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‘Financial toxicity’: Harsh side effect of cancer care
When 32-year-old Brittany Dicks was diagnosed with stage II triple negative breast cancer in January 2022, she wasn’t worried about the cost of treatment. A medical assistant in Charleston, S.C., Ms. Dicks had full-time employment with health benefits.
But when she wasn’t able to work for several months because of chemotherapy and its side effects, Ms. Dicks lost her job. Her health insurance coverage ended in May. And although she filed for Medicaid at the beginning of June, it wasn’t approved until September.
Meanwhile, Ms. Dicks still needed treatment. She estimates that she ran up close to $20,000 in medical debt while finishing chemotherapy during the 4 months she was uninsured.
The surgeon she had seen since her diagnosis terminated her care when she could no longer pay her bills. That left her delaying a much-needed mastectomy.
“I don’t sleep at night,” said Ms. Dicks, a single mother of two young kids, ages 3 and 11. “Mentally, I’m drained. Just because I have cancer, doesn’t mean the bills aren’t due every month.”
As soon as she felt well enough over the summer, she started working as a part-time delivery driver for DoorDash to help pay for food and gas.
But that was just a Band-Aid. Even when her new insurance kicked in, covering the costs of daily life remained a struggle.
Ms. Dicks is still in deep medical debt. Her Medicaid has covered new medical expenses, and she hopes Medicaid will reimburse her for the debt she incurred over the summer while she waited for her coverage to kick in. So far, though, Medicaid has not touched her $20,000 debt.
“I fear that I’m not going to be able to dig out of this hole,” Ms. Dicks said.
Researchers who study the financial impacts of cancer have a term for Ms. Dicks’ experience: financial toxicity.
Financial toxicity is a catchall term for the burden many Americans with cancer experience.
“Financial toxicity is a multidimensional concept. There’s both a material burden and a psychosocial one,” said Grace Li Smith, MD, PhD, MPH, a radiation oncologist at the University of Texas MD Anderson Cancer Center, Houston.
Researchers are also now beginning to understand the psychological effects these financial burdens can have on patients and their family.
“Financial toxicity is not unique to the patient,” said Dr. Li Smith. It “very directly impacts the whole family or household.”
Stifling financial pressures
Early in her career, Dr. Li Smith was already seeing how her patients’ worries extended beyond their physical disease.
One of Dr. Li Smith’s first patients told her their greatest worry wasn’t whether the treatment would work or what physical toxicity to expect, it was how they would pay for their care.
“There was much more anxiety and true distress about the financial burden than about the treatment itself,” Dr. Li Smith recalled.
This fear about the costs of cancer care is well founded. In the United States, cancer treatment costs reached an estimated $150 billion in 2020 and continue to rise. Patients shoulder a significant portion of that burden – with one study estimating that patients paid $21 billion for their cancer care in 2019.
The burden is often compounded by decreased income. Between 40% and 85% of patients with cancer needed to take time off work or quit their jobs during treatment. And for those, like Dicks, who find themselves with no insurance, out-of-pocket costs can quickly skyrocket.
In fact, one study of newly diagnosed cancer patients over age 50 reported that more than 42% of patients fully depleted their financial assets and around 30% incurred debt by the second year of their diagnosis.
Younger adults may be even more financially vulnerable. A study of patients in Washington found that those under 65 – which represent about half of cancer cases – were two to five times more likely to declare bankruptcy than patients over 65.
Dr. Li Smith and colleagues have found that younger patients aged 18-64 experienced greater monetary hardships, which meant less money for food, worse adherence to medications, as well as greater distress and anxiety overall. In fact, younger adults were over 4.5 times more likely to encounter severe financial toxicity, compared with older adults, and about 4 times more likely to experience severe psychological effects from this burden.
The distress, if left unchecked, can spiral out of control.
Molly MacDonald had just gone through a financially devastating divorce in 2005 when she was diagnosed with breast cancer. Recently out of work and dealing with a $1,300 monthly COBRA premium, the mother of five had no financial safety net. She risked having her car repossessed and her utilities shut off.
“I gave tentative thought to how I could take my life and make it look like an accident,” said Ms. MacDonald. “I thought the kids would be better off without me.”
For some, the loss of income can be even more worrisome than the medical bills. Some patients may go back to work during treatment, often against medical advice.
When Stephanie Caputo, 43, of Monroe, N.J., began treatment for stage III breast cancer in 2021, her physician recommended she stop working. Treatment would make her immunocompromised, and her job in a medical clinic could expose her to harmful pathogens, including the coronavirus.
Ms. Caputo went on disability and received $900 every 2 weeks. But that wasn’t enough to pay her mortgage, let alone cover her other monthly expenses as a single mother of 4 teenagers.
After finishing chemotherapy, and during radiation, Ms. Caputo went back to work, part time, against her doctor’s advice.
“My doctor is telling me I can’t work, but I also can’t have my house go into default,” said Ms. Caputo.
But being on her feet through 12-hour shifts made treatment side effects, especially back and joint pain, kick into overdrive. “The physicality of my job was really difficult to tolerate,” she said.
The physical burden was too great to take on more work, but the extra money also wasn’t enough to keep her afloat. Fortunately, her brother stepped in and covered 6 months of her mortgage payments.
Financial toxicity impacts families
Although financial toxicity research to date has largely focused on the patient, researchers are also starting to understand that family members and caregivers often share in the burden.
“We are just at the beginning of realizing that this is a real problem,” said Fumiko Chino, MD, a radiation oncologist at Memorial Sloan Kettering Cancer Center, New York.
Dr. Chino and colleagues recently showed that family members of patients with cancer were more likely to delay or forgo medical care than family members of people without cancer. The study found the effect was greatest among family members of younger adults with cancer.
“The caregiver and family burden related to cancer diagnosis and treatment is really underappreciated,” said Dr. Chino. “Family members and caregivers are neglecting their own health concerns, passing up career opportunities, struggling with financial concerns.”
Dr. Chino speaks from personal experience. When her fiancé, later husband, was diagnosed with neuroendocrine carcinoma in 2005, Dr. Chino quit her job as art director at a television production company to take care of him.
The couple, both in their 20s, struggled to afford his care. Dr. Chino put her own dental, medical, and mental health care on hold. She never, for instance, went to physical therapy to address injuries sustained sleeping in hospital chairs and moving around her husband who was over 6 feet tall. At one point, she walked with a limp.
Dr. Chino’s husband passed away in 2007, and even 15 years later, her injury from sleeping in hospital chairs remains “a significant physical burden,” she said. But like many caregivers “I wasn’t really thinking about my own health.”
Danielle Hadfield, 35, an ED nurse in Rochester, N.Y., also delayed her own care when her mom got sick.
Ms. Hadfield quit her job shortly after her mom was diagnosed with cholangiocarcinoma in August 2020. Ms. Hadfield knew her mom, who lived 3.5 hours away in Albany, N.Y., would need a lot of care in the upcoming months.
“I knew this was going to be the last year or so of her life, and I wanted to be there for her,” said Ms. Hadfield.
When Ms. Hadfield quit her job, she and her husband – who was self-employed – purchased health insurance coverage through the New York state marketplace. The monthly insurance payments for Ms. Hadfield, who was pregnant with her second child, her husband, and their toddler cost as much as the family’s monthly mortgage payments.
In addition to providing childcare for her young daughter and making frequent trips to Albany, Ms. Hadfield began a side business as a legal nurse consultant, working mostly at night, to replace a portion of her lost income. During this time, she began to experience pain attacks that would migrate through her body along with intermittent tongue and facial numbness. She ignored these health issues for nearly a year, until after her mother died in November 2021.
Only after her mother passed away did Ms. Hadfield begin seeking answers to her own pain. In September 2022, she finally got them. She had a nerve condition called small-fiber sensory neuropathy.
But even with a diagnosis, she is still facing more tests to root out the cause and understand the best treatment.
Is help out there?
What can physicians do to help patients and families at risk for financial toxicity?
Specific guidelines for dealing with financial toxicity do not exist in most professional guidelines, nor are there standard screening tools to identify it, said Dr. Li Smith.
These gaps put pressure on physicians to ask about financial barriers and concerns, but most do not know how to broach the topic or how to help. “Physicians may not know how to fix the problem or what resources exist,” Dr. Li Smith said.
Patients and family members, on the other hand, are often reluctant to bring up cost with physicians. Some may be ashamed to talk about their financial problems while others may fear doing so will prevent them from being offered the best possible treatments, said Ms. MacDonald.
But, experts say, financial toxicity needs to be dealt with head on. That means involving financial navigators or counselors and social workers who can, for instance, help patients and families find financial support for their basic living expenses.
From a research perspective, more clinical trials should include financial toxicity outcomes, said Joshua Palmer, MD, a radiation oncologist at the University of Michigan, Ann Arbor.
Dr. Palmer and colleagues recently showed that the number of radiation therapy clinical trials including financial toxicity endpoints increased significantly from 2001 to 2020, though the absolute rate of inclusion remains low, at roughly 1.5% of radiation therapy-based clinical trials including financial toxicity endpoints from 2016 to 2020.
“Financial burden is part of the broader discussion about shared decision-making,” said Dr. Palmer.
In shared decision-making, physicians discuss the risks and benefits of different treatment options, empowering the patient to make an informed choice with the physician.
What we want to avoid is patients feeling like they will get inferior care, if they have financial barriers, said Dr. Palmer.
And every little bit can help. In 2006, Ms. MacDonald started the Pink Fund – a nonprofit to help patients with cancer cover nonmedical cost-of-living expenses. Both Ms. Caputo and Ms. Dicks received grants from the Pink Fund. For Ms. Caputo, the funds covered 2 months of car payments and for Ms. Dicks, it covered 2 months of rent.
While the one-time grant was a big help, said Ms. Dicks, “cancer is an everyday thing.” And “we all deserve peace of mind” when trying to heal.
A version of this article first appeared on WebMD.com.
When 32-year-old Brittany Dicks was diagnosed with stage II triple negative breast cancer in January 2022, she wasn’t worried about the cost of treatment. A medical assistant in Charleston, S.C., Ms. Dicks had full-time employment with health benefits.
But when she wasn’t able to work for several months because of chemotherapy and its side effects, Ms. Dicks lost her job. Her health insurance coverage ended in May. And although she filed for Medicaid at the beginning of June, it wasn’t approved until September.
Meanwhile, Ms. Dicks still needed treatment. She estimates that she ran up close to $20,000 in medical debt while finishing chemotherapy during the 4 months she was uninsured.
The surgeon she had seen since her diagnosis terminated her care when she could no longer pay her bills. That left her delaying a much-needed mastectomy.
“I don’t sleep at night,” said Ms. Dicks, a single mother of two young kids, ages 3 and 11. “Mentally, I’m drained. Just because I have cancer, doesn’t mean the bills aren’t due every month.”
As soon as she felt well enough over the summer, she started working as a part-time delivery driver for DoorDash to help pay for food and gas.
But that was just a Band-Aid. Even when her new insurance kicked in, covering the costs of daily life remained a struggle.
Ms. Dicks is still in deep medical debt. Her Medicaid has covered new medical expenses, and she hopes Medicaid will reimburse her for the debt she incurred over the summer while she waited for her coverage to kick in. So far, though, Medicaid has not touched her $20,000 debt.
“I fear that I’m not going to be able to dig out of this hole,” Ms. Dicks said.
Researchers who study the financial impacts of cancer have a term for Ms. Dicks’ experience: financial toxicity.
Financial toxicity is a catchall term for the burden many Americans with cancer experience.
“Financial toxicity is a multidimensional concept. There’s both a material burden and a psychosocial one,” said Grace Li Smith, MD, PhD, MPH, a radiation oncologist at the University of Texas MD Anderson Cancer Center, Houston.
Researchers are also now beginning to understand the psychological effects these financial burdens can have on patients and their family.
“Financial toxicity is not unique to the patient,” said Dr. Li Smith. It “very directly impacts the whole family or household.”
Stifling financial pressures
Early in her career, Dr. Li Smith was already seeing how her patients’ worries extended beyond their physical disease.
One of Dr. Li Smith’s first patients told her their greatest worry wasn’t whether the treatment would work or what physical toxicity to expect, it was how they would pay for their care.
“There was much more anxiety and true distress about the financial burden than about the treatment itself,” Dr. Li Smith recalled.
This fear about the costs of cancer care is well founded. In the United States, cancer treatment costs reached an estimated $150 billion in 2020 and continue to rise. Patients shoulder a significant portion of that burden – with one study estimating that patients paid $21 billion for their cancer care in 2019.
The burden is often compounded by decreased income. Between 40% and 85% of patients with cancer needed to take time off work or quit their jobs during treatment. And for those, like Dicks, who find themselves with no insurance, out-of-pocket costs can quickly skyrocket.
In fact, one study of newly diagnosed cancer patients over age 50 reported that more than 42% of patients fully depleted their financial assets and around 30% incurred debt by the second year of their diagnosis.
Younger adults may be even more financially vulnerable. A study of patients in Washington found that those under 65 – which represent about half of cancer cases – were two to five times more likely to declare bankruptcy than patients over 65.
Dr. Li Smith and colleagues have found that younger patients aged 18-64 experienced greater monetary hardships, which meant less money for food, worse adherence to medications, as well as greater distress and anxiety overall. In fact, younger adults were over 4.5 times more likely to encounter severe financial toxicity, compared with older adults, and about 4 times more likely to experience severe psychological effects from this burden.
