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FDA gives nod to crisaborole for atopic dermatitis
The Food and Drug Administration has approved crisaborole topical ointment, 2%, to treat mild to moderate atopic dermatitis in patients 2 years of age and older. The boron-based phosphodiesterase 4 inhibitor, which will be marketed as Eucrisa, was developed by Anacor Pharmaceuticals, which Pfizer acquired in May of 2016.
“Today’s approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis,” Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement. Safety and efficacy of the drug were established in two placebo-controlled trials with a total of 1,522 participants aged 2-79 years with mild to moderate atopic dermatitis.
At the annual meeting of the Pacific Dermatologic Association in August 2016, Dr. Kelly Cordoro, a pediatric dermatologist at the University of California, San Francisco, described crisaborole as an anti-inflammatory agent that modifies inflammation by inhibiting the degradation of cAMP by PDE4, resulting in downstream modification of nuclear factor-kB and T-cell signaling pathways. “Crisaborole has shown promising results from four clinical studies in patients 2 years of age and older, with notable improvements in all atopic dermatitis parameters,” she said.
The results of the two phase III studies were recently published in the Journal of the American Academy of Dermatology (2016 Sept;75[3]:494-503).
The Food and Drug Administration has approved crisaborole topical ointment, 2%, to treat mild to moderate atopic dermatitis in patients 2 years of age and older. The boron-based phosphodiesterase 4 inhibitor, which will be marketed as Eucrisa, was developed by Anacor Pharmaceuticals, which Pfizer acquired in May of 2016.
“Today’s approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis,” Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement. Safety and efficacy of the drug were established in two placebo-controlled trials with a total of 1,522 participants aged 2-79 years with mild to moderate atopic dermatitis.
At the annual meeting of the Pacific Dermatologic Association in August 2016, Dr. Kelly Cordoro, a pediatric dermatologist at the University of California, San Francisco, described crisaborole as an anti-inflammatory agent that modifies inflammation by inhibiting the degradation of cAMP by PDE4, resulting in downstream modification of nuclear factor-kB and T-cell signaling pathways. “Crisaborole has shown promising results from four clinical studies in patients 2 years of age and older, with notable improvements in all atopic dermatitis parameters,” she said.
The results of the two phase III studies were recently published in the Journal of the American Academy of Dermatology (2016 Sept;75[3]:494-503).
The Food and Drug Administration has approved crisaborole topical ointment, 2%, to treat mild to moderate atopic dermatitis in patients 2 years of age and older. The boron-based phosphodiesterase 4 inhibitor, which will be marketed as Eucrisa, was developed by Anacor Pharmaceuticals, which Pfizer acquired in May of 2016.
“Today’s approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis,” Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement. Safety and efficacy of the drug were established in two placebo-controlled trials with a total of 1,522 participants aged 2-79 years with mild to moderate atopic dermatitis.
At the annual meeting of the Pacific Dermatologic Association in August 2016, Dr. Kelly Cordoro, a pediatric dermatologist at the University of California, San Francisco, described crisaborole as an anti-inflammatory agent that modifies inflammation by inhibiting the degradation of cAMP by PDE4, resulting in downstream modification of nuclear factor-kB and T-cell signaling pathways. “Crisaborole has shown promising results from four clinical studies in patients 2 years of age and older, with notable improvements in all atopic dermatitis parameters,” she said.
The results of the two phase III studies were recently published in the Journal of the American Academy of Dermatology (2016 Sept;75[3]:494-503).
Ohio governor vetoes 6-week abortion ban in favor of 20 weeks
Ohio Gov. John Kasich (R) has rejected a controversial bill that would have barred women in the state from having abortions as early as 6 weeks, but he signed another measure banning the procedure at 20 weeks.
The legislation, known as “the heartbeat bill,” would have prohibited abortions if a fetal heartbeat could be detected – usually around 6 weeks – and jailed physicians who performed the procedure without checking for a heartbeat or who provided an abortion after a heartbeat was found. The Ohio House approved the measure on Dec. 6 after earlier passage by the state senate. In his veto of the 6-week ban, Gov. Kasich noted that federal courts have struck down similar legislation in Arkansas and North Dakota, and that he did not want Ohio taxpayers to fund a losing legal challenge.
“Because the federal courts are bound to follow the Supreme Court’s rulings on abortion, the amendment ... will be struck down,” Gov. Kasich said in a statement. “The state of Ohio will be the losing party in that lawsuit and ... be forced to pay hundreds of thousands of taxpayer dollars to cover the legal fees of the pro-choice activists’ lawyers. Furthermore, such a defeat invites additional challenges to Ohio’s strong legal protections for unborn life. Therefore, this veto is in the public interest.”
Abortion rights advocates were quick to criticize the 20-week ban (SB 127), saying that Ohio lawmakers still intend to effectively end abortion in the state.
“The 20-week ban will force women to travel long distances and cross state lines in order to access safe, legal abortion – a barrier that many women simply cannot afford,” Dawn Laguens, Planned Parenthood Action Fund executive vice president said in a statement.
The American Congress of Obstetricians and Gynecologists Ohio Section also opposes the 20-week ban. In a Dec. 9 letter to Gov. Kasich, Wayne Trout, MD, chair of ACOG’s Ohio Section, said these types of laws come between physicians and patients and create unnecessary medical risks.
“A great number of pregnancy terminations beyond 20 weeks are due to identification of serious and fatal birth defects in otherwise highly desired pregnancies,” Dr. Trout wrote. “Continuation of these pregnancies would result in certain death of the baby and expose the newborn to needless pain. Meanwhile the mother is forced to carry the fetus to term and may be exposed to a myriad of medical and reproductive risks.”
The Ohio law also places doctors in a “precarious situation,” he noted, by criminalizing a medical procedure that is recognized by ACOG as a standard of care when women have a medical indication for termination of pregnancy.
Abortion opponents meanwhile, praised the 20-week ban, calling it a vehicle to end abortion. “It challenges the current national abortion standard and properly moves the legal needle from viability to the baby’s ability to feel pain,” Mike Gonidakis, President of Ohio Right to Life said in a statement.
agallegos@frontlinemedcom.com
On Twitter @legal_med
Ohio Gov. John Kasich (R) has rejected a controversial bill that would have barred women in the state from having abortions as early as 6 weeks, but he signed another measure banning the procedure at 20 weeks.
The legislation, known as “the heartbeat bill,” would have prohibited abortions if a fetal heartbeat could be detected – usually around 6 weeks – and jailed physicians who performed the procedure without checking for a heartbeat or who provided an abortion after a heartbeat was found. The Ohio House approved the measure on Dec. 6 after earlier passage by the state senate. In his veto of the 6-week ban, Gov. Kasich noted that federal courts have struck down similar legislation in Arkansas and North Dakota, and that he did not want Ohio taxpayers to fund a losing legal challenge.
“Because the federal courts are bound to follow the Supreme Court’s rulings on abortion, the amendment ... will be struck down,” Gov. Kasich said in a statement. “The state of Ohio will be the losing party in that lawsuit and ... be forced to pay hundreds of thousands of taxpayer dollars to cover the legal fees of the pro-choice activists’ lawyers. Furthermore, such a defeat invites additional challenges to Ohio’s strong legal protections for unborn life. Therefore, this veto is in the public interest.”
Abortion rights advocates were quick to criticize the 20-week ban (SB 127), saying that Ohio lawmakers still intend to effectively end abortion in the state.
“The 20-week ban will force women to travel long distances and cross state lines in order to access safe, legal abortion – a barrier that many women simply cannot afford,” Dawn Laguens, Planned Parenthood Action Fund executive vice president said in a statement.
The American Congress of Obstetricians and Gynecologists Ohio Section also opposes the 20-week ban. In a Dec. 9 letter to Gov. Kasich, Wayne Trout, MD, chair of ACOG’s Ohio Section, said these types of laws come between physicians and patients and create unnecessary medical risks.
“A great number of pregnancy terminations beyond 20 weeks are due to identification of serious and fatal birth defects in otherwise highly desired pregnancies,” Dr. Trout wrote. “Continuation of these pregnancies would result in certain death of the baby and expose the newborn to needless pain. Meanwhile the mother is forced to carry the fetus to term and may be exposed to a myriad of medical and reproductive risks.”
