Clinical Topics & News

Fundraising walks for multiple sclerosis (MS) should be familiar to everyone nationwide. They serve to raise money for MS, bolster public awareness of the disease, and build a sense of community. But such in-person events took a big hit during the pandemic.

Recently, this news organization spoke with Kristin Gibbs, vice president of Walk MS for the National MS Society. She described the challenges posed by the COVID pandemic on the National MS Society’s efforts to fundraise on behalf of the MS community.
 

How has the National MS Society raised money before the pandemic?

We are a peer-to-peer fundraising event. That means our registered participants ask their family, friends and coworkers to support them by donating. More than 90% of our participants are friends-and-family teams, and nearly everyone who participates in Walk MS has a connection to MS. We do also have corporate and national teams that fundraise, as well as national and local sponsors that provide monetary support of Walk MS.



About how many Walk MS events were held nationally in an average prepandemic year?

Going back to 2019, we held almost 400 Walk MS events. Next year, the Society will host 234 events, with at least one in each state. The reduction in the number of events reflects a prepandemic strategy of focusing our limited resources in areas where we can have the biggest impact.



How has the pandemic impacted fundraising and community building/outreach?

Fewer people registered and participated in our virtual events in 2020 and 2021, and the pandemic made it challenging for participants to fundraise. While normally we might see more than 200,000 participants nationally, in 2021 we attracted 40,000. Our fundraising decreased from nearly $40 million in prepandemic years to around $20 million in 2021. Our experience is similar to that of most nonprofit peer-to-peer events. However, we were encouraged by the individuals who did support Walk MS during the pandemic, as their fundraising averages were higher than prepandemic campaigns.



What kinds of ‘virtual events’ were held during the pandemic lockdowns?

When it comes to building community, during the pandemic we innovatively utilized online gathering technology, especially Teams, to bring our Walk MS participants together. We held numerous meetings for Team Captains and conducted pre-event pep rallies online to help share information and generate excitement. We produced Facebook Live broadcasts and launched a cutting-edge online version of a Walk MS event called Walk MS On Demand. On Demand visitors could create a virtual bib, learn about the Society, watch inspirational videos, and secure information from national and local sponsors.

 

How is fundraising handled nationally and locally?

In 2022 we will have 234 Walk MS events spread across the country. We are anticipating 100,000 participants will register and our goal is to raise $24 million. Our fundraising will come from individuals, teams, and corporations who contribute at the local and national levels. We are hopeful the excitement surrounding safely being back in person will allow the Walk MS campaign to quickly regain its financial and community-building impact.



Has the pandemic impacted corporate contributions?

We were extremely lucky to maintain support of our national sponsors, and to engage a strong number of local partners. Because we offered the Walk MS On Demand online experience where sponsors could showcase their companies in innovative ways, even though we were virtual we could provide our important partners with a unique way to connect to our constituents. That made a tremendous difference. Also, our partners are strongly committed to the mission and knew their continued support during the pandemic was critical to our organization.



How is the money distributed? Who benefits and how? 

Walk MS is the United States’ 7^th-largest nonprofit walk series, and the 12^th-largest nonprofit event overall. Our Walk MS funds help provide support, programming, and research for individuals diagnosed with MS. Over the history of Walk MS, participants and sponsors have generated more than $1 billion to support those who live with MS.

Courtesy of National MS Society

Fundraising walks for multiple sclerosis (MS) should be familiar to everyone nationwide. They serve to raise money for MS, bolster public awareness of the disease, and build a sense of community. But such in-person events took a big hit during the pandemic.

Recently, this news organization spoke with Kristin Gibbs, vice president of Walk MS for the National MS Society. She described the challenges posed by the COVID pandemic on the National MS Society’s efforts to fundraise on behalf of the MS community.
 

How has the National MS Society raised money before the pandemic?

We are a peer-to-peer fundraising event. That means our registered participants ask their family, friends and coworkers to support them by donating. More than 90% of our participants are friends-and-family teams, and nearly everyone who participates in Walk MS has a connection to MS. We do also have corporate and national teams that fundraise, as well as national and local sponsors that provide monetary support of Walk MS.



About how many Walk MS events were held nationally in an average prepandemic year?

Going back to 2019, we held almost 400 Walk MS events. Next year, the Society will host 234 events, with at least one in each state. The reduction in the number of events reflects a prepandemic strategy of focusing our limited resources in areas where we can have the biggest impact.



How has the pandemic impacted fundraising and community building/outreach?

Fewer people registered and participated in our virtual events in 2020 and 2021, and the pandemic made it challenging for participants to fundraise. While normally we might see more than 200,000 participants nationally, in 2021 we attracted 40,000. Our fundraising decreased from nearly $40 million in prepandemic years to around $20 million in 2021. Our experience is similar to that of most nonprofit peer-to-peer events. However, we were encouraged by the individuals who did support Walk MS during the pandemic, as their fundraising averages were higher than prepandemic campaigns.



What kinds of ‘virtual events’ were held during the pandemic lockdowns?

When it comes to building community, during the pandemic we innovatively utilized online gathering technology, especially Teams, to bring our Walk MS participants together. We held numerous meetings for Team Captains and conducted pre-event pep rallies online to help share information and generate excitement. We produced Facebook Live broadcasts and launched a cutting-edge online version of a Walk MS event called Walk MS On Demand. On Demand visitors could create a virtual bib, learn about the Society, watch inspirational videos, and secure information from national and local sponsors.

 

How is fundraising handled nationally and locally?

In 2022 we will have 234 Walk MS events spread across the country. We are anticipating 100,000 participants will register and our goal is to raise $24 million. Our fundraising will come from individuals, teams, and corporations who contribute at the local and national levels. We are hopeful the excitement surrounding safely being back in person will allow the Walk MS campaign to quickly regain its financial and community-building impact.



Has the pandemic impacted corporate contributions?

We were extremely lucky to maintain support of our national sponsors, and to engage a strong number of local partners. Because we offered the Walk MS On Demand online experience where sponsors could showcase their companies in innovative ways, even though we were virtual we could provide our important partners with a unique way to connect to our constituents. That made a tremendous difference. Also, our partners are strongly committed to the mission and knew their continued support during the pandemic was critical to our organization.



How is the money distributed? Who benefits and how? 

Walk MS is the United States’ 7^th-largest nonprofit walk series, and the 12^th-largest nonprofit event overall. Our Walk MS funds help provide support, programming, and research for individuals diagnosed with MS. Over the history of Walk MS, participants and sponsors have generated more than $1 billion to support those who live with MS.