The distress, if left unchecked, can spiral out of control.
Molly MacDonald had just gone through a financially devastating divorce in 2005 when she was diagnosed with breast cancer. Recently out of work and dealing with a $1,300 monthly COBRA premium, the mother of five had no financial safety net. She risked having her car repossessed and her utilities shut off.
“I gave tentative thought to how I could take my life and make it look like an accident,” said Ms. MacDonald. “I thought the kids would be better off without me.”
For some, the loss of income can be even more worrisome than the medical bills. Some patients may go back to work during treatment, often against medical advice.
When Stephanie Caputo, 43, of Monroe, N.J., began treatment for stage III breast cancer in 2021, her physician recommended she stop working. Treatment would make her immunocompromised, and her job in a medical clinic could expose her to harmful pathogens, including the coronavirus.
Ms. Caputo went on disability and received $900 every 2 weeks. But that wasn’t enough to pay her mortgage, let alone cover her other monthly expenses as a single mother of 4 teenagers.
After finishing chemotherapy, and during radiation, Ms. Caputo went back to work, part time, against her doctor’s advice.
“My doctor is telling me I can’t work, but I also can’t have my house go into default,” said Ms. Caputo.
But being on her feet through 12-hour shifts made treatment side effects, especially back and joint pain, kick into overdrive. “The physicality of my job was really difficult to tolerate,” she said.
The physical burden was too great to take on more work, but the extra money also wasn’t enough to keep her afloat. Fortunately, her brother stepped in and covered 6 months of her mortgage payments.
Financial toxicity impacts families
Although financial toxicity research to date has largely focused on the patient, researchers are also starting to understand that family members and caregivers often share in the burden.
“We are just at the beginning of realizing that this is a real problem,” said Fumiko Chino, MD, a radiation oncologist at Memorial Sloan Kettering Cancer Center, New York.
Dr. Chino and colleagues recently showed that family members of patients with cancer were more likely to delay or forgo medical care than family members of people without cancer. The study found the effect was greatest among family members of younger adults with cancer.
“The caregiver and family burden related to cancer diagnosis and treatment is really underappreciated,” said Dr. Chino. “Family members and caregivers are neglecting their own health concerns, passing up career opportunities, struggling with financial concerns.”
Dr. Chino speaks from personal experience. When her fiancé, later husband, was diagnosed with neuroendocrine carcinoma in 2005, Dr. Chino quit her job as art director at a television production company to take care of him.
The couple, both in their 20s, struggled to afford his care. Dr. Chino put her own dental, medical, and mental health care on hold. She never, for instance, went to physical therapy to address injuries sustained sleeping in hospital chairs and moving around her husband who was over 6 feet tall. At one point, she walked with a limp.
Dr. Chino’s husband passed away in 2007, and even 15 years later, her injury from sleeping in hospital chairs remains “a significant physical burden,” she said. But like many caregivers “I wasn’t really thinking about my own health.”
Danielle Hadfield, 35, an ED nurse in Rochester, N.Y., also delayed her own care when her mom got sick.
Ms. Hadfield quit her job shortly after her mom was diagnosed with cholangiocarcinoma in August 2020. Ms. Hadfield knew her mom, who lived 3.5 hours away in Albany, N.Y., would need a lot of care in the upcoming months.
“I knew this was going to be the last year or so of her life, and I wanted to be there for her,” said Ms. Hadfield.
When Ms. Hadfield quit her job, she and her husband – who was self-employed – purchased health insurance coverage through the New York state marketplace. The monthly insurance payments for Ms. Hadfield, who was pregnant with her second child, her husband, and their toddler cost as much as the family’s monthly mortgage payments.
In addition to providing childcare for her young daughter and making frequent trips to Albany, Ms. Hadfield began a side business as a legal nurse consultant, working mostly at night, to replace a portion of her lost income. During this time, she began to experience pain attacks that would migrate through her body along with intermittent tongue and facial numbness. She ignored these health issues for nearly a year, until after her mother died in November 2021.
Only after her mother passed away did Ms. Hadfield begin seeking answers to her own pain. In September 2022, she finally got them. She had a nerve condition called small-fiber sensory neuropathy.
But even with a diagnosis, she is still facing more tests to root out the cause and understand the best treatment.
Is help out there?
What can physicians do to help patients and families at risk for financial toxicity?
Specific guidelines for dealing with financial toxicity do not exist in most professional guidelines, nor are there standard screening tools to identify it, said Dr. Li Smith.
These gaps put pressure on physicians to ask about financial barriers and concerns, but most do not know how to broach the topic or how to help. “Physicians may not know how to fix the problem or what resources exist,” Dr. Li Smith said.
Patients and family members, on the other hand, are often reluctant to bring up cost with physicians. Some may be ashamed to talk about their financial problems while others may fear doing so will prevent them from being offered the best possible treatments, said Ms. MacDonald.
But, experts say, financial toxicity needs to be dealt with head on. That means involving financial navigators or counselors and social workers who can, for instance, help patients and families find financial support for their basic living expenses.
From a research perspective, more clinical trials should include financial toxicity outcomes, said Joshua Palmer, MD, a radiation oncologist at the University of Michigan, Ann Arbor.
Dr. Palmer and colleagues recently showed that the number of radiation therapy clinical trials including financial toxicity endpoints increased significantly from 2001 to 2020, though the absolute rate of inclusion remains low, at roughly 1.5% of radiation therapy-based clinical trials including financial toxicity endpoints from 2016 to 2020.
“Financial burden is part of the broader discussion about shared decision-making,” said Dr. Palmer.
In shared decision-making, physicians discuss the risks and benefits of different treatment options, empowering the patient to make an informed choice with the physician.
What we want to avoid is patients feeling like they will get inferior care, if they have financial barriers, said Dr. Palmer.
And every little bit can help. In 2006, Ms. MacDonald started the Pink Fund – a nonprofit to help patients with cancer cover nonmedical cost-of-living expenses. Both Ms. Caputo and Ms. Dicks received grants from the Pink Fund. For Ms. Caputo, the funds covered 2 months of car payments and for Ms. Dicks, it covered 2 months of rent.
While the one-time grant was a big help, said Ms. Dicks, “cancer is an everyday thing.” And “we all deserve peace of mind” when trying to heal.
A version of this article first appeared on WebMD.com.
When 32-year-old Brittany Dicks was diagnosed with stage II triple negative breast cancer in January 2022, she wasn’t worried about the cost of treatment. A medical assistant in Charleston, S.C., Ms. Dicks had full-time employment with health benefits.
But when she wasn’t able to work for several months because of chemotherapy and its side effects, Ms. Dicks lost her job. Her health insurance coverage ended in May. And although she filed for Medicaid at the beginning of June, it wasn’t approved until September.
Meanwhile, Ms. Dicks still needed treatment. She estimates that she ran up close to $20,000 in medical debt while finishing chemotherapy during the 4 months she was uninsured.
The surgeon she had seen since her diagnosis terminated her care when she could no longer pay her bills. That left her delaying a much-needed mastectomy.
“I don’t sleep at night,” said Ms. Dicks, a single mother of two young kids, ages 3 and 11. “Mentally, I’m drained. Just because I have cancer, doesn’t mean the bills aren’t due every month.”
As soon as she felt well enough over the summer, she started working as a part-time delivery driver for DoorDash to help pay for food and gas.
But that was just a Band-Aid. Even when her new insurance kicked in, covering the costs of daily life remained a struggle.
Ms. Dicks is still in deep medical debt. Her Medicaid has covered new medical expenses, and she hopes Medicaid will reimburse her for the debt she incurred over the summer while she waited for her coverage to kick in. So far, though, Medicaid has not touched her $20,000 debt.
“I fear that I’m not going to be able to dig out of this hole,” Ms. Dicks said.
Researchers who study the financial impacts of cancer have a term for Ms. Dicks’ experience: financial toxicity.
Financial toxicity is a catchall term for the burden many Americans with cancer experience.
“Financial toxicity is a multidimensional concept. There’s both a material burden and a psychosocial one,” said Grace Li Smith, MD, PhD, MPH, a radiation oncologist at the University of Texas MD Anderson Cancer Center, Houston.
Researchers are also now beginning to understand the psychological effects these financial burdens can have on patients and their family.
“Financial toxicity is not unique to the patient,” said Dr. Li Smith. It “very directly impacts the whole family or household.”
Stifling financial pressures
Early in her career, Dr. Li Smith was already seeing how her patients’ worries extended beyond their physical disease.
One of Dr. Li Smith’s first patients told her their greatest worry wasn’t whether the treatment would work or what physical toxicity to expect, it was how they would pay for their care.
“There was much more anxiety and true distress about the financial burden than about the treatment itself,” Dr. Li Smith recalled.
This fear about the costs of cancer care is well founded. In the United States, cancer treatment costs reached an estimated $150 billion in 2020 and continue to rise. Patients shoulder a significant portion of that burden – with one study estimating that patients paid $21 billion for their cancer care in 2019.
The burden is often compounded by decreased income. Between 40% and 85% of patients with cancer needed to take time off work or quit their jobs during treatment. And for those, like Dicks, who find themselves with no insurance, out-of-pocket costs can quickly skyrocket.
In fact, one study of newly diagnosed cancer patients over age 50 reported that more than 42% of patients fully depleted their financial assets and around 30% incurred debt by the second year of their diagnosis.
Younger adults may be even more financially vulnerable. A study of patients in Washington found that those under 65 – which represent about half of cancer cases – were two to five times more likely to declare bankruptcy than patients over 65.
Dr. Li Smith and colleagues have found that younger patients aged 18-64 experienced greater monetary hardships, which meant less money for food, worse adherence to medications, as well as greater distress and anxiety overall. In fact, younger adults were over 4.5 times more likely to encounter severe financial toxicity, compared with older adults, and about 4 times more likely to experience severe psychological effects from this burden.
The distress, if left unchecked, can spiral out of control.
Molly MacDonald had just gone through a financially devastating divorce in 2005 when she was diagnosed with breast cancer. Recently out of work and dealing with a $1,300 monthly COBRA premium, the mother of five had no financial safety net. She risked having her car repossessed and her utilities shut off.
“I gave tentative thought to how I could take my life and make it look like an accident,” said Ms. MacDonald. “I thought the kids would be better off without me.”
For some, the loss of income can be even more worrisome than the medical bills. Some patients may go back to work during treatment, often against medical advice.
When Stephanie Caputo, 43, of Monroe, N.J., began treatment for stage III breast cancer in 2021, her physician recommended she stop working. Treatment would make her immunocompromised, and her job in a medical clinic could expose her to harmful pathogens, including the coronavirus.
Ms. Caputo went on disability and received $900 every 2 weeks. But that wasn’t enough to pay her mortgage, let alone cover her other monthly expenses as a single mother of 4 teenagers.
After finishing chemotherapy, and during radiation, Ms. Caputo went back to work, part time, against her doctor’s advice.
“My doctor is telling me I can’t work, but I also can’t have my house go into default,” said Ms. Caputo.
But being on her feet through 12-hour shifts made treatment side effects, especially back and joint pain, kick into overdrive. “The physicality of my job was really difficult to tolerate,” she said.
The physical burden was too great to take on more work, but the extra money also wasn’t enough to keep her afloat. Fortunately, her brother stepped in and covered 6 months of her mortgage payments.
Financial toxicity impacts families
Although financial toxicity research to date has largely focused on the patient, researchers are also starting to understand that family members and caregivers often share in the burden.
“We are just at the beginning of realizing that this is a real problem,” said Fumiko Chino, MD, a radiation oncologist at Memorial Sloan Kettering Cancer Center, New York.
Dr. Chino and colleagues recently showed that family members of patients with cancer were more likely to delay or forgo medical care than family members of people without cancer. The study found the effect was greatest among family members of younger adults with cancer.
“The caregiver and family burden related to cancer diagnosis and treatment is really underappreciated,” said Dr. Chino. “Family members and caregivers are neglecting their own health concerns, passing up career opportunities, struggling with financial concerns.”
Dr. Chino speaks from personal experience. When her fiancé, later husband, was diagnosed with neuroendocrine carcinoma in 2005, Dr. Chino quit her job as art director at a television production company to take care of him.
The couple, both in their 20s, struggled to afford his care. Dr. Chino put her own dental, medical, and mental health care on hold. She never, for instance, went to physical therapy to address injuries sustained sleeping in hospital chairs and moving around her husband who was over 6 feet tall. At one point, she walked with a limp.
Dr. Chino’s husband passed away in 2007, and even 15 years later, her injury from sleeping in hospital chairs remains “a significant physical burden,” she said. But like many caregivers “I wasn’t really thinking about my own health.”
Danielle Hadfield, 35, an ED nurse in Rochester, N.Y., also delayed her own care when her mom got sick.
Ms. Hadfield quit her job shortly after her mom was diagnosed with cholangiocarcinoma in August 2020. Ms. Hadfield knew her mom, who lived 3.5 hours away in Albany, N.Y., would need a lot of care in the upcoming months.
“I knew this was going to be the last year or so of her life, and I wanted to be there for her,” said Ms. Hadfield.