The Ohio law also places doctors in a “precarious situation,” he noted, by criminalizing a medical procedure that is recognized by ACOG as a standard of care when women have a medical indication for termination of pregnancy.
Abortion opponents meanwhile, praised the 20-week ban, calling it a vehicle to end abortion. “It challenges the current national abortion standard and properly moves the legal needle from viability to the baby’s ability to feel pain,” Mike Gonidakis, President of Ohio Right to Life said in a statement.
agallegos@frontlinemedcom.com
On Twitter @legal_med
Ohio Gov. John Kasich (R) has rejected a controversial bill that would have barred women in the state from having abortions as early as 6 weeks, but he signed another measure banning the procedure at 20 weeks.
The legislation, known as “the heartbeat bill,” would have prohibited abortions if a fetal heartbeat could be detected – usually around 6 weeks – and jailed physicians who performed the procedure without checking for a heartbeat or who provided an abortion after a heartbeat was found. The Ohio House approved the measure on Dec. 6 after earlier passage by the state senate. In his veto of the 6-week ban, Gov. Kasich noted that federal courts have struck down similar legislation in Arkansas and North Dakota, and that he did not want Ohio taxpayers to fund a losing legal challenge.
“Because the federal courts are bound to follow the Supreme Court’s rulings on abortion, the amendment ... will be struck down,” Gov. Kasich said in a statement. “The state of Ohio will be the losing party in that lawsuit and ... be forced to pay hundreds of thousands of taxpayer dollars to cover the legal fees of the pro-choice activists’ lawyers. Furthermore, such a defeat invites additional challenges to Ohio’s strong legal protections for unborn life. Therefore, this veto is in the public interest.”
Abortion rights advocates were quick to criticize the 20-week ban (SB 127), saying that Ohio lawmakers still intend to effectively end abortion in the state.
“The 20-week ban will force women to travel long distances and cross state lines in order to access safe, legal abortion – a barrier that many women simply cannot afford,” Dawn Laguens, Planned Parenthood Action Fund executive vice president said in a statement.
The American Congress of Obstetricians and Gynecologists Ohio Section also opposes the 20-week ban. In a Dec. 9 letter to Gov. Kasich, Wayne Trout, MD, chair of ACOG’s Ohio Section, said these types of laws come between physicians and patients and create unnecessary medical risks.
“A great number of pregnancy terminations beyond 20 weeks are due to identification of serious and fatal birth defects in otherwise highly desired pregnancies,” Dr. Trout wrote. “Continuation of these pregnancies would result in certain death of the baby and expose the newborn to needless pain. Meanwhile the mother is forced to carry the fetus to term and may be exposed to a myriad of medical and reproductive risks.”
The Ohio law also places doctors in a “precarious situation,” he noted, by criminalizing a medical procedure that is recognized by ACOG as a standard of care when women have a medical indication for termination of pregnancy.
Abortion opponents meanwhile, praised the 20-week ban, calling it a vehicle to end abortion. “It challenges the current national abortion standard and properly moves the legal needle from viability to the baby’s ability to feel pain,” Mike Gonidakis, President of Ohio Right to Life said in a statement.
agallegos@frontlinemedcom.com
On Twitter @legal_med
Ask service members and veterans about sexual health
SILVER SPRING, MD. – Tending to the psychiatric and physical needs of military servicemen, servicewomen, and veterans must include attention to their sexual functioning, according to Col. (Ret.) Elspeth Cameron Ritchie, MD, MPH.
“Think of sexual activity as an activity of daily living,” Dr. Ritchie said at the Trauma Treatment from the Trenches meeting at the Forest Glen Annex in Silver Spring, Md., organized by Sawsan Ghurani, MD, a psychiatrist and Navy captain, and sponsored by the Walter Reed National Military Medical Center in Bethesda, Md.
Despite the deployment of 2.7 million service members over more than 15 years of war in the United States, research on the sexual health of this population has been scant, Dr. Ritchie said. Research has been similarly limited in the civilian population, except for the work that has been done among civilians on the impact of spinal cord injuries on sexual dysfunction, she said (J Spinal Cord Med. 2016 Aug 31:1-12).
Clinicians who work with service members and veterans find that wives complain about the impact of medical interventions on their partners, said Dr. Ritchie, a former Army psychiatry consultant and current chief of Community-Based Outpatient Clinics at the Washington (D.C.) Veterans Affairs Medical Center. “As part of the discussion on sexual health, I remind them that sexual activity is broader than penetration.”
Another issue to be aware of among service members is anger. “Often our patients are angry, and often that anger comes out to us as therapists,” she said. “We need to tell our colleagues about this and get them to expect it.”
Treating post-traumatic stress disorder can be a tricky proposition because of the sexual side effects caused by selective serotonin reuptake inhibitors, Dr. Ritchie said. She prefers bupropion because it is not linked to sexual side effects. Mood stabilizers cause weight gain, as do antipsychotics. Meanwhile, drug holidays lead to problems with adherence, she said. To mitigate side effects, Dr. Ritchie advised “trying one thing at a time and adding trazodone in low doses for sleep.” However, trazodone has been linked to priapism (Gen Hosp Psychiatry. 2015 Jan-Feb;37[1]:40-5), and so must be used with care.
Another treatment for PTSD that is showing promise is stellate ganglion block, which has proven effective for treating hot flashes in postmenopausal women and in addressing estrogen depletion tied to breast cancer treatment in small numbers of patients (Med Hypotheses. 2009 Jun;72[6]:657-61).
“Studies have found a reduction in PTSD symptoms as well as pain,” Dr. Ritchie said. “I’m pushing the VA to do more research in this area.”
In effort to treat sexual dysfunction, Dr. Ritchie said her family practice colleagues prescribe a lot of Viagra and other phosphodiesterase inhibitors. She speculated that flibanserin, a selective agonist for 5-HT1A and an antagonist for 5-HT2A receptors approved in 2015 by the Food and Drug Administration for premenopausal women with hypoactive sexual desire disorder, “will start making its way into the general population,” said Dr. Ritchie, whose comments about using phosphodiesterase inhibitors pertain to VA patients.
Many service members who participated in Operation Iraqi Freedom and Operation Enduring Freedom were aged 18-25 years. Partly because the Department of Defense (DOD) and the VA work with very young families, clinicians are tasked with teaching them about their needs as couples, including the need to discuss intimacy and sexual health. For political reasons, Dr. Ritchie said, in vitro fertilization is not covered by the VA, even though injuries from bomb blasts can make it impossible for couples to conceive naturally.
Toxic and infectious substances faced by troops that are not commonly found in the United States, such as chemicals, pesticides, and motor oils, also need to be acknowledged and addressed by clinicians. “We don’t do a good job about what a veteran thinks about what exposure does to their reproductive systems,” Dr. Ritchie said.
In an interview, Dr. Ghurani said that she came up with the title of the meeting to illustrate the extent to which providers treat PTSD in the military every day. Conference speakers examined the latest treatments on sexual trauma, and the state of the art therapy and research taking place at Walter Reed.
At the meeting, she discussed the distinction between military sexual trauma (MST) and sexual trauma within the civilian population. Research shows that veterans who screen positive for MST “are more likely to have a history of a suicide attempt documented in their VA medical record” (Psychiatry Res. 2016;244:257-65).
A 2008 study found that women are far more likely to screen positive for MST than men. Specifically, the study found that 25% of women and 1.3% of men who are screened for MST within the Veterans Health Administration screen positive (Trauma Violence Abuse. 2008 Oct;9[4]250-69).
Walter Reed’s Interpersonal Recovery Program at the Psychiatry Continuity Service is the only intensive outpatient program within the DOD that provides ongoing treatment for active duty service members with PTSD from a sexual trauma, Dr. Ghurani said.
Earlier during the meeting, Capt. (Ret.) William P. Nash, MD, director of psychological health at the Marine Corps and a 30-year veteran of the Navy, discussed moral injury, and contrasted it with PTSD and other sequelae of psychological trauma. He also described his work on the Moral Injury Events Scale as a tool for recognizing potentially morally injurious events in clinical and research settings.
Dr. Ritchie is the editor of “Intimacy Post-Injury: Combat Trauma and Sexual Health,” (New York: Oxford University Press, 2016). Dr. Ghurani contributed to a chapter in “Intimacy Post Injury,” and Dr. Nash has written extensively about PTSD, particularly among deployed Marines.