Courtesy of National MS Society

Fundraising walks for multiple sclerosis (MS) should be familiar to everyone nationwide. They serve to raise money for MS, bolster public awareness of the disease, and build a sense of community. But such in-person events took a big hit during the pandemic.

Recently, this news organization spoke with Kristin Gibbs, vice president of Walk MS for the National MS Society. She described the challenges posed by the COVID pandemic on the National MS Society’s efforts to fundraise on behalf of the MS community.
 

How has the National MS Society raised money before the pandemic?

We are a peer-to-peer fundraising event. That means our registered participants ask their family, friends and coworkers to support them by donating. More than 90% of our participants are friends-and-family teams, and nearly everyone who participates in Walk MS has a connection to MS. We do also have corporate and national teams that fundraise, as well as national and local sponsors that provide monetary support of Walk MS.



About how many Walk MS events were held nationally in an average prepandemic year?

Going back to 2019, we held almost 400 Walk MS events. Next year, the Society will host 234 events, with at least one in each state. The reduction in the number of events reflects a prepandemic strategy of focusing our limited resources in areas where we can have the biggest impact.



How has the pandemic impacted fundraising and community building/outreach?

Fewer people registered and participated in our virtual events in 2020 and 2021, and the pandemic made it challenging for participants to fundraise. While normally we might see more than 200,000 participants nationally, in 2021 we attracted 40,000. Our fundraising decreased from nearly $40 million in prepandemic years to around $20 million in 2021. Our experience is similar to that of most nonprofit peer-to-peer events. However, we were encouraged by the individuals who did support Walk MS during the pandemic, as their fundraising averages were higher than prepandemic campaigns.



What kinds of ‘virtual events’ were held during the pandemic lockdowns?

When it comes to building community, during the pandemic we innovatively utilized online gathering technology, especially Teams, to bring our Walk MS participants together. We held numerous meetings for Team Captains and conducted pre-event pep rallies online to help share information and generate excitement. We produced Facebook Live broadcasts and launched a cutting-edge online version of a Walk MS event called Walk MS On Demand. On Demand visitors could create a virtual bib, learn about the Society, watch inspirational videos, and secure information from national and local sponsors.

 

How is fundraising handled nationally and locally?

In 2022 we will have 234 Walk MS events spread across the country. We are anticipating 100,000 participants will register and our goal is to raise $24 million. Our fundraising will come from individuals, teams, and corporations who contribute at the local and national levels. We are hopeful the excitement surrounding safely being back in person will allow the Walk MS campaign to quickly regain its financial and community-building impact.



Has the pandemic impacted corporate contributions?

We were extremely lucky to maintain support of our national sponsors, and to engage a strong number of local partners. Because we offered the Walk MS On Demand online experience where sponsors could showcase their companies in innovative ways, even though we were virtual we could provide our important partners with a unique way to connect to our constituents. That made a tremendous difference. Also, our partners are strongly committed to the mission and knew their continued support during the pandemic was critical to our organization.



How is the money distributed? Who benefits and how? 

Walk MS is the United States’ 7^th-largest nonprofit walk series, and the 12^th-largest nonprofit event overall. Our Walk MS funds help provide support, programming, and research for individuals diagnosed with MS. Over the history of Walk MS, participants and sponsors have generated more than $1 billion to support those who live with MS.

Courtesy of National MS Society

Researchers writing in the British Journal of Dermatology confirm the long-term use of hydrochlorothiazide is associated with a dose-dependent, twofold increased risk of squamous cell carcinoma, compared with calcium channel blocker use.

The findings were originally reported in two Danish case-control studies in which physicians reported a fourfold increased risk of squamous cell carcinoma, and a moderate increased risk of basal cell carcinoma and cutaneous malignant melanoma in patients who used hydrochlorothiazide long-term.

And, while the new study did not find an increased risk of basal cell carcinoma and cutaneous malignant melanoma among long-term users of hydrochlorothiazide, they suggest that bendroflumethiazide “may be a safer alternative for patients at increased risk of skin cancer.” The long-term use of indapamide was associated with a moderately increased risk of cutaneous malignant melanoma but did not alter the risk of either squamous cell or basal cell carcinoma

“Our results suggest that bendroflumethiazide may be a safer alternative to hydrochlorothiazide and indapamide, especially for patients at increased risk of skin cancer, but future studies are needed to rule out a causal association between bendroflumethiazide and cutaneous malignant melanoma,” wrote authors who were led by Christoph R. Meier, PhD, a professor in pharmacy with University Hospital Basel (Switzerland) and a contributor to the Boston Collaborative Drug Surveillance Program.

This study adds to existing evidence that there is a dose-dependent increased risk of squamous cell carcinoma in users of high cumulative doses of hydrochlorothiazide, compared with non–hydrochlorothiazide users.

The study, an observational cohort study, was published earlier this year. It is based on data from the U.K.-based Clinical Practice Research Datalink. It included 271,154 new users of thiazides and thiazidelike diuretics, the majority at 87.6% having been prescribed bendroflumethiazide, 5.8% indapamide, and 3.6% hydrochlorothiazide. Outcomes were compared to those observed in 275,263 users of calcium channel blockers.

“The three primary outcomes of interest were a first-time diagnosis of cutaneous malignant melanoma, basal cell carcinoma, or squamous cell carcinoma,” the authors wrote.

Incidence rates and incidence rate ratios were estimated for both short-term and long-term users of thiazidelike diuretics and calcium channel blockers, while a propensity score (PS) analysis was done in order to control for 23 baseline covariates. The mean follow-up after PS weighting was 3.9 years for indapamide users and 5.5 years for hydrochlorothiazide users. Overall, the incidence rate ratios of squamous cell carcinoma were not markedly increased for either short-term or long-term users of thiazidelike diuretics, the authors reported.

In contrast, the incidence rate ratios of squamous cell carcinoma for hydrochlorothiazide users were increased by 29% for short-term users at an IRR of 1.29 while they were increased by almost twofold for long-term hydrochlorothiazide users at an IRR of 1.95.

Long-term use of hydrochlorothiazide was again associated with a 64% increased risk of basal cell carcinoma, compared with users of a renin-angiotensin inhibitor at a weighted IRR of 1.64.

In contrast, weighted incident rate ratios for basal cell carcinoma for both short-term and long-term thiazide users were not significantly different and results were similar for patients who took hydrochlorothiazide, indapamide, or bendroflumethiazide.

Weighted overall incident rate ratios for cutaneous malignant melanoma were not significantly different for either short-term or long-term users of thiazidelike diuretics, compared with calcium channel blocker users.