When Ms. Hadfield quit her job, she and her husband – who was self-employed – purchased health insurance coverage through the New York state marketplace. The monthly insurance payments for Ms. Hadfield, who was pregnant with her second child, her husband, and their toddler cost as much as the family’s monthly mortgage payments.
In addition to providing childcare for her young daughter and making frequent trips to Albany, Ms. Hadfield began a side business as a legal nurse consultant, working mostly at night, to replace a portion of her lost income. During this time, she began to experience pain attacks that would migrate through her body along with intermittent tongue and facial numbness. She ignored these health issues for nearly a year, until after her mother died in November 2021.
Only after her mother passed away did Ms. Hadfield begin seeking answers to her own pain. In September 2022, she finally got them. She had a nerve condition called small-fiber sensory neuropathy.
But even with a diagnosis, she is still facing more tests to root out the cause and understand the best treatment.
Is help out there?
What can physicians do to help patients and families at risk for financial toxicity?
Specific guidelines for dealing with financial toxicity do not exist in most professional guidelines, nor are there standard screening tools to identify it, said Dr. Li Smith.
These gaps put pressure on physicians to ask about financial barriers and concerns, but most do not know how to broach the topic or how to help. “Physicians may not know how to fix the problem or what resources exist,” Dr. Li Smith said.
Patients and family members, on the other hand, are often reluctant to bring up cost with physicians. Some may be ashamed to talk about their financial problems while others may fear doing so will prevent them from being offered the best possible treatments, said Ms. MacDonald.
But, experts say, financial toxicity needs to be dealt with head on. That means involving financial navigators or counselors and social workers who can, for instance, help patients and families find financial support for their basic living expenses.
From a research perspective, more clinical trials should include financial toxicity outcomes, said Joshua Palmer, MD, a radiation oncologist at the University of Michigan, Ann Arbor.
Dr. Palmer and colleagues recently showed that the number of radiation therapy clinical trials including financial toxicity endpoints increased significantly from 2001 to 2020, though the absolute rate of inclusion remains low, at roughly 1.5% of radiation therapy-based clinical trials including financial toxicity endpoints from 2016 to 2020.
“Financial burden is part of the broader discussion about shared decision-making,” said Dr. Palmer.
In shared decision-making, physicians discuss the risks and benefits of different treatment options, empowering the patient to make an informed choice with the physician.
What we want to avoid is patients feeling like they will get inferior care, if they have financial barriers, said Dr. Palmer.
And every little bit can help. In 2006, Ms. MacDonald started the Pink Fund – a nonprofit to help patients with cancer cover nonmedical cost-of-living expenses. Both Ms. Caputo and Ms. Dicks received grants from the Pink Fund. For Ms. Caputo, the funds covered 2 months of car payments and for Ms. Dicks, it covered 2 months of rent.
While the one-time grant was a big help, said Ms. Dicks, “cancer is an everyday thing.” And “we all deserve peace of mind” when trying to heal.
A version of this article first appeared on WebMD.com.
Tips on Better Patients Communication
SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.
These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).
Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.
To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”
Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”
Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”
She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.
The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”
For more about the initiative, visit the VA PX SharePoint.
The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.
Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”
In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable.
In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.
Dr. Valdez-Boyle reported no disclosures.
SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.
These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).
Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.
To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”
Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”
Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”
She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.
The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”
For more about the initiative, visit the VA PX SharePoint.
The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.
Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”
In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable.
In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.
Dr. Valdez-Boyle reported no disclosures.
SAN DIEGO—Don’t stand when you talk at bedside. Ditch the white gowns, turn away from your computers and pagers, and stop yourself from interrupting all the time.
These tips—and more—can help clinicians provide better and more effective care, said a colorectal surgeon who spoke about communication skills at the annual meeting of the Association of VA Hematology/Oncology (AVAHO).
Research has suggested that nearly half of Americans don’t think their health care practitioners (HCPs) are compassionate, “and that’s really sad,” said Lorene Valdez-Boyle, MD, MS, surgery chief at the New Mexico VA Health Care Service.
To combat this perception, she said, HCPs can adopt multiple strategies as they work with veterans and their families. The goal, she said, is “to try to get them to trust you and want to be part of their treatment. This is how we're going to have better outcomes.”
Some strategies are simple. Dr. Valdez-Boyle, for example, doesn’t wear a white gown when she sees patients. “Obviously, they’re really gross,” she said. “But also, I want them to be comfortable with me. I sit down at their level, and we have a conversation. We talk about our dogs and we bond, because that’s going to help them trust me and want to work with me. I do that with families too. We joke, and we laugh.”
Sitting bedside instead of standing is important, she said, and a 2016 study backs up this idea. “It’s difficult when you’re running around or you want to get to the next one, and the patient just keeps talking,” she said. But research showed that “when the clinician sat, the patient felt like they listened more carefully, and they explained things in a better way that was much easier for them to understand. They definitely had an improved perception of their [clinician’s] communication skills.”
She highlighted another 2016 study that examined a Commit to Sit initiative in which nurses were urged to sit with patients during each shift. Nurse communication scores and overall patient experience scores went up.
The VA now has a Commit to Sit initiative, which urges clinicians to put away computers, smart phones, and pagers. “The patient feels that we’ve listened more intently to their concerns and care more about them as a patient,” Dr. Valdez-Boyle said. “We have an improved understanding of their health as a result of this. It allows the site employee to continue to be efficient while still delivering compassionate care and fosters trusted relationships in an empathetic and respectful manner.”
For more about the initiative, visit the VA PX SharePoint.
The VA, she said, also has a Take a Moment initiative that emphasizes eye contact, face-to-face interaction without electronics for at least the first 5 minutes of each visit, and seated conversations.
Dr. Valdez-Boyle also urged colleagues to pay attention to how often they interrupt. She pointed to a 2019 study that reported that patients had a median of 11 seconds—yes, seconds—to explain their problem in two-thirds of clinician encounters. “I think some of it is because we think we know what they're going to say.”
In the age of COVID-19, she suggested turning to fist or elbow bumps instead of handshakes. And she said, let patients wear street clothes when appropriate so they’re more comfortable.
In the big picture, she said, good communication and a commitment to shared decision making “really create a shared responsibility. They give your patients ownership over their disease and the ability to make the decisions with their team.
Dr. Valdez-Boyle reported no disclosures.
Study affirms better breast cancer outcomes when chemo comes first
New efficacy and safety data from the monarchE study show that chemotherapy administered before treatment with abemaciclib and estrogen therapy, led to a clinically meaningful improvement in invasive disease-free survival and distant relapse-free survival for women with HR-positive, ERBB2-negative, node-positive, early breast cancer at high risk of recurrence.
The study was published earlier this year in JAMA Oncology.
Neoadjuvant chemotherapy is often provided to such patients in hopes of achieving breast-conserving surgery. Although pathologic complete response rates can be higher than 50% after chemotherapy treatment in triple-negative and ERBB2-positive breast cancer, most patients with HR-positive and ERBB2-negative breast cancer have residual tumor at surgery after neoadjuvant chemotherapy, which is associated with an increased risk of recurrence.
“To our knowledge, abemaciclib is the first agent added to standard adjuvant estrogen therapy that has been shown to reduce the risk of recurrence in patients with HR-positive, ERBB2-negative early breast cancer with residual disease after neoadjuvant chemotherapy,” wrote the authors, who were led by Miguel Martin, MD, PhD, Hospital General Universitario Gregorio Marañon, Spain.
In 2021, Food and Drug Administration approved abemaciclib (Verzenio, Lilly) with endocrine therapy for the treatment of HR-positive/ERBB2-negative, node-positive, high-risk early breast cancer. Their decision was based on data from the monarchE study.
The study is at odds with the previously published Penelope-B study, which found no benefit from treatment with the CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) after 42.8 months of follow-up. The authors suggest that the disparate outcomes may be due to pharmacological differences between the two drugs as well as different dosing schedules: In monarchE, patients received abemaciclib on a continuous basis, while patients in Penelope-B received palbociclib for 21 days, followed by 7 days off. The treatment duration was 2 years in monarchE and 1 year in Penelope-B. Abemaciclib can be dosed continuously because it is a stronger inhibitor of CDK4 versus CDK6 compared to abemaciclib, and in vitro studies suggest that continuous dosing could be a key factor in creating profound inhibition of DNA synthesis.
The monarchE study included 5,637 patients who were randomized to receive standard of care estrogen therapy for 5 years with or without abemaciclib (150 mg, twice per day) for 2 years; 36.5% received abemaciclib. The mean age was 49.9 years; 70.8% were White, 22.8% Asian, and 2.7% Black.
The abemaciclib group had a clinically and statistically significant benefit in invasive disease-free survival (IDFS) (hazard ratio, 0.61; nominal P < .001) and distant relapse-free survival (DRFS) (HR, 0.61; nominal P < .001). At 2 years, DRFS was 89.5% in the abemaciclib group and 82.8% in the estrogen therapy–only group. IDFS was 87.2% and 80.6%, respectively. Patients who underwent neoadjuvant chemotherapy had a similar safety profile to the estrogen therapy–only group, although there was a higher incidence of treatment-emergent adverse events. The most common were diarrhea, infections, neutropenia, and fatigue. The most frequent grade treatment-emergent adverse events (of at least 3) were neutropenia and leucopenia.
The researchers noted that patients who underwent neoadjuvant chemotherapy had a worse prognosis than the intent-to-treat arm, as evidenced by a higher risk of 2-year recurrence (19% versus 11%). Exploratory subgroup analyses revealed that treatment with abemaciclib and estrogen therapy conferred IDFS and DRFS benefits regardless of the pathological tumor size and number of positive axillary lymph nodes.
The study was limited by the fact that it was open label, and the subgroup analyses were not powered to find statistically significant associations.
Dr. Martin has received grants from Eli Lilly, which funded monarchE.
New efficacy and safety data from the monarchE study show that chemotherapy administered before treatment with abemaciclib and estrogen therapy, led to a clinically meaningful improvement in invasive disease-free survival and distant relapse-free survival for women with HR-positive, ERBB2-negative, node-positive, early breast cancer at high risk of recurrence.
The study was published earlier this year in JAMA Oncology.
Neoadjuvant chemotherapy is often provided to such patients in hopes of achieving breast-conserving surgery. Although pathologic complete response rates can be higher than 50% after chemotherapy treatment in triple-negative and ERBB2-positive breast cancer, most patients with HR-positive and ERBB2-negative breast cancer have residual tumor at surgery after neoadjuvant chemotherapy, which is associated with an increased risk of recurrence.
“To our knowledge, abemaciclib is the first agent added to standard adjuvant estrogen therapy that has been shown to reduce the risk of recurrence in patients with HR-positive, ERBB2-negative early breast cancer with residual disease after neoadjuvant chemotherapy,” wrote the authors, who were led by Miguel Martin, MD, PhD, Hospital General Universitario Gregorio Marañon, Spain.
In 2021, Food and Drug Administration approved abemaciclib (Verzenio, Lilly) with endocrine therapy for the treatment of HR-positive/ERBB2-negative, node-positive, high-risk early breast cancer. Their decision was based on data from the monarchE study.
The study is at odds with the previously published Penelope-B study, which found no benefit from treatment with the CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) after 42.8 months of follow-up. The authors suggest that the disparate outcomes may be due to pharmacological differences between the two drugs as well as different dosing schedules: In monarchE, patients received abemaciclib on a continuous basis, while patients in Penelope-B received palbociclib for 21 days, followed by 7 days off. The treatment duration was 2 years in monarchE and 1 year in Penelope-B. Abemaciclib can be dosed continuously because it is a stronger inhibitor of CDK4 versus CDK6 compared to abemaciclib, and in vitro studies suggest that continuous dosing could be a key factor in creating profound inhibition of DNA synthesis.
The monarchE study included 5,637 patients who were randomized to receive standard of care estrogen therapy for 5 years with or without abemaciclib (150 mg, twice per day) for 2 years; 36.5% received abemaciclib. The mean age was 49.9 years; 70.8% were White, 22.8% Asian, and 2.7% Black.
The abemaciclib group had a clinically and statistically significant benefit in invasive disease-free survival (IDFS) (hazard ratio, 0.61; nominal P < .001) and distant relapse-free survival (DRFS) (HR, 0.61; nominal P < .001). At 2 years, DRFS was 89.5% in the abemaciclib group and 82.8% in the estrogen therapy–only group. IDFS was 87.2% and 80.6%, respectively. Patients who underwent neoadjuvant chemotherapy had a similar safety profile to the estrogen therapy–only group, although there was a higher incidence of treatment-emergent adverse events. The most common were diarrhea, infections, neutropenia, and fatigue. The most frequent grade treatment-emergent adverse events (of at least 3) were neutropenia and leucopenia.
The researchers noted that patients who underwent neoadjuvant chemotherapy had a worse prognosis than the intent-to-treat arm, as evidenced by a higher risk of 2-year recurrence (19% versus 11%). Exploratory subgroup analyses revealed that treatment with abemaciclib and estrogen therapy conferred IDFS and DRFS benefits regardless of the pathological tumor size and number of positive axillary lymph nodes.
The study was limited by the fact that it was open label, and the subgroup analyses were not powered to find statistically significant associations.
Dr. Martin has received grants from Eli Lilly, which funded monarchE.
