The Canadian Task Force on Preventive Health Care recommends against the routine screening of all pregnant and postpartum women for depression using a standard questionnaire, according to its new guideline.

The basis for its position is the lack of evidence that such screening “adds value beyond discussions about overall wellbeing, depression, anxiety, and mood that are currently a part of established perinatal clinical care.

“We should not be using a one-size-fits all approach,” lead author Eddy Lang, MD, professor and head of emergency medicine at the Cumming School of Medicine, University of Calgary (Alta.), told this news organization.

Instead, the task force emphasizes regular clinical care, including asking patients about their wellbeing and support systems. The task force categorizes the recommendation as conditional and as having very low-certainty evidence.

The recommendation was published in CMAJ.
 

One randomized study

The task force is an independent panel of clinicians and scientists that makes recommendations on primary and secondary prevention in primary care. A working group of five members of the task force developed this recommendation with scientific support from Public Health Agency of Canada staff.

In its research, the task force found only one study that showed a benefit of routine depression screening in this population. This study was a randomized controlled trial conducted in Hong Kong. Researchers evaluated 462 postpartum women who were randomly assigned to receive screening with the Edinburgh Postnatal Depression Scale (EPDS) or no screening 2 months post partum.

“We found the effect of screening in this study to be very uncertain for the important outcomes of interest,” said Dr. Lang.

“These included parent-child stress, marital stress, and the number of infant hospital admissions. The effects of screening on all of these outcomes were very uncertain, mainly because it was such a small trial,” he said.

The task force also assessed how pregnant and postpartum women feel about being screened. What these women most wanted was a good relationship with a trusted primary care provider who would initiate discussions about their mental health in a caring atmosphere.

“Although they told us they liked the idea of universal screening, they admitted to their family doctors that they actually preferred to be asked about their wellbeing, [to be asked] how things were going at home, and [to have] a discussion about their mental health and wellbeing, rather than a formal screening process. They felt a discussion about depression with a primary health care provider during the pregnancy and postpartum period is critical,” said Dr. Lang.

Thus, the task force recommends “against instrument-based depression screening using a questionnaire with cutoff score to distinguish ‘screen positive’ and ‘screen negative’ administered to all individuals during pregnancy and the postpartum period (up to 1 year after childbirth).”
 

Screening remains common

“There’s a lot of uncertainty in the scientific community about whether it’s a good idea to administer a screening test to all pregnant and postpartum women to determine in a systematic way if they might be suffering from depression,” said Dr. Lang.

The task force recommended against screening for depression among perinatal or postpartum women in 2013, but screening is still performed in many provinces, said Dr. Lang.

Dr. Lang emphasized that the recommendation does not apply to usual care, in which the provider asks questions about and discusses a patient’s mental health and proceeds on the basis of their clinical judgment; nor does it apply to diagnostic pathways in which the clinician suspects that the individual may have depression and tests her accordingly.

“What we are saying in our recommendation is that all clinicians should ask about a patient’s wellbeing, about their mood, their anxiety, and these questions are an important part of the clinical assessment of pregnant and postpartum women. But we’re also saying the usefulness of doing so with a questionnaire and using a cutoff score on the questionnaire to decide who needs further assessment or possibly treatment is unproven by the research,” Dr. Lang said.
 

A growing problem

For Diane Francoeur, MD, CEO of the Society of Obstetricians and Gynecologists of Canada, this is all well and good, but the reality is that such screening is better than nothing.

Quebec is the only Canadian province that conducts universal screening for all pregnant and postpartum women, Dr. Francoeur said in an interview. She was not part of the task force.

“I agree that it should be more than one approach, but the problem is that there is such a shortage of resources. There are many issues that can arise when you follow a woman during her pregnancy,” she said.

Dr. Francoeur said that COVID-19 has been particularly tough on women, including pregnant and postpartum women, who are the most vulnerable.

“Especially during the COVID era, it was astonishing how women were not doing well. Their stress level was so high. We need to have a specific approach dedicated to prenatal mental health, because it’s a problem that is bigger than it used to be,” she said.

Violence against women has increased considerably since the beginning of the COVID-19 pandemic, said Dr. Francoeur. “Many more women have been killed by their partners. We have never seen anything like this before, and I hope we will never see this again,” she said.

“Help was more available a few years ago, but now, it’s really hard if and when you need to have a quick consultation with a specialist and the woman is really depressed. It can take forever. So, it’s okay to screen, but then, what’s next? Who is going to be there to take these women and help them? And we don’t have the answer,” Dr. Francoeur said.

Pregnant and postpartum women who suffer from depression need more than pills, she added. “We reassure them and treat their depression pharmacologically, but it’s also a time to give appropriate support and help them through the pregnancy and get well prepared to receive their newborn, because, as we now know, that first year of life is really important for the child, and the mom needs to be supported.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. Dr. Lang and Dr. Francoeur reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Canadian Task Force on Preventive Health Care recommends against the routine screening of all pregnant and postpartum women for depression using a standard questionnaire, according to its new guideline.

The basis for its position is the lack of evidence that such screening “adds value beyond discussions about overall wellbeing, depression, anxiety, and mood that are currently a part of established perinatal clinical care.

“We should not be using a one-size-fits all approach,” lead author Eddy Lang, MD, professor and head of emergency medicine at the Cumming School of Medicine, University of Calgary (Alta.), told this news organization.

Instead, the task force emphasizes regular clinical care, including asking patients about their wellbeing and support systems. The task force categorizes the recommendation as conditional and as having very low-certainty evidence.

The recommendation was published in CMAJ.
 

One randomized study

The task force is an independent panel of clinicians and scientists that makes recommendations on primary and secondary prevention in primary care. A working group of five members of the task force developed this recommendation with scientific support from Public Health Agency of Canada staff.

In its research, the task force found only one study that showed a benefit of routine depression screening in this population. This study was a randomized controlled trial conducted in Hong Kong. Researchers evaluated 462 postpartum women who were randomly assigned to receive screening with the Edinburgh Postnatal Depression Scale (EPDS) or no screening 2 months post partum.

“We found the effect of screening in this study to be very uncertain for the important outcomes of interest,” said Dr. Lang.

“These included parent-child stress, marital stress, and the number of infant hospital admissions. The effects of screening on all of these outcomes were very uncertain, mainly because it was such a small trial,” he said.

The task force also assessed how pregnant and postpartum women feel about being screened. What these women most wanted was a good relationship with a trusted primary care provider who would initiate discussions about their mental health in a caring atmosphere.

“Although they told us they liked the idea of universal screening, they admitted to their family doctors that they actually preferred to be asked about their wellbeing, [to be asked] how things were going at home, and [to have] a discussion about their mental health and wellbeing, rather than a formal screening process. They felt a discussion about depression with a primary health care provider during the pregnancy and postpartum period is critical,” said Dr. Lang.

Thus, the task force recommends “against instrument-based depression screening using a questionnaire with cutoff score to distinguish ‘screen positive’ and ‘screen negative’ administered to all individuals during pregnancy and the postpartum period (up to 1 year after childbirth).”
 

Screening remains common

“There’s a lot of uncertainty in the scientific community about whether it’s a good idea to administer a screening test to all pregnant and postpartum women to determine in a systematic way if they might be suffering from depression,” said Dr. Lang.

The task force recommended against screening for depression among perinatal or postpartum women in 2013, but screening is still performed in many provinces, said Dr. Lang.

Dr. Lang emphasized that the recommendation does not apply to usual care, in which the provider asks questions about and discusses a patient’s mental health and proceeds on the basis of their clinical judgment; nor does it apply to diagnostic pathways in which the clinician suspects that the individual may have depression and tests her accordingly.

“What we are saying in our recommendation is that all clinicians should ask about a patient’s wellbeing, about their mood, their anxiety, and these questions are an important part of the clinical assessment of pregnant and postpartum women. But we’re also saying the usefulness of doing so with a questionnaire and using a cutoff score on the questionnaire to decide who needs further assessment or possibly treatment is unproven by the research,” Dr. Lang said.
 

A growing problem

For Diane Francoeur, MD, CEO of the Society of Obstetricians and Gynecologists of Canada, this is all well and good, but the reality is that such screening is better than nothing.

Quebec is the only Canadian province that conducts universal screening for all pregnant and postpartum women, Dr. Francoeur said in an interview. She was not part of the task force.

“I agree that it should be more than one approach, but the problem is that there is such a shortage of resources. There are many issues that can arise when you follow a woman during her pregnancy,” she said.

Dr. Francoeur said that COVID-19 has been particularly tough on women, including pregnant and postpartum women, who are the most vulnerable.

“Especially during the COVID era, it was astonishing how women were not doing well. Their stress level was so high. We need to have a specific approach dedicated to prenatal mental health, because it’s a problem that is bigger than it used to be,” she said.

Violence against women has increased considerably since the beginning of the COVID-19 pandemic, said Dr. Francoeur. “Many more women have been killed by their partners. We have never seen anything like this before, and I hope we will never see this again,” she said.

“Help was more available a few years ago, but now, it’s really hard if and when you need to have a quick consultation with a specialist and the woman is really depressed. It can take forever. So, it’s okay to screen, but then, what’s next? Who is going to be there to take these women and help them? And we don’t have the answer,” Dr. Francoeur said.

Pregnant and postpartum women who suffer from depression need more than pills, she added. “We reassure them and treat their depression pharmacologically, but it’s also a time to give appropriate support and help them through the pregnancy and get well prepared to receive their newborn, because, as we now know, that first year of life is really important for the child, and the mom needs to be supported.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. Dr. Lang and Dr. Francoeur reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Canadian Task Force on Preventive Health Care recommends against the routine screening of all pregnant and postpartum women for depression using a standard questionnaire, according to its new guideline.

The basis for its position is the lack of evidence that such screening “adds value beyond discussions about overall wellbeing, depression, anxiety, and mood that are currently a part of established perinatal clinical care.

“We should not be using a one-size-fits all approach,” lead author Eddy Lang, MD, professor and head of emergency medicine at the Cumming School of Medicine, University of Calgary (Alta.), told this news organization.

Instead, the task force emphasizes regular clinical care, including asking patients about their wellbeing and support systems. The task force categorizes the recommendation as conditional and as having very low-certainty evidence.

The recommendation was published in CMAJ.
 

One randomized study

The task force is an independent panel of clinicians and scientists that makes recommendations on primary and secondary prevention in primary care. A working group of five members of the task force developed this recommendation with scientific support from Public Health Agency of Canada staff.

In its research, the task force found only one study that showed a benefit of routine depression screening in this population. This study was a randomized controlled trial conducted in Hong Kong. Researchers evaluated 462 postpartum women who were randomly assigned to receive screening with the Edinburgh Postnatal Depression Scale (EPDS) or no screening 2 months post partum.

“We found the effect of screening in this study to be very uncertain for the important outcomes of interest,” said Dr. Lang.

“These included parent-child stress, marital stress, and the number of infant hospital admissions. The effects of screening on all of these outcomes were very uncertain, mainly because it was such a small trial,” he said.

The task force also assessed how pregnant and postpartum women feel about being screened. What these women most wanted was a good relationship with a trusted primary care provider who would initiate discussions about their mental health in a caring atmosphere.

“Although they told us they liked the idea of universal screening, they admitted to their family doctors that they actually preferred to be asked about their wellbeing, [to be asked] how things were going at home, and [to have] a discussion about their mental health and wellbeing, rather than a formal screening process. They felt a discussion about depression with a primary health care provider during the pregnancy and postpartum period is critical,” said Dr. Lang.

Thus, the task force recommends “against instrument-based depression screening using a questionnaire with cutoff score to distinguish ‘screen positive’ and ‘screen negative’ administered to all individuals during pregnancy and the postpartum period (up to 1 year after childbirth).”
 

Screening remains common

“There’s a lot of uncertainty in the scientific community about whether it’s a good idea to administer a screening test to all pregnant and postpartum women to determine in a systematic way if they might be suffering from depression,” said Dr. Lang.

The task force recommended against screening for depression among perinatal or postpartum women in 2013, but screening is still performed in many provinces, said Dr. Lang.

Dr. Lang emphasized that the recommendation does not apply to usual care, in which the provider asks questions about and discusses a patient’s mental health and proceeds on the basis of their clinical judgment; nor does it apply to diagnostic pathways in which the clinician suspects that the individual may have depression and tests her accordingly.

“What we are saying in our recommendation is that all clinicians should ask about a patient’s wellbeing, about their mood, their anxiety, and these questions are an important part of the clinical assessment of pregnant and postpartum women. But we’re also saying the usefulness of doing so with a questionnaire and using a cutoff score on the questionnaire to decide who needs further assessment or possibly treatment is unproven by the research,” Dr. Lang said.
 

A growing problem

For Diane Francoeur, MD, CEO of the Society of Obstetricians and Gynecologists of Canada, this is all well and good, but the reality is that such screening is better than nothing.

Quebec is the only Canadian province that conducts universal screening for all pregnant and postpartum women, Dr. Francoeur said in an interview. She was not part of the task force.

“I agree that it should be more than one approach, but the problem is that there is such a shortage of resources. There are many issues that can arise when you follow a woman during her pregnancy,” she said.

Dr. Francoeur said that COVID-19 has been particularly tough on women, including pregnant and postpartum women, who are the most vulnerable.

“Especially during the COVID era, it was astonishing how women were not doing well. Their stress level was so high. We need to have a specific approach dedicated to prenatal mental health, because it’s a problem that is bigger than it used to be,” she said.

Violence against women has increased considerably since the beginning of the COVID-19 pandemic, said Dr. Francoeur. “Many more women have been killed by their partners. We have never seen anything like this before, and I hope we will never see this again,” she said.

“Help was more available a few years ago, but now, it’s really hard if and when you need to have a quick consultation with a specialist and the woman is really depressed. It can take forever. So, it’s okay to screen, but then, what’s next? Who is going to be there to take these women and help them? And we don’t have the answer,” Dr. Francoeur said.

Pregnant and postpartum women who suffer from depression need more than pills, she added. “We reassure them and treat their depression pharmacologically, but it’s also a time to give appropriate support and help them through the pregnancy and get well prepared to receive their newborn, because, as we now know, that first year of life is really important for the child, and the mom needs to be supported.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. Dr. Lang and Dr. Francoeur reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Approximately 80% of patients in intensive care showed clinical improvement in gram-positive bacterial infections after treatment with linezolid, based on data from more than 300 individuals.

Bacterial infections remain a challenge in the management of critically ill patients, as many gram-positive pathogens have become resistant to multiple drug options, Aijia Ma, MD, of West China Hospital of Sichuan University, and colleagues wrote.

Linezolid has demonstrated effectiveness against MRSA and skin and soft-tissue infections (SSTIs), but its use in critically ill patients with gram-positive infections in the ICU has not been characterized, they said.

In a multicenter, real-world study published in the Journal of Intensive Medicine, the researchers reviewed data from 52 hospitals between June 2018 and December 2019. The study population included 366 patients admitted to the ICU with a clinical or laboratory diagnosis of a gram-positive bacterial infection. Patients were treated with linezolid injections (200 mg/100 mL) and followed up once a day until 48 hours after discontinuing therapy, transferring out of the ICU, or death. Most of the patients (243) were older than 65 years; 90 were aged 18-65 years, and 30 were younger than 18 years. Approximately two-thirds (67%) were men. The primary outcome of clinical efficacy was success (cured or improved).

