Randy Dotinga

SAN DIEGO—As patients with cancer live longer, pain is going to become an even bigger challenge for clinicians, a palliative care specialist told cancer specialists in a presentation at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) in September, and decisions about treatment are becoming more complicated amid the opioid epidemic.

Fortunately, guidelines and clinical experience offer helpful insight into the best practices, said hematologist/oncologist Andrea Ruskin, MD, medical director of palliative care at Veterans Administration (VA) Connecticut Healthcare System (VACHS).

As Ruskin pointed out, two-thirds of newly diagnosed cancer patients are living for at least 5 years, “but with this progress comes challenges.” More than one-third (37%) of cancer survivors report cancer pain, 21% have noncancer pain, and 45% have both. About 5% to 8% of VA cancer survivors use opioids for the long term, she said, although there have been few studies in this population.

Among patients with head and neck cancer, specifically, chronic pain affects 45%, and severe pain affects 11%. Subclinical PTSD, depression, anxiety, and low quality of life are common in this population. “We may cure them, but they have a lot of issues going forward.”

One key strategy is to perform a comprehensive pain assessment at the first visit, and then address pain at every subsequent visit. She recommended a physician resource from the American Society of Clinical Oncology, and a template may be useful to provide helpful questions, Ruskin said.

At VACHS certain questions are routine. “Is pain interfering with your function? Sometimes people say it’s always a 10, but it’s not affecting function at all. Ask if the medicine is working. And how are they taking it? Sometimes they say, ‘I’m taking that for sleep,’ and we say ‘No, Mr. Smith, that is not a sleep medication.’”

Be aware that some patients may use nonmedical opioids, she said. And set expectations early on. “Safe opioid use starts with the very first prescription,” she said. “If I have somebody with myeloma or head and neck cancer, I make it very clear that my goal is that we want you off the opioids after the radiation or once the disease is in remission. I really make an effort at the very beginning to make sure that we're all on the same page.”

As you continue to see a patient, consider ordering urine tests, she said, not as a punitive measure but to make sure you’re offering the safest and most effective treatment. “We don’t do it to say ‘no, no, no.’ We do it for safety and to make sure they’re not getting meds elsewhere.”

What are the best practices when pain doesn’t go away? Should they stay on opioids? According to Ruskin, few evidence-based guidelines address the “more nuanced care” that patients need when their pain lasts for months or years.

But there are useful resources. Ruskin highlighted the National Comprehensive Cancer Network’s survivorship guidelines, and she summarized a few of the available painkiller options. “Opioids are great, and adjuvants are so-so. They work in some people, but we definitely have room for improvement.”

What if patients have persistent opioid use after cancer recovery? “I try to taper if I can, and I try to explain why I’m tapering. It could take months or years to taper patients,” she said. And consider transitioning the patient to buprenorphine, a drug that treats both pain and opioid use disorder, if appropriate. “You don’t need a waiver if you use it for pain. It’s definitely something we’re using more of.”

One important step is to bring in colleagues to help. Psychologists, chiropractors, physical therapists, physiatrists, and pain pharmacists can all be helpful, she said. “Learn about your VA resources and who can partner with you to help these complicated patients. They’re all at your fingertips.”

SAN DIEGO—As patients with cancer live longer, pain is going to become an even bigger challenge for clinicians, a palliative care specialist told cancer specialists in a presentation at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) in September, and decisions about treatment are becoming more complicated amid the opioid epidemic.

Fortunately, guidelines and clinical experience offer helpful insight into the best practices, said hematologist/oncologist Andrea Ruskin, MD, medical director of palliative care at Veterans Administration (VA) Connecticut Healthcare System (VACHS).

As Ruskin pointed out, two-thirds of newly diagnosed cancer patients are living for at least 5 years, “but with this progress comes challenges.” More than one-third (37%) of cancer survivors report cancer pain, 21% have noncancer pain, and 45% have both. About 5% to 8% of VA cancer survivors use opioids for the long term, she said, although there have been few studies in this population.

Among patients with head and neck cancer, specifically, chronic pain affects 45%, and severe pain affects 11%. Subclinical PTSD, depression, anxiety, and low quality of life are common in this population. “We may cure them, but they have a lot of issues going forward.”

One key strategy is to perform a comprehensive pain assessment at the first visit, and then address pain at every subsequent visit. She recommended a physician resource from the American Society of Clinical Oncology, and a template may be useful to provide helpful questions, Ruskin said.

At VACHS certain questions are routine. “Is pain interfering with your function? Sometimes people say it’s always a 10, but it’s not affecting function at all. Ask if the medicine is working. And how are they taking it? Sometimes they say, ‘I’m taking that for sleep,’ and we say ‘No, Mr. Smith, that is not a sleep medication.’”

Be aware that some patients may use nonmedical opioids, she said. And set expectations early on. “Safe opioid use starts with the very first prescription,” she said. “If I have somebody with myeloma or head and neck cancer, I make it very clear that my goal is that we want you off the opioids after the radiation or once the disease is in remission. I really make an effort at the very beginning to make sure that we're all on the same page.”

As you continue to see a patient, consider ordering urine tests, she said, not as a punitive measure but to make sure you’re offering the safest and most effective treatment. “We don’t do it to say ‘no, no, no.’ We do it for safety and to make sure they’re not getting meds elsewhere.”

What are the best practices when pain doesn’t go away? Should they stay on opioids? According to Ruskin, few evidence-based guidelines address the “more nuanced care” that patients need when their pain lasts for months or years.

But there are useful resources. Ruskin highlighted the National Comprehensive Cancer Network’s survivorship guidelines, and she summarized a few of the available painkiller options. “Opioids are great, and adjuvants are so-so. They work in some people, but we definitely have room for improvement.”

What if patients have persistent opioid use after cancer recovery? “I try to taper if I can, and I try to explain why I’m tapering. It could take months or years to taper patients,” she said. And consider transitioning the patient to buprenorphine, a drug that treats both pain and opioid use disorder, if appropriate. “You don’t need a waiver if you use it for pain. It’s definitely something we’re using more of.”

One important step is to bring in colleagues to help. Psychologists, chiropractors, physical therapists, physiatrists, and pain pharmacists can all be helpful, she said. “Learn about your VA resources and who can partner with you to help these complicated patients. They’re all at your fingertips.”

SAN DIEGO—As patients with cancer live longer, pain is going to become an even bigger challenge for clinicians, a palliative care specialist told cancer specialists in a presentation at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) in September, and decisions about treatment are becoming more complicated amid the opioid epidemic.

Fortunately, guidelines and clinical experience offer helpful insight into the best practices, said hematologist/oncologist Andrea Ruskin, MD, medical director of palliative care at Veterans Administration (VA) Connecticut Healthcare System (VACHS).

As Ruskin pointed out, two-thirds of newly diagnosed cancer patients are living for at least 5 years, “but with this progress comes challenges.” More than one-third (37%) of cancer survivors report cancer pain, 21% have noncancer pain, and 45% have both. About 5% to 8% of VA cancer survivors use opioids for the long term, she said, although there have been few studies in this population.

Among patients with head and neck cancer, specifically, chronic pain affects 45%, and severe pain affects 11%. Subclinical PTSD, depression, anxiety, and low quality of life are common in this population. “We may cure them, but they have a lot of issues going forward.”

One key strategy is to perform a comprehensive pain assessment at the first visit, and then address pain at every subsequent visit. She recommended a physician resource from the American Society of Clinical Oncology, and a template may be useful to provide helpful questions, Ruskin said.

At VACHS certain questions are routine. “Is pain interfering with your function? Sometimes people say it’s always a 10, but it’s not affecting function at all. Ask if the medicine is working. And how are they taking it? Sometimes they say, ‘I’m taking that for sleep,’ and we say ‘No, Mr. Smith, that is not a sleep medication.’”

Be aware that some patients may use nonmedical opioids, she said. And set expectations early on. “Safe opioid use starts with the very first prescription,” she said. “If I have somebody with myeloma or head and neck cancer, I make it very clear that my goal is that we want you off the opioids after the radiation or once the disease is in remission. I really make an effort at the very beginning to make sure that we're all on the same page.”

As you continue to see a patient, consider ordering urine tests, she said, not as a punitive measure but to make sure you’re offering the safest and most effective treatment. “We don’t do it to say ‘no, no, no.’ We do it for safety and to make sure they’re not getting meds elsewhere.”

What are the best practices when pain doesn’t go away? Should they stay on opioids? According to Ruskin, few evidence-based guidelines address the “more nuanced care” that patients need when their pain lasts for months or years.

But there are useful resources. Ruskin highlighted the National Comprehensive Cancer Network’s survivorship guidelines, and she summarized a few of the available painkiller options. “Opioids are great, and adjuvants are so-so. They work in some people, but we definitely have room for improvement.”

What if patients have persistent opioid use after cancer recovery? “I try to taper if I can, and I try to explain why I’m tapering. It could take months or years to taper patients,” she said. And consider transitioning the patient to buprenorphine, a drug that treats both pain and opioid use disorder, if appropriate. “You don’t need a waiver if you use it for pain. It’s definitely something we’re using more of.”

One important step is to bring in colleagues to help. Psychologists, chiropractors, physical therapists, physiatrists, and pain pharmacists can all be helpful, she said. “Learn about your VA resources and who can partner with you to help these complicated patients. They’re all at your fingertips.”

An analysis of more than 800,000 women in Denmark offers more insight into the murky links between female hormones and midlife mental illness in women: It hints that hormone therapy (HT) may boost the risk of depression, have no effect, or lower it – all depending on how it’s administered and when.

Women who took systemic HT had a higher risk of depression from age 48 to 50 (adjusted hazard ratio, 1.50; 95% confidence interval, 1.24-1.81), researchers reported in JAMA Network Open. However, there was no overall link between depression and locally administered HT (aHR, 1.15; 95% CI, 0.70-1.87) – except when HT was begun between ages 54 and 60, when there were signs of a protective effect (aHR, 0.80; 95% CI, 0.70-0.91).

“Women in menopause who initiate systemically administered HT should be aware of depression as a potential adverse effect,” epidemiologist and study corresponding author Merete Osler, MD, PhD, DMSc, of Bispebjerg and Frederiksberg (Denmark) Hospitals and the University of Copenhagen, said in an interview. ”Further, women and clinicians alike should be aware of any misinterpretation of symptoms of depression as menopausal disturbances.”

Dr. Osler said the researchers launched the study to better understand potential hormone-depression links in light of suspicions that lower levels of estrogen in menopause may contribute to depression.

Several randomized clinical trials and cohort and cross-sectional studies have explored whether systemic HT affects depression during menopause, Dr. Osler said, “but the results from these studies have been inconsistent, and few have explored the role of the route of administration.”

For the new registry-based study, researchers retrospectively tracked all women in Denmark who were aged 45 between 1995 and 2017 without prior oophorectomy, certain kinds of cancer, prior use of HT, or ongoing depression.

During follow-up to a mean age of 56, 23% of the women began HT (at a median age of 55), and 1.6% were hospitalized for depression. Of those on HT, 65.8% received locally administered HT.

Researchers adjusted hazard ratios for a long list of factors such as educational level, marital status, number of still births or live births, prior use of hormonal contraceptives, several medical conditions, and prior depression.

“We were surprised by our findings, which to some degree contradicted our prior hypothesis that systemic HT with estrogen would not be associated with first-time depression diagnosis in women aged 45 and above, while HT with progesterone would be associated with a slightly increased risk,” Dr. Osler said. “In our study, systemically administered HT was associated with an increased risk of depression with no difference between estrogen alone or in combination with progestin. As findings from previous studies have been inconsistent, our findings fit with some but not all previous studies.”

Why might the mode of administration make a difference? It’s possible that local administration may contribute less to the systemic circulation, Dr. Osler said, “or that menopausal symptoms including depression are more likely to be treated with systemic HT.”

As for age differences, Dr. Osler said “it is possible that women are more sensitive to the influence of HT on mood around menopause than at later ages. However, it should be noted that in the present study it was not possible to calculate precise risk estimates for use of systemic HT in menopausal women above age 54 because less than 1% initiated treatment with systemic HT after age 54 years.”

In an interview, psychiatrist Natalie Rasgon, MD, PhD, of Stanford (Calif.) University, who’s studied hormones and depression, said the study is “remarkably large and consistently executed.”

She cautioned, however, that the findings don’t prove any causality. “Saying that estrogen therapy or hormone therapy causes depression is patently incorrect.”

How can the findings be useful for medical professionals? “Women and physicians alike need to be very mindful of pre-existing mood disorders,” Dr. Rasgon said. “Women who in the past had anxiety disorders, mood swings, PTSD, or prior episodes of depression might have a differential response to hormone therapy in menopause.”

Also keep in mind, she said, that the transition from menopause to post menopause is “very volatile,” and depression may break through even in women undergoing treatment for the condition.

For her part, Dr. Osler said this study and others “emphasize the need for clinical guidelines to further consider the psychological side effects of systemic HT.”

Funding information was not provided. The study authors and Dr. Rasgon have no disclosures.

An analysis of more than 800,000 women in Denmark offers more insight into the murky links between female hormones and midlife mental illness in women: It hints that hormone therapy (HT) may boost the risk of depression, have no effect, or lower it – all depending on how it’s administered and when.