New efficacy and safety data from the monarchE study show that chemotherapy administered before treatment with abemaciclib and estrogen therapy, led to a clinically meaningful improvement in invasive disease-free survival and distant relapse-free survival for women with HR-positive, ERBB2-negative, node-positive, early breast cancer at high risk of recurrence.
The study was published earlier this year in JAMA Oncology.
Neoadjuvant chemotherapy is often provided to such patients in hopes of achieving breast-conserving surgery. Although pathologic complete response rates can be higher than 50% after chemotherapy treatment in triple-negative and ERBB2-positive breast cancer, most patients with HR-positive and ERBB2-negative breast cancer have residual tumor at surgery after neoadjuvant chemotherapy, which is associated with an increased risk of recurrence.
“To our knowledge, abemaciclib is the first agent added to standard adjuvant estrogen therapy that has been shown to reduce the risk of recurrence in patients with HR-positive, ERBB2-negative early breast cancer with residual disease after neoadjuvant chemotherapy,” wrote the authors, who were led by Miguel Martin, MD, PhD, Hospital General Universitario Gregorio Marañon, Spain.
In 2021, Food and Drug Administration approved abemaciclib (Verzenio, Lilly) with endocrine therapy for the treatment of HR-positive/ERBB2-negative, node-positive, high-risk early breast cancer. Their decision was based on data from the monarchE study.
The study is at odds with the previously published Penelope-B study, which found no benefit from treatment with the CDK4/6 inhibitor palbociclib (Ibrance, Pfizer) after 42.8 months of follow-up. The authors suggest that the disparate outcomes may be due to pharmacological differences between the two drugs as well as different dosing schedules: In monarchE, patients received abemaciclib on a continuous basis, while patients in Penelope-B received palbociclib for 21 days, followed by 7 days off. The treatment duration was 2 years in monarchE and 1 year in Penelope-B. Abemaciclib can be dosed continuously because it is a stronger inhibitor of CDK4 versus CDK6 compared to abemaciclib, and in vitro studies suggest that continuous dosing could be a key factor in creating profound inhibition of DNA synthesis.
The monarchE study included 5,637 patients who were randomized to receive standard of care estrogen therapy for 5 years with or without abemaciclib (150 mg, twice per day) for 2 years; 36.5% received abemaciclib. The mean age was 49.9 years; 70.8% were White, 22.8% Asian, and 2.7% Black.
The abemaciclib group had a clinically and statistically significant benefit in invasive disease-free survival (IDFS) (hazard ratio, 0.61; nominal P < .001) and distant relapse-free survival (DRFS) (HR, 0.61; nominal P < .001). At 2 years, DRFS was 89.5% in the abemaciclib group and 82.8% in the estrogen therapy–only group. IDFS was 87.2% and 80.6%, respectively. Patients who underwent neoadjuvant chemotherapy had a similar safety profile to the estrogen therapy–only group, although there was a higher incidence of treatment-emergent adverse events. The most common were diarrhea, infections, neutropenia, and fatigue. The most frequent grade treatment-emergent adverse events (of at least 3) were neutropenia and leucopenia.
The researchers noted that patients who underwent neoadjuvant chemotherapy had a worse prognosis than the intent-to-treat arm, as evidenced by a higher risk of 2-year recurrence (19% versus 11%). Exploratory subgroup analyses revealed that treatment with abemaciclib and estrogen therapy conferred IDFS and DRFS benefits regardless of the pathological tumor size and number of positive axillary lymph nodes.
The study was limited by the fact that it was open label, and the subgroup analyses were not powered to find statistically significant associations.
Dr. Martin has received grants from Eli Lilly, which funded monarchE.
FROM JAMA ONCOLOGY
EUS-guided RF ablation doubles survival for unresectable pancreatic cancer
CHARLOTTE, N.C. – In a small proof-of-concept study, patients with small unresectable pancreatic cancers treated with endoscopic ultrasound–guided radiofrequency ablation (EUS-RFA) had a more than twofold improvement in overall survival compared with historical controls with a similar disease history, investigators in Thailand found.
In a weighted analysis, median weighted overall survival – the primary outcome – was 14 months among 11 patients who underwent EUS-RFA, compared with 6.1 months for 35 matched controls, translating into a hazard ratio for death with EUS-RFA of 0.38 (P = .016), reported Chawin Lopimpisuth, MD, from King Chulalongkorn Memorial Hospital in Bangkok, Thailand.
Median weighted progression-free survival (PFS) was longer among cases than controls, but did not differ significantly, at 6.1 months and 3.9 months, respectively.
“In patients with unresectable pancreatic ductal adenocarcinomas that are less than 4 cm, EUS-RFA alone or combined with chemotherapy resulted in significantly improved overall survival and tended to improve progression-free survival with minimal adverse events,” Dr. Lopimpisuth reported at the annual meeting of the American College of Gastroenterology.
Small but unresectable tumors
Endoscopically guided radiofrequency ablation of pancreatic ductal tumors has been shown to be both feasible and safe in previous studies, he said, prompting his group to explore whether EUS-RFA could help to control the primary tumor and improve survival outcomes.
They enrolled 11 patients with primary pancreatic ductal adenocarcinoma tumors less than 4 cm in diameter that were unresectable due to blood vessel involvement or distant metastasis, and used propensity-score matching to pair them with a total of 35 controls. Controls were matched by tumor size, staging, age-adjusted Charlson Comorbidity Index, chemotherapy regimen received, and interactions between CCI, regimen, and staging.
The results were weighted to assure that covariate distribution among patients treated with chemotherapy only equaled that of patients who underwent EUS-RFA.
Patients underwent EUS-RFA with a 19-gauge needle, with 50 watts of energy delivered with an impedance of 100 ohms. Those patients deemed able to tolerate chemotherapy received that as well.
After a minimum of 1 year of follow-up, the median weighted survival, as noted before, was 14 months for patients who received EUS-RFA, compared with 6.1 months for controls.
Adjusted survival probabilities at 6 and 12 months were 73% and 64%, respectively, for patients in the EUS-RFA group, compared with 69% and 17% for controls. Adjusted PFS rates at 6 and 12 months were 55% and 36% in the EUS-RFA group, compared with 28% and 4% in the control group.
The only adverse event of significance was mild abdominal pain, reported by 8.3% of total EUS-RFA procedures.
Promising but preliminary
In an interview with this news organization, ACG President Samir A. Shah, MD, from Brown University and Miriam Hospital in Providence, R.I., who was not involved in the study, commented that “we have limited options with these patients, so it’s really exciting to see an initial trend toward efficacy, and their survival improvement was significant by several months.”
Dr. Shah was a moderator of the presidential symposium where the data were presented.
Comoderator Brooks D. Cash, MD, from the University of Texas Health Science Center at Houston, said that the advantage of EUS-RFA is that it’s only minimally invasive and appears to offer a significant survival advantage for patients with few effective treatment options.
He cautioned, however, that “it’s a small study and needs to be replicated in a larger venue and different sites as well, but I think it looks very promising.”
The investigators did not report a funding source for the study. Dr. Lopimpisuth, Dr. Shah, and Dr. Cash all reported having no relevant financial relationships to disclose.
CHARLOTTE, N.C. – In a small proof-of-concept study, patients with small unresectable pancreatic cancers treated with endoscopic ultrasound–guided radiofrequency ablation (EUS-RFA) had a more than twofold improvement in overall survival compared with historical controls with a similar disease history, investigators in Thailand found.
In a weighted analysis, median weighted overall survival – the primary outcome – was 14 months among 11 patients who underwent EUS-RFA, compared with 6.1 months for 35 matched controls, translating into a hazard ratio for death with EUS-RFA of 0.38 (P = .016), reported Chawin Lopimpisuth, MD, from King Chulalongkorn Memorial Hospital in Bangkok, Thailand.
Median weighted progression-free survival (PFS) was longer among cases than controls, but did not differ significantly, at 6.1 months and 3.9 months, respectively.
“In patients with unresectable pancreatic ductal adenocarcinomas that are less than 4 cm, EUS-RFA alone or combined with chemotherapy resulted in significantly improved overall survival and tended to improve progression-free survival with minimal adverse events,” Dr. Lopimpisuth reported at the annual meeting of the American College of Gastroenterology.
Small but unresectable tumors
Endoscopically guided radiofrequency ablation of pancreatic ductal tumors has been shown to be both feasible and safe in previous studies, he said, prompting his group to explore whether EUS-RFA could help to control the primary tumor and improve survival outcomes.
They enrolled 11 patients with primary pancreatic ductal adenocarcinoma tumors less than 4 cm in diameter that were unresectable due to blood vessel involvement or distant metastasis, and used propensity-score matching to pair them with a total of 35 controls. Controls were matched by tumor size, staging, age-adjusted Charlson Comorbidity Index, chemotherapy regimen received, and interactions between CCI, regimen, and staging.
The results were weighted to assure that covariate distribution among patients treated with chemotherapy only equaled that of patients who underwent EUS-RFA.
Patients underwent EUS-RFA with a 19-gauge needle, with 50 watts of energy delivered with an impedance of 100 ohms. Those patients deemed able to tolerate chemotherapy received that as well.
After a minimum of 1 year of follow-up, the median weighted survival, as noted before, was 14 months for patients who received EUS-RFA, compared with 6.1 months for controls.
Adjusted survival probabilities at 6 and 12 months were 73% and 64%, respectively, for patients in the EUS-RFA group, compared with 69% and 17% for controls. Adjusted PFS rates at 6 and 12 months were 55% and 36% in the EUS-RFA group, compared with 28% and 4% in the control group.
The only adverse event of significance was mild abdominal pain, reported by 8.3% of total EUS-RFA procedures.
Promising but preliminary
In an interview with this news organization, ACG President Samir A. Shah, MD, from Brown University and Miriam Hospital in Providence, R.I., who was not involved in the study, commented that “we have limited options with these patients, so it’s really exciting to see an initial trend toward efficacy, and their survival improvement was significant by several months.”
Dr. Shah was a moderator of the presidential symposium where the data were presented.
Comoderator Brooks D. Cash, MD, from the University of Texas Health Science Center at Houston, said that the advantage of EUS-RFA is that it’s only minimally invasive and appears to offer a significant survival advantage for patients with few effective treatment options.
He cautioned, however, that “it’s a small study and needs to be replicated in a larger venue and different sites as well, but I think it looks very promising.”
The investigators did not report a funding source for the study. Dr. Lopimpisuth, Dr. Shah, and Dr. Cash all reported having no relevant financial relationships to disclose.
CHARLOTTE, N.C. – In a small proof-of-concept study, patients with small unresectable pancreatic cancers treated with endoscopic ultrasound–guided radiofrequency ablation (EUS-RFA) had a more than twofold improvement in overall survival compared with historical controls with a similar disease history, investigators in Thailand found.
In a weighted analysis, median weighted overall survival – the primary outcome – was 14 months among 11 patients who underwent EUS-RFA, compared with 6.1 months for 35 matched controls, translating into a hazard ratio for death with EUS-RFA of 0.38 (P = .016), reported Chawin Lopimpisuth, MD, from King Chulalongkorn Memorial Hospital in Bangkok, Thailand.
Median weighted progression-free survival (PFS) was longer among cases than controls, but did not differ significantly, at 6.1 months and 3.9 months, respectively.
“In patients with unresectable pancreatic ductal adenocarcinomas that are less than 4 cm, EUS-RFA alone or combined with chemotherapy resulted in significantly improved overall survival and tended to improve progression-free survival with minimal adverse events,” Dr. Lopimpisuth reported at the annual meeting of the American College of Gastroenterology.
Small but unresectable tumors
Endoscopically guided radiofrequency ablation of pancreatic ductal tumors has been shown to be both feasible and safe in previous studies, he said, prompting his group to explore whether EUS-RFA could help to control the primary tumor and improve survival outcomes.
They enrolled 11 patients with primary pancreatic ductal adenocarcinoma tumors less than 4 cm in diameter that were unresectable due to blood vessel involvement or distant metastasis, and used propensity-score matching to pair them with a total of 35 controls. Controls were matched by tumor size, staging, age-adjusted Charlson Comorbidity Index, chemotherapy regimen received, and interactions between CCI, regimen, and staging.
The results were weighted to assure that covariate distribution among patients treated with chemotherapy only equaled that of patients who underwent EUS-RFA.
Patients underwent EUS-RFA with a 19-gauge needle, with 50 watts of energy delivered with an impedance of 100 ohms. Those patients deemed able to tolerate chemotherapy received that as well.
After a minimum of 1 year of follow-up, the median weighted survival, as noted before, was 14 months for patients who received EUS-RFA, compared with 6.1 months for controls.
Adjusted survival probabilities at 6 and 12 months were 73% and 64%, respectively, for patients in the EUS-RFA group, compared with 69% and 17% for controls. Adjusted PFS rates at 6 and 12 months were 55% and 36% in the EUS-RFA group, compared with 28% and 4% in the control group.
The only adverse event of significance was mild abdominal pain, reported by 8.3% of total EUS-RFA procedures.
Promising but preliminary
In an interview with this news organization, ACG President Samir A. Shah, MD, from Brown University and Miriam Hospital in Providence, R.I., who was not involved in the study, commented that “we have limited options with these patients, so it’s really exciting to see an initial trend toward efficacy, and their survival improvement was significant by several months.”