However, there was a 43% increased risk of cutaneous malignant melanoma among long-term indapamide users at a weighted IRR of 1.43, compared with calcium channel blocker users, the authors reported.

“Given the biological plausibility and the severe clinical implications of cutaneous malignant melanoma, this finding should be considered carefully,” they cautioned.

Limitations to the study include the fact that the database analyzed does not have information on sun exposure, skin characteristics, or socioeconomic status which may affect the amount of sun exposure participants received.

The authors had no conflicts of interest to declare.

Researchers writing in the British Journal of Dermatology confirm the long-term use of hydrochlorothiazide is associated with a dose-dependent, twofold increased risk of squamous cell carcinoma, compared with calcium channel blocker use.

The findings were originally reported in two Danish case-control studies in which physicians reported a fourfold increased risk of squamous cell carcinoma, and a moderate increased risk of basal cell carcinoma and cutaneous malignant melanoma in patients who used hydrochlorothiazide long-term.

And, while the new study did not find an increased risk of basal cell carcinoma and cutaneous malignant melanoma among long-term users of hydrochlorothiazide, they suggest that bendroflumethiazide “may be a safer alternative for patients at increased risk of skin cancer.” The long-term use of indapamide was associated with a moderately increased risk of cutaneous malignant melanoma but did not alter the risk of either squamous cell or basal cell carcinoma

“Our results suggest that bendroflumethiazide may be a safer alternative to hydrochlorothiazide and indapamide, especially for patients at increased risk of skin cancer, but future studies are needed to rule out a causal association between bendroflumethiazide and cutaneous malignant melanoma,” wrote authors who were led by Christoph R. Meier, PhD, a professor in pharmacy with University Hospital Basel (Switzerland) and a contributor to the Boston Collaborative Drug Surveillance Program.

This study adds to existing evidence that there is a dose-dependent increased risk of squamous cell carcinoma in users of high cumulative doses of hydrochlorothiazide, compared with non–hydrochlorothiazide users.

The study, an observational cohort study, was published earlier this year. It is based on data from the U.K.-based Clinical Practice Research Datalink. It included 271,154 new users of thiazides and thiazidelike diuretics, the majority at 87.6% having been prescribed bendroflumethiazide, 5.8% indapamide, and 3.6% hydrochlorothiazide. Outcomes were compared to those observed in 275,263 users of calcium channel blockers.

“The three primary outcomes of interest were a first-time diagnosis of cutaneous malignant melanoma, basal cell carcinoma, or squamous cell carcinoma,” the authors wrote.

Incidence rates and incidence rate ratios were estimated for both short-term and long-term users of thiazidelike diuretics and calcium channel blockers, while a propensity score (PS) analysis was done in order to control for 23 baseline covariates. The mean follow-up after PS weighting was 3.9 years for indapamide users and 5.5 years for hydrochlorothiazide users. Overall, the incidence rate ratios of squamous cell carcinoma were not markedly increased for either short-term or long-term users of thiazidelike diuretics, the authors reported.

In contrast, the incidence rate ratios of squamous cell carcinoma for hydrochlorothiazide users were increased by 29% for short-term users at an IRR of 1.29 while they were increased by almost twofold for long-term hydrochlorothiazide users at an IRR of 1.95.

Long-term use of hydrochlorothiazide was again associated with a 64% increased risk of basal cell carcinoma, compared with users of a renin-angiotensin inhibitor at a weighted IRR of 1.64.

In contrast, weighted incident rate ratios for basal cell carcinoma for both short-term and long-term thiazide users were not significantly different and results were similar for patients who took hydrochlorothiazide, indapamide, or bendroflumethiazide.

Weighted overall incident rate ratios for cutaneous malignant melanoma were not significantly different for either short-term or long-term users of thiazidelike diuretics, compared with calcium channel blocker users.

However, there was a 43% increased risk of cutaneous malignant melanoma among long-term indapamide users at a weighted IRR of 1.43, compared with calcium channel blocker users, the authors reported.

“Given the biological plausibility and the severe clinical implications of cutaneous malignant melanoma, this finding should be considered carefully,” they cautioned.

Limitations to the study include the fact that the database analyzed does not have information on sun exposure, skin characteristics, or socioeconomic status which may affect the amount of sun exposure participants received.

The authors had no conflicts of interest to declare.

Researchers writing in the British Journal of Dermatology confirm the long-term use of hydrochlorothiazide is associated with a dose-dependent, twofold increased risk of squamous cell carcinoma, compared with calcium channel blocker use.

The findings were originally reported in two Danish case-control studies in which physicians reported a fourfold increased risk of squamous cell carcinoma, and a moderate increased risk of basal cell carcinoma and cutaneous malignant melanoma in patients who used hydrochlorothiazide long-term.

And, while the new study did not find an increased risk of basal cell carcinoma and cutaneous malignant melanoma among long-term users of hydrochlorothiazide, they suggest that bendroflumethiazide “may be a safer alternative for patients at increased risk of skin cancer.” The long-term use of indapamide was associated with a moderately increased risk of cutaneous malignant melanoma but did not alter the risk of either squamous cell or basal cell carcinoma

“Our results suggest that bendroflumethiazide may be a safer alternative to hydrochlorothiazide and indapamide, especially for patients at increased risk of skin cancer, but future studies are needed to rule out a causal association between bendroflumethiazide and cutaneous malignant melanoma,” wrote authors who were led by Christoph R. Meier, PhD, a professor in pharmacy with University Hospital Basel (Switzerland) and a contributor to the Boston Collaborative Drug Surveillance Program.

This study adds to existing evidence that there is a dose-dependent increased risk of squamous cell carcinoma in users of high cumulative doses of hydrochlorothiazide, compared with non–hydrochlorothiazide users.

The study, an observational cohort study, was published earlier this year. It is based on data from the U.K.-based Clinical Practice Research Datalink. It included 271,154 new users of thiazides and thiazidelike diuretics, the majority at 87.6% having been prescribed bendroflumethiazide, 5.8% indapamide, and 3.6% hydrochlorothiazide. Outcomes were compared to those observed in 275,263 users of calcium channel blockers.

“The three primary outcomes of interest were a first-time diagnosis of cutaneous malignant melanoma, basal cell carcinoma, or squamous cell carcinoma,” the authors wrote.

Incidence rates and incidence rate ratios were estimated for both short-term and long-term users of thiazidelike diuretics and calcium channel blockers, while a propensity score (PS) analysis was done in order to control for 23 baseline covariates. The mean follow-up after PS weighting was 3.9 years for indapamide users and 5.5 years for hydrochlorothiazide users. Overall, the incidence rate ratios of squamous cell carcinoma were not markedly increased for either short-term or long-term users of thiazidelike diuretics, the authors reported.