Women who took systemic HT had a higher risk of depression from age 48 to 50 (adjusted hazard ratio, 1.50; 95% confidence interval, 1.24-1.81), researchers reported in JAMA Network Open. However, there was no overall link between depression and locally administered HT (aHR, 1.15; 95% CI, 0.70-1.87) – except when HT was begun between ages 54 and 60, when there were signs of a protective effect (aHR, 0.80; 95% CI, 0.70-0.91).

“Women in menopause who initiate systemically administered HT should be aware of depression as a potential adverse effect,” epidemiologist and study corresponding author Merete Osler, MD, PhD, DMSc, of Bispebjerg and Frederiksberg (Denmark) Hospitals and the University of Copenhagen, said in an interview. ”Further, women and clinicians alike should be aware of any misinterpretation of symptoms of depression as menopausal disturbances.”

Dr. Osler said the researchers launched the study to better understand potential hormone-depression links in light of suspicions that lower levels of estrogen in menopause may contribute to depression.

Several randomized clinical trials and cohort and cross-sectional studies have explored whether systemic HT affects depression during menopause, Dr. Osler said, “but the results from these studies have been inconsistent, and few have explored the role of the route of administration.”

For the new registry-based study, researchers retrospectively tracked all women in Denmark who were aged 45 between 1995 and 2017 without prior oophorectomy, certain kinds of cancer, prior use of HT, or ongoing depression.

During follow-up to a mean age of 56, 23% of the women began HT (at a median age of 55), and 1.6% were hospitalized for depression. Of those on HT, 65.8% received locally administered HT.

Researchers adjusted hazard ratios for a long list of factors such as educational level, marital status, number of still births or live births, prior use of hormonal contraceptives, several medical conditions, and prior depression.

“We were surprised by our findings, which to some degree contradicted our prior hypothesis that systemic HT with estrogen would not be associated with first-time depression diagnosis in women aged 45 and above, while HT with progesterone would be associated with a slightly increased risk,” Dr. Osler said. “In our study, systemically administered HT was associated with an increased risk of depression with no difference between estrogen alone or in combination with progestin. As findings from previous studies have been inconsistent, our findings fit with some but not all previous studies.”

Why might the mode of administration make a difference? It’s possible that local administration may contribute less to the systemic circulation, Dr. Osler said, “or that menopausal symptoms including depression are more likely to be treated with systemic HT.”

As for age differences, Dr. Osler said “it is possible that women are more sensitive to the influence of HT on mood around menopause than at later ages. However, it should be noted that in the present study it was not possible to calculate precise risk estimates for use of systemic HT in menopausal women above age 54 because less than 1% initiated treatment with systemic HT after age 54 years.”

In an interview, psychiatrist Natalie Rasgon, MD, PhD, of Stanford (Calif.) University, who’s studied hormones and depression, said the study is “remarkably large and consistently executed.”

She cautioned, however, that the findings don’t prove any causality. “Saying that estrogen therapy or hormone therapy causes depression is patently incorrect.”

How can the findings be useful for medical professionals? “Women and physicians alike need to be very mindful of pre-existing mood disorders,” Dr. Rasgon said. “Women who in the past had anxiety disorders, mood swings, PTSD, or prior episodes of depression might have a differential response to hormone therapy in menopause.”

Also keep in mind, she said, that the transition from menopause to post menopause is “very volatile,” and depression may break through even in women undergoing treatment for the condition.

For her part, Dr. Osler said this study and others “emphasize the need for clinical guidelines to further consider the psychological side effects of systemic HT.”

Funding information was not provided. The study authors and Dr. Rasgon have no disclosures.

An analysis of more than 800,000 women in Denmark offers more insight into the murky links between female hormones and midlife mental illness in women: It hints that hormone therapy (HT) may boost the risk of depression, have no effect, or lower it – all depending on how it’s administered and when.

Women who took systemic HT had a higher risk of depression from age 48 to 50 (adjusted hazard ratio, 1.50; 95% confidence interval, 1.24-1.81), researchers reported in JAMA Network Open. However, there was no overall link between depression and locally administered HT (aHR, 1.15; 95% CI, 0.70-1.87) – except when HT was begun between ages 54 and 60, when there were signs of a protective effect (aHR, 0.80; 95% CI, 0.70-0.91).

“Women in menopause who initiate systemically administered HT should be aware of depression as a potential adverse effect,” epidemiologist and study corresponding author Merete Osler, MD, PhD, DMSc, of Bispebjerg and Frederiksberg (Denmark) Hospitals and the University of Copenhagen, said in an interview. ”Further, women and clinicians alike should be aware of any misinterpretation of symptoms of depression as menopausal disturbances.”

Dr. Osler said the researchers launched the study to better understand potential hormone-depression links in light of suspicions that lower levels of estrogen in menopause may contribute to depression.

Several randomized clinical trials and cohort and cross-sectional studies have explored whether systemic HT affects depression during menopause, Dr. Osler said, “but the results from these studies have been inconsistent, and few have explored the role of the route of administration.”

For the new registry-based study, researchers retrospectively tracked all women in Denmark who were aged 45 between 1995 and 2017 without prior oophorectomy, certain kinds of cancer, prior use of HT, or ongoing depression.

During follow-up to a mean age of 56, 23% of the women began HT (at a median age of 55), and 1.6% were hospitalized for depression. Of those on HT, 65.8% received locally administered HT.

Researchers adjusted hazard ratios for a long list of factors such as educational level, marital status, number of still births or live births, prior use of hormonal contraceptives, several medical conditions, and prior depression.

“We were surprised by our findings, which to some degree contradicted our prior hypothesis that systemic HT with estrogen would not be associated with first-time depression diagnosis in women aged 45 and above, while HT with progesterone would be associated with a slightly increased risk,” Dr. Osler said. “In our study, systemically administered HT was associated with an increased risk of depression with no difference between estrogen alone or in combination with progestin. As findings from previous studies have been inconsistent, our findings fit with some but not all previous studies.”

Why might the mode of administration make a difference? It’s possible that local administration may contribute less to the systemic circulation, Dr. Osler said, “or that menopausal symptoms including depression are more likely to be treated with systemic HT.”

As for age differences, Dr. Osler said “it is possible that women are more sensitive to the influence of HT on mood around menopause than at later ages. However, it should be noted that in the present study it was not possible to calculate precise risk estimates for use of systemic HT in menopausal women above age 54 because less than 1% initiated treatment with systemic HT after age 54 years.”

In an interview, psychiatrist Natalie Rasgon, MD, PhD, of Stanford (Calif.) University, who’s studied hormones and depression, said the study is “remarkably large and consistently executed.”

She cautioned, however, that the findings don’t prove any causality. “Saying that estrogen therapy or hormone therapy causes depression is patently incorrect.”

How can the findings be useful for medical professionals? “Women and physicians alike need to be very mindful of pre-existing mood disorders,” Dr. Rasgon said. “Women who in the past had anxiety disorders, mood swings, PTSD, or prior episodes of depression might have a differential response to hormone therapy in menopause.”

Also keep in mind, she said, that the transition from menopause to post menopause is “very volatile,” and depression may break through even in women undergoing treatment for the condition.

For her part, Dr. Osler said this study and others “emphasize the need for clinical guidelines to further consider the psychological side effects of systemic HT.”

Funding information was not provided. The study authors and Dr. Rasgon have no disclosures.

When maternal-fetal medicine specialist Andra James, MD, MPH, trained as a midwife decades ago, women with sickle cell disease (SCD) were urged to never get pregnant. If they did, termination was considered the best option.

“If they did carry a pregnancy, the baby would not survive to the point of viability,” Dr. James, emeritus professor of obstetrics and gynecology at Duke University, Durham, N.C., recalled in an interview.

The fates of women with SCD have transformed dramatically since those grim days. In general, this blood disorder no longer robs patients of decades of life, and many women with SCD bear healthy children. But their pregnancies are still considered high risk with significant potential for health crises and death. Now, there’s a new complication: The overturning of Roe v. Wade.

Many states imposed tighter restrictions on abortions in the wake of the U.S. Supreme Court’s landmark Dobbs ruling, sparking worry among physicians that women with SCD won’t be able to get proper maternal care in some parts of the United States.

For example, women with SCD may be unable able to seek elective abortions in some states even if their pregnancies pose a danger to their lives. And abortion restrictions are imperiling access to a medication that’s used to treat miscarriages, which are more common in women with SCD.

“The situation with Dobbs is dire, and maternal health care is being compromised,” Johns Hopkins University pediatric hematologist Lydia Pecker, MD, who treats young people with SCD and studies its impact on pregnancy, said in an interview. “Women with sickle cell disease who are pregnant constitute an underserved and understudied population with special health care needs, and the Dobbs decision will only make providing their care even more difficult in many parts of the country.”

For her part, Dr. James described the risk to pregnant women with SCD this way: In the wake of the court ruling, “we increase the opportunity for them to lose their lives and for their babies to die.”
 

SCD’s impact on pregnancy

While physicians no longer advise women with SCD to avoid motherhood, pregnancy is still uniquely dangerous for them. “Most of them have babies and children who are thriving, but it’s not easy for them,” University of North Carolina at Chapel Hill hematologist and SCD specialist Jane Little, MD, said in an interview. And in some cases, she said, pregnancies “do not end well.”

For a 2022 report, Dr. Pecker and colleagues analyzed 2012-2018 data for 6,610 U.S. hospital admissions among women with SCD (87% of whom were Black). These women were more likely than were unaffected women to suffer severe maternal morbidity (odds ratio[OR], 4.63, 95% confidence interval [CI], 4.16-5.16, P < .001). Cerebrovascular event were especially more common in SCD (OR, 13.94, P < .001).

According to a 2019 report, pregnant women with SCD “are more likely to develop a host of complications, particularly hypertensive syndromes (such as preeclampsia), venous thromboembolism (VTE), preterm labor, and fetal loss. Newborns are more likely to have growth problems and prematurity.”

Although data are sparse, experts say it’s also clear that women with SCD face significantly higher risk of death in pregnancy compared to other women. In fact, the maternal mortality rate for females with SCD “is higher than for Black females without SCD, who already suffer from a higher mortality rate than White females during pregnancy and childbirth,” Andrea Roe, MD, MPH, assistant professor of obstetrics and gynecology at the Hospital of the University of Pennsylvania, Philadelphia, said in an interview.

Women with SCD also are more likely to have premature and stillborn births.

Some of the health challenges in pregnant women with SCD stem from the body’s inability to boost blood production in order to supply the placenta, said Dr. James, the Duke University emeritus professor. “Her bone marrow is already turning out red blood cells as fast as it can.”

In addition, she said, these women are more susceptible to infection, blood clots, and damage to the kidneys and lungs.

Still, in most cases of SCD in pregnancy, “we counsel a woman that we can get you safely through it,” Dr. James said. “But there is a subset of patients that will have organ damage from their sickle cell disease and should not become pregnant or stay pregnant if they become pregnant.”
 

Court ruling limits options in some states

The Dobbs ruling affects pregnant women with SCD in two ways: It allows states to restrict or ban abortion to greater extents than were possible over the last 50 years, and it has spawned further limitations on access to mifepristone, which is commonly used to treat early miscarriages.

In some cases, Dr. James said, abortions in this population are elective. “People with sickle cell disease are frequently in pain, they are frequently hospitalized. They may have suffered strokes or subclinical strokes or have some cognitive impairment, and they don’t have the mental and physical fortitude [to tolerate pregnancy and birth].”

In other cases, abortions are medically necessary to preserve the mother’s life. The American Society of Hematology highlighted the risks posed by SCD to maternal health in a June 24 statement that criticized the Dobbs ruling. “In some cases, denying women their right to terminate a pregnancy puts them at risk of serious illness or death,” wrote Jane N. Winter, MD, president of ASH and professor of medicine at Northwestern University, Chicago.

There do not appear to be any statistics about abortion rates among women with SCD in the United States or whether the rates are higher than in other groups.

As for miscarriages in SCD, an analysis of first pregnancies in California women with SCD from 1991 to 2016 found that about 16% were “incomplete,” mainly (59.3%) from miscarriage.

The Dobbs ruling allows states to further restrict the drug combination of mifepristone and misoprostol, which is used to trigger abortions and to treat early pregnancy loss. Access to mifepristone was already limited prior to the ruling due to tight regulation, and advocates say it’s now even harder to get.
 

What now? Physicians urge focus on contraception

As the ramifications of the Dobbs ruling sink in, SCD specialists are emphasizing the importance of providing gynecological and contraceptive care to help women with the condition avoid unwanted pregnancies. At the University of North Carolina, “we’re pretty aggressive about trying to give women the option to see a gynecologist to get the best care they can,” Dr. Little said. “We have a shared gynecology and sickle cell clinic because we really want women to be making the choice [to become pregnant] when they are ready because it’s a strain on their health and their lives.”

Dr. Pecker, the Johns Hopkins University pediatric hematologist, urged colleagues to partner with maternal-fetal medicine specialists so they can quickly get help for pregnant patients when needed. “That way they can get high-quality pregnancy care and help to end pregnancies that need to be ended.”