Dr. Shah was a moderator of the presidential symposium where the data were presented.
Comoderator Brooks D. Cash, MD, from the University of Texas Health Science Center at Houston, said that the advantage of EUS-RFA is that it’s only minimally invasive and appears to offer a significant survival advantage for patients with few effective treatment options.
He cautioned, however, that “it’s a small study and needs to be replicated in a larger venue and different sites as well, but I think it looks very promising.”
The investigators did not report a funding source for the study. Dr. Lopimpisuth, Dr. Shah, and Dr. Cash all reported having no relevant financial relationships to disclose.
AT ACG 2022
Durvalumab combinations show tentative promise in NSCLC
in patients with unresectable stage 3 non–small-cell lung cancer.
Combinations of the PD-L1 inhibitor durvalumab (Imfinzi, AstraZeneca) with the anti-CD73 monoclonal antibody oleclumab or the anti-NKG2A monoclonal antibody monalizumab led to improved overall response rate and progression-free survival compared to durvalumab alone.
The findings support further study in a phase 3 clinical trial, according to the authors of the study recently published in the Journal of Clinical Oncology.
Durvalumab is the standard treatment following consolidation therapy of chemoradiotherapy in unresectable stage 3 non–small-cell lung cancer (NSCLC). Although it extended progression-free survival (PFS) and overall survival in the PACIFIC phase 3 study, some patients experience a recurrence, which has led to exploration of immunotherapy combinations.
Oleclumab inhibits the enzyme CD73, found on the surfaces of both tumor and immune cells. Its activity leads to an immunosuppressive effect in the tumor microenvironment, and preclinical studies have shown that it can have an additive antitumor effect when combined with PD-1 or PD-L1 inhibitors. A phase 1 study also suggested efficacy. Monalizumab blocks interactions between major histocompatibility complex-E (HLA-E) and an inhibitor receptor. A number of tumors overexpress HLA-E, triggering inhibitor signals that inhibit natural killer and CD8+ T cells.
“COAST was an interesting study that, although not definitive, suggested that the combination of durvalumab with oleclumab or with monalizumab was more effective than durvalumab alone in the consolidation setting after definitive concurrent chemoradiation for patients with stage 3 unresectable NSCLC,” said Nathan Pennell, MD, PhD, who wrote an accompanying editorial.
Despite the positive signal, Dr. Pennell expressed some skepticism that the combinations would pass a phase 3 test. He questioned the choice of response rate as the primary endpoint of the phase 2 study, and noted that the durvalumab arm had worse progression-free survival (PFS) than the previous PACIFIC trial. It could be that the clinical characteristics of the study population differed between the two trials, in which case the improved objective response rate (ORR) and PFS results should be encouraging. It’s also possible the COAST trial’s small sample size led to a mismatch between the control and treatment group despite randomization, in which case the findings may not be valid.
“These are the kinds of issues that keep drug developers up at night. There really is no way to know which scenario is correct without doing the larger trial. I do hope though that the phase 3 trials have robust biomarker analysis including PDL1 to make sure the arms are as well matched for known prognostic and predictive markers as possible,” said Dr. Pennell, who is vice chair of clinical research at Taussig Cancer Institute.
The study details
The researchers randomized 189 patients to durvalumab, durvalumab plus oleclumab, or durvalumab plus monalizumab between January 2019 and July 2020. After a median follow-up of 11.5 months, there was a higher confirmed objective response rate in the durvalumab plus oleclumab group (30.0%; 95% confidence interval, 18.8%-43.2%) and the durvalumab plus monalizumab group (35.5%; 95% CI, 23.7%-48.7%) versus durvalumab alone (17.9%; 95% CI, 9.6%-29.2%).
Compared to durvalumab alone, there was improved PFS in both durvalumab plus oleclumab (stratified hazard ratio, 0.44; 95% CI, 0.26-0.75) and durvalumab plus monalizumab (HR, 0.42; 95% CI, 0.24-0.72). At 12 months, PFS was 62.6% (95% CI, 48.1-74.2%) for durvalumab plus oleclumab, 72.7% (95% CI, 58.8-82.6%) for durvalumab plus monalizumab, and 33.9% (95% CI, 21.2-47.1%) for durvalumab alone.
The study was funded by AstraZeneca.
in patients with unresectable stage 3 non–small-cell lung cancer.
Combinations of the PD-L1 inhibitor durvalumab (Imfinzi, AstraZeneca) with the anti-CD73 monoclonal antibody oleclumab or the anti-NKG2A monoclonal antibody monalizumab led to improved overall response rate and progression-free survival compared to durvalumab alone.
The findings support further study in a phase 3 clinical trial, according to the authors of the study recently published in the Journal of Clinical Oncology.
Durvalumab is the standard treatment following consolidation therapy of chemoradiotherapy in unresectable stage 3 non–small-cell lung cancer (NSCLC). Although it extended progression-free survival (PFS) and overall survival in the PACIFIC phase 3 study, some patients experience a recurrence, which has led to exploration of immunotherapy combinations.
Oleclumab inhibits the enzyme CD73, found on the surfaces of both tumor and immune cells. Its activity leads to an immunosuppressive effect in the tumor microenvironment, and preclinical studies have shown that it can have an additive antitumor effect when combined with PD-1 or PD-L1 inhibitors. A phase 1 study also suggested efficacy. Monalizumab blocks interactions between major histocompatibility complex-E (HLA-E) and an inhibitor receptor. A number of tumors overexpress HLA-E, triggering inhibitor signals that inhibit natural killer and CD8+ T cells.
“COAST was an interesting study that, although not definitive, suggested that the combination of durvalumab with oleclumab or with monalizumab was more effective than durvalumab alone in the consolidation setting after definitive concurrent chemoradiation for patients with stage 3 unresectable NSCLC,” said Nathan Pennell, MD, PhD, who wrote an accompanying editorial.
Despite the positive signal, Dr. Pennell expressed some skepticism that the combinations would pass a phase 3 test. He questioned the choice of response rate as the primary endpoint of the phase 2 study, and noted that the durvalumab arm had worse progression-free survival (PFS) than the previous PACIFIC trial. It could be that the clinical characteristics of the study population differed between the two trials, in which case the improved objective response rate (ORR) and PFS results should be encouraging. It’s also possible the COAST trial’s small sample size led to a mismatch between the control and treatment group despite randomization, in which case the findings may not be valid.
“These are the kinds of issues that keep drug developers up at night. There really is no way to know which scenario is correct without doing the larger trial. I do hope though that the phase 3 trials have robust biomarker analysis including PDL1 to make sure the arms are as well matched for known prognostic and predictive markers as possible,” said Dr. Pennell, who is vice chair of clinical research at Taussig Cancer Institute.
The study details
The researchers randomized 189 patients to durvalumab, durvalumab plus oleclumab, or durvalumab plus monalizumab between January 2019 and July 2020. After a median follow-up of 11.5 months, there was a higher confirmed objective response rate in the durvalumab plus oleclumab group (30.0%; 95% confidence interval, 18.8%-43.2%) and the durvalumab plus monalizumab group (35.5%; 95% CI, 23.7%-48.7%) versus durvalumab alone (17.9%; 95% CI, 9.6%-29.2%).
Compared to durvalumab alone, there was improved PFS in both durvalumab plus oleclumab (stratified hazard ratio, 0.44; 95% CI, 0.26-0.75) and durvalumab plus monalizumab (HR, 0.42; 95% CI, 0.24-0.72). At 12 months, PFS was 62.6% (95% CI, 48.1-74.2%) for durvalumab plus oleclumab, 72.7% (95% CI, 58.8-82.6%) for durvalumab plus monalizumab, and 33.9% (95% CI, 21.2-47.1%) for durvalumab alone.
The study was funded by AstraZeneca.
in patients with unresectable stage 3 non–small-cell lung cancer.
Combinations of the PD-L1 inhibitor durvalumab (Imfinzi, AstraZeneca) with the anti-CD73 monoclonal antibody oleclumab or the anti-NKG2A monoclonal antibody monalizumab led to improved overall response rate and progression-free survival compared to durvalumab alone.
The findings support further study in a phase 3 clinical trial, according to the authors of the study recently published in the Journal of Clinical Oncology.
Durvalumab is the standard treatment following consolidation therapy of chemoradiotherapy in unresectable stage 3 non–small-cell lung cancer (NSCLC). Although it extended progression-free survival (PFS) and overall survival in the PACIFIC phase 3 study, some patients experience a recurrence, which has led to exploration of immunotherapy combinations.
Oleclumab inhibits the enzyme CD73, found on the surfaces of both tumor and immune cells. Its activity leads to an immunosuppressive effect in the tumor microenvironment, and preclinical studies have shown that it can have an additive antitumor effect when combined with PD-1 or PD-L1 inhibitors. A phase 1 study also suggested efficacy. Monalizumab blocks interactions between major histocompatibility complex-E (HLA-E) and an inhibitor receptor. A number of tumors overexpress HLA-E, triggering inhibitor signals that inhibit natural killer and CD8+ T cells.
“COAST was an interesting study that, although not definitive, suggested that the combination of durvalumab with oleclumab or with monalizumab was more effective than durvalumab alone in the consolidation setting after definitive concurrent chemoradiation for patients with stage 3 unresectable NSCLC,” said Nathan Pennell, MD, PhD, who wrote an accompanying editorial.
Despite the positive signal, Dr. Pennell expressed some skepticism that the combinations would pass a phase 3 test. He questioned the choice of response rate as the primary endpoint of the phase 2 study, and noted that the durvalumab arm had worse progression-free survival (PFS) than the previous PACIFIC trial. It could be that the clinical characteristics of the study population differed between the two trials, in which case the improved objective response rate (ORR) and PFS results should be encouraging. It’s also possible the COAST trial’s small sample size led to a mismatch between the control and treatment group despite randomization, in which case the findings may not be valid.
“These are the kinds of issues that keep drug developers up at night. There really is no way to know which scenario is correct without doing the larger trial. I do hope though that the phase 3 trials have robust biomarker analysis including PDL1 to make sure the arms are as well matched for known prognostic and predictive markers as possible,” said Dr. Pennell, who is vice chair of clinical research at Taussig Cancer Institute.
The study details
The researchers randomized 189 patients to durvalumab, durvalumab plus oleclumab, or durvalumab plus monalizumab between January 2019 and July 2020. After a median follow-up of 11.5 months, there was a higher confirmed objective response rate in the durvalumab plus oleclumab group (30.0%; 95% confidence interval, 18.8%-43.2%) and the durvalumab plus monalizumab group (35.5%; 95% CI, 23.7%-48.7%) versus durvalumab alone (17.9%; 95% CI, 9.6%-29.2%).
Compared to durvalumab alone, there was improved PFS in both durvalumab plus oleclumab (stratified hazard ratio, 0.44; 95% CI, 0.26-0.75) and durvalumab plus monalizumab (HR, 0.42; 95% CI, 0.24-0.72). At 12 months, PFS was 62.6% (95% CI, 48.1-74.2%) for durvalumab plus oleclumab, 72.7% (95% CI, 58.8-82.6%) for durvalumab plus monalizumab, and 33.9% (95% CI, 21.2-47.1%) for durvalumab alone.
The study was funded by AstraZeneca.
FROM JOURNAL OF CLINICAL ONCOLOGY
Pancreatic cancer screening appears safe, effective for high-risk patients
Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.
Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.
Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.
“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”
Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.
To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.
The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.
Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.
Screening was performed annually with either endoscopic ultrasound (EUS) or magnetic resonance cholangiopancreatography (MRCP). Fasting blood sugar was recorded annually to screen for new-onset diabetes.
Among 252 patients, 208 underwent EUS and 44 underwent MRCP. At the time of enrollment, 38.5% underwent their first screening, and 61.5% had a prior screening. The average age was 60, 69% were women, and 79% were White.
The most common indication was a BRCA1 or BRCA2 pathogenic variant in 93 patients (or 36.5%), followed by FPC syndrome in 80 patients (or 31.7%).
Low-risk pancreas pathology was noted in 23.4% of patients, with 17.5% having chronic pancreatitis-like changes. Intermediate risk was found in 31.7%, with nearly all detected as branch-duct IPMNs without worrisome features, Dr. Silva-Santisteban said.
Two patients (.8%) fell into the high-risk category with pancreatic adenocarcinoma. Both were positive for BRCA2 mutation and family history of pancreatic cancer.
In the first patient, who was compliant with screening, EUS showed a 3-cm adenocarcinoma (T2N1M0 stage IIB). The patient underwent neoadjuvant chemotherapy, followed by total pancreatectomy, and is currently in cancer remission. No complications from surgery were noted.
In the second patient, who was not compliant with screening and was lost to follow-up for 6 years, EUS showed a 2.5-cm adenocarcinoma and four metastatic lesions in the liver (T2N1M1 stage IV). The patient underwent palliative chemotherapy.
EUS was more likely to identify chronic pancreatitis-like changes, but MRCP was more likely to identify BD-IPMN. The two patients with pancreatic adenocarcinoma were identified with EUS. However, there wasn’t a significant difference between EUS and MRCP in identifying high-risk lesions.
In patients undergoing screening, new-onset prediabetes was noted in 18.2%, and new-onset diabetes was noted in 1.7%. However, there was no association between abnormal blood sugar and pancreas pathology.
