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FDA approves mogamulizumab for MF, SS
The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.
Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.
Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.
The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.
The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.
MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.
Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.
Baseline characteristics were similar between the treatment arms.
The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).
The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).
For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.
After crossover, the ORR in the mogamulizumab arm was 30% (41/136).
The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.
For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.
The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:
- Infusion-related reactions (33.2% vs 0.5%)
- Drug eruptions (23.9% vs 0.5%)
- Diarrhea (23.4% vs 61.8%)
- Nausea (15.2% vs 42.5%)
- Thrombocytopenia (11.4% vs 30.6%)
- Dysgeusia (3.3% vs 28.0%)
- Increased blood creatinine (3.3% vs 28.0%)
- Decreased appetite (7.6% vs 24.7%).
There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).
The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.
Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.
Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.
The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.
The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.
MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.
Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.
Baseline characteristics were similar between the treatment arms.
The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).
The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).
For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.
After crossover, the ORR in the mogamulizumab arm was 30% (41/136).
The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.
For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.
The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:
- Infusion-related reactions (33.2% vs 0.5%)
- Drug eruptions (23.9% vs 0.5%)
- Diarrhea (23.4% vs 61.8%)
- Nausea (15.2% vs 42.5%)
- Thrombocytopenia (11.4% vs 30.6%)
- Dysgeusia (3.3% vs 28.0%)
- Increased blood creatinine (3.3% vs 28.0%)
- Decreased appetite (7.6% vs 24.7%).
There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).
The US Food and Drug Administration (FDA) has approved mogamulizumab-kpkc (Poteligeo®) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least 1 prior systemic therapy.
Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4). It is the first biologic agent targeting CCR4 to be approved for patients in the US.
Mogamulizumab is expected to be commercially available in the fourth quarter of 2018.
The FDA previously granted mogamulizumab breakthrough therapy and orphan drug designations as well as priority review.
The FDA’s approval of mogamulizumab is supported by the phase 3 MAVORIC trial. Results from this trial were presented at the 10th Annual T-cell Lymphoma Forum in February.
MAVORIC enrolled 372 adults with histologically confirmed MF or SS who had failed at least 1 systemic therapy. They were randomized to receive mogamulizumab at 1.0 mg/kg (weekly for the first 4-week cycle and then every 2 weeks) or vorinostat at 400 mg daily.
Patients were treated until disease progression or unacceptable toxicity. Those receiving vorinostat could cross over to mogamulizumab if they progressed or experienced intolerable toxicity.
Baseline characteristics were similar between the treatment arms.
The study’s primary endpoint was progression-free survival. The median progression-free survival was 7.7 months with mogamulizumab and 3.1 months with vorinostat (hazard ratio=0.53, P<0.0001).
The global overall response rate (ORR) was 28% (52/189) in the mogamulizumab arm and 5% (9/186) in the vorinostat arm (P<0.0001).
For patients with MF, the ORR was 21% with mogamulizumab and 7% with vorinostat. For SS patients, the ORR was 37% and 2%, respectively.
After crossover, the ORR in the mogamulizumab arm was 30% (41/136).
The median duration of response (DOR) was 14 months in the mogamulizumab arm and 9 months in the vorinostat arm.
For MF patients, the median DOR was 13 months with mogamulizumab and 9 months with vorinostat. For SS patients, the median DOR was 17 months and 7 months, respectively.
The most common treatment-emergent adverse events (AEs), occurring in at least 20% of patients in either arm (mogamulizumab and vorinostat, respectively), were:
- Infusion-related reactions (33.2% vs 0.5%)
- Drug eruptions (23.9% vs 0.5%)
- Diarrhea (23.4% vs 61.8%)
- Nausea (15.2% vs 42.5%)
- Thrombocytopenia (11.4% vs 30.6%)
- Dysgeusia (3.3% vs 28.0%)
- Increased blood creatinine (3.3% vs 28.0%)
- Decreased appetite (7.6% vs 24.7%).
There were no grade 4 AEs in the mogamulizumab arm. Grade 3 AEs in mogamulizumab recipients included drug eruptions (n=8), infusion-related reactions (n=3), fatigue (n=3), decreased appetite (n=2), nausea (n=1), pyrexia (n=1), and diarrhea (n=1).
Judge seeks replication of efforts to support people with SMI
Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.
“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.
Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.
In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.
Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”
Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.
The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.
Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).
Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.
Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.
Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.
Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.
“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.
Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.
In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.
Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”
Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.
The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.
Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).
Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.
Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.
Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.
Florida’s Miami-Dade County reportedly has the largest percentage of residents with serious mental illnesses (SMI) among large U.S. communities. And a Florida judge who helped develop approaches aimed at sparing his state’s residents with mental illness from harmful, avoidable, and expensive bouts of prison time wants to see his strategies replicated.
“There is something terribly wrong with a society that is willing to spend more money to incarcerate people who are ill than to treat them,” Judge Steve Leifman of the 11th judicial circuit court said at a National Institute of Mental Health conference on mental health services research.
Judge Leifman in 2000 created the Criminal Mental Health Project. It’s been recognized for its success in keeping people with SMI from becoming ensnared in the criminal justice system because of minor offenses. It also helps those who do spend time in jail from returning.
In Miami-Dade County, for example, 97 people were a significant driver of costs in the criminal justice system in a study that was completed in 2010, Judge Leifman said. The members of this group were largely men who suffered from schizophrenia spectrum disorders and were homeless with a co-occurring disorder. Combined, the number of arrests for this group was about 2,200 over a 5-year period, Judge Leifman said. They spent 27,000 days in the Miami-Dade County jail – costing taxpayers about $13.7 million.
Judge Leifman said. “They would have had a shot at an education. They would have had housing. They probably would have done a lot better.”
Through the Criminal Mental Health Project, Judge Leifman and his colleagues seek to both prevent people with mental illness from being arrested and jailed for minor offenses, and to provide a support network for those who have reached jail. The project’s “prebooking diversion” efforts are built on a model developed in Memphis, Tenn., in the late 1980s. Through it, police officers get special training in recognizing mental illness and resolving crises in which people who have these disorders are involved.
The project’s “postbooking diversion” techniques require participants to voluntarily consent to mental health treatment and services. The program is open only to those less serious felonies, which can include drug charges and theft. Through participation in the Criminal Mental Health Project, people can have charges dismissed or reduced. The program provides them with connections to community-based treatment, support, and housing services, according to its website.
Participants in the program who were charged with minor felonies had 75% fewer jail bookings and jail days after enrolling in the Criminal Mental Health Project (N Engl J Med. 2016;374:1701-3).
Judge Leifman said the postbooking jail diversion program has, since 2001, served more than 4,000 individuals. Recidivism rates among participants charged with misdemeanors dropped from roughly 75% to 20%, he said.
