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Geographic Clusters Show Uneven Cancer Screening in the US
Geographic Clusters Show Uneven Cancer Screening in the US
TOPLINE:
An analysis of 3142 US counties revealed that county-level screening for breast, cervical, and colorectal cancer increased overall between 1997 and 2019; however, despite the reduced geographic variation, persistently high-screening clusters remained in the Northeast, whereas persistently low-screening clusters remained in the Southwest.
METHODOLOGY:
- Cancer screening reduces mortality. Despite guideline recommendation, the uptake of breast, cervical, and colorectal cancer screening in the US falls short of national goals and varies across sociodemographic groups. To date, only a few studies have examined geographic and temporal patterns of screening.
- To address this gap, researchers conducted a cross-sectional study using an ecological panel design to analyze county-level screening prevalence across 3142 US mainland counties from 1997 to 2019, deriving prevalence estimates from Behavioral Risk Factor Surveillance System (BRFSS) and National Health Interview Survey (NHIS) data over 3- to 5-year periods.
- Spatial autocorrelation analyses, including Global Moran I and the bivariate local indicator of spatial autocorrelation, were performed to assess geographic clusters of cancer screening within each period. Four types of local geographic clusters of county-level cancer screening were identified: counties with persistently high screening rates, counties with persistently low screening rates, counties in which screening rates decreased from high to low, and counties in which screening rates increased from low to high.
- Screening prevalence was compared across multiple time windows for different modalities (mammography, a Papanicolaou test, colonoscopy, colorectal cancer test, endoscopy, and a fecal occult blood test [FOBT]). Overall, 3101 counties were analyzed for mammography and the Papanicolaou test, 3107 counties for colonoscopy, 3100 counties for colorectal cancer test, 3089 counties for endoscopy, and 3090 counties for the FOBT.
TAKEAWAY:
- Overall screening prevalence increased from 1997 to 2019, and global spatial autocorrelation declined over time. For instance, the distribution of mammography screening became 83% more uniform in more recent years (Moran I, 0.57 in 1997-1999 vs 0.10 in 2017-2019). Similarly, Papanicolaou test screening became more uniform in more recent years (Moran I, 0.44 vs. 0.07). These changes indicate reduced geographic heterogeneity.
- Colonoscopy and endoscopy use increased, surpassing a 50% prevalence in many counties for 2010; however, FOBT use declined. Spatial clustering also attenuated, with a 23.4% declined in Moran I for colonoscopy from 2011-2016 to 2017-2019, a 12.3% decline in the colorectal cancer test from 2004-2007 to 2008-2010, and a 14.0% decline for endoscopy from 2004-2007 to 2008-2010.
- Persistently high-/high-screening clusters were concentrated in the Northeast for mammography and colorectal cancer screening and in the East for Papanicolaou test screening, whereas persistently low-/low-screening clusters were concentrated in the Southwest for the same modalities.
- Clusters of low- and high-screening counties were more disadvantaged -- with lower socioeconomic status and a higher proportion of non-White residents -- than other cluster types, suggesting some improvement in screening uptake in more disadvantaged areas. Counties with persistently low screening exhibited greater socioeconomic disadvantages -- lower media household income, higher poverty, lower home values, and lower educational attainment -- than those with persistently high screening.
IN PRACTICE:
"This cross-sectional study found that despite secular increases that reduced geographic variation in screening, local clusters of high and low screening persisted in the Northeast and Southwest US, respectively. Future studies could incorporate health care access characteristics to explain why areas of low screening did not catch up to optimize cancer screening practice," the authors wrote.
SOURCE:
The study, led by Pranoti Pradhan, PhD, Harvard T.H. Chan School of Public Health, Boston, was published online in JAMA Network Open.
LIMITATIONS:
The county-level estimates were modeled using BRFSS, NHIS, and US Census data, which might be susceptible to sampling biases despite corrections for nonresponse and noncoverage. Researchers lacked data on specific health systems characteristics that may have directly driven changes in prevalence and were restricted to using screening time intervals available from the Small Area Estimates for Cancer-Relates Measures from the National Cancer Institute, rather than those according to US Preventive Services Task Force guidelines. Additionally, the spatial cluster method was sensitive to county size and arrangement, which may have influenced local cluster detection.
DISCLOSURES:
This research was supported by the T32 Cancer Prevention and Control Funding Fellowship and T32 Cancer Epidemiology Fellowship at the Harvard T.H. Chan School of Public Health. The authors declared having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
An analysis of 3142 US counties revealed that county-level screening for breast, cervical, and colorectal cancer increased overall between 1997 and 2019; however, despite the reduced geographic variation, persistently high-screening clusters remained in the Northeast, whereas persistently low-screening clusters remained in the Southwest.
METHODOLOGY:
- Cancer screening reduces mortality. Despite guideline recommendation, the uptake of breast, cervical, and colorectal cancer screening in the US falls short of national goals and varies across sociodemographic groups. To date, only a few studies have examined geographic and temporal patterns of screening.
- To address this gap, researchers conducted a cross-sectional study using an ecological panel design to analyze county-level screening prevalence across 3142 US mainland counties from 1997 to 2019, deriving prevalence estimates from Behavioral Risk Factor Surveillance System (BRFSS) and National Health Interview Survey (NHIS) data over 3- to 5-year periods.
- Spatial autocorrelation analyses, including Global Moran I and the bivariate local indicator of spatial autocorrelation, were performed to assess geographic clusters of cancer screening within each period. Four types of local geographic clusters of county-level cancer screening were identified: counties with persistently high screening rates, counties with persistently low screening rates, counties in which screening rates decreased from high to low, and counties in which screening rates increased from low to high.
- Screening prevalence was compared across multiple time windows for different modalities (mammography, a Papanicolaou test, colonoscopy, colorectal cancer test, endoscopy, and a fecal occult blood test [FOBT]). Overall, 3101 counties were analyzed for mammography and the Papanicolaou test, 3107 counties for colonoscopy, 3100 counties for colorectal cancer test, 3089 counties for endoscopy, and 3090 counties for the FOBT.
TAKEAWAY:
- Overall screening prevalence increased from 1997 to 2019, and global spatial autocorrelation declined over time. For instance, the distribution of mammography screening became 83% more uniform in more recent years (Moran I, 0.57 in 1997-1999 vs 0.10 in 2017-2019). Similarly, Papanicolaou test screening became more uniform in more recent years (Moran I, 0.44 vs. 0.07). These changes indicate reduced geographic heterogeneity.
- Colonoscopy and endoscopy use increased, surpassing a 50% prevalence in many counties for 2010; however, FOBT use declined. Spatial clustering also attenuated, with a 23.4% declined in Moran I for colonoscopy from 2011-2016 to 2017-2019, a 12.3% decline in the colorectal cancer test from 2004-2007 to 2008-2010, and a 14.0% decline for endoscopy from 2004-2007 to 2008-2010.
- Persistently high-/high-screening clusters were concentrated in the Northeast for mammography and colorectal cancer screening and in the East for Papanicolaou test screening, whereas persistently low-/low-screening clusters were concentrated in the Southwest for the same modalities.
- Clusters of low- and high-screening counties were more disadvantaged -- with lower socioeconomic status and a higher proportion of non-White residents -- than other cluster types, suggesting some improvement in screening uptake in more disadvantaged areas. Counties with persistently low screening exhibited greater socioeconomic disadvantages -- lower media household income, higher poverty, lower home values, and lower educational attainment -- than those with persistently high screening.
IN PRACTICE:
"This cross-sectional study found that despite secular increases that reduced geographic variation in screening, local clusters of high and low screening persisted in the Northeast and Southwest US, respectively. Future studies could incorporate health care access characteristics to explain why areas of low screening did not catch up to optimize cancer screening practice," the authors wrote.
SOURCE:
The study, led by Pranoti Pradhan, PhD, Harvard T.H. Chan School of Public Health, Boston, was published online in JAMA Network Open.
LIMITATIONS:
The county-level estimates were modeled using BRFSS, NHIS, and US Census data, which might be susceptible to sampling biases despite corrections for nonresponse and noncoverage. Researchers lacked data on specific health systems characteristics that may have directly driven changes in prevalence and were restricted to using screening time intervals available from the Small Area Estimates for Cancer-Relates Measures from the National Cancer Institute, rather than those according to US Preventive Services Task Force guidelines. Additionally, the spatial cluster method was sensitive to county size and arrangement, which may have influenced local cluster detection.
DISCLOSURES:
This research was supported by the T32 Cancer Prevention and Control Funding Fellowship and T32 Cancer Epidemiology Fellowship at the Harvard T.H. Chan School of Public Health. The authors declared having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
An analysis of 3142 US counties revealed that county-level screening for breast, cervical, and colorectal cancer increased overall between 1997 and 2019; however, despite the reduced geographic variation, persistently high-screening clusters remained in the Northeast, whereas persistently low-screening clusters remained in the Southwest.
METHODOLOGY:
- Cancer screening reduces mortality. Despite guideline recommendation, the uptake of breast, cervical, and colorectal cancer screening in the US falls short of national goals and varies across sociodemographic groups. To date, only a few studies have examined geographic and temporal patterns of screening.
- To address this gap, researchers conducted a cross-sectional study using an ecological panel design to analyze county-level screening prevalence across 3142 US mainland counties from 1997 to 2019, deriving prevalence estimates from Behavioral Risk Factor Surveillance System (BRFSS) and National Health Interview Survey (NHIS) data over 3- to 5-year periods.
- Spatial autocorrelation analyses, including Global Moran I and the bivariate local indicator of spatial autocorrelation, were performed to assess geographic clusters of cancer screening within each period. Four types of local geographic clusters of county-level cancer screening were identified: counties with persistently high screening rates, counties with persistently low screening rates, counties in which screening rates decreased from high to low, and counties in which screening rates increased from low to high.
- Screening prevalence was compared across multiple time windows for different modalities (mammography, a Papanicolaou test, colonoscopy, colorectal cancer test, endoscopy, and a fecal occult blood test [FOBT]). Overall, 3101 counties were analyzed for mammography and the Papanicolaou test, 3107 counties for colonoscopy, 3100 counties for colorectal cancer test, 3089 counties for endoscopy, and 3090 counties for the FOBT.
TAKEAWAY:
- Overall screening prevalence increased from 1997 to 2019, and global spatial autocorrelation declined over time. For instance, the distribution of mammography screening became 83% more uniform in more recent years (Moran I, 0.57 in 1997-1999 vs 0.10 in 2017-2019). Similarly, Papanicolaou test screening became more uniform in more recent years (Moran I, 0.44 vs. 0.07). These changes indicate reduced geographic heterogeneity.
- Colonoscopy and endoscopy use increased, surpassing a 50% prevalence in many counties for 2010; however, FOBT use declined. Spatial clustering also attenuated, with a 23.4% declined in Moran I for colonoscopy from 2011-2016 to 2017-2019, a 12.3% decline in the colorectal cancer test from 2004-2007 to 2008-2010, and a 14.0% decline for endoscopy from 2004-2007 to 2008-2010.
- Persistently high-/high-screening clusters were concentrated in the Northeast for mammography and colorectal cancer screening and in the East for Papanicolaou test screening, whereas persistently low-/low-screening clusters were concentrated in the Southwest for the same modalities.
- Clusters of low- and high-screening counties were more disadvantaged -- with lower socioeconomic status and a higher proportion of non-White residents -- than other cluster types, suggesting some improvement in screening uptake in more disadvantaged areas. Counties with persistently low screening exhibited greater socioeconomic disadvantages -- lower media household income, higher poverty, lower home values, and lower educational attainment -- than those with persistently high screening.
IN PRACTICE:
"This cross-sectional study found that despite secular increases that reduced geographic variation in screening, local clusters of high and low screening persisted in the Northeast and Southwest US, respectively. Future studies could incorporate health care access characteristics to explain why areas of low screening did not catch up to optimize cancer screening practice," the authors wrote.
SOURCE:
The study, led by Pranoti Pradhan, PhD, Harvard T.H. Chan School of Public Health, Boston, was published online in JAMA Network Open.
LIMITATIONS:
The county-level estimates were modeled using BRFSS, NHIS, and US Census data, which might be susceptible to sampling biases despite corrections for nonresponse and noncoverage. Researchers lacked data on specific health systems characteristics that may have directly driven changes in prevalence and were restricted to using screening time intervals available from the Small Area Estimates for Cancer-Relates Measures from the National Cancer Institute, rather than those according to US Preventive Services Task Force guidelines. Additionally, the spatial cluster method was sensitive to county size and arrangement, which may have influenced local cluster detection.
DISCLOSURES:
This research was supported by the T32 Cancer Prevention and Control Funding Fellowship and T32 Cancer Epidemiology Fellowship at the Harvard T.H. Chan School of Public Health. The authors declared having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Geographic Clusters Show Uneven Cancer Screening in the US
Geographic Clusters Show Uneven Cancer Screening in the US
Team-Based Care is Crucial for Head-and-Neck Cancer Cases
Team-Based Care is Crucial for Head-and-Neck Cancer Cases
PHOENIX – A 70-year-old Vietnam veteran with oropharyngeal cancer presented challenges beyond his disease.
He couldn’t afford transportation for daily radiation treatments and had lost > 10% of his body weight due to pain and eating difficulties, recalled radiation oncologist Vinita Takiar, MD, PhD, in a presentation at the annual meeting of the Association of VA Hematology/Oncology.
To make matters more difficult, his wife held medical power of attorney despite his apparent competence to make decisions, said Takiar, who formerly worked with the US Department of Veterans Affairs (VA) Cincinnati Healthcare System and is now chair of radiation oncology at Penn State University.
All these factors would likely have derailed his treatment if not for a coordinated team intervention, Takiar said. Fortunately, the clinic launched a multifaceted effort involving representatives from the social work, dentistry, ethics, nutrition, and chaplaincy departments.
When surgery became impossible because the patient couldn’t lie on the operating table for adequate tumor exposure, she said, the existing team framework enabled a seamless and rapid transition to radiation with concurrent chemotherapy.
The patient completed treatment with an excellent response, offering a lesson in the importance of multidisciplinary care in head-and-neck cancers, she said.
In fact, when it comes to these forms of cancer, coordinated care “is probably more impactful than any treatment that we’re going to come up with,” she said. “The data show that when we do multidisciplinary care and we do it well, it actually improves the patient experience and outcomes.”
As Takiar noted, teamwork matters in many ways. It leads to better logistics and can address disparities, reduce financial burden and stigma, and even increase clinical trial involvement.
She pointed to studies linking teamwork to better outcomes, support for patients, and overall survival.
Takiar highlighted different parts of teams headed by radiation oncologists who act as “a node to improve multimodal care delivery.”
