After cancer, abortion experience highlights post-Roe reality

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After cancer, abortion experience highlights post-Roe reality

The drive from Texas to the clinic in Albuquerque, N.M., took 10 hours. It was mid-April of this year. There wasn’t much to see along the mostly barren stretch, and there wasn’t much for Kailee DeSpain to do aside from think about where she was going and why.

Her husband was driving. She sensed his nervous glances toward the passenger seat where she sat struggling to quiet her thoughts.

No, she wasn’t having any pain, she told him. No, she wasn’t feeling like she did the last time or the two times before that.

This pregnancy was different. It was the first in which she feared for her own life. Her fetus – Finley – had triploidy, a rare chromosomal abnormality. Because of the condition, which affects 1%-3% of pregnancies, his heart, brain, and kidneys were not developing properly.

At 19 weeks, Finley was already struggling to draw breath from lungs squeezed inside an overcrowded chest cavity. Ms. DeSpain wanted nothing more than to carry Finley to term, hold him, meet him even for a moment before saying goodbye.

But his condition meant he would likely suffocate in utero well before that. And Ms. DeSpain knew that carrying him longer would likely raise her risk of bleeding and of her blood pressure increasing to dangerous highs.

“This could kill you,” her husband told her. “Do you realize you could die bringing a baby into this world who is not going to live? I don’t want to lose you.’”

Unlike her other pregnancies, the timing of this one and the decision she faced to end it put her health in even greater danger.
 

Imminent danger

On Sept. 1, 2021, a bill went into effect in Texas that banned abortions from as early as 6 weeks’ gestation. Texas Senate Bill 8 (SB8) became one of the most restrictive abortion laws in the country. It prohibited abortions whenever a fetal heartbeat, defined by lawmakers, could be detected on an ultrasound, often before many women knew they were pregnant.

The Texas abortion law was hardly the last word on the topic. Ms. DeSpain didn’t know it on her drive to New Mexico in April, but the U.S. Supreme Court was weeks away from overturning the landmark Roe v. Wade decision.

On June 24, the Supreme Court delivered its 6-3 ruling overturning Roe v. Wade, the 1973 case that granted women the right to abortion.

This decision set in motion “trigger laws” in some states – laws that essentially fully banned abortions. Those states included Ms. DeSpain’s home state of Texas, where abortion is now a felony except when the life of the mother is in peril.

However, legal definitions of what qualifies as “life-threatening” remain murky.

The law is unclear, says Lisa Harris, MD, PhD, professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor. “What does the risk of death have to be, and how imminent must it be?” she asked in a recent editorial in the New England Journal of Medicine. Is 25% enough? 50%? Or does a woman have to be moments from dying?

“This whole thing makes me so angry,” says Shikha Jain, MD, a medical oncologist at University of Illinois Health, Chicago. “A patient may not be experiencing an emergency right now, but if we don’t take care of the situation, it may become an emergency in 2 hours or 2 days.”

Even before the Roe v. Wade decision, pregnancy had been a high-stakes endeavor for many women. In 2019, more than 750 women died from pregnancy-related events in the United States. In 2020, that number rose to 850. Each year dozens more suffer pregnancy-related events that require lifesaving interventions.

Now, in a post-Roe world, the number of maternal deaths will likely climb as more abortion bans take effect and fewer women have access to lifesaving care, experts say. A 2021 study that compared 2017 maternal mortality rates in states with different levels of abortion restrictions found that the rate of maternal mortality was almost two times higher in states that restricted abortion access compared with those that protected it – 28.5 per 100,000 women vs. 15.7.

Some women living in states with abortion bans won’t have the resources to cross state lines for care.

“This is just going to widen the health care disparities that are already so prevalent in this country,” Dr. Jain says.
 

 

 

Navigating a crossroads

Ms. DeSpain’s medical history reads like a checklist of pregnancy-related perils: chronic high blood pressure, persistent clotting problems, and a high risk of hemorrhage. She was also diagnosed with cervical cancer in 2020, which left her body more fragile.

Cardiovascular conditions, including hypertension and hemorrhage, are the leading causes of maternal mortality, responsible for more than one-third of pregnancy-related deaths. Preeclampsia, characterized by high blood pressure, accounts for more than 7% of maternal deaths in the United States. Although less common, genetic disorders, such as spinal muscular atrophy and triploidy, or cancer during pregnancy can put a mother and fetus at risk.

Cancer – which affects about 1 in 1,000 pregnant women and results in termination in as many as 28% of cases – brings sharp focus to the new dangers and complex decision-making patients and their doctors face as abortion bans take hold.

Before the Supreme Court decision, a pregnant woman with cancer was already facing great uncertainty. The decision to treat cancer during pregnancy involves “weighing the risk of exposing the fetus to medication vs. the risk to the mother’s untreated illness if you don’t expose the fetus to medication,” Elyce Cardonick, MD, an obstetrician at Cooper University Health Care, Camden, N.J., who specializes in high-risk pregnancies, told the National Cancer Institute.

Oncologists generally agree that it’s safe for pregnant women to receive chemotherapy during the second and third trimesters. But for women with aggressive cancers that are diagnosed in the first trimester, chemotherapy is dangerous. For women who need immunotherapy, the risks of treatment remain unclear.

In these cases, Alice S. Mims, MD, must broach the possibility of terminating the pregnancy.

“Cancer is a very urgent condition,” says Dr. Mims, a hematology specialist at the Ohio State University Comprehensive Cancer Center, Columbus, who sees patients who are pregnant. “These women may have other children at home, and they want to do their best to fight the disease so they can be around for their family long term.”

Now the changing legal landscape on abortion will put hundreds more pregnant women with cancer in danger. In a recent viewpoint article published in JAMA Oncology, Jordyn Silverstein and Katherine Van Loon, MD, MPH, estimate that during the next year, up to 420 pregnant women living in states with restricted abortion access will face threats to their cancer care and potentially their life.

“The repercussions of overturning Roe v. Wade – and the failure of the Supreme Court to provide any guidance on exceptions related to the life and health of the mother – are potentially catastrophic for a subset of women who face a life-threating diagnosis of [pregnancy-associated cancer],” they write.

The choice Ms. DeSpain faced after her cervical cancer diagnosis was different. She was not pregnant at the time, but she was at a crossroads.

Although it was caught early, the cancer was aggressive. Her oncologist recommended that she undergo a hysterectomy – the surgery that would give her the best chance for a cancer-free future. It would also mean she could no longer become pregnant.

With a less invasive procedure, on the other hand, she could still carry a child, but she would face a much greater chance that the cancer would come back.

At 27, Ms. DeSpain was not ready to close the pregnancy door. She opted for a surgery in which part of her cervix was removed, allowing her to try for another baby.

But she faced a ticking clock in the event her cancer returned.

If you want to have a baby, “try soon,” her doctor warned.
 

 

 

A dead end

After her cancer surgery and a third miscarriage, Ms. DeSpain and her husband were surprised and excited when in late 2021 she again became pregnant.

The first trimester seemed blissfully uneventful. As the weeks passed, Finley’s heart started to beat.

But the 16-week ultrasound signaled a turning point. The sonographer was too quiet.

“This is really bad, isn’t it?” Ms. DeSpain asked her sonographer.

The doctors told her he wouldn’t survive. Finley had no heart chambers. His heart couldn’t pump blood properly. He was missing one kidney, and his brain was split in the back. With almost no amniotic fluid, her doctor said he would likely die in utero, crushed to death without support from the protective liquid.

She fought for him anyway. She sought specialty care, followed bed rest orders, and traveled 3 hours to Houston to enroll in a clinical trial.

But every road was a dead end.

Ultimately, testing revealed Finley had triploidy, and all lines led to one point.

“There were too many things wrong, too much wrong for them to fix,” says Ms. DeSpain, recalling the news from her doctor in Houston. “I was in shock. My husband was just sitting with his hands flat on the table, staring at nothing, shaking a little bit.”

However, Finley still had a heartbeat, making an abortion after 6 weeks a felony in Texas. Even a compassionate induction was now out of the question unless her death was imminent.

Ms. DeSpain called the abortion clinic in Albuquerque and made an appointment. She would have to wait 2 weeks because of an influx of pregnant patients coming from Texas.

She welcomed the wait … just in case she changed her mind.

“At that point I wanted to carry him as far as I could,” she says.

For those 2 weeks, Ms. DeSpain remained on bed rest. She cried all day every day. She worried that Finley was experiencing pain.

Through this process, her doctor’s support helped keep her grounded.

“She cried with us in her office and said, ‘I wish that you didn’t have to go, but I think you’re doing the right thing, doing what keeps you safest,’ “ Ms. DeSpain recalls.

Ms. DeSpain declined to share the name of her doctor out of fear that even expressing compassion for a patient’s safety could put the physician in legal jeopardy and provoke harassment.

That fear is warranted. Some doctors will be forced to choose between doing what is legal – even though the law is vague – and doing what is right for patients, says law professor Jamie Abrams, who was recently diagnosed with breast cancer.

To live in a world where there’s talk of criminalizing doctors for taking care of their patients, where there’s “this national movement to position some women to be shunned and exiled for seeking care that’s right for them, their health, and might save their life is staggering and beyond comprehension,” says Ms. Abrams, professor of law at the American University Washington College of Law.