She recommended “highly effective” progesterone-based birth control as the best first-line contraceptive for women with SCD. And, she said, every woman of child-bearing age with SCD should be assessed annually for their intentions regarding pregnancy. As she put it, “there’s so much that we can do to reduce harms.”

Dr. Pecker disclosed financial relationships with the National Institutes of Health, American Society of Hematology, Doris Duke Charitable Foundation, the Mellon Foundation, Global Blood Therapeutics, and Novo Nordisk. Dr. Little disclosed financial relationships with Global Blood Therapeutics, Bluebird Bio, and Forma Therapeutics. Dr. Roe has no disclosures.

When maternal-fetal medicine specialist Andra James, MD, MPH, trained as a midwife decades ago, women with sickle cell disease (SCD) were urged to never get pregnant. If they did, termination was considered the best option.

“If they did carry a pregnancy, the baby would not survive to the point of viability,” Dr. James, emeritus professor of obstetrics and gynecology at Duke University, Durham, N.C., recalled in an interview.

The fates of women with SCD have transformed dramatically since those grim days. In general, this blood disorder no longer robs patients of decades of life, and many women with SCD bear healthy children. But their pregnancies are still considered high risk with significant potential for health crises and death. Now, there’s a new complication: The overturning of Roe v. Wade.

Many states imposed tighter restrictions on abortions in the wake of the U.S. Supreme Court’s landmark Dobbs ruling, sparking worry among physicians that women with SCD won’t be able to get proper maternal care in some parts of the United States.

For example, women with SCD may be unable able to seek elective abortions in some states even if their pregnancies pose a danger to their lives. And abortion restrictions are imperiling access to a medication that’s used to treat miscarriages, which are more common in women with SCD.

“The situation with Dobbs is dire, and maternal health care is being compromised,” Johns Hopkins University pediatric hematologist Lydia Pecker, MD, who treats young people with SCD and studies its impact on pregnancy, said in an interview. “Women with sickle cell disease who are pregnant constitute an underserved and understudied population with special health care needs, and the Dobbs decision will only make providing their care even more difficult in many parts of the country.”

For her part, Dr. James described the risk to pregnant women with SCD this way: In the wake of the court ruling, “we increase the opportunity for them to lose their lives and for their babies to die.”
 

SCD’s impact on pregnancy

While physicians no longer advise women with SCD to avoid motherhood, pregnancy is still uniquely dangerous for them. “Most of them have babies and children who are thriving, but it’s not easy for them,” University of North Carolina at Chapel Hill hematologist and SCD specialist Jane Little, MD, said in an interview. And in some cases, she said, pregnancies “do not end well.”

For a 2022 report, Dr. Pecker and colleagues analyzed 2012-2018 data for 6,610 U.S. hospital admissions among women with SCD (87% of whom were Black). These women were more likely than were unaffected women to suffer severe maternal morbidity (odds ratio[OR], 4.63, 95% confidence interval [CI], 4.16-5.16, P < .001). Cerebrovascular event were especially more common in SCD (OR, 13.94, P < .001).

According to a 2019 report, pregnant women with SCD “are more likely to develop a host of complications, particularly hypertensive syndromes (such as preeclampsia), venous thromboembolism (VTE), preterm labor, and fetal loss. Newborns are more likely to have growth problems and prematurity.”

Although data are sparse, experts say it’s also clear that women with SCD face significantly higher risk of death in pregnancy compared to other women. In fact, the maternal mortality rate for females with SCD “is higher than for Black females without SCD, who already suffer from a higher mortality rate than White females during pregnancy and childbirth,” Andrea Roe, MD, MPH, assistant professor of obstetrics and gynecology at the Hospital of the University of Pennsylvania, Philadelphia, said in an interview.

Women with SCD also are more likely to have premature and stillborn births.

Some of the health challenges in pregnant women with SCD stem from the body’s inability to boost blood production in order to supply the placenta, said Dr. James, the Duke University emeritus professor. “Her bone marrow is already turning out red blood cells as fast as it can.”

In addition, she said, these women are more susceptible to infection, blood clots, and damage to the kidneys and lungs.

Still, in most cases of SCD in pregnancy, “we counsel a woman that we can get you safely through it,” Dr. James said. “But there is a subset of patients that will have organ damage from their sickle cell disease and should not become pregnant or stay pregnant if they become pregnant.”
 

Court ruling limits options in some states

The Dobbs ruling affects pregnant women with SCD in two ways: It allows states to restrict or ban abortion to greater extents than were possible over the last 50 years, and it has spawned further limitations on access to mifepristone, which is commonly used to treat early miscarriages.

In some cases, Dr. James said, abortions in this population are elective. “People with sickle cell disease are frequently in pain, they are frequently hospitalized. They may have suffered strokes or subclinical strokes or have some cognitive impairment, and they don’t have the mental and physical fortitude [to tolerate pregnancy and birth].”

In other cases, abortions are medically necessary to preserve the mother’s life. The American Society of Hematology highlighted the risks posed by SCD to maternal health in a June 24 statement that criticized the Dobbs ruling. “In some cases, denying women their right to terminate a pregnancy puts them at risk of serious illness or death,” wrote Jane N. Winter, MD, president of ASH and professor of medicine at Northwestern University, Chicago.

There do not appear to be any statistics about abortion rates among women with SCD in the United States or whether the rates are higher than in other groups.

As for miscarriages in SCD, an analysis of first pregnancies in California women with SCD from 1991 to 2016 found that about 16% were “incomplete,” mainly (59.3%) from miscarriage.

The Dobbs ruling allows states to further restrict the drug combination of mifepristone and misoprostol, which is used to trigger abortions and to treat early pregnancy loss. Access to mifepristone was already limited prior to the ruling due to tight regulation, and advocates say it’s now even harder to get.
 

What now? Physicians urge focus on contraception

As the ramifications of the Dobbs ruling sink in, SCD specialists are emphasizing the importance of providing gynecological and contraceptive care to help women with the condition avoid unwanted pregnancies. At the University of North Carolina, “we’re pretty aggressive about trying to give women the option to see a gynecologist to get the best care they can,” Dr. Little said. “We have a shared gynecology and sickle cell clinic because we really want women to be making the choice [to become pregnant] when they are ready because it’s a strain on their health and their lives.”

Dr. Pecker, the Johns Hopkins University pediatric hematologist, urged colleagues to partner with maternal-fetal medicine specialists so they can quickly get help for pregnant patients when needed. “That way they can get high-quality pregnancy care and help to end pregnancies that need to be ended.”

She recommended “highly effective” progesterone-based birth control as the best first-line contraceptive for women with SCD. And, she said, every woman of child-bearing age with SCD should be assessed annually for their intentions regarding pregnancy. As she put it, “there’s so much that we can do to reduce harms.”

Dr. Pecker disclosed financial relationships with the National Institutes of Health, American Society of Hematology, Doris Duke Charitable Foundation, the Mellon Foundation, Global Blood Therapeutics, and Novo Nordisk. Dr. Little disclosed financial relationships with Global Blood Therapeutics, Bluebird Bio, and Forma Therapeutics. Dr. Roe has no disclosures.

When maternal-fetal medicine specialist Andra James, MD, MPH, trained as a midwife decades ago, women with sickle cell disease (SCD) were urged to never get pregnant. If they did, termination was considered the best option.

“If they did carry a pregnancy, the baby would not survive to the point of viability,” Dr. James, emeritus professor of obstetrics and gynecology at Duke University, Durham, N.C., recalled in an interview.

The fates of women with SCD have transformed dramatically since those grim days. In general, this blood disorder no longer robs patients of decades of life, and many women with SCD bear healthy children. But their pregnancies are still considered high risk with significant potential for health crises and death. Now, there’s a new complication: The overturning of Roe v. Wade.

Many states imposed tighter restrictions on abortions in the wake of the U.S. Supreme Court’s landmark Dobbs ruling, sparking worry among physicians that women with SCD won’t be able to get proper maternal care in some parts of the United States.

For example, women with SCD may be unable able to seek elective abortions in some states even if their pregnancies pose a danger to their lives. And abortion restrictions are imperiling access to a medication that’s used to treat miscarriages, which are more common in women with SCD.

“The situation with Dobbs is dire, and maternal health care is being compromised,” Johns Hopkins University pediatric hematologist Lydia Pecker, MD, who treats young people with SCD and studies its impact on pregnancy, said in an interview. “Women with sickle cell disease who are pregnant constitute an underserved and understudied population with special health care needs, and the Dobbs decision will only make providing their care even more difficult in many parts of the country.”

For her part, Dr. James described the risk to pregnant women with SCD this way: In the wake of the court ruling, “we increase the opportunity for them to lose their lives and for their babies to die.”
 

SCD’s impact on pregnancy

While physicians no longer advise women with SCD to avoid motherhood, pregnancy is still uniquely dangerous for them. “Most of them have babies and children who are thriving, but it’s not easy for them,” University of North Carolina at Chapel Hill hematologist and SCD specialist Jane Little, MD, said in an interview. And in some cases, she said, pregnancies “do not end well.”

For a 2022 report, Dr. Pecker and colleagues analyzed 2012-2018 data for 6,610 U.S. hospital admissions among women with SCD (87% of whom were Black). These women were more likely than were unaffected women to suffer severe maternal morbidity (odds ratio[OR], 4.63, 95% confidence interval [CI], 4.16-5.16, P < .001). Cerebrovascular event were especially more common in SCD (OR, 13.94, P < .001).

According to a 2019 report, pregnant women with SCD “are more likely to develop a host of complications, particularly hypertensive syndromes (such as preeclampsia), venous thromboembolism (VTE), preterm labor, and fetal loss. Newborns are more likely to have growth problems and prematurity.”

Although data are sparse, experts say it’s also clear that women with SCD face significantly higher risk of death in pregnancy compared to other women. In fact, the maternal mortality rate for females with SCD “is higher than for Black females without SCD, who already suffer from a higher mortality rate than White females during pregnancy and childbirth,” Andrea Roe, MD, MPH, assistant professor of obstetrics and gynecology at the Hospital of the University of Pennsylvania, Philadelphia, said in an interview.

Women with SCD also are more likely to have premature and stillborn births.

Some of the health challenges in pregnant women with SCD stem from the body’s inability to boost blood production in order to supply the placenta, said Dr. James, the Duke University emeritus professor. “Her bone marrow is already turning out red blood cells as fast as it can.”

In addition, she said, these women are more susceptible to infection, blood clots, and damage to the kidneys and lungs.

Still, in most cases of SCD in pregnancy, “we counsel a woman that we can get you safely through it,” Dr. James said. “But there is a subset of patients that will have organ damage from their sickle cell disease and should not become pregnant or stay pregnant if they become pregnant.”
 

Court ruling limits options in some states

The Dobbs ruling affects pregnant women with SCD in two ways: It allows states to restrict or ban abortion to greater extents than were possible over the last 50 years, and it has spawned further limitations on access to mifepristone, which is commonly used to treat early miscarriages.

In some cases, Dr. James said, abortions in this population are elective. “People with sickle cell disease are frequently in pain, they are frequently hospitalized. They may have suffered strokes or subclinical strokes or have some cognitive impairment, and they don’t have the mental and physical fortitude [to tolerate pregnancy and birth].”

In other cases, abortions are medically necessary to preserve the mother’s life. The American Society of Hematology highlighted the risks posed by SCD to maternal health in a June 24 statement that criticized the Dobbs ruling. “In some cases, denying women their right to terminate a pregnancy puts them at risk of serious illness or death,” wrote Jane N. Winter, MD, president of ASH and professor of medicine at Northwestern University, Chicago.

There do not appear to be any statistics about abortion rates among women with SCD in the United States or whether the rates are higher than in other groups.

As for miscarriages in SCD, an analysis of first pregnancies in California women with SCD from 1991 to 2016 found that about 16% were “incomplete,” mainly (59.3%) from miscarriage.

The Dobbs ruling allows states to further restrict the drug combination of mifepristone and misoprostol, which is used to trigger abortions and to treat early pregnancy loss. Access to mifepristone was already limited prior to the ruling due to tight regulation, and advocates say it’s now even harder to get.
 

What now? Physicians urge focus on contraception

As the ramifications of the Dobbs ruling sink in, SCD specialists are emphasizing the importance of providing gynecological and contraceptive care to help women with the condition avoid unwanted pregnancies. At the University of North Carolina, “we’re pretty aggressive about trying to give women the option to see a gynecologist to get the best care they can,” Dr. Little said. “We have a shared gynecology and sickle cell clinic because we really want women to be making the choice [to become pregnant] when they are ready because it’s a strain on their health and their lives.”

Dr. Pecker, the Johns Hopkins University pediatric hematologist, urged colleagues to partner with maternal-fetal medicine specialists so they can quickly get help for pregnant patients when needed. “That way they can get high-quality pregnancy care and help to end pregnancies that need to be ended.”

She recommended “highly effective” progesterone-based birth control as the best first-line contraceptive for women with SCD. And, she said, every woman of child-bearing age with SCD should be assessed annually for their intentions regarding pregnancy. As she put it, “there’s so much that we can do to reduce harms.”