Speech and swallowing specialists, for example, are helpful in head-and-neck cancer because “there’s an impact on speech, swallowing, and appearance. Our patients don’t want to go out to dinner with friends because they can’t do it.”
Dentists and prosthodontists are key team members too: “I have dentists who have my cell phone number. They just call me: ‘Can I do this extraction? Was this in your radiation field? What was the dose?’”
Other team members include ear, nose, and throat specialists, palliative and supportive care specialists, medical oncologists, nurses, pathologists, transportation workers, and service connection specialists. She noted that previous military experience can affect radiation therapy. For example, the physical restraints required during treatment present particular challenges for veterans who’ve had wartime trauma. These patients may require therapy adjustments.
What’s next on the horizon? Takiar highlighted precision oncology and molecular profiling, artificial intelligence in care decisions and in radiation planning, telemedicine and virtual tumor boards, and expanded survivorship programs.
As for now, she urged colleagues to not be afraid to chat with radiation oncologists. “Please talk to us. We prioritize open communication and shared decision-making with the entire team,” she said. “If you see something and think your radiation oncologist should know about it, you think it was caused by the radiation, you should reach out to us.”
Takiar reported no disclosures.
PHOENIX – A 70-year-old Vietnam veteran with oropharyngeal cancer presented challenges beyond his disease.
He couldn’t afford transportation for daily radiation treatments and had lost > 10% of his body weight due to pain and eating difficulties, recalled radiation oncologist Vinita Takiar, MD, PhD, in a presentation at the annual meeting of the Association of VA Hematology/Oncology.
To make matters more difficult, his wife held medical power of attorney despite his apparent competence to make decisions, said Takiar, who formerly worked with the US Department of Veterans Affairs (VA) Cincinnati Healthcare System and is now chair of radiation oncology at Penn State University.
All these factors would likely have derailed his treatment if not for a coordinated team intervention, Takiar said. Fortunately, the clinic launched a multifaceted effort involving representatives from the social work, dentistry, ethics, nutrition, and chaplaincy departments.
When surgery became impossible because the patient couldn’t lie on the operating table for adequate tumor exposure, she said, the existing team framework enabled a seamless and rapid transition to radiation with concurrent chemotherapy.
The patient completed treatment with an excellent response, offering a lesson in the importance of multidisciplinary care in head-and-neck cancers, she said.
In fact, when it comes to these forms of cancer, coordinated care “is probably more impactful than any treatment that we’re going to come up with,” she said. “The data show that when we do multidisciplinary care and we do it well, it actually improves the patient experience and outcomes.”
As Takiar noted, teamwork matters in many ways. It leads to better logistics and can address disparities, reduce financial burden and stigma, and even increase clinical trial involvement.
She pointed to studies linking teamwork to better outcomes, support for patients, and overall survival.
Takiar highlighted different parts of teams headed by radiation oncologists who act as “a node to improve multimodal care delivery.”
Speech and swallowing specialists, for example, are helpful in head-and-neck cancer because “there’s an impact on speech, swallowing, and appearance. Our patients don’t want to go out to dinner with friends because they can’t do it.”
Dentists and prosthodontists are key team members too: “I have dentists who have my cell phone number. They just call me: ‘Can I do this extraction? Was this in your radiation field? What was the dose?’”
Other team members include ear, nose, and throat specialists, palliative and supportive care specialists, medical oncologists, nurses, pathologists, transportation workers, and service connection specialists. She noted that previous military experience can affect radiation therapy. For example, the physical restraints required during treatment present particular challenges for veterans who’ve had wartime trauma. These patients may require therapy adjustments.
What’s next on the horizon? Takiar highlighted precision oncology and molecular profiling, artificial intelligence in care decisions and in radiation planning, telemedicine and virtual tumor boards, and expanded survivorship programs.
As for now, she urged colleagues to not be afraid to chat with radiation oncologists. “Please talk to us. We prioritize open communication and shared decision-making with the entire team,” she said. “If you see something and think your radiation oncologist should know about it, you think it was caused by the radiation, you should reach out to us.”
Takiar reported no disclosures.
PHOENIX – A 70-year-old Vietnam veteran with oropharyngeal cancer presented challenges beyond his disease.
He couldn’t afford transportation for daily radiation treatments and had lost > 10% of his body weight due to pain and eating difficulties, recalled radiation oncologist Vinita Takiar, MD, PhD, in a presentation at the annual meeting of the Association of VA Hematology/Oncology.
To make matters more difficult, his wife held medical power of attorney despite his apparent competence to make decisions, said Takiar, who formerly worked with the US Department of Veterans Affairs (VA) Cincinnati Healthcare System and is now chair of radiation oncology at Penn State University.
All these factors would likely have derailed his treatment if not for a coordinated team intervention, Takiar said. Fortunately, the clinic launched a multifaceted effort involving representatives from the social work, dentistry, ethics, nutrition, and chaplaincy departments.
When surgery became impossible because the patient couldn’t lie on the operating table for adequate tumor exposure, she said, the existing team framework enabled a seamless and rapid transition to radiation with concurrent chemotherapy.
The patient completed treatment with an excellent response, offering a lesson in the importance of multidisciplinary care in head-and-neck cancers, she said.
In fact, when it comes to these forms of cancer, coordinated care “is probably more impactful than any treatment that we’re going to come up with,” she said. “The data show that when we do multidisciplinary care and we do it well, it actually improves the patient experience and outcomes.”
As Takiar noted, teamwork matters in many ways. It leads to better logistics and can address disparities, reduce financial burden and stigma, and even increase clinical trial involvement.
She pointed to studies linking teamwork to better outcomes, support for patients, and overall survival.
Takiar highlighted different parts of teams headed by radiation oncologists who act as “a node to improve multimodal care delivery.”
Speech and swallowing specialists, for example, are helpful in head-and-neck cancer because “there’s an impact on speech, swallowing, and appearance. Our patients don’t want to go out to dinner with friends because they can’t do it.”
Dentists and prosthodontists are key team members too: “I have dentists who have my cell phone number. They just call me: ‘Can I do this extraction? Was this in your radiation field? What was the dose?’”
Other team members include ear, nose, and throat specialists, palliative and supportive care specialists, medical oncologists, nurses, pathologists, transportation workers, and service connection specialists. She noted that previous military experience can affect radiation therapy. For example, the physical restraints required during treatment present particular challenges for veterans who’ve had wartime trauma. These patients may require therapy adjustments.
What’s next on the horizon? Takiar highlighted precision oncology and molecular profiling, artificial intelligence in care decisions and in radiation planning, telemedicine and virtual tumor boards, and expanded survivorship programs.
As for now, she urged colleagues to not be afraid to chat with radiation oncologists. “Please talk to us. We prioritize open communication and shared decision-making with the entire team,” she said. “If you see something and think your radiation oncologist should know about it, you think it was caused by the radiation, you should reach out to us.”
Takiar reported no disclosures.
Team-Based Care is Crucial for Head-and-Neck Cancer Cases
Team-Based Care is Crucial for Head-and-Neck Cancer Cases
Rising Cancer Rates Among Young People Spur New Fertility Preservation Options
Rising Cancer Rates Among Young People Spur New Fertility Preservation Options
ATLANTA —Jacqueline Lee, MD, a reproductive endocrinologist at Emory School of Medicine, frequently treats patients with cancer. Recently, she treated 4 women in their 30s with histories of colon cancer, acute lymphoblastic leukemia, lymphoma, and breast cancer. A young man in his 20s sought her care, to discuss his case of lymphoma.
All these patients sought guidance from Lee because they want to protect their ability to have children. At the annual meeting of the Association of VA Hematology/Oncology, Lee explained that plenty of patients are finding themselves in similar straits due in part to recent trends.
Cancer rates in the US have been rising among people aged 15 to 39 years, who now account for 4.2% of all cancer cases. An estimated 84,100 people in this age group are expected to be diagnosed with cancer this year. Meanwhile, women are having children later in life-birth rates are up among those aged 25 to 49 years-making it more likely that they have histories of cancer.
Although it's difficult to predict how cancer will affect fertility, Lee emphasized that many chemotherapy medications, including cisplatin and carboplatin, are cytotoxic. "It's hard to always predict what someone's arc of care is going to be," she said, "so I really have a low threshold for recommending fertility preservation in patients who have a strong desire to have future childbearing."
For women with cancer, egg preservation isn't the only strategy. Clinicians can also try to protect ovarian tissue from pelvic radiation through surgical reposition of the ovaries, Lee noted. In addition goserelin, a hormone-suppressing therapy, may protect the ovaries from chemotherapy, though its effectiveness in boosting pregnancy rates is still unclear.
"When I mentioned this option, it's usually for patients who can't preserve fertility via egg or embryo preservation, or we don't have the luxury of that kind of time," Lee said. "I say that if helps at all, it might help you resume menses after treatment. But infertility is still very common."
For some patients, freezing eggs is an easy decision. "They don't have a reproductive partner they're ready to make embryos with, so we proceed with egg preservation. It's no longer considered experimental and comes with lower upfront costs since the costs of actually making embryos are deferred until the future."
In addition, she said, freezing eggs also avoids the touchy topic of disposing of embryos. Lee cautions patients that retrieving eggs is a 2-week process that requires any initiation of cancer care to be delayed. However, the retrieval process can be adjusted in patients with special needs due to the type of cancer they have.
For prepubertal girls with cancer, ovarian tissue can be removed and frozen as a fertility preservation option. However, this is not considered standard of care. "We don't do it," she said. "We refer out if needed. Hopefully we'll develop a program in the future."
As for the 5 patients that Lee mentioned, with details changed to protect their privacy, their outcomes were as follows:
- The woman with colon cancer, who had undergone a hemicolectomy, chose to defer fertility preservation.
- The woman with acute lymphoblastic leukemia, who was taking depo-Lupron, had undetectable anti-Müllerian hormone (AMH) levels. Lee discussed the possibility of IVF with a donor egg.
- The woman with breast cancer, who was newly diagnosed, deferred fertility preservation.
- The man with lymphoma (Hodgkin's), who was awaiting chemotherapy, had his sperm frozen.
- The woman with lymphoma (new diagnosis) had 27 eggs frozen.
Lee had no disclosures to report.
ATLANTA —Jacqueline Lee, MD, a reproductive endocrinologist at Emory School of Medicine, frequently treats patients with cancer. Recently, she treated 4 women in their 30s with histories of colon cancer, acute lymphoblastic leukemia, lymphoma, and breast cancer. A young man in his 20s sought her care, to discuss his case of lymphoma.
All these patients sought guidance from Lee because they want to protect their ability to have children. At the annual meeting of the Association of VA Hematology/Oncology, Lee explained that plenty of patients are finding themselves in similar straits due in part to recent trends.
Cancer rates in the US have been rising among people aged 15 to 39 years, who now account for 4.2% of all cancer cases. An estimated 84,100 people in this age group are expected to be diagnosed with cancer this year. Meanwhile, women are having children later in life-birth rates are up among those aged 25 to 49 years-making it more likely that they have histories of cancer.
Although it's difficult to predict how cancer will affect fertility, Lee emphasized that many chemotherapy medications, including cisplatin and carboplatin, are cytotoxic. "It's hard to always predict what someone's arc of care is going to be," she said, "so I really have a low threshold for recommending fertility preservation in patients who have a strong desire to have future childbearing."
For women with cancer, egg preservation isn't the only strategy. Clinicians can also try to protect ovarian tissue from pelvic radiation through surgical reposition of the ovaries, Lee noted. In addition goserelin, a hormone-suppressing therapy, may protect the ovaries from chemotherapy, though its effectiveness in boosting pregnancy rates is still unclear.
"When I mentioned this option, it's usually for patients who can't preserve fertility via egg or embryo preservation, or we don't have the luxury of that kind of time," Lee said. "I say that if helps at all, it might help you resume menses after treatment. But infertility is still very common."
For some patients, freezing eggs is an easy decision. "They don't have a reproductive partner they're ready to make embryos with, so we proceed with egg preservation. It's no longer considered experimental and comes with lower upfront costs since the costs of actually making embryos are deferred until the future."
In addition, she said, freezing eggs also avoids the touchy topic of disposing of embryos. Lee cautions patients that retrieving eggs is a 2-week process that requires any initiation of cancer care to be delayed. However, the retrieval process can be adjusted in patients with special needs due to the type of cancer they have.
For prepubertal girls with cancer, ovarian tissue can be removed and frozen as a fertility preservation option. However, this is not considered standard of care. "We don't do it," she said. "We refer out if needed. Hopefully we'll develop a program in the future."
As for the 5 patients that Lee mentioned, with details changed to protect their privacy, their outcomes were as follows:
- The woman with colon cancer, who had undergone a hemicolectomy, chose to defer fertility preservation.
- The woman with acute lymphoblastic leukemia, who was taking depo-Lupron, had undetectable anti-Müllerian hormone (AMH) levels. Lee discussed the possibility of IVF with a donor egg.
- The woman with breast cancer, who was newly diagnosed, deferred fertility preservation.
- The man with lymphoma (Hodgkin's), who was awaiting chemotherapy, had his sperm frozen.
- The woman with lymphoma (new diagnosis) had 27 eggs frozen.
Lee had no disclosures to report.
ATLANTA —Jacqueline Lee, MD, a reproductive endocrinologist at Emory School of Medicine, frequently treats patients with cancer. Recently, she treated 4 women in their 30s with histories of colon cancer, acute lymphoblastic leukemia, lymphoma, and breast cancer. A young man in his 20s sought her care, to discuss his case of lymphoma.
All these patients sought guidance from Lee because they want to protect their ability to have children. At the annual meeting of the Association of VA Hematology/Oncology, Lee explained that plenty of patients are finding themselves in similar straits due in part to recent trends.
Cancer rates in the US have been rising among people aged 15 to 39 years, who now account for 4.2% of all cancer cases. An estimated 84,100 people in this age group are expected to be diagnosed with cancer this year. Meanwhile, women are having children later in life-birth rates are up among those aged 25 to 49 years-making it more likely that they have histories of cancer.
Although it's difficult to predict how cancer will affect fertility, Lee emphasized that many chemotherapy medications, including cisplatin and carboplatin, are cytotoxic. "It's hard to always predict what someone's arc of care is going to be," she said, "so I really have a low threshold for recommending fertility preservation in patients who have a strong desire to have future childbearing."
For women with cancer, egg preservation isn't the only strategy. Clinicians can also try to protect ovarian tissue from pelvic radiation through surgical reposition of the ovaries, Lee noted. In addition goserelin, a hormone-suppressing therapy, may protect the ovaries from chemotherapy, though its effectiveness in boosting pregnancy rates is still unclear.