Ms. Abrams, who was diagnosed with hormone receptor–positive invasive breast cancer the same day she read the leaked Supreme Court draft on the decision to end of Roe v. Wade, said that “overnight, I became a person who would need an abortion if I became pregnant, because my treatment would compromise a healthy birth or delay necessary cancer care.” Ms. Abrams was also told she could no longer use hormonal contraception.

Dr. Harris’s advice to clinicians is to try to do what they feel is best for patients, including referring them to centers that have legal resources and protections regarding abortions.

Dr. Mims agrees and recommends that doctors reach out to those with more resources and legal backing for support. “I would advise doctors in [states with restrictive laws] to familiarize themselves with available resources and organizations taking action to deal with questionable cases,” Dr. Mims says.
 

 

 

‘Baby killers work here’

Following her 10-hour drive to Albuquerque, Ms. DeSpain encountered lines of protesters at the clinic. They were holding signs that said, “Abortion is murder,” and “Baby killers work here.”

“Please don’t kill your baby – we have resources for you,” a woman screeched through a megaphone as Ms. DeSpain, nearly 20 weeks’ pregnant, stepped out of the car to enter the clinic.

“I remember turning around, looking at her and making eye contact, and yelling back, ‘My baby has triploidy – he is dying! He is going to suffocate if I carry him full term. You don’t know what you’re talking about!’ “

A nurse held her hand during the procedure.

“He said, ‘You’re doing great, you’re okay,’ “ she recalls. She knew there was a chance that Finley’s face would be crushed by contractions during labor because of the lack of amniotic fluid, but she hoped not. Ms. DeSpain longed for a photo.

There was no photo to take home the next day, but Ms. DeSpain did receive Finley’s footprints, and his heartbeat – as captured by the specialty team in Houston – lives on in a stuffed giraffe.

His ashes arrived a few weeks later.

By then, the Supreme Court draft had been leaked. Ms. DeSpain knew her predicament in Texas would soon affect women across the United States and make any future pregnancy attempt for her even more risky.

The weeks and months that followed were a blur of grief, anger, and medical testing.

But she received some good news. A second triploidy pregnancy was extremely unlikely.

Several weeks later, Ms. DeSpain got more good news.

“I had a follow-up cancer appointment, and everything was completely clear,” she says.

She remains hopeful that she will be able to give birth, but her doctor cautioned that it’s no longer safe to become pregnant in Texas.

“I need you to understand that if you get pregnant and you have complications, we can’t intervene unless the baby doesn’t have a heartbeat, even if it would save your life,” Ms. DeSpain recalls her doctor saying.

If Texas remains a dangerous place to be pregnant, Ms. DeSpain and her husband will have to move.

For now, Ms. DeSpain wants people to know her story and to continue to fight for her right to govern her body.

In a public post to Facebook, she laid bare her pregnancy journey.

“No one should have to share a story like mine to justify abortion,” she wrote. “My choice is not yours to judge, and my rights are not yours to gleefully take away.”

Ms. Abrams, Ms. DeSpain, Dr. Harris, Dr. Jain, and Dr. Mims have disclosed no relevant financial relationships.

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

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The drive from Texas to the clinic in Albuquerque, N.M., took 10 hours. It was mid-April of this year. There wasn’t much to see along the mostly barren stretch, and there wasn’t much for Kailee DeSpain to do aside from think about where she was going and why.

Her husband was driving. She sensed his nervous glances toward the passenger seat where she sat struggling to quiet her thoughts.

No, she wasn’t having any pain, she told him. No, she wasn’t feeling like she did the last time or the two times before that.

This pregnancy was different. It was the first in which she feared for her own life. Her fetus – Finley – had triploidy, a rare chromosomal abnormality. Because of the condition, which affects 1%-3% of pregnancies, his heart, brain, and kidneys were not developing properly.

At 19 weeks, Finley was already struggling to draw breath from lungs squeezed inside an overcrowded chest cavity. Ms. DeSpain wanted nothing more than to carry Finley to term, hold him, meet him even for a moment before saying goodbye.

But his condition meant he would likely suffocate in utero well before that. And Ms. DeSpain knew that carrying him longer would likely raise her risk of bleeding and of her blood pressure increasing to dangerous highs.

“This could kill you,” her husband told her. “Do you realize you could die bringing a baby into this world who is not going to live? I don’t want to lose you.’”

Unlike her other pregnancies, the timing of this one and the decision she faced to end it put her health in even greater danger.
 

Imminent danger

On Sept. 1, 2021, a bill went into effect in Texas that banned abortions from as early as 6 weeks’ gestation. Texas Senate Bill 8 (SB8) became one of the most restrictive abortion laws in the country. It prohibited abortions whenever a fetal heartbeat, defined by lawmakers, could be detected on an ultrasound, often before many women knew they were pregnant.

The Texas abortion law was hardly the last word on the topic. Ms. DeSpain didn’t know it on her drive to New Mexico in April, but the U.S. Supreme Court was weeks away from overturning the landmark Roe v. Wade decision.

On June 24, the Supreme Court delivered its 6-3 ruling overturning Roe v. Wade, the 1973 case that granted women the right to abortion.

This decision set in motion “trigger laws” in some states – laws that essentially fully banned abortions. Those states included Ms. DeSpain’s home state of Texas, where abortion is now a felony except when the life of the mother is in peril.

However, legal definitions of what qualifies as “life-threatening” remain murky.

The law is unclear, says Lisa Harris, MD, PhD, professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor. “What does the risk of death have to be, and how imminent must it be?” she asked in a recent editorial in the New England Journal of Medicine. Is 25% enough? 50%? Or does a woman have to be moments from dying?

“This whole thing makes me so angry,” says Shikha Jain, MD, a medical oncologist at University of Illinois Health, Chicago. “A patient may not be experiencing an emergency right now, but if we don’t take care of the situation, it may become an emergency in 2 hours or 2 days.”

Even before the Roe v. Wade decision, pregnancy had been a high-stakes endeavor for many women. In 2019, more than 750 women died from pregnancy-related events in the United States. In 2020, that number rose to 850. Each year dozens more suffer pregnancy-related events that require lifesaving interventions.

Now, in a post-Roe world, the number of maternal deaths will likely climb as more abortion bans take effect and fewer women have access to lifesaving care, experts say. A 2021 study that compared 2017 maternal mortality rates in states with different levels of abortion restrictions found that the rate of maternal mortality was almost two times higher in states that restricted abortion access compared with those that protected it – 28.5 per 100,000 women vs. 15.7.

Some women living in states with abortion bans won’t have the resources to cross state lines for care.

“This is just going to widen the health care disparities that are already so prevalent in this country,” Dr. Jain says.
 

 

 

Navigating a crossroads

Ms. DeSpain’s medical history reads like a checklist of pregnancy-related perils: chronic high blood pressure, persistent clotting problems, and a high risk of hemorrhage. She was also diagnosed with cervical cancer in 2020, which left her body more fragile.

Cardiovascular conditions, including hypertension and hemorrhage, are the leading causes of maternal mortality, responsible for more than one-third of pregnancy-related deaths. Preeclampsia, characterized by high blood pressure, accounts for more than 7% of maternal deaths in the United States. Although less common, genetic disorders, such as spinal muscular atrophy and triploidy, or cancer during pregnancy can put a mother and fetus at risk.

Cancer – which affects about 1 in 1,000 pregnant women and results in termination in as many as 28% of cases – brings sharp focus to the new dangers and complex decision-making patients and their doctors face as abortion bans take hold.

Before the Supreme Court decision, a pregnant woman with cancer was already facing great uncertainty. The decision to treat cancer during pregnancy involves “weighing the risk of exposing the fetus to medication vs. the risk to the mother’s untreated illness if you don’t expose the fetus to medication,” Elyce Cardonick, MD, an obstetrician at Cooper University Health Care, Camden, N.J., who specializes in high-risk pregnancies, told the National Cancer Institute.

Oncologists generally agree that it’s safe for pregnant women to receive chemotherapy during the second and third trimesters. But for women with aggressive cancers that are diagnosed in the first trimester, chemotherapy is dangerous. For women who need immunotherapy, the risks of treatment remain unclear.

In these cases, Alice S. Mims, MD, must broach the possibility of terminating the pregnancy.

“Cancer is a very urgent condition,” says Dr. Mims, a hematology specialist at the Ohio State University Comprehensive Cancer Center, Columbus, who sees patients who are pregnant. “These women may have other children at home, and they want to do their best to fight the disease so they can be around for their family long term.”

Now the changing legal landscape on abortion will put hundreds more pregnant women with cancer in danger. In a recent viewpoint article published in JAMA Oncology, Jordyn Silverstein and Katherine Van Loon, MD, MPH, estimate that during the next year, up to 420 pregnant women living in states with restricted abortion access will face threats to their cancer care and potentially their life.

“The repercussions of overturning Roe v. Wade – and the failure of the Supreme Court to provide any guidance on exceptions related to the life and health of the mother – are potentially catastrophic for a subset of women who face a life-threating diagnosis of [pregnancy-associated cancer],” they write.