Still, Judge Leifman describes his role as a judge as making him a “gatekeeper to the largest psychiatric facility in Florida – the Miami-Dade County Jail.” The jail houses about 1,200 people with serious mental illness on any given day, according to the Criminal Mental Health Project’s website.
Judge Leifman said that, ultimately, he wants more communities to devote more resources to providing medical care for people with mental illness.
REPORTING FROM AN NIMH CONFERENCE
Discharge opioid prescriptions for many surgical hospitalizations may be unnecessary
Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.
Study design: Cross-sectional study.
Setting: Two Boston-area acute care hospitals from May 2014 to September 2016.
Synopsis: The authors identified 6,548 inpatient surgical hospitalizations lasting longer than 1 day with a discharge to home in which the patient used no opioid medications in the final 24 hours prior to discharge. Of these, 43.7% received an opioid prescription at discharge. The mean prescription morphine milligram equivalents (MME) provided to this group was 343. The authors identified these cases as instances in which overprescription of opiates may have occurred. Surgical services that tended to have more patients still using opioids at the time of discharge had a higher likelihood of potential overprescription. For patients who used opioids during the final 24 hours of their hospitalization and received an opioid prescription at discharge, inpatient MME use and prescription MME were only weakly correlated (R2 = 0.112). The retrospective two-site design of this study may limit its generalizability.
Bottom line: In postoperative surgical patients, overprescription of opioid medications may occur frequently.
Citation: Chen EY et al. Correlation between 24-hour predischarge opioid use and amount of opioids prescribed at hospital discharge. JAMA Surg. 2018;153(2):e174859.
Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.
Study design: Cross-sectional study.
Setting: Two Boston-area acute care hospitals from May 2014 to September 2016.
Synopsis: The authors identified 6,548 inpatient surgical hospitalizations lasting longer than 1 day with a discharge to home in which the patient used no opioid medications in the final 24 hours prior to discharge. Of these, 43.7% received an opioid prescription at discharge. The mean prescription morphine milligram equivalents (MME) provided to this group was 343. The authors identified these cases as instances in which overprescription of opiates may have occurred. Surgical services that tended to have more patients still using opioids at the time of discharge had a higher likelihood of potential overprescription. For patients who used opioids during the final 24 hours of their hospitalization and received an opioid prescription at discharge, inpatient MME use and prescription MME were only weakly correlated (R2 = 0.112). The retrospective two-site design of this study may limit its generalizability.
Bottom line: In postoperative surgical patients, overprescription of opioid medications may occur frequently.
Citation: Chen EY et al. Correlation between 24-hour predischarge opioid use and amount of opioids prescribed at hospital discharge. JAMA Surg. 2018;153(2):e174859.
Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
Background: Prescription opioids play a significant role in the current opioid epidemic. Opioids used for nonmedical purposes often are obtained from the prescription of friends and family members, and a majority of heroin users report that their first opioid exposure was via a prescription opioid. Prescription of opioids following low-risk surgical procedures has increased over the past decade.
Study design: Cross-sectional study.
Setting: Two Boston-area acute care hospitals from May 2014 to September 2016.
Synopsis: The authors identified 6,548 inpatient surgical hospitalizations lasting longer than 1 day with a discharge to home in which the patient used no opioid medications in the final 24 hours prior to discharge. Of these, 43.7% received an opioid prescription at discharge. The mean prescription morphine milligram equivalents (MME) provided to this group was 343. The authors identified these cases as instances in which overprescription of opiates may have occurred. Surgical services that tended to have more patients still using opioids at the time of discharge had a higher likelihood of potential overprescription. For patients who used opioids during the final 24 hours of their hospitalization and received an opioid prescription at discharge, inpatient MME use and prescription MME were only weakly correlated (R2 = 0.112). The retrospective two-site design of this study may limit its generalizability.
Bottom line: In postoperative surgical patients, overprescription of opioid medications may occur frequently.
Citation: Chen EY et al. Correlation between 24-hour predischarge opioid use and amount of opioids prescribed at hospital discharge. JAMA Surg. 2018;153(2):e174859.
Dr. Salber is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.
Not all drugs are created equal in the U.S. drug crisis
Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.
“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.
Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.
The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.
Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.
“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.
Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.
Click here to read the Forbes article.
Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.
“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.
Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.
The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.
Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.
“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.
Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.
Click here to read the Forbes article.
Conversation surrounding the drug crisis in the United States tends to focus on OxyContin, methamphetamine, fentanyl, and heroin. They are trouble for sure and are ruining the lives of many. But, as argued by Nicole Fisher in an article in Forbes, the discussion needs to be broadened to consider the purity and potency of the drugs being consumed.
“At face value, one might think that OxyContin is OxyContin or heroin is heroin. But that couldn’t be further from the truth,” writes Ms. Fisher.
Illicit drugs can contain other compounds, like methamphetamine and other addictive substances, or even rat poison. The result can be a lethal brew. Only a decade ago, when methamphetamine was cooked up in basement labs, the purity was nowhere near that of the nearly pure product made now by drug cartels.
The purity of meth has skyrocketed from 39% in 2008 to more than 93% now.
Just fighting opioid prescription abuse may be a simplistic response to a more complex problem. The variations in the composition and potency of illicit drugs is important but is being overlooked.
“As we craft ways to fight the opioid crisis in the U.S., it is necessary to ensure that we understand exactly what chemical compositions we are battling against,” Ms. Fisher writes.
Recent data on the purity of drugs seized by the U.S. Drug Enforcement Agency hammer home this point. The data reveal a varied picture across the country. Whatever the reason – the origin of the product, the distribution network, the dealers involved in the preparation and sale, and more – the result can be a more lethal drug, especially in a user from an area where less pure drugs are the norm.
Click here to read the Forbes article.
CUBE-C initiative aims to educate about atopic dermatitis
WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.
In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”
She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”
Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.
More information on CUBE-C is available on the NEA website.
The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.
In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”
She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”
Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.
More information on CUBE-C is available on the NEA website.
The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
WASHINGTON – The National Eczema Association (NEA) has established the Coalition United for Better Eczema Care (CUBE-C) to provide practitioners with a resource for “trustworthy, up-to-date, state of the art” information on atopic dermatitis, with the goal of improving health outcomes, according to Julie Block, president and chief executive officer of the NEA.
In an interview at a symposium presented by CUBE-C, Ms. Block provided more information on CUBE-C, including how and why it started and what it can offer to dermatologists, as well as primary care physicians, who care for patients with atopic dermatitis. She said that the NEA convened dermatologists, allergists, immunologists, psychologists, nurse practitioners, physician assistants, and patients “to design a curriculum that provided an entire picture of the patient experience, so that we could go out and educate not only on the basics of eczema and atopic dermatitis for a variety of practitioners ... but also for the specialists who are now going to be engaging in new innovations and new therapies for their patients.”