Linezolid was used as second-line and first-line treatment in 232 (63.4%) and 134 (36.6%) patients, respectively. The most common isolated strain was Staphylococcus aureus (31% MRSA; 12.6% methicillin-susceptible S. aureus [MSSA]) followed by Enterococci (6.7% vancomycin resistant, 9.2% vancomycin susceptible) and Streptococcus pneumoniae (3.4% multidrug resistant, 1.7% non–multidrug resistant).

Overall, 82.2% of patients met the criteria for clinical success; 34 (9.3%) were cured and 267 (73%) improved. Clinical success rates for first-line and second-line linezolid therapy were 79.9% and 83.6%, respectively. Failure rates for linezolid were higher for second-line versus first-line treatment (9.5% vs. 5.2%).

The clinical success rate was highest against MSSA (93.3%), followed by MRSA (83.8%). The average daily linezolid dose was 1,109 mg, and the mean treatment time was 5.1 days.

A total of eight patients (2.2%) reported linezolid-related adverse events, and four patients discontinued the medication because of them; none reported treatment-related serious adverse events. The low incidence of thrombocytopenia in the current study (two patients), compared with previous studies may have been related to avoidance of linezolid for at-risk patients as determined by clinicians, and the relatively short duration of linezolid use, the researchers wrote.

The study findings were limited by several factors, including the observational design and inability to compare the efficacy of different drugs; the small sample size; and the lack of data on drugs used prior to ICU admission, the researchers noted. Other limitations included the low detection rate of gram-positive bacteria and potential underreporting of adverse events.

However, the results suggest that linezolid is a safe and effective treatment for gram-positive bacterial infections, although clinicians will need to pay close attention to possible side effects and evaluate patient conditions on an individual basis before using linezolid in the clinic, they concluded.

The study was supported by grants from West China Hospital of Sichuan University. The researchers reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Approximately 80% of patients in intensive care showed clinical improvement in gram-positive bacterial infections after treatment with linezolid, based on data from more than 300 individuals.

Bacterial infections remain a challenge in the management of critically ill patients, as many gram-positive pathogens have become resistant to multiple drug options, Aijia Ma, MD, of West China Hospital of Sichuan University, and colleagues wrote.

Linezolid has demonstrated effectiveness against MRSA and skin and soft-tissue infections (SSTIs), but its use in critically ill patients with gram-positive infections in the ICU has not been characterized, they said.

In a multicenter, real-world study published in the Journal of Intensive Medicine, the researchers reviewed data from 52 hospitals between June 2018 and December 2019. The study population included 366 patients admitted to the ICU with a clinical or laboratory diagnosis of a gram-positive bacterial infection. Patients were treated with linezolid injections (200 mg/100 mL) and followed up once a day until 48 hours after discontinuing therapy, transferring out of the ICU, or death. Most of the patients (243) were older than 65 years; 90 were aged 18-65 years, and 30 were younger than 18 years. Approximately two-thirds (67%) were men. The primary outcome of clinical efficacy was success (cured or improved).

Linezolid was used as second-line and first-line treatment in 232 (63.4%) and 134 (36.6%) patients, respectively. The most common isolated strain was Staphylococcus aureus (31% MRSA; 12.6% methicillin-susceptible S. aureus [MSSA]) followed by Enterococci (6.7% vancomycin resistant, 9.2% vancomycin susceptible) and Streptococcus pneumoniae (3.4% multidrug resistant, 1.7% non–multidrug resistant).

Overall, 82.2% of patients met the criteria for clinical success; 34 (9.3%) were cured and 267 (73%) improved. Clinical success rates for first-line and second-line linezolid therapy were 79.9% and 83.6%, respectively. Failure rates for linezolid were higher for second-line versus first-line treatment (9.5% vs. 5.2%).

The clinical success rate was highest against MSSA (93.3%), followed by MRSA (83.8%). The average daily linezolid dose was 1,109 mg, and the mean treatment time was 5.1 days.

A total of eight patients (2.2%) reported linezolid-related adverse events, and four patients discontinued the medication because of them; none reported treatment-related serious adverse events. The low incidence of thrombocytopenia in the current study (two patients), compared with previous studies may have been related to avoidance of linezolid for at-risk patients as determined by clinicians, and the relatively short duration of linezolid use, the researchers wrote.

The study findings were limited by several factors, including the observational design and inability to compare the efficacy of different drugs; the small sample size; and the lack of data on drugs used prior to ICU admission, the researchers noted. Other limitations included the low detection rate of gram-positive bacteria and potential underreporting of adverse events.

However, the results suggest that linezolid is a safe and effective treatment for gram-positive bacterial infections, although clinicians will need to pay close attention to possible side effects and evaluate patient conditions on an individual basis before using linezolid in the clinic, they concluded.

The study was supported by grants from West China Hospital of Sichuan University. The researchers reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Approximately 80% of patients in intensive care showed clinical improvement in gram-positive bacterial infections after treatment with linezolid, based on data from more than 300 individuals.

Bacterial infections remain a challenge in the management of critically ill patients, as many gram-positive pathogens have become resistant to multiple drug options, Aijia Ma, MD, of West China Hospital of Sichuan University, and colleagues wrote.

Linezolid has demonstrated effectiveness against MRSA and skin and soft-tissue infections (SSTIs), but its use in critically ill patients with gram-positive infections in the ICU has not been characterized, they said.

In a multicenter, real-world study published in the Journal of Intensive Medicine, the researchers reviewed data from 52 hospitals between June 2018 and December 2019. The study population included 366 patients admitted to the ICU with a clinical or laboratory diagnosis of a gram-positive bacterial infection. Patients were treated with linezolid injections (200 mg/100 mL) and followed up once a day until 48 hours after discontinuing therapy, transferring out of the ICU, or death. Most of the patients (243) were older than 65 years; 90 were aged 18-65 years, and 30 were younger than 18 years. Approximately two-thirds (67%) were men. The primary outcome of clinical efficacy was success (cured or improved).

Linezolid was used as second-line and first-line treatment in 232 (63.4%) and 134 (36.6%) patients, respectively. The most common isolated strain was Staphylococcus aureus (31% MRSA; 12.6% methicillin-susceptible S. aureus [MSSA]) followed by Enterococci (6.7% vancomycin resistant, 9.2% vancomycin susceptible) and Streptococcus pneumoniae (3.4% multidrug resistant, 1.7% non–multidrug resistant).

Overall, 82.2% of patients met the criteria for clinical success; 34 (9.3%) were cured and 267 (73%) improved. Clinical success rates for first-line and second-line linezolid therapy were 79.9% and 83.6%, respectively. Failure rates for linezolid were higher for second-line versus first-line treatment (9.5% vs. 5.2%).

The clinical success rate was highest against MSSA (93.3%), followed by MRSA (83.8%). The average daily linezolid dose was 1,109 mg, and the mean treatment time was 5.1 days.

A total of eight patients (2.2%) reported linezolid-related adverse events, and four patients discontinued the medication because of them; none reported treatment-related serious adverse events. The low incidence of thrombocytopenia in the current study (two patients), compared with previous studies may have been related to avoidance of linezolid for at-risk patients as determined by clinicians, and the relatively short duration of linezolid use, the researchers wrote.

The study findings were limited by several factors, including the observational design and inability to compare the efficacy of different drugs; the small sample size; and the lack of data on drugs used prior to ICU admission, the researchers noted. Other limitations included the low detection rate of gram-positive bacteria and potential underreporting of adverse events.

However, the results suggest that linezolid is a safe and effective treatment for gram-positive bacterial infections, although clinicians will need to pay close attention to possible side effects and evaluate patient conditions on an individual basis before using linezolid in the clinic, they concluded.

The study was supported by grants from West China Hospital of Sichuan University. The researchers reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In advanced renal cell carcinoma, four out of five immuno-oncology drug-based combination treatments are showing impressive results in trials, a new review finds. Based on initial data, all appear to show advantages over the standard first-line treatment with the older targeted-therapy drug sunitinib.

However, the review, published in the International Journal of Urology, cautions that uncertainty remains because of the “absence of long-term prognostic as well as safety data regarding these combination therapies.”

The review, led by Ken-ichi Harada MD, PhD, of Kobe (Japan) University, notes that the introduction of targeted therapies and immuno-oncology drugs over the last 2 decades has revolutionized the treatment of advanced renal cell carcinoma. Multiple combination therapies based on immuno-oncology drugs are now recommended by treatment guidelines.

However, the lack of head-to-head data means that “it is still challenging for physicians to make the best decision on first-line therapy,” the authors wrote.

In the review, the authors recapped the evidence regarding several combination therapies:

• Ipilimumab plus nivolumab, a combination of two monoclonal antibodies, has shown higher overall survival than sunitinib in multiple studies. Treatment-related adverse events are common, however, with one trial reporting that they led 69% of patients to discontinue treatment. Even so, “ipilimumab plus nivolumab therapy continues to demonstrate durable efficacy benefits over sunitinib in advanced renal cell carcinoma patients classified into intermediate or poor risk group after long-term follow-up.”
• Avelumab, a monoclonal antibody, plus the tyrosine kinase inhibitor (TKI) axitinib has not shown better overall survival rates versus sunitinib in a single trial, although there are signs of better progression-free survival. “Accordingly, avelumab plus axitinib is either not or discreetly recommended as a standard first-line therapy for advanced renal cell carcinoma patients by major clinical guidelines.”
• Pembrolizumab, a monoclonal antibody, plus axitinib has shown better progression-free survival and overall survival than sunitinib in a single trial. “Accordingly, pembrolizumab plus axitinib could be expected to have a powerful impact on favorable long-term cancer control with less frequent occurrence of severe adverse events, considering almost equivalent landmark overall survival to ipilimumab plus nivolumab.”
• Nivolumab plus cabozantinib, a TKI, beat sunitinib in a single trial in terms of progression-free survival and overall survival. “Nivolumab plus cabozantinib could be regarded as an efficacious therapeutic option for untreated advanced renal cell carcinoma patients with manageable safety.”
• Pembrolizumab plus lenvatinib, a TKI, showed better overall survival versus sunitinib in a single trial.

“These findings suggest that pembrolizumab plus lenvatinib could provide marked benefits with regard to cancer control in treatment-naive advanced renal cell carcinoma patients, and that caution should be exercised regarding the safety profile, considering the initial introduction of lenvatinib in the field of urological malignancies,” the authors wrote.

When compared against each other, most of these treatments appear to perform similarly, the authors wrote. With the exception of avelumab plus axitinib, all “showed almost similar advantages for the improvement of overall survival compared with sunitinib, judging from hazard ratios, and all five immuno-oncology drug-based combination therapies, particularly pembrolizumab plus lenvatinib, significantly prolonged progression-free survival, compared with sunitinib.”

No study funding was reported. The authors report various disclosures including relationships to Novartis, Pfizer, Ono, Takeda, MSD, Merck, and Bristol-Myers Squibb.

In advanced renal cell carcinoma, four out of five immuno-oncology drug-based combination treatments are showing impressive results in trials, a new review finds. Based on initial data, all appear to show advantages over the standard first-line treatment with the older targeted-therapy drug sunitinib.

However, the review, published in the International Journal of Urology, cautions that uncertainty remains because of the “absence of long-term prognostic as well as safety data regarding these combination therapies.”

The review, led by Ken-ichi Harada MD, PhD, of Kobe (Japan) University, notes that the introduction of targeted therapies and immuno-oncology drugs over the last 2 decades has revolutionized the treatment of advanced renal cell carcinoma. Multiple combination therapies based on immuno-oncology drugs are now recommended by treatment guidelines.

However, the lack of head-to-head data means that “it is still challenging for physicians to make the best decision on first-line therapy,” the authors wrote.

In the review, the authors recapped the evidence regarding several combination therapies:

• Ipilimumab plus nivolumab, a combination of two monoclonal antibodies, has shown higher overall survival than sunitinib in multiple studies. Treatment-related adverse events are common, however, with one trial reporting that they led 69% of patients to discontinue treatment. Even so, “ipilimumab plus nivolumab therapy continues to demonstrate durable efficacy benefits over sunitinib in advanced renal cell carcinoma patients classified into intermediate or poor risk group after long-term follow-up.”
• Avelumab, a monoclonal antibody, plus the tyrosine kinase inhibitor (TKI) axitinib has not shown better overall survival rates versus sunitinib in a single trial, although there are signs of better progression-free survival. “Accordingly, avelumab plus axitinib is either not or discreetly recommended as a standard first-line therapy for advanced renal cell carcinoma patients by major clinical guidelines.”
• Pembrolizumab, a monoclonal antibody, plus axitinib has shown better progression-free survival and overall survival than sunitinib in a single trial. “Accordingly, pembrolizumab plus axitinib could be expected to have a powerful impact on favorable long-term cancer control with less frequent occurrence of severe adverse events, considering almost equivalent landmark overall survival to ipilimumab plus nivolumab.”
• Nivolumab plus cabozantinib, a TKI, beat sunitinib in a single trial in terms of progression-free survival and overall survival. “Nivolumab plus cabozantinib could be regarded as an efficacious therapeutic option for untreated advanced renal cell carcinoma patients with manageable safety.”
• Pembrolizumab plus lenvatinib, a TKI, showed better overall survival versus sunitinib in a single trial.

“These findings suggest that pembrolizumab plus lenvatinib could provide marked benefits with regard to cancer control in treatment-naive advanced renal cell carcinoma patients, and that caution should be exercised regarding the safety profile, considering the initial introduction of lenvatinib in the field of urological malignancies,” the authors wrote.

When compared against each other, most of these treatments appear to perform similarly, the authors wrote. With the exception of avelumab plus axitinib, all “showed almost similar advantages for the improvement of overall survival compared with sunitinib, judging from hazard ratios, and all five immuno-oncology drug-based combination therapies, particularly pembrolizumab plus lenvatinib, significantly prolonged progression-free survival, compared with sunitinib.”

No study funding was reported. The authors report various disclosures including relationships to Novartis, Pfizer, Ono, Takeda, MSD, Merck, and Bristol-Myers Squibb.

In advanced renal cell carcinoma, four out of five immuno-oncology drug-based combination treatments are showing impressive results in trials, a new review finds. Based on initial data, all appear to show advantages over the standard first-line treatment with the older targeted-therapy drug sunitinib.

However, the review, published in the International Journal of Urology, cautions that uncertainty remains because of the “absence of long-term prognostic as well as safety data regarding these combination therapies.”

The review, led by Ken-ichi Harada MD, PhD, of Kobe (Japan) University, notes that the introduction of targeted therapies and immuno-oncology drugs over the last 2 decades has revolutionized the treatment of advanced renal cell carcinoma. Multiple combination therapies based on immuno-oncology drugs are now recommended by treatment guidelines.

However, the lack of head-to-head data means that “it is still challenging for physicians to make the best decision on first-line therapy,” the authors wrote.