Dr. Pecker disclosed financial relationships with the National Institutes of Health, American Society of Hematology, Doris Duke Charitable Foundation, the Mellon Foundation, Global Blood Therapeutics, and Novo Nordisk. Dr. Little disclosed financial relationships with Global Blood Therapeutics, Bluebird Bio, and Forma Therapeutics. Dr. Roe has no disclosures.

In a survey taken before the Supreme Court’s Dobbs ruling regarding abortion rights, two-thirds of assisted reproduction technology (ART) physicians who don’t offer mifepristone/misoprostol to patients with early pregnancy loss (EPL) reported that they lack access to the drugs.

The numbers are likely higher now. In the wake of the court ruling, some physicians in states with new abortion restrictions fear they won’t be able to properly treat women with miscarriages. Access to mifepristone, a component of medication abortions along with misoprostol, is at the center of their concerns.

“These restrictions that were put in place to restrict abortion care have far-reaching implications regarding miscarriages and early pregnancy loss and the assisted reproduction community is not immune,” obstetrics and gynecology specialist Zachary Anderson, MD, a resident physician at the University of Southern California, Los Angeles, said in an interview. He presented the findings at the American Society for Reproductive Medicine’s 2022 meeting.

Early pregnancy loss – defined as a miscarriage within 12 weeks and 6 days of conception – is common in all pregnancies and affects an estimated 15% of those who rely on in vitro fertilization (IVF). In women who conceive through intrauterine insemination or IVF, “an abnormal karyotype embryo/fetus is the cause of miscarriage in more than two-thirds of cases,” Mark P. Trolice, MD, director of the IVF Center and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview. “The options of management are observation – with no ability to determine when passage of the products of conception will occur – vs. mifepristone/misoprostol or suction D&C.”

Dr. Trolice added that “most woman select the medical treatment protocol, which is 200 mg mifepristone orally followed by 800 mcg misoprostol vaginally 24 hours later. If no signs of heavy bleeding occur after 3 hours following misoprostol, the patient should repeat the dose of 800 micrograms vaginally.”

According to the Reuters news service, some abortion bans target mifepristone. In October 2022, the American College of Obstetricians and Gynecologists asked the Food and Drug Administration to approve mifepristone for use in miscarriage management; such use is now off label, although it is approved to end early pregnancies in conjunction with misoprostol.

For the new study, researchers sent anonymous surveys to 826 members of the Society of Reproductive Endocrinology and Infertility and received 101 responses (12% response rate, 51% women, 86% non-Hispanic White, average age 52, 52% urban, and 51% in private practice).

More than two-thirds (70%) said they diagnosed early pregnancy loss at least once a week; 47% prefer treatment with misoprostol alone, 18% surgery in an operating room, 15% expectant management (monitoring a miscarriage as it occurs without medical intervention), 10% surgery in the office, and 3% mifepristone-misoprostol.

Of those who don’t offer mifepristone-misoprostol, 68% said they lack access, and 26% said they lack familiarity with the treatment.

Study coauthor Brian T. Nguyen, MD, MSc, assistant professor of obstetrics and gynecology at USC, said in an interview that mifepristone, a highly effective drug, is treated differently from other medications “for no good reason.”

Dr. Anderson, who led the study, urged colleagues to get the appropriate certification to prescribe mifepristone. “Providers overestimate how difficult it is to become certified to prescribe it,” he said.

Dr. Trolice, who is familiar with the study findings, said the response rate is low, and the results might be biased because those with preconceived opinions may be more likely to respond.

However, he said, “The results are not surprising in that medication is more commonly preferred (nearly 50%) given the devastation of a miscarriage and the desire to expedite resolution. Approximately one-third prefer surgical management, which would allow for genetic testing of the embryo/fetus to potentially determine a cause of the pregnancy loss.”

As for the medications used to treat early pregnancy loss, many ART physicians “treat pregnancy loss with misoprostol both pre- and post Dobbs,” he said. “The difficulty in obtaining mifepristone remains.”

The study authors and Dr. Trolice report no disclosures.

In a survey taken before the Supreme Court’s Dobbs ruling regarding abortion rights, two-thirds of assisted reproduction technology (ART) physicians who don’t offer mifepristone/misoprostol to patients with early pregnancy loss (EPL) reported that they lack access to the drugs.

The numbers are likely higher now. In the wake of the court ruling, some physicians in states with new abortion restrictions fear they won’t be able to properly treat women with miscarriages. Access to mifepristone, a component of medication abortions along with misoprostol, is at the center of their concerns.

“These restrictions that were put in place to restrict abortion care have far-reaching implications regarding miscarriages and early pregnancy loss and the assisted reproduction community is not immune,” obstetrics and gynecology specialist Zachary Anderson, MD, a resident physician at the University of Southern California, Los Angeles, said in an interview. He presented the findings at the American Society for Reproductive Medicine’s 2022 meeting.

Early pregnancy loss – defined as a miscarriage within 12 weeks and 6 days of conception – is common in all pregnancies and affects an estimated 15% of those who rely on in vitro fertilization (IVF). In women who conceive through intrauterine insemination or IVF, “an abnormal karyotype embryo/fetus is the cause of miscarriage in more than two-thirds of cases,” Mark P. Trolice, MD, director of the IVF Center and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview. “The options of management are observation – with no ability to determine when passage of the products of conception will occur – vs. mifepristone/misoprostol or suction D&C.”

Dr. Trolice added that “most woman select the medical treatment protocol, which is 200 mg mifepristone orally followed by 800 mcg misoprostol vaginally 24 hours later. If no signs of heavy bleeding occur after 3 hours following misoprostol, the patient should repeat the dose of 800 micrograms vaginally.”

According to the Reuters news service, some abortion bans target mifepristone. In October 2022, the American College of Obstetricians and Gynecologists asked the Food and Drug Administration to approve mifepristone for use in miscarriage management; such use is now off label, although it is approved to end early pregnancies in conjunction with misoprostol.

For the new study, researchers sent anonymous surveys to 826 members of the Society of Reproductive Endocrinology and Infertility and received 101 responses (12% response rate, 51% women, 86% non-Hispanic White, average age 52, 52% urban, and 51% in private practice).

More than two-thirds (70%) said they diagnosed early pregnancy loss at least once a week; 47% prefer treatment with misoprostol alone, 18% surgery in an operating room, 15% expectant management (monitoring a miscarriage as it occurs without medical intervention), 10% surgery in the office, and 3% mifepristone-misoprostol.

Of those who don’t offer mifepristone-misoprostol, 68% said they lack access, and 26% said they lack familiarity with the treatment.

Study coauthor Brian T. Nguyen, MD, MSc, assistant professor of obstetrics and gynecology at USC, said in an interview that mifepristone, a highly effective drug, is treated differently from other medications “for no good reason.”

Dr. Anderson, who led the study, urged colleagues to get the appropriate certification to prescribe mifepristone. “Providers overestimate how difficult it is to become certified to prescribe it,” he said.

Dr. Trolice, who is familiar with the study findings, said the response rate is low, and the results might be biased because those with preconceived opinions may be more likely to respond.

However, he said, “The results are not surprising in that medication is more commonly preferred (nearly 50%) given the devastation of a miscarriage and the desire to expedite resolution. Approximately one-third prefer surgical management, which would allow for genetic testing of the embryo/fetus to potentially determine a cause of the pregnancy loss.”

As for the medications used to treat early pregnancy loss, many ART physicians “treat pregnancy loss with misoprostol both pre- and post Dobbs,” he said. “The difficulty in obtaining mifepristone remains.”

The study authors and Dr. Trolice report no disclosures.

In a survey taken before the Supreme Court’s Dobbs ruling regarding abortion rights, two-thirds of assisted reproduction technology (ART) physicians who don’t offer mifepristone/misoprostol to patients with early pregnancy loss (EPL) reported that they lack access to the drugs.

The numbers are likely higher now. In the wake of the court ruling, some physicians in states with new abortion restrictions fear they won’t be able to properly treat women with miscarriages. Access to mifepristone, a component of medication abortions along with misoprostol, is at the center of their concerns.

“These restrictions that were put in place to restrict abortion care have far-reaching implications regarding miscarriages and early pregnancy loss and the assisted reproduction community is not immune,” obstetrics and gynecology specialist Zachary Anderson, MD, a resident physician at the University of Southern California, Los Angeles, said in an interview. He presented the findings at the American Society for Reproductive Medicine’s 2022 meeting.

Early pregnancy loss – defined as a miscarriage within 12 weeks and 6 days of conception – is common in all pregnancies and affects an estimated 15% of those who rely on in vitro fertilization (IVF). In women who conceive through intrauterine insemination or IVF, “an abnormal karyotype embryo/fetus is the cause of miscarriage in more than two-thirds of cases,” Mark P. Trolice, MD, director of the IVF Center and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview. “The options of management are observation – with no ability to determine when passage of the products of conception will occur – vs. mifepristone/misoprostol or suction D&C.”

Dr. Trolice added that “most woman select the medical treatment protocol, which is 200 mg mifepristone orally followed by 800 mcg misoprostol vaginally 24 hours later. If no signs of heavy bleeding occur after 3 hours following misoprostol, the patient should repeat the dose of 800 micrograms vaginally.”

According to the Reuters news service, some abortion bans target mifepristone. In October 2022, the American College of Obstetricians and Gynecologists asked the Food and Drug Administration to approve mifepristone for use in miscarriage management; such use is now off label, although it is approved to end early pregnancies in conjunction with misoprostol.

For the new study, researchers sent anonymous surveys to 826 members of the Society of Reproductive Endocrinology and Infertility and received 101 responses (12% response rate, 51% women, 86% non-Hispanic White, average age 52, 52% urban, and 51% in private practice).

More than two-thirds (70%) said they diagnosed early pregnancy loss at least once a week; 47% prefer treatment with misoprostol alone, 18% surgery in an operating room, 15% expectant management (monitoring a miscarriage as it occurs without medical intervention), 10% surgery in the office, and 3% mifepristone-misoprostol.

Of those who don’t offer mifepristone-misoprostol, 68% said they lack access, and 26% said they lack familiarity with the treatment.

Study coauthor Brian T. Nguyen, MD, MSc, assistant professor of obstetrics and gynecology at USC, said in an interview that mifepristone, a highly effective drug, is treated differently from other medications “for no good reason.”

Dr. Anderson, who led the study, urged colleagues to get the appropriate certification to prescribe mifepristone. “Providers overestimate how difficult it is to become certified to prescribe it,” he said.

Dr. Trolice, who is familiar with the study findings, said the response rate is low, and the results might be biased because those with preconceived opinions may be more likely to respond.

However, he said, “The results are not surprising in that medication is more commonly preferred (nearly 50%) given the devastation of a miscarriage and the desire to expedite resolution. Approximately one-third prefer surgical management, which would allow for genetic testing of the embryo/fetus to potentially determine a cause of the pregnancy loss.”

As for the medications used to treat early pregnancy loss, many ART physicians “treat pregnancy loss with misoprostol both pre- and post Dobbs,” he said. “The difficulty in obtaining mifepristone remains.”

The study authors and Dr. Trolice report no disclosures.

A new study provides more evidence that HPV infection doesn’t raise the risk of poor outcomes in women who undergo fertility treatment via in vitro fertilization with fresh embryos. In fact, HPV-positive women were somewhat more likely than HPV-negative women to become pregnant (relative risk, 1.20; 95% confidence interval, 1.03-1.39) and have live births (RR, 1.39; 95% CI, 1.13-1.70), researchers reported Oct. 24 at the American Society for Reproductive Medicine’s 2022 meeting .

“This evidence should reassure women that being HPV positive will not affect live birth rates after a fresh embryo transfer cycle,” said study coauthor and ob.gyn. Nina Vyas, MD, a clinical fellow at Weill Cornell Medicine, New York, in an interview.

According to Dr. Vyas, previous studies have offered conflicting results about whether HPV affects pregnancy outcomes. In 2006, for example, her group performed a pilot study (Fertil Steril. Jun 16. doi: 10.1016/j.fertnstert.2006.01.051) that linked lower pregnancy rates to HPV-positive tests on the day of egg retrieval.

“We sought to reevaluate this finding in a retrospective manner,” Dr. Vyas said. “You’re taking eggs out of their home, injecting with sperm, and putting them back. There’s so much that we don’t know, and we want to make sure there’s no extra risk.”

Also, she added, “prior studies had a relatively low sample size. We sought to use our patient volume to address this question on a larger scale. Our current study benefits from a large sample size and using the clinically meaningful endpoint of live birth as our primary outcome.”

For the new study, researchers retrospectively analyzed 1,333 patients (of 2,209 screened) who received first fresh embryo transfers from 2017 to 2019. All had cytology or HPV status documented per cervical cancer screening guidelines within 6 months before embryos were transferred.

The researchers looked at only fresh embryo transfers “so we could account for pregnancy outcomes closest to the documented HPV status at the time of egg retrieval,” Dr. Vyas said.

Ten percent (133) of patients were HPV positive. Of those, 60.1% became pregnant, and 43.6% of them had live births. Of the HPV-negative women (90% of subjects, n = 1,200), 52.2% became pregnant and 33.5% had live births. The researchers didn’t calculate P values, but Dr. Vyas said an analysis determined that the differences between HPV-positive and HPV-negative women were statistically significant.

