beneficiaries are weakly but significantly correlated with reductions in hospital 30-day mortality rates after discharge, according to Kumar Dharmarajan, MD, of Yale New Haven (Conn.) Health, and colleagues (JAMA 2017 Jul 18;318[3]:270-8. doi: 10.1001/jama.2017.8444).
From 2008 to 2014, the RARRs declined in aggregate across hospitals (–0.053% for heart failure, –0.044% for acute MI, and –0.033% for pneumonia).
“In contrast, monthly aggregate trends across hospitals in 30-day risk-adjusted mortality rates after discharge varied by admitting condition” the investigators said.
For heart failure, acute MI, and pneumonia, there was an increase of 0.008%, a decrease of 0.003%, and an increase of 0.001%, respectively, they said. However, paired monthly trends in 30-day RARRs and 30-day RAMRs after discharge “identified concomitant reduction in readmission and mortality rates within hospitals.”
Correlation coefficients of the paired monthly trends for heart failure, acute MI, and pneumonia in 2008-2014 were 0.066, 0.067, and 0.108, respectively.
“Paired trends in hospital 30-day risk-adjusted readmission rates and both 90-day risk-adjusted mortality rates after discharge and 90-day risk-adjusted mortality rates after the admission date also identified concomitant reductions in readmission and mortality rates within hospitals,” the authors wrote.
The findings “do not support increasing postdischarge mortality related to reducing hospital readmissions,” they concluded.
The authors work under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures. Dr. Dharmarajan reported serving as a consultant and scientific advisory board member for Clover Health at the time this research was performed. He is supported by grants from the National Institute on Aging and the American Federation for Aging Research, and the Yale Claude D. Pepper Older Americans Independence Center.
The findings by Dharmarajan and colleagues are “certainly good news,” Karen E. Joynt Maddox, MD, wrote in an editorial.
The study provides support for strategies that hospitals are using to reduce readmissions, and also underscores the importance of evaluating unintended consequences of policy changes such as the Affordable Care Act’s Hospital Readmissions Reduction Program (HRRP), she said (JAMA. 2017 Jul 18;318[3]:243-4).
The study did not address the possibility that attention to reducing readmissions has taken priority over reducing mortality, which could have the unintended consequence of slowing improvements in mortality, she noted, suggesting that for this and other reasons it may be “time to reexamine and reengineer the HRRP to avoid unintended consequences and to ensure that its incentives are fully aligned with the ultimate goal of improving the health outcomes of patients.
“Only with full knowledge of the advantages and disadvantages of a particular policy decision can policy makers and advocates work to craft statutes and rules that maximize benefits while minimizing harms,” she wrote.
Dr. Joynt Maddox is with Brigham and Women’s Hospital, Boston. She is supported by a grant from the National Heart, Lung, and Blood Institute.
The findings by Dharmarajan and colleagues are “certainly good news,” Karen E. Joynt Maddox, MD, wrote in an editorial.
The study provides support for strategies that hospitals are using to reduce readmissions, and also underscores the importance of evaluating unintended consequences of policy changes such as the Affordable Care Act’s Hospital Readmissions Reduction Program (HRRP), she said (JAMA. 2017 Jul 18;318[3]:243-4).
The study did not address the possibility that attention to reducing readmissions has taken priority over reducing mortality, which could have the unintended consequence of slowing improvements in mortality, she noted, suggesting that for this and other reasons it may be “time to reexamine and reengineer the HRRP to avoid unintended consequences and to ensure that its incentives are fully aligned with the ultimate goal of improving the health outcomes of patients.
“Only with full knowledge of the advantages and disadvantages of a particular policy decision can policy makers and advocates work to craft statutes and rules that maximize benefits while minimizing harms,” she wrote.
Dr. Joynt Maddox is with Brigham and Women’s Hospital, Boston. She is supported by a grant from the National Heart, Lung, and Blood Institute.
The findings by Dharmarajan and colleagues are “certainly good news,” Karen E. Joynt Maddox, MD, wrote in an editorial.
The study provides support for strategies that hospitals are using to reduce readmissions, and also underscores the importance of evaluating unintended consequences of policy changes such as the Affordable Care Act’s Hospital Readmissions Reduction Program (HRRP), she said (JAMA. 2017 Jul 18;318[3]:243-4).
The study did not address the possibility that attention to reducing readmissions has taken priority over reducing mortality, which could have the unintended consequence of slowing improvements in mortality, she noted, suggesting that for this and other reasons it may be “time to reexamine and reengineer the HRRP to avoid unintended consequences and to ensure that its incentives are fully aligned with the ultimate goal of improving the health outcomes of patients.
“Only with full knowledge of the advantages and disadvantages of a particular policy decision can policy makers and advocates work to craft statutes and rules that maximize benefits while minimizing harms,” she wrote.
Dr. Joynt Maddox is with Brigham and Women’s Hospital, Boston. She is supported by a grant from the National Heart, Lung, and Blood Institute.