"When I mentioned this option, it's usually for patients who can't preserve fertility via egg or embryo preservation, or we don't have the luxury of that kind of time," Lee said. "I say that if helps at all, it might help you resume menses after treatment. But infertility is still very common."
For some patients, freezing eggs is an easy decision. "They don't have a reproductive partner they're ready to make embryos with, so we proceed with egg preservation. It's no longer considered experimental and comes with lower upfront costs since the costs of actually making embryos are deferred until the future."
In addition, she said, freezing eggs also avoids the touchy topic of disposing of embryos. Lee cautions patients that retrieving eggs is a 2-week process that requires any initiation of cancer care to be delayed. However, the retrieval process can be adjusted in patients with special needs due to the type of cancer they have.
For prepubertal girls with cancer, ovarian tissue can be removed and frozen as a fertility preservation option. However, this is not considered standard of care. "We don't do it," she said. "We refer out if needed. Hopefully we'll develop a program in the future."
As for the 5 patients that Lee mentioned, with details changed to protect their privacy, their outcomes were as follows:
- The woman with colon cancer, who had undergone a hemicolectomy, chose to defer fertility preservation.
- The woman with acute lymphoblastic leukemia, who was taking depo-Lupron, had undetectable anti-Müllerian hormone (AMH) levels. Lee discussed the possibility of IVF with a donor egg.
- The woman with breast cancer, who was newly diagnosed, deferred fertility preservation.
- The man with lymphoma (Hodgkin's), who was awaiting chemotherapy, had his sperm frozen.
- The woman with lymphoma (new diagnosis) had 27 eggs frozen.
Lee had no disclosures to report.
Rising Cancer Rates Among Young People Spur New Fertility Preservation Options
Rising Cancer Rates Among Young People Spur New Fertility Preservation Options
VA Cancer Clinical Trials as a Strategy for Increasing Accrual of Racial and Ethnic Underrepresented Groups
Background
Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.
Methods
We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.
Results
Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.
Conclusions
The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.
Background
Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.
Methods
We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.
Results
Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.
Conclusions
The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.
Background
Cancer clinical trials (CCTs) are central to improving cancer care. However, generalizability of findings from CCTs is difficult due to the lack of diversity in most United States CCTs. Clinical trial accrual of underrepresented groups, is low throughout the United States and is approximately 4-5% in most CCTs. Reasons for low accrual in this population are multifactorial. Despite numerous factors related to accruing racial and ethnic underrepresented groups, many institutions have sought to address these barriers. We conducted a scoping review to identify evidence-based approaches to increase participation in cancer treatment clinical trials.
Methods
We reviewed the Salisbury VA Medical Center Oncology clinical trial database from October 2019 to June 2024. The participants in these clinical trials required consent. These clinical trials included treatment interventional as well as non-treatment interventional. Fifteen studies were included and over 260 Veterans participated.
Results
Key themes emerged that included a focus on patient education, cultural competency, and building capacity in the clinics to care for the Veteran population at three separate sites in the Salisbury VA system. The Black Veteran accrual rate of 29% was achieved. This accrual rate is representative of our VA catchment population of 33% for Black Veterans, and is five times the national average.
Conclusions
The research team’s success in enrolling Black Veterans in clinical trials is attributed to several factors. The demographic composition of Veterans served by the Salisbury, Charlotte, and Kernersville VA provided a diverse population that included a 33% Black group. The type of clinical trials focused on patients who were most impacted by the disease. The VA did afford less barriers to access to health care.
US Cancer Institute Studying Ivermectin's 'Ability to Kill Cancer Cells'
US Cancer Institute Studying Ivermectin's 'Ability to Kill Cancer Cells'
The National Cancer Institute (NCI), the federal research agency charged with leading the war against the nation’s second-largest killer, is studying ivermectin as a potential cancer treatment, according to its top official.
“There are enough reports of it, enough interest in it, that we actually did — ivermectin, in particular — did engage in sort of a better preclinical study of its properties and its ability to kill cancer cells,” said Anthony Letai, a physician the Trump administration appointed as NCI director in September.
Letai did not cite new evidence that might have prompted the institute to research the effectiveness of the antiparasitic drug against cancer. The drug, largely used to treat people or animals for infections caused by parasites, is a popular dewormer for horses.
“We’ll probably have those results in a few months,” Letai said. “So we are taking it seriously.”
He spoke about ivermectin at a January 30 event, “Reclaiming Science: The People’s NIH,” with National Institutes of Health (NIH) Director Jay Bhattacharya and other senior agency officials at Washington, DC’s Willard Hotel. The MAHA Institute hosted the discussion, framed by the “Make America Healthy Again” agenda of Health and Human Services (HSS) Secretary Robert F. Kennedy Jr. The National Cancer Institute is the largest of the NIH’s 27 branches.
During the COVID pandemic, ivermectin’s popularity surged as fringe medical groups promoted it as an effective treatment. Clinical trials have found it isn’t effective against COVID.
Ivermectin has become a symbol of resistance against the medical establishment among MAHA adherents and conservatives. Like-minded commentators and wellness and other online influencers have hyped — without evidence — ivermectin as a miracle cure for a host of diseases, including cancer. Trump officials have pointed to research on ivermectin as an example of the administration’s receptiveness to ideas the scientific establishment has rejected.
“If lots of people believe it and it’s moving public health, we as NIH have an obligation, again, to treat it seriously,” Bhattacharya said at the event. According to The Chronicle at Duke University, Bhattacharya recently said he wants the NIH to be “the research arm of MAHA.”
The decision by the world’s premier cancer research institute to study ivermectin as a cancer treatment has alarmed career scientists at the agency.
“I am shocked and appalled,” one NCI scientist said. “We are moving funds away from so much promising research in order to do a preclinical study based on nonscientific ideas. It’s absurd.”
KFF Health News granted the scientist and other NCI workers anonymity because they are not authorized to speak to the press and fear retaliation.
HHS and the National Cancer Institute did not answer KFF Health News’ questions on the amount of money the cancer institute is spending on the study, who is carrying it out, and whether there was new evidence that prompted NCI to look into ivermectin as an anticancer therapy. Emily Hilliard, an HHS spokesperson, said NIH is dedicated to “rigorous, gold-standard research,” something the administration has repeatedly professed.
A preclinical study is an early phase of research conducted in a lab to test whether a drug or treatment may be useful and to assess potential harms. These studies take place before human clinical trials.
The scientist questioned whether there is enough initial evidence to warrant NCI’s spending of taxpayer funds to investigate the drug’s potential as a cancer treatment.
The FDA has approved ivermectin for certain uses in humans and animals. Tablets are used to treat conditions caused by parasitic worms, and the FDA has approved ivermectin lotions to treat lice and rosacea. Two scientists involved in its discovery won the Nobel Prize in 2015, tied to the drug’s success in treating certain parasitic diseases.
The FDA has warned that large doses of ivermectin can be dangerous. Overdoses can cause seizures, comas, or death.
Kennedy, supporters of the MAHA movement, and some conservative commentators have promoted the idea that the government and pharmaceutical companies quashed ivermectin and other inexpensive, off-patent drugs because they’re not profitable for the drug industry.
“FDA’s war on public health is about to end,” Kennedy wrote in an October 2024 X post that has since gone viral. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma.”
Previous laboratory research has shown that ivermectin could have anticancer effects because it promotes cell death and inhibits the growth of tumor cells. “It actually has been studied both with NIH funds and outside of NIH funds,” Letai said.
However, there is no evidence that ivermectin is safe and effective in treating cancer in humans. Preliminary data from a small clinical trial that gave ivermectin to patients with one type of metastatic breast cancer, in combination with immunotherapy, found no significant benefit from the addition of ivermectin.
Some physicians are concerned that patients will delay or forgo effective cancer treatments, or be harmed in other ways, if they believe unfounded claims that ivermectin can treat their disease.
“Many, many, many things work in a test tube. Quite a few things work in a mouse or a monkey. It still doesn’t mean it’s going to work in people,” said Jeffery Edenfield, executive medical director of oncology for the South Carolina-based Prisma Health Cancer Institute.
Edenfield said cancer patients ask him about ivermectin “regularly,” mostly because of what they see on social media. He said he persuaded a patient to stop using it, and a colleague recently had a patient who decided “to forgo highly effective standard therapy in favor of ivermectin.”
“People come to the discussion having largely already made up their mind,” Edenfield said. “We’re in this delicate time when there’s sort of a fundamental mistrust of medicine,” he added. “Some people are just not going to believe me. I just have to keep trying.”
A June letter by clinicians at Cincinnati Children’s Hospital Medical Center in Ohio detailed how an adolescent patient with metastatic bone cancer started taking ivermectin “after encountering social media posts touting its benefits.” The patient — who hadn’t been given a prescription by a clinician — experienced ivermectin-related neurotoxicity and had to seek emergency care because of nausea, fatigue, and other symptoms.
“We urge the pediatric oncology community to advocate for sensible health policy that prioritizes the well-being of our patients,” the clinicians wrote. The lack of evidence about ivermectin and cancer hasn’t stopped celebrities and online influencers from promoting the notion that the drug is a cure-all. On a January 2025 episode of Joe Rogan’s podcast, actor Mel Gibson claimed that a combination of drugs that included ivermectin cured 3friends with stage IV cancer. The episode has been viewed > 12 million times.
Lawmakers in a handful of states have made the drug available over the counter. And Florida — which, under Republican Governor Ron DeSantis, has become a hotbed for anti-vaccine policies and the spread of public health misinformation — announced last fall that the state plans to fund research to study the drug as a potential cancer treatment.
The Florida Department of Health did not respond to questions about that effort.
Letai, previously a Dana-Farber Cancer Institute oncologist, started at the National Cancer Institute after months of upheaval caused by Trump administration policies.
“What you’re hearing at the NIH now is an openness to ideas — even ideas that scientists would say, ‘Oh, there’s no way it could work’ — but nevertheless applying rigorous scientific methods to those ideas,” Bhattacharya said at the January 30 event.
A second NCI scientist, who was granted anonymity due to fear of retaliation, said the notion that NIH was not open to investigating the value of off-label drugs in cancer is “ridiculous.”
“This is not a new idea they came up with,” the scientist said.
Letai didn’t elaborate on whether NCI scientists are conducting the research or if it has directed funding to an outside institution. Three-fourths of the cancer institute’s research dollars go to outside scientists.
He also aimed to temper expectations.
“At least on a population level,” Letai said, “it’s not going to be a cure-all for cancer.”
The National Cancer Institute (NCI), the federal research agency charged with leading the war against the nation’s second-largest killer, is studying ivermectin as a potential cancer treatment, according to its top official.
“There are enough reports of it, enough interest in it, that we actually did — ivermectin, in particular — did engage in sort of a better preclinical study of its properties and its ability to kill cancer cells,” said Anthony Letai, a physician the Trump administration appointed as NCI director in September.
Letai did not cite new evidence that might have prompted the institute to research the effectiveness of the antiparasitic drug against cancer. The drug, largely used to treat people or animals for infections caused by parasites, is a popular dewormer for horses.
“We’ll probably have those results in a few months,” Letai said. “So we are taking it seriously.”
He spoke about ivermectin at a January 30 event, “Reclaiming Science: The People’s NIH,” with National Institutes of Health (NIH) Director Jay Bhattacharya and other senior agency officials at Washington, DC’s Willard Hotel. The MAHA Institute hosted the discussion, framed by the “Make America Healthy Again” agenda of Health and Human Services (HSS) Secretary Robert F. Kennedy Jr. The National Cancer Institute is the largest of the NIH’s 27 branches.
During the COVID pandemic, ivermectin’s popularity surged as fringe medical groups promoted it as an effective treatment. Clinical trials have found it isn’t effective against COVID.
Ivermectin has become a symbol of resistance against the medical establishment among MAHA adherents and conservatives. Like-minded commentators and wellness and other online influencers have hyped — without evidence — ivermectin as a miracle cure for a host of diseases, including cancer. Trump officials have pointed to research on ivermectin as an example of the administration’s receptiveness to ideas the scientific establishment has rejected.
“If lots of people believe it and it’s moving public health, we as NIH have an obligation, again, to treat it seriously,” Bhattacharya said at the event. According to The Chronicle at Duke University, Bhattacharya recently said he wants the NIH to be “the research arm of MAHA.”
The decision by the world’s premier cancer research institute to study ivermectin as a cancer treatment has alarmed career scientists at the agency.
“I am shocked and appalled,” one NCI scientist said. “We are moving funds away from so much promising research in order to do a preclinical study based on nonscientific ideas. It’s absurd.”
KFF Health News granted the scientist and other NCI workers anonymity because they are not authorized to speak to the press and fear retaliation.
HHS and the National Cancer Institute did not answer KFF Health News’ questions on the amount of money the cancer institute is spending on the study, who is carrying it out, and whether there was new evidence that prompted NCI to look into ivermectin as an anticancer therapy. Emily Hilliard, an HHS spokesperson, said NIH is dedicated to “rigorous, gold-standard research,” something the administration has repeatedly professed.
A preclinical study is an early phase of research conducted in a lab to test whether a drug or treatment may be useful and to assess potential harms. These studies take place before human clinical trials.
The scientist questioned whether there is enough initial evidence to warrant NCI’s spending of taxpayer funds to investigate the drug’s potential as a cancer treatment.
The FDA has approved ivermectin for certain uses in humans and animals. Tablets are used to treat conditions caused by parasitic worms, and the FDA has approved ivermectin lotions to treat lice and rosacea. Two scientists involved in its discovery won the Nobel Prize in 2015, tied to the drug’s success in treating certain parasitic diseases.
The FDA has warned that large doses of ivermectin can be dangerous. Overdoses can cause seizures, comas, or death.
Kennedy, supporters of the MAHA movement, and some conservative commentators have promoted the idea that the government and pharmaceutical companies quashed ivermectin and other inexpensive, off-patent drugs because they’re not profitable for the drug industry.
“FDA’s war on public health is about to end,” Kennedy wrote in an October 2024 X post that has since gone viral. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma.”
Previous laboratory research has shown that ivermectin could have anticancer effects because it promotes cell death and inhibits the growth of tumor cells. “It actually has been studied both with NIH funds and outside of NIH funds,” Letai said.
However, there is no evidence that ivermectin is safe and effective in treating cancer in humans. Preliminary data from a small clinical trial that gave ivermectin to patients with one type of metastatic breast cancer, in combination with immunotherapy, found no significant benefit from the addition of ivermectin.
Some physicians are concerned that patients will delay or forgo effective cancer treatments, or be harmed in other ways, if they believe unfounded claims that ivermectin can treat their disease.
“Many, many, many things work in a test tube. Quite a few things work in a mouse or a monkey. It still doesn’t mean it’s going to work in people,” said Jeffery Edenfield, executive medical director of oncology for the South Carolina-based Prisma Health Cancer Institute.