The study size doesn’t allow researchers to determine whether HPV actually has a protective effect on pregnancy/live birth rates in IVF, Dr. Vyas said. Even if it did, the virus is dangerous.

What else could explain the discrepancy? “Some elements driving this could the smaller sample size of the HPV-positive group, differences in HPV prevalence between the general population and our population,” she said, “or other confounding factors we were not able to appreciate due to the limitations of the retrospective study.”

Researchers also reported that they found “no significant difference in biochemical or spontaneous abortion rates” between HPV-positive and HPV-negative women.

What is the message of the study? “Women with HPV can rest assured that they won’t have worse outcomes than their non-HPV [infected] counterparts after a fresh embryo transfer cycle,” Dr. Vyas said.

In an interview, McGill University, Montreal, epidemiologist Helen Trottier, PhD, MSc, noted that she recently coauthored a study that linked persistent HPV infection in pregnancy to premature births. The findings appear convincing, she said: “I think we can say that HPV is associated with preterm birth.”

She praised the new study but noted “the relative risks that are reported need to be adjusted for race and possibly other factors.”

Dr. Vyas said that kind of adjustment will occur in a future study that’s in progress. “We are now prospectively enrolling patients and collecting cytology data to understand whether there might be a difference for women with higher malignancy potential/different types of HPV genotypes.”

The study authors have no disclosures. Disclosure information for Dr. Trottier was unavailable.

A new study provides more evidence that HPV infection doesn’t raise the risk of poor outcomes in women who undergo fertility treatment via in vitro fertilization with fresh embryos. In fact, HPV-positive women were somewhat more likely than HPV-negative women to become pregnant (relative risk, 1.20; 95% confidence interval, 1.03-1.39) and have live births (RR, 1.39; 95% CI, 1.13-1.70), researchers reported Oct. 24 at the American Society for Reproductive Medicine’s 2022 meeting .

“This evidence should reassure women that being HPV positive will not affect live birth rates after a fresh embryo transfer cycle,” said study coauthor and ob.gyn. Nina Vyas, MD, a clinical fellow at Weill Cornell Medicine, New York, in an interview.

According to Dr. Vyas, previous studies have offered conflicting results about whether HPV affects pregnancy outcomes. In 2006, for example, her group performed a pilot study (Fertil Steril. Jun 16. doi: 10.1016/j.fertnstert.2006.01.051) that linked lower pregnancy rates to HPV-positive tests on the day of egg retrieval.

“We sought to reevaluate this finding in a retrospective manner,” Dr. Vyas said. “You’re taking eggs out of their home, injecting with sperm, and putting them back. There’s so much that we don’t know, and we want to make sure there’s no extra risk.”

Also, she added, “prior studies had a relatively low sample size. We sought to use our patient volume to address this question on a larger scale. Our current study benefits from a large sample size and using the clinically meaningful endpoint of live birth as our primary outcome.”

For the new study, researchers retrospectively analyzed 1,333 patients (of 2,209 screened) who received first fresh embryo transfers from 2017 to 2019. All had cytology or HPV status documented per cervical cancer screening guidelines within 6 months before embryos were transferred.

The researchers looked at only fresh embryo transfers “so we could account for pregnancy outcomes closest to the documented HPV status at the time of egg retrieval,” Dr. Vyas said.

Ten percent (133) of patients were HPV positive. Of those, 60.1% became pregnant, and 43.6% of them had live births. Of the HPV-negative women (90% of subjects, n = 1,200), 52.2% became pregnant and 33.5% had live births. The researchers didn’t calculate P values, but Dr. Vyas said an analysis determined that the differences between HPV-positive and HPV-negative women were statistically significant.

The study size doesn’t allow researchers to determine whether HPV actually has a protective effect on pregnancy/live birth rates in IVF, Dr. Vyas said. Even if it did, the virus is dangerous.

What else could explain the discrepancy? “Some elements driving this could the smaller sample size of the HPV-positive group, differences in HPV prevalence between the general population and our population,” she said, “or other confounding factors we were not able to appreciate due to the limitations of the retrospective study.”

Researchers also reported that they found “no significant difference in biochemical or spontaneous abortion rates” between HPV-positive and HPV-negative women.

What is the message of the study? “Women with HPV can rest assured that they won’t have worse outcomes than their non-HPV [infected] counterparts after a fresh embryo transfer cycle,” Dr. Vyas said.

In an interview, McGill University, Montreal, epidemiologist Helen Trottier, PhD, MSc, noted that she recently coauthored a study that linked persistent HPV infection in pregnancy to premature births. The findings appear convincing, she said: “I think we can say that HPV is associated with preterm birth.”

She praised the new study but noted “the relative risks that are reported need to be adjusted for race and possibly other factors.”

Dr. Vyas said that kind of adjustment will occur in a future study that’s in progress. “We are now prospectively enrolling patients and collecting cytology data to understand whether there might be a difference for women with higher malignancy potential/different types of HPV genotypes.”

The study authors have no disclosures. Disclosure information for Dr. Trottier was unavailable.

A new study provides more evidence that HPV infection doesn’t raise the risk of poor outcomes in women who undergo fertility treatment via in vitro fertilization with fresh embryos. In fact, HPV-positive women were somewhat more likely than HPV-negative women to become pregnant (relative risk, 1.20; 95% confidence interval, 1.03-1.39) and have live births (RR, 1.39; 95% CI, 1.13-1.70), researchers reported Oct. 24 at the American Society for Reproductive Medicine’s 2022 meeting .

“This evidence should reassure women that being HPV positive will not affect live birth rates after a fresh embryo transfer cycle,” said study coauthor and ob.gyn. Nina Vyas, MD, a clinical fellow at Weill Cornell Medicine, New York, in an interview.

According to Dr. Vyas, previous studies have offered conflicting results about whether HPV affects pregnancy outcomes. In 2006, for example, her group performed a pilot study (Fertil Steril. Jun 16. doi: 10.1016/j.fertnstert.2006.01.051) that linked lower pregnancy rates to HPV-positive tests on the day of egg retrieval.

“We sought to reevaluate this finding in a retrospective manner,” Dr. Vyas said. “You’re taking eggs out of their home, injecting with sperm, and putting them back. There’s so much that we don’t know, and we want to make sure there’s no extra risk.”

Also, she added, “prior studies had a relatively low sample size. We sought to use our patient volume to address this question on a larger scale. Our current study benefits from a large sample size and using the clinically meaningful endpoint of live birth as our primary outcome.”

For the new study, researchers retrospectively analyzed 1,333 patients (of 2,209 screened) who received first fresh embryo transfers from 2017 to 2019. All had cytology or HPV status documented per cervical cancer screening guidelines within 6 months before embryos were transferred.

The researchers looked at only fresh embryo transfers “so we could account for pregnancy outcomes closest to the documented HPV status at the time of egg retrieval,” Dr. Vyas said.

Ten percent (133) of patients were HPV positive. Of those, 60.1% became pregnant, and 43.6% of them had live births. Of the HPV-negative women (90% of subjects, n = 1,200), 52.2% became pregnant and 33.5% had live births. The researchers didn’t calculate P values, but Dr. Vyas said an analysis determined that the differences between HPV-positive and HPV-negative women were statistically significant.

The study size doesn’t allow researchers to determine whether HPV actually has a protective effect on pregnancy/live birth rates in IVF, Dr. Vyas said. Even if it did, the virus is dangerous.

What else could explain the discrepancy? “Some elements driving this could the smaller sample size of the HPV-positive group, differences in HPV prevalence between the general population and our population,” she said, “or other confounding factors we were not able to appreciate due to the limitations of the retrospective study.”

Researchers also reported that they found “no significant difference in biochemical or spontaneous abortion rates” between HPV-positive and HPV-negative women.

What is the message of the study? “Women with HPV can rest assured that they won’t have worse outcomes than their non-HPV [infected] counterparts after a fresh embryo transfer cycle,” Dr. Vyas said.

In an interview, McGill University, Montreal, epidemiologist Helen Trottier, PhD, MSc, noted that she recently coauthored a study that linked persistent HPV infection in pregnancy to premature births. The findings appear convincing, she said: “I think we can say that HPV is associated with preterm birth.”

She praised the new study but noted “the relative risks that are reported need to be adjusted for race and possibly other factors.”

Dr. Vyas said that kind of adjustment will occur in a future study that’s in progress. “We are now prospectively enrolling patients and collecting cytology data to understand whether there might be a difference for women with higher malignancy potential/different types of HPV genotypes.”

The study authors have no disclosures. Disclosure information for Dr. Trottier was unavailable.

SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.

These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).

Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.

To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”

Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”

Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”

She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.

The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”

For more about the initiative, visit the VA PX SharePoint.

The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.

Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”

In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable. 

In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.

Dr. Valdez-Boyle reported no disclosures.

SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.

These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).

Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.

To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”

Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”

Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”

She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.

The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”

For more about the initiative, visit the VA PX SharePoint.

The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.

Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”

In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable. 

In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.

Dr. Valdez-Boyle reported no disclosures.

SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.

These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).

Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.

To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”

Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”

Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”

She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.

The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”

For more about the initiative, visit the VA PX SharePoint.

The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.

Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”

In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable. 

In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.

Dr. Valdez-Boyle reported no disclosures.

An optimistic new review offers guidance about treating mantle cell lymphoma (MCL) in the new era of chimeric antigen receptor (CAR)-T cell therapy and medication choices informed by risk stratification.

Traditionally, MCL has had a notoriously poor prognosis and is still impossible to cure. But survival rates are rising thanks to better treatments, the review authors wrote, and even relapsed/refractory patients have a growing number of options that can potentially give them extra years of life.

“Prognosis has certainly changed in past 10 years. We have been able to have an excellent control of disease, and patients are living longer, even past the 8- or 10-year mark,” Moffit Cancer Center/Memorial Healthcare System hematologist-oncologist Jose Sandoval‐Sus, MD, said in an interview. He is corresponding author of the review, which appeared in the October issue of Current Oncology Reports.

MCL – which affects cells in the mantle zone of lymph nodes – is rare. It usually strikes older men, often presents at an advanced stage, and accounts for 6%-8% of non-Hodgkin lymphomas in the United States.

Prognoses are improving. The review highlights a study released earlier this year that found that median 5-year overall survival has increased from 68.8% (2002-2009) to 81.6% (2010-2015).

Now, the review notes, there are several first-line chemotherapy options that combine agents with rituximab such as rituximab/bendamustine, which “has generally been established as an effective treatment for MCL at first relapse in patients who are bendamustine naive when compared to other chemotherapy agents.”

Other treatments include rituximab, bortezomib, cyclophosphamide, doxorubicin, vincristine, and prednisolone; rituximab, bendamustine and cytarabine; and rituximab, gemcitabine, and oxaliplatin.

“I think of rituximab as a medication of maintenance, either after autologous stem cell transplant or even in patients who have not been through transplant,” Dr. Sandoval‐Sus said. “As maintenance, it really has improved outcomes for these patients.”

But the first step before treatment, he said, is to explore prognostic factors such as alterations on the TP53 gene that “really dictate a lot in terms of the prognosis of patients.” As the review notes, these alterations – either bi-allelic del17p or TP53 mutations – “are associated with poor outcomes after frontline and salvage regimens, including targeted agents such as Burton’s tyrosine kinase inhibitors (BTKis).”

These patients, who make up about 20% of those with MCL, also are most unlikely to benefit from autologous stem cell transplantation, Dr. Sandoval‐Sus said.

What about refracted/relapsed (R/R) cases? BTKis have been a major advance for these patients, he said. However, choosing the best drug can be a challenge. As the review notes, “all approved BTKis for R/R MCL seem to have similar clinical outcomes based on identical mechanism of action, and there are no prospective trials comparing these agents in a head-to-head fashion.”

The authors added that “we wonder if AEs [adverse events] could be decreased by using combinations based on new generation BTKi, but it is still a question that needs to be resolved in the clinical trial arena.”

Stem cell transplants may be an option, the review said, but “in practice the clinical benefit ... is limited to single-center series or small multi-institutional registries with few prospective studies.”

Then there’s CAR-T cell therapy, the game-changer. A type called brexucabtagene autoleucel (Brexu-cel) is now approved in MCL, the review authors wrote, and real-world data “serve as a platform to expand CAR-T therapy to more R/R MCL patients that do not fit the strict inclusion criteria of the studies (e.g., controlled comorbidities and worse performance status)... We strongly recommend early referral of these patients to accredited institutions with ample cellular therapy experience, including high-risk MCL patients (e.g., blastoid/pleomorphic morphology, biallelic del17p, TP53 mutations) so an appropriate bridging strategy and a CAR-T cell roadmap is planned with the patient and caretakers.”

Some researchers are exploring combination treatment with both BTKis and CAR T-cell therapy, “which may be considered for patients with R/R MCL who are naive to both CAR T-cell and BTKi therapy, because combination therapy may increase treatment efficacy,” wrote the authors of another review that appeared in the October issue of Current Oncology Reports. “Based on limited data in patients with CLL, BTKi therapy may be initiated as bridging therapy and continued during lymphodepletion prior to CAR T-cell infusion”

What’s next? Multiple treatments are in the research stage, Dr. Sandoval‐Sus said. “There are a lot of things in development that are really incredible.”