In contrast, the incidence rate ratios of squamous cell carcinoma for hydrochlorothiazide users were increased by 29% for short-term users at an IRR of 1.29 while they were increased by almost twofold for long-term hydrochlorothiazide users at an IRR of 1.95.

Long-term use of hydrochlorothiazide was again associated with a 64% increased risk of basal cell carcinoma, compared with users of a renin-angiotensin inhibitor at a weighted IRR of 1.64.

In contrast, weighted incident rate ratios for basal cell carcinoma for both short-term and long-term thiazide users were not significantly different and results were similar for patients who took hydrochlorothiazide, indapamide, or bendroflumethiazide.

Weighted overall incident rate ratios for cutaneous malignant melanoma were not significantly different for either short-term or long-term users of thiazidelike diuretics, compared with calcium channel blocker users.

However, there was a 43% increased risk of cutaneous malignant melanoma among long-term indapamide users at a weighted IRR of 1.43, compared with calcium channel blocker users, the authors reported.

“Given the biological plausibility and the severe clinical implications of cutaneous malignant melanoma, this finding should be considered carefully,” they cautioned.

Limitations to the study include the fact that the database analyzed does not have information on sun exposure, skin characteristics, or socioeconomic status which may affect the amount of sun exposure participants received.

The authors had no conflicts of interest to declare.

An increasing number of people who are unvaccinated and pregnant are being hospitalized for COVID-19, report investigators who saw hospital admissions double in a single year.

“With the surge, we had expected to begin treating patients who developed severe or critical illness again in pregnancy,” says Emily Adhikari, MD, from the University of Texas Southwestern Medical Center in Dallas. “But we did not expect the level of respiratory illness that we began to see in our patients. That was a surprise and an alarming finding that we felt was really important to get out there.”

The researchers followed more than 1,500 pregnant women diagnosed with COVID-19 who received care from Parkland Health and Hospital System in Dallas County, one of the nation’s busiest for deliveries. After the emergence of the Delta variant, the number of pregnant women hospitalized with COVID-19 more than doubled over the previous year.

And 82 pregnant women went on to develop severe or critical COVID, they report in their study, published online in the American Journal of Obstetrics and Gynecology. All but 1 of these patients were unvaccinated, 10 needed a ventilator, and two died.

The proportion of cases that were critical was about 5% in 2020. However, in April 2021, even though the number of total cases remained low, the number of severe illnesses started to rise. After the Delta variant became dominant, both the number and severity of cases increased, and after August 2021, more than 25% of pregnant people diagnosed with COVID-19 required hospitalization.
 

Hospitalizations Double

“We need to focus and really act urgently to recommend vaccination in pregnancy because that is the primary prevention tool that we have,” says Dr. Adhikari. “We do not have a proven cure for this illness, and that is important to know.”

These findings, which focus on a vulnerable population, are especially important given the elevated prevalence of COVID-19 in pregnant people of lower economic status, said Lissette Tanner, MD, MPH, from Emory University in Atlanta, who was not involved with the study.

“There are higher rates of hospitalization and death among Black, Hispanic, and Native American communities,” she reported. “It is essential to know how the virus is affecting those most affected and often most disadvantaged to deal with the pandemic.”

Vaccination rates are low in this population; just 19.2% of pregnant women receive at least one dose during pregnancy, according to the CDC. But pregnancy confers a higher risk for severe COVID-19 illness and for adverse outcomes, such as preterm birth and stillbirth.

Of the 665 people in the study cohort who were pregnant or had given birth when the vaccines were available, only 21.4% received at least one dose of a COVID-19 vaccine.

Given the increased risk for COVID-19 during pregnancy, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC recommend vaccination for people who are pregnant, breastfeeding, or trying to get pregnant.

According to ACOG, pregnant women who are fully vaccinated can follow the same guidelines as everyone else who is fully vaccinated; however, to prevent breakthrough infections, they might want to continue wearing a mask. ACOG also recommends that those not fully vaccinated follow physical-distancing guidelines and limit contact with people as much as possible to avoid infection.

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

An increasing number of people who are unvaccinated and pregnant are being hospitalized for COVID-19, report investigators who saw hospital admissions double in a single year.

“With the surge, we had expected to begin treating patients who developed severe or critical illness again in pregnancy,” says Emily Adhikari, MD, from the University of Texas Southwestern Medical Center in Dallas. “But we did not expect the level of respiratory illness that we began to see in our patients. That was a surprise and an alarming finding that we felt was really important to get out there.”

The researchers followed more than 1,500 pregnant women diagnosed with COVID-19 who received care from Parkland Health and Hospital System in Dallas County, one of the nation’s busiest for deliveries. After the emergence of the Delta variant, the number of pregnant women hospitalized with COVID-19 more than doubled over the previous year.

And 82 pregnant women went on to develop severe or critical COVID, they report in their study, published online in the American Journal of Obstetrics and Gynecology. All but 1 of these patients were unvaccinated, 10 needed a ventilator, and two died.

The proportion of cases that were critical was about 5% in 2020. However, in April 2021, even though the number of total cases remained low, the number of severe illnesses started to rise. After the Delta variant became dominant, both the number and severity of cases increased, and after August 2021, more than 25% of pregnant people diagnosed with COVID-19 required hospitalization.
 

Hospitalizations Double

“We need to focus and really act urgently to recommend vaccination in pregnancy because that is the primary prevention tool that we have,” says Dr. Adhikari. “We do not have a proven cure for this illness, and that is important to know.”

These findings, which focus on a vulnerable population, are especially important given the elevated prevalence of COVID-19 in pregnant people of lower economic status, said Lissette Tanner, MD, MPH, from Emory University in Atlanta, who was not involved with the study.

“There are higher rates of hospitalization and death among Black, Hispanic, and Native American communities,” she reported. “It is essential to know how the virus is affecting those most affected and often most disadvantaged to deal with the pandemic.”

Vaccination rates are low in this population; just 19.2% of pregnant women receive at least one dose during pregnancy, according to the CDC. But pregnancy confers a higher risk for severe COVID-19 illness and for adverse outcomes, such as preterm birth and stillbirth.

Of the 665 people in the study cohort who were pregnant or had given birth when the vaccines were available, only 21.4% received at least one dose of a COVID-19 vaccine.