SILVER SPRING, MD. – Tending to the psychiatric and physical needs of military servicemen, servicewomen, and veterans must include attention to their sexual functioning, according to Col. (Ret.) Elspeth Cameron Ritchie, MD, MPH.
“Think of sexual activity as an activity of daily living,” Dr. Ritchie said at the Trauma Treatment from the Trenches meeting at the Forest Glen Annex in Silver Spring, Md., organized by Sawsan Ghurani, MD, a psychiatrist and Navy captain, and sponsored by the Walter Reed National Military Medical Center in Bethesda, Md.
Despite the deployment of 2.7 million service members over more than 15 years of war in the United States, research on the sexual health of this population has been scant, Dr. Ritchie said. Research has been similarly limited in the civilian population, except for the work that has been done among civilians on the impact of spinal cord injuries on sexual dysfunction, she said (J Spinal Cord Med. 2016 Aug 31:1-12).
Clinicians who work with service members and veterans find that wives complain about the impact of medical interventions on their partners, said Dr. Ritchie, a former Army psychiatry consultant and current chief of Community-Based Outpatient Clinics at the Washington (D.C.) Veterans Affairs Medical Center. “As part of the discussion on sexual health, I remind them that sexual activity is broader than penetration.”
Another issue to be aware of among service members is anger. “Often our patients are angry, and often that anger comes out to us as therapists,” she said. “We need to tell our colleagues about this and get them to expect it.”
Treating post-traumatic stress disorder can be a tricky proposition because of the sexual side effects caused by selective serotonin reuptake inhibitors, Dr. Ritchie said. She prefers bupropion because it is not linked to sexual side effects. Mood stabilizers cause weight gain, as do antipsychotics. Meanwhile, drug holidays lead to problems with adherence, she said. To mitigate side effects, Dr. Ritchie advised “trying one thing at a time and adding trazodone in low doses for sleep.” However, trazodone has been linked to priapism (Gen Hosp Psychiatry. 2015 Jan-Feb;37[1]:40-5), and so must be used with care.
Another treatment for PTSD that is showing promise is stellate ganglion block, which has proven effective for treating hot flashes in postmenopausal women and in addressing estrogen depletion tied to breast cancer treatment in small numbers of patients (Med Hypotheses. 2009 Jun;72[6]:657-61).
“Studies have found a reduction in PTSD symptoms as well as pain,” Dr. Ritchie said. “I’m pushing the VA to do more research in this area.”
In effort to treat sexual dysfunction, Dr. Ritchie said her family practice colleagues prescribe a lot of Viagra and other phosphodiesterase inhibitors. She speculated that flibanserin, a selective agonist for 5-HT1A and an antagonist for 5-HT2A receptors approved in 2015 by the Food and Drug Administration for premenopausal women with hypoactive sexual desire disorder, “will start making its way into the general population,” said Dr. Ritchie, whose comments about using phosphodiesterase inhibitors pertain to VA patients.
Many service members who participated in Operation Iraqi Freedom and Operation Enduring Freedom were aged 18-25 years. Partly because the Department of Defense (DOD) and the VA work with very young families, clinicians are tasked with teaching them about their needs as couples, including the need to discuss intimacy and sexual health. For political reasons, Dr. Ritchie said, in vitro fertilization is not covered by the VA, even though injuries from bomb blasts can make it impossible for couples to conceive naturally.
Toxic and infectious substances faced by troops that are not commonly found in the United States, such as chemicals, pesticides, and motor oils, also need to be acknowledged and addressed by clinicians. “We don’t do a good job about what a veteran thinks about what exposure does to their reproductive systems,” Dr. Ritchie said.
In an interview, Dr. Ghurani said that she came up with the title of the meeting to illustrate the extent to which providers treat PTSD in the military every day. Conference speakers examined the latest treatments on sexual trauma, and the state of the art therapy and research taking place at Walter Reed.
At the meeting, she discussed the distinction between military sexual trauma (MST) and sexual trauma within the civilian population. Research shows that veterans who screen positive for MST “are more likely to have a history of a suicide attempt documented in their VA medical record” (Psychiatry Res. 2016;244:257-65).
A 2008 study found that women are far more likely to screen positive for MST than men. Specifically, the study found that 25% of women and 1.3% of men who are screened for MST within the Veterans Health Administration screen positive (Trauma Violence Abuse. 2008 Oct;9[4]250-69).
Walter Reed’s Interpersonal Recovery Program at the Psychiatry Continuity Service is the only intensive outpatient program within the DOD that provides ongoing treatment for active duty service members with PTSD from a sexual trauma, Dr. Ghurani said.
Earlier during the meeting, Capt. (Ret.) William P. Nash, MD, director of psychological health at the Marine Corps and a 30-year veteran of the Navy, discussed moral injury, and contrasted it with PTSD and other sequelae of psychological trauma. He also described his work on the Moral Injury Events Scale as a tool for recognizing potentially morally injurious events in clinical and research settings.
Dr. Ritchie is the editor of “Intimacy Post-Injury: Combat Trauma and Sexual Health,” (New York: Oxford University Press, 2016). Dr. Ghurani contributed to a chapter in “Intimacy Post Injury,” and Dr. Nash has written extensively about PTSD, particularly among deployed Marines.
SILVER SPRING, MD. – Tending to the psychiatric and physical needs of military servicemen, servicewomen, and veterans must include attention to their sexual functioning, according to Col. (Ret.) Elspeth Cameron Ritchie, MD, MPH.
“Think of sexual activity as an activity of daily living,” Dr. Ritchie said at the Trauma Treatment from the Trenches meeting at the Forest Glen Annex in Silver Spring, Md., organized by Sawsan Ghurani, MD, a psychiatrist and Navy captain, and sponsored by the Walter Reed National Military Medical Center in Bethesda, Md.
Despite the deployment of 2.7 million service members over more than 15 years of war in the United States, research on the sexual health of this population has been scant, Dr. Ritchie said. Research has been similarly limited in the civilian population, except for the work that has been done among civilians on the impact of spinal cord injuries on sexual dysfunction, she said (J Spinal Cord Med. 2016 Aug 31:1-12).
Clinicians who work with service members and veterans find that wives complain about the impact of medical interventions on their partners, said Dr. Ritchie, a former Army psychiatry consultant and current chief of Community-Based Outpatient Clinics at the Washington (D.C.) Veterans Affairs Medical Center. “As part of the discussion on sexual health, I remind them that sexual activity is broader than penetration.”
Another issue to be aware of among service members is anger. “Often our patients are angry, and often that anger comes out to us as therapists,” she said. “We need to tell our colleagues about this and get them to expect it.”
Treating post-traumatic stress disorder can be a tricky proposition because of the sexual side effects caused by selective serotonin reuptake inhibitors, Dr. Ritchie said. She prefers bupropion because it is not linked to sexual side effects. Mood stabilizers cause weight gain, as do antipsychotics. Meanwhile, drug holidays lead to problems with adherence, she said. To mitigate side effects, Dr. Ritchie advised “trying one thing at a time and adding trazodone in low doses for sleep.” However, trazodone has been linked to priapism (Gen Hosp Psychiatry. 2015 Jan-Feb;37[1]:40-5), and so must be used with care.
Another treatment for PTSD that is showing promise is stellate ganglion block, which has proven effective for treating hot flashes in postmenopausal women and in addressing estrogen depletion tied to breast cancer treatment in small numbers of patients (Med Hypotheses. 2009 Jun;72[6]:657-61).
“Studies have found a reduction in PTSD symptoms as well as pain,” Dr. Ritchie said. “I’m pushing the VA to do more research in this area.”
In effort to treat sexual dysfunction, Dr. Ritchie said her family practice colleagues prescribe a lot of Viagra and other phosphodiesterase inhibitors. She speculated that flibanserin, a selective agonist for 5-HT1A and an antagonist for 5-HT2A receptors approved in 2015 by the Food and Drug Administration for premenopausal women with hypoactive sexual desire disorder, “will start making its way into the general population,” said Dr. Ritchie, whose comments about using phosphodiesterase inhibitors pertain to VA patients.