Edenfield said cancer patients ask him about ivermectin “regularly,” mostly because of what they see on social media. He said he persuaded a patient to stop using it, and a colleague recently had a patient who decided “to forgo highly effective standard therapy in favor of ivermectin.”
“People come to the discussion having largely already made up their mind,” Edenfield said. “We’re in this delicate time when there’s sort of a fundamental mistrust of medicine,” he added. “Some people are just not going to believe me. I just have to keep trying.”
A June letter by clinicians at Cincinnati Children’s Hospital Medical Center in Ohio detailed how an adolescent patient with metastatic bone cancer started taking ivermectin “after encountering social media posts touting its benefits.” The patient — who hadn’t been given a prescription by a clinician — experienced ivermectin-related neurotoxicity and had to seek emergency care because of nausea, fatigue, and other symptoms.
“We urge the pediatric oncology community to advocate for sensible health policy that prioritizes the well-being of our patients,” the clinicians wrote. The lack of evidence about ivermectin and cancer hasn’t stopped celebrities and online influencers from promoting the notion that the drug is a cure-all. On a January 2025 episode of Joe Rogan’s podcast, actor Mel Gibson claimed that a combination of drugs that included ivermectin cured 3friends with stage IV cancer. The episode has been viewed > 12 million times.
Lawmakers in a handful of states have made the drug available over the counter. And Florida — which, under Republican Governor Ron DeSantis, has become a hotbed for anti-vaccine policies and the spread of public health misinformation — announced last fall that the state plans to fund research to study the drug as a potential cancer treatment.
The Florida Department of Health did not respond to questions about that effort.
Letai, previously a Dana-Farber Cancer Institute oncologist, started at the National Cancer Institute after months of upheaval caused by Trump administration policies.
“What you’re hearing at the NIH now is an openness to ideas — even ideas that scientists would say, ‘Oh, there’s no way it could work’ — but nevertheless applying rigorous scientific methods to those ideas,” Bhattacharya said at the January 30 event.
A second NCI scientist, who was granted anonymity due to fear of retaliation, said the notion that NIH was not open to investigating the value of off-label drugs in cancer is “ridiculous.”
“This is not a new idea they came up with,” the scientist said.
Letai didn’t elaborate on whether NCI scientists are conducting the research or if it has directed funding to an outside institution. Three-fourths of the cancer institute’s research dollars go to outside scientists.
He also aimed to temper expectations.
“At least on a population level,” Letai said, “it’s not going to be a cure-all for cancer.”
The National Cancer Institute (NCI), the federal research agency charged with leading the war against the nation’s second-largest killer, is studying ivermectin as a potential cancer treatment, according to its top official.
“There are enough reports of it, enough interest in it, that we actually did — ivermectin, in particular — did engage in sort of a better preclinical study of its properties and its ability to kill cancer cells,” said Anthony Letai, a physician the Trump administration appointed as NCI director in September.
Letai did not cite new evidence that might have prompted the institute to research the effectiveness of the antiparasitic drug against cancer. The drug, largely used to treat people or animals for infections caused by parasites, is a popular dewormer for horses.
“We’ll probably have those results in a few months,” Letai said. “So we are taking it seriously.”
He spoke about ivermectin at a January 30 event, “Reclaiming Science: The People’s NIH,” with National Institutes of Health (NIH) Director Jay Bhattacharya and other senior agency officials at Washington, DC’s Willard Hotel. The MAHA Institute hosted the discussion, framed by the “Make America Healthy Again” agenda of Health and Human Services (HSS) Secretary Robert F. Kennedy Jr. The National Cancer Institute is the largest of the NIH’s 27 branches.
During the COVID pandemic, ivermectin’s popularity surged as fringe medical groups promoted it as an effective treatment. Clinical trials have found it isn’t effective against COVID.
Ivermectin has become a symbol of resistance against the medical establishment among MAHA adherents and conservatives. Like-minded commentators and wellness and other online influencers have hyped — without evidence — ivermectin as a miracle cure for a host of diseases, including cancer. Trump officials have pointed to research on ivermectin as an example of the administration’s receptiveness to ideas the scientific establishment has rejected.
“If lots of people believe it and it’s moving public health, we as NIH have an obligation, again, to treat it seriously,” Bhattacharya said at the event. According to The Chronicle at Duke University, Bhattacharya recently said he wants the NIH to be “the research arm of MAHA.”
The decision by the world’s premier cancer research institute to study ivermectin as a cancer treatment has alarmed career scientists at the agency.
“I am shocked and appalled,” one NCI scientist said. “We are moving funds away from so much promising research in order to do a preclinical study based on nonscientific ideas. It’s absurd.”
KFF Health News granted the scientist and other NCI workers anonymity because they are not authorized to speak to the press and fear retaliation.
HHS and the National Cancer Institute did not answer KFF Health News’ questions on the amount of money the cancer institute is spending on the study, who is carrying it out, and whether there was new evidence that prompted NCI to look into ivermectin as an anticancer therapy. Emily Hilliard, an HHS spokesperson, said NIH is dedicated to “rigorous, gold-standard research,” something the administration has repeatedly professed.
A preclinical study is an early phase of research conducted in a lab to test whether a drug or treatment may be useful and to assess potential harms. These studies take place before human clinical trials.
The scientist questioned whether there is enough initial evidence to warrant NCI’s spending of taxpayer funds to investigate the drug’s potential as a cancer treatment.
The FDA has approved ivermectin for certain uses in humans and animals. Tablets are used to treat conditions caused by parasitic worms, and the FDA has approved ivermectin lotions to treat lice and rosacea. Two scientists involved in its discovery won the Nobel Prize in 2015, tied to the drug’s success in treating certain parasitic diseases.
The FDA has warned that large doses of ivermectin can be dangerous. Overdoses can cause seizures, comas, or death.
Kennedy, supporters of the MAHA movement, and some conservative commentators have promoted the idea that the government and pharmaceutical companies quashed ivermectin and other inexpensive, off-patent drugs because they’re not profitable for the drug industry.
“FDA’s war on public health is about to end,” Kennedy wrote in an October 2024 X post that has since gone viral. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma.”
Previous laboratory research has shown that ivermectin could have anticancer effects because it promotes cell death and inhibits the growth of tumor cells. “It actually has been studied both with NIH funds and outside of NIH funds,” Letai said.
However, there is no evidence that ivermectin is safe and effective in treating cancer in humans. Preliminary data from a small clinical trial that gave ivermectin to patients with one type of metastatic breast cancer, in combination with immunotherapy, found no significant benefit from the addition of ivermectin.
Some physicians are concerned that patients will delay or forgo effective cancer treatments, or be harmed in other ways, if they believe unfounded claims that ivermectin can treat their disease.
“Many, many, many things work in a test tube. Quite a few things work in a mouse or a monkey. It still doesn’t mean it’s going to work in people,” said Jeffery Edenfield, executive medical director of oncology for the South Carolina-based Prisma Health Cancer Institute.
Edenfield said cancer patients ask him about ivermectin “regularly,” mostly because of what they see on social media. He said he persuaded a patient to stop using it, and a colleague recently had a patient who decided “to forgo highly effective standard therapy in favor of ivermectin.”
“People come to the discussion having largely already made up their mind,” Edenfield said. “We’re in this delicate time when there’s sort of a fundamental mistrust of medicine,” he added. “Some people are just not going to believe me. I just have to keep trying.”
A June letter by clinicians at Cincinnati Children’s Hospital Medical Center in Ohio detailed how an adolescent patient with metastatic bone cancer started taking ivermectin “after encountering social media posts touting its benefits.” The patient — who hadn’t been given a prescription by a clinician — experienced ivermectin-related neurotoxicity and had to seek emergency care because of nausea, fatigue, and other symptoms.
“We urge the pediatric oncology community to advocate for sensible health policy that prioritizes the well-being of our patients,” the clinicians wrote. The lack of evidence about ivermectin and cancer hasn’t stopped celebrities and online influencers from promoting the notion that the drug is a cure-all. On a January 2025 episode of Joe Rogan’s podcast, actor Mel Gibson claimed that a combination of drugs that included ivermectin cured 3friends with stage IV cancer. The episode has been viewed > 12 million times.
Lawmakers in a handful of states have made the drug available over the counter. And Florida — which, under Republican Governor Ron DeSantis, has become a hotbed for anti-vaccine policies and the spread of public health misinformation — announced last fall that the state plans to fund research to study the drug as a potential cancer treatment.
The Florida Department of Health did not respond to questions about that effort.
Letai, previously a Dana-Farber Cancer Institute oncologist, started at the National Cancer Institute after months of upheaval caused by Trump administration policies.
“What you’re hearing at the NIH now is an openness to ideas — even ideas that scientists would say, ‘Oh, there’s no way it could work’ — but nevertheless applying rigorous scientific methods to those ideas,” Bhattacharya said at the January 30 event.
A second NCI scientist, who was granted anonymity due to fear of retaliation, said the notion that NIH was not open to investigating the value of off-label drugs in cancer is “ridiculous.”
“This is not a new idea they came up with,” the scientist said.
Letai didn’t elaborate on whether NCI scientists are conducting the research or if it has directed funding to an outside institution. Three-fourths of the cancer institute’s research dollars go to outside scientists.
He also aimed to temper expectations.
“At least on a population level,” Letai said, “it’s not going to be a cure-all for cancer.”
US Cancer Institute Studying Ivermectin's 'Ability to Kill Cancer Cells'
US Cancer Institute Studying Ivermectin's 'Ability to Kill Cancer Cells'
Q&A: Why Are More Americans Under 50 Years of Age Dying of Colorectal Cancer?
Why Are More Americans Under Age 50 Dying of CRC?
First, the good news: Fewer Americans aged < 50 years are dying from cancer vs just a decade ago — reflecting progress in prevention, early detection, and treatment. There is, however, one big exception. Colorectal cancer mortality has been steadily inching up, and the disease now stands as the leading cause of cancer death in this age group, up from the fifth-leading in the early 1990s.
Those are the major findings of a recent study by the American Cancer Society (ACS), published as a research letter in JAMA.
Using SEER data, researchers found that the overall age-adjusted cancer death rate among Americans aged < 50 years dropped by 44% between 1990 and 2023 — from 25.5 to 14.2 per 100,000. And for 4 of the 5 leading causes of cancer death, there were mean annual declines from 2014 to 2023. The biggest change was in lung cancer deaths, which fell by an average of 5.7% per year. Meanwhile, leukemia and breast cancer deaths showed annual declines of 2.3% and 1.4%, respectively, despite rising incidences of both diseases among younger Americans.
The outlier is colorectal cancer, where mortality has been rising by about 1% per year since 2005. And it’s a pattern seen in both men and women.
Study coauthor Nikita Sandeep Wagle, PhD, MBBS, principal scientist, Cancer Surveillance Research at the ACS, and Arif Kamal, MD, ACS chief patient officer, discussed the research and its implications with Medscape Medical News.
Can you offer some possible reasons for the declining mortality in most of the cancers you studied?
Wagle: Mortality is going down for most of the cancers because we are getting better at finding cancers earlier and treating them more effectively. We have also seen improvements in screening, imaging, and therapy, and that means more people are being diagnosed at earlier stages and are surviving longer after diagnosis.
Regarding the rise in colorectal cancer mortality, do you think it's due to the rising incidence of early-onset colorectal cancer?
Kamal: Partially, but not completely, because the relationship between incidence and mortality is not always straightforward. For example, breast cancer incidence has been increasing, while mortality is going down. The rising mortality in people younger than 50 years is likely suggestive of more aggressive cancers being diagnosed — potentially secondary to environmental, dietary, or lifestyle factors. The colon is a unique organ because everything we put in our bodies passes through the colon, so food-based risk factors — for example, low fiber intake, red meat, and ultra-processed foods — are increasingly rising to the top as culprits.
Further, we know that only about 25% of people between the ages of 45 and 50 years are up to date with recommended colon cancer screenings, which can lead to later-stage diagnoses and thus higher mortality. So higher mortality speaks to the need to focus on lifestyle and diet changes and get more younger people to complete recommended cancer screenings.
Wagle: I think the “why” of your question is very important. Many researchers are trying to understand possible causes, such as diet, lifestyle, environmental factors, and genetics. But we cannot pinpoint one single cause. We need even more focus on research toward understanding the etiology of early-onset colorectal cancer.
What makes colorectal cancer different is that, unlike some other major cancers in this age group where mortality has declined despite rising incidence, roughly 3 in 4 colorectal cancers diagnosed in people younger than 50 years are [regional or distant], where the outcomes are worse.
Can you contextualize the rise in colorectal cancer mortality? What is the absolute rate among younger Americans now?
Wagle: It is around two deaths per 100,000 population in 2023 for people younger than 50 years. That number may not seem large, but the upward trend — a 1.1% annual increase from 2014 to 2023 — is concerning when you think about how overall mortality in this age group has dropped substantially over the past few decades. Colorectal cancer is moving in the opposite direction. I think the hopeful part is that it is also one of the most preventable cancers. Screening can stop cancer before it starts by removing precancerous polyps. Early-stage disease is highly treatable, and outcomes are better. That means better awareness and timely screening could make a real difference.
How can clinicians use this new information with regard to screening?
Wagle: For cancers with established screening guidelines, such as colorectal cancer, clinicians should continue to emphasize guideline-based screening and individualized risk assessment.
For colorectal cancer, screening now is recommended to start at age 45 for individuals at average risk, and earlier for [some], due to family history or other risk factors. Clinicians can use these findings to remind younger individuals that colorectal cancer is not only a disease of older adults and that screening at the recommended age can save lives.
In addition, red-flag symptoms such as persistent rectal bleeding, unexplained abdominal pain, difficulty in bowel movements, or signs of anemia should prompt appropriate evaluation in younger individuals.
Kamal: Clinicians should continue to emphasize timely completion of regular screening, starting at age 45 [for average-risk people]. Many still believe that the recommended starting age is 50 or that colonoscopy is the only way to get screened. Highlighting home-based screening options often helps patients make cancer screening logistically fit better into their busy lives.
Could you elaborate on the red-flag symptoms you mentioned, and what is an appropriate evaluation in younger individuals?
Kamal: Appropriate evaluation for any suspected bleeding — bright red or black and tarry — starts with an in-office evaluation by a primary care physician. Referral to a specialist, such as a gastroenterologist or surgeon, is done later, typically for direct visualization, such as with a colonoscopy. Rarely, imaging such as CT scans or ultrasounds is performed. Overall, because of the rising incidence of colon cancer in younger people, any concerning symptoms should be reported to a physician for an in-office evaluation as the first step.
Do these findings suggest that the starting age for average-risk people should be lowered—to age 40, for example?