Given the increased risk for COVID-19 during pregnancy, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC recommend vaccination for people who are pregnant, breastfeeding, or trying to get pregnant.

According to ACOG, pregnant women who are fully vaccinated can follow the same guidelines as everyone else who is fully vaccinated; however, to prevent breakthrough infections, they might want to continue wearing a mask. ACOG also recommends that those not fully vaccinated follow physical-distancing guidelines and limit contact with people as much as possible to avoid infection.

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

An increasing number of people who are unvaccinated and pregnant are being hospitalized for COVID-19, report investigators who saw hospital admissions double in a single year.

“With the surge, we had expected to begin treating patients who developed severe or critical illness again in pregnancy,” says Emily Adhikari, MD, from the University of Texas Southwestern Medical Center in Dallas. “But we did not expect the level of respiratory illness that we began to see in our patients. That was a surprise and an alarming finding that we felt was really important to get out there.”

The researchers followed more than 1,500 pregnant women diagnosed with COVID-19 who received care from Parkland Health and Hospital System in Dallas County, one of the nation’s busiest for deliveries. After the emergence of the Delta variant, the number of pregnant women hospitalized with COVID-19 more than doubled over the previous year.

And 82 pregnant women went on to develop severe or critical COVID, they report in their study, published online in the American Journal of Obstetrics and Gynecology. All but 1 of these patients were unvaccinated, 10 needed a ventilator, and two died.

The proportion of cases that were critical was about 5% in 2020. However, in April 2021, even though the number of total cases remained low, the number of severe illnesses started to rise. After the Delta variant became dominant, both the number and severity of cases increased, and after August 2021, more than 25% of pregnant people diagnosed with COVID-19 required hospitalization.
 

Hospitalizations Double

“We need to focus and really act urgently to recommend vaccination in pregnancy because that is the primary prevention tool that we have,” says Dr. Adhikari. “We do not have a proven cure for this illness, and that is important to know.”

These findings, which focus on a vulnerable population, are especially important given the elevated prevalence of COVID-19 in pregnant people of lower economic status, said Lissette Tanner, MD, MPH, from Emory University in Atlanta, who was not involved with the study.

“There are higher rates of hospitalization and death among Black, Hispanic, and Native American communities,” she reported. “It is essential to know how the virus is affecting those most affected and often most disadvantaged to deal with the pandemic.”

Vaccination rates are low in this population; just 19.2% of pregnant women receive at least one dose during pregnancy, according to the CDC. But pregnancy confers a higher risk for severe COVID-19 illness and for adverse outcomes, such as preterm birth and stillbirth.

Of the 665 people in the study cohort who were pregnant or had given birth when the vaccines were available, only 21.4% received at least one dose of a COVID-19 vaccine.

Given the increased risk for COVID-19 during pregnancy, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC recommend vaccination for people who are pregnant, breastfeeding, or trying to get pregnant.

According to ACOG, pregnant women who are fully vaccinated can follow the same guidelines as everyone else who is fully vaccinated; however, to prevent breakthrough infections, they might want to continue wearing a mask. ACOG also recommends that those not fully vaccinated follow physical-distancing guidelines and limit contact with people as much as possible to avoid infection.

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

Implementing a selective type-and-screen blood testing policy in the labor and delivery unit was associated with projected annual savings of close to $200,000, a large single-center study found. Furthermore, there was no evidence of increased maternal morbidity in the university-based facility performing more than 4,400 deliveries per year, according to Ashley E. Benson, MD, MA, of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, and colleagues.

The study, published in Obstetrics & Gynecology, evaluated patient safety, resource utilization, and transfusion-related costs after a policy change from universal type and screen to selective, risk-based type and screen on admission to labor and delivery.

“There had been some national interest in moving toward decreased resource utilization, and findings that universal screening was not cost effective,” Dr. Benson, who has since relocated to Oregon Health & Science University, Portland, said in an interview. An earlier cost-effective modeling study at her center had suggested that universal test and screen was not cost effective and likely not safer either. “So based on that data we felt an implementation study was warranted.”

The switch to a selective policy was made in 2018, after which her group compared outcomes from October 2017 to September 2019, looking those both 1 year preimplementation and 1 year post implementation.

One year post implementation, the following outcomes emerged, compared with preimplementation:

• Overall projected saving of $181,000 a year in the maternity unit
• Lower mean monthly type- and screen-related costs, such as those for ABO typing, antibody screen, and antibody workup. cross-matches, hold clots, and transfused products: $9,753 vs. $20,676 in the preimplementation year (P < .001)
• A lower mean monthly cost of total transfusion preparedness: $25,090 vs. $39,211 (P < .001)
• No differences in emergency-release transfusion events (four vs. three, P = .99),the study’s primary safety outcome
• Fewer emergency-release red blood cell units transfused (9 vs. 24, P = .002) and O-negative RBC units transfused (8 vs. 18, P = .016)
• No differences in hysterectomies (0.05% vs. 0.1%, P = .44) and ICU admissions (0.45% vs. 0.51%, P = .43)

“In a year of selective type and screen, we saw a 51% reduction in costs related to type and screen, and a 38% reduction in overall transfusion-related costs,” the authors wrote. “This study supports other literature suggesting that more judicious use of type and screen may be safe and cost effective.”

Dr. Benson said the results were positively received when presented a meeting 2 years ago but the published version has yet to prompt feedback.
 

The study

Antepartum patients underwent transfusion preparedness tests according to the center’s standard antenatal admission order sets and were risk stratified in alignment with California Maternal Quality Care Collaborative recommendations. The mean maternal age of patients in both time periods was similar at just over 29 years and the mean gestational age at delivery was just under 38 weeks.

Under the new policy, a “hold clot” is obtained for women stratified as low or medium risk on admission. In this instance, a tube of patient blood is held in the blood bank but processed only if needed, as in the event of active hemorrhage or an order for transfusion. A blood cross-match is obtained on all women stratified as high risk or having a prior positive antibody screen.

Relevant costs were the direct costs of transfusion-related testing in the labor and delivery unit from a health system perspective.

Obstetric hemorrhage is the leading cause of maternal death worldwide, the authors pointed out. While transfusion in obstetric patients occurs in only 1% or 2% of all deliveries it is nevertheless difficult to predict which patients will need transfusion, with only 2%-8% of those stratified as high risk ultimately requiring transfusion. Although obstetric hemorrhage safety bundles recommend risk stratification on admission to labor and delivery with selective type and screen for higher-risk individuals, for safety and simplicity’s sake, many labor and delivery units perform universal type and screen.