The choice Ms. DeSpain faced after her cervical cancer diagnosis was different. She was not pregnant at the time, but she was at a crossroads.

Although it was caught early, the cancer was aggressive. Her oncologist recommended that she undergo a hysterectomy – the surgery that would give her the best chance for a cancer-free future. It would also mean she could no longer become pregnant.

With a less invasive procedure, on the other hand, she could still carry a child, but she would face a much greater chance that the cancer would come back.

At 27, Ms. DeSpain was not ready to close the pregnancy door. She opted for a surgery in which part of her cervix was removed, allowing her to try for another baby.

But she faced a ticking clock in the event her cancer returned.

If you want to have a baby, “try soon,” her doctor warned.
 

 

 

A dead end

After her cancer surgery and a third miscarriage, Ms. DeSpain and her husband were surprised and excited when in late 2021 she again became pregnant.

The first trimester seemed blissfully uneventful. As the weeks passed, Finley’s heart started to beat.

But the 16-week ultrasound signaled a turning point. The sonographer was too quiet.

“This is really bad, isn’t it?” Ms. DeSpain asked her sonographer.

The doctors told her he wouldn’t survive. Finley had no heart chambers. His heart couldn’t pump blood properly. He was missing one kidney, and his brain was split in the back. With almost no amniotic fluid, her doctor said he would likely die in utero, crushed to death without support from the protective liquid.

She fought for him anyway. She sought specialty care, followed bed rest orders, and traveled 3 hours to Houston to enroll in a clinical trial.

But every road was a dead end.

Ultimately, testing revealed Finley had triploidy, and all lines led to one point.

“There were too many things wrong, too much wrong for them to fix,” says Ms. DeSpain, recalling the news from her doctor in Houston. “I was in shock. My husband was just sitting with his hands flat on the table, staring at nothing, shaking a little bit.”

However, Finley still had a heartbeat, making an abortion after 6 weeks a felony in Texas. Even a compassionate induction was now out of the question unless her death was imminent.

Ms. DeSpain called the abortion clinic in Albuquerque and made an appointment. She would have to wait 2 weeks because of an influx of pregnant patients coming from Texas.

She welcomed the wait … just in case she changed her mind.

“At that point I wanted to carry him as far as I could,” she says.

For those 2 weeks, Ms. DeSpain remained on bed rest. She cried all day every day. She worried that Finley was experiencing pain.

Through this process, her doctor’s support helped keep her grounded.

“She cried with us in her office and said, ‘I wish that you didn’t have to go, but I think you’re doing the right thing, doing what keeps you safest,’ “ Ms. DeSpain recalls.

Ms. DeSpain declined to share the name of her doctor out of fear that even expressing compassion for a patient’s safety could put the physician in legal jeopardy and provoke harassment.

That fear is warranted. Some doctors will be forced to choose between doing what is legal – even though the law is vague – and doing what is right for patients, says law professor Jamie Abrams, who was recently diagnosed with breast cancer.

To live in a world where there’s talk of criminalizing doctors for taking care of their patients, where there’s “this national movement to position some women to be shunned and exiled for seeking care that’s right for them, their health, and might save their life is staggering and beyond comprehension,” says Ms. Abrams, professor of law at the American University Washington College of Law.

Ms. Abrams, who was diagnosed with hormone receptor–positive invasive breast cancer the same day she read the leaked Supreme Court draft on the decision to end of Roe v. Wade, said that “overnight, I became a person who would need an abortion if I became pregnant, because my treatment would compromise a healthy birth or delay necessary cancer care.” Ms. Abrams was also told she could no longer use hormonal contraception.

Dr. Harris’s advice to clinicians is to try to do what they feel is best for patients, including referring them to centers that have legal resources and protections regarding abortions.

Dr. Mims agrees and recommends that doctors reach out to those with more resources and legal backing for support. “I would advise doctors in [states with restrictive laws] to familiarize themselves with available resources and organizations taking action to deal with questionable cases,” Dr. Mims says.
 

 

 

‘Baby killers work here’

Following her 10-hour drive to Albuquerque, Ms. DeSpain encountered lines of protesters at the clinic. They were holding signs that said, “Abortion is murder,” and “Baby killers work here.”

“Please don’t kill your baby – we have resources for you,” a woman screeched through a megaphone as Ms. DeSpain, nearly 20 weeks’ pregnant, stepped out of the car to enter the clinic.

“I remember turning around, looking at her and making eye contact, and yelling back, ‘My baby has triploidy – he is dying! He is going to suffocate if I carry him full term. You don’t know what you’re talking about!’ “

A nurse held her hand during the procedure.

“He said, ‘You’re doing great, you’re okay,’ “ she recalls. She knew there was a chance that Finley’s face would be crushed by contractions during labor because of the lack of amniotic fluid, but she hoped not. Ms. DeSpain longed for a photo.

There was no photo to take home the next day, but Ms. DeSpain did receive Finley’s footprints, and his heartbeat – as captured by the specialty team in Houston – lives on in a stuffed giraffe.

His ashes arrived a few weeks later.

By then, the Supreme Court draft had been leaked. Ms. DeSpain knew her predicament in Texas would soon affect women across the United States and make any future pregnancy attempt for her even more risky.

The weeks and months that followed were a blur of grief, anger, and medical testing.

But she received some good news. A second triploidy pregnancy was extremely unlikely.

Several weeks later, Ms. DeSpain got more good news.

“I had a follow-up cancer appointment, and everything was completely clear,” she says.

She remains hopeful that she will be able to give birth, but her doctor cautioned that it’s no longer safe to become pregnant in Texas.

“I need you to understand that if you get pregnant and you have complications, we can’t intervene unless the baby doesn’t have a heartbeat, even if it would save your life,” Ms. DeSpain recalls her doctor saying.

If Texas remains a dangerous place to be pregnant, Ms. DeSpain and her husband will have to move.

For now, Ms. DeSpain wants people to know her story and to continue to fight for her right to govern her body.

In a public post to Facebook, she laid bare her pregnancy journey.

“No one should have to share a story like mine to justify abortion,” she wrote. “My choice is not yours to judge, and my rights are not yours to gleefully take away.”

Ms. Abrams, Ms. DeSpain, Dr. Harris, Dr. Jain, and Dr. Mims have disclosed no relevant financial relationships.

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

The drive from Texas to the clinic in Albuquerque, N.M., took 10 hours. It was mid-April of this year. There wasn’t much to see along the mostly barren stretch, and there wasn’t much for Kailee DeSpain to do aside from think about where she was going and why.

Her husband was driving. She sensed his nervous glances toward the passenger seat where she sat struggling to quiet her thoughts.

No, she wasn’t having any pain, she told him. No, she wasn’t feeling like she did the last time or the two times before that.

This pregnancy was different. It was the first in which she feared for her own life. Her fetus – Finley – had triploidy, a rare chromosomal abnormality. Because of the condition, which affects 1%-3% of pregnancies, his heart, brain, and kidneys were not developing properly.

At 19 weeks, Finley was already struggling to draw breath from lungs squeezed inside an overcrowded chest cavity. Ms. DeSpain wanted nothing more than to carry Finley to term, hold him, meet him even for a moment before saying goodbye.

But his condition meant he would likely suffocate in utero well before that. And Ms. DeSpain knew that carrying him longer would likely raise her risk of bleeding and of her blood pressure increasing to dangerous highs.

“This could kill you,” her husband told her. “Do you realize you could die bringing a baby into this world who is not going to live? I don’t want to lose you.’”

Unlike her other pregnancies, the timing of this one and the decision she faced to end it put her health in even greater danger.
 

Imminent danger

On Sept. 1, 2021, a bill went into effect in Texas that banned abortions from as early as 6 weeks’ gestation. Texas Senate Bill 8 (SB8) became one of the most restrictive abortion laws in the country. It prohibited abortions whenever a fetal heartbeat, defined by lawmakers, could be detected on an ultrasound, often before many women knew they were pregnant.

The Texas abortion law was hardly the last word on the topic. Ms. DeSpain didn’t know it on her drive to New Mexico in April, but the U.S. Supreme Court was weeks away from overturning the landmark Roe v. Wade decision.

On June 24, the Supreme Court delivered its 6-3 ruling overturning Roe v. Wade, the 1973 case that granted women the right to abortion.

This decision set in motion “trigger laws” in some states – laws that essentially fully banned abortions. Those states included Ms. DeSpain’s home state of Texas, where abortion is now a felony except when the life of the mother is in peril.

However, legal definitions of what qualifies as “life-threatening” remain murky.

The law is unclear, says Lisa Harris, MD, PhD, professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor. “What does the risk of death have to be, and how imminent must it be?” she asked in a recent editorial in the New England Journal of Medicine. Is 25% enough? 50%? Or does a woman have to be moments from dying?

“This whole thing makes me so angry,” says Shikha Jain, MD, a medical oncologist at University of Illinois Health, Chicago. “A patient may not be experiencing an emergency right now, but if we don’t take care of the situation, it may become an emergency in 2 hours or 2 days.”