In the review, the authors recapped the evidence regarding several combination therapies:

• Ipilimumab plus nivolumab, a combination of two monoclonal antibodies, has shown higher overall survival than sunitinib in multiple studies. Treatment-related adverse events are common, however, with one trial reporting that they led 69% of patients to discontinue treatment. Even so, “ipilimumab plus nivolumab therapy continues to demonstrate durable efficacy benefits over sunitinib in advanced renal cell carcinoma patients classified into intermediate or poor risk group after long-term follow-up.”
• Avelumab, a monoclonal antibody, plus the tyrosine kinase inhibitor (TKI) axitinib has not shown better overall survival rates versus sunitinib in a single trial, although there are signs of better progression-free survival. “Accordingly, avelumab plus axitinib is either not or discreetly recommended as a standard first-line therapy for advanced renal cell carcinoma patients by major clinical guidelines.”
• Pembrolizumab, a monoclonal antibody, plus axitinib has shown better progression-free survival and overall survival than sunitinib in a single trial. “Accordingly, pembrolizumab plus axitinib could be expected to have a powerful impact on favorable long-term cancer control with less frequent occurrence of severe adverse events, considering almost equivalent landmark overall survival to ipilimumab plus nivolumab.”
• Nivolumab plus cabozantinib, a TKI, beat sunitinib in a single trial in terms of progression-free survival and overall survival. “Nivolumab plus cabozantinib could be regarded as an efficacious therapeutic option for untreated advanced renal cell carcinoma patients with manageable safety.”
• Pembrolizumab plus lenvatinib, a TKI, showed better overall survival versus sunitinib in a single trial.

“These findings suggest that pembrolizumab plus lenvatinib could provide marked benefits with regard to cancer control in treatment-naive advanced renal cell carcinoma patients, and that caution should be exercised regarding the safety profile, considering the initial introduction of lenvatinib in the field of urological malignancies,” the authors wrote.

When compared against each other, most of these treatments appear to perform similarly, the authors wrote. With the exception of avelumab plus axitinib, all “showed almost similar advantages for the improvement of overall survival compared with sunitinib, judging from hazard ratios, and all five immuno-oncology drug-based combination therapies, particularly pembrolizumab plus lenvatinib, significantly prolonged progression-free survival, compared with sunitinib.”

No study funding was reported. The authors report various disclosures including relationships to Novartis, Pfizer, Ono, Takeda, MSD, Merck, and Bristol-Myers Squibb.

On June 24, the U.S. Supreme Court overturned Roe v. Wade, a decision that was issued in 1973. From now on, each state will be able to choose the laws that it wants to put in place regarding abortion. Several states have already decided to ban abortion altogether. As a physician, but also as a woman, I am stunned to see this opposition to a right that, in my opinion, is also a matter of public health.

International data

In Belgium, voluntary termination of pregnancy (VTP) has been allowed since 1990. Except in the case of a serious medical problem, the abortion must take place before the end of the 12th week after conception. So, 14 weeks from the last menstrual period (LMP).

Beyond that time frame, a VTP can be performed only when the continuation of the pregnancy endangers the health of the woman or when it is certain that the unborn child will be affected by a condition of particular gravity and recognized as incurable at the time of diagnosis. This is referred to as termination for medical reasons (TFMR).
 

First observation

The annual number of VTPs did not climb following legalization. For the past 20 years in Belgium, that number has remained stable, hovering around 19,000. Abortion continues to be an action – neither trivialized nor minimized – that is difficult for any woman to take, no matter what her reason.

Second observation

Over 60% of women who had an abortion were using a form of contraception. So, while the burden of contraception still rests almost exclusively on the woman, it cannot be said that those who had a VTP did not use some method of birth control.

Even more important, legal abortions have very few complications, either physical or psychological. Studies show that pregnancy itself carries a higher risk for psychopathological manifestations than a VTP. These VTPs are safe, and women quickly recover from them. The most sensitive time seems to be the period before the abortion, and it’s at this stage that most of the psychological and psychopathological manifestations accumulate. The majority of women facing a VTP experience feelings of relief, and only a minority develop psychological problems, usually when there is already a history of mental disorder. The literature shows that the levels of anxiety and depression decrease in the month following the abortion. Being denied a VTP, on the other hand, significantly increases the woman’s risk of developing a mental disorder.

Should a VTP be denied, a woman, if she determines that she doesn’t have any other choice, may then end up turning to a back-alley abortion. The methods used for this are medieval, dangerous, and may not prove successful – things like using chemicals, piercing the amniotic sac with a needle or sharp object (the famous coat hanger), eating or drinking abortifacient herbs, taking large quantities of medication, punching the stomach, falling down stairs, and engaging in intense physical exercise.

From there, these risky methods inevitably lead to numerous complications: Incomplete abortions, infections, septicemia, breakthrough bleeding, subsequent sterility, laceration of the uterine wall, or death.

Around one-third of women who undergo risky abortions develop complications, while less than half receive care.

The World Health Organization estimates that back-alley abortions represent 49% of abortions worldwide. It puts the number of illegal abortions performed each year at 20 million.

Each year, around 60,000 women worldwide die as a result of an unsafe VTP. That’s one woman every 9 minutes. And odds are that these figures are underestimated.

Making the decision to resort to a VTP is always difficult. Ideally, you should be able to discuss it with your partner, when there is one, and with your close friends and family, to have someone go with you as support, to weigh the pros and cons, and to make a choice in line with your convictions and your conscience. But first and foremost, the law must guarantee the right to be able to ask oneself this question, because guaranteeing this right is also guaranteeing the health and safety of women, and that is why this remains a public health imperative.

A version of this article first appeared on Medscape.com. This article was translated from MediQuality.

On June 24, the U.S. Supreme Court overturned Roe v. Wade, a decision that was issued in 1973. From now on, each state will be able to choose the laws that it wants to put in place regarding abortion. Several states have already decided to ban abortion altogether. As a physician, but also as a woman, I am stunned to see this opposition to a right that, in my opinion, is also a matter of public health.

International data

In Belgium, voluntary termination of pregnancy (VTP) has been allowed since 1990. Except in the case of a serious medical problem, the abortion must take place before the end of the 12th week after conception. So, 14 weeks from the last menstrual period (LMP).

Beyond that time frame, a VTP can be performed only when the continuation of the pregnancy endangers the health of the woman or when it is certain that the unborn child will be affected by a condition of particular gravity and recognized as incurable at the time of diagnosis. This is referred to as termination for medical reasons (TFMR).
 

First observation

The annual number of VTPs did not climb following legalization. For the past 20 years in Belgium, that number has remained stable, hovering around 19,000. Abortion continues to be an action – neither trivialized nor minimized – that is difficult for any woman to take, no matter what her reason.

Second observation

Over 60% of women who had an abortion were using a form of contraception. So, while the burden of contraception still rests almost exclusively on the woman, it cannot be said that those who had a VTP did not use some method of birth control.

Even more important, legal abortions have very few complications, either physical or psychological. Studies show that pregnancy itself carries a higher risk for psychopathological manifestations than a VTP. These VTPs are safe, and women quickly recover from them. The most sensitive time seems to be the period before the abortion, and it’s at this stage that most of the psychological and psychopathological manifestations accumulate. The majority of women facing a VTP experience feelings of relief, and only a minority develop psychological problems, usually when there is already a history of mental disorder. The literature shows that the levels of anxiety and depression decrease in the month following the abortion. Being denied a VTP, on the other hand, significantly increases the woman’s risk of developing a mental disorder.

Should a VTP be denied, a woman, if she determines that she doesn’t have any other choice, may then end up turning to a back-alley abortion. The methods used for this are medieval, dangerous, and may not prove successful – things like using chemicals, piercing the amniotic sac with a needle or sharp object (the famous coat hanger), eating or drinking abortifacient herbs, taking large quantities of medication, punching the stomach, falling down stairs, and engaging in intense physical exercise.

From there, these risky methods inevitably lead to numerous complications: Incomplete abortions, infections, septicemia, breakthrough bleeding, subsequent sterility, laceration of the uterine wall, or death.

Around one-third of women who undergo risky abortions develop complications, while less than half receive care.

The World Health Organization estimates that back-alley abortions represent 49% of abortions worldwide. It puts the number of illegal abortions performed each year at 20 million.

Each year, around 60,000 women worldwide die as a result of an unsafe VTP. That’s one woman every 9 minutes. And odds are that these figures are underestimated.

Making the decision to resort to a VTP is always difficult. Ideally, you should be able to discuss it with your partner, when there is one, and with your close friends and family, to have someone go with you as support, to weigh the pros and cons, and to make a choice in line with your convictions and your conscience. But first and foremost, the law must guarantee the right to be able to ask oneself this question, because guaranteeing this right is also guaranteeing the health and safety of women, and that is why this remains a public health imperative.

A version of this article first appeared on Medscape.com. This article was translated from MediQuality.

On June 24, the U.S. Supreme Court overturned Roe v. Wade, a decision that was issued in 1973. From now on, each state will be able to choose the laws that it wants to put in place regarding abortion. Several states have already decided to ban abortion altogether. As a physician, but also as a woman, I am stunned to see this opposition to a right that, in my opinion, is also a matter of public health.

International data

In Belgium, voluntary termination of pregnancy (VTP) has been allowed since 1990. Except in the case of a serious medical problem, the abortion must take place before the end of the 12th week after conception. So, 14 weeks from the last menstrual period (LMP).

Beyond that time frame, a VTP can be performed only when the continuation of the pregnancy endangers the health of the woman or when it is certain that the unborn child will be affected by a condition of particular gravity and recognized as incurable at the time of diagnosis. This is referred to as termination for medical reasons (TFMR).
 

First observation

The annual number of VTPs did not climb following legalization. For the past 20 years in Belgium, that number has remained stable, hovering around 19,000. Abortion continues to be an action – neither trivialized nor minimized – that is difficult for any woman to take, no matter what her reason.

Second observation

Over 60% of women who had an abortion were using a form of contraception. So, while the burden of contraception still rests almost exclusively on the woman, it cannot be said that those who had a VTP did not use some method of birth control.

Even more important, legal abortions have very few complications, either physical or psychological. Studies show that pregnancy itself carries a higher risk for psychopathological manifestations than a VTP. These VTPs are safe, and women quickly recover from them. The most sensitive time seems to be the period before the abortion, and it’s at this stage that most of the psychological and psychopathological manifestations accumulate. The majority of women facing a VTP experience feelings of relief, and only a minority develop psychological problems, usually when there is already a history of mental disorder. The literature shows that the levels of anxiety and depression decrease in the month following the abortion. Being denied a VTP, on the other hand, significantly increases the woman’s risk of developing a mental disorder.

Should a VTP be denied, a woman, if she determines that she doesn’t have any other choice, may then end up turning to a back-alley abortion. The methods used for this are medieval, dangerous, and may not prove successful – things like using chemicals, piercing the amniotic sac with a needle or sharp object (the famous coat hanger), eating or drinking abortifacient herbs, taking large quantities of medication, punching the stomach, falling down stairs, and engaging in intense physical exercise.

From there, these risky methods inevitably lead to numerous complications: Incomplete abortions, infections, septicemia, breakthrough bleeding, subsequent sterility, laceration of the uterine wall, or death.

Around one-third of women who undergo risky abortions develop complications, while less than half receive care.

The World Health Organization estimates that back-alley abortions represent 49% of abortions worldwide. It puts the number of illegal abortions performed each year at 20 million.

Each year, around 60,000 women worldwide die as a result of an unsafe VTP. That’s one woman every 9 minutes. And odds are that these figures are underestimated.

Making the decision to resort to a VTP is always difficult. Ideally, you should be able to discuss it with your partner, when there is one, and with your close friends and family, to have someone go with you as support, to weigh the pros and cons, and to make a choice in line with your convictions and your conscience. But first and foremost, the law must guarantee the right to be able to ask oneself this question, because guaranteeing this right is also guaranteeing the health and safety of women, and that is why this remains a public health imperative.

A version of this article first appeared on Medscape.com. This article was translated from MediQuality.

The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).

From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.

This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.

SAGE recommends updating HPV dose schedules as follows:

• One- or two-dose schedule for the primary target of girls aged 9-14 years.
• One- or two-dose schedule for young women aged 15-20.
• Two doses with a 6-month interval for women older than 21.

The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.

“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.

For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
 

Policy makers need to make changes

Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.

“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.

Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.

The editorialists also make a radical proposal.

Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).

To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
 

Two doses in high-income countries

But it is unclear whether high-income countries are ready to move to a one-dose schedule.

Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”

However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.

“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”

Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.

“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.

At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.

Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.

But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.

Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
 

Trials of one-dose schedules

The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.

The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.

A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.

Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”

Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.

“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
 

Ethics of the vaccine

In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”

It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.

To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”

Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.

Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).

From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.

This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.

SAGE recommends updating HPV dose schedules as follows:

• One- or two-dose schedule for the primary target of girls aged 9-14 years.
• One- or two-dose schedule for young women aged 15-20.
• Two doses with a 6-month interval for women older than 21.

The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.

“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.

For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
 

Policy makers need to make changes

Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.

“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.

Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.

The editorialists also make a radical proposal.

Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).

To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
 

Two doses in high-income countries

But it is unclear whether high-income countries are ready to move to a one-dose schedule.

Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”

However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.

“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”

Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.

“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.

At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.

Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.

But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.

Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
 

Trials of one-dose schedules

The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.

The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.

A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.

Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”

Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.

“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
 

Ethics of the vaccine

In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”

It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.

To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”

Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.

Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE) has changed the recommendation for vaccines against human papillomavirus (HPV).

From the available evidence, SAGE has concluded that a single dose of vaccine offers solid protection against HPV, comparable to that achieved with two-dose schedules.

This could be a “game-changer for the prevention of the disease,” as it would allow “more doses of the life-saving jab reach more girls,” the WHO declared in a press release.

SAGE recommends updating HPV dose schedules as follows:

• One- or two-dose schedule for the primary target of girls aged 9-14 years.
• One- or two-dose schedule for young women aged 15-20.
• Two doses with a 6-month interval for women older than 21.

The HPV vaccine is highly effective for the prevention of HPV serotypes 16 and 18, which cause 70% of cases of cervical cancer, said Alejandro Cravioto, MD, PhD, SAGE chair, in a statement.

“SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch up of missed and older cohorts of girls. These recommendations will enable more girls and women to be vaccinated and thus preventing them from having cervical cancer and all its consequences over the course of their lifetimes,” he added.

For individuals who are immunocompromised, including those with HIV, three doses of the vaccine should be given if feasible, and if not, then at least two doses. There is limited evidence regarding the efficacy of a single dose in this group, the advisory group noted.
 

Policy makers need to make changes

Now that the WHO has deemed that one dose of HPV vaccine is sufficient, policy makers should make changes, say experts in a recent editorial comment published in The Lancet Oncology.

“Policy makers should consider modifying their HPV immunization schedules for girls aged 9-14 years from a two-dose regimen to a one-dose regimen,” wrote Jeff D’Souza, PhD, Institute for Better Health, Trillium Health Partners, Mississauga, Ont., and David Nderitu, PhD, Egerton University, Nakuru County, Kenya.

Policy makers also need to consider reorienting their efforts on cervical cancer screening and treatment, and they should ensure that all girls globally have access to an effective HPV vaccination schedule, they add.

The editorialists also make a radical proposal.

Existing supply constraints of the HPV vaccine at the country level are expected to continue for the next 3 years, and the vast majority of new cervical cancer cases and related deaths occur in low- and middle-income countries (LMICs).

To overcome these problems, they suggest that “high-income countries that currently offer two-dose regimens to girls aged 9-14 years should consider opting for a one-dose vaccination schedule, and give any excess of vaccines to countries in greater need of them.”
 

Two doses in high-income countries

But it is unclear whether high-income countries are ready to move to a one-dose schedule.

Approached for comment, Maurie Markman, MD, president of medicine and science at Cancer Treatment Centers of America, Philadelphia, told this news organization that while he can’t say for certain, he suspects that the United States will be slower to accept this recommendation for a single dose of HPV vaccine “as a component of a ‘standard-of-care’ approach.”