The authors cautioned that these results occurred in an academic tertiary care center with systems fine-tuned to deal with active hemorrhage and deliver timely transfusable blood. “At the moment we don’t have enough data to say whether the selective approach would be safe in hospitals with more limited blood bank capacity and access and fewer transfusion specialists in a setting optimized to respond to emergent needs, Dr. Benson said.

Katayoun F. M. Fomani, MD, a transfusion medicine specialist and medical director of blood bank and transfusion services at Long Island Jewish Medical Center, New York, agreed. “This approach only works in a controlled environment such as in this study where eligible women were assessed antenatally at the same center, but it would not work at every institution,” she said in an interview. “In addition, all patients were assessed according to the California Collaborative guideline, which itself increases the safety level but is not followed everywhere.”

The obstetric division at her hospital in New York adheres to the universal type and screen. “We have patients coming in from outside whose antenatal testing was not done at our hospital,” she said. “For this selective approach to work you need a controlled population and the electronic resources and personnel to follow each patient carefully.”

The authors indicated no specific funding for this study and disclosed no potential conflicts of interest. Dr. Fomani had no potential competing interests to declare.

Implementing a selective type-and-screen blood testing policy in the labor and delivery unit was associated with projected annual savings of close to $200,000, a large single-center study found. Furthermore, there was no evidence of increased maternal morbidity in the university-based facility performing more than 4,400 deliveries per year, according to Ashley E. Benson, MD, MA, of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, and colleagues.

The study, published in Obstetrics & Gynecology, evaluated patient safety, resource utilization, and transfusion-related costs after a policy change from universal type and screen to selective, risk-based type and screen on admission to labor and delivery.

“There had been some national interest in moving toward decreased resource utilization, and findings that universal screening was not cost effective,” Dr. Benson, who has since relocated to Oregon Health & Science University, Portland, said in an interview. An earlier cost-effective modeling study at her center had suggested that universal test and screen was not cost effective and likely not safer either. “So based on that data we felt an implementation study was warranted.”

The switch to a selective policy was made in 2018, after which her group compared outcomes from October 2017 to September 2019, looking those both 1 year preimplementation and 1 year post implementation.

One year post implementation, the following outcomes emerged, compared with preimplementation:

• Overall projected saving of $181,000 a year in the maternity unit
• Lower mean monthly type- and screen-related costs, such as those for ABO typing, antibody screen, and antibody workup. cross-matches, hold clots, and transfused products: $9,753 vs. $20,676 in the preimplementation year (P < .001)
• A lower mean monthly cost of total transfusion preparedness: $25,090 vs. $39,211 (P < .001)
• No differences in emergency-release transfusion events (four vs. three, P = .99),the study’s primary safety outcome
• Fewer emergency-release red blood cell units transfused (9 vs. 24, P = .002) and O-negative RBC units transfused (8 vs. 18, P = .016)
• No differences in hysterectomies (0.05% vs. 0.1%, P = .44) and ICU admissions (0.45% vs. 0.51%, P = .43)

“In a year of selective type and screen, we saw a 51% reduction in costs related to type and screen, and a 38% reduction in overall transfusion-related costs,” the authors wrote. “This study supports other literature suggesting that more judicious use of type and screen may be safe and cost effective.”

Dr. Benson said the results were positively received when presented a meeting 2 years ago but the published version has yet to prompt feedback.
 

The study

Antepartum patients underwent transfusion preparedness tests according to the center’s standard antenatal admission order sets and were risk stratified in alignment with California Maternal Quality Care Collaborative recommendations. The mean maternal age of patients in both time periods was similar at just over 29 years and the mean gestational age at delivery was just under 38 weeks.

Under the new policy, a “hold clot” is obtained for women stratified as low or medium risk on admission. In this instance, a tube of patient blood is held in the blood bank but processed only if needed, as in the event of active hemorrhage or an order for transfusion. A blood cross-match is obtained on all women stratified as high risk or having a prior positive antibody screen.

Relevant costs were the direct costs of transfusion-related testing in the labor and delivery unit from a health system perspective.

Obstetric hemorrhage is the leading cause of maternal death worldwide, the authors pointed out. While transfusion in obstetric patients occurs in only 1% or 2% of all deliveries it is nevertheless difficult to predict which patients will need transfusion, with only 2%-8% of those stratified as high risk ultimately requiring transfusion. Although obstetric hemorrhage safety bundles recommend risk stratification on admission to labor and delivery with selective type and screen for higher-risk individuals, for safety and simplicity’s sake, many labor and delivery units perform universal type and screen.

The authors cautioned that these results occurred in an academic tertiary care center with systems fine-tuned to deal with active hemorrhage and deliver timely transfusable blood. “At the moment we don’t have enough data to say whether the selective approach would be safe in hospitals with more limited blood bank capacity and access and fewer transfusion specialists in a setting optimized to respond to emergent needs, Dr. Benson said.

Katayoun F. M. Fomani, MD, a transfusion medicine specialist and medical director of blood bank and transfusion services at Long Island Jewish Medical Center, New York, agreed. “This approach only works in a controlled environment such as in this study where eligible women were assessed antenatally at the same center, but it would not work at every institution,” she said in an interview. “In addition, all patients were assessed according to the California Collaborative guideline, which itself increases the safety level but is not followed everywhere.”

The obstetric division at her hospital in New York adheres to the universal type and screen. “We have patients coming in from outside whose antenatal testing was not done at our hospital,” she said. “For this selective approach to work you need a controlled population and the electronic resources and personnel to follow each patient carefully.”

The authors indicated no specific funding for this study and disclosed no potential conflicts of interest. Dr. Fomani had no potential competing interests to declare.

Implementing a selective type-and-screen blood testing policy in the labor and delivery unit was associated with projected annual savings of close to $200,000, a large single-center study found. Furthermore, there was no evidence of increased maternal morbidity in the university-based facility performing more than 4,400 deliveries per year, according to Ashley E. Benson, MD, MA, of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, and colleagues.

The study, published in Obstetrics & Gynecology, evaluated patient safety, resource utilization, and transfusion-related costs after a policy change from universal type and screen to selective, risk-based type and screen on admission to labor and delivery.

“There had been some national interest in moving toward decreased resource utilization, and findings that universal screening was not cost effective,” Dr. Benson, who has since relocated to Oregon Health & Science University, Portland, said in an interview. An earlier cost-effective modeling study at her center had suggested that universal test and screen was not cost effective and likely not safer either. “So based on that data we felt an implementation study was warranted.”

The switch to a selective policy was made in 2018, after which her group compared outcomes from October 2017 to September 2019, looking those both 1 year preimplementation and 1 year post implementation.