Even before the Roe v. Wade decision, pregnancy had been a high-stakes endeavor for many women. In 2019, more than 750 women died from pregnancy-related events in the United States. In 2020, that number rose to 850. Each year dozens more suffer pregnancy-related events that require lifesaving interventions.

Now, in a post-Roe world, the number of maternal deaths will likely climb as more abortion bans take effect and fewer women have access to lifesaving care, experts say. A 2021 study that compared 2017 maternal mortality rates in states with different levels of abortion restrictions found that the rate of maternal mortality was almost two times higher in states that restricted abortion access compared with those that protected it – 28.5 per 100,000 women vs. 15.7.

Some women living in states with abortion bans won’t have the resources to cross state lines for care.

“This is just going to widen the health care disparities that are already so prevalent in this country,” Dr. Jain says.
 

 

 

Navigating a crossroads

Ms. DeSpain’s medical history reads like a checklist of pregnancy-related perils: chronic high blood pressure, persistent clotting problems, and a high risk of hemorrhage. She was also diagnosed with cervical cancer in 2020, which left her body more fragile.

Cardiovascular conditions, including hypertension and hemorrhage, are the leading causes of maternal mortality, responsible for more than one-third of pregnancy-related deaths. Preeclampsia, characterized by high blood pressure, accounts for more than 7% of maternal deaths in the United States. Although less common, genetic disorders, such as spinal muscular atrophy and triploidy, or cancer during pregnancy can put a mother and fetus at risk.

Cancer – which affects about 1 in 1,000 pregnant women and results in termination in as many as 28% of cases – brings sharp focus to the new dangers and complex decision-making patients and their doctors face as abortion bans take hold.

Before the Supreme Court decision, a pregnant woman with cancer was already facing great uncertainty. The decision to treat cancer during pregnancy involves “weighing the risk of exposing the fetus to medication vs. the risk to the mother’s untreated illness if you don’t expose the fetus to medication,” Elyce Cardonick, MD, an obstetrician at Cooper University Health Care, Camden, N.J., who specializes in high-risk pregnancies, told the National Cancer Institute.

Oncologists generally agree that it’s safe for pregnant women to receive chemotherapy during the second and third trimesters. But for women with aggressive cancers that are diagnosed in the first trimester, chemotherapy is dangerous. For women who need immunotherapy, the risks of treatment remain unclear.

In these cases, Alice S. Mims, MD, must broach the possibility of terminating the pregnancy.

“Cancer is a very urgent condition,” says Dr. Mims, a hematology specialist at the Ohio State University Comprehensive Cancer Center, Columbus, who sees patients who are pregnant. “These women may have other children at home, and they want to do their best to fight the disease so they can be around for their family long term.”

Now the changing legal landscape on abortion will put hundreds more pregnant women with cancer in danger. In a recent viewpoint article published in JAMA Oncology, Jordyn Silverstein and Katherine Van Loon, MD, MPH, estimate that during the next year, up to 420 pregnant women living in states with restricted abortion access will face threats to their cancer care and potentially their life.

“The repercussions of overturning Roe v. Wade – and the failure of the Supreme Court to provide any guidance on exceptions related to the life and health of the mother – are potentially catastrophic for a subset of women who face a life-threating diagnosis of [pregnancy-associated cancer],” they write.

The choice Ms. DeSpain faced after her cervical cancer diagnosis was different. She was not pregnant at the time, but she was at a crossroads.

Although it was caught early, the cancer was aggressive. Her oncologist recommended that she undergo a hysterectomy – the surgery that would give her the best chance for a cancer-free future. It would also mean she could no longer become pregnant.

With a less invasive procedure, on the other hand, she could still carry a child, but she would face a much greater chance that the cancer would come back.

At 27, Ms. DeSpain was not ready to close the pregnancy door. She opted for a surgery in which part of her cervix was removed, allowing her to try for another baby.

But she faced a ticking clock in the event her cancer returned.

If you want to have a baby, “try soon,” her doctor warned.
 

 

 

A dead end

After her cancer surgery and a third miscarriage, Ms. DeSpain and her husband were surprised and excited when in late 2021 she again became pregnant.

The first trimester seemed blissfully uneventful. As the weeks passed, Finley’s heart started to beat.

But the 16-week ultrasound signaled a turning point. The sonographer was too quiet.

“This is really bad, isn’t it?” Ms. DeSpain asked her sonographer.

The doctors told her he wouldn’t survive. Finley had no heart chambers. His heart couldn’t pump blood properly. He was missing one kidney, and his brain was split in the back. With almost no amniotic fluid, her doctor said he would likely die in utero, crushed to death without support from the protective liquid.

She fought for him anyway. She sought specialty care, followed bed rest orders, and traveled 3 hours to Houston to enroll in a clinical trial.

But every road was a dead end.

Ultimately, testing revealed Finley had triploidy, and all lines led to one point.

“There were too many things wrong, too much wrong for them to fix,” says Ms. DeSpain, recalling the news from her doctor in Houston. “I was in shock. My husband was just sitting with his hands flat on the table, staring at nothing, shaking a little bit.”

However, Finley still had a heartbeat, making an abortion after 6 weeks a felony in Texas. Even a compassionate induction was now out of the question unless her death was imminent.

Ms. DeSpain called the abortion clinic in Albuquerque and made an appointment. She would have to wait 2 weeks because of an influx of pregnant patients coming from Texas.

She welcomed the wait … just in case she changed her mind.

“At that point I wanted to carry him as far as I could,” she says.

For those 2 weeks, Ms. DeSpain remained on bed rest. She cried all day every day. She worried that Finley was experiencing pain.

Through this process, her doctor’s support helped keep her grounded.

“She cried with us in her office and said, ‘I wish that you didn’t have to go, but I think you’re doing the right thing, doing what keeps you safest,’ “ Ms. DeSpain recalls.

Ms. DeSpain declined to share the name of her doctor out of fear that even expressing compassion for a patient’s safety could put the physician in legal jeopardy and provoke harassment.

That fear is warranted. Some doctors will be forced to choose between doing what is legal – even though the law is vague – and doing what is right for patients, says law professor Jamie Abrams, who was recently diagnosed with breast cancer.

To live in a world where there’s talk of criminalizing doctors for taking care of their patients, where there’s “this national movement to position some women to be shunned and exiled for seeking care that’s right for them, their health, and might save their life is staggering and beyond comprehension,” says Ms. Abrams, professor of law at the American University Washington College of Law.

Ms. Abrams, who was diagnosed with hormone receptor–positive invasive breast cancer the same day she read the leaked Supreme Court draft on the decision to end of Roe v. Wade, said that “overnight, I became a person who would need an abortion if I became pregnant, because my treatment would compromise a healthy birth or delay necessary cancer care.” Ms. Abrams was also told she could no longer use hormonal contraception.

Dr. Harris’s advice to clinicians is to try to do what they feel is best for patients, including referring them to centers that have legal resources and protections regarding abortions.

Dr. Mims agrees and recommends that doctors reach out to those with more resources and legal backing for support. “I would advise doctors in [states with restrictive laws] to familiarize themselves with available resources and organizations taking action to deal with questionable cases,” Dr. Mims says.
 

 

 

‘Baby killers work here’

Following her 10-hour drive to Albuquerque, Ms. DeSpain encountered lines of protesters at the clinic. They were holding signs that said, “Abortion is murder,” and “Baby killers work here.”

“Please don’t kill your baby – we have resources for you,” a woman screeched through a megaphone as Ms. DeSpain, nearly 20 weeks’ pregnant, stepped out of the car to enter the clinic.

“I remember turning around, looking at her and making eye contact, and yelling back, ‘My baby has triploidy – he is dying! He is going to suffocate if I carry him full term. You don’t know what you’re talking about!’ “

A nurse held her hand during the procedure.

“He said, ‘You’re doing great, you’re okay,’ “ she recalls. She knew there was a chance that Finley’s face would be crushed by contractions during labor because of the lack of amniotic fluid, but she hoped not. Ms. DeSpain longed for a photo.

There was no photo to take home the next day, but Ms. DeSpain did receive Finley’s footprints, and his heartbeat – as captured by the specialty team in Houston – lives on in a stuffed giraffe.

His ashes arrived a few weeks later.

By then, the Supreme Court draft had been leaked. Ms. DeSpain knew her predicament in Texas would soon affect women across the United States and make any future pregnancy attempt for her even more risky.

The weeks and months that followed were a blur of grief, anger, and medical testing.

But she received some good news. A second triploidy pregnancy was extremely unlikely.

Several weeks later, Ms. DeSpain got more good news.

“I had a follow-up cancer appointment, and everything was completely clear,” she says.

She remains hopeful that she will be able to give birth, but her doctor cautioned that it’s no longer safe to become pregnant in Texas.

“I need you to understand that if you get pregnant and you have complications, we can’t intervene unless the baby doesn’t have a heartbeat, even if it would save your life,” Ms. DeSpain recalls her doctor saying.

If Texas remains a dangerous place to be pregnant, Ms. DeSpain and her husband will have to move.

For now, Ms. DeSpain wants people to know her story and to continue to fight for her right to govern her body.

In a public post to Facebook, she laid bare her pregnancy journey.