She was joined by Adam Friedman, MD, professor of dermatology and residency program director at George Washington University, Washington, where the symposium, a resident’s boot camp, was held. The boot camp was somewhat unique in that it was geared more towards trainees; typically, the CUBE-C program is a CME program for practitioners, but this reflects the flexibility of the program, which can be tailored to the audience, Dr. Friedman pointed out. “The hope is that programs like these pop up all over the place ... anywhere you have a critical mass of individuals who want to learn about this,” where planners can choose from a menu of topics provided by CUBE-C – which include therapeutics, infections, pathogenesis, and access to care – and “easily formulate a conference like we held here today for the right audience.”
Topics covered at the George Washington University symposium included the impact of climate on the prevalence of childhood eczema, the diagnosis and differential diagnosis in children, infections in atopic dermatitis patients, and itch treatment.
More information on CUBE-C is available on the NEA website.
The symposium was supported by an educational grant from Sanofi Genzyme, Regeneron Pharmaceuticals, and Pfizer. Dr. Friedman reported serving as a speaker for Regeneron, Pfizer, and other companies. He also consults and serves on the advisory board for Pfizer and multiple other companies developing and marketing atopic dermatitis therapies and products.
Parents’ religiosity tied to reduced suicide risk in girls
Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.
Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.
The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).
A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.
“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.
Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.
“,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”
Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.
Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.
Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.
The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).
A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.
“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.
Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.
“,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”
Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.
Girls with parents who considered religion important in their lives were less likely to consider or attempt suicide, according to Connie Svob, PhD, of Columbia University, New York, and her associates.
Data were collected from an ongoing, 30-year, three-generational, observational study at the New York State Psychiatric Institute and Columbia University. In the study, the second and third generations were determined to be at high or low risk for major depressive disorder because of either the presence or absence of MDD in the first generation.
The study included 214 children aged 6-18 years from 112 unique families, who had undergone at least one assessment of religiosity, and a parent from each included family. Among the children, religious importance was associated with reduced suicide risk in girls (OR, 0.48; 95% CI, 0.33-0.70) but not in boys (OR, 1.15; 95% CI, 0.74-1.80).
A similar association was found for religious attendance, where girls saw a reduced risk (OR, 0.64; 95% CI, 0.49-0.84) and boys did not (OR, 0.94; 95% CI, 0.69-1.27), Dr. Svob and her associates reported in JAMA Psychiatry.
“These findings suggest that a parent’s belief in the importance of religion may be a more robust factor than a parent’s attendance at religious services and make one wonder whether religious importance might be more strongly associated with teaching and beliefs about suicide within the home than is service attendance, or whether some other mechanism might be responsible,” the authors noted.
Study limitations included a homogeneous population who were all white and predominantly Roman Catholic or Protestant, as well as a small sample size of children with suicidal behavior or ideation.
“,” Dr. Svob and her associates wrote. “These include conducting a brief spiritual history with parents of offspring being brought in for psychiatric consultations, as well as assessing an offspring’s own beliefs (religious importance) and behaviors (religious service attendance), particularly with girls.”
Dr. Svob reported no disclosures. The study was supported partly by the John Templeton Foundation and the National Institute of Mental Health.
SOURCE: Svob C et al. JAMA Psychiatry. 2018 Aug 8. doi: 10.1001/jamapsychiatry.2018.2060.
FROM JAMA PSYCHIATRY
Making the referral and navigating care
Be familiar with local post-acute care resources
Presenter
Elisabeth Schainker, MD, MSc
Session title
Making the referral and navigating “A Whole New World” of care
Session summary
By describing different types of post-acute care clinical services, Dr. Schainker empowered the HM18 audience to rethink how to best identify patients and conditions appropriate for transitions of care, from short-term acute care environments to long-term acute care places, inpatient rehabs, or skilled nursing facilities.
With increasing numbers of pediatric patients with medical complexity, who are dependent on technology devices and complicated care needs, hospitalists need to be knowledgeable about the rules of engagement for prolonged or enhanced recoveries, families’ needs, and insurance qualifications. The role of the hospitalist is to make sure that things are in place for safe and successful discharges, keeping in mind patients’ complexity, resources available within family and community, and fair assessments of readmission risks.
Whether rehab needs pertain to pulmonary, medical, or post NICU stays – length of stay averaging 70-80 days – hospitalists still need to ensure that patients have a clear potential to do better and transition to home eventually. There are inadequate numbers of such pediatric post-acute care facilities, 36 hospitals to be precise. Franciscan Children’s, where Dr. Schainker practices, was beautifully represented in a short movie played during the session at the annual meeting of the Society of Hospital Medicine. The protagonists in the movie were children: Mae and Luke.
Key takeaways for HM
1. Knowledge: Post-acute care services facilitate safe discharges of complex medical patients that eventually get home.
2. Attitude: Hospitalists need to identify what would benefit their patients and counsel families, as well as make proper and timely referrals.
3. Behavior: Hospitalists should be familiar with local resources and engage with available providers of post-acute care services.
Dr. Giordano is a pediatric neurosurgery hospitalist at Columbia University Medical Center in New York.
Be familiar with local post-acute care resources
Be familiar with local post-acute care resources
Presenter
Elisabeth Schainker, MD, MSc
Session title
Making the referral and navigating “A Whole New World” of care
Session summary
By describing different types of post-acute care clinical services, Dr. Schainker empowered the HM18 audience to rethink how to best identify patients and conditions appropriate for transitions of care, from short-term acute care environments to long-term acute care places, inpatient rehabs, or skilled nursing facilities.
With increasing numbers of pediatric patients with medical complexity, who are dependent on technology devices and complicated care needs, hospitalists need to be knowledgeable about the rules of engagement for prolonged or enhanced recoveries, families’ needs, and insurance qualifications. The role of the hospitalist is to make sure that things are in place for safe and successful discharges, keeping in mind patients’ complexity, resources available within family and community, and fair assessments of readmission risks.
Whether rehab needs pertain to pulmonary, medical, or post NICU stays – length of stay averaging 70-80 days – hospitalists still need to ensure that patients have a clear potential to do better and transition to home eventually. There are inadequate numbers of such pediatric post-acute care facilities, 36 hospitals to be precise. Franciscan Children’s, where Dr. Schainker practices, was beautifully represented in a short movie played during the session at the annual meeting of the Society of Hospital Medicine. The protagonists in the movie were children: Mae and Luke.
Key takeaways for HM
1. Knowledge: Post-acute care services facilitate safe discharges of complex medical patients that eventually get home.
2. Attitude: Hospitalists need to identify what would benefit their patients and counsel families, as well as make proper and timely referrals.
3. Behavior: Hospitalists should be familiar with local resources and engage with available providers of post-acute care services.
Dr. Giordano is a pediatric neurosurgery hospitalist at Columbia University Medical Center in New York.
Presenter
Elisabeth Schainker, MD, MSc
Session title
Making the referral and navigating “A Whole New World” of care
Session summary
By describing different types of post-acute care clinical services, Dr. Schainker empowered the HM18 audience to rethink how to best identify patients and conditions appropriate for transitions of care, from short-term acute care environments to long-term acute care places, inpatient rehabs, or skilled nursing facilities.