However, it “might formally acknowledge that if an individual/parent will only accept a single vaccine dose (or ultimately refuses to return for a recommended second dose), this will be considered a favorable outcome, both for the individual and society.

“I do not know if regulatory bodies in the United States will accept the existing studies performed to address the one-dose vaccination strategy to rather dramatically change the approach in our country,” he said. “The issue would be that if a single dose was stated to be a clinically acceptable option in the United States, it would rapidly become the standard approach, and the regulators would want to be as certain as possible that this would not have a negative effect on what is now recognized to be a remarkably safe and effective cancer prevention effort.”

Another expert who was approached for comment, Stephanie V. Blank, MD, professor of gynecologic oncology at the Icahn School of Medicine at Mount Sinai, New York, said: “In higher-resourced countries, two doses are still preferred, as they are more effective than one.

“The modeling on which the SAGE recommendation is based is all from studies in LMICs and other modeling studies,” she added.

At present, the Centers for Disease Control and Prevention recommends a two-dose schedule of HPV vaccines for individuals who receive the first dose before their 15th birthday. The three-dose schedule is recommended for those who receive the first dose on or after their 15th birthday and for people with certain immunocompromising conditions.

Studies have shown that two doses of HPV vaccine given to children aged 9-14 years provide as good or better protection than three doses given to older adolescents or young adults.

But even with a two-dose schedule, the WHO reports that uptake of the vaccine has been slow, and coverage is much lower than their 90% target. In 2020, global coverage with two doses was only 13%.

Factors that have influenced the slow uptake and low coverage of HPV vaccines include supply challenges, programmatic challenges, and costs related to delivering a two-dose regimen to older girls who are not typically included in childhood vaccination programs. The relatively high cost of HPV vaccines has also been problematic, particularly for middle-income countries.
 

Trials of one-dose schedules

The one-dose vaccine schedule has garnered a lot of interest, with several studies showing efficacy.

The KEN SHE trial, based in Kenya, showed that a single dose of the HPV vaccine was highly effective at preventing oncogenic infection, rivaling the protection offered by multidose regimens. Vaccine efficacy was 97.5% (P < .001) against HPV 16/18 for both the bivalent and monovalent vaccines, which is “comparable to that seen in multidose vaccine trials,” the researchers noted.

A study in India found that efficacy against persistent HPV 16 and 18 infection among participants evaluable for the endpoint was 95.4% for the single dose, 93.1% for the two-dose schedule, and 93.3% for the three-dose series.

Commenting on this trial in India in a recent interview with this news organization, Geoffroy Canlorbe, MD, PhD, of the department of gynecologic and breast surgery and oncology, Pitié-Salpêtrière Hospital, Paris, said the findings from India would need “to be confirmed by other studies.” The results were nonetheless “excellent news for developing countries where there are challenges when it comes to access to vaccination.”

Speaking at the 45th Congress of the French Society for Colposcopy and Cervical and Vaginal Diseases, he emphasized that at this stage, the findings “cannot be extrapolated” to France. HPV vaccination coverage is low in France (it is estimated that the rate is 23.7%, placing the country 28th of 31 countries in Europe), and he recommended continuing with the two- or three-dose schedule for the time being.

“This poor coverage has nothing to do with health care–related logistical or organizational issues; instead, it has to do with people’s mistrust when it comes to vaccination. Here, people who get the first dose get the subsequent ones,” said Dr. Canlorbe. “The very fact of getting two to three doses allows the person’s body to increase the production of antibodies and get a longer-lasting response to the vaccine.”
 

Ethics of the vaccine

In their editorial, Dr. D’Souza and Dr. Nderitu note that there are ethical considerations with the HPV vaccine that can “help guide deliberations, covering nonmaleficence, beneficence, health equity, stewardship, and solidarity.”

It would be inequitable and unjustifiable, they write, to offer a two-dose regimen to girls aged 9-14 years without also introducing multi-age cohort catch-up campaigns or programs for women who do not have access. “When it comes to an effective HPV vaccination schedule, no woman or girl should be left behind,” they say.

To achieve the goal of eliminating cervical cancer, “countries must ensure that 90% of girls are vaccinated, 70% of women are screened, and 90% of women with precancerous lesions receive treatment and care,” they write. “Given resource constraints, particularly in low-middle income countries, policy makers have a responsibility to ensure that resources are used in an optimal manner that promotes the right to health of all individuals.”

Thus, countries that are lagging far behind in cervical cancer education, screening, and treatment should consider opting for a one-dose regimen for girls aged 9-14 years, as well as using additional resources to close the gap in these other areas.

Dr. Markman has relationships with Genentech, AstraZeneca, Celgene, Clovis, and Amgen; he is also a regular contributor to Medscape Oncology with the Markamn on Oncology video column. Dr. D’Souza and Dr. Nderitu have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cee Elliot is afraid of pregnancy. The 29-year-old retail manager in Connecticut said she has felt that way since puberty, when she “finally understood” pregnancy and reproduction. Always squeamish around babies and pregnant people, she said, as she learned more about the complications birth can cause, the idea of carrying a child herself became increasingly repulsive.

Later, Ms. Elliot said, she was treated poorly by a partner because of her fears, leading to regular panic attacks. She moved on from that partner, but her fear of pregnancy did not. Along the way, she felt her fears were dismissed by doctors and peers alike.

Tokophobia – a severe fear of childbirth – goes beyond the typical anxieties about birth or pregnancy that women often experience. The condition can intrude on everyday life, crippling social interaction and interrupting regular sleep patterns. Although statistics in the United States don’t exist, as many as 14% of women internationally are thought to have tokophobia.

Although psychiatric treatment focusing on past traumas can help, many women resort to managing the condition themselves. Some seek sterilization, whereas others take multiple forms of contraception simultaneously – combining intrauterine devices and oral birth control, for example, experts said. Some women have sought abortions and some even have attempted suicide rather than face giving birth, according to Leila Frodsham, MbChB, a women’s health expert at King’s College London, who has studied tokophobia.

The International Classification of Diseases added tokophobia to its list of diagnostic codes in 2018. But the Diagnostic and Statistical Manual of Mental Disorders, used by clinicians in the United States, has yet to do the same. Without this designation, some doctors are more inclined to diagnose tokophobia than others, Dr. Frodsham said.

“I think some clinicians struggle to understand how much this condition affects women. There isn’t training in it, and I’d like to see it discussed more,” Dr. Frodsham told this news organization.

Dr. Frodsham said she has seen hundreds of patients seeking help with their fear of pregnancy. Many of these women don’t know that they might have a condition that could benefit from psychiatric treatment.

Tokophobia typically takes two forms: primary, which affects women who have never given birth; and secondary, which stems from a previous traumatic birth experience.

“It’s not the pain of childbirth they are afraid of, but rather their fear comes out of a sense that they lack control over themselves and the situation of being pregnant,” Dr. Frodsham said.

Although the phenomenon has been studied internationally, particularly in Europe, fear of childbirth remains almost entirely unexplored in the United States literature.

One of the only scientific examinations of tokophobia in this country was a 2016 survey of 22 women with the condition by researchers at the University of Michigan, Ann Arbor. Published in the Journal of Obstetric, Gynecology & Neonatal Nursing, the survey found that many of the women expressed concern that their race, gender, or level of income might affect the quality of their care. Some women surveyed said they had experienced traumas directly related to systemic inequalities in the health care system.

Lee Roosevelt, PhD, MPH, CNM, a nurse and midwife and a coauthor of the study, said fear of the health care system, coupled with concern over the loss of bodily autonomy, can foster severe aversion to childbirth. In her experience, she said, clinicians often handle these patients poorly.

“If a woman is making the decision not to have children, we want it to be because she has decided for her, and her body, that it is the right thing,” added Lisa Kane Low, PhD, CNM, professor of obstetrics and gynecology at the University of Michigan, who worked with Dr. Roosevelt on the survey. “She shouldn’t feel the decision is made because she can’t access what she needs or the health care system is unable to provide it.”

Access to midwives, doulas, or therapists trained in trauma counseling can allow women to have a voice in their treatment, Dr. Roosevelt said.

No specific medication exists to treat tokophobia; however, drugs for depression or anxiety sometimes help, Dr. Low said. “Women with tokophobia may not need medication but would benefit from other therapies like desensitization or biobehavioral approaches or combinations of those,” she said.
 

Treating triggers

According to Dr. Frodsham, women with tokophobia often experience guilt and isolation. They may avoid speaking to women who are pregnant or avoid discussing pregnancy and childbirth, afraid that doing so may trigger their fear.

“They can’t see how they can get close to this catastrophic thing they think is going to happen to them,” she said. “Many of them think they will die.”

Many patients avoid thinking about memories of traumatic events so as to not trigger extreme emotional responses.

Dr. Roosevelt said developing ways to assess and treat tokophobia has become more urgent, since the Supreme Court’s recent decision to overturn Roe v. Wade could lead to more instances of women carrying unwanted pregnancies.
 

Seeking community

The internet has become a place where women with tokophobia and less severe fears about pregnancy can share their experiences. On the online bulletin board Reddit, r/Tokphobia and r/childfree contain thousands of queries and personal stories about the condition, as well as requests for advice.

Jillian Kilcoyne, who lives in New York and attends college in Michigan, said: “Pregnancy has always freaked me out. A part of me believes it’s a biological injustice that women have to go through such pain and be ignored by the medical community just to give birth.” Ms. Kilcoyne said she has not sought counseling or help from a clinician.

“I’m not sure I even want it,” she told this news organization. “Some people want to get over their phobia because they want families, and others don’t want children at all. I think that those individuals should have the help they need.”

Claudia, a South Carolina resident who asked to be identified only by her first name owing to concerns about her privacy, said her tokophobia began when she started having sex. It grew worse when she developed health conditions that could be exacerbated by pregnancy. She said she stocks up on contraceptives and periodically takes a pregnancy test to ease her nerves.

“This started for me when I realized that having children wasn’t a requirement for life. I didn’t even know there was a name for what I was feeling,” Claudia said in an interview. “So, letting women know they have options, and then not making them feel guilty, or ashamed, is the most important thing. We shouldn’t try to convince women that motherhood is the only, or the correct, path.”

Ms. Elliot urged clinicians to have compassion: “Treat tokophobic patients – especially a pregnant one seeking an abortion – like someone with a life-threatening parasite. Don’t belittle or dismiss them. We’re already going to lose so many lives because of unwanted pregnancies and birth. Don’t add to the number.”

A version of this article first appeared on Medscape.com.

Cee Elliot is afraid of pregnancy. The 29-year-old retail manager in Connecticut said she has felt that way since puberty, when she “finally understood” pregnancy and reproduction. Always squeamish around babies and pregnant people, she said, as she learned more about the complications birth can cause, the idea of carrying a child herself became increasingly repulsive.

Later, Ms. Elliot said, she was treated poorly by a partner because of her fears, leading to regular panic attacks. She moved on from that partner, but her fear of pregnancy did not. Along the way, she felt her fears were dismissed by doctors and peers alike.

Tokophobia – a severe fear of childbirth – goes beyond the typical anxieties about birth or pregnancy that women often experience. The condition can intrude on everyday life, crippling social interaction and interrupting regular sleep patterns. Although statistics in the United States don’t exist, as many as 14% of women internationally are thought to have tokophobia.

Although psychiatric treatment focusing on past traumas can help, many women resort to managing the condition themselves. Some seek sterilization, whereas others take multiple forms of contraception simultaneously – combining intrauterine devices and oral birth control, for example, experts said. Some women have sought abortions and some even have attempted suicide rather than face giving birth, according to Leila Frodsham, MbChB, a women’s health expert at King’s College London, who has studied tokophobia.

The International Classification of Diseases added tokophobia to its list of diagnostic codes in 2018. But the Diagnostic and Statistical Manual of Mental Disorders, used by clinicians in the United States, has yet to do the same. Without this designation, some doctors are more inclined to diagnose tokophobia than others, Dr. Frodsham said.

“I think some clinicians struggle to understand how much this condition affects women. There isn’t training in it, and I’d like to see it discussed more,” Dr. Frodsham told this news organization.

Dr. Frodsham said she has seen hundreds of patients seeking help with their fear of pregnancy. Many of these women don’t know that they might have a condition that could benefit from psychiatric treatment.

Tokophobia typically takes two forms: primary, which affects women who have never given birth; and secondary, which stems from a previous traumatic birth experience.

“It’s not the pain of childbirth they are afraid of, but rather their fear comes out of a sense that they lack control over themselves and the situation of being pregnant,” Dr. Frodsham said.

Although the phenomenon has been studied internationally, particularly in Europe, fear of childbirth remains almost entirely unexplored in the United States literature.

One of the only scientific examinations of tokophobia in this country was a 2016 survey of 22 women with the condition by researchers at the University of Michigan, Ann Arbor. Published in the Journal of Obstetric, Gynecology & Neonatal Nursing, the survey found that many of the women expressed concern that their race, gender, or level of income might affect the quality of their care. Some women surveyed said they had experienced traumas directly related to systemic inequalities in the health care system.

Lee Roosevelt, PhD, MPH, CNM, a nurse and midwife and a coauthor of the study, said fear of the health care system, coupled with concern over the loss of bodily autonomy, can foster severe aversion to childbirth. In her experience, she said, clinicians often handle these patients poorly.

“If a woman is making the decision not to have children, we want it to be because she has decided for her, and her body, that it is the right thing,” added Lisa Kane Low, PhD, CNM, professor of obstetrics and gynecology at the University of Michigan, who worked with Dr. Roosevelt on the survey. “She shouldn’t feel the decision is made because she can’t access what she needs or the health care system is unable to provide it.”

Access to midwives, doulas, or therapists trained in trauma counseling can allow women to have a voice in their treatment, Dr. Roosevelt said.

No specific medication exists to treat tokophobia; however, drugs for depression or anxiety sometimes help, Dr. Low said. “Women with tokophobia may not need medication but would benefit from other therapies like desensitization or biobehavioral approaches or combinations of those,” she said.
 

Treating triggers

According to Dr. Frodsham, women with tokophobia often experience guilt and isolation. They may avoid speaking to women who are pregnant or avoid discussing pregnancy and childbirth, afraid that doing so may trigger their fear.

“They can’t see how they can get close to this catastrophic thing they think is going to happen to them,” she said. “Many of them think they will die.”

Many patients avoid thinking about memories of traumatic events so as to not trigger extreme emotional responses.

Dr. Roosevelt said developing ways to assess and treat tokophobia has become more urgent, since the Supreme Court’s recent decision to overturn Roe v. Wade could lead to more instances of women carrying unwanted pregnancies.
 

Seeking community

The internet has become a place where women with tokophobia and less severe fears about pregnancy can share their experiences. On the online bulletin board Reddit, r/Tokphobia and r/childfree contain thousands of queries and personal stories about the condition, as well as requests for advice.

Jillian Kilcoyne, who lives in New York and attends college in Michigan, said: “Pregnancy has always freaked me out. A part of me believes it’s a biological injustice that women have to go through such pain and be ignored by the medical community just to give birth.” Ms. Kilcoyne said she has not sought counseling or help from a clinician.

“I’m not sure I even want it,” she told this news organization. “Some people want to get over their phobia because they want families, and others don’t want children at all. I think that those individuals should have the help they need.”