Many service members who participated in Operation Iraqi Freedom and Operation Enduring Freedom were aged 18-25 years. Partly because the Department of Defense (DOD) and the VA work with very young families, clinicians are tasked with teaching them about their needs as couples, including the need to discuss intimacy and sexual health. For political reasons, Dr. Ritchie said, in vitro fertilization is not covered by the VA, even though injuries from bomb blasts can make it impossible for couples to conceive naturally.
Toxic and infectious substances faced by troops that are not commonly found in the United States, such as chemicals, pesticides, and motor oils, also need to be acknowledged and addressed by clinicians. “We don’t do a good job about what a veteran thinks about what exposure does to their reproductive systems,” Dr. Ritchie said.
In an interview, Dr. Ghurani said that she came up with the title of the meeting to illustrate the extent to which providers treat PTSD in the military every day. Conference speakers examined the latest treatments on sexual trauma, and the state of the art therapy and research taking place at Walter Reed.
At the meeting, she discussed the distinction between military sexual trauma (MST) and sexual trauma within the civilian population. Research shows that veterans who screen positive for MST “are more likely to have a history of a suicide attempt documented in their VA medical record” (Psychiatry Res. 2016;244:257-65).
A 2008 study found that women are far more likely to screen positive for MST than men. Specifically, the study found that 25% of women and 1.3% of men who are screened for MST within the Veterans Health Administration screen positive (Trauma Violence Abuse. 2008 Oct;9[4]250-69).
Walter Reed’s Interpersonal Recovery Program at the Psychiatry Continuity Service is the only intensive outpatient program within the DOD that provides ongoing treatment for active duty service members with PTSD from a sexual trauma, Dr. Ghurani said.
Earlier during the meeting, Capt. (Ret.) William P. Nash, MD, director of psychological health at the Marine Corps and a 30-year veteran of the Navy, discussed moral injury, and contrasted it with PTSD and other sequelae of psychological trauma. He also described his work on the Moral Injury Events Scale as a tool for recognizing potentially morally injurious events in clinical and research settings.
Dr. Ritchie is the editor of “Intimacy Post-Injury: Combat Trauma and Sexual Health,” (New York: Oxford University Press, 2016). Dr. Ghurani contributed to a chapter in “Intimacy Post Injury,” and Dr. Nash has written extensively about PTSD, particularly among deployed Marines.
FROM TRAUMA TREATMENT FROM THE TRENCHES
Kimford J. Meador, MD
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What can administrators and ObGyns do together to reduce physician burnout?
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Lower-risk approach for aortic arch repair
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Aortic arch reconstruction through a median sternotomy on bypass in newborns and infants had lower rates for recurrent obstruction than did a thoracotomy approach.
Major finding: Of 11 patients who required reintervention, one had a median sternotomy and 10 had a lateral thoracotomy.
Data source: Retrospective review of 183 consecutive newborns and infants with coarctation and hypoplastic aortic arch from 1996 to 2013.
Disclosures: Dr. Tulzer and coauthors had no financial relationships to disclose.
Novel trial aims to BEAT AML
SAN DIEGO – A multi-arm clinical trial aims to transform the treatment of acute myeloid leukemia, a deadly blood cancer whose standard of care has remained essentially unchanged for 4 decades.
Launched in October 2016, the multicenter BEAT AML Master Trial is based on a simple but radical goal – turn around genomic tests of bone marrow biopsies within 7 days to allow targeted therapy, said lead investigator Brian Druker, MD, of Oregon Health and Science University Knight Cancer Institute in Portland.
Speaking at a press conference at the annual meeting of the American Society of Hematology, he emphasized that rapid, accurate genomic testing is the only way to prescribe targeted agents for AML in time for them to help patients. “It really is about matching the right patient with the right drug,” he said. He also spoke about AML in a video interview at the conference.
That is a major departure from the current approach to treating AML, in which patients receive standard chemotherapy regimens that are toxic and largely ineffective. “Patients themselves call this barbaric therapy,” said John Byrd, MD, who is co-leading the trial on behalf of the Ohio State University Wexner Medical Center in Columbus. “In this trial, we’re going to move away from toxic therapy that is not potentially curative to give more targeted medicine instead.”
In addition to Dr. Druker’s and Dr. Byrd’s centers, Memorial Sloan Kettering Cancer Center, New York, and Dana-Farber Cancer Institute and Massachusetts General Hospital, both in Boston, are onboard for the study. The lead investigators hope to add another six centers to the study group and to have 10 arms of the study underway by mid-2017.
Older patients with AML find chemotherapy especially hard to tolerate and typically respond poorly. Accordingly, the trial will enroll those aged 60 years and up regardless of their genomic profile, the researchers said. Patients lacking targetable markers will be offered investigational therapies showing broad activity in AML.
Another complexity of AML is that any patient can have a variety of mutations, including some affecting only a small subset of leukemia cells, Dr. Byrd noted. Targeting those mutations cannot eradicate disease, but past trials did not rank or choose therapies based on mutation prevalence. Thus, this trial is the first to ask “which mutation is in all of the cells, which gives you the opportunity to get rid of all the disease,” he emphasized. Again, patients – not individual markers or agents – are the priority.
The study also is meant to be nimble – arms can be quickly opened or closed if bench or clinical data are promising or lackluster. This design does not preclude FDA approvals, said Louis J. DeGennaro, PhD, of the Leukemia and Lymphoma Society, which is sponsoring the trial. “We have worked closely with FDA to design a unique protocol that we believe will change the paradigm of AML treatment and future clinical trials,” he added. “This is an unprecedented collaboration.”
Dr. Druker agreed. “If we do this correctly, we can potentially see large effects, and that can become the impetus for rapid FDA approval of these drugs for the right patients,” he said. “That one of the things this trial is designed to do.”
Dr. DeGennaro is president and chief executive officer of the Leukemia and Lymphoma Society, which is sponsoring the BEAT AML Master trial. Dr. Druker disclosed ties to a number of pharmaceutical companies. Dr. Byrd had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN DIEGO – A multi-arm clinical trial aims to transform the treatment of acute myeloid leukemia, a deadly blood cancer whose standard of care has remained essentially unchanged for 4 decades.
Launched in October 2016, the multicenter BEAT AML Master Trial is based on a simple but radical goal – turn around genomic tests of bone marrow biopsies within 7 days to allow targeted therapy, said lead investigator Brian Druker, MD, of Oregon Health and Science University Knight Cancer Institute in Portland.
Speaking at a press conference at the annual meeting of the American Society of Hematology, he emphasized that rapid, accurate genomic testing is the only way to prescribe targeted agents for AML in time for them to help patients. “It really is about matching the right patient with the right drug,” he said. He also spoke about AML in a video interview at the conference.
That is a major departure from the current approach to treating AML, in which patients receive standard chemotherapy regimens that are toxic and largely ineffective. “Patients themselves call this barbaric therapy,” said John Byrd, MD, who is co-leading the trial on behalf of the Ohio State University Wexner Medical Center in Columbus. “In this trial, we’re going to move away from toxic therapy that is not potentially curative to give more targeted medicine instead.”
In addition to Dr. Druker’s and Dr. Byrd’s centers, Memorial Sloan Kettering Cancer Center, New York, and Dana-Farber Cancer Institute and Massachusetts General Hospital, both in Boston, are onboard for the study. The lead investigators hope to add another six centers to the study group and to have 10 arms of the study underway by mid-2017.
Older patients with AML find chemotherapy especially hard to tolerate and typically respond poorly. Accordingly, the trial will enroll those aged 60 years and up regardless of their genomic profile, the researchers said. Patients lacking targetable markers will be offered investigational therapies showing broad activity in AML.
Another complexity of AML is that any patient can have a variety of mutations, including some affecting only a small subset of leukemia cells, Dr. Byrd noted. Targeting those mutations cannot eradicate disease, but past trials did not rank or choose therapies based on mutation prevalence. Thus, this trial is the first to ask “which mutation is in all of the cells, which gives you the opportunity to get rid of all the disease,” he emphasized. Again, patients – not individual markers or agents – are the priority.
The study also is meant to be nimble – arms can be quickly opened or closed if bench or clinical data are promising or lackluster. This design does not preclude FDA approvals, said Louis J. DeGennaro, PhD, of the Leukemia and Lymphoma Society, which is sponsoring the trial. “We have worked closely with FDA to design a unique protocol that we believe will change the paradigm of AML treatment and future clinical trials,” he added. “This is an unprecedented collaboration.”