With increasing numbers of pediatric patients with medical complexity, who are dependent on technology devices and complicated care needs, hospitalists need to be knowledgeable about the rules of engagement for prolonged or enhanced recoveries, families’ needs, and insurance qualifications. The role of the hospitalist is to make sure that things are in place for safe and successful discharges, keeping in mind patients’ complexity, resources available within family and community, and fair assessments of readmission risks.
Whether rehab needs pertain to pulmonary, medical, or post NICU stays – length of stay averaging 70-80 days – hospitalists still need to ensure that patients have a clear potential to do better and transition to home eventually. There are inadequate numbers of such pediatric post-acute care facilities, 36 hospitals to be precise. Franciscan Children’s, where Dr. Schainker practices, was beautifully represented in a short movie played during the session at the annual meeting of the Society of Hospital Medicine. The protagonists in the movie were children: Mae and Luke.
Key takeaways for HM
1. Knowledge: Post-acute care services facilitate safe discharges of complex medical patients that eventually get home.
2. Attitude: Hospitalists need to identify what would benefit their patients and counsel families, as well as make proper and timely referrals.
3. Behavior: Hospitalists should be familiar with local resources and engage with available providers of post-acute care services.
Dr. Giordano is a pediatric neurosurgery hospitalist at Columbia University Medical Center in New York.
Trabectedin bests supportive care in advanced soft-tissue sarcomas
CHICAGO – Trabectedin (Yondelis) was superior to best supportive care at prolonging progression-free survival in patients with heavily pretreated advanced leiomyosarcomas and liposarcomas, investigators in the randomized phase 3 T-SAR trial reported.
Among 103 patients with soft-tissue sarcomas that had progressed after two to four lines of standard chemotherapy, median progression-free survival (PFS) for patients randomized to trabectedin was 3.12 months, compared with 1.51 for patients randomized to best supportive care.
This difference translated into a hazard ratio (HR) favoring trabectedin of 0.39 (P less than .0001), Axel Le Cesne, MD, of Gustave Roussy Cancer Institute in Villejuif, France, reported on behalf of colleagues in the French Sarcoma Group.
All of the benefit was apparently among patients with what he termed “L-sarcomas” – leiomyosarcoma and liposarcoma – compared with other sarcoma histologies.
“The tumor control rate after six courses of trabectedin is similar to previous studies. As already reported, trabectedin is well-tolerated,” he said at the annual meeting of the American Society of Clinical Oncology.
Trabectedin was shown to be superior to best supportive care at delaying disease progression among patients with advanced translocation-related sarcomas in a randomized phase 2 trial in Japan, but had not been studied in this setting against other sarcoma histologies, Dr. Le Cesne said.
The investigators enrolled 103 patients and randomly assigned them to receive either best supportive care or trabectedin in a 1.5 mg/m2 infusion over 24 hours every 3 weeks. Patients in the best supportive care arm could be crossed over to the trabectedin arm at the time of progression.
Sarcoma histologies included liposarcoma, leiomyosarcoma, undifferentiated sarcomas, myxofibrosarcoma, synovial sarcoma, and others. The L-sarcomas accounted for 60.2% of the patient population.
Fifty-two patients were randomized to trabectedin and 51 to best supportive care, but 2 patients assigned to best supportive care dropped out soon after randomization, leaving 52 and 49 patients, respectively, for the as-treated analysis. All 103 patients were assessable for efficacy.
After a median follow-up of 26 months, median PFS for all patients, as noted before, was 3.12 months in the trabectedin arm and 1.51 months in the best supportive care arm.
The overall response rate in the trabectedin arm was 13.7%, composed of seven partial responses. There were no responses in the best supportive care arm. In all, 66.7% of patients in the trabectedin arm and 61.2% of patients in the best supportive care arm had stable disease, and 19.6% and 38.8%, respectively, had disease progression.
An analysis of PFS by sarcoma histology showed that all of the benefit appeared to be in patients with L-sarcomas, with a median PFS for trabectedin-treated patients of 5.13 months compared with 1.41 months for controls (HR 0.29, P less than .0001).
In contrast, there was no significant difference between the groups among patients with non–L sarcomas, with respective median PFS of 1.81 and 1.51 months (HR 0.60, P = .16). There were no treatment responses among patients in either treatment arm in this subgroup.
Not surprisingly, there were more grade 3 or 4 adverse events among patients in the trabectedin arm. Neutropenia was seen in 23 patients given trabectedin and 1 given best supportive care; leukopenia in 18 patients vs. 0, thrombocytopenia in 13 vs. 0, and elevated liver transaminases in 17 vs. 1, respectively.
In all, 45 of the 49 patients who were treated in the best supportive care arm were crossed over to trabectedin.
Median overall survival was 13.6 months in the trabectedin arm and 10.8 months in the best supportive care arm. This difference was not statistically significant.
Dr Le Cesne noted that the tumor control rate of 30% with trabectedin was similar to that seen in an earlier French trial (Lancet Oncol. 2015 Mar 1;16[3]:312-19).
Pharmamar supplied trabectedin for the study. Dr. Le Cesne disclosed honoraria from the company and from Amgen, Bayer, Lilly, Novartis, and Pfizer.
SOURCE: Le Cesne A et al. ASCO 2018. Abstract 11508.
CHICAGO – Trabectedin (Yondelis) was superior to best supportive care at prolonging progression-free survival in patients with heavily pretreated advanced leiomyosarcomas and liposarcomas, investigators in the randomized phase 3 T-SAR trial reported.
Among 103 patients with soft-tissue sarcomas that had progressed after two to four lines of standard chemotherapy, median progression-free survival (PFS) for patients randomized to trabectedin was 3.12 months, compared with 1.51 for patients randomized to best supportive care.
This difference translated into a hazard ratio (HR) favoring trabectedin of 0.39 (P less than .0001), Axel Le Cesne, MD, of Gustave Roussy Cancer Institute in Villejuif, France, reported on behalf of colleagues in the French Sarcoma Group.
All of the benefit was apparently among patients with what he termed “L-sarcomas” – leiomyosarcoma and liposarcoma – compared with other sarcoma histologies.
“The tumor control rate after six courses of trabectedin is similar to previous studies. As already reported, trabectedin is well-tolerated,” he said at the annual meeting of the American Society of Clinical Oncology.
Trabectedin was shown to be superior to best supportive care at delaying disease progression among patients with advanced translocation-related sarcomas in a randomized phase 2 trial in Japan, but had not been studied in this setting against other sarcoma histologies, Dr. Le Cesne said.
The investigators enrolled 103 patients and randomly assigned them to receive either best supportive care or trabectedin in a 1.5 mg/m2 infusion over 24 hours every 3 weeks. Patients in the best supportive care arm could be crossed over to the trabectedin arm at the time of progression.