One year post implementation, the following outcomes emerged, compared with preimplementation:

• Overall projected saving of $181,000 a year in the maternity unit
• Lower mean monthly type- and screen-related costs, such as those for ABO typing, antibody screen, and antibody workup. cross-matches, hold clots, and transfused products: $9,753 vs. $20,676 in the preimplementation year (P < .001)
• A lower mean monthly cost of total transfusion preparedness: $25,090 vs. $39,211 (P < .001)
• No differences in emergency-release transfusion events (four vs. three, P = .99),the study’s primary safety outcome
• Fewer emergency-release red blood cell units transfused (9 vs. 24, P = .002) and O-negative RBC units transfused (8 vs. 18, P = .016)
• No differences in hysterectomies (0.05% vs. 0.1%, P = .44) and ICU admissions (0.45% vs. 0.51%, P = .43)

“In a year of selective type and screen, we saw a 51% reduction in costs related to type and screen, and a 38% reduction in overall transfusion-related costs,” the authors wrote. “This study supports other literature suggesting that more judicious use of type and screen may be safe and cost effective.”

Dr. Benson said the results were positively received when presented a meeting 2 years ago but the published version has yet to prompt feedback.
 

The study

Antepartum patients underwent transfusion preparedness tests according to the center’s standard antenatal admission order sets and were risk stratified in alignment with California Maternal Quality Care Collaborative recommendations. The mean maternal age of patients in both time periods was similar at just over 29 years and the mean gestational age at delivery was just under 38 weeks.

Under the new policy, a “hold clot” is obtained for women stratified as low or medium risk on admission. In this instance, a tube of patient blood is held in the blood bank but processed only if needed, as in the event of active hemorrhage or an order for transfusion. A blood cross-match is obtained on all women stratified as high risk or having a prior positive antibody screen.

Relevant costs were the direct costs of transfusion-related testing in the labor and delivery unit from a health system perspective.

Obstetric hemorrhage is the leading cause of maternal death worldwide, the authors pointed out. While transfusion in obstetric patients occurs in only 1% or 2% of all deliveries it is nevertheless difficult to predict which patients will need transfusion, with only 2%-8% of those stratified as high risk ultimately requiring transfusion. Although obstetric hemorrhage safety bundles recommend risk stratification on admission to labor and delivery with selective type and screen for higher-risk individuals, for safety and simplicity’s sake, many labor and delivery units perform universal type and screen.

The authors cautioned that these results occurred in an academic tertiary care center with systems fine-tuned to deal with active hemorrhage and deliver timely transfusable blood. “At the moment we don’t have enough data to say whether the selective approach would be safe in hospitals with more limited blood bank capacity and access and fewer transfusion specialists in a setting optimized to respond to emergent needs, Dr. Benson said.

Katayoun F. M. Fomani, MD, a transfusion medicine specialist and medical director of blood bank and transfusion services at Long Island Jewish Medical Center, New York, agreed. “This approach only works in a controlled environment such as in this study where eligible women were assessed antenatally at the same center, but it would not work at every institution,” she said in an interview. “In addition, all patients were assessed according to the California Collaborative guideline, which itself increases the safety level but is not followed everywhere.”

The obstetric division at her hospital in New York adheres to the universal type and screen. “We have patients coming in from outside whose antenatal testing was not done at our hospital,” she said. “For this selective approach to work you need a controlled population and the electronic resources and personnel to follow each patient carefully.”

The authors indicated no specific funding for this study and disclosed no potential conflicts of interest. Dr. Fomani had no potential competing interests to declare.

In ongoing efforts to investigate a link between vitamin D and colorectal cancer, new research shows that women who consume higher levels of vitamin D – particularly from dietary sources – have a reduced risk of developing early-onset colorectal cancer, compared with those who have lower levels.

This is according to an observational study published in the journal Gastroenterology. The study included 94,205 women (aged 25-42 years) who were followed between 1991 and 2015 during which 111 incident cases of early-onset colorectal cancer were diagnosed. Among 29,186 women who had at least one lower endoscopy from 1991 to 2011, 1,439 newly diagnosed conventional adenomas and 1,878 serrated polyps were found.

Women who consumed the highest average levels of total vitamin D of 450 IU per day, compared with those consuming less than 300 IU per day, showed a significantly reduced risk of early-onset colorectal cancer. Consuming 400 IU each day was associated with a 54% reduced risk of early-onset colorectal cancer.

“If confirmed, our findings could potentially lead to recommendations for higher vitamin D intake as an inexpensive low-risk complement to colorectal cancer screening as a prevention strategy for adults younger than age 50,” wrote the study authors, led by Edward L. Giovannucci, MD, ScD, of the Harvard School of Public Health, Boston.

Associations between vitamin D levels and colorectal cancer have been documented in review articles over the years. The link is the subject of 10 recently completed or ongoing clinical trials. Few studies have focused on early colorectal cancer and vitamin D intake. Unlike advanced colorectal cancer, the early-onset form of the disease is not as strongly associated with the traditional risk factors of a family history of colorectal cancer and it is therefore believed to be more strongly linked to other factors, such as lifestyle and diet – including vitamin D supplementation.
 

The evidence is in, but it’s incomplete

In addition to the new study in Gastroenterology, other observational studies, as well as laboratory and animal studies, suggest that vitamin D plays a role in inhibiting carcinogenesis. Vitamin D, researchers theorize, contains anti-inflammatory, immunomodulatory, and tumor angiogenesis properties that can slow the growth of tumors, but the evidence is mixed.

A meta-analysis of 137,567 patients published in 2013 in Preventive Medicine found an inverse association between 25-hydroxyvitamin D (25[OH]D) and total cancer mortality in women, but not among men. Three meta-analyses published in 2014 and 2019 found that vitamin D supplementation does not affect cancer incidence but does significantly reduce total cancer mortality rates by 12%-13%.

In 2019, researchers led by Marjorie McCullough, ScD, RD, senior scientific director of epidemiology research for the American Cancer Society, described a causal relationship between circulating vitamin D and colorectal cancer risk among 17 cohorts from a pooled analysis. “Our study suggests that optimal circulating 25(OH)D concentrations for colorectal cancer risk reduction are 75-100 nmol/L, [which is] higher than current Institute of Medicine recommendations for bone health,” she and colleagues wrote. Their findings were published in the Journal of the National Cancer Institute.

The Vitamin D and Omega-3 Trial (VITAL) published in 2019 in the New England Journal of Medicine, showed no significant effect of vitamin D₃ supplementation of 2,000 IU/day in lowering the risk of invasive cancer or cardiovascular events.