Reversible BTKis, for example, appear to be effective at controlling disease and are well-tolerated, he said. “And we are awaiting the results of clinical trials of targeted therapies.”

For now, he said, the best advice for hematologists is to gain a full understanding of a patient’s MCL, in order to provide the most appropriate treatment. Community oncologists should get at least one second opinion from an academic center or other clinic that treats these kinds of lymphomas, he said, and molecular tests are crucial. A discussion about stem cell transplantation after remission is a good idea, he said, and so is an exploration of clinical trials “from the get-go.”

“In patients who relapse and have high-risk features, they should be started on a BTKi inhibitor for the most part,” he said, “although we need to weigh risks and benefits between the side effects of different BTKi inhibitors. And they should be referred earlier to a CAR T cell therapy center, so they can discuss the benefits and see if they’re an appropriate patient. I think patients are being referred a little bit too late in the second- or third-line setting.”

What about CAR T therapy as a first-line therapy? It’s not FDA-approved, Dr. Sandoval‐Sus said, and “definitely not a standard of care.” But clinical trials are exploring the idea, he said. As for messages to patients, Dr. Sandoval-Sus said he would tell them that MCL is not yet curable, “but the future is very bright.”

Dr. Sandoval-Sus declared advisory board relationships with Seagen, Incyte, Janssen, ADC Therapeutics, TG therapeutics, and Genmab. The other review authors had no disclosures.

An optimistic new review offers guidance about treating mantle cell lymphoma (MCL) in the new era of chimeric antigen receptor (CAR)-T cell therapy and medication choices informed by risk stratification.

Traditionally, MCL has had a notoriously poor prognosis and is still impossible to cure. But survival rates are rising thanks to better treatments, the review authors wrote, and even relapsed/refractory patients have a growing number of options that can potentially give them extra years of life.

“Prognosis has certainly changed in past 10 years. We have been able to have an excellent control of disease, and patients are living longer, even past the 8- or 10-year mark,” Moffit Cancer Center/Memorial Healthcare System hematologist-oncologist Jose Sandoval‐Sus, MD, said in an interview. He is corresponding author of the review, which appeared in the October issue of Current Oncology Reports.

MCL – which affects cells in the mantle zone of lymph nodes – is rare. It usually strikes older men, often presents at an advanced stage, and accounts for 6%-8% of non-Hodgkin lymphomas in the United States.

Prognoses are improving. The review highlights a study released earlier this year that found that median 5-year overall survival has increased from 68.8% (2002-2009) to 81.6% (2010-2015).

Now, the review notes, there are several first-line chemotherapy options that combine agents with rituximab such as rituximab/bendamustine, which “has generally been established as an effective treatment for MCL at first relapse in patients who are bendamustine naive when compared to other chemotherapy agents.”

Other treatments include rituximab, bortezomib, cyclophosphamide, doxorubicin, vincristine, and prednisolone; rituximab, bendamustine and cytarabine; and rituximab, gemcitabine, and oxaliplatin.

“I think of rituximab as a medication of maintenance, either after autologous stem cell transplant or even in patients who have not been through transplant,” Dr. Sandoval‐Sus said. “As maintenance, it really has improved outcomes for these patients.”

But the first step before treatment, he said, is to explore prognostic factors such as alterations on the TP53 gene that “really dictate a lot in terms of the prognosis of patients.” As the review notes, these alterations – either bi-allelic del17p or TP53 mutations – “are associated with poor outcomes after frontline and salvage regimens, including targeted agents such as Burton’s tyrosine kinase inhibitors (BTKis).”

These patients, who make up about 20% of those with MCL, also are most unlikely to benefit from autologous stem cell transplantation, Dr. Sandoval‐Sus said.

What about refracted/relapsed (R/R) cases? BTKis have been a major advance for these patients, he said. However, choosing the best drug can be a challenge. As the review notes, “all approved BTKis for R/R MCL seem to have similar clinical outcomes based on identical mechanism of action, and there are no prospective trials comparing these agents in a head-to-head fashion.”

The authors added that “we wonder if AEs [adverse events] could be decreased by using combinations based on new generation BTKi, but it is still a question that needs to be resolved in the clinical trial arena.”

Stem cell transplants may be an option, the review said, but “in practice the clinical benefit ... is limited to single-center series or small multi-institutional registries with few prospective studies.”

Then there’s CAR-T cell therapy, the game-changer. A type called brexucabtagene autoleucel (Brexu-cel) is now approved in MCL, the review authors wrote, and real-world data “serve as a platform to expand CAR-T therapy to more R/R MCL patients that do not fit the strict inclusion criteria of the studies (e.g., controlled comorbidities and worse performance status)... We strongly recommend early referral of these patients to accredited institutions with ample cellular therapy experience, including high-risk MCL patients (e.g., blastoid/pleomorphic morphology, biallelic del17p, TP53 mutations) so an appropriate bridging strategy and a CAR-T cell roadmap is planned with the patient and caretakers.”

Some researchers are exploring combination treatment with both BTKis and CAR T-cell therapy, “which may be considered for patients with R/R MCL who are naive to both CAR T-cell and BTKi therapy, because combination therapy may increase treatment efficacy,” wrote the authors of another review that appeared in the October issue of Current Oncology Reports. “Based on limited data in patients with CLL, BTKi therapy may be initiated as bridging therapy and continued during lymphodepletion prior to CAR T-cell infusion”

What’s next? Multiple treatments are in the research stage, Dr. Sandoval‐Sus said. “There are a lot of things in development that are really incredible.”

Reversible BTKis, for example, appear to be effective at controlling disease and are well-tolerated, he said. “And we are awaiting the results of clinical trials of targeted therapies.”

For now, he said, the best advice for hematologists is to gain a full understanding of a patient’s MCL, in order to provide the most appropriate treatment. Community oncologists should get at least one second opinion from an academic center or other clinic that treats these kinds of lymphomas, he said, and molecular tests are crucial. A discussion about stem cell transplantation after remission is a good idea, he said, and so is an exploration of clinical trials “from the get-go.”

“In patients who relapse and have high-risk features, they should be started on a BTKi inhibitor for the most part,” he said, “although we need to weigh risks and benefits between the side effects of different BTKi inhibitors. And they should be referred earlier to a CAR T cell therapy center, so they can discuss the benefits and see if they’re an appropriate patient. I think patients are being referred a little bit too late in the second- or third-line setting.”

What about CAR T therapy as a first-line therapy? It’s not FDA-approved, Dr. Sandoval‐Sus said, and “definitely not a standard of care.” But clinical trials are exploring the idea, he said. As for messages to patients, Dr. Sandoval-Sus said he would tell them that MCL is not yet curable, “but the future is very bright.”

Dr. Sandoval-Sus declared advisory board relationships with Seagen, Incyte, Janssen, ADC Therapeutics, TG therapeutics, and Genmab. The other review authors had no disclosures.

An optimistic new review offers guidance about treating mantle cell lymphoma (MCL) in the new era of chimeric antigen receptor (CAR)-T cell therapy and medication choices informed by risk stratification.

Traditionally, MCL has had a notoriously poor prognosis and is still impossible to cure. But survival rates are rising thanks to better treatments, the review authors wrote, and even relapsed/refractory patients have a growing number of options that can potentially give them extra years of life.

“Prognosis has certainly changed in past 10 years. We have been able to have an excellent control of disease, and patients are living longer, even past the 8- or 10-year mark,” Moffit Cancer Center/Memorial Healthcare System hematologist-oncologist Jose Sandoval‐Sus, MD, said in an interview. He is corresponding author of the review, which appeared in the October issue of Current Oncology Reports.

MCL – which affects cells in the mantle zone of lymph nodes – is rare. It usually strikes older men, often presents at an advanced stage, and accounts for 6%-8% of non-Hodgkin lymphomas in the United States.

Prognoses are improving. The review highlights a study released earlier this year that found that median 5-year overall survival has increased from 68.8% (2002-2009) to 81.6% (2010-2015).

Now, the review notes, there are several first-line chemotherapy options that combine agents with rituximab such as rituximab/bendamustine, which “has generally been established as an effective treatment for MCL at first relapse in patients who are bendamustine naive when compared to other chemotherapy agents.”

Other treatments include rituximab, bortezomib, cyclophosphamide, doxorubicin, vincristine, and prednisolone; rituximab, bendamustine and cytarabine; and rituximab, gemcitabine, and oxaliplatin.

“I think of rituximab as a medication of maintenance, either after autologous stem cell transplant or even in patients who have not been through transplant,” Dr. Sandoval‐Sus said. “As maintenance, it really has improved outcomes for these patients.”

But the first step before treatment, he said, is to explore prognostic factors such as alterations on the TP53 gene that “really dictate a lot in terms of the prognosis of patients.” As the review notes, these alterations – either bi-allelic del17p or TP53 mutations – “are associated with poor outcomes after frontline and salvage regimens, including targeted agents such as Burton’s tyrosine kinase inhibitors (BTKis).”

These patients, who make up about 20% of those with MCL, also are most unlikely to benefit from autologous stem cell transplantation, Dr. Sandoval‐Sus said.

What about refracted/relapsed (R/R) cases? BTKis have been a major advance for these patients, he said. However, choosing the best drug can be a challenge. As the review notes, “all approved BTKis for R/R MCL seem to have similar clinical outcomes based on identical mechanism of action, and there are no prospective trials comparing these agents in a head-to-head fashion.”

The authors added that “we wonder if AEs [adverse events] could be decreased by using combinations based on new generation BTKi, but it is still a question that needs to be resolved in the clinical trial arena.”

Stem cell transplants may be an option, the review said, but “in practice the clinical benefit ... is limited to single-center series or small multi-institutional registries with few prospective studies.”

Then there’s CAR-T cell therapy, the game-changer. A type called brexucabtagene autoleucel (Brexu-cel) is now approved in MCL, the review authors wrote, and real-world data “serve as a platform to expand CAR-T therapy to more R/R MCL patients that do not fit the strict inclusion criteria of the studies (e.g., controlled comorbidities and worse performance status)... We strongly recommend early referral of these patients to accredited institutions with ample cellular therapy experience, including high-risk MCL patients (e.g., blastoid/pleomorphic morphology, biallelic del17p, TP53 mutations) so an appropriate bridging strategy and a CAR-T cell roadmap is planned with the patient and caretakers.”

Some researchers are exploring combination treatment with both BTKis and CAR T-cell therapy, “which may be considered for patients with R/R MCL who are naive to both CAR T-cell and BTKi therapy, because combination therapy may increase treatment efficacy,” wrote the authors of another review that appeared in the October issue of Current Oncology Reports. “Based on limited data in patients with CLL, BTKi therapy may be initiated as bridging therapy and continued during lymphodepletion prior to CAR T-cell infusion”

What’s next? Multiple treatments are in the research stage, Dr. Sandoval‐Sus said. “There are a lot of things in development that are really incredible.”

Reversible BTKis, for example, appear to be effective at controlling disease and are well-tolerated, he said. “And we are awaiting the results of clinical trials of targeted therapies.”

For now, he said, the best advice for hematologists is to gain a full understanding of a patient’s MCL, in order to provide the most appropriate treatment. Community oncologists should get at least one second opinion from an academic center or other clinic that treats these kinds of lymphomas, he said, and molecular tests are crucial. A discussion about stem cell transplantation after remission is a good idea, he said, and so is an exploration of clinical trials “from the get-go.”

“In patients who relapse and have high-risk features, they should be started on a BTKi inhibitor for the most part,” he said, “although we need to weigh risks and benefits between the side effects of different BTKi inhibitors. And they should be referred earlier to a CAR T cell therapy center, so they can discuss the benefits and see if they’re an appropriate patient. I think patients are being referred a little bit too late in the second- or third-line setting.”

What about CAR T therapy as a first-line therapy? It’s not FDA-approved, Dr. Sandoval‐Sus said, and “definitely not a standard of care.” But clinical trials are exploring the idea, he said. As for messages to patients, Dr. Sandoval-Sus said he would tell them that MCL is not yet curable, “but the future is very bright.”

Dr. Sandoval-Sus declared advisory board relationships with Seagen, Incyte, Janssen, ADC Therapeutics, TG therapeutics, and Genmab. The other review authors had no disclosures.

SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.

At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.

Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy. 

The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.

Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”

At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”

Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.

The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”

The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.

As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”

Dr. Perry has no disclosures.

SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.

At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.

Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy. 

The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.

Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”

At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”

Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.

The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”

The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.

As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”

Dr. Perry has no disclosures.

SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.

At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.

Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy. 

The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.

Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”

At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”

Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.

The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”

The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.

As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”

Dr. Perry has no disclosures.

SAN DIEGO—Before the pandemic, an estimated one-third of oncologists worldwide suffered a high level of burnout. Cancer physicians face many of the same risk factors as their colleagues—high workloads, lack of autonomy, and no support—along with the added pressure of working in a medical field where patients often die. Then COVID-19 hit, and the burnout crisis got even worse.

This tide can be reversed with a focus on best practices and resilience, a mental health researcher told cancer professionals at the September 2022 annual meeting of the Association of VA Hematology/Oncology. Assessments, long-term interventions, and communication are all key, said Fay J. Hlubocky, PhD, MA, a clinical health psychologist and ethicist at the University of Chicago.