Twelve patients (4.8%) underwent further pancreatic evaluation because of screening findings. None of the patients underwent low-yield pancreatic surgery, which was lower than reported in the literature, at 2.8%. Overall, there were no complications as a direct result of screening with EUS or MRI.
“Patients should be carefully counseled regarding benefits and harms from pancreatic cancer screening,” Dr. Silva-Santisteban said. “When feasible, such screening should be performed within the confines of a research study so more precise estimates of screening outcomes can be determined.”
The study funding was not disclosed. One author reported a consultant relationship with Pentax Medical, and the other authors indicated no relevant financial relationships.
Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.
Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.
Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.
“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”
Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.
To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.
The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.
Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.
Screening was performed annually with either endoscopic ultrasound (EUS) or magnetic resonance cholangiopancreatography (MRCP). Fasting blood sugar was recorded annually to screen for new-onset diabetes.
Among 252 patients, 208 underwent EUS and 44 underwent MRCP. At the time of enrollment, 38.5% underwent their first screening, and 61.5% had a prior screening. The average age was 60, 69% were women, and 79% were White.
The most common indication was a BRCA1 or BRCA2 pathogenic variant in 93 patients (or 36.5%), followed by FPC syndrome in 80 patients (or 31.7%).
Low-risk pancreas pathology was noted in 23.4% of patients, with 17.5% having chronic pancreatitis-like changes. Intermediate risk was found in 31.7%, with nearly all detected as branch-duct IPMNs without worrisome features, Dr. Silva-Santisteban said.
Two patients (.8%) fell into the high-risk category with pancreatic adenocarcinoma. Both were positive for BRCA2 mutation and family history of pancreatic cancer.
In the first patient, who was compliant with screening, EUS showed a 3-cm adenocarcinoma (T2N1M0 stage IIB). The patient underwent neoadjuvant chemotherapy, followed by total pancreatectomy, and is currently in cancer remission. No complications from surgery were noted.
In the second patient, who was not compliant with screening and was lost to follow-up for 6 years, EUS showed a 2.5-cm adenocarcinoma and four metastatic lesions in the liver (T2N1M1 stage IV). The patient underwent palliative chemotherapy.
EUS was more likely to identify chronic pancreatitis-like changes, but MRCP was more likely to identify BD-IPMN. The two patients with pancreatic adenocarcinoma were identified with EUS. However, there wasn’t a significant difference between EUS and MRCP in identifying high-risk lesions.
In patients undergoing screening, new-onset prediabetes was noted in 18.2%, and new-onset diabetes was noted in 1.7%. However, there was no association between abnormal blood sugar and pancreas pathology.
Twelve patients (4.8%) underwent further pancreatic evaluation because of screening findings. None of the patients underwent low-yield pancreatic surgery, which was lower than reported in the literature, at 2.8%. Overall, there were no complications as a direct result of screening with EUS or MRI.
“Patients should be carefully counseled regarding benefits and harms from pancreatic cancer screening,” Dr. Silva-Santisteban said. “When feasible, such screening should be performed within the confines of a research study so more precise estimates of screening outcomes can be determined.”
The study funding was not disclosed. One author reported a consultant relationship with Pentax Medical, and the other authors indicated no relevant financial relationships.
Pancreatic cancer screening appears to be safe and effective for certain patients with high-risk indications due to genetic susceptibility, according to a prospective multicenter study presented at the annual meeting of the American College of Gastroenterology.
Screening in high-risk patients detected high-risk lesions in 0.8% of patients, which was lower than the typical range found in the literature, at 3%, said Andy Silva-Santisteban, MD, a research fellow at Beth Israel Deaconess Medical Center at Harvard Medical School in Boston.
Pancreatic cancer is the third leading cause of cancer death in the U.S., which is estimated to become the second leading cause by 2030. About 15%-20% of patients are candidates for surgical resection at the time of diagnosis, with survival rates below 10%.
“These statistics have led pancreatic cancer screening to be studied with the goal of detecting earlier stages of the disease to improve survival,” Dr. Silva-Santisteban said. “However, pancreatic cancer screening is not recommended for the general population.”
Pancreatic cancer screening is recommended for patients with increased risk due to genetic susceptibility, yet recent studies have found that screening studies face limitations from factors like small sample sizes, single-center focus, retrospective nature, nonconsecutive accrual of patients, varied inclusion criteria, and use of nonstandardized screening protocols.
To overcome these limitations, Dr. Silva-Santisteban and colleagues conducted a prospective multicenter study of pancreatic cancer screening in consecutive high-risk patients at five centers in the United States between 2020 and 2022, also called the Pancreas Scan Study. Dr. Silva-Santisteban presented results from the first round of enrollment, which was awarded the Outstanding Research Award in the Biliary/Pancreas Category for Trainee.
The research team evaluated the yield (low-, moderate-, and high-risk pancreatic pathology), safety, and outcomes of screening. Low-risk pancreas pathology was categorized as fatty pancreas and chronic pancreatitis-like changes. Intermediate-risk was categorized as branch duct–intraductal papillary mucinous neoplasm or neuroendocrine tumor under 2 cm. High-risk was categorized as main duct–intraductal papillary mucinous neoplasm (MD-IPMN), pancreatic intraepithelial neoplasia grade III (PanIN-III)/dysplasia, neuroendocrine tumor over 2 cm, or pancreatic cancer.
Patients were included if they were 18 years or older and had at least one of the following: BRCA1, BRCA2, or PALB2 plus a family history of pancreatic cancer; Lynch syndrome plus a family history of pancreatic cancer; Peutz-Jeghers syndrome; familial atypical multiple mole melanoma (FAMMM); ataxia telangiectasia mutated plus family history of pancreatic cancer; hereditary pancreatitis; or familial pancreatic cancer (FPC) syndrome.
Screening was performed annually with either endoscopic ultrasound (EUS) or magnetic resonance cholangiopancreatography (MRCP). Fasting blood sugar was recorded annually to screen for new-onset diabetes.
Among 252 patients, 208 underwent EUS and 44 underwent MRCP. At the time of enrollment, 38.5% underwent their first screening, and 61.5% had a prior screening. The average age was 60, 69% were women, and 79% were White.
The most common indication was a BRCA1 or BRCA2 pathogenic variant in 93 patients (or 36.5%), followed by FPC syndrome in 80 patients (or 31.7%).
Low-risk pancreas pathology was noted in 23.4% of patients, with 17.5% having chronic pancreatitis-like changes. Intermediate risk was found in 31.7%, with nearly all detected as branch-duct IPMNs without worrisome features, Dr. Silva-Santisteban said.
Two patients (.8%) fell into the high-risk category with pancreatic adenocarcinoma. Both were positive for BRCA2 mutation and family history of pancreatic cancer.
In the first patient, who was compliant with screening, EUS showed a 3-cm adenocarcinoma (T2N1M0 stage IIB). The patient underwent neoadjuvant chemotherapy, followed by total pancreatectomy, and is currently in cancer remission. No complications from surgery were noted.
In the second patient, who was not compliant with screening and was lost to follow-up for 6 years, EUS showed a 2.5-cm adenocarcinoma and four metastatic lesions in the liver (T2N1M1 stage IV). The patient underwent palliative chemotherapy.
EUS was more likely to identify chronic pancreatitis-like changes, but MRCP was more likely to identify BD-IPMN. The two patients with pancreatic adenocarcinoma were identified with EUS. However, there wasn’t a significant difference between EUS and MRCP in identifying high-risk lesions.
In patients undergoing screening, new-onset prediabetes was noted in 18.2%, and new-onset diabetes was noted in 1.7%. However, there was no association between abnormal blood sugar and pancreas pathology.
Twelve patients (4.8%) underwent further pancreatic evaluation because of screening findings. None of the patients underwent low-yield pancreatic surgery, which was lower than reported in the literature, at 2.8%. Overall, there were no complications as a direct result of screening with EUS or MRI.
“Patients should be carefully counseled regarding benefits and harms from pancreatic cancer screening,” Dr. Silva-Santisteban said. “When feasible, such screening should be performed within the confines of a research study so more precise estimates of screening outcomes can be determined.”
The study funding was not disclosed. One author reported a consultant relationship with Pentax Medical, and the other authors indicated no relevant financial relationships.
FROM ACG 2022
FDA approves new immunotherapy combo for liver cancer
(HCC), the most common type of liver cancer.
The new combination comprises a single dose of tremelimumab (Imjudo, AstraZeneca) followed by treatment with durvalumab (Imfinzi, AstraZeneca) in what is known as the STRIDE (single-tremelimumab regular-interval durvalumab) regimen.
This marks the first worldwide approval for tremelimumab, which is a CTLA-4 antibody.
The other drug in the combination, durvalumab, is an anti-PDL1 antibody and is already approved by the FDA for use in several tumor types, including lung cancer, bladder cancer, and biliary tract cancers.
The STRIDE regimen is composed of a single 300-mg dose of tremelimumab followed by durvalumab 1,500 mg given every 4 weeks.
This regimen was used in the HIMALAYA phase 3 trial, which was published in June 2022 in the New England Journal of Medicine.
Results from this trial showed that 30% of patients treated with that combination were still alive at 3 years, compared with 20% of patients who were treated with the standard regimen, sorafenib.
“In addition to this regimen demonstrating a favorable 3-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease,” commented the principal investigator of this trial, Ghassan Abou-Alfa, MD, MBA, attending physician at Memorial Sloan Kettering Cancer Center, New York.
“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival,” he commented in a press release from the drug’s manufacturer, AstraZeneca.
When the results from this trial were presented earlier this year at the ASCO Gastrointestinal Cancers meeting, the discussant for that abstract, Anthony B. El-Khoueiry, MD, from the University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, suggested that the STRIDE regimen offers a new first-line treatment option for patients with advanced HCC.
He also made several comments about the design of the HIMALAYA trial, which has a third treatment arm in which patients received durvalumab alone. Dr. El-Khoueiry noted that single-agent durvalumab was noninferior to sorafenib, but he added that no conclusions could be drawn about the STRIDE regimen in comparison with durvalumab as a single agent, because the trial was not powered for that.
The STRIDE regimen showed a lower risk of bleeding in comparison with combinations that include VEGF inhibitors (such as bevacizumab), he said, but he also pointed out that this trial excluded patients with main portal vein thrombosis, who are at high risk of bleeding.
Details of adverse events
In the NEJM article, the trialists report that grade 3/4 treatment-emergent adverse events occurred in 50.5% of patients with STRIDE, 37.1% with durvalumab alone, and 52.4% of patients with sorafenib.
The manufacturer noted that severe and fatal immune-mediated adverse reactions may occur, including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, and others.
The company also noted that among the patients with unresectable HCC in the HIMALAYA study who received the STRIDE regimen, the most common adverse reactions (occurring in ≥ 20% of patients) were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain.
Serious adverse reactions occurred in 41% of patients and included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%).
Fatal adverse reactions occurred in 8% of patients who received the combination, including death (1%), intracranial hemorrhage (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%).
Permanent discontinuation of the treatment regimen because of an adverse reaction occurred in 14% of patients.
A version of this article first appeared on Medscape.com.
(HCC), the most common type of liver cancer.
The new combination comprises a single dose of tremelimumab (Imjudo, AstraZeneca) followed by treatment with durvalumab (Imfinzi, AstraZeneca) in what is known as the STRIDE (single-tremelimumab regular-interval durvalumab) regimen.
This marks the first worldwide approval for tremelimumab, which is a CTLA-4 antibody.
The other drug in the combination, durvalumab, is an anti-PDL1 antibody and is already approved by the FDA for use in several tumor types, including lung cancer, bladder cancer, and biliary tract cancers.
The STRIDE regimen is composed of a single 300-mg dose of tremelimumab followed by durvalumab 1,500 mg given every 4 weeks.
This regimen was used in the HIMALAYA phase 3 trial, which was published in June 2022 in the New England Journal of Medicine.
Results from this trial showed that 30% of patients treated with that combination were still alive at 3 years, compared with 20% of patients who were treated with the standard regimen, sorafenib.
“In addition to this regimen demonstrating a favorable 3-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease,” commented the principal investigator of this trial, Ghassan Abou-Alfa, MD, MBA, attending physician at Memorial Sloan Kettering Cancer Center, New York.
“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival,” he commented in a press release from the drug’s manufacturer, AstraZeneca.
When the results from this trial were presented earlier this year at the ASCO Gastrointestinal Cancers meeting, the discussant for that abstract, Anthony B. El-Khoueiry, MD, from the University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, suggested that the STRIDE regimen offers a new first-line treatment option for patients with advanced HCC.
He also made several comments about the design of the HIMALAYA trial, which has a third treatment arm in which patients received durvalumab alone. Dr. El-Khoueiry noted that single-agent durvalumab was noninferior to sorafenib, but he added that no conclusions could be drawn about the STRIDE regimen in comparison with durvalumab as a single agent, because the trial was not powered for that.
The STRIDE regimen showed a lower risk of bleeding in comparison with combinations that include VEGF inhibitors (such as bevacizumab), he said, but he also pointed out that this trial excluded patients with main portal vein thrombosis, who are at high risk of bleeding.
Details of adverse events
In the NEJM article, the trialists report that grade 3/4 treatment-emergent adverse events occurred in 50.5% of patients with STRIDE, 37.1% with durvalumab alone, and 52.4% of patients with sorafenib.