Claudia, a South Carolina resident who asked to be identified only by her first name owing to concerns about her privacy, said her tokophobia began when she started having sex. It grew worse when she developed health conditions that could be exacerbated by pregnancy. She said she stocks up on contraceptives and periodically takes a pregnancy test to ease her nerves.

“This started for me when I realized that having children wasn’t a requirement for life. I didn’t even know there was a name for what I was feeling,” Claudia said in an interview. “So, letting women know they have options, and then not making them feel guilty, or ashamed, is the most important thing. We shouldn’t try to convince women that motherhood is the only, or the correct, path.”

Ms. Elliot urged clinicians to have compassion: “Treat tokophobic patients – especially a pregnant one seeking an abortion – like someone with a life-threatening parasite. Don’t belittle or dismiss them. We’re already going to lose so many lives because of unwanted pregnancies and birth. Don’t add to the number.”

A version of this article first appeared on Medscape.com.

Cee Elliot is afraid of pregnancy. The 29-year-old retail manager in Connecticut said she has felt that way since puberty, when she “finally understood” pregnancy and reproduction. Always squeamish around babies and pregnant people, she said, as she learned more about the complications birth can cause, the idea of carrying a child herself became increasingly repulsive.

Later, Ms. Elliot said, she was treated poorly by a partner because of her fears, leading to regular panic attacks. She moved on from that partner, but her fear of pregnancy did not. Along the way, she felt her fears were dismissed by doctors and peers alike.

Tokophobia – a severe fear of childbirth – goes beyond the typical anxieties about birth or pregnancy that women often experience. The condition can intrude on everyday life, crippling social interaction and interrupting regular sleep patterns. Although statistics in the United States don’t exist, as many as 14% of women internationally are thought to have tokophobia.

Although psychiatric treatment focusing on past traumas can help, many women resort to managing the condition themselves. Some seek sterilization, whereas others take multiple forms of contraception simultaneously – combining intrauterine devices and oral birth control, for example, experts said. Some women have sought abortions and some even have attempted suicide rather than face giving birth, according to Leila Frodsham, MbChB, a women’s health expert at King’s College London, who has studied tokophobia.

The International Classification of Diseases added tokophobia to its list of diagnostic codes in 2018. But the Diagnostic and Statistical Manual of Mental Disorders, used by clinicians in the United States, has yet to do the same. Without this designation, some doctors are more inclined to diagnose tokophobia than others, Dr. Frodsham said.

“I think some clinicians struggle to understand how much this condition affects women. There isn’t training in it, and I’d like to see it discussed more,” Dr. Frodsham told this news organization.

Dr. Frodsham said she has seen hundreds of patients seeking help with their fear of pregnancy. Many of these women don’t know that they might have a condition that could benefit from psychiatric treatment.

Tokophobia typically takes two forms: primary, which affects women who have never given birth; and secondary, which stems from a previous traumatic birth experience.

“It’s not the pain of childbirth they are afraid of, but rather their fear comes out of a sense that they lack control over themselves and the situation of being pregnant,” Dr. Frodsham said.

Although the phenomenon has been studied internationally, particularly in Europe, fear of childbirth remains almost entirely unexplored in the United States literature.

One of the only scientific examinations of tokophobia in this country was a 2016 survey of 22 women with the condition by researchers at the University of Michigan, Ann Arbor. Published in the Journal of Obstetric, Gynecology & Neonatal Nursing, the survey found that many of the women expressed concern that their race, gender, or level of income might affect the quality of their care. Some women surveyed said they had experienced traumas directly related to systemic inequalities in the health care system.

Lee Roosevelt, PhD, MPH, CNM, a nurse and midwife and a coauthor of the study, said fear of the health care system, coupled with concern over the loss of bodily autonomy, can foster severe aversion to childbirth. In her experience, she said, clinicians often handle these patients poorly.

“If a woman is making the decision not to have children, we want it to be because she has decided for her, and her body, that it is the right thing,” added Lisa Kane Low, PhD, CNM, professor of obstetrics and gynecology at the University of Michigan, who worked with Dr. Roosevelt on the survey. “She shouldn’t feel the decision is made because she can’t access what she needs or the health care system is unable to provide it.”

Access to midwives, doulas, or therapists trained in trauma counseling can allow women to have a voice in their treatment, Dr. Roosevelt said.

No specific medication exists to treat tokophobia; however, drugs for depression or anxiety sometimes help, Dr. Low said. “Women with tokophobia may not need medication but would benefit from other therapies like desensitization or biobehavioral approaches or combinations of those,” she said.
 

Treating triggers

According to Dr. Frodsham, women with tokophobia often experience guilt and isolation. They may avoid speaking to women who are pregnant or avoid discussing pregnancy and childbirth, afraid that doing so may trigger their fear.

“They can’t see how they can get close to this catastrophic thing they think is going to happen to them,” she said. “Many of them think they will die.”

Many patients avoid thinking about memories of traumatic events so as to not trigger extreme emotional responses.

Dr. Roosevelt said developing ways to assess and treat tokophobia has become more urgent, since the Supreme Court’s recent decision to overturn Roe v. Wade could lead to more instances of women carrying unwanted pregnancies.
 

Seeking community

The internet has become a place where women with tokophobia and less severe fears about pregnancy can share their experiences. On the online bulletin board Reddit, r/Tokphobia and r/childfree contain thousands of queries and personal stories about the condition, as well as requests for advice.

Jillian Kilcoyne, who lives in New York and attends college in Michigan, said: “Pregnancy has always freaked me out. A part of me believes it’s a biological injustice that women have to go through such pain and be ignored by the medical community just to give birth.” Ms. Kilcoyne said she has not sought counseling or help from a clinician.

“I’m not sure I even want it,” she told this news organization. “Some people want to get over their phobia because they want families, and others don’t want children at all. I think that those individuals should have the help they need.”

Claudia, a South Carolina resident who asked to be identified only by her first name owing to concerns about her privacy, said her tokophobia began when she started having sex. It grew worse when she developed health conditions that could be exacerbated by pregnancy. She said she stocks up on contraceptives and periodically takes a pregnancy test to ease her nerves.

“This started for me when I realized that having children wasn’t a requirement for life. I didn’t even know there was a name for what I was feeling,” Claudia said in an interview. “So, letting women know they have options, and then not making them feel guilty, or ashamed, is the most important thing. We shouldn’t try to convince women that motherhood is the only, or the correct, path.”

Ms. Elliot urged clinicians to have compassion: “Treat tokophobic patients – especially a pregnant one seeking an abortion – like someone with a life-threatening parasite. Don’t belittle or dismiss them. We’re already going to lose so many lives because of unwanted pregnancies and birth. Don’t add to the number.”

A version of this article first appeared on Medscape.com.

New research offers more evidence linking targeted therapies for patients with advanced renal cell carcinoma to higher risks for major adverse cardiovascular events.

Patients on targeted therapy were more likely to develop conditions such as heart attacks and stroke than were those who took cytokine therapy (adjusted hazard ratio, 1.80; 95% confidence interval [CI] 1.19-2.74), according to a retrospective Taiwanese study reports.

“These findings may inform the evaluation of cardiovascular risk when considering targeted cancer therapies for patients with advanced renal cell carcinoma in real-world clinical practice,” wrote the authors of the report, which appeared in JACC: CardioOncology.

The study notes that one kind of targeted therapy – tyrosine kinase inhibitors with anti–vascular endothelial growth factor (VEGFR-TKI) have been linked to higher rates of major adverse cardiovascular events (1.38-22.7). There have also been reports linking another kind of targeted therapy, mechanistic target of rapamycin inhibitors (mTOR), to major adverse cardiovascular events.

In the new study, Dong-Yi Chen, MD, of Chang Gung University, Taiwan, and colleagues, tracked patients with renal cell carcinoma who underwent treatment with targeted therapy (sunitinib, sorafenib, pazopanib, everolimus, or temsirolimus, (n = 2,257, 81%) or cytokine therapy (interleukin-2 or interferon gamma, n = 528, 19%) from 2007 to 2018.

The two groups had similar gender, age and socioeconomic levels. Combined, the groups were 74% male, the median age was 63, and 68% had hypertension.

After stabilized inverse probability of treatment weighting, the adjusted incidence rates of major cardiovascular events were 6.65 and 3.36 per 100 person-years in the targeted and cytokine therapy groups, respectively. “The higher cardiovascular risk of the targeted group was driven primarily by the VEGFR TKI–treated patients,” the authors wrote.

Two drugs were linked to statistically significant higher rates of major cardiovascular adverse events compared with the reference drug sunitinib: the VEGFR TKI sorafenib (univariable HR, 1.94, 95% CI, 1.11-3.39), P = .021) and the mTOR temsirolimus (univariable HR, 2.11, 95% CI, 1.24-3.59, P = .006). Sunitinib was by far the most commonly used targeted therapy drug.

Among patients on targeted therapy, several factors were linked to higher rates of major cardiovascular events, such as baseline history of heart failure (HR, 3.88, 95% CI, 2.25-6.71), atrial fibrillation (HR, 3.60, 95% CI, 2.16-5.99), venous thromboembolism (HR, 2.50, 95% CI, 1.27-4.92), ischemic stroke (HR, 1.88, 95% CI, 1.14-3.11), and age at least 65 years (HR, 1.81, 95% CI, 1.27-2.58).

According to the authors, there are several theories about why targeted therapy may boost the risk of major adverse cardiovascular risk. “VEGF signaling inhibitors have been associated with hypertension,” which is a risk factor for cardiac death, they noted. Also, “multi-receptor TKIs, including VEGFR and platelet-derived growth factor receptor inhibitors, could destabilize the coronary microvascular endothelial network and reduce coronary flow reserve, leading to an increased risk for thrombosis and arterial ischemic events, including myocardial infarction and ischemic stroke.”

The study was funded by Chang Gung Memorial Hospital.

New research offers more evidence linking targeted therapies for patients with advanced renal cell carcinoma to higher risks for major adverse cardiovascular events.

Patients on targeted therapy were more likely to develop conditions such as heart attacks and stroke than were those who took cytokine therapy (adjusted hazard ratio, 1.80; 95% confidence interval [CI] 1.19-2.74), according to a retrospective Taiwanese study reports.

“These findings may inform the evaluation of cardiovascular risk when considering targeted cancer therapies for patients with advanced renal cell carcinoma in real-world clinical practice,” wrote the authors of the report, which appeared in JACC: CardioOncology.

The study notes that one kind of targeted therapy – tyrosine kinase inhibitors with anti–vascular endothelial growth factor (VEGFR-TKI) have been linked to higher rates of major adverse cardiovascular events (1.38-22.7). There have also been reports linking another kind of targeted therapy, mechanistic target of rapamycin inhibitors (mTOR), to major adverse cardiovascular events.

In the new study, Dong-Yi Chen, MD, of Chang Gung University, Taiwan, and colleagues, tracked patients with renal cell carcinoma who underwent treatment with targeted therapy (sunitinib, sorafenib, pazopanib, everolimus, or temsirolimus, (n = 2,257, 81%) or cytokine therapy (interleukin-2 or interferon gamma, n = 528, 19%) from 2007 to 2018.

The two groups had similar gender, age and socioeconomic levels. Combined, the groups were 74% male, the median age was 63, and 68% had hypertension.

After stabilized inverse probability of treatment weighting, the adjusted incidence rates of major cardiovascular events were 6.65 and 3.36 per 100 person-years in the targeted and cytokine therapy groups, respectively. “The higher cardiovascular risk of the targeted group was driven primarily by the VEGFR TKI–treated patients,” the authors wrote.

Two drugs were linked to statistically significant higher rates of major cardiovascular adverse events compared with the reference drug sunitinib: the VEGFR TKI sorafenib (univariable HR, 1.94, 95% CI, 1.11-3.39), P = .021) and the mTOR temsirolimus (univariable HR, 2.11, 95% CI, 1.24-3.59, P = .006). Sunitinib was by far the most commonly used targeted therapy drug.

Among patients on targeted therapy, several factors were linked to higher rates of major cardiovascular events, such as baseline history of heart failure (HR, 3.88, 95% CI, 2.25-6.71), atrial fibrillation (HR, 3.60, 95% CI, 2.16-5.99), venous thromboembolism (HR, 2.50, 95% CI, 1.27-4.92), ischemic stroke (HR, 1.88, 95% CI, 1.14-3.11), and age at least 65 years (HR, 1.81, 95% CI, 1.27-2.58).

According to the authors, there are several theories about why targeted therapy may boost the risk of major adverse cardiovascular risk. “VEGF signaling inhibitors have been associated with hypertension,” which is a risk factor for cardiac death, they noted. Also, “multi-receptor TKIs, including VEGFR and platelet-derived growth factor receptor inhibitors, could destabilize the coronary microvascular endothelial network and reduce coronary flow reserve, leading to an increased risk for thrombosis and arterial ischemic events, including myocardial infarction and ischemic stroke.”

The study was funded by Chang Gung Memorial Hospital.

New research offers more evidence linking targeted therapies for patients with advanced renal cell carcinoma to higher risks for major adverse cardiovascular events.

Patients on targeted therapy were more likely to develop conditions such as heart attacks and stroke than were those who took cytokine therapy (adjusted hazard ratio, 1.80; 95% confidence interval [CI] 1.19-2.74), according to a retrospective Taiwanese study reports.

“These findings may inform the evaluation of cardiovascular risk when considering targeted cancer therapies for patients with advanced renal cell carcinoma in real-world clinical practice,” wrote the authors of the report, which appeared in JACC: CardioOncology.

The study notes that one kind of targeted therapy – tyrosine kinase inhibitors with anti–vascular endothelial growth factor (VEGFR-TKI) have been linked to higher rates of major adverse cardiovascular events (1.38-22.7). There have also been reports linking another kind of targeted therapy, mechanistic target of rapamycin inhibitors (mTOR), to major adverse cardiovascular events.

In the new study, Dong-Yi Chen, MD, of Chang Gung University, Taiwan, and colleagues, tracked patients with renal cell carcinoma who underwent treatment with targeted therapy (sunitinib, sorafenib, pazopanib, everolimus, or temsirolimus, (n = 2,257, 81%) or cytokine therapy (interleukin-2 or interferon gamma, n = 528, 19%) from 2007 to 2018.

The two groups had similar gender, age and socioeconomic levels. Combined, the groups were 74% male, the median age was 63, and 68% had hypertension.

After stabilized inverse probability of treatment weighting, the adjusted incidence rates of major cardiovascular events were 6.65 and 3.36 per 100 person-years in the targeted and cytokine therapy groups, respectively. “The higher cardiovascular risk of the targeted group was driven primarily by the VEGFR TKI–treated patients,” the authors wrote.

Two drugs were linked to statistically significant higher rates of major cardiovascular adverse events compared with the reference drug sunitinib: the VEGFR TKI sorafenib (univariable HR, 1.94, 95% CI, 1.11-3.39), P = .021) and the mTOR temsirolimus (univariable HR, 2.11, 95% CI, 1.24-3.59, P = .006). Sunitinib was by far the most commonly used targeted therapy drug.

Among patients on targeted therapy, several factors were linked to higher rates of major cardiovascular events, such as baseline history of heart failure (HR, 3.88, 95% CI, 2.25-6.71), atrial fibrillation (HR, 3.60, 95% CI, 2.16-5.99), venous thromboembolism (HR, 2.50, 95% CI, 1.27-4.92), ischemic stroke (HR, 1.88, 95% CI, 1.14-3.11), and age at least 65 years (HR, 1.81, 95% CI, 1.27-2.58).