Dr. Druker agreed. “If we do this correctly, we can potentially see large effects, and that can become the impetus for rapid FDA approval of these drugs for the right patients,” he said. “That one of the things this trial is designed to do.”
Dr. DeGennaro is president and chief executive officer of the Leukemia and Lymphoma Society, which is sponsoring the BEAT AML Master trial. Dr. Druker disclosed ties to a number of pharmaceutical companies. Dr. Byrd had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN DIEGO – A multi-arm clinical trial aims to transform the treatment of acute myeloid leukemia, a deadly blood cancer whose standard of care has remained essentially unchanged for 4 decades.
Launched in October 2016, the multicenter BEAT AML Master Trial is based on a simple but radical goal – turn around genomic tests of bone marrow biopsies within 7 days to allow targeted therapy, said lead investigator Brian Druker, MD, of Oregon Health and Science University Knight Cancer Institute in Portland.
Speaking at a press conference at the annual meeting of the American Society of Hematology, he emphasized that rapid, accurate genomic testing is the only way to prescribe targeted agents for AML in time for them to help patients. “It really is about matching the right patient with the right drug,” he said. He also spoke about AML in a video interview at the conference.
That is a major departure from the current approach to treating AML, in which patients receive standard chemotherapy regimens that are toxic and largely ineffective. “Patients themselves call this barbaric therapy,” said John Byrd, MD, who is co-leading the trial on behalf of the Ohio State University Wexner Medical Center in Columbus. “In this trial, we’re going to move away from toxic therapy that is not potentially curative to give more targeted medicine instead.”
In addition to Dr. Druker’s and Dr. Byrd’s centers, Memorial Sloan Kettering Cancer Center, New York, and Dana-Farber Cancer Institute and Massachusetts General Hospital, both in Boston, are onboard for the study. The lead investigators hope to add another six centers to the study group and to have 10 arms of the study underway by mid-2017.
Older patients with AML find chemotherapy especially hard to tolerate and typically respond poorly. Accordingly, the trial will enroll those aged 60 years and up regardless of their genomic profile, the researchers said. Patients lacking targetable markers will be offered investigational therapies showing broad activity in AML.
Another complexity of AML is that any patient can have a variety of mutations, including some affecting only a small subset of leukemia cells, Dr. Byrd noted. Targeting those mutations cannot eradicate disease, but past trials did not rank or choose therapies based on mutation prevalence. Thus, this trial is the first to ask “which mutation is in all of the cells, which gives you the opportunity to get rid of all the disease,” he emphasized. Again, patients – not individual markers or agents – are the priority.
The study also is meant to be nimble – arms can be quickly opened or closed if bench or clinical data are promising or lackluster. This design does not preclude FDA approvals, said Louis J. DeGennaro, PhD, of the Leukemia and Lymphoma Society, which is sponsoring the trial. “We have worked closely with FDA to design a unique protocol that we believe will change the paradigm of AML treatment and future clinical trials,” he added. “This is an unprecedented collaboration.”
Dr. Druker agreed. “If we do this correctly, we can potentially see large effects, and that can become the impetus for rapid FDA approval of these drugs for the right patients,” he said. “That one of the things this trial is designed to do.”
Dr. DeGennaro is president and chief executive officer of the Leukemia and Lymphoma Society, which is sponsoring the BEAT AML Master trial. Dr. Druker disclosed ties to a number of pharmaceutical companies. Dr. Byrd had no relevant disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT ASH 2016
An unclear future ahead for health care
In the aftermath of the most acrimonious presidential election of my lifetime, we are left with recriminations, celebrations, and more questions than answers. And, of course, no real answers for the medical field at all. Just as in 2008, we face an unknown future.
Will this be good or bad for us? I have no idea. Some of the health care changes that hit small practices hardest were the requirements to upgrade or be penalized. Many of us, including myself, didn’t have the financial means to do that and elected to take the penalties. It would be nice to see those rolled back. Since all insurers peg their rates to Medicare, I’d be thrilled to see those increase, too. The repeal of the hated Sustainable Growth Rate formula showed that the parties can get something done when they’re actually willing to do the work they were elected to do.
Also, there’s something wrong with a system where (as Bill Bryson wrote in his book, “Neither Here Nor There: Travels in Europe”), “no one seemed to think it particularly disgraceful that a child with a brain tumor could be allowed to die because his father didn’t have the wherewithal to pay a surgeon, or where an insurance company could be permitted by a state insurance commissioner to cancel the policies of its 14,000 sickest patients because it wasn’t having a very good year (as happened in California in 1989).”
Obamacare is far from perfect. It has serious flaws. But the idea behind it is, to me, a step in the right direction. I hope those in power, rather then destroying things and reverting to the broken system we had before, will work to remove the broken parts (such as the failing insurance exchanges here in Arizona) and replace them with something that is more sustainable and fair in the long term.
More than any natural resource, a country’s people are the key drivers of its innovation and economy. So keeping them as healthy as possible is critical to our national well-being. This has to be balanced with a way to make it affordable, since resources are finite.
Where does this leave doctors? I have no idea. Like most of us, I just want to take care of patients. That’s what I came here for. The need to run the practice of medicine as a business is a necessary evil. I hope the changes to come will allow all of us to do what we do best: help those who need us.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
In the aftermath of the most acrimonious presidential election of my lifetime, we are left with recriminations, celebrations, and more questions than answers. And, of course, no real answers for the medical field at all. Just as in 2008, we face an unknown future.
Will this be good or bad for us? I have no idea. Some of the health care changes that hit small practices hardest were the requirements to upgrade or be penalized. Many of us, including myself, didn’t have the financial means to do that and elected to take the penalties. It would be nice to see those rolled back. Since all insurers peg their rates to Medicare, I’d be thrilled to see those increase, too. The repeal of the hated Sustainable Growth Rate formula showed that the parties can get something done when they’re actually willing to do the work they were elected to do.
Also, there’s something wrong with a system where (as Bill Bryson wrote in his book, “Neither Here Nor There: Travels in Europe”), “no one seemed to think it particularly disgraceful that a child with a brain tumor could be allowed to die because his father didn’t have the wherewithal to pay a surgeon, or where an insurance company could be permitted by a state insurance commissioner to cancel the policies of its 14,000 sickest patients because it wasn’t having a very good year (as happened in California in 1989).”
Obamacare is far from perfect. It has serious flaws. But the idea behind it is, to me, a step in the right direction. I hope those in power, rather then destroying things and reverting to the broken system we had before, will work to remove the broken parts (such as the failing insurance exchanges here in Arizona) and replace them with something that is more sustainable and fair in the long term.
More than any natural resource, a country’s people are the key drivers of its innovation and economy. So keeping them as healthy as possible is critical to our national well-being. This has to be balanced with a way to make it affordable, since resources are finite.
Where does this leave doctors? I have no idea. Like most of us, I just want to take care of patients. That’s what I came here for. The need to run the practice of medicine as a business is a necessary evil. I hope the changes to come will allow all of us to do what we do best: help those who need us.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
In the aftermath of the most acrimonious presidential election of my lifetime, we are left with recriminations, celebrations, and more questions than answers. And, of course, no real answers for the medical field at all. Just as in 2008, we face an unknown future.
Will this be good or bad for us? I have no idea. Some of the health care changes that hit small practices hardest were the requirements to upgrade or be penalized. Many of us, including myself, didn’t have the financial means to do that and elected to take the penalties. It would be nice to see those rolled back. Since all insurers peg their rates to Medicare, I’d be thrilled to see those increase, too. The repeal of the hated Sustainable Growth Rate formula showed that the parties can get something done when they’re actually willing to do the work they were elected to do.
Also, there’s something wrong with a system where (as Bill Bryson wrote in his book, “Neither Here Nor There: Travels in Europe”), “no one seemed to think it particularly disgraceful that a child with a brain tumor could be allowed to die because his father didn’t have the wherewithal to pay a surgeon, or where an insurance company could be permitted by a state insurance commissioner to cancel the policies of its 14,000 sickest patients because it wasn’t having a very good year (as happened in California in 1989).”