“No one should have to share a story like mine to justify abortion,” she wrote. “My choice is not yours to judge, and my rights are not yours to gleefully take away.”

Ms. Abrams, Ms. DeSpain, Dr. Harris, Dr. Jain, and Dr. Mims have disclosed no relevant financial relationships.

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

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Meta-analysis demonstrates better survival outcomes with breast-conserving surgery vs mastectomy

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Key clinical point: Women with early-stage invasive breast cancer (BC) who underwent breast-conserving surgery with radiotherapy (BCS) had better overall survival (OS) than those who underwent mastectomy.

Major finding: Compared with mastectomy, BCS was associated with improved OS in the overall population of patients with early-stage invasive BC (relative risk [RR] 0.64; 95% CI 0.55-0.74), with stronger effects observed in women followed-up for <10 years (RR 0.54; 95% CI 0.46-0.64).

Study details: Findings are from a meta-analysis of 30 studies including 1,802,128 women with early-stage invasive BC, of which 1,075,563 and 744,565 patients underwent BCS and mastectomy, respectively, and were followed-up for 4-20 years.

Disclosures: This study did not receive any external funding. Dr. Chatterjee declared serving as a consultant for 3M and Royal.

Source: De la Cruz Ku G et al. Does breast-conserving surgery with radiotherapy have a better survival than mastectomy? A meta-analysis of more than 1,500,000 patients. Ann Surg Oncol. 2022 (Jul 25). Doi: 10.1245/s10434-022-12133-8

 

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Key clinical point: Women with early-stage invasive breast cancer (BC) who underwent breast-conserving surgery with radiotherapy (BCS) had better overall survival (OS) than those who underwent mastectomy.

Major finding: Compared with mastectomy, BCS was associated with improved OS in the overall population of patients with early-stage invasive BC (relative risk [RR] 0.64; 95% CI 0.55-0.74), with stronger effects observed in women followed-up for <10 years (RR 0.54; 95% CI 0.46-0.64).

Study details: Findings are from a meta-analysis of 30 studies including 1,802,128 women with early-stage invasive BC, of which 1,075,563 and 744,565 patients underwent BCS and mastectomy, respectively, and were followed-up for 4-20 years.

Disclosures: This study did not receive any external funding. Dr. Chatterjee declared serving as a consultant for 3M and Royal.

Source: De la Cruz Ku G et al. Does breast-conserving surgery with radiotherapy have a better survival than mastectomy? A meta-analysis of more than 1,500,000 patients. Ann Surg Oncol. 2022 (Jul 25). Doi: 10.1245/s10434-022-12133-8

 

Key clinical point: Women with early-stage invasive breast cancer (BC) who underwent breast-conserving surgery with radiotherapy (BCS) had better overall survival (OS) than those who underwent mastectomy.

Major finding: Compared with mastectomy, BCS was associated with improved OS in the overall population of patients with early-stage invasive BC (relative risk [RR] 0.64; 95% CI 0.55-0.74), with stronger effects observed in women followed-up for <10 years (RR 0.54; 95% CI 0.46-0.64).

Study details: Findings are from a meta-analysis of 30 studies including 1,802,128 women with early-stage invasive BC, of which 1,075,563 and 744,565 patients underwent BCS and mastectomy, respectively, and were followed-up for 4-20 years.

Disclosures: This study did not receive any external funding. Dr. Chatterjee declared serving as a consultant for 3M and Royal.

Source: De la Cruz Ku G et al. Does breast-conserving surgery with radiotherapy have a better survival than mastectomy? A meta-analysis of more than 1,500,000 patients. Ann Surg Oncol. 2022 (Jul 25). Doi: 10.1245/s10434-022-12133-8

 

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Childbirth does not impact survival in women with previously treated BC

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Key clinical point: A live birth (LB) after the diagnosis of breast cancer (BC) does not have a negative impact on a woman’s overall survival.

Major finding: Compared with women with no subsequent LB after BC diagnosis, the overall cohort of women with subsequent LB (hazard ratio [HR] 0.65; P  =  .002), women with only 1 subsequent LB (HR 0.73; P  =  .033), women with subsequent LB and no prior history of pregnancy (HR 0.56; P  =  .003), and women with LB within 5 years of BC diagnosis (HR 0.66; P  =  .006) had improved survival.

Study details: Findings are from a survival analysis in a national cohort of 5181 women diagnosed with BC at the age of 20-39 years, of which 290 had ≥1 LB and 1682 had no LB after BC diagnosis.

Disclosures: This study was partly supported by the MRC Centre for Reproductive Health, UK. Two authors declared serving as consultants or receiving speaker honoraria from several sources.

Source: Anderson RA et al. Survival after breast cancer in women with a subsequent live birth: Influence of age at diagnosis and interval to subsequent pregnancy. Eur J Cancer. 2022;173:113-122 (Jul 19). Doi:  10.1016/j.ejca.2022.06.048

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Key clinical point: A live birth (LB) after the diagnosis of breast cancer (BC) does not have a negative impact on a woman’s overall survival.

Major finding: Compared with women with no subsequent LB after BC diagnosis, the overall cohort of women with subsequent LB (hazard ratio [HR] 0.65; P  =  .002), women with only 1 subsequent LB (HR 0.73; P  =  .033), women with subsequent LB and no prior history of pregnancy (HR 0.56; P  =  .003), and women with LB within 5 years of BC diagnosis (HR 0.66; P  =  .006) had improved survival.

Study details: Findings are from a survival analysis in a national cohort of 5181 women diagnosed with BC at the age of 20-39 years, of which 290 had ≥1 LB and 1682 had no LB after BC diagnosis.

Disclosures: This study was partly supported by the MRC Centre for Reproductive Health, UK. Two authors declared serving as consultants or receiving speaker honoraria from several sources.

Source: Anderson RA et al. Survival after breast cancer in women with a subsequent live birth: Influence of age at diagnosis and interval to subsequent pregnancy. Eur J Cancer. 2022;173:113-122 (Jul 19). Doi:  10.1016/j.ejca.2022.06.048

Key clinical point: A live birth (LB) after the diagnosis of breast cancer (BC) does not have a negative impact on a woman’s overall survival.

Major finding: Compared with women with no subsequent LB after BC diagnosis, the overall cohort of women with subsequent LB (hazard ratio [HR] 0.65; P  =  .002), women with only 1 subsequent LB (HR 0.73; P  =  .033), women with subsequent LB and no prior history of pregnancy (HR 0.56; P  =  .003), and women with LB within 5 years of BC diagnosis (HR 0.66; P  =  .006) had improved survival.

Study details: Findings are from a survival analysis in a national cohort of 5181 women diagnosed with BC at the age of 20-39 years, of which 290 had ≥1 LB and 1682 had no LB after BC diagnosis.

Disclosures: This study was partly supported by the MRC Centre for Reproductive Health, UK. Two authors declared serving as consultants or receiving speaker honoraria from several sources.

Source: Anderson RA et al. Survival after breast cancer in women with a subsequent live birth: Influence of age at diagnosis and interval to subsequent pregnancy. Eur J Cancer. 2022;173:113-122 (Jul 19). Doi:  10.1016/j.ejca.2022.06.048

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ER+ BC: Long-term benefits of endocrine therapy in premenopausal women

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Key clinical point: Adjuvant endocrine therapy (ET) for 2 years showed a long-term (20 years) advantage in premenopausal women with estrogen receptor-positive (ER+) breast cancer (BC), with differential treatment benefit observed in genomic high-risk vs low-risk tumors.

Major finding: Goserelin (hazard ratio [HR] 0.49; 95% CI 0.32-0.75), tamoxifen (HR 0.57; 95% CI 0.38-0.87), and combined goserelin-tamoxifen (HR 0.63; 95% CI 0.42-0.94) vs no adjuvant ET improved long-term distant recurrence-free interval in the overall cohort of patients, with tamoxifen and goserelin benefitting genomic low-risk (HR 0.24; 95% CI 0.10-0.60) and high-risk (HR 0.24; 95% CI 0.10-0.54) patients, respectively.

Study details: Findings are from the secondary analysis of the Stockholm trial including 584 premenopausal patients with ER+ BC who were randomly assigned to receive goserelin, tamoxifen, combined goserelin-tamoxifen, or no adjuvant ET for 2 years.

Disclosures: This study was supported by the Swedish Research Council and other sources. Some authors declared serving as consultants or advisors or leaders for, being employees or stockowners of, or receiving research funding, honoraria, travel, or accommodation expense from several sources.

Source: Johansson A et al. Twenty-year benefit from adjuvant goserelin and tamoxifen in premenopausal patients with breast cancer in a controlled randomized clinical trial. J Clin Oncol. 2022 (Jul 21). Doi: 10.1200/JCO.21.02844

 

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Key clinical point: Adjuvant endocrine therapy (ET) for 2 years showed a long-term (20 years) advantage in premenopausal women with estrogen receptor-positive (ER+) breast cancer (BC), with differential treatment benefit observed in genomic high-risk vs low-risk tumors.