Kamal: ACS screening guidelines for all cancers are part of an ongoing guideline development process by ACS scientists and volunteers. We monitor medical and scientific literature for new evidence that may support a change in current guidelines or the development of new guidelines and for information about cancer screening that should be conveyed to clinicians and target populations.
Keith Mulvihill is a freelance writer based in New York City.
A version of this article first appeared on Medscape.com.
First, the good news: Fewer Americans aged < 50 years are dying from cancer vs just a decade ago — reflecting progress in prevention, early detection, and treatment. There is, however, one big exception. Colorectal cancer mortality has been steadily inching up, and the disease now stands as the leading cause of cancer death in this age group, up from the fifth-leading in the early 1990s.
Those are the major findings of a recent study by the American Cancer Society (ACS), published as a research letter in JAMA.
Using SEER data, researchers found that the overall age-adjusted cancer death rate among Americans aged < 50 years dropped by 44% between 1990 and 2023 — from 25.5 to 14.2 per 100,000. And for 4 of the 5 leading causes of cancer death, there were mean annual declines from 2014 to 2023. The biggest change was in lung cancer deaths, which fell by an average of 5.7% per year. Meanwhile, leukemia and breast cancer deaths showed annual declines of 2.3% and 1.4%, respectively, despite rising incidences of both diseases among younger Americans.
The outlier is colorectal cancer, where mortality has been rising by about 1% per year since 2005. And it’s a pattern seen in both men and women.
Study coauthor Nikita Sandeep Wagle, PhD, MBBS, principal scientist, Cancer Surveillance Research at the ACS, and Arif Kamal, MD, ACS chief patient officer, discussed the research and its implications with Medscape Medical News.
Can you offer some possible reasons for the declining mortality in most of the cancers you studied?
Wagle: Mortality is going down for most of the cancers because we are getting better at finding cancers earlier and treating them more effectively. We have also seen improvements in screening, imaging, and therapy, and that means more people are being diagnosed at earlier stages and are surviving longer after diagnosis.
Regarding the rise in colorectal cancer mortality, do you think it's due to the rising incidence of early-onset colorectal cancer?
Kamal: Partially, but not completely, because the relationship between incidence and mortality is not always straightforward. For example, breast cancer incidence has been increasing, while mortality is going down. The rising mortality in people younger than 50 years is likely suggestive of more aggressive cancers being diagnosed — potentially secondary to environmental, dietary, or lifestyle factors. The colon is a unique organ because everything we put in our bodies passes through the colon, so food-based risk factors — for example, low fiber intake, red meat, and ultra-processed foods — are increasingly rising to the top as culprits.
Further, we know that only about 25% of people between the ages of 45 and 50 years are up to date with recommended colon cancer screenings, which can lead to later-stage diagnoses and thus higher mortality. So higher mortality speaks to the need to focus on lifestyle and diet changes and get more younger people to complete recommended cancer screenings.
Wagle: I think the “why” of your question is very important. Many researchers are trying to understand possible causes, such as diet, lifestyle, environmental factors, and genetics. But we cannot pinpoint one single cause. We need even more focus on research toward understanding the etiology of early-onset colorectal cancer.
What makes colorectal cancer different is that, unlike some other major cancers in this age group where mortality has declined despite rising incidence, roughly 3 in 4 colorectal cancers diagnosed in people younger than 50 years are [regional or distant], where the outcomes are worse.
Can you contextualize the rise in colorectal cancer mortality? What is the absolute rate among younger Americans now?
Wagle: It is around two deaths per 100,000 population in 2023 for people younger than 50 years. That number may not seem large, but the upward trend — a 1.1% annual increase from 2014 to 2023 — is concerning when you think about how overall mortality in this age group has dropped substantially over the past few decades. Colorectal cancer is moving in the opposite direction. I think the hopeful part is that it is also one of the most preventable cancers. Screening can stop cancer before it starts by removing precancerous polyps. Early-stage disease is highly treatable, and outcomes are better. That means better awareness and timely screening could make a real difference.
How can clinicians use this new information with regard to screening?
Wagle: For cancers with established screening guidelines, such as colorectal cancer, clinicians should continue to emphasize guideline-based screening and individualized risk assessment.
For colorectal cancer, screening now is recommended to start at age 45 for individuals at average risk, and earlier for [some], due to family history or other risk factors. Clinicians can use these findings to remind younger individuals that colorectal cancer is not only a disease of older adults and that screening at the recommended age can save lives.
In addition, red-flag symptoms such as persistent rectal bleeding, unexplained abdominal pain, difficulty in bowel movements, or signs of anemia should prompt appropriate evaluation in younger individuals.
Kamal: Clinicians should continue to emphasize timely completion of regular screening, starting at age 45 [for average-risk people]. Many still believe that the recommended starting age is 50 or that colonoscopy is the only way to get screened. Highlighting home-based screening options often helps patients make cancer screening logistically fit better into their busy lives.
Could you elaborate on the red-flag symptoms you mentioned, and what is an appropriate evaluation in younger individuals?
Kamal: Appropriate evaluation for any suspected bleeding — bright red or black and tarry — starts with an in-office evaluation by a primary care physician. Referral to a specialist, such as a gastroenterologist or surgeon, is done later, typically for direct visualization, such as with a colonoscopy. Rarely, imaging such as CT scans or ultrasounds is performed. Overall, because of the rising incidence of colon cancer in younger people, any concerning symptoms should be reported to a physician for an in-office evaluation as the first step.
Do these findings suggest that the starting age for average-risk people should be lowered—to age 40, for example?
Kamal: ACS screening guidelines for all cancers are part of an ongoing guideline development process by ACS scientists and volunteers. We monitor medical and scientific literature for new evidence that may support a change in current guidelines or the development of new guidelines and for information about cancer screening that should be conveyed to clinicians and target populations.
Keith Mulvihill is a freelance writer based in New York City.
A version of this article first appeared on Medscape.com.
First, the good news: Fewer Americans aged < 50 years are dying from cancer vs just a decade ago — reflecting progress in prevention, early detection, and treatment. There is, however, one big exception. Colorectal cancer mortality has been steadily inching up, and the disease now stands as the leading cause of cancer death in this age group, up from the fifth-leading in the early 1990s.
Those are the major findings of a recent study by the American Cancer Society (ACS), published as a research letter in JAMA.
Using SEER data, researchers found that the overall age-adjusted cancer death rate among Americans aged < 50 years dropped by 44% between 1990 and 2023 — from 25.5 to 14.2 per 100,000. And for 4 of the 5 leading causes of cancer death, there were mean annual declines from 2014 to 2023. The biggest change was in lung cancer deaths, which fell by an average of 5.7% per year. Meanwhile, leukemia and breast cancer deaths showed annual declines of 2.3% and 1.4%, respectively, despite rising incidences of both diseases among younger Americans.
The outlier is colorectal cancer, where mortality has been rising by about 1% per year since 2005. And it’s a pattern seen in both men and women.
Study coauthor Nikita Sandeep Wagle, PhD, MBBS, principal scientist, Cancer Surveillance Research at the ACS, and Arif Kamal, MD, ACS chief patient officer, discussed the research and its implications with Medscape Medical News.
Can you offer some possible reasons for the declining mortality in most of the cancers you studied?
Wagle: Mortality is going down for most of the cancers because we are getting better at finding cancers earlier and treating them more effectively. We have also seen improvements in screening, imaging, and therapy, and that means more people are being diagnosed at earlier stages and are surviving longer after diagnosis.
Regarding the rise in colorectal cancer mortality, do you think it's due to the rising incidence of early-onset colorectal cancer?
Kamal: Partially, but not completely, because the relationship between incidence and mortality is not always straightforward. For example, breast cancer incidence has been increasing, while mortality is going down. The rising mortality in people younger than 50 years is likely suggestive of more aggressive cancers being diagnosed — potentially secondary to environmental, dietary, or lifestyle factors. The colon is a unique organ because everything we put in our bodies passes through the colon, so food-based risk factors — for example, low fiber intake, red meat, and ultra-processed foods — are increasingly rising to the top as culprits.
Further, we know that only about 25% of people between the ages of 45 and 50 years are up to date with recommended colon cancer screenings, which can lead to later-stage diagnoses and thus higher mortality. So higher mortality speaks to the need to focus on lifestyle and diet changes and get more younger people to complete recommended cancer screenings.
Wagle: I think the “why” of your question is very important. Many researchers are trying to understand possible causes, such as diet, lifestyle, environmental factors, and genetics. But we cannot pinpoint one single cause. We need even more focus on research toward understanding the etiology of early-onset colorectal cancer.
What makes colorectal cancer different is that, unlike some other major cancers in this age group where mortality has declined despite rising incidence, roughly 3 in 4 colorectal cancers diagnosed in people younger than 50 years are [regional or distant], where the outcomes are worse.
Can you contextualize the rise in colorectal cancer mortality? What is the absolute rate among younger Americans now?
Wagle: It is around two deaths per 100,000 population in 2023 for people younger than 50 years. That number may not seem large, but the upward trend — a 1.1% annual increase from 2014 to 2023 — is concerning when you think about how overall mortality in this age group has dropped substantially over the past few decades. Colorectal cancer is moving in the opposite direction. I think the hopeful part is that it is also one of the most preventable cancers. Screening can stop cancer before it starts by removing precancerous polyps. Early-stage disease is highly treatable, and outcomes are better. That means better awareness and timely screening could make a real difference.
How can clinicians use this new information with regard to screening?
Wagle: For cancers with established screening guidelines, such as colorectal cancer, clinicians should continue to emphasize guideline-based screening and individualized risk assessment.
For colorectal cancer, screening now is recommended to start at age 45 for individuals at average risk, and earlier for [some], due to family history or other risk factors. Clinicians can use these findings to remind younger individuals that colorectal cancer is not only a disease of older adults and that screening at the recommended age can save lives.
In addition, red-flag symptoms such as persistent rectal bleeding, unexplained abdominal pain, difficulty in bowel movements, or signs of anemia should prompt appropriate evaluation in younger individuals.
Kamal: Clinicians should continue to emphasize timely completion of regular screening, starting at age 45 [for average-risk people]. Many still believe that the recommended starting age is 50 or that colonoscopy is the only way to get screened. Highlighting home-based screening options often helps patients make cancer screening logistically fit better into their busy lives.
Could you elaborate on the red-flag symptoms you mentioned, and what is an appropriate evaluation in younger individuals?
Kamal: Appropriate evaluation for any suspected bleeding — bright red or black and tarry — starts with an in-office evaluation by a primary care physician. Referral to a specialist, such as a gastroenterologist or surgeon, is done later, typically for direct visualization, such as with a colonoscopy. Rarely, imaging such as CT scans or ultrasounds is performed. Overall, because of the rising incidence of colon cancer in younger people, any concerning symptoms should be reported to a physician for an in-office evaluation as the first step.
Do these findings suggest that the starting age for average-risk people should be lowered—to age 40, for example?
Kamal: ACS screening guidelines for all cancers are part of an ongoing guideline development process by ACS scientists and volunteers. We monitor medical and scientific literature for new evidence that may support a change in current guidelines or the development of new guidelines and for information about cancer screening that should be conveyed to clinicians and target populations.
Keith Mulvihill is a freelance writer based in New York City.
A version of this article first appeared on Medscape.com.
Why Are More Americans Under Age 50 Dying of CRC?
Why Are More Americans Under Age 50 Dying of CRC?
Do Ultraprocessed Foods Impact Survival After Cancer?
Do Ultraprocessed Foods Impact Survival After Cancer?
Diets heavy in ultraprocessed foods (UPFs) are associated with earlier death in cancer survivors, a new study finds — though issues with the research design suggest that the findings should be taken with a grain of salt.
The study, published on February 4 in Cancer Epidemiology, Biomarkers & Prevention, is among the latest to point to health hazards from eating too many foods full of preservatives, dyes, and other industrially made ingredients.
These so-called UPFs have been linked to an increased risk for cancer, but whether they have any relationship to long-term survival after cancer has been unclear.
In the new study, of 802 adults with a previous cancer diagnosis, those in the top third for UPF consumption had a 48% higher rate of death from any cause over 15 years than those in the bottom third. Similarly, heavier UPF consumers had a 57% higher rate of death from cancer.
Those excess risks were seen after adjustment for numerous variables, including age, physical activity, BMI, smoking status, and socioeconomic indicators.
“Clinicians should encourage a shift toward fresh, minimally processed foods, [and] away from heavily industrially processed products,” said lead author Marialaura Bonaccio, PhD, of the Research Unit of Epidemiology and Prevention at IRCCS Neuromed in Pozzilli, Italy.
Oncologists not involved in the work said the findings support what researchers have suspected.
“UPFs have been linked to increased risk of obesity, diabetes, inflammation, cardiovascular disease, and...all-cause mortality and cardiovascular mortality,” said Urvi A. Shah, MD, a myeloma specialist who conducts nutrition research at Memorial Sloan Kettering Cancer Center in New York City. “However, there was limited data on cancer-specific mortality to date until this study.”
The findings also dovetail with recommendations on cancer prevention that emphasize diets rich in plant foods and low in processed foods, particularly those loaded with sugar, starch, and fat.
The study “may make oncologists think twice before assuring patients to ‘eat whatever you want, it doesn’t really matter’ because these investigators show that it does,” said Donald I. Abrams, MD, an integrative oncologist at the UCSF Osher Center for Integrative Health.
However, Gideon Meyerowitz-Katz, PhD, an epidemiologist at the University of Wollongong in Wollongong, Australia, was not impressed by the analysis.
He pointed to several sources of potential bias and noted that the crude results actually showed that cancer survivors with the lowest UPF consumption had a higher rate of death than the heaviest consumers.
“The story of UPFs being bad is consistent with this data, but so is the story of UPFs being fine,” said Meyerowitz-Katz, who has written about prior research on the subject.
The broad questions of whether and how UPFs might be harming human health have been gaining research interest, partly because of their ubiquity. The foods reportedly make up about 60% of the typical American diet.
There’s no universal agreement on the precise definition of “ultraprocessed,” but researchers generally use the NOVA classification system, which assigns foods into one of four groups based on the level and purpose of processing. UPFs contain ingredients not found in the standard home kitchen (such as high-fructose corn syrup) and often have artificial flavors, colors, and other additives.
Examples of UPFs include the usual “junk food,” such as candy, soda, and processed meat, but many healthy-sounding products, such as flavored yogurts and plant-based milk, also qualify.
For their study, Bonaccio and her colleagues identified 802 cancer survivors from the Moli-sani cohort study (476 women and 326 men) who completed food-frequency questionnaires an average of 8 years postdiagnosis.
Using the NOVA system, the team calculated the amount of UPF in participants’ diets as both weight and energy ratios.