According to the authors, there are several theories about why targeted therapy may boost the risk of major adverse cardiovascular risk. “VEGF signaling inhibitors have been associated with hypertension,” which is a risk factor for cardiac death, they noted. Also, “multi-receptor TKIs, including VEGFR and platelet-derived growth factor receptor inhibitors, could destabilize the coronary microvascular endothelial network and reduce coronary flow reserve, leading to an increased risk for thrombosis and arterial ischemic events, including myocardial infarction and ischemic stroke.”

The study was funded by Chang Gung Memorial Hospital.

The Food and Drug Administration has approved belimumab (Benlysta) for treating active lupus nephritis (LN) in children aged 5-17 years. The drug can now be used to treat adult and pediatric patients with systemic lupus erythematosus (SLE) and LN. The decision expands therapeutic options for the estimated 1.5 million Americans currently living with lupus.

“This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in a press release issued by the manufacturer, GlaxoSmithKline. LN is a condition that sometimes develops in people with lupus. In LN, the autoimmune cells produced by the disease attack the kidney. Roughly 40% of people with SLE experience LN.

Olivier Le Moal/Getty Images

Damage to the kidneys causes the body to have difficulty processing waste and toxins. This can create a host of problems, including end-stage kidney disease, which may be treated only with dialysis or kidney transplant. These situations significantly increase mortality among people with lupus, especially children.

Prior to the approval, the only treatment pathway for children with active LN included immunosuppressants and corticosteroids. While they may be effective, use of these classes of drugs may come with many side effects, including susceptibility to other diseases and infections. Belimumab, by contrast, is a B-lymphocyte stimulator protein inhibitor. It inhibits the survival of B cells, which are thought to play a role in the disease’s pathophysiology.

Belimumab was first approved to treat patients with SLE in 2011. It was approved for children with SLE 8 years later. The drug’s indications were expanded to include adults with LN in 2020.

Organizations within the lupus research community have communicated their support of the FDA’s decision. “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis,” Lupus Research Alliance President and CEO Kenneth M. Farber said in a release from the organization.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved belimumab (Benlysta) for treating active lupus nephritis (LN) in children aged 5-17 years. The drug can now be used to treat adult and pediatric patients with systemic lupus erythematosus (SLE) and LN. The decision expands therapeutic options for the estimated 1.5 million Americans currently living with lupus.

“This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in a press release issued by the manufacturer, GlaxoSmithKline. LN is a condition that sometimes develops in people with lupus. In LN, the autoimmune cells produced by the disease attack the kidney. Roughly 40% of people with SLE experience LN.

Olivier Le Moal/Getty Images

Damage to the kidneys causes the body to have difficulty processing waste and toxins. This can create a host of problems, including end-stage kidney disease, which may be treated only with dialysis or kidney transplant. These situations significantly increase mortality among people with lupus, especially children.

Prior to the approval, the only treatment pathway for children with active LN included immunosuppressants and corticosteroids. While they may be effective, use of these classes of drugs may come with many side effects, including susceptibility to other diseases and infections. Belimumab, by contrast, is a B-lymphocyte stimulator protein inhibitor. It inhibits the survival of B cells, which are thought to play a role in the disease’s pathophysiology.

Belimumab was first approved to treat patients with SLE in 2011. It was approved for children with SLE 8 years later. The drug’s indications were expanded to include adults with LN in 2020.

Organizations within the lupus research community have communicated their support of the FDA’s decision. “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis,” Lupus Research Alliance President and CEO Kenneth M. Farber said in a release from the organization.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved belimumab (Benlysta) for treating active lupus nephritis (LN) in children aged 5-17 years. The drug can now be used to treat adult and pediatric patients with systemic lupus erythematosus (SLE) and LN. The decision expands therapeutic options for the estimated 1.5 million Americans currently living with lupus.

“This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in a press release issued by the manufacturer, GlaxoSmithKline. LN is a condition that sometimes develops in people with lupus. In LN, the autoimmune cells produced by the disease attack the kidney. Roughly 40% of people with SLE experience LN.

Olivier Le Moal/Getty Images

Damage to the kidneys causes the body to have difficulty processing waste and toxins. This can create a host of problems, including end-stage kidney disease, which may be treated only with dialysis or kidney transplant. These situations significantly increase mortality among people with lupus, especially children.

Prior to the approval, the only treatment pathway for children with active LN included immunosuppressants and corticosteroids. While they may be effective, use of these classes of drugs may come with many side effects, including susceptibility to other diseases and infections. Belimumab, by contrast, is a B-lymphocyte stimulator protein inhibitor. It inhibits the survival of B cells, which are thought to play a role in the disease’s pathophysiology.

Belimumab was first approved to treat patients with SLE in 2011. It was approved for children with SLE 8 years later. The drug’s indications were expanded to include adults with LN in 2020.

Organizations within the lupus research community have communicated their support of the FDA’s decision. “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis,” Lupus Research Alliance President and CEO Kenneth M. Farber said in a release from the organization.

A version of this article first appeared on Medscape.com.

As cases of monkeypox continue to mount in the United States and abroad, infectious disease experts are closely monitoring one group of people in particular: women.

So far, the overwhelming majority of cases of the viral disease have been reported in men who have sex with men. But in recent days, officials have learned of a handful of cases in women – possibly indicating that the outbreak may be widening.

Researchers are keeping close tabs on the proportion of cases in women to “assess whether the outbreak is moving away” from networks of men who have sex with men, where most of the initial cases have been identified, according to a briefing from the UK Health Security Agency (UKHSA).

“There is insufficient evidence to support a change in the transmission dynamics,” the agency said. “However, over the last few weeks the proportion of female cases has been increasing, so this trend needs to be monitored closely.”

A global collaboration of researchers and clinicians recently described 528 cases of monkeypox in 16 countries – but none were in women.

Since data collection for that study ended in June, the research group has confirmed cases in women, said study coauthor John P. Thornhill, MD, PhD, consultant physician in sexual health and HIV and clinical senior lecturer at Barts Health NHS Trust and Queen Mary University of London.

“Cases in women have certainly been reported but are currently far less common,” Dr. Thornhill told this news organization.

Although infections in women have been outliers during the current outbreak, they can be severe when they do occur. Several women in England have been hospitalized with severe symptoms.

A similar pattern has been seen in New York City, where just one woman is among the 639 total cases, according to a July 21 report from the city’s health agency.

Researchers have recently published guidance on monkeypox for ob.gyns., maternal-fetal medicine subspecialists, and people who are pregnant or breastfeeding in anticipation of the possibility of more cases in women.

The Centers for Disease Control and Prevention advises that “pregnant, recently pregnant, and breastfeeding people should be prioritized for medical treatment” of monkeypox if needed. 

One monkeypox vaccine, Jynneos, can be offered to people who are pregnant or breastfeeding and are otherwise eligible for vaccination on the basis of confirmed or likely contact with cases, ideally within 4 days of exposure. Some people at high risk for exposure, such as laboratory workers, may receive the vaccine preemptively.

Another vaccine, ACAM2000, is contraindicated in people who are pregnant or breastfeeding, according to the CDC.
 

Transmission dynamics

Investigators have not yet identified substantial spread of monkeypox beyond men who have sex with men, although transmission among household contacts, including women and children, has been reported.

Most initial infections during the current outbreak occurred during sexual activity. But monkeypox can spread through any close contact with skin lesions or body fluids and possibly through touching contaminated items like clothing or linens, according to the CDC. It also may spread from mother to child in utero.

Infected pets have been known to spread the disease as well. A multistate monkeypox outbreak in the United States in 2003 was linked to pet prairie dogs, including in childcare and school settings. That year, 55% of the 71 cases occurred in female patients.
 

More testing, higher positivity rates in men

Since May, more men than women in the United Kingdom have undergone testing for monkeypox, with 3,467 tests in men versus 447 tests in women. Among those tested, the positivity rate has been far higher in men than in women, 54% versus 2.2%, respectively.

As of July 20, about 0.65% of U.K. cases with known gender were in women. Two weeks prior, about 0.4% were in women.

In all, 13 monkeypox cases in England have been in women, and four had severe manifestations that required hospitalization, according to the UKHSA.

Globally, more than 16,000 monkeypox cases have been reported, according to the World Health Organization. The agency said that it plans to rename the disease to reduce stigma.
 

Monkeypox and pregnancy

Ob.gyns. are often on the “front line in terms of identifying people with infectious diseases,” said Denise J. Jamieson, MD, MPH, Emory University, Atlanta. Dr. Jamieson coauthored “A Primer on Monkeypox Virus for Obstetrician-Gynecologists,” published in Obstetrics & Gynecology.

“Obstetricians need to be aware of what infectious diseases are circulating and be aware of what is going on in the community,” she said.

With monkeypox, “it is anybody’s guess as to how widespread this is going to be,” Dr. Jamieson said.

“The initial monkeypox cases in the current outbreak have been predominately but not exclusively among men who have sex with men; enhanced transmission in this group may be facilitated by sexual activity and spread through complex sexual networks,” Dr. Thornhill said. “As the outbreak continues, we will likely see more monkeypox infections” outside that group.

“Those working in sexual health should have a high index of suspicion in all individuals presenting with genital and oral ulcers and those with proctitis,” he added.

During previous monkeypox outbreaks, the chain of household transmissions has been short, typically two or three people, said Chloe M. Orkin, MD, professor of HIV medicine at Queen Mary University of London. Dr. Orkin directs the Sexual Health and HIV All East Research (SHARE) Collaborative, which has worked to compile the international case series.

Though monkeypox has mainly been transmitted among men who have sex with men, not all identify as gay and some may also have female and nonbinary partners, Dr. Orkin said.

“Clinicians should bear this in mind when examining any person,” she said.

A version of this article first appeared on Medscape.com.

As cases of monkeypox continue to mount in the United States and abroad, infectious disease experts are closely monitoring one group of people in particular: women.

So far, the overwhelming majority of cases of the viral disease have been reported in men who have sex with men. But in recent days, officials have learned of a handful of cases in women – possibly indicating that the outbreak may be widening.

Researchers are keeping close tabs on the proportion of cases in women to “assess whether the outbreak is moving away” from networks of men who have sex with men, where most of the initial cases have been identified, according to a briefing from the UK Health Security Agency (UKHSA).

“There is insufficient evidence to support a change in the transmission dynamics,” the agency said. “However, over the last few weeks the proportion of female cases has been increasing, so this trend needs to be monitored closely.”

A global collaboration of researchers and clinicians recently described 528 cases of monkeypox in 16 countries – but none were in women.

Since data collection for that study ended in June, the research group has confirmed cases in women, said study coauthor John P. Thornhill, MD, PhD, consultant physician in sexual health and HIV and clinical senior lecturer at Barts Health NHS Trust and Queen Mary University of London.

“Cases in women have certainly been reported but are currently far less common,” Dr. Thornhill told this news organization.

Although infections in women have been outliers during the current outbreak, they can be severe when they do occur. Several women in England have been hospitalized with severe symptoms.

A similar pattern has been seen in New York City, where just one woman is among the 639 total cases, according to a July 21 report from the city’s health agency.

Researchers have recently published guidance on monkeypox for ob.gyns., maternal-fetal medicine subspecialists, and people who are pregnant or breastfeeding in anticipation of the possibility of more cases in women.

The Centers for Disease Control and Prevention advises that “pregnant, recently pregnant, and breastfeeding people should be prioritized for medical treatment” of monkeypox if needed. 

One monkeypox vaccine, Jynneos, can be offered to people who are pregnant or breastfeeding and are otherwise eligible for vaccination on the basis of confirmed or likely contact with cases, ideally within 4 days of exposure. Some people at high risk for exposure, such as laboratory workers, may receive the vaccine preemptively.

Another vaccine, ACAM2000, is contraindicated in people who are pregnant or breastfeeding, according to the CDC.
 

Transmission dynamics

Investigators have not yet identified substantial spread of monkeypox beyond men who have sex with men, although transmission among household contacts, including women and children, has been reported.

Most initial infections during the current outbreak occurred during sexual activity. But monkeypox can spread through any close contact with skin lesions or body fluids and possibly through touching contaminated items like clothing or linens, according to the CDC. It also may spread from mother to child in utero.

Infected pets have been known to spread the disease as well. A multistate monkeypox outbreak in the United States in 2003 was linked to pet prairie dogs, including in childcare and school settings. That year, 55% of the 71 cases occurred in female patients.
 

More testing, higher positivity rates in men

Since May, more men than women in the United Kingdom have undergone testing for monkeypox, with 3,467 tests in men versus 447 tests in women. Among those tested, the positivity rate has been far higher in men than in women, 54% versus 2.2%, respectively.

As of July 20, about 0.65% of U.K. cases with known gender were in women. Two weeks prior, about 0.4% were in women.

In all, 13 monkeypox cases in England have been in women, and four had severe manifestations that required hospitalization, according to the UKHSA.

Globally, more than 16,000 monkeypox cases have been reported, according to the World Health Organization. The agency said that it plans to rename the disease to reduce stigma.
 

Monkeypox and pregnancy

Ob.gyns. are often on the “front line in terms of identifying people with infectious diseases,” said Denise J. Jamieson, MD, MPH, Emory University, Atlanta. Dr. Jamieson coauthored “A Primer on Monkeypox Virus for Obstetrician-Gynecologists,” published in Obstetrics & Gynecology.

“Obstetricians need to be aware of what infectious diseases are circulating and be aware of what is going on in the community,” she said.

With monkeypox, “it is anybody’s guess as to how widespread this is going to be,” Dr. Jamieson said.

“The initial monkeypox cases in the current outbreak have been predominately but not exclusively among men who have sex with men; enhanced transmission in this group may be facilitated by sexual activity and spread through complex sexual networks,” Dr. Thornhill said. “As the outbreak continues, we will likely see more monkeypox infections” outside that group.

“Those working in sexual health should have a high index of suspicion in all individuals presenting with genital and oral ulcers and those with proctitis,” he added.

During previous monkeypox outbreaks, the chain of household transmissions has been short, typically two or three people, said Chloe M. Orkin, MD, professor of HIV medicine at Queen Mary University of London. Dr. Orkin directs the Sexual Health and HIV All East Research (SHARE) Collaborative, which has worked to compile the international case series.

Though monkeypox has mainly been transmitted among men who have sex with men, not all identify as gay and some may also have female and nonbinary partners, Dr. Orkin said.

“Clinicians should bear this in mind when examining any person,” she said.

A version of this article first appeared on Medscape.com.

As cases of monkeypox continue to mount in the United States and abroad, infectious disease experts are closely monitoring one group of people in particular: women.

So far, the overwhelming majority of cases of the viral disease have been reported in men who have sex with men. But in recent days, officials have learned of a handful of cases in women – possibly indicating that the outbreak may be widening.

Researchers are keeping close tabs on the proportion of cases in women to “assess whether the outbreak is moving away” from networks of men who have sex with men, where most of the initial cases have been identified, according to a briefing from the UK Health Security Agency (UKHSA).

“There is insufficient evidence to support a change in the transmission dynamics,” the agency said. “However, over the last few weeks the proportion of female cases has been increasing, so this trend needs to be monitored closely.”

A global collaboration of researchers and clinicians recently described 528 cases of monkeypox in 16 countries – but none were in women.

Since data collection for that study ended in June, the research group has confirmed cases in women, said study coauthor John P. Thornhill, MD, PhD, consultant physician in sexual health and HIV and clinical senior lecturer at Barts Health NHS Trust and Queen Mary University of London.