Major finding: Goserelin (hazard ratio [HR] 0.49; 95% CI 0.32-0.75), tamoxifen (HR 0.57; 95% CI 0.38-0.87), and combined goserelin-tamoxifen (HR 0.63; 95% CI 0.42-0.94) vs no adjuvant ET improved long-term distant recurrence-free interval in the overall cohort of patients, with tamoxifen and goserelin benefitting genomic low-risk (HR 0.24; 95% CI 0.10-0.60) and high-risk (HR 0.24; 95% CI 0.10-0.54) patients, respectively.

Study details: Findings are from the secondary analysis of the Stockholm trial including 584 premenopausal patients with ER+ BC who were randomly assigned to receive goserelin, tamoxifen, combined goserelin-tamoxifen, or no adjuvant ET for 2 years.

Disclosures: This study was supported by the Swedish Research Council and other sources. Some authors declared serving as consultants or advisors or leaders for, being employees or stockowners of, or receiving research funding, honoraria, travel, or accommodation expense from several sources.

Source: Johansson A et al. Twenty-year benefit from adjuvant goserelin and tamoxifen in premenopausal patients with breast cancer in a controlled randomized clinical trial. J Clin Oncol. 2022 (Jul 21). Doi: 10.1200/JCO.21.02844

 

Key clinical point: Adjuvant endocrine therapy (ET) for 2 years showed a long-term (20 years) advantage in premenopausal women with estrogen receptor-positive (ER+) breast cancer (BC), with differential treatment benefit observed in genomic high-risk vs low-risk tumors.

Major finding: Goserelin (hazard ratio [HR] 0.49; 95% CI 0.32-0.75), tamoxifen (HR 0.57; 95% CI 0.38-0.87), and combined goserelin-tamoxifen (HR 0.63; 95% CI 0.42-0.94) vs no adjuvant ET improved long-term distant recurrence-free interval in the overall cohort of patients, with tamoxifen and goserelin benefitting genomic low-risk (HR 0.24; 95% CI 0.10-0.60) and high-risk (HR 0.24; 95% CI 0.10-0.54) patients, respectively.

Study details: Findings are from the secondary analysis of the Stockholm trial including 584 premenopausal patients with ER+ BC who were randomly assigned to receive goserelin, tamoxifen, combined goserelin-tamoxifen, or no adjuvant ET for 2 years.

Disclosures: This study was supported by the Swedish Research Council and other sources. Some authors declared serving as consultants or advisors or leaders for, being employees or stockowners of, or receiving research funding, honoraria, travel, or accommodation expense from several sources.

Source: Johansson A et al. Twenty-year benefit from adjuvant goserelin and tamoxifen in premenopausal patients with breast cancer in a controlled randomized clinical trial. J Clin Oncol. 2022 (Jul 21). Doi: 10.1200/JCO.21.02844

 

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Early-stage ER+ BC: No recurrence or mortality with systemic or vaginal hormone therapy

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Key clinical point: Vaginal estrogen therapy (VET) or menopausal hormone therapy (MHT) did not increase the risk for recurrence/mortality in postmenopausal women with early-stage, estrogen receptor-positive (ER+) BC; however, the recurrence risk was higher in patients receiving aromatase inhibitors (AI)+VET.

Major finding: The recurrence risk among women receiving VET (adjusted hazard ratio [aHR] 1.08; 95% CI 0.89-1.32) or MHT (aHR 1.05; 95% CI 0.62-1.78) was similar to that among never-users of hormone therapy; however, the risk was elevated in patients receiving VET+AI (aHR 1.39; 95% CI 1.04-1.85). Neither VET (aHR 0.78; 95% CI 0.71-0.87) nor MHT (aHR 0.94; 95% CI 0.70-1.26) was associated with increased overall mortality, irrespective of the receipt of AI.

Study details: Findings are from an observational cohort study including 8461 postmenopausal women with early-stage, invasive, nonmetastatic, ER+ BC who received no endocrine treatment or 5-year adjuvant endocrine therapy.

Disclosures: This study was supported by Breast Friends, a part of the Danish Cancer Society. Some authors declared receiving support, honoraria, or institutional grants from several sources.

Source: Cold S et al. Systemic or vaginal hormone therapy after early breast cancer: A Danish observational cohort study. J Natl Cancer Inst. 2022 (Jul 20). Doi: 10.1093/jnci/djac112

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Key clinical point: Vaginal estrogen therapy (VET) or menopausal hormone therapy (MHT) did not increase the risk for recurrence/mortality in postmenopausal women with early-stage, estrogen receptor-positive (ER+) BC; however, the recurrence risk was higher in patients receiving aromatase inhibitors (AI)+VET.

Major finding: The recurrence risk among women receiving VET (adjusted hazard ratio [aHR] 1.08; 95% CI 0.89-1.32) or MHT (aHR 1.05; 95% CI 0.62-1.78) was similar to that among never-users of hormone therapy; however, the risk was elevated in patients receiving VET+AI (aHR 1.39; 95% CI 1.04-1.85). Neither VET (aHR 0.78; 95% CI 0.71-0.87) nor MHT (aHR 0.94; 95% CI 0.70-1.26) was associated with increased overall mortality, irrespective of the receipt of AI.

Study details: Findings are from an observational cohort study including 8461 postmenopausal women with early-stage, invasive, nonmetastatic, ER+ BC who received no endocrine treatment or 5-year adjuvant endocrine therapy.

Disclosures: This study was supported by Breast Friends, a part of the Danish Cancer Society. Some authors declared receiving support, honoraria, or institutional grants from several sources.

Source: Cold S et al. Systemic or vaginal hormone therapy after early breast cancer: A Danish observational cohort study. J Natl Cancer Inst. 2022 (Jul 20). Doi: 10.1093/jnci/djac112

Key clinical point: Vaginal estrogen therapy (VET) or menopausal hormone therapy (MHT) did not increase the risk for recurrence/mortality in postmenopausal women with early-stage, estrogen receptor-positive (ER+) BC; however, the recurrence risk was higher in patients receiving aromatase inhibitors (AI)+VET.

Major finding: The recurrence risk among women receiving VET (adjusted hazard ratio [aHR] 1.08; 95% CI 0.89-1.32) or MHT (aHR 1.05; 95% CI 0.62-1.78) was similar to that among never-users of hormone therapy; however, the risk was elevated in patients receiving VET+AI (aHR 1.39; 95% CI 1.04-1.85). Neither VET (aHR 0.78; 95% CI 0.71-0.87) nor MHT (aHR 0.94; 95% CI 0.70-1.26) was associated with increased overall mortality, irrespective of the receipt of AI.

Study details: Findings are from an observational cohort study including 8461 postmenopausal women with early-stage, invasive, nonmetastatic, ER+ BC who received no endocrine treatment or 5-year adjuvant endocrine therapy.

Disclosures: This study was supported by Breast Friends, a part of the Danish Cancer Society. Some authors declared receiving support, honoraria, or institutional grants from several sources.

Source: Cold S et al. Systemic or vaginal hormone therapy after early breast cancer: A Danish observational cohort study. J Natl Cancer Inst. 2022 (Jul 20). Doi: 10.1093/jnci/djac112

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ER+ HER2− early BC: Patients with PEPI 0-1/pCR can safely skip adjuvant chemotherapy

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Key clinical point: Postmenopausal patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) who achieve a preoperative endocrine prognostic index (PEPI) score of 0-1/pathological complete response (pCR) with only neoadjuvant endocrine therapy (NET) can be safely treated without adjuvant chemotherapy.

Major finding: After a median follow-up of 60 months, the 5-year recurrence-free survival (RFS) improved significantly in patients who had PEPI 0-1/pCR without chemotherapy vs PEPI ≥2 (hazard ratio 0.18; P  =  .028). In patients who had PEPI ≥2, the 5-year RFS was similar regardless of the receipt of adjuvant chemotherapy (P  =  .432).

Study details: Findings are from a phase 2 trial including 352 postmenopausal women with early-stage, strongly ER+ and HER2− BC who received NET for 4 months before surgery; after surgery, patients with PEPI 0-1/pCR and PEPI ≥2 were recommended only adjuvant ET and adjuvant ET±chemotherapy, respectively.

Disclosures: This study was supported by Novartis. The authors declared no conflicts of interest.

Source: Wang X et al. Neoadjuvant endocrine therapy for strongly hormone receptor-positive and HER2-negative early breast cancer: results of a prospective multi-center study. Breast Cancer Res Treat. 2022 (Aug 2(. Doi: 10.1007/s10549-022-06686-1

 

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Key clinical point: Postmenopausal patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) who achieve a preoperative endocrine prognostic index (PEPI) score of 0-1/pathological complete response (pCR) with only neoadjuvant endocrine therapy (NET) can be safely treated without adjuvant chemotherapy.

Major finding: After a median follow-up of 60 months, the 5-year recurrence-free survival (RFS) improved significantly in patients who had PEPI 0-1/pCR without chemotherapy vs PEPI ≥2 (hazard ratio 0.18; P  =  .028). In patients who had PEPI ≥2, the 5-year RFS was similar regardless of the receipt of adjuvant chemotherapy (P  =  .432).

Study details: Findings are from a phase 2 trial including 352 postmenopausal women with early-stage, strongly ER+ and HER2− BC who received NET for 4 months before surgery; after surgery, patients with PEPI 0-1/pCR and PEPI ≥2 were recommended only adjuvant ET and adjuvant ET±chemotherapy, respectively.