The manufacturer noted that severe and fatal immune-mediated adverse reactions may occur, including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, and others.
The company also noted that among the patients with unresectable HCC in the HIMALAYA study who received the STRIDE regimen, the most common adverse reactions (occurring in ≥ 20% of patients) were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain.
Serious adverse reactions occurred in 41% of patients and included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%).
Fatal adverse reactions occurred in 8% of patients who received the combination, including death (1%), intracranial hemorrhage (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%).
Permanent discontinuation of the treatment regimen because of an adverse reaction occurred in 14% of patients.
A version of this article first appeared on Medscape.com.
(HCC), the most common type of liver cancer.
The new combination comprises a single dose of tremelimumab (Imjudo, AstraZeneca) followed by treatment with durvalumab (Imfinzi, AstraZeneca) in what is known as the STRIDE (single-tremelimumab regular-interval durvalumab) regimen.
This marks the first worldwide approval for tremelimumab, which is a CTLA-4 antibody.
The other drug in the combination, durvalumab, is an anti-PDL1 antibody and is already approved by the FDA for use in several tumor types, including lung cancer, bladder cancer, and biliary tract cancers.
The STRIDE regimen is composed of a single 300-mg dose of tremelimumab followed by durvalumab 1,500 mg given every 4 weeks.
This regimen was used in the HIMALAYA phase 3 trial, which was published in June 2022 in the New England Journal of Medicine.
Results from this trial showed that 30% of patients treated with that combination were still alive at 3 years, compared with 20% of patients who were treated with the standard regimen, sorafenib.
“In addition to this regimen demonstrating a favorable 3-year survival rate in the HIMALAYA trial, safety data showed no increase in severe liver toxicity or bleeding risk for the combination, important factors for patients with liver cancer who also have advanced liver disease,” commented the principal investigator of this trial, Ghassan Abou-Alfa, MD, MBA, attending physician at Memorial Sloan Kettering Cancer Center, New York.
“Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival,” he commented in a press release from the drug’s manufacturer, AstraZeneca.
When the results from this trial were presented earlier this year at the ASCO Gastrointestinal Cancers meeting, the discussant for that abstract, Anthony B. El-Khoueiry, MD, from the University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, suggested that the STRIDE regimen offers a new first-line treatment option for patients with advanced HCC.
He also made several comments about the design of the HIMALAYA trial, which has a third treatment arm in which patients received durvalumab alone. Dr. El-Khoueiry noted that single-agent durvalumab was noninferior to sorafenib, but he added that no conclusions could be drawn about the STRIDE regimen in comparison with durvalumab as a single agent, because the trial was not powered for that.
The STRIDE regimen showed a lower risk of bleeding in comparison with combinations that include VEGF inhibitors (such as bevacizumab), he said, but he also pointed out that this trial excluded patients with main portal vein thrombosis, who are at high risk of bleeding.
Details of adverse events
In the NEJM article, the trialists report that grade 3/4 treatment-emergent adverse events occurred in 50.5% of patients with STRIDE, 37.1% with durvalumab alone, and 52.4% of patients with sorafenib.
The manufacturer noted that severe and fatal immune-mediated adverse reactions may occur, including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic reactions, and others.
The company also noted that among the patients with unresectable HCC in the HIMALAYA study who received the STRIDE regimen, the most common adverse reactions (occurring in ≥ 20% of patients) were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain.
Serious adverse reactions occurred in 41% of patients and included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%).
Fatal adverse reactions occurred in 8% of patients who received the combination, including death (1%), intracranial hemorrhage (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%).
Permanent discontinuation of the treatment regimen because of an adverse reaction occurred in 14% of patients.
A version of this article first appeared on Medscape.com.
Reminder that COVID-19 and cancer can be a deadly combo
A new study underscores the importance of COVID-19 and regular COVID-19 testing among adults with a recent cancer diagnosis.
The Indiana statewide study, conducted at the beginning of the pandemic, found that
“This analysis provides additional empirical evidence on the magnitude of risk to patients with cancer whose immune systems are often weakened either by the disease or treatment,” the study team wrote.
The study was published online in JMIR Cancer.
Although evidence has consistently revealed similar findings, the risk of death among unvaccinated people with cancer and COVID-19 has not been nearly as high in previous studies, lead author Brian E. Dixon, PhD, MBA, with Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, said in a statement. Previous studies from China, for instance, reported a two- to threefold greater risk of all-cause mortality among unvaccinated adults with cancer and COVID-19.
A potential reason for this discrepancy, Dr. Dixon noted, is that earlier studies were “generally smaller and made calculations based on data from a single cancer center or health system.”
Another reason is testing for COVID-19 early in the pandemic was limited to symptomatic individuals who may have had more severe infections, possibly leading to an overestimate of the association between SARS-CoV-2 infection, cancer, and all-cause mortality.
In the current analysis, researchers used electronic health records linked to Indiana’s statewide SARS-CoV-2 testing database and state vital records to evaluate the association between SARS-CoV-2 infection and all-cause mortality among 41,924 adults newly diagnosed with cancer between Jan. 1, 2019, and Dec. 31, 2020.
Most people with cancer were White (78.4%) and about half were male. At the time of diagnosis, 17% had one comorbid condition and about 10% had two or more. Most patients had breast cancer (14%), prostate cancer (13%), or melanoma (13%).
During the study period, 2,894 patients (7%) tested positive for SARS-CoV-2.
In multivariate adjusted analysis, the risk of death among those newly diagnosed with cancer increased by 91% (adjusted hazard ratio, 1.91) during the first year of the pandemic before vaccines were available, compared with the year before (January 2019 to Jan. 14, 2020).
During the pandemic period, the risk of death was roughly threefold higher among adults 65 years old and older, compared with adults 18-44 years old (aHR, 3.35).
When looking at the time from a cancer diagnosis to SARS-CoV-2 infection, infection was associated with an almost sevenfold increase in all-cause mortality (aHR, 6.91). Adults 65 years old and older had an almost threefold increased risk of dying, compared with their younger peers (aHR, 2.74).
Dr. Dixon and colleagues also observed an increased risk of death in men with cancer and COVID, compared with women (aHR, 1.23) and those with at least two comorbid conditions versus none (aHR, 2.12). In addition, the risk of dying was 9% higher among Indiana’s rural population than urban dwellers.
Compared with other cancer types, individuals with lung cancer and other digestive cancers had the highest risk of death after SARS-CoV-2 infection (aHR, 1.45 and 1.80, respectively).
“Our findings highlight the increased risk of death for adult cancer patients who test positive for COVID and underscore the importance to cancer patients – including those in remission – of vaccinations, boosters, and regular COVID testing,” Dr. Dixon commented.
“Our results should encourage individuals diagnosed with cancer not only to take preventive action, but also to expeditiously seek out treatments available in the marketplace should they test positive for COVID,” he added.
Support for the study was provided by Indiana University Simon Cancer Center and the Centers for Disease Control and Prevention. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study underscores the importance of COVID-19 and regular COVID-19 testing among adults with a recent cancer diagnosis.
The Indiana statewide study, conducted at the beginning of the pandemic, found that
“This analysis provides additional empirical evidence on the magnitude of risk to patients with cancer whose immune systems are often weakened either by the disease or treatment,” the study team wrote.
The study was published online in JMIR Cancer.
Although evidence has consistently revealed similar findings, the risk of death among unvaccinated people with cancer and COVID-19 has not been nearly as high in previous studies, lead author Brian E. Dixon, PhD, MBA, with Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, said in a statement. Previous studies from China, for instance, reported a two- to threefold greater risk of all-cause mortality among unvaccinated adults with cancer and COVID-19.
A potential reason for this discrepancy, Dr. Dixon noted, is that earlier studies were “generally smaller and made calculations based on data from a single cancer center or health system.”
Another reason is testing for COVID-19 early in the pandemic was limited to symptomatic individuals who may have had more severe infections, possibly leading to an overestimate of the association between SARS-CoV-2 infection, cancer, and all-cause mortality.
In the current analysis, researchers used electronic health records linked to Indiana’s statewide SARS-CoV-2 testing database and state vital records to evaluate the association between SARS-CoV-2 infection and all-cause mortality among 41,924 adults newly diagnosed with cancer between Jan. 1, 2019, and Dec. 31, 2020.
Most people with cancer were White (78.4%) and about half were male. At the time of diagnosis, 17% had one comorbid condition and about 10% had two or more. Most patients had breast cancer (14%), prostate cancer (13%), or melanoma (13%).
During the study period, 2,894 patients (7%) tested positive for SARS-CoV-2.
In multivariate adjusted analysis, the risk of death among those newly diagnosed with cancer increased by 91% (adjusted hazard ratio, 1.91) during the first year of the pandemic before vaccines were available, compared with the year before (January 2019 to Jan. 14, 2020).
During the pandemic period, the risk of death was roughly threefold higher among adults 65 years old and older, compared with adults 18-44 years old (aHR, 3.35).
When looking at the time from a cancer diagnosis to SARS-CoV-2 infection, infection was associated with an almost sevenfold increase in all-cause mortality (aHR, 6.91). Adults 65 years old and older had an almost threefold increased risk of dying, compared with their younger peers (aHR, 2.74).
Dr. Dixon and colleagues also observed an increased risk of death in men with cancer and COVID, compared with women (aHR, 1.23) and those with at least two comorbid conditions versus none (aHR, 2.12). In addition, the risk of dying was 9% higher among Indiana’s rural population than urban dwellers.
Compared with other cancer types, individuals with lung cancer and other digestive cancers had the highest risk of death after SARS-CoV-2 infection (aHR, 1.45 and 1.80, respectively).
“Our findings highlight the increased risk of death for adult cancer patients who test positive for COVID and underscore the importance to cancer patients – including those in remission – of vaccinations, boosters, and regular COVID testing,” Dr. Dixon commented.
“Our results should encourage individuals diagnosed with cancer not only to take preventive action, but also to expeditiously seek out treatments available in the marketplace should they test positive for COVID,” he added.
Support for the study was provided by Indiana University Simon Cancer Center and the Centers for Disease Control and Prevention. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study underscores the importance of COVID-19 and regular COVID-19 testing among adults with a recent cancer diagnosis.
The Indiana statewide study, conducted at the beginning of the pandemic, found that
“This analysis provides additional empirical evidence on the magnitude of risk to patients with cancer whose immune systems are often weakened either by the disease or treatment,” the study team wrote.
The study was published online in JMIR Cancer.
Although evidence has consistently revealed similar findings, the risk of death among unvaccinated people with cancer and COVID-19 has not been nearly as high in previous studies, lead author Brian E. Dixon, PhD, MBA, with Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, said in a statement. Previous studies from China, for instance, reported a two- to threefold greater risk of all-cause mortality among unvaccinated adults with cancer and COVID-19.
A potential reason for this discrepancy, Dr. Dixon noted, is that earlier studies were “generally smaller and made calculations based on data from a single cancer center or health system.”
Another reason is testing for COVID-19 early in the pandemic was limited to symptomatic individuals who may have had more severe infections, possibly leading to an overestimate of the association between SARS-CoV-2 infection, cancer, and all-cause mortality.
In the current analysis, researchers used electronic health records linked to Indiana’s statewide SARS-CoV-2 testing database and state vital records to evaluate the association between SARS-CoV-2 infection and all-cause mortality among 41,924 adults newly diagnosed with cancer between Jan. 1, 2019, and Dec. 31, 2020.
Most people with cancer were White (78.4%) and about half were male. At the time of diagnosis, 17% had one comorbid condition and about 10% had two or more. Most patients had breast cancer (14%), prostate cancer (13%), or melanoma (13%).
During the study period, 2,894 patients (7%) tested positive for SARS-CoV-2.
In multivariate adjusted analysis, the risk of death among those newly diagnosed with cancer increased by 91% (adjusted hazard ratio, 1.91) during the first year of the pandemic before vaccines were available, compared with the year before (January 2019 to Jan. 14, 2020).
During the pandemic period, the risk of death was roughly threefold higher among adults 65 years old and older, compared with adults 18-44 years old (aHR, 3.35).
When looking at the time from a cancer diagnosis to SARS-CoV-2 infection, infection was associated with an almost sevenfold increase in all-cause mortality (aHR, 6.91). Adults 65 years old and older had an almost threefold increased risk of dying, compared with their younger peers (aHR, 2.74).
Dr. Dixon and colleagues also observed an increased risk of death in men with cancer and COVID, compared with women (aHR, 1.23) and those with at least two comorbid conditions versus none (aHR, 2.12). In addition, the risk of dying was 9% higher among Indiana’s rural population than urban dwellers.
Compared with other cancer types, individuals with lung cancer and other digestive cancers had the highest risk of death after SARS-CoV-2 infection (aHR, 1.45 and 1.80, respectively).
“Our findings highlight the increased risk of death for adult cancer patients who test positive for COVID and underscore the importance to cancer patients – including those in remission – of vaccinations, boosters, and regular COVID testing,” Dr. Dixon commented.
“Our results should encourage individuals diagnosed with cancer not only to take preventive action, but also to expeditiously seek out treatments available in the marketplace should they test positive for COVID,” he added.