Obamacare is far from perfect. It has serious flaws. But the idea behind it is, to me, a step in the right direction. I hope those in power, rather then destroying things and reverting to the broken system we had before, will work to remove the broken parts (such as the failing insurance exchanges here in Arizona) and replace them with something that is more sustainable and fair in the long term.
More than any natural resource, a country’s people are the key drivers of its innovation and economy. So keeping them as healthy as possible is critical to our national well-being. This has to be balanced with a way to make it affordable, since resources are finite.
Where does this leave doctors? I have no idea. Like most of us, I just want to take care of patients. That’s what I came here for. The need to run the practice of medicine as a business is a necessary evil. I hope the changes to come will allow all of us to do what we do best: help those who need us.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Abortion denial increases short-term anxiety, depression
Women denied an abortion appear to experience more psychological problems in the short term, compared with women who are able to access the procedure, according to findings published in JAMA Psychiatry.
The prospective, longitudinal Turnaway Study involved regular follow-up telephone interviews of 956 women recruited from 30 abortion facilities in 21 states. Of these women, 273 received abortions in the first trimester, 452 received abortions just under the facility’s gestational limit, 161 sought an abortion but were turned away because they were just past the limit and later gave birth (turnaway-births), and 70 were turned away but either miscarried or obtained an abortion elsewhere (turnaway-no-births).
At 1 week after seeking an abortion, women denied an abortion reported significantly more anxiety symptoms (turnaway-births, coefficient 0.57; 95% CI, 0.01 to 1.13; turnaway-no-births, 2.29; 95% CI, 1.39 to 3.18) and lower self-esteem (turnaway-births, –0.33; 95% CI, –0.56 to –0.09; turnaway-no-births, –0.40; 95% CI, –0.78 to –0.02), compared with women who received abortions near the gestational limit.
Similarly, women denied abortions experienced lower life satisfaction at 1 week (turnaway-births, –0.16; 95% CI, –0.38 to 0.06; turnaway-no-births, –0.41; 95% CI, –0.77 to –0.06).
The study found that levels of depression were similar between the abortion and no-abortion groups in the first week, and depression levels also declined significantly over time in all groups except among women who were turned away for an abortion and later gave birth (JAMA Psychiatry. 2016 Dec 14. doi: 10.1001/jamapsychiatry.2016.3478).
“Our findings add to the body of evidence rejecting the notion that abortion increases women’s risk of experiencing adverse psychological outcomes,” wrote M. Antonia Biggs, PhD, of the Bixby Center for Global Reproductive Health at the University of California, San Francisco, and her coauthors. “Women who had an abortion demonstrated more positive outcomes initially compared with women who were denied an abortion.”
At the last follow-up, 5-6 years after the seeking of an abortion, the differences in mental well-being between women who had received an abortion and those who had not had all but disappeared.
“These initial elevated levels of distress experienced by both turnaway groups may be a response to being denied an abortion, as well as other social and emotional challenges faced on discovery of unwanted pregnancy and abortion seeking,” the researchers wrote.
Of all the groups, women who were initially denied an abortion but later miscarried or received an abortion elsewhere showed the most elevated levels of anxiety and lowest self-esteem and life satisfaction 1 week after being denied an abortion. Women in the turnaway-no-birth group may have had higher levels of stress because they were trying to find and travel to another abortion facility, or to raise extra money to pay for the procedure, the researchers noted.
Given these study findings, there is no evidence to justify laws requiring women seeking abortion to be warned about negative psychological responses, according to the researchers. “Women considering abortion are best served by being provided with the most accurate, scientific information available to help them make their pregnancy decisions,” they wrote.
The study was supported by grants from the Wallace Alexander Gerbode Foundation, the David and Lucile Packard Foundation, the William and Flora Hewlett Foundation, and an anonymous foundation. The researchers reported having no relevant financial disclosures.
Women denied an abortion appear to experience more psychological problems in the short term, compared with women who are able to access the procedure, according to findings published in JAMA Psychiatry.
The prospective, longitudinal Turnaway Study involved regular follow-up telephone interviews of 956 women recruited from 30 abortion facilities in 21 states. Of these women, 273 received abortions in the first trimester, 452 received abortions just under the facility’s gestational limit, 161 sought an abortion but were turned away because they were just past the limit and later gave birth (turnaway-births), and 70 were turned away but either miscarried or obtained an abortion elsewhere (turnaway-no-births).
At 1 week after seeking an abortion, women denied an abortion reported significantly more anxiety symptoms (turnaway-births, coefficient 0.57; 95% CI, 0.01 to 1.13; turnaway-no-births, 2.29; 95% CI, 1.39 to 3.18) and lower self-esteem (turnaway-births, –0.33; 95% CI, –0.56 to –0.09; turnaway-no-births, –0.40; 95% CI, –0.78 to –0.02), compared with women who received abortions near the gestational limit.
Similarly, women denied abortions experienced lower life satisfaction at 1 week (turnaway-births, –0.16; 95% CI, –0.38 to 0.06; turnaway-no-births, –0.41; 95% CI, –0.77 to –0.06).
The study found that levels of depression were similar between the abortion and no-abortion groups in the first week, and depression levels also declined significantly over time in all groups except among women who were turned away for an abortion and later gave birth (JAMA Psychiatry. 2016 Dec 14. doi: 10.1001/jamapsychiatry.2016.3478).
“Our findings add to the body of evidence rejecting the notion that abortion increases women’s risk of experiencing adverse psychological outcomes,” wrote M. Antonia Biggs, PhD, of the Bixby Center for Global Reproductive Health at the University of California, San Francisco, and her coauthors. “Women who had an abortion demonstrated more positive outcomes initially compared with women who were denied an abortion.”
At the last follow-up, 5-6 years after the seeking of an abortion, the differences in mental well-being between women who had received an abortion and those who had not had all but disappeared.
“These initial elevated levels of distress experienced by both turnaway groups may be a response to being denied an abortion, as well as other social and emotional challenges faced on discovery of unwanted pregnancy and abortion seeking,” the researchers wrote.
Of all the groups, women who were initially denied an abortion but later miscarried or received an abortion elsewhere showed the most elevated levels of anxiety and lowest self-esteem and life satisfaction 1 week after being denied an abortion. Women in the turnaway-no-birth group may have had higher levels of stress because they were trying to find and travel to another abortion facility, or to raise extra money to pay for the procedure, the researchers noted.
Given these study findings, there is no evidence to justify laws requiring women seeking abortion to be warned about negative psychological responses, according to the researchers. “Women considering abortion are best served by being provided with the most accurate, scientific information available to help them make their pregnancy decisions,” they wrote.
The study was supported by grants from the Wallace Alexander Gerbode Foundation, the David and Lucile Packard Foundation, the William and Flora Hewlett Foundation, and an anonymous foundation. The researchers reported having no relevant financial disclosures.
Women denied an abortion appear to experience more psychological problems in the short term, compared with women who are able to access the procedure, according to findings published in JAMA Psychiatry.
The prospective, longitudinal Turnaway Study involved regular follow-up telephone interviews of 956 women recruited from 30 abortion facilities in 21 states. Of these women, 273 received abortions in the first trimester, 452 received abortions just under the facility’s gestational limit, 161 sought an abortion but were turned away because they were just past the limit and later gave birth (turnaway-births), and 70 were turned away but either miscarried or obtained an abortion elsewhere (turnaway-no-births).
At 1 week after seeking an abortion, women denied an abortion reported significantly more anxiety symptoms (turnaway-births, coefficient 0.57; 95% CI, 0.01 to 1.13; turnaway-no-births, 2.29; 95% CI, 1.39 to 3.18) and lower self-esteem (turnaway-births, –0.33; 95% CI, –0.56 to –0.09; turnaway-no-births, –0.40; 95% CI, –0.78 to –0.02), compared with women who received abortions near the gestational limit.
Similarly, women denied abortions experienced lower life satisfaction at 1 week (turnaway-births, –0.16; 95% CI, –0.38 to 0.06; turnaway-no-births, –0.41; 95% CI, –0.77 to –0.06).
The study found that levels of depression were similar between the abortion and no-abortion groups in the first week, and depression levels also declined significantly over time in all groups except among women who were turned away for an abortion and later gave birth (JAMA Psychiatry. 2016 Dec 14. doi: 10.1001/jamapsychiatry.2016.3478).