Over a median follow-up of nearly 15 years, there were 281 deaths. In the lowest third of UPF consumption (4.3% mean intake by weight), there were 3.3 deaths per 100 patient-years, compared with 2.4 per 100 patient-years in the highest UPF tertile (16.7% mean intake by weight). For cancer-specific deaths, those numbers were 1.5 and 1.4, respectively.
However, after adjustment for age and total energy intake, the top UPF-intake group showed significantly higher death rates. In the final model, which adjusted for > 20 variables, the hazard ratios for the highest versus lowest UPF consumption were 1.48 (95% CI, 1.07-2.03) for all-cause mortality and 1.57 (95% CI, 1.00-2.47) for cancer mortality.
To explore potential biological mechanisms, the researchers also analyzed certain biomarkers. They found that adjustment for inflammatory markers and resting heart rate at baseline attenuated the association between UPF and all-cause deaths by nearly 40%.
The authors acknowledged some limitations of their study, including its use of self-report and potential survivor bias.
But Meyerowitz-Katz found additional weak points. For one, he said the authors “downplayed” the impact of their analysis controlling for inflammation and heart rate.
“Inflammation and heart rate are both strong markers of future cancer risk,” Meyerowitz-Katz said. “In this cohort, there would be people who were already experiencing cancer recurrence, which is important to control for at baseline.”
He also highlighted a little-known but important issue in observational research called collider bias, which can create a false association between an exposure and outcome. In this study, he said, the researchers introduced “a huge potential for collider bias” by controlling for energy intake, because both UPF consumption and cancer recurrence are causally associated with energy intake.
Bonaccio called that particular critique “a fair methodological question” but defended her work.
She pointed out that study participants were long-term survivors, which reduces the chance that their calorie intake was mainly driven by active cancer or treatment side effects.
“And,” she said, “our models include a wide set of baseline covariates that capture major determinants of both mortality and dietary intake.”
For Bonaccio, the take-home message for patients remains the same: “Emphasizing simple, home-cooked meals and traditional dietary patterns might be especially beneficial during the survivorship phase.”
The two US experts agreed that overall diet quality is key, with limits on UPFs being part of that. They also noted that the average American’s diet contains substantially more UPFs than what was seen in this Italian study.
“I spend 20 minutes of my 60-minute new patient consult in integrative oncology advising patients to eat an organic, plant-based, antioxidant-rich, anti-inflammatory, real and whole-foods diet,” Abrams said.
For her part, Shah said that cancer survivors should aim to get at least 25-30 grams of dietary fiber daily. She also suggested they avoid particular types of UPF with little to no nutritional value, such as processed meats, sugar-laden beverages, and fast food.
The study received no commercial funding. Bonaccio, Abrams, and Meyerowitz-Katz reported no financial disclosures. Shah is principle investigator on the NUTRIVENTION trial and reported receiving research funding and/or personal fees from Celgene/BMS, Janssen, and Sanofi.
A version of this article first appeared on Medscape.com.
Diets heavy in ultraprocessed foods (UPFs) are associated with earlier death in cancer survivors, a new study finds — though issues with the research design suggest that the findings should be taken with a grain of salt.
The study, published on February 4 in Cancer Epidemiology, Biomarkers & Prevention, is among the latest to point to health hazards from eating too many foods full of preservatives, dyes, and other industrially made ingredients.
These so-called UPFs have been linked to an increased risk for cancer, but whether they have any relationship to long-term survival after cancer has been unclear.
In the new study, of 802 adults with a previous cancer diagnosis, those in the top third for UPF consumption had a 48% higher rate of death from any cause over 15 years than those in the bottom third. Similarly, heavier UPF consumers had a 57% higher rate of death from cancer.
Those excess risks were seen after adjustment for numerous variables, including age, physical activity, BMI, smoking status, and socioeconomic indicators.
“Clinicians should encourage a shift toward fresh, minimally processed foods, [and] away from heavily industrially processed products,” said lead author Marialaura Bonaccio, PhD, of the Research Unit of Epidemiology and Prevention at IRCCS Neuromed in Pozzilli, Italy.
Oncologists not involved in the work said the findings support what researchers have suspected.
“UPFs have been linked to increased risk of obesity, diabetes, inflammation, cardiovascular disease, and...all-cause mortality and cardiovascular mortality,” said Urvi A. Shah, MD, a myeloma specialist who conducts nutrition research at Memorial Sloan Kettering Cancer Center in New York City. “However, there was limited data on cancer-specific mortality to date until this study.”
The findings also dovetail with recommendations on cancer prevention that emphasize diets rich in plant foods and low in processed foods, particularly those loaded with sugar, starch, and fat.
The study “may make oncologists think twice before assuring patients to ‘eat whatever you want, it doesn’t really matter’ because these investigators show that it does,” said Donald I. Abrams, MD, an integrative oncologist at the UCSF Osher Center for Integrative Health.
However, Gideon Meyerowitz-Katz, PhD, an epidemiologist at the University of Wollongong in Wollongong, Australia, was not impressed by the analysis.
He pointed to several sources of potential bias and noted that the crude results actually showed that cancer survivors with the lowest UPF consumption had a higher rate of death than the heaviest consumers.
“The story of UPFs being bad is consistent with this data, but so is the story of UPFs being fine,” said Meyerowitz-Katz, who has written about prior research on the subject.
The broad questions of whether and how UPFs might be harming human health have been gaining research interest, partly because of their ubiquity. The foods reportedly make up about 60% of the typical American diet.
There’s no universal agreement on the precise definition of “ultraprocessed,” but researchers generally use the NOVA classification system, which assigns foods into one of four groups based on the level and purpose of processing. UPFs contain ingredients not found in the standard home kitchen (such as high-fructose corn syrup) and often have artificial flavors, colors, and other additives.
Examples of UPFs include the usual “junk food,” such as candy, soda, and processed meat, but many healthy-sounding products, such as flavored yogurts and plant-based milk, also qualify.
For their study, Bonaccio and her colleagues identified 802 cancer survivors from the Moli-sani cohort study (476 women and 326 men) who completed food-frequency questionnaires an average of 8 years postdiagnosis.
Using the NOVA system, the team calculated the amount of UPF in participants’ diets as both weight and energy ratios.
Over a median follow-up of nearly 15 years, there were 281 deaths. In the lowest third of UPF consumption (4.3% mean intake by weight), there were 3.3 deaths per 100 patient-years, compared with 2.4 per 100 patient-years in the highest UPF tertile (16.7% mean intake by weight). For cancer-specific deaths, those numbers were 1.5 and 1.4, respectively.
However, after adjustment for age and total energy intake, the top UPF-intake group showed significantly higher death rates. In the final model, which adjusted for > 20 variables, the hazard ratios for the highest versus lowest UPF consumption were 1.48 (95% CI, 1.07-2.03) for all-cause mortality and 1.57 (95% CI, 1.00-2.47) for cancer mortality.
To explore potential biological mechanisms, the researchers also analyzed certain biomarkers. They found that adjustment for inflammatory markers and resting heart rate at baseline attenuated the association between UPF and all-cause deaths by nearly 40%.
The authors acknowledged some limitations of their study, including its use of self-report and potential survivor bias.
But Meyerowitz-Katz found additional weak points. For one, he said the authors “downplayed” the impact of their analysis controlling for inflammation and heart rate.
“Inflammation and heart rate are both strong markers of future cancer risk,” Meyerowitz-Katz said. “In this cohort, there would be people who were already experiencing cancer recurrence, which is important to control for at baseline.”
He also highlighted a little-known but important issue in observational research called collider bias, which can create a false association between an exposure and outcome. In this study, he said, the researchers introduced “a huge potential for collider bias” by controlling for energy intake, because both UPF consumption and cancer recurrence are causally associated with energy intake.
Bonaccio called that particular critique “a fair methodological question” but defended her work.
She pointed out that study participants were long-term survivors, which reduces the chance that their calorie intake was mainly driven by active cancer or treatment side effects.
“And,” she said, “our models include a wide set of baseline covariates that capture major determinants of both mortality and dietary intake.”
For Bonaccio, the take-home message for patients remains the same: “Emphasizing simple, home-cooked meals and traditional dietary patterns might be especially beneficial during the survivorship phase.”
The two US experts agreed that overall diet quality is key, with limits on UPFs being part of that. They also noted that the average American’s diet contains substantially more UPFs than what was seen in this Italian study.
“I spend 20 minutes of my 60-minute new patient consult in integrative oncology advising patients to eat an organic, plant-based, antioxidant-rich, anti-inflammatory, real and whole-foods diet,” Abrams said.
For her part, Shah said that cancer survivors should aim to get at least 25-30 grams of dietary fiber daily. She also suggested they avoid particular types of UPF with little to no nutritional value, such as processed meats, sugar-laden beverages, and fast food.
The study received no commercial funding. Bonaccio, Abrams, and Meyerowitz-Katz reported no financial disclosures. Shah is principle investigator on the NUTRIVENTION trial and reported receiving research funding and/or personal fees from Celgene/BMS, Janssen, and Sanofi.
A version of this article first appeared on Medscape.com.
Diets heavy in ultraprocessed foods (UPFs) are associated with earlier death in cancer survivors, a new study finds — though issues with the research design suggest that the findings should be taken with a grain of salt.
The study, published on February 4 in Cancer Epidemiology, Biomarkers & Prevention, is among the latest to point to health hazards from eating too many foods full of preservatives, dyes, and other industrially made ingredients.
These so-called UPFs have been linked to an increased risk for cancer, but whether they have any relationship to long-term survival after cancer has been unclear.
In the new study, of 802 adults with a previous cancer diagnosis, those in the top third for UPF consumption had a 48% higher rate of death from any cause over 15 years than those in the bottom third. Similarly, heavier UPF consumers had a 57% higher rate of death from cancer.
Those excess risks were seen after adjustment for numerous variables, including age, physical activity, BMI, smoking status, and socioeconomic indicators.
“Clinicians should encourage a shift toward fresh, minimally processed foods, [and] away from heavily industrially processed products,” said lead author Marialaura Bonaccio, PhD, of the Research Unit of Epidemiology and Prevention at IRCCS Neuromed in Pozzilli, Italy.
Oncologists not involved in the work said the findings support what researchers have suspected.
“UPFs have been linked to increased risk of obesity, diabetes, inflammation, cardiovascular disease, and...all-cause mortality and cardiovascular mortality,” said Urvi A. Shah, MD, a myeloma specialist who conducts nutrition research at Memorial Sloan Kettering Cancer Center in New York City. “However, there was limited data on cancer-specific mortality to date until this study.”
The findings also dovetail with recommendations on cancer prevention that emphasize diets rich in plant foods and low in processed foods, particularly those loaded with sugar, starch, and fat.
The study “may make oncologists think twice before assuring patients to ‘eat whatever you want, it doesn’t really matter’ because these investigators show that it does,” said Donald I. Abrams, MD, an integrative oncologist at the UCSF Osher Center for Integrative Health.
However, Gideon Meyerowitz-Katz, PhD, an epidemiologist at the University of Wollongong in Wollongong, Australia, was not impressed by the analysis.
He pointed to several sources of potential bias and noted that the crude results actually showed that cancer survivors with the lowest UPF consumption had a higher rate of death than the heaviest consumers.
“The story of UPFs being bad is consistent with this data, but so is the story of UPFs being fine,” said Meyerowitz-Katz, who has written about prior research on the subject.
The broad questions of whether and how UPFs might be harming human health have been gaining research interest, partly because of their ubiquity. The foods reportedly make up about 60% of the typical American diet.
There’s no universal agreement on the precise definition of “ultraprocessed,” but researchers generally use the NOVA classification system, which assigns foods into one of four groups based on the level and purpose of processing. UPFs contain ingredients not found in the standard home kitchen (such as high-fructose corn syrup) and often have artificial flavors, colors, and other additives.
Examples of UPFs include the usual “junk food,” such as candy, soda, and processed meat, but many healthy-sounding products, such as flavored yogurts and plant-based milk, also qualify.
For their study, Bonaccio and her colleagues identified 802 cancer survivors from the Moli-sani cohort study (476 women and 326 men) who completed food-frequency questionnaires an average of 8 years postdiagnosis.
Using the NOVA system, the team calculated the amount of UPF in participants’ diets as both weight and energy ratios.
Over a median follow-up of nearly 15 years, there were 281 deaths. In the lowest third of UPF consumption (4.3% mean intake by weight), there were 3.3 deaths per 100 patient-years, compared with 2.4 per 100 patient-years in the highest UPF tertile (16.7% mean intake by weight). For cancer-specific deaths, those numbers were 1.5 and 1.4, respectively.
However, after adjustment for age and total energy intake, the top UPF-intake group showed significantly higher death rates. In the final model, which adjusted for > 20 variables, the hazard ratios for the highest versus lowest UPF consumption were 1.48 (95% CI, 1.07-2.03) for all-cause mortality and 1.57 (95% CI, 1.00-2.47) for cancer mortality.
To explore potential biological mechanisms, the researchers also analyzed certain biomarkers. They found that adjustment for inflammatory markers and resting heart rate at baseline attenuated the association between UPF and all-cause deaths by nearly 40%.
The authors acknowledged some limitations of their study, including its use of self-report and potential survivor bias.
But Meyerowitz-Katz found additional weak points. For one, he said the authors “downplayed” the impact of their analysis controlling for inflammation and heart rate.
“Inflammation and heart rate are both strong markers of future cancer risk,” Meyerowitz-Katz said. “In this cohort, there would be people who were already experiencing cancer recurrence, which is important to control for at baseline.”
He also highlighted a little-known but important issue in observational research called collider bias, which can create a false association between an exposure and outcome. In this study, he said, the researchers introduced “a huge potential for collider bias” by controlling for energy intake, because both UPF consumption and cancer recurrence are causally associated with energy intake.
Bonaccio called that particular critique “a fair methodological question” but defended her work.
She pointed out that study participants were long-term survivors, which reduces the chance that their calorie intake was mainly driven by active cancer or treatment side effects.
“And,” she said, “our models include a wide set of baseline covariates that capture major determinants of both mortality and dietary intake.”
For Bonaccio, the take-home message for patients remains the same: “Emphasizing simple, home-cooked meals and traditional dietary patterns might be especially beneficial during the survivorship phase.”
The two US experts agreed that overall diet quality is key, with limits on UPFs being part of that. They also noted that the average American’s diet contains substantially more UPFs than what was seen in this Italian study.
“I spend 20 minutes of my 60-minute new patient consult in integrative oncology advising patients to eat an organic, plant-based, antioxidant-rich, anti-inflammatory, real and whole-foods diet,” Abrams said.