Sarcoma histologies included liposarcoma, leiomyosarcoma, undifferentiated sarcomas, myxofibrosarcoma, synovial sarcoma, and others. The L-sarcomas accounted for 60.2% of the patient population.
Fifty-two patients were randomized to trabectedin and 51 to best supportive care, but 2 patients assigned to best supportive care dropped out soon after randomization, leaving 52 and 49 patients, respectively, for the as-treated analysis. All 103 patients were assessable for efficacy.
After a median follow-up of 26 months, median PFS for all patients, as noted before, was 3.12 months in the trabectedin arm and 1.51 months in the best supportive care arm.
The overall response rate in the trabectedin arm was 13.7%, composed of seven partial responses. There were no responses in the best supportive care arm. In all, 66.7% of patients in the trabectedin arm and 61.2% of patients in the best supportive care arm had stable disease, and 19.6% and 38.8%, respectively, had disease progression.
An analysis of PFS by sarcoma histology showed that all of the benefit appeared to be in patients with L-sarcomas, with a median PFS for trabectedin-treated patients of 5.13 months compared with 1.41 months for controls (HR 0.29, P less than .0001).
In contrast, there was no significant difference between the groups among patients with non–L sarcomas, with respective median PFS of 1.81 and 1.51 months (HR 0.60, P = .16). There were no treatment responses among patients in either treatment arm in this subgroup.
Not surprisingly, there were more grade 3 or 4 adverse events among patients in the trabectedin arm. Neutropenia was seen in 23 patients given trabectedin and 1 given best supportive care; leukopenia in 18 patients vs. 0, thrombocytopenia in 13 vs. 0, and elevated liver transaminases in 17 vs. 1, respectively.
In all, 45 of the 49 patients who were treated in the best supportive care arm were crossed over to trabectedin.
Median overall survival was 13.6 months in the trabectedin arm and 10.8 months in the best supportive care arm. This difference was not statistically significant.
Dr Le Cesne noted that the tumor control rate of 30% with trabectedin was similar to that seen in an earlier French trial (Lancet Oncol. 2015 Mar 1;16[3]:312-19).
Pharmamar supplied trabectedin for the study. Dr. Le Cesne disclosed honoraria from the company and from Amgen, Bayer, Lilly, Novartis, and Pfizer.
SOURCE: Le Cesne A et al. ASCO 2018. Abstract 11508.
CHICAGO – Trabectedin (Yondelis) was superior to best supportive care at prolonging progression-free survival in patients with heavily pretreated advanced leiomyosarcomas and liposarcomas, investigators in the randomized phase 3 T-SAR trial reported.
Among 103 patients with soft-tissue sarcomas that had progressed after two to four lines of standard chemotherapy, median progression-free survival (PFS) for patients randomized to trabectedin was 3.12 months, compared with 1.51 for patients randomized to best supportive care.
This difference translated into a hazard ratio (HR) favoring trabectedin of 0.39 (P less than .0001), Axel Le Cesne, MD, of Gustave Roussy Cancer Institute in Villejuif, France, reported on behalf of colleagues in the French Sarcoma Group.
All of the benefit was apparently among patients with what he termed “L-sarcomas” – leiomyosarcoma and liposarcoma – compared with other sarcoma histologies.
“The tumor control rate after six courses of trabectedin is similar to previous studies. As already reported, trabectedin is well-tolerated,” he said at the annual meeting of the American Society of Clinical Oncology.
Trabectedin was shown to be superior to best supportive care at delaying disease progression among patients with advanced translocation-related sarcomas in a randomized phase 2 trial in Japan, but had not been studied in this setting against other sarcoma histologies, Dr. Le Cesne said.
The investigators enrolled 103 patients and randomly assigned them to receive either best supportive care or trabectedin in a 1.5 mg/m2 infusion over 24 hours every 3 weeks. Patients in the best supportive care arm could be crossed over to the trabectedin arm at the time of progression.
Sarcoma histologies included liposarcoma, leiomyosarcoma, undifferentiated sarcomas, myxofibrosarcoma, synovial sarcoma, and others. The L-sarcomas accounted for 60.2% of the patient population.
Fifty-two patients were randomized to trabectedin and 51 to best supportive care, but 2 patients assigned to best supportive care dropped out soon after randomization, leaving 52 and 49 patients, respectively, for the as-treated analysis. All 103 patients were assessable for efficacy.
After a median follow-up of 26 months, median PFS for all patients, as noted before, was 3.12 months in the trabectedin arm and 1.51 months in the best supportive care arm.
The overall response rate in the trabectedin arm was 13.7%, composed of seven partial responses. There were no responses in the best supportive care arm. In all, 66.7% of patients in the trabectedin arm and 61.2% of patients in the best supportive care arm had stable disease, and 19.6% and 38.8%, respectively, had disease progression.
An analysis of PFS by sarcoma histology showed that all of the benefit appeared to be in patients with L-sarcomas, with a median PFS for trabectedin-treated patients of 5.13 months compared with 1.41 months for controls (HR 0.29, P less than .0001).
In contrast, there was no significant difference between the groups among patients with non–L sarcomas, with respective median PFS of 1.81 and 1.51 months (HR 0.60, P = .16). There were no treatment responses among patients in either treatment arm in this subgroup.
Not surprisingly, there were more grade 3 or 4 adverse events among patients in the trabectedin arm. Neutropenia was seen in 23 patients given trabectedin and 1 given best supportive care; leukopenia in 18 patients vs. 0, thrombocytopenia in 13 vs. 0, and elevated liver transaminases in 17 vs. 1, respectively.
In all, 45 of the 49 patients who were treated in the best supportive care arm were crossed over to trabectedin.
Median overall survival was 13.6 months in the trabectedin arm and 10.8 months in the best supportive care arm. This difference was not statistically significant.
Dr Le Cesne noted that the tumor control rate of 30% with trabectedin was similar to that seen in an earlier French trial (Lancet Oncol. 2015 Mar 1;16[3]:312-19).
Pharmamar supplied trabectedin for the study. Dr. Le Cesne disclosed honoraria from the company and from Amgen, Bayer, Lilly, Novartis, and Pfizer.
SOURCE: Le Cesne A et al. ASCO 2018. Abstract 11508.
REPORTING FROM ASCO 2018
Key clinical point: Trabectedin was superior to best supportive care in delaying disease progression among patients with advanced soft tissue sarcomas.
Major finding: Median progression-free survival for patients with leiomyosarcoma or liposarcoma treated with trabectedin was 5.13 months vs. 1.41 months for patients treated with best supportive care.
Study details: Randomized open-label trial of 103 patients with histologically proven advanced soft-tissue sarcoma who progressed after at least 1 anthracycline-containing regimen.