Support for the study was provided by Indiana University Simon Cancer Center and the Centers for Disease Control and Prevention. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JMIR CANCER
VA Center Dramatically Shrinks Wait Times for Bone Marrow Biopsies
SAN DIEGO–The Louis Stokes Cleveland VA Medical Center in Ohio dramatically reduced wait times for bone marrow biopsies and treatment by ditching the radiology department and opening a weekly clinic devoted to the procedures, a cancer care team reported at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) September 16 to 18, 2022.
The average time from biopsy order to procedure fell by more than two-thirds from 23.1 days to 7.0 days, and the time from order to diagnosis dipped from 27.8 days to 11.6 days. The time from treatment fell from 54.8 days to 20.2 days.
The new strategy aims to avoid sending patients to the radiology department and treat them in a clinic within the cancer center instead. “It’s great to be able to keep as many hematology/oncology–related things such as infusion, scheduling, and procedures within our department. It provides continuity for the veteran, and it’s helpful for them from that aspect,” said nurse practitioner Kyle Stimpert, MSN, RN, ACNP, of VA Northeast Ohio Healthcare System.
As the cancer team reported in an abstract presented at the AVAHO meeting, “bone marrow biopsies often need to be performed expeditiously to alleviate patient concerns and quickly determine a diagnosis and treatment plan. However, with increasing subspecialization, there are fewer hematology/oncology providers available to perform this procedure.”
The Cleveland VA tried to address this problem by sending patients to interventional radiology, but it still took weeks for bone marrow biopsies to be performed: From August 4, 2020, to August 12, 2021, when 140 biopsies were performed, the average time from order to procedure was 23.1 days. The time from order to diagnosis was 27.8 days, and from order to treatment was 54.8 days.
The bone marrow biopsies provide insight into diseases such as hematologic malignancies and myelodysplastic syndromes, Stimpert said. The procedures may lead to diagnoses or reveal how treatment is progressing.
In 2021, new leadership sought to shrink the wait times. “We put together a small team and started brainstorming,” said oncology clinical nurse specialist Alecia Smalheer, MSN, APRN, OCN, in an interview. With the help of staff who’d come from other facilities, she said, “we were able to see what was being done in surrounding community hospitals and come up with a model and a checklist.”
The team modified a space to create a new weekly, half-day bone marrow biopsy clinic. They also worked on procedures, documentation, education of patients, and training of staff, Smalheer said.
After implementation in the summer of 2021, the biopsy clinic performed 89 procedures through August 31, 2022. The average time from order to procedure was 7.0 days. The time to diagnosis was 11.6 days, and the time to treatment was 20.2 days. The differences between the pre-implementation and postimplementation periods were statistically significant. (P < .001 for each).
The biopsy clinic now sees about 3 to 4 patients a week. “Just yesterday, I had a vet whose cancer was going down. I was able to just do this bone marrow right there, and it was amazing. He didn’t have to go home [and come back],” Stimpert said. “A lot of patients travel a far distance or on oxygen, or it’s hard for them to get around. Coming to the facility for repeat appointments can just take a lot out of them. So it’s really nice to be able to get it all done in one visit.”
There are multiple benefits to shortening wait times, Smalheer said. “They can start treatment much sooner… but it also alleviates some of the emotional distress of waiting. They still have some waiting to do, but it’s definitely not as long.”
And, Stimpert added, patients are familiar with the infusion center and will see faces they know.
As for cost, the biopsy clinic may save money due to several factors related to how and where the biopsy procedures are performed, Stimpert said.
No disclosures are reported.
SAN DIEGO–The Louis Stokes Cleveland VA Medical Center in Ohio dramatically reduced wait times for bone marrow biopsies and treatment by ditching the radiology department and opening a weekly clinic devoted to the procedures, a cancer care team reported at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) September 16 to 18, 2022.
The average time from biopsy order to procedure fell by more than two-thirds from 23.1 days to 7.0 days, and the time from order to diagnosis dipped from 27.8 days to 11.6 days. The time from treatment fell from 54.8 days to 20.2 days.
The new strategy aims to avoid sending patients to the radiology department and treat them in a clinic within the cancer center instead. “It’s great to be able to keep as many hematology/oncology–related things such as infusion, scheduling, and procedures within our department. It provides continuity for the veteran, and it’s helpful for them from that aspect,” said nurse practitioner Kyle Stimpert, MSN, RN, ACNP, of VA Northeast Ohio Healthcare System.
As the cancer team reported in an abstract presented at the AVAHO meeting, “bone marrow biopsies often need to be performed expeditiously to alleviate patient concerns and quickly determine a diagnosis and treatment plan. However, with increasing subspecialization, there are fewer hematology/oncology providers available to perform this procedure.”
The Cleveland VA tried to address this problem by sending patients to interventional radiology, but it still took weeks for bone marrow biopsies to be performed: From August 4, 2020, to August 12, 2021, when 140 biopsies were performed, the average time from order to procedure was 23.1 days. The time from order to diagnosis was 27.8 days, and from order to treatment was 54.8 days.
The bone marrow biopsies provide insight into diseases such as hematologic malignancies and myelodysplastic syndromes, Stimpert said. The procedures may lead to diagnoses or reveal how treatment is progressing.
In 2021, new leadership sought to shrink the wait times. “We put together a small team and started brainstorming,” said oncology clinical nurse specialist Alecia Smalheer, MSN, APRN, OCN, in an interview. With the help of staff who’d come from other facilities, she said, “we were able to see what was being done in surrounding community hospitals and come up with a model and a checklist.”
The team modified a space to create a new weekly, half-day bone marrow biopsy clinic. They also worked on procedures, documentation, education of patients, and training of staff, Smalheer said.
After implementation in the summer of 2021, the biopsy clinic performed 89 procedures through August 31, 2022. The average time from order to procedure was 7.0 days. The time to diagnosis was 11.6 days, and the time to treatment was 20.2 days. The differences between the pre-implementation and postimplementation periods were statistically significant. (P < .001 for each).
The biopsy clinic now sees about 3 to 4 patients a week. “Just yesterday, I had a vet whose cancer was going down. I was able to just do this bone marrow right there, and it was amazing. He didn’t have to go home [and come back],” Stimpert said. “A lot of patients travel a far distance or on oxygen, or it’s hard for them to get around. Coming to the facility for repeat appointments can just take a lot out of them. So it’s really nice to be able to get it all done in one visit.”
There are multiple benefits to shortening wait times, Smalheer said. “They can start treatment much sooner… but it also alleviates some of the emotional distress of waiting. They still have some waiting to do, but it’s definitely not as long.”
And, Stimpert added, patients are familiar with the infusion center and will see faces they know.
As for cost, the biopsy clinic may save money due to several factors related to how and where the biopsy procedures are performed, Stimpert said.
No disclosures are reported.
SAN DIEGO–The Louis Stokes Cleveland VA Medical Center in Ohio dramatically reduced wait times for bone marrow biopsies and treatment by ditching the radiology department and opening a weekly clinic devoted to the procedures, a cancer care team reported at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) September 16 to 18, 2022.
The average time from biopsy order to procedure fell by more than two-thirds from 23.1 days to 7.0 days, and the time from order to diagnosis dipped from 27.8 days to 11.6 days. The time from treatment fell from 54.8 days to 20.2 days.
The new strategy aims to avoid sending patients to the radiology department and treat them in a clinic within the cancer center instead. “It’s great to be able to keep as many hematology/oncology–related things such as infusion, scheduling, and procedures within our department. It provides continuity for the veteran, and it’s helpful for them from that aspect,” said nurse practitioner Kyle Stimpert, MSN, RN, ACNP, of VA Northeast Ohio Healthcare System.
As the cancer team reported in an abstract presented at the AVAHO meeting, “bone marrow biopsies often need to be performed expeditiously to alleviate patient concerns and quickly determine a diagnosis and treatment plan. However, with increasing subspecialization, there are fewer hematology/oncology providers available to perform this procedure.”
The Cleveland VA tried to address this problem by sending patients to interventional radiology, but it still took weeks for bone marrow biopsies to be performed: From August 4, 2020, to August 12, 2021, when 140 biopsies were performed, the average time from order to procedure was 23.1 days. The time from order to diagnosis was 27.8 days, and from order to treatment was 54.8 days.
The bone marrow biopsies provide insight into diseases such as hematologic malignancies and myelodysplastic syndromes, Stimpert said. The procedures may lead to diagnoses or reveal how treatment is progressing.
In 2021, new leadership sought to shrink the wait times. “We put together a small team and started brainstorming,” said oncology clinical nurse specialist Alecia Smalheer, MSN, APRN, OCN, in an interview. With the help of staff who’d come from other facilities, she said, “we were able to see what was being done in surrounding community hospitals and come up with a model and a checklist.”
The team modified a space to create a new weekly, half-day bone marrow biopsy clinic. They also worked on procedures, documentation, education of patients, and training of staff, Smalheer said.
After implementation in the summer of 2021, the biopsy clinic performed 89 procedures through August 31, 2022. The average time from order to procedure was 7.0 days. The time to diagnosis was 11.6 days, and the time to treatment was 20.2 days. The differences between the pre-implementation and postimplementation periods were statistically significant. (P < .001 for each).
The biopsy clinic now sees about 3 to 4 patients a week. “Just yesterday, I had a vet whose cancer was going down. I was able to just do this bone marrow right there, and it was amazing. He didn’t have to go home [and come back],” Stimpert said. “A lot of patients travel a far distance or on oxygen, or it’s hard for them to get around. Coming to the facility for repeat appointments can just take a lot out of them. So it’s really nice to be able to get it all done in one visit.”
There are multiple benefits to shortening wait times, Smalheer said. “They can start treatment much sooner… but it also alleviates some of the emotional distress of waiting. They still have some waiting to do, but it’s definitely not as long.”
And, Stimpert added, patients are familiar with the infusion center and will see faces they know.
As for cost, the biopsy clinic may save money due to several factors related to how and where the biopsy procedures are performed, Stimpert said.
No disclosures are reported.
In VA Oncology, Discussion Groups Are Transforming the Workplace
SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.
At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.
Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy.
The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.
Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”
At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”
Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.
The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”
The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.
As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”
Dr. Perry has no disclosures.
SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.
At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.
Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy.
The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.
Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”
At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”
Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.
The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”
The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.
As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”
Dr. Perry has no disclosures.
SAN DIEGO—From coast to coast, 10 US Department of Veterans Affairs (VA) medical centers are holding meetings designed to help clinicians and colleagues talk openly about touchy workplace topics, such as compassion, burnout, and medical errors. New data suggests that “Schwartz Rounds” have tremendous power to change how medical professionals cope, communicate, and commiserate.
At the VA Connecticut Healthcare System (VACHS), nearly all (98%) respondents who took part in Schwartz Round sessions rated them as either good or excellent, 89% reported feeling less isolated in their work with patients, 98% had new insights into the perspectives and experiences of colleagues, and 93% felt more open to communicating with colleagues, reported oncologist Edward Perry, MD, of VA Connecticut and Yale University School of Medicine, in a presentation here at the annual meeting of the Association of VA Hematology/Oncology (AVAHO) held September 16 to 18, 2022.
Schwartz Rounds have been around for 25 years and are named after the late Ken Schwartz, a 40-year-old Boston health care attorney who wrote movingly in 1995 about the “exquisite compassion” he experienced while being treated for advanced lung cancer—and the risk that the rapidly evolving health care system would lose its sense of empathy.
The Boston-based nonprofit Schwartz Center for Compassionate Healthcare facilitates Schwartz Rounds, which are now held at about 600 health care organizations around the world. That number includes the 10 VA medical centers, mostly in the Northeast (Massachusetts, New York, Connecticut, and New Hampshire) but also in California, Illinois, and Minnesota.
Site teams work with the Schwartz Center to plan the rounds and gather data about their effectiveness. “Unlike traditional clinical or ethics rounds, this is not a didactic or problem-solving session. The focus is not on what happened, but how those who were involved felt. In other words, the human dimension of medicine,” Dr. Perry said. “There are no right or wrong answers. Everything that is said during short rounds is confidential. We do encourage people to continue discussion of the general themes afterward but not to share any specifics of what was discussed.”
At VACHS, Schwartz rounds began shortly before the COVID-19 pandemic, Perry said, and they’ve been held virtually since the first meeting. “Schwartz Rounds are open to all employees, trainees, and students at the institution. Anyone with a VA badge is welcome to attend,” he said. “We're averaging about 150 attendees per session.”
Speakers have addressed social/emotional topics, including delivering bad news to patients, maintaining compassion during adversity, and providing compassionate care to patients with substance use disorders.
The VACHS survey of Schwartz Rounds participants had a 50% response rate, with about 400 people responding to each question. Nearly all (98%) said they planned to attend the rounds again, and 55% agreed that a specific discussion “suggests that changes may be needed in departmental or institutional policies or practices.”
The administration has agreed to continue the Schwartz Rounds in light of the positive results, Perry said. As he noted, the Schwartz Center charges dues and initiation fees. The Marjorie Stanzler Financial Aid Fund underwrites the initiation fees for qualifying organizations, including VA facilities.
As for lessons, he said the topics of Schwartz Rounds “should be emotionally resonant. They should involve multiple disciplines and perspectives. They should illuminate an issue or experience that is not often discussed. And should inspire participants to share their own experiences and highlight instances of compassionate care—or barriers to providing compassionate care.”
Dr. Perry has no disclosures.