For her part, Shah said that cancer survivors should aim to get at least 25-30 grams of dietary fiber daily. She also suggested they avoid particular types of UPF with little to no nutritional value, such as processed meats, sugar-laden beverages, and fast food.
The study received no commercial funding. Bonaccio, Abrams, and Meyerowitz-Katz reported no financial disclosures. Shah is principle investigator on the NUTRIVENTION trial and reported receiving research funding and/or personal fees from Celgene/BMS, Janssen, and Sanofi.
A version of this article first appeared on Medscape.com.
Do Ultraprocessed Foods Impact Survival After Cancer?
Do Ultraprocessed Foods Impact Survival After Cancer?
TB, Chronic Bronchitis Tied to Lung Cancer in Never Smokers
TB, Chronic Bronchitis Tied to Lung Cancer in Never Smokers
TOPLINE:
A history of tuberculosis (TB) and a history of chronic bronchitis were associated with an increased risk for lung cancer in individuals who had never smoked, whereas asthma had a positive, nonsignificant association overall and a significant association in women.
METHODOLOGY:
- Researchers conducted a systematic review and meta-analysis of clinical databases from inception to July 2025, to assess the association between asthma, TB, and/or chronic bronchitis and the risk for lung cancer among participants aged 18 years or older who had never smoked.
- They included data from 20 case-control studies involving 54,135 participants and five cohort studies involving 377,983 participants.
- The primary outcome was the risk for lung cancer among participants with a history of TB, asthma, or chronic bronchitis.
- Participants were labeled as “never smokers” if they were explicitly described in the manuscripts as having “never smoked” or reported smoking < 100 cigarettes in their lifetime.
TAKEAWAY:
- In case-control studies, TB (16 studies) and chronic bronchitis (9 studies) were significantly associated with an increased risk for lung cancer (odds ratio [OR], 1.76; P < .001 and OR, 1.36; P = .012, respectively).
- In four case-cohort studies, TB was associated with an increased but nonsignificant risk for lung cancer (hazard ratio, 1.64).
- Eleven case-control studies demonstrated a positive but nonsignificant association between asthma and the risk for lung cancer (OR, 1.34). However, a significant association emerged when analyses were limited to women (five studies; OR, 1.61; P < .01).
IN PRACTICE:
History of TB was especially associated with increased LC [lung cancer] risk, meriting particular attention for prospective CT screening studies,” the authors of the study wrote.
SOURCE:
This study was led by Nishwant Swami, MD, Hospital of the University of Pennsylvania, Philadelphia. It was published online on January 11, 2026, in Chest.
LIMITATIONS:
Most studies lacked uniform adjustment for key confounders, increasing the risk for residual confounding. The inclusion of few cohort studies in the analysis may have limited the assessment of temporality and precision. Additionally, differences in covariate adjustment, variable definitions, and language restrictions may have limited comparability and generalizability.
DISCLOSURES:
No specific funding was reported for this study. One author reported serving as a consultant or advisor for various companies, including AstraZeneca, Merck, and Pfizer. Another author reported receiving funding, in part, through the Prostate Cancer Foundation Young Investigator Award and through the Cancer Center Support Grant from the National Cancer Institute.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A history of tuberculosis (TB) and a history of chronic bronchitis were associated with an increased risk for lung cancer in individuals who had never smoked, whereas asthma had a positive, nonsignificant association overall and a significant association in women.
METHODOLOGY:
- Researchers conducted a systematic review and meta-analysis of clinical databases from inception to July 2025, to assess the association between asthma, TB, and/or chronic bronchitis and the risk for lung cancer among participants aged 18 years or older who had never smoked.
- They included data from 20 case-control studies involving 54,135 participants and five cohort studies involving 377,983 participants.
- The primary outcome was the risk for lung cancer among participants with a history of TB, asthma, or chronic bronchitis.
- Participants were labeled as “never smokers” if they were explicitly described in the manuscripts as having “never smoked” or reported smoking < 100 cigarettes in their lifetime.
TAKEAWAY:
- In case-control studies, TB (16 studies) and chronic bronchitis (9 studies) were significantly associated with an increased risk for lung cancer (odds ratio [OR], 1.76; P < .001 and OR, 1.36; P = .012, respectively).
- In four case-cohort studies, TB was associated with an increased but nonsignificant risk for lung cancer (hazard ratio, 1.64).
- Eleven case-control studies demonstrated a positive but nonsignificant association between asthma and the risk for lung cancer (OR, 1.34). However, a significant association emerged when analyses were limited to women (five studies; OR, 1.61; P < .01).
IN PRACTICE:
History of TB was especially associated with increased LC [lung cancer] risk, meriting particular attention for prospective CT screening studies,” the authors of the study wrote.
SOURCE:
This study was led by Nishwant Swami, MD, Hospital of the University of Pennsylvania, Philadelphia. It was published online on January 11, 2026, in Chest.
LIMITATIONS:
Most studies lacked uniform adjustment for key confounders, increasing the risk for residual confounding. The inclusion of few cohort studies in the analysis may have limited the assessment of temporality and precision. Additionally, differences in covariate adjustment, variable definitions, and language restrictions may have limited comparability and generalizability.
DISCLOSURES:
No specific funding was reported for this study. One author reported serving as a consultant or advisor for various companies, including AstraZeneca, Merck, and Pfizer. Another author reported receiving funding, in part, through the Prostate Cancer Foundation Young Investigator Award and through the Cancer Center Support Grant from the National Cancer Institute.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A history of tuberculosis (TB) and a history of chronic bronchitis were associated with an increased risk for lung cancer in individuals who had never smoked, whereas asthma had a positive, nonsignificant association overall and a significant association in women.
METHODOLOGY:
- Researchers conducted a systematic review and meta-analysis of clinical databases from inception to July 2025, to assess the association between asthma, TB, and/or chronic bronchitis and the risk for lung cancer among participants aged 18 years or older who had never smoked.
- They included data from 20 case-control studies involving 54,135 participants and five cohort studies involving 377,983 participants.
- The primary outcome was the risk for lung cancer among participants with a history of TB, asthma, or chronic bronchitis.
- Participants were labeled as “never smokers” if they were explicitly described in the manuscripts as having “never smoked” or reported smoking < 100 cigarettes in their lifetime.
TAKEAWAY:
- In case-control studies, TB (16 studies) and chronic bronchitis (9 studies) were significantly associated with an increased risk for lung cancer (odds ratio [OR], 1.76; P < .001 and OR, 1.36; P = .012, respectively).
- In four case-cohort studies, TB was associated with an increased but nonsignificant risk for lung cancer (hazard ratio, 1.64).
- Eleven case-control studies demonstrated a positive but nonsignificant association between asthma and the risk for lung cancer (OR, 1.34). However, a significant association emerged when analyses were limited to women (five studies; OR, 1.61; P < .01).
IN PRACTICE:
History of TB was especially associated with increased LC [lung cancer] risk, meriting particular attention for prospective CT screening studies,” the authors of the study wrote.
SOURCE:
This study was led by Nishwant Swami, MD, Hospital of the University of Pennsylvania, Philadelphia. It was published online on January 11, 2026, in Chest.
LIMITATIONS:
Most studies lacked uniform adjustment for key confounders, increasing the risk for residual confounding. The inclusion of few cohort studies in the analysis may have limited the assessment of temporality and precision. Additionally, differences in covariate adjustment, variable definitions, and language restrictions may have limited comparability and generalizability.
DISCLOSURES:
No specific funding was reported for this study. One author reported serving as a consultant or advisor for various companies, including AstraZeneca, Merck, and Pfizer. Another author reported receiving funding, in part, through the Prostate Cancer Foundation Young Investigator Award and through the Cancer Center Support Grant from the National Cancer Institute.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TB, Chronic Bronchitis Tied to Lung Cancer in Never Smokers
TB, Chronic Bronchitis Tied to Lung Cancer in Never Smokers
Fecal Microbiota Transplant Safety Goal Met in Kidney Cancer
Fecal Microbiota Transplant Safety Goal Met in Kidney Cancer
TOPLINE:
Healthy donor fecal microbiota transplantation (FMT) combined with immune checkpoint inhibitors (ICI) in metastatic renal cell carcinoma demonstrated safety with a 50% objective response rate and no grade 4-5 toxicities. Successful engraftment of diverse, anti-inflammatory microbiota correlated with improved clinical response and reduced immune-related adverse events.
METHODOLOGY:
- Many patients with metastatic renal cell carcinoma who take ICI experience immune-related adverse events that may require treatment interruption. Recent studies have provided proof of concept for microbiome modulation as a therapeutic adjunct in metastatic renal cell carcinoma, with FMT showing efficacy in resolving TKI-induced toxicities. However, the safety and clinical activity of healthy donor FMT in metastatic renal cell carcinoma remained unexplored, and its mechanism of action was unclear prior to this study.
- The new phase 1 trial enrolled 20 treatment-naive patients with metastatic renal cell carcinoma classified as intermediate-risk or poor-risk disease, who received encapsulated healthy donor FMT (LND101) combined with ipilimumab plus nivolumab (n = 16), pembrolizumab plus axitinib (n = 3), or pembrolizumab plus lenvatinib (n = 1).
- Participants underwent polyethylene glycol bowel preparation before receiving one full dose (36-40 capsules containing 80-100 g of stool) and two half-doses (20-25 capsules each containing 50-60 g of stool) of FMT from rigorously screened healthy donors.
- The primary endpoint was safety assessed through incidence and severity of immune-related adverse events, while secondary endpoints included objective response rate by response evaluation criteria in solid tumors version 1.1, gut microbiome changes, immune correlates, and quality of life.
- Analysis included longitudinal monitoring of stool and blood samples at five timepoints: baseline, week 1 post-FMT, week 4, week 7, and week 10, with a median follow-up of 21.9 months.
TAKEAWAY:
- The safety endpoint was met, with half (10 of 20) of patients experiencing grade 3 immune-related adverse events and no serious FMT-related toxicities or grade 4-5 immune-related adverse events. One patient (5%) reported experiencing an FMT-related grade 1 gastrointestinal event.
- Among evaluable patients (n = 18), the objective response rate was 50% (9 of 18), including two complete responses (11%; 2 of 18), while 67% (12 of 18) achieved clinical benefit defined as complete response, partial response, or stable disease for at least 6 months.
- Higher alpha diversity and greater functional engraftment of short-chain fatty acid-producing and anti-inflammatory taxa correlated with protection from severe immune-related adverse events (P = .041) and improved therapeutic response (P = .006).
- Expansion of Segatella copri above 10 counts per million at 10 weeks post-FMT predicted severe toxicity in patients receiving ipilimumab plus nivolumab, regardless of donor or recipient microbiota origin.
IN PRACTICE:
These findings demonstrate the safety and potential for functional microbiome engraftment to optimize response and minimize toxicity in ICI-treated [metastatic renal cell carcinoma]. Together, our results underscore the importance of functional donor screening and targeted modulation of the microbiome in optimizing the safety and efficacy of next-generation immune-based therapies,” wrote the authors of the study.
SOURCE:
The study was led by Ricardo Fernandes, Behnam Jabbarizadeh, and Adnan Rajeh, London Health Sciences Centre, London, Ontario, Canada. It was published online on January 28 in Nature Medicine.
LIMITATIONS:
According to the authors, the study’s primary limitation was its small sample size, which was not powered to define the ideal donor microbiome composition for enhancing immunotherapy efficacy without additional toxicities. The single-center design and highly selected patient population may limit external generalizability, requiring validation in larger, multicenter trials to refine donor selection criteria and clarify microbiome-immunity mechanisms.
DISCLOSURES:
The clinical trial was primarily funded through philanthropic donations to co-authors Saman Maleki Vareki and Fernandes through the London Health Sciences Foundation clinical trials program. Vareki and Michael Silverman, another co-author, reported having US Patent application no. 63/913,940 related to FMT donor screening. Vareki reported receiving grants from the Lotte and John Hecht Memorial Foundation, the Weston Family Foundation, and the Canadian Institutes of Health Research. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Healthy donor fecal microbiota transplantation (FMT) combined with immune checkpoint inhibitors (ICI) in metastatic renal cell carcinoma demonstrated safety with a 50% objective response rate and no grade 4-5 toxicities. Successful engraftment of diverse, anti-inflammatory microbiota correlated with improved clinical response and reduced immune-related adverse events.
METHODOLOGY:
- Many patients with metastatic renal cell carcinoma who take ICI experience immune-related adverse events that may require treatment interruption. Recent studies have provided proof of concept for microbiome modulation as a therapeutic adjunct in metastatic renal cell carcinoma, with FMT showing efficacy in resolving TKI-induced toxicities. However, the safety and clinical activity of healthy donor FMT in metastatic renal cell carcinoma remained unexplored, and its mechanism of action was unclear prior to this study.
- The new phase 1 trial enrolled 20 treatment-naive patients with metastatic renal cell carcinoma classified as intermediate-risk or poor-risk disease, who received encapsulated healthy donor FMT (LND101) combined with ipilimumab plus nivolumab (n = 16), pembrolizumab plus axitinib (n = 3), or pembrolizumab plus lenvatinib (n = 1).
- Participants underwent polyethylene glycol bowel preparation before receiving one full dose (36-40 capsules containing 80-100 g of stool) and two half-doses (20-25 capsules each containing 50-60 g of stool) of FMT from rigorously screened healthy donors.
- The primary endpoint was safety assessed through incidence and severity of immune-related adverse events, while secondary endpoints included objective response rate by response evaluation criteria in solid tumors version 1.1, gut microbiome changes, immune correlates, and quality of life.
- Analysis included longitudinal monitoring of stool and blood samples at five timepoints: baseline, week 1 post-FMT, week 4, week 7, and week 10, with a median follow-up of 21.9 months.
TAKEAWAY:
- The safety endpoint was met, with half (10 of 20) of patients experiencing grade 3 immune-related adverse events and no serious FMT-related toxicities or grade 4-5 immune-related adverse events. One patient (5%) reported experiencing an FMT-related grade 1 gastrointestinal event.
- Among evaluable patients (n = 18), the objective response rate was 50% (9 of 18), including two complete responses (11%; 2 of 18), while 67% (12 of 18) achieved clinical benefit defined as complete response, partial response, or stable disease for at least 6 months.
- Higher alpha diversity and greater functional engraftment of short-chain fatty acid-producing and anti-inflammatory taxa correlated with protection from severe immune-related adverse events (P = .041) and improved therapeutic response (P = .006).
- Expansion of Segatella copri above 10 counts per million at 10 weeks post-FMT predicted severe toxicity in patients receiving ipilimumab plus nivolumab, regardless of donor or recipient microbiota origin.