Even simple actions like taking time for “mindful moments” and checking in with a colleague can make a difference, she said. But institutions must act, she said. “Long-term tailored strategies are incredibly important to promote well-being.”

Hlubocky, who led an American Society of Clinical Oncology committee on burnout prior to the pandemic, noted that statistics about burnout in American medicine and oncology specifically, are grim. In 2017, a systematic review and meta-analysis found that significant numbers of oncologists suffered from high burnout (32%), high psychiatric morbidity (27%), depression (at least 12%), and alcohol misuse (as many as 30%).

The pandemic piled on more stressors. In the second half of 2020, researchers interviewed 25 American oncologists in focus groups and found that their “underlying oncologist burnout exacerbated stressors associated with disruptions in care, education, research, financial practice health, and telemedicine. Many feared delays in cancer screening, diagnosis, and treatment [and] strongly considered working part-time or taking early retirement.”

As one participant put it, “everyone is seeing a lot of death and heartache and social isolation and anger that they’re not used to encountering and in very new and different ways.”

Major contributors to oncologist burnout, Hlubocky said, include moral distress, moral injury, and compassion fatigue. “Moral distress occurs when that individual believes he or she knows the right thing to do, but institutional constraints make it really difficult to do what is right,” Hlubocky said. “The individual is aware of the moral problem, acknowledges and takes moral responsibility, makes some moral judgments, but yet—as a result of these constraints — participates in perceived moral wrongdoing.”

Moral injury refers to the damage that can be caused by moral distress or by witnessing acts that violate morals, such as during military service. Compassion fatigue, meanwhile, is defined by the American Stress Institute as “a low level, chronic clouding of caring and concern for others in your life.”

What can be done? Hlubocky highlighted multiple interventions, such as adjustment of work patterns, cognitive behavioral therapy, and training in mindfulness, relaxation, and communication. One strategy is to adopt multiple in-person interventions simultaneously.

But first it’s crucial for administrators to understand the problem in a specific workplace: “You have to know what’s going on in your organization to intervene on it,” she said. “There are multiple tools that have been validated in other health care fields and can be used on a regular basis over time to measure burnout, satisfaction, and engagement.”

For individuals, other strategies include daily check-ins with colleagues to catch signs of stress, she said, as Toronto oncologists started doing amid the pandemic. The check-ins can include simple questions like: How are you doing? How are you feeling? Are you sleeping, eating and exercising? Do you need help?

As for resilience, Hlubocky said it must grow at the individual level. “We can't rely so much on the organization. We need to develop our personal resilience in order for professional resilience to flourish again, and we have to do a lot to protect ourselves. It’s about focusing on the strength of the individual—that empowerment to rise above adversity, that vitality, that engagement, that self-efficacy. It supports health and enhances coping, and it is the key element of physician and clinician well-being.”

Research into resilience offers guidance about how to achieve it, she said. A 2013 German study of 200 physicians found that the most resilient physicians change their attitudes and behaviors, take time off, set boundaries, spend time with family and friends, and ask colleagues for help. And they gained resilience, the study found, by getting older and becoming more experienced.

Hlubocky pointed to several useful resources for burned-out medical professionals, including mindfulness, cognitive behavioral therapy and breathing apps: She highlighted Breathe2Relax, Headspace, MoodGYM, Stress Gym, and guided audio files from the University of California at San Diego. And she said ASCO has resources on combatting burnout and promoting well-being.

Hlubocky has no relevant disclosures.

SAN DIEGO—Before the pandemic, an estimated one-third of oncologists worldwide suffered a high level of burnout. Cancer physicians face many of the same risk factors as their colleagues—high workloads, lack of autonomy, and no support—along with the added pressure of working in a medical field where patients often die. Then COVID-19 hit, and the burnout crisis got even worse.

This tide can be reversed with a focus on best practices and resilience, a mental health researcher told cancer professionals at the September 2022 annual meeting of the Association of VA Hematology/Oncology. Assessments, long-term interventions, and communication are all key, said Fay J. Hlubocky, PhD, MA, a clinical health psychologist and ethicist at the University of Chicago.

Even simple actions like taking time for “mindful moments” and checking in with a colleague can make a difference, she said. But institutions must act, she said. “Long-term tailored strategies are incredibly important to promote well-being.”

Hlubocky, who led an American Society of Clinical Oncology committee on burnout prior to the pandemic, noted that statistics about burnout in American medicine and oncology specifically, are grim. In 2017, a systematic review and meta-analysis found that significant numbers of oncologists suffered from high burnout (32%), high psychiatric morbidity (27%), depression (at least 12%), and alcohol misuse (as many as 30%).

The pandemic piled on more stressors. In the second half of 2020, researchers interviewed 25 American oncologists in focus groups and found that their “underlying oncologist burnout exacerbated stressors associated with disruptions in care, education, research, financial practice health, and telemedicine. Many feared delays in cancer screening, diagnosis, and treatment [and] strongly considered working part-time or taking early retirement.”

As one participant put it, “everyone is seeing a lot of death and heartache and social isolation and anger that they’re not used to encountering and in very new and different ways.”

Major contributors to oncologist burnout, Hlubocky said, include moral distress, moral injury, and compassion fatigue. “Moral distress occurs when that individual believes he or she knows the right thing to do, but institutional constraints make it really difficult to do what is right,” Hlubocky said. “The individual is aware of the moral problem, acknowledges and takes moral responsibility, makes some moral judgments, but yet—as a result of these constraints — participates in perceived moral wrongdoing.”

Moral injury refers to the damage that can be caused by moral distress or by witnessing acts that violate morals, such as during military service. Compassion fatigue, meanwhile, is defined by the American Stress Institute as “a low level, chronic clouding of caring and concern for others in your life.”

What can be done? Hlubocky highlighted multiple interventions, such as adjustment of work patterns, cognitive behavioral therapy, and training in mindfulness, relaxation, and communication. One strategy is to adopt multiple in-person interventions simultaneously.

But first it’s crucial for administrators to understand the problem in a specific workplace: “You have to know what’s going on in your organization to intervene on it,” she said. “There are multiple tools that have been validated in other health care fields and can be used on a regular basis over time to measure burnout, satisfaction, and engagement.”

For individuals, other strategies include daily check-ins with colleagues to catch signs of stress, she said, as Toronto oncologists started doing amid the pandemic. The check-ins can include simple questions like: How are you doing? How are you feeling? Are you sleeping, eating and exercising? Do you need help?

As for resilience, Hlubocky said it must grow at the individual level. “We can't rely so much on the organization. We need to develop our personal resilience in order for professional resilience to flourish again, and we have to do a lot to protect ourselves. It’s about focusing on the strength of the individual—that empowerment to rise above adversity, that vitality, that engagement, that self-efficacy. It supports health and enhances coping, and it is the key element of physician and clinician well-being.”

Research into resilience offers guidance about how to achieve it, she said. A 2013 German study of 200 physicians found that the most resilient physicians change their attitudes and behaviors, take time off, set boundaries, spend time with family and friends, and ask colleagues for help. And they gained resilience, the study found, by getting older and becoming more experienced.

Hlubocky pointed to several useful resources for burned-out medical professionals, including mindfulness, cognitive behavioral therapy and breathing apps: She highlighted Breathe2Relax, Headspace, MoodGYM, Stress Gym, and guided audio files from the University of California at San Diego. And she said ASCO has resources on combatting burnout and promoting well-being.

Hlubocky has no relevant disclosures.

SAN DIEGO—Before the pandemic, an estimated one-third of oncologists worldwide suffered a high level of burnout. Cancer physicians face many of the same risk factors as their colleagues—high workloads, lack of autonomy, and no support—along with the added pressure of working in a medical field where patients often die. Then COVID-19 hit, and the burnout crisis got even worse.

This tide can be reversed with a focus on best practices and resilience, a mental health researcher told cancer professionals at the September 2022 annual meeting of the Association of VA Hematology/Oncology. Assessments, long-term interventions, and communication are all key, said Fay J. Hlubocky, PhD, MA, a clinical health psychologist and ethicist at the University of Chicago.

Even simple actions like taking time for “mindful moments” and checking in with a colleague can make a difference, she said. But institutions must act, she said. “Long-term tailored strategies are incredibly important to promote well-being.”

Hlubocky, who led an American Society of Clinical Oncology committee on burnout prior to the pandemic, noted that statistics about burnout in American medicine and oncology specifically, are grim. In 2017, a systematic review and meta-analysis found that significant numbers of oncologists suffered from high burnout (32%), high psychiatric morbidity (27%), depression (at least 12%), and alcohol misuse (as many as 30%).

The pandemic piled on more stressors. In the second half of 2020, researchers interviewed 25 American oncologists in focus groups and found that their “underlying oncologist burnout exacerbated stressors associated with disruptions in care, education, research, financial practice health, and telemedicine. Many feared delays in cancer screening, diagnosis, and treatment [and] strongly considered working part-time or taking early retirement.”

As one participant put it, “everyone is seeing a lot of death and heartache and social isolation and anger that they’re not used to encountering and in very new and different ways.”

Major contributors to oncologist burnout, Hlubocky said, include moral distress, moral injury, and compassion fatigue. “Moral distress occurs when that individual believes he or she knows the right thing to do, but institutional constraints make it really difficult to do what is right,” Hlubocky said. “The individual is aware of the moral problem, acknowledges and takes moral responsibility, makes some moral judgments, but yet—as a result of these constraints — participates in perceived moral wrongdoing.”

Moral injury refers to the damage that can be caused by moral distress or by witnessing acts that violate morals, such as during military service. Compassion fatigue, meanwhile, is defined by the American Stress Institute as “a low level, chronic clouding of caring and concern for others in your life.”

What can be done? Hlubocky highlighted multiple interventions, such as adjustment of work patterns, cognitive behavioral therapy, and training in mindfulness, relaxation, and communication. One strategy is to adopt multiple in-person interventions simultaneously.

But first it’s crucial for administrators to understand the problem in a specific workplace: “You have to know what’s going on in your organization to intervene on it,” she said. “There are multiple tools that have been validated in other health care fields and can be used on a regular basis over time to measure burnout, satisfaction, and engagement.”

For individuals, other strategies include daily check-ins with colleagues to catch signs of stress, she said, as Toronto oncologists started doing amid the pandemic. The check-ins can include simple questions like: How are you doing? How are you feeling? Are you sleeping, eating and exercising? Do you need help?

As for resilience, Hlubocky said it must grow at the individual level. “We can't rely so much on the organization. We need to develop our personal resilience in order for professional resilience to flourish again, and we have to do a lot to protect ourselves. It’s about focusing on the strength of the individual—that empowerment to rise above adversity, that vitality, that engagement, that self-efficacy. It supports health and enhances coping, and it is the key element of physician and clinician well-being.”

Research into resilience offers guidance about how to achieve it, she said. A 2013 German study of 200 physicians found that the most resilient physicians change their attitudes and behaviors, take time off, set boundaries, spend time with family and friends, and ask colleagues for help. And they gained resilience, the study found, by getting older and becoming more experienced.

Hlubocky pointed to several useful resources for burned-out medical professionals, including mindfulness, cognitive behavioral therapy and breathing apps: She highlighted Breathe2Relax, Headspace, MoodGYM, Stress Gym, and guided audio files from the University of California at San Diego. And she said ASCO has resources on combatting burnout and promoting well-being.

Hlubocky has no relevant disclosures.

While great strides have been made in children’s leukemia care during the past 50 years, statistics have remained grim. For acute myeloid leukemia (AML), the most common type, 5-year survival rates were just 69% for children younger than 15 between 2009 and 2015. Patients who do survive past adolescence face high risks of future complications.

Specialists say the challenges hindering more progress include a lack of clinical research, an emphasis on competition over cooperation, and sparse insight into how best to adjust adult leukemia treatments to children. Now, a large clinical trial launched by the Leukemia & Lymphoma Society (LLS) seeks to revolutionize pediatric AML care by testing multiple experimental treatments across the globe. Its goal goes beyond simply boosting survival.

“Our project aims to find better treatments, more targeted treatments, that will leave children with fewer long-term health problems as adults. We want them to not just survive but thrive,” Gwen Nichols, MD, chief medical officer of LLS, said in an interview. “What we’ve had was not working for anybody. So we have to try a different approach.”

The LLS Pediatric Acute Leukemia (PedAL) Master Trial launched in spring of 2022. Seventy-five study locations from Nova Scotia to Hawaii are now recruiting patients up to age 22 with known or suspected relapsed/refractory AML, mixed phenotype acute leukemia, or relapsed acute lymphoblastic leukemia (ALL).

The 5-year trial expects to recruit 960 participants in the United States and Canada. Clinics in Europe, Australia, and New Zealand also are taking part.

“Pediatric oncologists should know that PedAL, for the first time, is providing a cooperative, seamless way to interrogate [the genomics of] a child’s leukemia,” hematologist/oncologist Todd Cooper, DO, section chief of pediatric oncology at Seattle Children’s Cancer and Blood Disorders Center, said in an interview. “It is also providing a seamless and efficient way for children to be assigned to clinical trials that are going to be tailored towards a particular child’s leukemia. This is something that’s never been done.”