Disclosures: This study was supported by Novartis. The authors declared no conflicts of interest.

Source: Wang X et al. Neoadjuvant endocrine therapy for strongly hormone receptor-positive and HER2-negative early breast cancer: results of a prospective multi-center study. Breast Cancer Res Treat. 2022 (Aug 2(. Doi: 10.1007/s10549-022-06686-1

 

Key clinical point: Postmenopausal patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) who achieve a preoperative endocrine prognostic index (PEPI) score of 0-1/pathological complete response (pCR) with only neoadjuvant endocrine therapy (NET) can be safely treated without adjuvant chemotherapy.

Major finding: After a median follow-up of 60 months, the 5-year recurrence-free survival (RFS) improved significantly in patients who had PEPI 0-1/pCR without chemotherapy vs PEPI ≥2 (hazard ratio 0.18; P  =  .028). In patients who had PEPI ≥2, the 5-year RFS was similar regardless of the receipt of adjuvant chemotherapy (P  =  .432).

Study details: Findings are from a phase 2 trial including 352 postmenopausal women with early-stage, strongly ER+ and HER2− BC who received NET for 4 months before surgery; after surgery, patients with PEPI 0-1/pCR and PEPI ≥2 were recommended only adjuvant ET and adjuvant ET±chemotherapy, respectively.

Disclosures: This study was supported by Novartis. The authors declared no conflicts of interest.

Source: Wang X et al. Neoadjuvant endocrine therapy for strongly hormone receptor-positive and HER2-negative early breast cancer: results of a prospective multi-center study. Breast Cancer Res Treat. 2022 (Aug 2(. Doi: 10.1007/s10549-022-06686-1

 

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Oral paclitaxel+encequidar offers a possible alternative to IV paclitaxel in metastatic BC

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Key clinical point: Patients with metastatic breast cancer (BC) who received oral paclitaxel plus encequidar to facilitate the absorption of oral paclitaxel showed higher confirmed tumor response compared with 3 weekly intravenous (IV) paclitaxel doses.

Major finding: Confirmed tumor response rate improved significantly with oral paclitaxel+encequidar vs IV paclitaxel (36% vs 23%; P  =  .011). The incidence of grade ≥2 neuropathy (31% vs 8%) and grade 2 alopecia (48% vs 29%) were higher with IV paclitaxel vs oral paclitaxel+encequidar; however, the incidence of grade ≥3 gastrointestinal disorders (11.7% vs 3.7%) was higher with oral paclitaxel+encequidar vs IV paclitaxel.

Study details: Findings are from the open-label, phase 3 study including 402 postmenopausal women with metastatic BC who were randomly assigned to receive oral paclitaxel+encequidar or IV paclitaxel.

Disclosures: This study was supported by Athenex, Inc. Four authors declared being employees and owning stocks in Athenex, and the other authors reported ties with several sources, including Athenex.

Source: Rugo HS et al. Open-label, randomized, multicenter, phase III study comparing oral paclitaxel plus encequidar versus intravenous paclitaxel in patients with metastatic breast cancer. J Clin Oncol. 2022 (Jul 20). Doi: 10.1200/JCO.21.02953

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Key clinical point: Patients with metastatic breast cancer (BC) who received oral paclitaxel plus encequidar to facilitate the absorption of oral paclitaxel showed higher confirmed tumor response compared with 3 weekly intravenous (IV) paclitaxel doses.

Major finding: Confirmed tumor response rate improved significantly with oral paclitaxel+encequidar vs IV paclitaxel (36% vs 23%; P  =  .011). The incidence of grade ≥2 neuropathy (31% vs 8%) and grade 2 alopecia (48% vs 29%) were higher with IV paclitaxel vs oral paclitaxel+encequidar; however, the incidence of grade ≥3 gastrointestinal disorders (11.7% vs 3.7%) was higher with oral paclitaxel+encequidar vs IV paclitaxel.

Study details: Findings are from the open-label, phase 3 study including 402 postmenopausal women with metastatic BC who were randomly assigned to receive oral paclitaxel+encequidar or IV paclitaxel.

Disclosures: This study was supported by Athenex, Inc. Four authors declared being employees and owning stocks in Athenex, and the other authors reported ties with several sources, including Athenex.

Source: Rugo HS et al. Open-label, randomized, multicenter, phase III study comparing oral paclitaxel plus encequidar versus intravenous paclitaxel in patients with metastatic breast cancer. J Clin Oncol. 2022 (Jul 20). Doi: 10.1200/JCO.21.02953

Key clinical point: Patients with metastatic breast cancer (BC) who received oral paclitaxel plus encequidar to facilitate the absorption of oral paclitaxel showed higher confirmed tumor response compared with 3 weekly intravenous (IV) paclitaxel doses.

Major finding: Confirmed tumor response rate improved significantly with oral paclitaxel+encequidar vs IV paclitaxel (36% vs 23%; P  =  .011). The incidence of grade ≥2 neuropathy (31% vs 8%) and grade 2 alopecia (48% vs 29%) were higher with IV paclitaxel vs oral paclitaxel+encequidar; however, the incidence of grade ≥3 gastrointestinal disorders (11.7% vs 3.7%) was higher with oral paclitaxel+encequidar vs IV paclitaxel.

Study details: Findings are from the open-label, phase 3 study including 402 postmenopausal women with metastatic BC who were randomly assigned to receive oral paclitaxel+encequidar or IV paclitaxel.

Disclosures: This study was supported by Athenex, Inc. Four authors declared being employees and owning stocks in Athenex, and the other authors reported ties with several sources, including Athenex.

Source: Rugo HS et al. Open-label, randomized, multicenter, phase III study comparing oral paclitaxel plus encequidar versus intravenous paclitaxel in patients with metastatic breast cancer. J Clin Oncol. 2022 (Jul 20). Doi: 10.1200/JCO.21.02953

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ERBB2-positive BC: Adding atezolizumab to PATH shows acceptable pCR rate in phase 2

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Key clinical point: Neoadjuvant atezolizumab plus docetaxel, trastuzumab, and pertuzumab (PATH) demonstrated an acceptable pathological complete response (pCR) rate and a modest safety profile in patients with human epidermal growth factor receptor 2 (ERBB2)-positive early breast cancer (BC).

Major finding: Rate of pCR was 61% in the overall cohort and was higher in patients with hormone receptor-negative vs -positive subtype (77% vs 44%), stages IIA and IIB vs stage III BC (69% and 70% vs 39% respectively), and positive vs negative programmed cell death 1 expression (100% vs 53%). Few patients reported grade ≥3 neutropenia (12%) and febrile neutropenia (8%).

Study details: Findings are from a single-arm phase 2 trial including 67 patients with ERBB2-positive stage II/III BC who initiated 6 cycles of PATH+atezolizumab every 3 weeks.

Disclosures: This study was supported by the Ministry of Health and Welfare, Republic of Korea, and other sources. The authors declared serving on advisory boards or receiving personal fees, grants, honoraria, consulting fees, or nonfinancial support from several sources.

Source: Ahn HK et al. Response rate and safety of a neoadjuvant pertuzumab, atezolizumab, docetaxel, and trastuzumab regimen for patients with ERBB2-positive stage II/III breast cancer: The neo-PATH phase 2 nonrandomized clinical trial. JAMA Oncol. 2022 (Jul 7). Doi: 10.1001/jamaoncol.2022.2310

 

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Key clinical point: Neoadjuvant atezolizumab plus docetaxel, trastuzumab, and pertuzumab (PATH) demonstrated an acceptable pathological complete response (pCR) rate and a modest safety profile in patients with human epidermal growth factor receptor 2 (ERBB2)-positive early breast cancer (BC).

Major finding: Rate of pCR was 61% in the overall cohort and was higher in patients with hormone receptor-negative vs -positive subtype (77% vs 44%), stages IIA and IIB vs stage III BC (69% and 70% vs 39% respectively), and positive vs negative programmed cell death 1 expression (100% vs 53%). Few patients reported grade ≥3 neutropenia (12%) and febrile neutropenia (8%).

Study details: Findings are from a single-arm phase 2 trial including 67 patients with ERBB2-positive stage II/III BC who initiated 6 cycles of PATH+atezolizumab every 3 weeks.

Disclosures: This study was supported by the Ministry of Health and Welfare, Republic of Korea, and other sources. The authors declared serving on advisory boards or receiving personal fees, grants, honoraria, consulting fees, or nonfinancial support from several sources.

Source: Ahn HK et al. Response rate and safety of a neoadjuvant pertuzumab, atezolizumab, docetaxel, and trastuzumab regimen for patients with ERBB2-positive stage II/III breast cancer: The neo-PATH phase 2 nonrandomized clinical trial. JAMA Oncol. 2022 (Jul 7). Doi: 10.1001/jamaoncol.2022.2310

 

Key clinical point: Neoadjuvant atezolizumab plus docetaxel, trastuzumab, and pertuzumab (PATH) demonstrated an acceptable pathological complete response (pCR) rate and a modest safety profile in patients with human epidermal growth factor receptor 2 (ERBB2)-positive early breast cancer (BC).