IN PRACTICE:
These findings demonstrate the safety and potential for functional microbiome engraftment to optimize response and minimize toxicity in ICI-treated [metastatic renal cell carcinoma]. Together, our results underscore the importance of functional donor screening and targeted modulation of the microbiome in optimizing the safety and efficacy of next-generation immune-based therapies,” wrote the authors of the study.
SOURCE:
The study was led by Ricardo Fernandes, Behnam Jabbarizadeh, and Adnan Rajeh, London Health Sciences Centre, London, Ontario, Canada. It was published online on January 28 in Nature Medicine.
LIMITATIONS:
According to the authors, the study’s primary limitation was its small sample size, which was not powered to define the ideal donor microbiome composition for enhancing immunotherapy efficacy without additional toxicities. The single-center design and highly selected patient population may limit external generalizability, requiring validation in larger, multicenter trials to refine donor selection criteria and clarify microbiome-immunity mechanisms.
DISCLOSURES:
The clinical trial was primarily funded through philanthropic donations to co-authors Saman Maleki Vareki and Fernandes through the London Health Sciences Foundation clinical trials program. Vareki and Michael Silverman, another co-author, reported having US Patent application no. 63/913,940 related to FMT donor screening. Vareki reported receiving grants from the Lotte and John Hecht Memorial Foundation, the Weston Family Foundation, and the Canadian Institutes of Health Research. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Healthy donor fecal microbiota transplantation (FMT) combined with immune checkpoint inhibitors (ICI) in metastatic renal cell carcinoma demonstrated safety with a 50% objective response rate and no grade 4-5 toxicities. Successful engraftment of diverse, anti-inflammatory microbiota correlated with improved clinical response and reduced immune-related adverse events.
METHODOLOGY:
- Many patients with metastatic renal cell carcinoma who take ICI experience immune-related adverse events that may require treatment interruption. Recent studies have provided proof of concept for microbiome modulation as a therapeutic adjunct in metastatic renal cell carcinoma, with FMT showing efficacy in resolving TKI-induced toxicities. However, the safety and clinical activity of healthy donor FMT in metastatic renal cell carcinoma remained unexplored, and its mechanism of action was unclear prior to this study.
- The new phase 1 trial enrolled 20 treatment-naive patients with metastatic renal cell carcinoma classified as intermediate-risk or poor-risk disease, who received encapsulated healthy donor FMT (LND101) combined with ipilimumab plus nivolumab (n = 16), pembrolizumab plus axitinib (n = 3), or pembrolizumab plus lenvatinib (n = 1).
- Participants underwent polyethylene glycol bowel preparation before receiving one full dose (36-40 capsules containing 80-100 g of stool) and two half-doses (20-25 capsules each containing 50-60 g of stool) of FMT from rigorously screened healthy donors.
- The primary endpoint was safety assessed through incidence and severity of immune-related adverse events, while secondary endpoints included objective response rate by response evaluation criteria in solid tumors version 1.1, gut microbiome changes, immune correlates, and quality of life.
- Analysis included longitudinal monitoring of stool and blood samples at five timepoints: baseline, week 1 post-FMT, week 4, week 7, and week 10, with a median follow-up of 21.9 months.
TAKEAWAY:
- The safety endpoint was met, with half (10 of 20) of patients experiencing grade 3 immune-related adverse events and no serious FMT-related toxicities or grade 4-5 immune-related adverse events. One patient (5%) reported experiencing an FMT-related grade 1 gastrointestinal event.
- Among evaluable patients (n = 18), the objective response rate was 50% (9 of 18), including two complete responses (11%; 2 of 18), while 67% (12 of 18) achieved clinical benefit defined as complete response, partial response, or stable disease for at least 6 months.
- Higher alpha diversity and greater functional engraftment of short-chain fatty acid-producing and anti-inflammatory taxa correlated with protection from severe immune-related adverse events (P = .041) and improved therapeutic response (P = .006).
- Expansion of Segatella copri above 10 counts per million at 10 weeks post-FMT predicted severe toxicity in patients receiving ipilimumab plus nivolumab, regardless of donor or recipient microbiota origin.
IN PRACTICE:
These findings demonstrate the safety and potential for functional microbiome engraftment to optimize response and minimize toxicity in ICI-treated [metastatic renal cell carcinoma]. Together, our results underscore the importance of functional donor screening and targeted modulation of the microbiome in optimizing the safety and efficacy of next-generation immune-based therapies,” wrote the authors of the study.
SOURCE:
The study was led by Ricardo Fernandes, Behnam Jabbarizadeh, and Adnan Rajeh, London Health Sciences Centre, London, Ontario, Canada. It was published online on January 28 in Nature Medicine.
LIMITATIONS:
According to the authors, the study’s primary limitation was its small sample size, which was not powered to define the ideal donor microbiome composition for enhancing immunotherapy efficacy without additional toxicities. The single-center design and highly selected patient population may limit external generalizability, requiring validation in larger, multicenter trials to refine donor selection criteria and clarify microbiome-immunity mechanisms.
DISCLOSURES:
The clinical trial was primarily funded through philanthropic donations to co-authors Saman Maleki Vareki and Fernandes through the London Health Sciences Foundation clinical trials program. Vareki and Michael Silverman, another co-author, reported having US Patent application no. 63/913,940 related to FMT donor screening. Vareki reported receiving grants from the Lotte and John Hecht Memorial Foundation, the Weston Family Foundation, and the Canadian Institutes of Health Research. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Fecal Microbiota Transplant Safety Goal Met in Kidney Cancer
Fecal Microbiota Transplant Safety Goal Met in Kidney Cancer
High-Deductible Plans May Be Linked to Worse Cancer Survival
High-Deductible Plans May Be Linked to Worse Cancer Survival
TOPLINE:
A new analysis found that high-deductible health plans were associated with worse overall survival and cancer-specific survival among cancer survivors. High-deductible plans, however, were not associated with worse overall survival among adults without a history of cancer.
METHODOLOGY:
- Previous studies have linked high-deductible health plans with decreased or delayed health utilization among cancer survivors and higher out-of-pocket costs. However, it’s not clear whether these plans influence cancer outcomes.
- In a cross-sectional study, researchers analyzed data from 147,254 respondents (aged 18 to 84 years) in the National Health Interview Survey from 2011 to 2018 and identified individuals with high-deductible plans — 2331 cancer survivors and 37,473 people without a history of cancer.
- The researchers acquired linked mortality files from the National Death Index, which included data on mortality events through the end of 2019.
- High-deductible health plans were identified through survey responses and defined as plans with yearly deductibles of at least $1200-$1350 for individuals or at least $2400-$2700 for families.
- The primary endpoints included overall survival and cancer-specific survival. Researchers adjusted for insurance status, marital status, sex, comorbidities, education, household income, geographic region, cancer site, and time since diagnosis.
TAKEAWAY:
- Among cancer survivors, having a high-deductible health plan was associated with worse overall survival (hazard ratio [HR], 1.46) and cancer-specific survival (HR, 1.34). However, sensitivity analyses incorporating time since diagnosis slightly attenuated the cancer-specific survival association (HR, 1.20; 95% CI, 0.92-1.55).
- Among adults without a history of cancer, having a high-deductible health plan was not associated with significantly worse overall survival (HR, 1.08; 95% CI, 0.96-1.21).
- General concerns over finances, worry about medical bills, cost-related delays, or forgone care, as well as cost-related underuse of medications were significant mediators of the associations between high-deductible health plan status and mortality outcomes among cancer survivors.
- High-deductible health plan status was also associated with worse cancer-specific survival among cancer survivors with incomes at least 400% of the federal poverty level (HR, 1.65; P for interaction = .03).
IN PRACTICE:
“These data suggest that insurance coverage that financially discourages medical care may financially discourage necessary care and ultimately worsen cancer outcomes,” the study authors wrote. “This danger appears to be unique to cancer survivors, as [high-deductible health plans] were not associated with survival among adults without a cancer history.”
SOURCE:
The study, led by Justin M. Barnes, MD, MS, Department of Radiation Oncology, Mayo Clinic in Rochester, Minnesota, was published online on January 29 in JAMA Network Open.
LIMITATIONS:
High-deductible health plan status was self-reported and may have been inaccurate for some individuals, with more than half of consumers being unsure about their annual deductible amount. The study lacked specific plan details and exact deductible amounts, and high-deductible health plan status was based on a single time point during survey participation. Additionally, researchers lacked information about cancer stage, cancer-directed therapies, recurrences, or complications, and cancer mortality could be from cancers diagnosed after survey participation.
DISCLOSURES:
Meera Ragavan, MD, MPH, disclosed receiving personal fees from Trial Library and AstraZeneca and grants from Merck, outside the submitted work. Other authors reported receiving personal fees from Costs of Care during the study. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A new analysis found that high-deductible health plans were associated with worse overall survival and cancer-specific survival among cancer survivors. High-deductible plans, however, were not associated with worse overall survival among adults without a history of cancer.
METHODOLOGY:
- Previous studies have linked high-deductible health plans with decreased or delayed health utilization among cancer survivors and higher out-of-pocket costs. However, it’s not clear whether these plans influence cancer outcomes.
- In a cross-sectional study, researchers analyzed data from 147,254 respondents (aged 18 to 84 years) in the National Health Interview Survey from 2011 to 2018 and identified individuals with high-deductible plans — 2331 cancer survivors and 37,473 people without a history of cancer.
- The researchers acquired linked mortality files from the National Death Index, which included data on mortality events through the end of 2019.
- High-deductible health plans were identified through survey responses and defined as plans with yearly deductibles of at least $1200-$1350 for individuals or at least $2400-$2700 for families.
- The primary endpoints included overall survival and cancer-specific survival. Researchers adjusted for insurance status, marital status, sex, comorbidities, education, household income, geographic region, cancer site, and time since diagnosis.
TAKEAWAY:
- Among cancer survivors, having a high-deductible health plan was associated with worse overall survival (hazard ratio [HR], 1.46) and cancer-specific survival (HR, 1.34). However, sensitivity analyses incorporating time since diagnosis slightly attenuated the cancer-specific survival association (HR, 1.20; 95% CI, 0.92-1.55).
- Among adults without a history of cancer, having a high-deductible health plan was not associated with significantly worse overall survival (HR, 1.08; 95% CI, 0.96-1.21).
- General concerns over finances, worry about medical bills, cost-related delays, or forgone care, as well as cost-related underuse of medications were significant mediators of the associations between high-deductible health plan status and mortality outcomes among cancer survivors.
- High-deductible health plan status was also associated with worse cancer-specific survival among cancer survivors with incomes at least 400% of the federal poverty level (HR, 1.65; P for interaction = .03).
IN PRACTICE:
“These data suggest that insurance coverage that financially discourages medical care may financially discourage necessary care and ultimately worsen cancer outcomes,” the study authors wrote. “This danger appears to be unique to cancer survivors, as [high-deductible health plans] were not associated with survival among adults without a cancer history.”
SOURCE:
The study, led by Justin M. Barnes, MD, MS, Department of Radiation Oncology, Mayo Clinic in Rochester, Minnesota, was published online on January 29 in JAMA Network Open.
LIMITATIONS:
High-deductible health plan status was self-reported and may have been inaccurate for some individuals, with more than half of consumers being unsure about their annual deductible amount. The study lacked specific plan details and exact deductible amounts, and high-deductible health plan status was based on a single time point during survey participation. Additionally, researchers lacked information about cancer stage, cancer-directed therapies, recurrences, or complications, and cancer mortality could be from cancers diagnosed after survey participation.
DISCLOSURES:
Meera Ragavan, MD, MPH, disclosed receiving personal fees from Trial Library and AstraZeneca and grants from Merck, outside the submitted work. Other authors reported receiving personal fees from Costs of Care during the study. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
A new analysis found that high-deductible health plans were associated with worse overall survival and cancer-specific survival among cancer survivors. High-deductible plans, however, were not associated with worse overall survival among adults without a history of cancer.
METHODOLOGY:
- Previous studies have linked high-deductible health plans with decreased or delayed health utilization among cancer survivors and higher out-of-pocket costs. However, it’s not clear whether these plans influence cancer outcomes.
- In a cross-sectional study, researchers analyzed data from 147,254 respondents (aged 18 to 84 years) in the National Health Interview Survey from 2011 to 2018 and identified individuals with high-deductible plans — 2331 cancer survivors and 37,473 people without a history of cancer.
- The researchers acquired linked mortality files from the National Death Index, which included data on mortality events through the end of 2019.
- High-deductible health plans were identified through survey responses and defined as plans with yearly deductibles of at least $1200-$1350 for individuals or at least $2400-$2700 for families.
- The primary endpoints included overall survival and cancer-specific survival. Researchers adjusted for insurance status, marital status, sex, comorbidities, education, household income, geographic region, cancer site, and time since diagnosis.
TAKEAWAY:
- Among cancer survivors, having a high-deductible health plan was associated with worse overall survival (hazard ratio [HR], 1.46) and cancer-specific survival (HR, 1.34). However, sensitivity analyses incorporating time since diagnosis slightly attenuated the cancer-specific survival association (HR, 1.20; 95% CI, 0.92-1.55).
- Among adults without a history of cancer, having a high-deductible health plan was not associated with significantly worse overall survival (HR, 1.08; 95% CI, 0.96-1.21).
- General concerns over finances, worry about medical bills, cost-related delays, or forgone care, as well as cost-related underuse of medications were significant mediators of the associations between high-deductible health plan status and mortality outcomes among cancer survivors.
- High-deductible health plan status was also associated with worse cancer-specific survival among cancer survivors with incomes at least 400% of the federal poverty level (HR, 1.65; P for interaction = .03).
IN PRACTICE:
“These data suggest that insurance coverage that financially discourages medical care may financially discourage necessary care and ultimately worsen cancer outcomes,” the study authors wrote. “This danger appears to be unique to cancer survivors, as [high-deductible health plans] were not associated with survival among adults without a cancer history.”
SOURCE:
The study, led by Justin M. Barnes, MD, MS, Department of Radiation Oncology, Mayo Clinic in Rochester, Minnesota, was published online on January 29 in JAMA Network Open.
LIMITATIONS:
High-deductible health plan status was self-reported and may have been inaccurate for some individuals, with more than half of consumers being unsure about their annual deductible amount. The study lacked specific plan details and exact deductible amounts, and high-deductible health plan status was based on a single time point during survey participation. Additionally, researchers lacked information about cancer stage, cancer-directed therapies, recurrences, or complications, and cancer mortality could be from cancers diagnosed after survey participation.
DISCLOSURES:
Meera Ragavan, MD, MPH, disclosed receiving personal fees from Trial Library and AstraZeneca and grants from Merck, outside the submitted work. Other authors reported receiving personal fees from Costs of Care during the study. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
High-Deductible Plans May Be Linked to Worse Cancer Survival
High-Deductible Plans May Be Linked to Worse Cancer Survival