Disclosures: Pharmamar supplied trabectedin for the study. Dr. Le Cesne disclosed receiving honoraria from the company and from Amgen, Bayer, Lilly, Novartis, and Pfizer.
Source: Le Cesne A et al. ASCO 2018. Abstract 11508.
Barriers loom for HCV care in young people who inject drugs
Young adults who inject drugs and are infected with hepatitis C virus “face unique barriers to HCV testing, counseling, and treatment,” according to Margie R. Skeer, ScD, of Tufts University, Boston, and her fellow researchers.
Dr. Skeer and her colleagues found five themes in 24 in-depth interviews with people aged 22-30 years who inject drugs and have HCV infection. At the time of the interviews, none of the patients had received the newer HCV treatment regimens (Drug Alcohol Depend. 2018 Sep 1;190:246-54).
These themes captured the knowledge of and experience of HCV along the continuum of care:
1. Deservingness of HCV treatment and stigma.
2. Dissatisfaction with provider interactions.
3. Perceived lack of referral to treatment and care continuity.
4. Disincentives around HCV treatment for PWID.
5. Perceived need for treatment.
The interviewees were largely uninformed about HCV prior to diagnosis and reported learning more about the virus after their diagnosis. They also tended to affirm the belief that they did not deserve treatment. They felt stigmatized by insurance companies and clinicians, thereby reducing their engagement in the care continuum. And, at the time, insurance companies enforced “sobriety” restrictions dictating the length of time patients had to be off drugs before qualifying for HCV treatment. In the words of one interviewee: “[Caregivers] have a big stigma when it comes to addicts. ... Their whole demeanor changes. They rush you, they slam things, they are very impatient with you, and it is very saddening to see.”
Interviewees reported no or incomplete referrals or being given pamphlets and flyers. They reported little follow-up as to whether they sought additional care, and experienced a lack of confidence from medical professionals that they could be counted on to adhere to an HCV treatment regimen.
Interviewees stated that injection drug use and HCV are inevitably linked, and that IV drug users will eventually contract HCV infections.
“Hep C’s no big deal, Hep C’s like the common cold for the junkie. ... It might take 5 years away from your, you know, life but, you know, we’re not even gonna live that long anyways, so who cares about it anyway,” remarked a 28-year old woman, who was not currently injecting drugs.
The study authors said there is an increased need to provide patient-oriented care for young injection drug users and described the potential benefits of some insurance companies reducing their sobriety and disease severity restrictions.
“Reducing stigma among healthcare professionals, which cuts across the different levels of the HCV care continuum, improving referral patterns and continuity of care, better informing people about their HCV status through patient-oriented testing and disclosure experiences, and reducing perceptions of personal responsibility for disease are crucial next steps to increasing treatment as prevention,” Dr. Skeer and her colleagues concluded.
The authors reported that they had no conflicts of interest.
Young adults who inject drugs and are infected with hepatitis C virus “face unique barriers to HCV testing, counseling, and treatment,” according to Margie R. Skeer, ScD, of Tufts University, Boston, and her fellow researchers.
Dr. Skeer and her colleagues found five themes in 24 in-depth interviews with people aged 22-30 years who inject drugs and have HCV infection. At the time of the interviews, none of the patients had received the newer HCV treatment regimens (Drug Alcohol Depend. 2018 Sep 1;190:246-54).
These themes captured the knowledge of and experience of HCV along the continuum of care:
1. Deservingness of HCV treatment and stigma.
2. Dissatisfaction with provider interactions.
3. Perceived lack of referral to treatment and care continuity.
4. Disincentives around HCV treatment for PWID.
5. Perceived need for treatment.
The interviewees were largely uninformed about HCV prior to diagnosis and reported learning more about the virus after their diagnosis. They also tended to affirm the belief that they did not deserve treatment. They felt stigmatized by insurance companies and clinicians, thereby reducing their engagement in the care continuum. And, at the time, insurance companies enforced “sobriety” restrictions dictating the length of time patients had to be off drugs before qualifying for HCV treatment. In the words of one interviewee: “[Caregivers] have a big stigma when it comes to addicts. ... Their whole demeanor changes. They rush you, they slam things, they are very impatient with you, and it is very saddening to see.”
Interviewees reported no or incomplete referrals or being given pamphlets and flyers. They reported little follow-up as to whether they sought additional care, and experienced a lack of confidence from medical professionals that they could be counted on to adhere to an HCV treatment regimen.
Interviewees stated that injection drug use and HCV are inevitably linked, and that IV drug users will eventually contract HCV infections.
“Hep C’s no big deal, Hep C’s like the common cold for the junkie. ... It might take 5 years away from your, you know, life but, you know, we’re not even gonna live that long anyways, so who cares about it anyway,” remarked a 28-year old woman, who was not currently injecting drugs.
The study authors said there is an increased need to provide patient-oriented care for young injection drug users and described the potential benefits of some insurance companies reducing their sobriety and disease severity restrictions.
“Reducing stigma among healthcare professionals, which cuts across the different levels of the HCV care continuum, improving referral patterns and continuity of care, better informing people about their HCV status through patient-oriented testing and disclosure experiences, and reducing perceptions of personal responsibility for disease are crucial next steps to increasing treatment as prevention,” Dr. Skeer and her colleagues concluded.
The authors reported that they had no conflicts of interest.
Young adults who inject drugs and are infected with hepatitis C virus “face unique barriers to HCV testing, counseling, and treatment,” according to Margie R. Skeer, ScD, of Tufts University, Boston, and her fellow researchers.
Dr. Skeer and her colleagues found five themes in 24 in-depth interviews with people aged 22-30 years who inject drugs and have HCV infection. At the time of the interviews, none of the patients had received the newer HCV treatment regimens (Drug Alcohol Depend. 2018 Sep 1;190:246-54).
These themes captured the knowledge of and experience of HCV along the continuum of care:
1. Deservingness of HCV treatment and stigma.
2. Dissatisfaction with provider interactions.
3. Perceived lack of referral to treatment and care continuity.
4. Disincentives around HCV treatment for PWID.
5. Perceived need for treatment.
The interviewees were largely uninformed about HCV prior to diagnosis and reported learning more about the virus after their diagnosis. They also tended to affirm the belief that they did not deserve treatment. They felt stigmatized by insurance companies and clinicians, thereby reducing their engagement in the care continuum. And, at the time, insurance companies enforced “sobriety” restrictions dictating the length of time patients had to be off drugs before qualifying for HCV treatment. In the words of one interviewee: “[Caregivers] have a big stigma when it comes to addicts. ... Their whole demeanor changes. They rush you, they slam things, they are very impatient with you, and it is very saddening to see.”
Interviewees reported no or incomplete referrals or being given pamphlets and flyers. They reported little follow-up as to whether they sought additional care, and experienced a lack of confidence from medical professionals that they could be counted on to adhere to an HCV treatment regimen.