Concerns that efforts to reduce 30-day hospital readmission rates under the Affordable Care Act’s Hospital Readmission Reduction Program might lead to unintended increases in mortality rates appear to be unfounded, according to a review of more than 6.7 million hospitalizations for heart failure, acute myocardial infarction, or pneumonia between 2008 and 2014.
In fact, reductions in 30-day readmission rates among Medicare fee-for-service beneficiaries are weakly but significantly correlated with reductions in hospital 30-day mortality rates after discharge, according to Kumar Dharmarajan, MD, of Yale New Haven (Conn.) Health, and colleagues (JAMA 2017 Jul 18;318[3]:270-8. doi: 10.1001/jama.2017.8444).
From 2008 to 2014, the RARRs declined in aggregate across hospitals (–0.053% for heart failure, –0.044% for acute MI, and –0.033% for pneumonia).
“In contrast, monthly aggregate trends across hospitals in 30-day risk-adjusted mortality rates after discharge varied by admitting condition” the investigators said.
For heart failure, acute MI, and pneumonia, there was an increase of 0.008%, a decrease of 0.003%, and an increase of 0.001%, respectively, they said. However, paired monthly trends in 30-day RARRs and 30-day RAMRs after discharge “identified concomitant reduction in readmission and mortality rates within hospitals.”
Correlation coefficients of the paired monthly trends for heart failure, acute MI, and pneumonia in 2008-2014 were 0.066, 0.067, and 0.108, respectively.
“Paired trends in hospital 30-day risk-adjusted readmission rates and both 90-day risk-adjusted mortality rates after discharge and 90-day risk-adjusted mortality rates after the admission date also identified concomitant reductions in readmission and mortality rates within hospitals,” the authors wrote.
The findings “do not support increasing postdischarge mortality related to reducing hospital readmissions,” they concluded.
The authors work under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures. Dr. Dharmarajan reported serving as a consultant and scientific advisory board member for Clover Health at the time this research was performed. He is supported by grants from the National Institute on Aging and the American Federation for Aging Research, and the Yale Claude D. Pepper Older Americans Independence Center.
Concerns that efforts to reduce 30-day hospital readmission rates under the Affordable Care Act’s Hospital Readmission Reduction Program might lead to unintended increases in mortality rates appear to be unfounded, according to a review of more than 6.7 million hospitalizations for heart failure, acute myocardial infarction, or pneumonia between 2008 and 2014.
In fact, reductions in 30-day readmission rates among Medicare fee-for-service beneficiaries are weakly but significantly correlated with reductions in hospital 30-day mortality rates after discharge, according to Kumar Dharmarajan, MD, of Yale New Haven (Conn.) Health, and colleagues (JAMA 2017 Jul 18;318[3]:270-8. doi: 10.1001/jama.2017.8444).
From 2008 to 2014, the RARRs declined in aggregate across hospitals (–0.053% for heart failure, –0.044% for acute MI, and –0.033% for pneumonia).
“In contrast, monthly aggregate trends across hospitals in 30-day risk-adjusted mortality rates after discharge varied by admitting condition” the investigators said.
For heart failure, acute MI, and pneumonia, there was an increase of 0.008%, a decrease of 0.003%, and an increase of 0.001%, respectively, they said. However, paired monthly trends in 30-day RARRs and 30-day RAMRs after discharge “identified concomitant reduction in readmission and mortality rates within hospitals.”
Correlation coefficients of the paired monthly trends for heart failure, acute MI, and pneumonia in 2008-2014 were 0.066, 0.067, and 0.108, respectively.
“Paired trends in hospital 30-day risk-adjusted readmission rates and both 90-day risk-adjusted mortality rates after discharge and 90-day risk-adjusted mortality rates after the admission date also identified concomitant reductions in readmission and mortality rates within hospitals,” the authors wrote.
The findings “do not support increasing postdischarge mortality related to reducing hospital readmissions,” they concluded.
The authors work under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures. Dr. Dharmarajan reported serving as a consultant and scientific advisory board member for Clover Health at the time this research was performed. He is supported by grants from the National Institute on Aging and the American Federation for Aging Research, and the Yale Claude D. Pepper Older Americans Independence Center.
FROM JAMA
Key clinical point:
Major finding: Correlation coefficients of the paired monthly trends for heart failure, acute myocardial infarction, and pneumonia in 2008-2014 were 0.066, 0.067, and 0.108, respectively.
Data source: A retrospective review of more than 6.7 million hospitalized Medicare fee-for-service beneficiaries.
Disclosures: The authors work under contract with the Centers for Medicare & Medicaid Services to develop and maintain performance measures. Dr. Dharmarajan reported serving as a consultant and scientific advisory board member for Clover Health at the time this research was performed. He is supported by grants from the National Institute on Aging and the American Federation for Aging Research, and the Yale Claude D. Pepper Older Americans Independence Center.