Major finding: Rate of pCR was 61% in the overall cohort and was higher in patients with hormone receptor-negative vs -positive subtype (77% vs 44%), stages IIA and IIB vs stage III BC (69% and 70% vs 39% respectively), and positive vs negative programmed cell death 1 expression (100% vs 53%). Few patients reported grade ≥3 neutropenia (12%) and febrile neutropenia (8%).

Study details: Findings are from a single-arm phase 2 trial including 67 patients with ERBB2-positive stage II/III BC who initiated 6 cycles of PATH+atezolizumab every 3 weeks.

Disclosures: This study was supported by the Ministry of Health and Welfare, Republic of Korea, and other sources. The authors declared serving on advisory boards or receiving personal fees, grants, honoraria, consulting fees, or nonfinancial support from several sources.

Source: Ahn HK et al. Response rate and safety of a neoadjuvant pertuzumab, atezolizumab, docetaxel, and trastuzumab regimen for patients with ERBB2-positive stage II/III breast cancer: The neo-PATH phase 2 nonrandomized clinical trial. JAMA Oncol. 2022 (Jul 7). Doi: 10.1001/jamaoncol.2022.2310

 

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TNBC: First-line nab-paclitaxel+cisplatin effective and safe in phase 3

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Key clinical point: In patients with metastatic triple-negative breast cancer (TNBC), first-line treatment with nanoparticle albumin-bound (nab)-paclitaxel+cisplatin significantly reduced the risk for disease progression/death compared with gemcitabine+cisplatin, with both the combinations showing a consistent safety profile.

Major finding: Progression-free survival (stratified hazard ratio 0.67; P  =  .004) and objective response rate (81.1% vs 56.3%; P < .001) improved significantly in patients receiving nab-paclitaxel+cisplatin vs gemcitabine+cisplatin. Grade ≥3 only neuropathy (19% vs 0%) and nausea and vomiting (6% vs 1%) were higher in the nab-paclitaxel+cisplatin vs gemcitabine+cisplatin arm, whereas grade ≥3 thrombocytopenia (29.4% vs 3.9%) was more common in the gemcitabine+cisplatin vs nab-paclitaxel+cisplatin arm.

Study details: Findings are from an open-label phase 3 study including 254 patients with untreated metastatic TNBC who were randomly assigned to receive nab-paclitaxel+cisplatin or gemcitabine+cisplatin.

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wang B et al. A randomized phase 3 trial of gemcitabine or nab-paclitaxel combined with cisplatin as first-line treatment in patients with metastatic triple-negative breast cancer. Nat Commun. 2022;13:4025 (Jul 12). Doi: 10.1038/s41467-022-31704-7

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Key clinical point: In patients with metastatic triple-negative breast cancer (TNBC), first-line treatment with nanoparticle albumin-bound (nab)-paclitaxel+cisplatin significantly reduced the risk for disease progression/death compared with gemcitabine+cisplatin, with both the combinations showing a consistent safety profile.

Major finding: Progression-free survival (stratified hazard ratio 0.67; P  =  .004) and objective response rate (81.1% vs 56.3%; P < .001) improved significantly in patients receiving nab-paclitaxel+cisplatin vs gemcitabine+cisplatin. Grade ≥3 only neuropathy (19% vs 0%) and nausea and vomiting (6% vs 1%) were higher in the nab-paclitaxel+cisplatin vs gemcitabine+cisplatin arm, whereas grade ≥3 thrombocytopenia (29.4% vs 3.9%) was more common in the gemcitabine+cisplatin vs nab-paclitaxel+cisplatin arm.

Study details: Findings are from an open-label phase 3 study including 254 patients with untreated metastatic TNBC who were randomly assigned to receive nab-paclitaxel+cisplatin or gemcitabine+cisplatin.

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wang B et al. A randomized phase 3 trial of gemcitabine or nab-paclitaxel combined with cisplatin as first-line treatment in patients with metastatic triple-negative breast cancer. Nat Commun. 2022;13:4025 (Jul 12). Doi: 10.1038/s41467-022-31704-7

Key clinical point: In patients with metastatic triple-negative breast cancer (TNBC), first-line treatment with nanoparticle albumin-bound (nab)-paclitaxel+cisplatin significantly reduced the risk for disease progression/death compared with gemcitabine+cisplatin, with both the combinations showing a consistent safety profile.

Major finding: Progression-free survival (stratified hazard ratio 0.67; P  =  .004) and objective response rate (81.1% vs 56.3%; P < .001) improved significantly in patients receiving nab-paclitaxel+cisplatin vs gemcitabine+cisplatin. Grade ≥3 only neuropathy (19% vs 0%) and nausea and vomiting (6% vs 1%) were higher in the nab-paclitaxel+cisplatin vs gemcitabine+cisplatin arm, whereas grade ≥3 thrombocytopenia (29.4% vs 3.9%) was more common in the gemcitabine+cisplatin vs nab-paclitaxel+cisplatin arm.

Study details: Findings are from an open-label phase 3 study including 254 patients with untreated metastatic TNBC who were randomly assigned to receive nab-paclitaxel+cisplatin or gemcitabine+cisplatin.

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Wang B et al. A randomized phase 3 trial of gemcitabine or nab-paclitaxel combined with cisplatin as first-line treatment in patients with metastatic triple-negative breast cancer. Nat Commun. 2022;13:4025 (Jul 12). Doi: 10.1038/s41467-022-31704-7

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Bed boost after WBI reduces local recurrence of ductal carcinoma in situ in the breast

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Key clinical point: In patients with ductal carcinoma in situ (DCIS), tumor bed boost after postoperative whole breast irradiation (WBI) reduced local recurrence but with higher toxicity. Hypofractionated WBI was as effective as conventional WBI.

Major finding: The 5-year free-from-local-recurrence rates improved significantly with vs without tumor bed boost after postoperative WBI (hazard ratio 0.47; P < .001) and did not worsen with hypofractionated vs conventional WBI (P  =  .85). The rates of grade ≥2 breast pain (P  =  .003) and induration (P < .001) were higher with vs without tumor bed boost.

Study details: Findings are from a multicenter, phase 3 study including 1608 adult women with unilateral, non-low-risk DCIS who underwent breast-conserving surgery and were randomly assigned to receive WBI (conventional or hypofractionated) with or without tumor bed boost.

Disclosures: This study was funded by the National Health and Medical Research Council of Australia and other sources. Some authors declared receiving research grants, funding, or non-direct financial support from several sources.

Source: Chua BH et al. Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3–07/TROG 07.01): A randomised, factorial, multicentre, open-label, phase 3 study Lancet. 2022;400(10350):431-440 (Aug 6). Doi: 10.1016/S0140-6736(22)01246-6

 

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Key clinical point: In patients with ductal carcinoma in situ (DCIS), tumor bed boost after postoperative whole breast irradiation (WBI) reduced local recurrence but with higher toxicity. Hypofractionated WBI was as effective as conventional WBI.

Major finding: The 5-year free-from-local-recurrence rates improved significantly with vs without tumor bed boost after postoperative WBI (hazard ratio 0.47; P < .001) and did not worsen with hypofractionated vs conventional WBI (P  =  .85). The rates of grade ≥2 breast pain (P  =  .003) and induration (P < .001) were higher with vs without tumor bed boost.

Study details: Findings are from a multicenter, phase 3 study including 1608 adult women with unilateral, non-low-risk DCIS who underwent breast-conserving surgery and were randomly assigned to receive WBI (conventional or hypofractionated) with or without tumor bed boost.

Disclosures: This study was funded by the National Health and Medical Research Council of Australia and other sources. Some authors declared receiving research grants, funding, or non-direct financial support from several sources.

Source: Chua BH et al. Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3–07/TROG 07.01): A randomised, factorial, multicentre, open-label, phase 3 study Lancet. 2022;400(10350):431-440 (Aug 6). Doi: 10.1016/S0140-6736(22)01246-6

 

Key clinical point: In patients with ductal carcinoma in situ (DCIS), tumor bed boost after postoperative whole breast irradiation (WBI) reduced local recurrence but with higher toxicity. Hypofractionated WBI was as effective as conventional WBI.

Major finding: The 5-year free-from-local-recurrence rates improved significantly with vs without tumor bed boost after postoperative WBI (hazard ratio 0.47; P < .001) and did not worsen with hypofractionated vs conventional WBI (P  =  .85). The rates of grade ≥2 breast pain (P  =  .003) and induration (P < .001) were higher with vs without tumor bed boost.

Study details: Findings are from a multicenter, phase 3 study including 1608 adult women with unilateral, non-low-risk DCIS who underwent breast-conserving surgery and were randomly assigned to receive WBI (conventional or hypofractionated) with or without tumor bed boost.

Disclosures: This study was funded by the National Health and Medical Research Council of Australia and other sources. Some authors declared receiving research grants, funding, or non-direct financial support from several sources.

Source: Chua BH et al. Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3–07/TROG 07.01): A randomised, factorial, multicentre, open-label, phase 3 study Lancet. 2022;400(10350):431-440 (Aug 6). Doi: 10.1016/S0140-6736(22)01246-6

 

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