Interviewees stated that injection drug use and HCV are inevitably linked, and that IV drug users will eventually contract HCV infections.
“Hep C’s no big deal, Hep C’s like the common cold for the junkie. ... It might take 5 years away from your, you know, life but, you know, we’re not even gonna live that long anyways, so who cares about it anyway,” remarked a 28-year old woman, who was not currently injecting drugs.
The study authors said there is an increased need to provide patient-oriented care for young injection drug users and described the potential benefits of some insurance companies reducing their sobriety and disease severity restrictions.
“Reducing stigma among healthcare professionals, which cuts across the different levels of the HCV care continuum, improving referral patterns and continuity of care, better informing people about their HCV status through patient-oriented testing and disclosure experiences, and reducing perceptions of personal responsibility for disease are crucial next steps to increasing treatment as prevention,” Dr. Skeer and her colleagues concluded.
The authors reported that they had no conflicts of interest.
FROM DRUG AND ALCOHOL DEPENDENCE
Immunosuppression often triggers skin side effects
LAKE TAHOE, CALIF. – , and side effects of vemurafenib treatment.
In a presentation on the cutaneous sequelae of different immunosuppressive regimens at the annual meeting of the Society for Pediatric Dermatology, Carrie C. Coughlin, MD, opened with a discussion of AD triggered by the tumor necrosis factor (TNF) blocker infliximab, especially in the setting of therapy for Crohn’s disease. “In this patient population you often think of psoriasis as a consequence of infliximab and other TNF therapies,” said Dr. Coughlin, a pediatric dermatologist at Washington University, St. Louis. “But you can also get true atopic dermatitis with infliximab as well. Who’s more at risk for this? Patients with Crohn’s disease seem to be. Most of the literature is in adults, but there are a few series of children. In a series of children looking at cutaneous sequelae of infliximab therapy, about 20% of cutaneous eruptions were atopic dermatitis. I think it’s a great opportunity for us in dermatology to do a more research in this area.”
Some researchers have proposed that atopic disease could be a marker of over-suppression of TNF-alpha in young Crohn’s disease patients on infliximab (Inflamm Bowel Dis. 2014; 20[8]:1309-15). “One question you could ask is, could these patients actually tolerate a dose reduction?” Dr. Coughlin said. She promoted the role of dermatologists in working at managing side effects to keep patients on medications helping their GI disease, but acknowledged this is not always possible.
Atopic disease can also occur after a solid organ transplant. In fact, the incidence of new-onset food allergies after a liver transplant is 6%-30% of cases, mainly in young patients (Pediatr Transplant. 2009;13[1]:63-9, Pediatr Transplant 2013;17[3]:251-5). “There are some mechanisms, including liver presentation of antigens, that spread through portal veins that could potentially put people at risk who have liver dysfunction,” Dr. Coughlin explained. “They could potentially have a higher risk for food allergies and AD. There is also some thought that tacrolimus potentially predisposes patients to having atopic dermatitis and atopy after their transplant. When you look at the mechanism of action of tacrolimus, you see increased levels of IL-5, IL-13, and skewing of IgE levels.”
Dr. Coughlin also discussed the possibilities of development of AD after transplant being a delayed presentation of an allergic sensitization that patients already had. Younger patients are at higher risk for AD post transplant. The renal transplant population, meanwhile, generally receives the transplant at a later age, “so they may not have that delay in terms of presentation; they may have already had their allergies and grown out of them by the time they’re getting their transplant,” she said. “I think there’s more for us to investigate.”
Solid organ transplant recipients also face an increased risk of skin cancer as a long-term side effect of immunosuppressive therapy. Risk factors include fair skin, sun exposure, and remote time from transplant. “Time from transplant is a risk factor,” Dr. Coughlin said. “Longer time on immunosuppression could predispose you to a risk for skin cancer. Our patients are living longer post transplant than they used to, so they have more potential years to develop their skin cancers.” She focused on the importance of educating transplant recipients and families early about photoprotection. “It’s interesting to think about how we can continue to intervene early on to continue to decrease risk.”
Young patients exposed to voriconazole also face an increased risk for skin cancer. “We know that longer-term dosing and higher cumulative dosing puts you at higher risk,” she said. Lung transplant recipients, who are often more likely to be treated with voriconazole, are thus at higher risk.
Dr. Coughlin ended her presentation by noting that side effects of the BRAF inhibitor vemurafenib (Zelboraf) used to treat advanced melanoma in children are similar to, but not the same as, those in adults. “We see BRAF mutations in multiple different tumor types: Langerhans cell histiocytosis, gliomas, and melanoma,” she said. “Trials of vemurafenib and dabrafenib are under way in the pediatric population. Vemurafenib can cause keratosis pilaris, panniculitis, alopecia, and granulomatous dermatitis.” In her experience, she has seen more alopecia in the older teenage population, but younger patients may not be asked about this side effect as frequently.
She counsels patients to expect keratosis pilaris–like eruptions and to take sun protection seriously. “It’s important to emphasize that each time they come in,” Dr. Coughlin said. She also discussed the potential for changing nevi and treatment options for vemurafenib-associated panniculitis.
Dr. Coughlin disclosed that she is the recipient of active pilot grants from the Pediatric Dermatology Research Alliance and the SPD.
LAKE TAHOE, CALIF. – , and side effects of vemurafenib treatment.
In a presentation on the cutaneous sequelae of different immunosuppressive regimens at the annual meeting of the Society for Pediatric Dermatology, Carrie C. Coughlin, MD, opened with a discussion of AD triggered by the tumor necrosis factor (TNF) blocker infliximab, especially in the setting of therapy for Crohn’s disease. “In this patient population you often think of psoriasis as a consequence of infliximab and other TNF therapies,” said Dr. Coughlin, a pediatric dermatologist at Washington University, St. Louis. “But you can also get true atopic dermatitis with infliximab as well. Who’s more at risk for this? Patients with Crohn’s disease seem to be. Most of the literature is in adults, but there are a few series of children. In a series of children looking at cutaneous sequelae of infliximab therapy, about 20% of cutaneous eruptions were atopic dermatitis. I think it’s a great opportunity for us in dermatology to do a more research in this area.”
Some researchers have proposed that atopic disease could be a marker of over-suppression of TNF-alpha in young Crohn’s disease patients on infliximab (Inflamm Bowel Dis. 2014; 20[8]:1309-15). “One question you could ask is, could these patients actually tolerate a dose reduction?” Dr. Coughlin said. She promoted the role of dermatologists in working at managing side effects to keep patients on medications helping their GI disease, but acknowledged this is not always possible.