“Our findings add to the body of evidence rejecting the notion that abortion increases women’s risk of experiencing adverse psychological outcomes,” wrote M. Antonia Biggs, PhD, of the Bixby Center for Global Reproductive Health at the University of California, San Francisco, and her coauthors. “Women who had an abortion demonstrated more positive outcomes initially compared with women who were denied an abortion.”
At the last follow-up, 5-6 years after the seeking of an abortion, the differences in mental well-being between women who had received an abortion and those who had not had all but disappeared.
“These initial elevated levels of distress experienced by both turnaway groups may be a response to being denied an abortion, as well as other social and emotional challenges faced on discovery of unwanted pregnancy and abortion seeking,” the researchers wrote.
Of all the groups, women who were initially denied an abortion but later miscarried or received an abortion elsewhere showed the most elevated levels of anxiety and lowest self-esteem and life satisfaction 1 week after being denied an abortion. Women in the turnaway-no-birth group may have had higher levels of stress because they were trying to find and travel to another abortion facility, or to raise extra money to pay for the procedure, the researchers noted.
Given these study findings, there is no evidence to justify laws requiring women seeking abortion to be warned about negative psychological responses, according to the researchers. “Women considering abortion are best served by being provided with the most accurate, scientific information available to help them make their pregnancy decisions,” they wrote.
The study was supported by grants from the Wallace Alexander Gerbode Foundation, the David and Lucile Packard Foundation, the William and Flora Hewlett Foundation, and an anonymous foundation. The researchers reported having no relevant financial disclosures.
FROM JAMA PSYCHIATRY
Key clinical point:
Major finding: After 1 week, women denied an abortion reported significantly more anxiety symptoms, lower self-esteem, and lower life satisfaction than did women who received abortions.
Data source: Prospective longitudinal study in 956 women requesting abortions at 30 facilities across the United States.
Disclosures: The study was supported by grants from the Wallace Alexander Gerbode Foundation, the David and Lucile Packard Foundation, the William and Flora Hewlett Foundation, and an anonymous foundation. The researchers reported having no relevant financial disclosures.
VIDEO: Improved QOL an added benefit of pembrolizumab for NSCLC patients
VIENNA – Patients with metastatic non–small-cell lung cancer with high levels of PD-L1 who received first-line pembrolizumab treatment had clinically meaningful improvement in their quality of life, compared with patients randomized to chemotherapy, in a prespecified secondary analysis of data from the drug’s pivotal trial.
This boost in quality of life as well as other measures of health status add to the pivotal trial’s primary finding of significantly increased progression-free survival compared with chemotherapy, as well as previously-reported secondary findings of superior overall survival, objective response rate, and safety with pembrolizumab compared with chemotherapy (N Engl J Med. 2016 Nov 10;375[19]:1823-33), Julie R. Brahmer, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
The primary endpoint of the Study of Pembrolizumab Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non–Small Cell Lung Cancer (KEYNOTE-024) showed an average 4.3-month increase in progression-free survival with pembrolizumab immunotherapy, compared with a standard chemotherapy regimen.
Improved quality of life on top of improved efficacy and safety is an important added benefit from pembrolizumab that should further spur its widespread adoption as first-line treatment for approved patients, Dr. Brahmer said in a video interview.
“When you talk about improving efficacy by months, patients and physicians want to also see improved quality of life,” said Dr. Brahmer, director of thoracic oncology at the Johns Hopkins Kimmel Cancer Center in Baltimore. “If symptoms are not improved or there are a ton of side effects with the treatment then use might be low.”
Based on its performance in KEYNOTE-024, pembrolizumab (Keytruda) received Food and Drug Administration approval on Oct. 24, 2016, as first-line treatment for patients with metastatic non–small-cell lung cancer that has a tumor proportion score of at least 50% for programmed death ligand 1 (PD-L1). Pembrolizumab is a monoclonal antibody that binds and blocks PD-1, the immune-cell receptor that tumor-cell PD-L1 binds to make immune cells less active. Other new immune checkpoint inhibitor drugs that act by blocking PD-1 or PD-L1 have shown similar quality of life benefits, she noted.
Routine availability of pembrolizumab as initial treatment for patients who have tumors with this level of PD-L1 expression (and also have no EGFR or ALK genomic aberrations) is shifting practice, Dr. Brahmer said.
“It’s catching on. The limitation right now is making sure patients get tested” for their PD-L1 tumor proportion score at the time they are first diagnosed. “Medical oncologists need to educate pathologists that we need this testing automatically, upfront. It’s not there yet,” she said.
Patients also are enthused. “There is a lot of chemo-exhaustion among patients. They are looking for something different, and something that uses their immune system makes sense.” But only about one quarter of patients have tumors with this level of PD-L1 expression; the others must start chemotherapy first before trying immunotherapy, unless they have an EGFR mutation. Out-of-pocket cost for pembrolizumab is also a major issues for many patients, she said.
KEYNOTE-024 randomized 305 patients at 102 international sites and followed patients for a median of 11 months. Dr. Brahmer and her associates made two primary analyses of patient-reported outcomes. One was measurement of global health status at 15 weeks after the start of treatment using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire designed to assess quality of life. Weighted averaging of the EORTC QCQ-C30 scores showed a mean improvement of 7.8 points (P = .002) in the pembrolizumab patients compared with the chemotherapy patients, a difference Dr. Brahmer called “clinically meaningful” as well as statistically significant.
A second analysis of patient-reported outcomes used a second EORTC instrument, the QLC-LC13, which combines assessment of cough, chest pain, and dyspnea. Treatment with pembrolizumab significantly reduced the time to deterioration as measured by this questionnaire by a relative 34%, (P = .029).
A third analysis looked at 15 individual function or symptom domains that make up the QLQ-C30. In general, these showed more improvements with pembrolizumab than with chemotherapy. One notable subcategory was fatigue, which showed significant improvement with pembrolizumab compared with a small worsening with chemotherapy.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
This is a very nice analysis using a well-validated group of instruments to assess quality of life. The researchers also achieved a high level of compliance, with 79%-85% of patients completing the quality-of life questionnaire at 15 weeks, when the primary measure of health status occurred.
The mean difference of the weighted global health status score of 7.8 points between the pembrolizumab and chemotherapy patients was a little less than a minimally important difference, but in the context of a randomized, controlled trial this difference probably tells us that there is health status improvement in the pembrolizumab patients. In addition, the individual symptom and function domains showed that in general pembrolizumab performed better than chemotherapy.
Michael Boyer, MD , is professor of medicine at the University of Sydney and a thoracic oncologist and chief clinical officer of the Chris O’Brien Lifehouse in Sydney. He has received research support from Merck and from Pfizer, Roche, Eli Lilly, BMS, AstraZeneca, and Clovis. He made these comments as designated discussant for the report.
This is a very nice analysis using a well-validated group of instruments to assess quality of life. The researchers also achieved a high level of compliance, with 79%-85% of patients completing the quality-of life questionnaire at 15 weeks, when the primary measure of health status occurred.
The mean difference of the weighted global health status score of 7.8 points between the pembrolizumab and chemotherapy patients was a little less than a minimally important difference, but in the context of a randomized, controlled trial this difference probably tells us that there is health status improvement in the pembrolizumab patients. In addition, the individual symptom and function domains showed that in general pembrolizumab performed better than chemotherapy.
Michael Boyer, MD , is professor of medicine at the University of Sydney and a thoracic oncologist and chief clinical officer of the Chris O’Brien Lifehouse in Sydney. He has received research support from Merck and from Pfizer, Roche, Eli Lilly, BMS, AstraZeneca, and Clovis. He made these comments as designated discussant for the report.
This is a very nice analysis using a well-validated group of instruments to assess quality of life. The researchers also achieved a high level of compliance, with 79%-85% of patients completing the quality-of life questionnaire at 15 weeks, when the primary measure of health status occurred.
The mean difference of the weighted global health status score of 7.8 points between the pembrolizumab and chemotherapy patients was a little less than a minimally important difference, but in the context of a randomized, controlled trial this difference probably tells us that there is health status improvement in the pembrolizumab patients. In addition, the individual symptom and function domains showed that in general pembrolizumab performed better than chemotherapy.