“Cases in women have certainly been reported but are currently far less common,” Dr. Thornhill told this news organization.

Although infections in women have been outliers during the current outbreak, they can be severe when they do occur. Several women in England have been hospitalized with severe symptoms.

A similar pattern has been seen in New York City, where just one woman is among the 639 total cases, according to a July 21 report from the city’s health agency.

Researchers have recently published guidance on monkeypox for ob.gyns., maternal-fetal medicine subspecialists, and people who are pregnant or breastfeeding in anticipation of the possibility of more cases in women.

The Centers for Disease Control and Prevention advises that “pregnant, recently pregnant, and breastfeeding people should be prioritized for medical treatment” of monkeypox if needed. 

One monkeypox vaccine, Jynneos, can be offered to people who are pregnant or breastfeeding and are otherwise eligible for vaccination on the basis of confirmed or likely contact with cases, ideally within 4 days of exposure. Some people at high risk for exposure, such as laboratory workers, may receive the vaccine preemptively.

Another vaccine, ACAM2000, is contraindicated in people who are pregnant or breastfeeding, according to the CDC.
 

Transmission dynamics

Investigators have not yet identified substantial spread of monkeypox beyond men who have sex with men, although transmission among household contacts, including women and children, has been reported.

Most initial infections during the current outbreak occurred during sexual activity. But monkeypox can spread through any close contact with skin lesions or body fluids and possibly through touching contaminated items like clothing or linens, according to the CDC. It also may spread from mother to child in utero.

Infected pets have been known to spread the disease as well. A multistate monkeypox outbreak in the United States in 2003 was linked to pet prairie dogs, including in childcare and school settings. That year, 55% of the 71 cases occurred in female patients.
 

More testing, higher positivity rates in men

Since May, more men than women in the United Kingdom have undergone testing for monkeypox, with 3,467 tests in men versus 447 tests in women. Among those tested, the positivity rate has been far higher in men than in women, 54% versus 2.2%, respectively.

As of July 20, about 0.65% of U.K. cases with known gender were in women. Two weeks prior, about 0.4% were in women.

In all, 13 monkeypox cases in England have been in women, and four had severe manifestations that required hospitalization, according to the UKHSA.

Globally, more than 16,000 monkeypox cases have been reported, according to the World Health Organization. The agency said that it plans to rename the disease to reduce stigma.
 

Monkeypox and pregnancy

Ob.gyns. are often on the “front line in terms of identifying people with infectious diseases,” said Denise J. Jamieson, MD, MPH, Emory University, Atlanta. Dr. Jamieson coauthored “A Primer on Monkeypox Virus for Obstetrician-Gynecologists,” published in Obstetrics & Gynecology.

“Obstetricians need to be aware of what infectious diseases are circulating and be aware of what is going on in the community,” she said.

With monkeypox, “it is anybody’s guess as to how widespread this is going to be,” Dr. Jamieson said.

“The initial monkeypox cases in the current outbreak have been predominately but not exclusively among men who have sex with men; enhanced transmission in this group may be facilitated by sexual activity and spread through complex sexual networks,” Dr. Thornhill said. “As the outbreak continues, we will likely see more monkeypox infections” outside that group.

“Those working in sexual health should have a high index of suspicion in all individuals presenting with genital and oral ulcers and those with proctitis,” he added.

During previous monkeypox outbreaks, the chain of household transmissions has been short, typically two or three people, said Chloe M. Orkin, MD, professor of HIV medicine at Queen Mary University of London. Dr. Orkin directs the Sexual Health and HIV All East Research (SHARE) Collaborative, which has worked to compile the international case series.

Though monkeypox has mainly been transmitted among men who have sex with men, not all identify as gay and some may also have female and nonbinary partners, Dr. Orkin said.

“Clinicians should bear this in mind when examining any person,” she said.

A version of this article first appeared on Medscape.com.

It was 2 a.m. And Rebecca Shatsky, MD, could not sleep.

The breast oncologist was thinking about a patient of hers with metastatic cancer.

The patient’s disease had been asymptomatic for some time. Then without warning, her cancer suddenly exploded. Her bone marrow was failing, and her liver was not far behind.

Dr. Shatsky had a treatment plan ready to go but still, she felt uneasy.

“I had to be honest with her that I didn’t know if this plan would work,” says Dr. Shatsky, a medical oncologist at University of California, San Diego (UCSD).

That night, after visiting the patient in the hospital, Dr. Shatsky lay awake going over her next move, making sure it was the right one and hoping it would help keep the disease at bay.

“It’s so much pressure when someone is depending on you to make life or death decisions,” Dr. Shatsky said.

And in the quiet hours of night, these concerns grow louder.

Dr. Shatsky is not alone. Oncologists face difficult decisions every day, and many wrestle with these choices long after their day in the clinic is over.

“There’s no off button,” says Aaron Goodman, MD, a hematologist at UCSD Health who goes by “Papa Heme” on Twitter. “I’m always thinking about my patients. Constantly.”

The public rarely gets a glimpse of these private moments. On occasion, oncologists will share a personal story, but more often, insights come from broad research on the ethical, emotional, and psychological toll of practicing medicine.

Many oncologists carry this baggage home with them because they have no other option.

“There is simply no time to process the weight of the day when I’ve got seven more patients who need my full attention before lunch,” Mark Lewis, MD, director, department of gastrointestinal oncology, Intermountain Healthcare, Salt Lake City, Utah. “That is why my processing happens outside of the office, when my brain can be quiet.”
 

What am I missing?

Dr. Goodman recognizes the gravity of each decision he makes. He pores over every detail of a patient’s scans, lab results, history, and symptoms.

But no matter how many times he checks and rechecks, one question nags at him: What am I missing?

For Dr. Goodman, this exhaustive level of attention is worth it.

“When errors are made, it’s someone’s life,” Dr. Goodman said. “Nothing would have prepared me for this responsibility. Until it lies on you, it’s impossible to understand how much trust patients put into us.”

That trust becomes most apparent for Dr. Goodman when facing a decision about how to treat a patient with acute myeloid leukemia who’s in remission.

Give more chemotherapy to root out the leukemia cells still lurking in the body, and the patient faces a high risk of the cancer returning. Pick stem cell transplant, and the chance of being cured goes up significantly, but the patient could also die within 100 days of the transplant.

“All together, the data show I’m helping patients with a transplant, but for the individual, I could be causing harm. Someone could be living less because of a decision I made,” Dr. Goodman said.

For patients with advanced cancer, oncologists may need to think several moves ahead. Mapping out a patient’s treatment options can feel like a game of chess. Dr. Shatsky is always trying to anticipate how the tumor will behave, what is driving it, and how lifestyle factors may influence a patient’s response in the present and the future.

“It is a mind game,” she says. “Like in chess, I try to outsmart my opponent. But with advanced cancer, there are not necessarily clear-cut guidelines or one way to manage the disease, and I have to do the best I can with drugs I have.”

That’s the art of oncology: Balancing the many knowns and unknowns of a person’s cancer alongside the toxicities of treatment and a patient’s hopes and goals.

Throughout the year, Don Dizon, MD, will see a number of patients with advanced disease. In these instances, the question he often wrestles with is if the patient can’t be cured, whether more treatment will just cause greater harm.

Dr. Dizon recently faced this dilemma with an older patient with metastatic disease who had not done well with an initial treatment regimen. After outlining the risks for more chemotherapy, he explained one option would be to forgo it and simply treat her symptoms.

“It’s an impossible choice,” says Dr. Dizon, director of women’s cancers at Lifespan Cancer Institute and director of medical oncology at Rhode Island Hospital, Providence.

Chemotherapy can provide symptom relief, but it can also be toxic – and patients may be so frail, they can die from more therapy.

“I told my patient, if in your heart, you want to try more therapy, that’s okay. But it’s also okay if you don’t,” Dr. Dizon recalled.

Her response: “You’re supposed to give me the answer.”

However, for patients approaching the end of life, there often is no right answer. 

“It’s part of the discomfort you live with as a patient and oncologist, and when I leave the clinic, that’s one thing that follows me home,” Dr. Dizon said. “At the end of the day, I need to look in the mirror and know I did the best I could.”
 

The difficult conversation

Every Sunday, Dr. Lewis feels the weight of the week ahead. He and his wife, a pediatrician, call it the “Sunday scaries.”

It’s when Dr. Lewis begins thinking about the delicate conversations to come, rehearsing how he’s going to share the news that a person has advanced cancer or that a cancer, once in remission, has returned.

“Before the pandemic, I had 36 people come to a visit where I delivered some very heavy news and it became a Greek chorus of sobbing,” he recalls.

For every oncologist, delivering bad news is an integral part of the job. But after spending months, sometimes years, with a patient and the family, Dr. Lewis knows how to take the temperature of the room – who will likely prefer a more blunt style and who might need a gentler touch.

“The longer you know a patient and family, the better you can gauge the best approach,” Dr. Lewis said. “And for some, you know it’ll be complete devastation no matter what.”

When Jennifer Lycette, MD, prepares for a difficult conversation, she’ll run down all the possible ways it could go. Sometimes her brain will get stuck in a loop, cycling through the different trajectories on repeat.

“For years, I didn’t know how to cope with that,” said Dr. Lycette, medical director at Providence Oncology and Hematology Care Clinic in Seaside, Ore. “I wasn’t taught the tools to cope with that in my medical training. It took midcareer professional coaching that I sought out on my own to learn to remind myself that no matter what the person says, I have the experience and skill set to handle what comes next and to simply be present in the moment with the patient.”

The question that now sits with Dr. Lycette hours after a visit is what she could have done better. She knows from experience how important it is to choose her words carefully.

Early in her career, Dr. Lycette had a patient with stage IV cancer who wanted to know more about the death process. Because most people ask about pain, she assured him that he likely wouldn’t experience too much pain with his type of cancer.

“It will probably be like falling asleep,” said Dr. Lycette, hoping she was offering comfort. “When I saw him next, he told me he hadn’t slept.”

He was afraid that if he did, he wouldn’t wake up.

In that moment, Dr. Lycette realized the power that her words carry and the importance of trying to understand the inner lives of her patients.
 

Life outside the clinic

Sometimes an oncologist’s late-night ruminations have little to do with cancer itself.

Manali Patel, MD, finds herself worrying if her patients will have enough to eat and whether she will be able to help.

“I was up at 3 a.m. one morning, thinking about how we’re going to fund a project for patients from low-income households who we discovered were experiencing severe food insecurity – what grants we need, what foundations we can work with,” said Dr. Patel, a medical oncologist at Stanford Hospital and Clinics and the VA Palo Alto Health Care System in California.

The past few years of the pandemic have added a new layer of worry for Dr. Patel.

“I don’t want my patients to die from a preventable virus when they’ve already been through so much suffering,” Dr. Patel said.

This thought feeds worries about how her actions outside the clinic could unintentionally harm her patients. Should she go to a big medical conference? A family gathering? The grocery store?

“There are some places you can’t avoid, but these decisions have caused a lot of strife for me,” she said. “The health and safety of our patients – that’s in our wheelhouse – but so many of the policies are outside of our control.”
 

The inevitable losses and the wins

For patients with metastatic disease, eventually the treatment options will run out.

Dr. Shatsky likes to be up front with patients about that reality: “There will come a day when I will tell you there’s nothing more I can do, and you need to trust that I’m being honest with you and that’s the truth.”

For Dr. Goodman, the devastation that bad news brings patients and families is glaring. He knows there will be no more normalcy in their lives.

“I see a lot of suffering, but I know the suffering happens regardless of whether I see it or not,” Dr. Goodman said.

That’s why holding on to the victories can be so important. Dr. Goodman recalled a young patient who came to him with a 20-cm tumor and is now cured. “Had I not met that individual and done what I had done, he’d be dead, but now he’s going to live his life,” Dr. Goodman said. “But I don’t wake up at 2 a.m. thinking about that.”

Dr. Shatsky gets a lot of joy from the wins – the patients who do really well, the times when she can help a friend or colleagues – and those moments go a long way to outweigh the hurt, worry, and workload.

When dealing with so much gray, “the wins are important, knowing you can make a difference is important,” Dr. Dizon said.

And there’s a delicate balance.

“I think patients want an oncologist who cares and is genuinely invested in their outcomes but not someone who is so sad all the time,” Dr. Lewis said. “When I lose a patient, I still grieve each loss, but I can’t mourn every patient’s death like it’s a family member. Otherwise, I’d break.”

What would you do if you had terminal cancer?

Dr. Dizon recalled how a friend handled the news. She went home and made dinner, he said.

Ultimately, she lived for many years. She saw her kids get married, met her first grandchild, and had time to prepare, something not everyone gets the chance to do.

That’s why it’s important to “do what you normally do as long as you can,” Dr. Dizon said. “Live your life.”

A version of this article first appeared on Medscape.com.

It was 2 a.m. And Rebecca Shatsky, MD, could not sleep.

The breast oncologist was thinking about a patient of hers with metastatic cancer.

The patient’s disease had been asymptomatic for some time. Then without warning, her cancer suddenly exploded. Her bone marrow was failing, and her liver was not far behind.

Dr. Shatsky had a treatment plan ready to go but still, she felt uneasy.

“I had to be honest with her that I didn’t know if this plan would work,” says Dr. Shatsky, a medical oncologist at University of California, San Diego (UCSD).

That night, after visiting the patient in the hospital, Dr. Shatsky lay awake going over her next move, making sure it was the right one and hoping it would help keep the disease at bay.

“It’s so much pressure when someone is depending on you to make life or death decisions,” Dr. Shatsky said.

And in the quiet hours of night, these concerns grow louder.

Dr. Shatsky is not alone. Oncologists face difficult decisions every day, and many wrestle with these choices long after their day in the clinic is over.

“There’s no off button,” says Aaron Goodman, MD, a hematologist at UCSD Health who goes by “Papa Heme” on Twitter. “I’m always thinking about my patients. Constantly.”

The public rarely gets a glimpse of these private moments. On occasion, oncologists will share a personal story, but more often, insights come from broad research on the ethical, emotional, and psychological toll of practicing medicine.

Many oncologists carry this baggage home with them because they have no other option.

“There is simply no time to process the weight of the day when I’ve got seven more patients who need my full attention before lunch,” Mark Lewis, MD, director, department of gastrointestinal oncology, Intermountain Healthcare, Salt Lake City, Utah. “That is why my processing happens outside of the office, when my brain can be quiet.”
 

What am I missing?

Dr. Goodman recognizes the gravity of each decision he makes. He pores over every detail of a patient’s scans, lab results, history, and symptoms.

But no matter how many times he checks and rechecks, one question nags at him: What am I missing?

For Dr. Goodman, this exhaustive level of attention is worth it.

“When errors are made, it’s someone’s life,” Dr. Goodman said. “Nothing would have prepared me for this responsibility. Until it lies on you, it’s impossible to understand how much trust patients put into us.”

That trust becomes most apparent for Dr. Goodman when facing a decision about how to treat a patient with acute myeloid leukemia who’s in remission.

Give more chemotherapy to root out the leukemia cells still lurking in the body, and the patient faces a high risk of the cancer returning. Pick stem cell transplant, and the chance of being cured goes up significantly, but the patient could also die within 100 days of the transplant.

“All together, the data show I’m helping patients with a transplant, but for the individual, I could be causing harm. Someone could be living less because of a decision I made,” Dr. Goodman said.