In North America, all trial participants with relapsed AML will undergo genetic sequencing for free as part of the screening process. Clinics “can’t always access genomic screening for their patients,” Dr. Nichols said. “We’re providing that even if they don’t participate in any other part of the trial, even if they go and get another available therapy or go on a different trial. We want them to know that this is available, and they will get the results. And if they’re looking for a trial when they get those results, we have trained oncology nurses who will help them navigate and find clinical trials.”

In PedAL itself, one subtrial is now in progress: An open-label phase 3 randomized multicenter analysis of whether the oral leukemia drug venetoclax combined with the intensive infused chemotherapy treatment FLA+GO (fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin) will improve overall survival compared to FLA+GO alone. Ninety-eight subjects are expected to join the 5-year subtrial.

“We expect within the next year to open three or four different subtrials of targeted therapies for specific groups of patients,” E. Anders Kolb, MD, chief of oncology and hematology at Nemours Children’s Health in Delaware and cochair of the PedAL trial, said in an interview. “Over the course of the next few years, we’re going to learn a lot about the natural history of relapsed leukemia – we don’t have a ton of data on that – and then how targeted therapies may alter some of those outcomes.”

Discussions with multiple drugmakers are in progress regarding the potential subtrials, he said.

The PedAL strategy addresses the lack of new drugs for children with AML, Seattle Children’s Dr. Cooper said. One main reason for the gap is that childhood leukemia is much less common than the adult form, he said, so a lot of drug development is geared toward adults. As a result, he said, new drugs “are geared towards adults whose leukemia is not as aggressive. Whereas in children, the acute leukemias, especially AML, are quite aggressive and need therapies that are often more intense.”

In addition, he said, “we have only recently become aware of how AML is biologically much different than in adults.”

In AML, Delaware’s Dr. Kolb explained, “there are many different phenotypes – ways that these cells can look and behave. But we treat them with a single regimen. What I like to tell families is that we’ve got a few tools in our toolbox, but they all happen to be sledgehammers. The key to the challenge in AML is that it is a molecular disease, but we’re treating it with therapies that were developed 40-50 years ago.”

In PedAL, the goal is to figure out the best ways to target therapy for the specific types that patients have. On this front, the genomic screening in the trial is crucial because it will identify which patients express certain targets and allow them to be assigned to appropriate sub-trials, Dr. Coooper said.

What’s next? “LLS has planned for this to be ongoing for the next 5 to 7 years, so that we can get a number of studies up and running,” Dr. Nichols said. “After that, those studies will continue. We will hope that most of them can be self-funded by then.”

As for cost, she noted that the PedAL trial is part of the society’s Dare to Dream Project, formerly known as the Children’s Initiative, which focuses on pediatric blood cancers. The project, with a fundraising goal of $175 million, focuses on research, patient services and survivorship.

”We have a whole range of services, travel assistance, copay programs and educational resources that doctors may want to use as a valid source of information,” she said. ‘When I was in practice, patients were always asking me, ‘Do you have anything I can read or take home to give my son something about his disease?’ LLS has good-quality, patient-level information for patients. We welcome people contacting us or going to our website and taking advantage of that for free.”

Dr. Nichols and Dr. Kolb report no disclosures. Dr. Cooper reports academic funding from LLS.

While great strides have been made in children’s leukemia care during the past 50 years, statistics have remained grim. For acute myeloid leukemia (AML), the most common type, 5-year survival rates were just 69% for children younger than 15 between 2009 and 2015. Patients who do survive past adolescence face high risks of future complications.

Specialists say the challenges hindering more progress include a lack of clinical research, an emphasis on competition over cooperation, and sparse insight into how best to adjust adult leukemia treatments to children. Now, a large clinical trial launched by the Leukemia & Lymphoma Society (LLS) seeks to revolutionize pediatric AML care by testing multiple experimental treatments across the globe. Its goal goes beyond simply boosting survival.

“Our project aims to find better treatments, more targeted treatments, that will leave children with fewer long-term health problems as adults. We want them to not just survive but thrive,” Gwen Nichols, MD, chief medical officer of LLS, said in an interview. “What we’ve had was not working for anybody. So we have to try a different approach.”

The LLS Pediatric Acute Leukemia (PedAL) Master Trial launched in spring of 2022. Seventy-five study locations from Nova Scotia to Hawaii are now recruiting patients up to age 22 with known or suspected relapsed/refractory AML, mixed phenotype acute leukemia, or relapsed acute lymphoblastic leukemia (ALL).

The 5-year trial expects to recruit 960 participants in the United States and Canada. Clinics in Europe, Australia, and New Zealand also are taking part.

“Pediatric oncologists should know that PedAL, for the first time, is providing a cooperative, seamless way to interrogate [the genomics of] a child’s leukemia,” hematologist/oncologist Todd Cooper, DO, section chief of pediatric oncology at Seattle Children’s Cancer and Blood Disorders Center, said in an interview. “It is also providing a seamless and efficient way for children to be assigned to clinical trials that are going to be tailored towards a particular child’s leukemia. This is something that’s never been done.”

In North America, all trial participants with relapsed AML will undergo genetic sequencing for free as part of the screening process. Clinics “can’t always access genomic screening for their patients,” Dr. Nichols said. “We’re providing that even if they don’t participate in any other part of the trial, even if they go and get another available therapy or go on a different trial. We want them to know that this is available, and they will get the results. And if they’re looking for a trial when they get those results, we have trained oncology nurses who will help them navigate and find clinical trials.”

In PedAL itself, one subtrial is now in progress: An open-label phase 3 randomized multicenter analysis of whether the oral leukemia drug venetoclax combined with the intensive infused chemotherapy treatment FLA+GO (fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin) will improve overall survival compared to FLA+GO alone. Ninety-eight subjects are expected to join the 5-year subtrial.

“We expect within the next year to open three or four different subtrials of targeted therapies for specific groups of patients,” E. Anders Kolb, MD, chief of oncology and hematology at Nemours Children’s Health in Delaware and cochair of the PedAL trial, said in an interview. “Over the course of the next few years, we’re going to learn a lot about the natural history of relapsed leukemia – we don’t have a ton of data on that – and then how targeted therapies may alter some of those outcomes.”

Discussions with multiple drugmakers are in progress regarding the potential subtrials, he said.

The PedAL strategy addresses the lack of new drugs for children with AML, Seattle Children’s Dr. Cooper said. One main reason for the gap is that childhood leukemia is much less common than the adult form, he said, so a lot of drug development is geared toward adults. As a result, he said, new drugs “are geared towards adults whose leukemia is not as aggressive. Whereas in children, the acute leukemias, especially AML, are quite aggressive and need therapies that are often more intense.”

In addition, he said, “we have only recently become aware of how AML is biologically much different than in adults.”

In AML, Delaware’s Dr. Kolb explained, “there are many different phenotypes – ways that these cells can look and behave. But we treat them with a single regimen. What I like to tell families is that we’ve got a few tools in our toolbox, but they all happen to be sledgehammers. The key to the challenge in AML is that it is a molecular disease, but we’re treating it with therapies that were developed 40-50 years ago.”

In PedAL, the goal is to figure out the best ways to target therapy for the specific types that patients have. On this front, the genomic screening in the trial is crucial because it will identify which patients express certain targets and allow them to be assigned to appropriate sub-trials, Dr. Coooper said.

What’s next? “LLS has planned for this to be ongoing for the next 5 to 7 years, so that we can get a number of studies up and running,” Dr. Nichols said. “After that, those studies will continue. We will hope that most of them can be self-funded by then.”

As for cost, she noted that the PedAL trial is part of the society’s Dare to Dream Project, formerly known as the Children’s Initiative, which focuses on pediatric blood cancers. The project, with a fundraising goal of $175 million, focuses on research, patient services and survivorship.

”We have a whole range of services, travel assistance, copay programs and educational resources that doctors may want to use as a valid source of information,” she said. ‘When I was in practice, patients were always asking me, ‘Do you have anything I can read or take home to give my son something about his disease?’ LLS has good-quality, patient-level information for patients. We welcome people contacting us or going to our website and taking advantage of that for free.”

Dr. Nichols and Dr. Kolb report no disclosures. Dr. Cooper reports academic funding from LLS.

While great strides have been made in children’s leukemia care during the past 50 years, statistics have remained grim. For acute myeloid leukemia (AML), the most common type, 5-year survival rates were just 69% for children younger than 15 between 2009 and 2015. Patients who do survive past adolescence face high risks of future complications.

Specialists say the challenges hindering more progress include a lack of clinical research, an emphasis on competition over cooperation, and sparse insight into how best to adjust adult leukemia treatments to children. Now, a large clinical trial launched by the Leukemia & Lymphoma Society (LLS) seeks to revolutionize pediatric AML care by testing multiple experimental treatments across the globe. Its goal goes beyond simply boosting survival.

“Our project aims to find better treatments, more targeted treatments, that will leave children with fewer long-term health problems as adults. We want them to not just survive but thrive,” Gwen Nichols, MD, chief medical officer of LLS, said in an interview. “What we’ve had was not working for anybody. So we have to try a different approach.”

The LLS Pediatric Acute Leukemia (PedAL) Master Trial launched in spring of 2022. Seventy-five study locations from Nova Scotia to Hawaii are now recruiting patients up to age 22 with known or suspected relapsed/refractory AML, mixed phenotype acute leukemia, or relapsed acute lymphoblastic leukemia (ALL).

The 5-year trial expects to recruit 960 participants in the United States and Canada. Clinics in Europe, Australia, and New Zealand also are taking part.

“Pediatric oncologists should know that PedAL, for the first time, is providing a cooperative, seamless way to interrogate [the genomics of] a child’s leukemia,” hematologist/oncologist Todd Cooper, DO, section chief of pediatric oncology at Seattle Children’s Cancer and Blood Disorders Center, said in an interview. “It is also providing a seamless and efficient way for children to be assigned to clinical trials that are going to be tailored towards a particular child’s leukemia. This is something that’s never been done.”

In North America, all trial participants with relapsed AML will undergo genetic sequencing for free as part of the screening process. Clinics “can’t always access genomic screening for their patients,” Dr. Nichols said. “We’re providing that even if they don’t participate in any other part of the trial, even if they go and get another available therapy or go on a different trial. We want them to know that this is available, and they will get the results. And if they’re looking for a trial when they get those results, we have trained oncology nurses who will help them navigate and find clinical trials.”

In PedAL itself, one subtrial is now in progress: An open-label phase 3 randomized multicenter analysis of whether the oral leukemia drug venetoclax combined with the intensive infused chemotherapy treatment FLA+GO (fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin) will improve overall survival compared to FLA+GO alone. Ninety-eight subjects are expected to join the 5-year subtrial.

“We expect within the next year to open three or four different subtrials of targeted therapies for specific groups of patients,” E. Anders Kolb, MD, chief of oncology and hematology at Nemours Children’s Health in Delaware and cochair of the PedAL trial, said in an interview. “Over the course of the next few years, we’re going to learn a lot about the natural history of relapsed leukemia – we don’t have a ton of data on that – and then how targeted therapies may alter some of those outcomes.”

Discussions with multiple drugmakers are in progress regarding the potential subtrials, he said.

The PedAL strategy addresses the lack of new drugs for children with AML, Seattle Children’s Dr. Cooper said. One main reason for the gap is that childhood leukemia is much less common than the adult form, he said, so a lot of drug development is geared toward adults. As a result, he said, new drugs “are geared towards adults whose leukemia is not as aggressive. Whereas in children, the acute leukemias, especially AML, are quite aggressive and need therapies that are often more intense.”

In addition, he said, “we have only recently become aware of how AML is biologically much different than in adults.”

In AML, Delaware’s Dr. Kolb explained, “there are many different phenotypes – ways that these cells can look and behave. But we treat them with a single regimen. What I like to tell families is that we’ve got a few tools in our toolbox, but they all happen to be sledgehammers. The key to the challenge in AML is that it is a molecular disease, but we’re treating it with therapies that were developed 40-50 years ago.”

In PedAL, the goal is to figure out the best ways to target therapy for the specific types that patients have. On this front, the genomic screening in the trial is crucial because it will identify which patients express certain targets and allow them to be assigned to appropriate sub-trials, Dr. Coooper said.

What’s next? “LLS has planned for this to be ongoing for the next 5 to 7 years, so that we can get a number of studies up and running,” Dr. Nichols said. “After that, those studies will continue. We will hope that most of them can be self-funded by then.”

As for cost, she noted that the PedAL trial is part of the society’s Dare to Dream Project, formerly known as the Children’s Initiative, which focuses on pediatric blood cancers. The project, with a fundraising goal of $175 million, focuses on research, patient services and survivorship.

”We have a whole range of services, travel assistance, copay programs and educational resources that doctors may want to use as a valid source of information,” she said. ‘When I was in practice, patients were always asking me, ‘Do you have anything I can read or take home to give my son something about his disease?’ LLS has good-quality, patient-level information for patients. We welcome people contacting us or going to our website and taking advantage of that for free.”

Dr. Nichols and Dr. Kolb report no disclosures. Dr. Cooper reports academic funding from LLS.