Michael Boyer, MD , is professor of medicine at the University of Sydney and a thoracic oncologist and chief clinical officer of the Chris O’Brien Lifehouse in Sydney. He has received research support from Merck and from Pfizer, Roche, Eli Lilly, BMS, AstraZeneca, and Clovis. He made these comments as designated discussant for the report.
VIENNA – Patients with metastatic non–small-cell lung cancer with high levels of PD-L1 who received first-line pembrolizumab treatment had clinically meaningful improvement in their quality of life, compared with patients randomized to chemotherapy, in a prespecified secondary analysis of data from the drug’s pivotal trial.
This boost in quality of life as well as other measures of health status add to the pivotal trial’s primary finding of significantly increased progression-free survival compared with chemotherapy, as well as previously-reported secondary findings of superior overall survival, objective response rate, and safety with pembrolizumab compared with chemotherapy (N Engl J Med. 2016 Nov 10;375[19]:1823-33), Julie R. Brahmer, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
The primary endpoint of the Study of Pembrolizumab Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non–Small Cell Lung Cancer (KEYNOTE-024) showed an average 4.3-month increase in progression-free survival with pembrolizumab immunotherapy, compared with a standard chemotherapy regimen.
Improved quality of life on top of improved efficacy and safety is an important added benefit from pembrolizumab that should further spur its widespread adoption as first-line treatment for approved patients, Dr. Brahmer said in a video interview.
“When you talk about improving efficacy by months, patients and physicians want to also see improved quality of life,” said Dr. Brahmer, director of thoracic oncology at the Johns Hopkins Kimmel Cancer Center in Baltimore. “If symptoms are not improved or there are a ton of side effects with the treatment then use might be low.”
Based on its performance in KEYNOTE-024, pembrolizumab (Keytruda) received Food and Drug Administration approval on Oct. 24, 2016, as first-line treatment for patients with metastatic non–small-cell lung cancer that has a tumor proportion score of at least 50% for programmed death ligand 1 (PD-L1). Pembrolizumab is a monoclonal antibody that binds and blocks PD-1, the immune-cell receptor that tumor-cell PD-L1 binds to make immune cells less active. Other new immune checkpoint inhibitor drugs that act by blocking PD-1 or PD-L1 have shown similar quality of life benefits, she noted.
Routine availability of pembrolizumab as initial treatment for patients who have tumors with this level of PD-L1 expression (and also have no EGFR or ALK genomic aberrations) is shifting practice, Dr. Brahmer said.
“It’s catching on. The limitation right now is making sure patients get tested” for their PD-L1 tumor proportion score at the time they are first diagnosed. “Medical oncologists need to educate pathologists that we need this testing automatically, upfront. It’s not there yet,” she said.
Patients also are enthused. “There is a lot of chemo-exhaustion among patients. They are looking for something different, and something that uses their immune system makes sense.” But only about one quarter of patients have tumors with this level of PD-L1 expression; the others must start chemotherapy first before trying immunotherapy, unless they have an EGFR mutation. Out-of-pocket cost for pembrolizumab is also a major issues for many patients, she said.
KEYNOTE-024 randomized 305 patients at 102 international sites and followed patients for a median of 11 months. Dr. Brahmer and her associates made two primary analyses of patient-reported outcomes. One was measurement of global health status at 15 weeks after the start of treatment using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire designed to assess quality of life. Weighted averaging of the EORTC QCQ-C30 scores showed a mean improvement of 7.8 points (P = .002) in the pembrolizumab patients compared with the chemotherapy patients, a difference Dr. Brahmer called “clinically meaningful” as well as statistically significant.
A second analysis of patient-reported outcomes used a second EORTC instrument, the QLC-LC13, which combines assessment of cough, chest pain, and dyspnea. Treatment with pembrolizumab significantly reduced the time to deterioration as measured by this questionnaire by a relative 34%, (P = .029).
A third analysis looked at 15 individual function or symptom domains that make up the QLQ-C30. In general, these showed more improvements with pembrolizumab than with chemotherapy. One notable subcategory was fatigue, which showed significant improvement with pembrolizumab compared with a small worsening with chemotherapy.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
VIENNA – Patients with metastatic non–small-cell lung cancer with high levels of PD-L1 who received first-line pembrolizumab treatment had clinically meaningful improvement in their quality of life, compared with patients randomized to chemotherapy, in a prespecified secondary analysis of data from the drug’s pivotal trial.
This boost in quality of life as well as other measures of health status add to the pivotal trial’s primary finding of significantly increased progression-free survival compared with chemotherapy, as well as previously-reported secondary findings of superior overall survival, objective response rate, and safety with pembrolizumab compared with chemotherapy (N Engl J Med. 2016 Nov 10;375[19]:1823-33), Julie R. Brahmer, MD, said at the World Conference on Lung Cancer, sponsored by the International Association for the Study of Lung Cancer.
The primary endpoint of the Study of Pembrolizumab Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non–Small Cell Lung Cancer (KEYNOTE-024) showed an average 4.3-month increase in progression-free survival with pembrolizumab immunotherapy, compared with a standard chemotherapy regimen.
Improved quality of life on top of improved efficacy and safety is an important added benefit from pembrolizumab that should further spur its widespread adoption as first-line treatment for approved patients, Dr. Brahmer said in a video interview.
“When you talk about improving efficacy by months, patients and physicians want to also see improved quality of life,” said Dr. Brahmer, director of thoracic oncology at the Johns Hopkins Kimmel Cancer Center in Baltimore. “If symptoms are not improved or there are a ton of side effects with the treatment then use might be low.”
Based on its performance in KEYNOTE-024, pembrolizumab (Keytruda) received Food and Drug Administration approval on Oct. 24, 2016, as first-line treatment for patients with metastatic non–small-cell lung cancer that has a tumor proportion score of at least 50% for programmed death ligand 1 (PD-L1). Pembrolizumab is a monoclonal antibody that binds and blocks PD-1, the immune-cell receptor that tumor-cell PD-L1 binds to make immune cells less active. Other new immune checkpoint inhibitor drugs that act by blocking PD-1 or PD-L1 have shown similar quality of life benefits, she noted.
Routine availability of pembrolizumab as initial treatment for patients who have tumors with this level of PD-L1 expression (and also have no EGFR or ALK genomic aberrations) is shifting practice, Dr. Brahmer said.
“It’s catching on. The limitation right now is making sure patients get tested” for their PD-L1 tumor proportion score at the time they are first diagnosed. “Medical oncologists need to educate pathologists that we need this testing automatically, upfront. It’s not there yet,” she said.
Patients also are enthused. “There is a lot of chemo-exhaustion among patients. They are looking for something different, and something that uses their immune system makes sense.” But only about one quarter of patients have tumors with this level of PD-L1 expression; the others must start chemotherapy first before trying immunotherapy, unless they have an EGFR mutation. Out-of-pocket cost for pembrolizumab is also a major issues for many patients, she said.
KEYNOTE-024 randomized 305 patients at 102 international sites and followed patients for a median of 11 months. Dr. Brahmer and her associates made two primary analyses of patient-reported outcomes. One was measurement of global health status at 15 weeks after the start of treatment using the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire designed to assess quality of life. Weighted averaging of the EORTC QCQ-C30 scores showed a mean improvement of 7.8 points (P = .002) in the pembrolizumab patients compared with the chemotherapy patients, a difference Dr. Brahmer called “clinically meaningful” as well as statistically significant.
A second analysis of patient-reported outcomes used a second EORTC instrument, the QLC-LC13, which combines assessment of cough, chest pain, and dyspnea. Treatment with pembrolizumab significantly reduced the time to deterioration as measured by this questionnaire by a relative 34%, (P = .029).
A third analysis looked at 15 individual function or symptom domains that make up the QLQ-C30. In general, these showed more improvements with pembrolizumab than with chemotherapy. One notable subcategory was fatigue, which showed significant improvement with pembrolizumab compared with a small worsening with chemotherapy.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT WCLC 2016
Key clinical point:
Major finding: The weighted average change from baseline in QLQ-C30 was 7.8 points higher in pembrolizumab patients compared with chemotherapy patients.
Data source: KEYNOTE-024, a multicenter, international randomized trial comprising 305 patients.
Disclosures: Merck, which markets pembrolizumab (Keytruda), sponsored KEYNOTE-024. Dr. Brahmer has served on an advisory board for Merck.