Atopic disease can also occur after a solid organ transplant. In fact, the incidence of new-onset food allergies after a liver transplant is 6%-30% of cases, mainly in young patients (Pediatr Transplant. 2009;13[1]:63-9, Pediatr Transplant 2013;17[3]:251-5). “There are some mechanisms, including liver presentation of antigens, that spread through portal veins that could potentially put people at risk who have liver dysfunction,” Dr. Coughlin explained. “They could potentially have a higher risk for food allergies and AD. There is also some thought that tacrolimus potentially predisposes patients to having atopic dermatitis and atopy after their transplant. When you look at the mechanism of action of tacrolimus, you see increased levels of IL-5, IL-13, and skewing of IgE levels.”
Dr. Coughlin also discussed the possibilities of development of AD after transplant being a delayed presentation of an allergic sensitization that patients already had. Younger patients are at higher risk for AD post transplant. The renal transplant population, meanwhile, generally receives the transplant at a later age, “so they may not have that delay in terms of presentation; they may have already had their allergies and grown out of them by the time they’re getting their transplant,” she said. “I think there’s more for us to investigate.”
Solid organ transplant recipients also face an increased risk of skin cancer as a long-term side effect of immunosuppressive therapy. Risk factors include fair skin, sun exposure, and remote time from transplant. “Time from transplant is a risk factor,” Dr. Coughlin said. “Longer time on immunosuppression could predispose you to a risk for skin cancer. Our patients are living longer post transplant than they used to, so they have more potential years to develop their skin cancers.” She focused on the importance of educating transplant recipients and families early about photoprotection. “It’s interesting to think about how we can continue to intervene early on to continue to decrease risk.”
Young patients exposed to voriconazole also face an increased risk for skin cancer. “We know that longer-term dosing and higher cumulative dosing puts you at higher risk,” she said. Lung transplant recipients, who are often more likely to be treated with voriconazole, are thus at higher risk.
Dr. Coughlin ended her presentation by noting that side effects of the BRAF inhibitor vemurafenib (Zelboraf) used to treat advanced melanoma in children are similar to, but not the same as, those in adults. “We see BRAF mutations in multiple different tumor types: Langerhans cell histiocytosis, gliomas, and melanoma,” she said. “Trials of vemurafenib and dabrafenib are under way in the pediatric population. Vemurafenib can cause keratosis pilaris, panniculitis, alopecia, and granulomatous dermatitis.” In her experience, she has seen more alopecia in the older teenage population, but younger patients may not be asked about this side effect as frequently.
She counsels patients to expect keratosis pilaris–like eruptions and to take sun protection seriously. “It’s important to emphasize that each time they come in,” Dr. Coughlin said. She also discussed the potential for changing nevi and treatment options for vemurafenib-associated panniculitis.
Dr. Coughlin disclosed that she is the recipient of active pilot grants from the Pediatric Dermatology Research Alliance and the SPD.
LAKE TAHOE, CALIF. – , and side effects of vemurafenib treatment.
In a presentation on the cutaneous sequelae of different immunosuppressive regimens at the annual meeting of the Society for Pediatric Dermatology, Carrie C. Coughlin, MD, opened with a discussion of AD triggered by the tumor necrosis factor (TNF) blocker infliximab, especially in the setting of therapy for Crohn’s disease. “In this patient population you often think of psoriasis as a consequence of infliximab and other TNF therapies,” said Dr. Coughlin, a pediatric dermatologist at Washington University, St. Louis. “But you can also get true atopic dermatitis with infliximab as well. Who’s more at risk for this? Patients with Crohn’s disease seem to be. Most of the literature is in adults, but there are a few series of children. In a series of children looking at cutaneous sequelae of infliximab therapy, about 20% of cutaneous eruptions were atopic dermatitis. I think it’s a great opportunity for us in dermatology to do a more research in this area.”
Some researchers have proposed that atopic disease could be a marker of over-suppression of TNF-alpha in young Crohn’s disease patients on infliximab (Inflamm Bowel Dis. 2014; 20[8]:1309-15). “One question you could ask is, could these patients actually tolerate a dose reduction?” Dr. Coughlin said. She promoted the role of dermatologists in working at managing side effects to keep patients on medications helping their GI disease, but acknowledged this is not always possible.
Atopic disease can also occur after a solid organ transplant. In fact, the incidence of new-onset food allergies after a liver transplant is 6%-30% of cases, mainly in young patients (Pediatr Transplant. 2009;13[1]:63-9, Pediatr Transplant 2013;17[3]:251-5). “There are some mechanisms, including liver presentation of antigens, that spread through portal veins that could potentially put people at risk who have liver dysfunction,” Dr. Coughlin explained. “They could potentially have a higher risk for food allergies and AD. There is also some thought that tacrolimus potentially predisposes patients to having atopic dermatitis and atopy after their transplant. When you look at the mechanism of action of tacrolimus, you see increased levels of IL-5, IL-13, and skewing of IgE levels.”
Dr. Coughlin also discussed the possibilities of development of AD after transplant being a delayed presentation of an allergic sensitization that patients already had. Younger patients are at higher risk for AD post transplant. The renal transplant population, meanwhile, generally receives the transplant at a later age, “so they may not have that delay in terms of presentation; they may have already had their allergies and grown out of them by the time they’re getting their transplant,” she said. “I think there’s more for us to investigate.”
Solid organ transplant recipients also face an increased risk of skin cancer as a long-term side effect of immunosuppressive therapy. Risk factors include fair skin, sun exposure, and remote time from transplant. “Time from transplant is a risk factor,” Dr. Coughlin said. “Longer time on immunosuppression could predispose you to a risk for skin cancer. Our patients are living longer post transplant than they used to, so they have more potential years to develop their skin cancers.” She focused on the importance of educating transplant recipients and families early about photoprotection. “It’s interesting to think about how we can continue to intervene early on to continue to decrease risk.”
Young patients exposed to voriconazole also face an increased risk for skin cancer. “We know that longer-term dosing and higher cumulative dosing puts you at higher risk,” she said. Lung transplant recipients, who are often more likely to be treated with voriconazole, are thus at higher risk.
Dr. Coughlin ended her presentation by noting that side effects of the BRAF inhibitor vemurafenib (Zelboraf) used to treat advanced melanoma in children are similar to, but not the same as, those in adults. “We see BRAF mutations in multiple different tumor types: Langerhans cell histiocytosis, gliomas, and melanoma,” she said. “Trials of vemurafenib and dabrafenib are under way in the pediatric population. Vemurafenib can cause keratosis pilaris, panniculitis, alopecia, and granulomatous dermatitis.” In her experience, she has seen more alopecia in the older teenage population, but younger patients may not be asked about this side effect as frequently.
She counsels patients to expect keratosis pilaris–like eruptions and to take sun protection seriously. “It’s important to emphasize that each time they come in,” Dr. Coughlin said. She also discussed the potential for changing nevi and treatment options for vemurafenib-associated panniculitis.
Dr. Coughlin disclosed that she is the recipient of active pilot grants from the Pediatric Dermatology Research Alliance and the SPD.
REPORTING FROM SPD 2018