For patients with advanced cancer, oncologists may need to think several moves ahead. Mapping out a patient’s treatment options can feel like a game of chess. Dr. Shatsky is always trying to anticipate how the tumor will behave, what is driving it, and how lifestyle factors may influence a patient’s response in the present and the future.

“It is a mind game,” she says. “Like in chess, I try to outsmart my opponent. But with advanced cancer, there are not necessarily clear-cut guidelines or one way to manage the disease, and I have to do the best I can with drugs I have.”

That’s the art of oncology: Balancing the many knowns and unknowns of a person’s cancer alongside the toxicities of treatment and a patient’s hopes and goals.

Throughout the year, Don Dizon, MD, will see a number of patients with advanced disease. In these instances, the question he often wrestles with is if the patient can’t be cured, whether more treatment will just cause greater harm.

Dr. Dizon recently faced this dilemma with an older patient with metastatic disease who had not done well with an initial treatment regimen. After outlining the risks for more chemotherapy, he explained one option would be to forgo it and simply treat her symptoms.

“It’s an impossible choice,” says Dr. Dizon, director of women’s cancers at Lifespan Cancer Institute and director of medical oncology at Rhode Island Hospital, Providence.

Chemotherapy can provide symptom relief, but it can also be toxic – and patients may be so frail, they can die from more therapy.

“I told my patient, if in your heart, you want to try more therapy, that’s okay. But it’s also okay if you don’t,” Dr. Dizon recalled.

Her response: “You’re supposed to give me the answer.”

However, for patients approaching the end of life, there often is no right answer. 

“It’s part of the discomfort you live with as a patient and oncologist, and when I leave the clinic, that’s one thing that follows me home,” Dr. Dizon said. “At the end of the day, I need to look in the mirror and know I did the best I could.”
 

The difficult conversation

Every Sunday, Dr. Lewis feels the weight of the week ahead. He and his wife, a pediatrician, call it the “Sunday scaries.”

It’s when Dr. Lewis begins thinking about the delicate conversations to come, rehearsing how he’s going to share the news that a person has advanced cancer or that a cancer, once in remission, has returned.

“Before the pandemic, I had 36 people come to a visit where I delivered some very heavy news and it became a Greek chorus of sobbing,” he recalls.

For every oncologist, delivering bad news is an integral part of the job. But after spending months, sometimes years, with a patient and the family, Dr. Lewis knows how to take the temperature of the room – who will likely prefer a more blunt style and who might need a gentler touch.

“The longer you know a patient and family, the better you can gauge the best approach,” Dr. Lewis said. “And for some, you know it’ll be complete devastation no matter what.”

When Jennifer Lycette, MD, prepares for a difficult conversation, she’ll run down all the possible ways it could go. Sometimes her brain will get stuck in a loop, cycling through the different trajectories on repeat.

“For years, I didn’t know how to cope with that,” said Dr. Lycette, medical director at Providence Oncology and Hematology Care Clinic in Seaside, Ore. “I wasn’t taught the tools to cope with that in my medical training. It took midcareer professional coaching that I sought out on my own to learn to remind myself that no matter what the person says, I have the experience and skill set to handle what comes next and to simply be present in the moment with the patient.”

The question that now sits with Dr. Lycette hours after a visit is what she could have done better. She knows from experience how important it is to choose her words carefully.

Early in her career, Dr. Lycette had a patient with stage IV cancer who wanted to know more about the death process. Because most people ask about pain, she assured him that he likely wouldn’t experience too much pain with his type of cancer.

“It will probably be like falling asleep,” said Dr. Lycette, hoping she was offering comfort. “When I saw him next, he told me he hadn’t slept.”

He was afraid that if he did, he wouldn’t wake up.

In that moment, Dr. Lycette realized the power that her words carry and the importance of trying to understand the inner lives of her patients.
 

Life outside the clinic

Sometimes an oncologist’s late-night ruminations have little to do with cancer itself.

Manali Patel, MD, finds herself worrying if her patients will have enough to eat and whether she will be able to help.

“I was up at 3 a.m. one morning, thinking about how we’re going to fund a project for patients from low-income households who we discovered were experiencing severe food insecurity – what grants we need, what foundations we can work with,” said Dr. Patel, a medical oncologist at Stanford Hospital and Clinics and the VA Palo Alto Health Care System in California.

The past few years of the pandemic have added a new layer of worry for Dr. Patel.

“I don’t want my patients to die from a preventable virus when they’ve already been through so much suffering,” Dr. Patel said.

This thought feeds worries about how her actions outside the clinic could unintentionally harm her patients. Should she go to a big medical conference? A family gathering? The grocery store?

“There are some places you can’t avoid, but these decisions have caused a lot of strife for me,” she said. “The health and safety of our patients – that’s in our wheelhouse – but so many of the policies are outside of our control.”
 

The inevitable losses and the wins

For patients with metastatic disease, eventually the treatment options will run out.

Dr. Shatsky likes to be up front with patients about that reality: “There will come a day when I will tell you there’s nothing more I can do, and you need to trust that I’m being honest with you and that’s the truth.”

For Dr. Goodman, the devastation that bad news brings patients and families is glaring. He knows there will be no more normalcy in their lives.

“I see a lot of suffering, but I know the suffering happens regardless of whether I see it or not,” Dr. Goodman said.

That’s why holding on to the victories can be so important. Dr. Goodman recalled a young patient who came to him with a 20-cm tumor and is now cured. “Had I not met that individual and done what I had done, he’d be dead, but now he’s going to live his life,” Dr. Goodman said. “But I don’t wake up at 2 a.m. thinking about that.”

Dr. Shatsky gets a lot of joy from the wins – the patients who do really well, the times when she can help a friend or colleagues – and those moments go a long way to outweigh the hurt, worry, and workload.

When dealing with so much gray, “the wins are important, knowing you can make a difference is important,” Dr. Dizon said.

And there’s a delicate balance.

“I think patients want an oncologist who cares and is genuinely invested in their outcomes but not someone who is so sad all the time,” Dr. Lewis said. “When I lose a patient, I still grieve each loss, but I can’t mourn every patient’s death like it’s a family member. Otherwise, I’d break.”

What would you do if you had terminal cancer?

Dr. Dizon recalled how a friend handled the news. She went home and made dinner, he said.

Ultimately, she lived for many years. She saw her kids get married, met her first grandchild, and had time to prepare, something not everyone gets the chance to do.

That’s why it’s important to “do what you normally do as long as you can,” Dr. Dizon said. “Live your life.”

A version of this article first appeared on Medscape.com.

It was 2 a.m. And Rebecca Shatsky, MD, could not sleep.

The breast oncologist was thinking about a patient of hers with metastatic cancer.

The patient’s disease had been asymptomatic for some time. Then without warning, her cancer suddenly exploded. Her bone marrow was failing, and her liver was not far behind.

Dr. Shatsky had a treatment plan ready to go but still, she felt uneasy.

“I had to be honest with her that I didn’t know if this plan would work,” says Dr. Shatsky, a medical oncologist at University of California, San Diego (UCSD).

That night, after visiting the patient in the hospital, Dr. Shatsky lay awake going over her next move, making sure it was the right one and hoping it would help keep the disease at bay.

“It’s so much pressure when someone is depending on you to make life or death decisions,” Dr. Shatsky said.

And in the quiet hours of night, these concerns grow louder.

Dr. Shatsky is not alone. Oncologists face difficult decisions every day, and many wrestle with these choices long after their day in the clinic is over.

“There’s no off button,” says Aaron Goodman, MD, a hematologist at UCSD Health who goes by “Papa Heme” on Twitter. “I’m always thinking about my patients. Constantly.”

The public rarely gets a glimpse of these private moments. On occasion, oncologists will share a personal story, but more often, insights come from broad research on the ethical, emotional, and psychological toll of practicing medicine.

Many oncologists carry this baggage home with them because they have no other option.

“There is simply no time to process the weight of the day when I’ve got seven more patients who need my full attention before lunch,” Mark Lewis, MD, director, department of gastrointestinal oncology, Intermountain Healthcare, Salt Lake City, Utah. “That is why my processing happens outside of the office, when my brain can be quiet.”
 

What am I missing?

Dr. Goodman recognizes the gravity of each decision he makes. He pores over every detail of a patient’s scans, lab results, history, and symptoms.

But no matter how many times he checks and rechecks, one question nags at him: What am I missing?

For Dr. Goodman, this exhaustive level of attention is worth it.

“When errors are made, it’s someone’s life,” Dr. Goodman said. “Nothing would have prepared me for this responsibility. Until it lies on you, it’s impossible to understand how much trust patients put into us.”

That trust becomes most apparent for Dr. Goodman when facing a decision about how to treat a patient with acute myeloid leukemia who’s in remission.

Give more chemotherapy to root out the leukemia cells still lurking in the body, and the patient faces a high risk of the cancer returning. Pick stem cell transplant, and the chance of being cured goes up significantly, but the patient could also die within 100 days of the transplant.

“All together, the data show I’m helping patients with a transplant, but for the individual, I could be causing harm. Someone could be living less because of a decision I made,” Dr. Goodman said.

For patients with advanced cancer, oncologists may need to think several moves ahead. Mapping out a patient’s treatment options can feel like a game of chess. Dr. Shatsky is always trying to anticipate how the tumor will behave, what is driving it, and how lifestyle factors may influence a patient’s response in the present and the future.

“It is a mind game,” she says. “Like in chess, I try to outsmart my opponent. But with advanced cancer, there are not necessarily clear-cut guidelines or one way to manage the disease, and I have to do the best I can with drugs I have.”

That’s the art of oncology: Balancing the many knowns and unknowns of a person’s cancer alongside the toxicities of treatment and a patient’s hopes and goals.

Throughout the year, Don Dizon, MD, will see a number of patients with advanced disease. In these instances, the question he often wrestles with is if the patient can’t be cured, whether more treatment will just cause greater harm.

Dr. Dizon recently faced this dilemma with an older patient with metastatic disease who had not done well with an initial treatment regimen. After outlining the risks for more chemotherapy, he explained one option would be to forgo it and simply treat her symptoms.

“It’s an impossible choice,” says Dr. Dizon, director of women’s cancers at Lifespan Cancer Institute and director of medical oncology at Rhode Island Hospital, Providence.

Chemotherapy can provide symptom relief, but it can also be toxic – and patients may be so frail, they can die from more therapy.

“I told my patient, if in your heart, you want to try more therapy, that’s okay. But it’s also okay if you don’t,” Dr. Dizon recalled.

Her response: “You’re supposed to give me the answer.”

However, for patients approaching the end of life, there often is no right answer. 

“It’s part of the discomfort you live with as a patient and oncologist, and when I leave the clinic, that’s one thing that follows me home,” Dr. Dizon said. “At the end of the day, I need to look in the mirror and know I did the best I could.”
 

The difficult conversation

Every Sunday, Dr. Lewis feels the weight of the week ahead. He and his wife, a pediatrician, call it the “Sunday scaries.”

It’s when Dr. Lewis begins thinking about the delicate conversations to come, rehearsing how he’s going to share the news that a person has advanced cancer or that a cancer, once in remission, has returned.

“Before the pandemic, I had 36 people come to a visit where I delivered some very heavy news and it became a Greek chorus of sobbing,” he recalls.

For every oncologist, delivering bad news is an integral part of the job. But after spending months, sometimes years, with a patient and the family, Dr. Lewis knows how to take the temperature of the room – who will likely prefer a more blunt style and who might need a gentler touch.

“The longer you know a patient and family, the better you can gauge the best approach,” Dr. Lewis said. “And for some, you know it’ll be complete devastation no matter what.”

When Jennifer Lycette, MD, prepares for a difficult conversation, she’ll run down all the possible ways it could go. Sometimes her brain will get stuck in a loop, cycling through the different trajectories on repeat.

“For years, I didn’t know how to cope with that,” said Dr. Lycette, medical director at Providence Oncology and Hematology Care Clinic in Seaside, Ore. “I wasn’t taught the tools to cope with that in my medical training. It took midcareer professional coaching that I sought out on my own to learn to remind myself that no matter what the person says, I have the experience and skill set to handle what comes next and to simply be present in the moment with the patient.”

The question that now sits with Dr. Lycette hours after a visit is what she could have done better. She knows from experience how important it is to choose her words carefully.

Early in her career, Dr. Lycette had a patient with stage IV cancer who wanted to know more about the death process. Because most people ask about pain, she assured him that he likely wouldn’t experience too much pain with his type of cancer.

“It will probably be like falling asleep,” said Dr. Lycette, hoping she was offering comfort. “When I saw him next, he told me he hadn’t slept.”

He was afraid that if he did, he wouldn’t wake up.

In that moment, Dr. Lycette realized the power that her words carry and the importance of trying to understand the inner lives of her patients.
 

Life outside the clinic

Sometimes an oncologist’s late-night ruminations have little to do with cancer itself.

Manali Patel, MD, finds herself worrying if her patients will have enough to eat and whether she will be able to help.

“I was up at 3 a.m. one morning, thinking about how we’re going to fund a project for patients from low-income households who we discovered were experiencing severe food insecurity – what grants we need, what foundations we can work with,” said Dr. Patel, a medical oncologist at Stanford Hospital and Clinics and the VA Palo Alto Health Care System in California.

The past few years of the pandemic have added a new layer of worry for Dr. Patel.

“I don’t want my patients to die from a preventable virus when they’ve already been through so much suffering,” Dr. Patel said.

This thought feeds worries about how her actions outside the clinic could unintentionally harm her patients. Should she go to a big medical conference? A family gathering? The grocery store?

“There are some places you can’t avoid, but these decisions have caused a lot of strife for me,” she said. “The health and safety of our patients – that’s in our wheelhouse – but so many of the policies are outside of our control.”
 

The inevitable losses and the wins

For patients with metastatic disease, eventually the treatment options will run out.

Dr. Shatsky likes to be up front with patients about that reality: “There will come a day when I will tell you there’s nothing more I can do, and you need to trust that I’m being honest with you and that’s the truth.”

For Dr. Goodman, the devastation that bad news brings patients and families is glaring. He knows there will be no more normalcy in their lives.

“I see a lot of suffering, but I know the suffering happens regardless of whether I see it or not,” Dr. Goodman said.

That’s why holding on to the victories can be so important. Dr. Goodman recalled a young patient who came to him with a 20-cm tumor and is now cured. “Had I not met that individual and done what I had done, he’d be dead, but now he’s going to live his life,” Dr. Goodman said. “But I don’t wake up at 2 a.m. thinking about that.”

Dr. Shatsky gets a lot of joy from the wins – the patients who do really well, the times when she can help a friend or colleagues – and those moments go a long way to outweigh the hurt, worry, and workload.

When dealing with so much gray, “the wins are important, knowing you can make a difference is important,” Dr. Dizon said.

And there’s a delicate balance.

“I think patients want an oncologist who cares and is genuinely invested in their outcomes but not someone who is so sad all the time,” Dr. Lewis said. “When I lose a patient, I still grieve each loss, but I can’t mourn every patient’s death like it’s a family member. Otherwise, I’d break.”

What would you do if you had terminal cancer?

Dr. Dizon recalled how a friend handled the news. She went home and made dinner, he said.

Ultimately, she lived for many years. She saw her kids get married, met her first grandchild, and had time to prepare, something not everyone gets the chance to do.

That’s why it’s important to “do what you normally do as long as you can,” Dr. Dizon said. “Live your life.”

A version of this article first appeared on Medscape.com.