Despite the mixed results, studies offer valuable insights into cancer risks, said Scott Kopetz, MD, PhD, codirector of the colorectal cancer moon shot research program at the University of Texas MD Anderson Cancer Center, Houston.

The Gastroenterology study is noteworthy because it focuses on early-onset colorectal cancer, he said.

“[The authors] demonstrate for the first time that there is an association of vitamin D intake with early-onset colorectal incidence, especially in the left side of the colon and rectum where the increase in early onset colorectal cancer manifests,” Dr. Kopetz said. “The analysis suggests that it may require long-term vitamin D intake to derive the benefit, which may explain why some shorter-term randomized studies failed to demonstrate.”

In animal models, vitamin D₃ is “estimated to lower the incidence of colorectal cancer by 50%,” according to Lidija Klampfer, PhD, formerly a molecular biologist and senior research scientist with the Southern Research Institute, Birmingham, Ala.

Dr. Klampfer, a founding partner of ProteXase Therapeutics, is the author of an article on vitamin D and colon cancer published in 2014 in the World Journal of Gastrointestinal Oncology.

“The levels of vitamin D3 appear to be an essential determinant for the development and progression of colon cancer and supplementation with vitamin D3 is effective in suppressing intestinal tumorigenesis in animal models,” she wrote. “Studies have shown that 1,25 dihydroxyvitamin D₃ can inhibit tumor-promoting inflammation leading to the development and progression of colon cancer.”
 

The hazards of a vitamin D deficiency

A severe vitamin D deficiency is associated with compromised bone and muscle health, calcium absorption, immunity, heart function and it can affect mood. Other studies have linked vitamin D deficiency to colorectal cancer, blood cancers, and bowel cancer.

Serum 25(OH)D is the primary circulating form of vitamin D and is considered the best marker for assessing vitamin D status, says Karin Amrein, MD, MSc, an endocrinologist with the Medical University of Graz (Austria). She was the lead author of a review on vitamin D deficiency published in January 2020 in the European Journal of Clinical Nutrition.

The Global Consensus Recommendations define vitamin D insufficiency as 12-20 ng/mL (30-50 nmol/L) and a deficiency as a serum 25OHD concentration less than 12 ng/mL (30 nmol/L). A deficiency in adults is usually treated with 50,000 IU of vitamin D2 or D3 once weekly for 8 weeks followed by maintenance dosages of cholecalciferol (vitamin D₃) at 800-1,000 IU daily from dietary and supplemental sources.

Screening is recommended for individuals who exhibit symptoms and conditions associated with a vitamin D deficiency, but there is little agreement on recommended serum levels because every individual is different, according to the U.S. Preventive Services Task Force which updated its vitamin D recommendations in April for the first time in 7 years.

In ongoing efforts to investigate a link between vitamin D and colorectal cancer, new research shows that women who consume higher levels of vitamin D – particularly from dietary sources – have a reduced risk of developing early-onset colorectal cancer, compared with those who have lower levels.

This is according to an observational study published in the journal Gastroenterology. The study included 94,205 women (aged 25-42 years) who were followed between 1991 and 2015 during which 111 incident cases of early-onset colorectal cancer were diagnosed. Among 29,186 women who had at least one lower endoscopy from 1991 to 2011, 1,439 newly diagnosed conventional adenomas and 1,878 serrated polyps were found.

Women who consumed the highest average levels of total vitamin D of 450 IU per day, compared with those consuming less than 300 IU per day, showed a significantly reduced risk of early-onset colorectal cancer. Consuming 400 IU each day was associated with a 54% reduced risk of early-onset colorectal cancer.

“If confirmed, our findings could potentially lead to recommendations for higher vitamin D intake as an inexpensive low-risk complement to colorectal cancer screening as a prevention strategy for adults younger than age 50,” wrote the study authors, led by Edward L. Giovannucci, MD, ScD, of the Harvard School of Public Health, Boston.

Associations between vitamin D levels and colorectal cancer have been documented in review articles over the years. The link is the subject of 10 recently completed or ongoing clinical trials. Few studies have focused on early colorectal cancer and vitamin D intake. Unlike advanced colorectal cancer, the early-onset form of the disease is not as strongly associated with the traditional risk factors of a family history of colorectal cancer and it is therefore believed to be more strongly linked to other factors, such as lifestyle and diet – including vitamin D supplementation.
 

The evidence is in, but it’s incomplete

In addition to the new study in Gastroenterology, other observational studies, as well as laboratory and animal studies, suggest that vitamin D plays a role in inhibiting carcinogenesis. Vitamin D, researchers theorize, contains anti-inflammatory, immunomodulatory, and tumor angiogenesis properties that can slow the growth of tumors, but the evidence is mixed.

A meta-analysis of 137,567 patients published in 2013 in Preventive Medicine found an inverse association between 25-hydroxyvitamin D (25[OH]D) and total cancer mortality in women, but not among men. Three meta-analyses published in 2014 and 2019 found that vitamin D supplementation does not affect cancer incidence but does significantly reduce total cancer mortality rates by 12%-13%.

In 2019, researchers led by Marjorie McCullough, ScD, RD, senior scientific director of epidemiology research for the American Cancer Society, described a causal relationship between circulating vitamin D and colorectal cancer risk among 17 cohorts from a pooled analysis. “Our study suggests that optimal circulating 25(OH)D concentrations for colorectal cancer risk reduction are 75-100 nmol/L, [which is] higher than current Institute of Medicine recommendations for bone health,” she and colleagues wrote. Their findings were published in the Journal of the National Cancer Institute.

The Vitamin D and Omega-3 Trial (VITAL) published in 2019 in the New England Journal of Medicine, showed no significant effect of vitamin D₃ supplementation of 2,000 IU/day in lowering the risk of invasive cancer or cardiovascular events.

Despite the mixed results, studies offer valuable insights into cancer risks, said Scott Kopetz, MD, PhD, codirector of the colorectal cancer moon shot research program at the University of Texas MD Anderson Cancer Center, Houston.

The Gastroenterology study is noteworthy because it focuses on early-onset colorectal cancer, he said.

“[The authors] demonstrate for the first time that there is an association of vitamin D intake with early-onset colorectal incidence, especially in the left side of the colon and rectum where the increase in early onset colorectal cancer manifests,” Dr. Kopetz said. “The analysis suggests that it may require long-term vitamin D intake to derive the benefit, which may explain why some shorter-term randomized studies failed to demonstrate.”

In animal models, vitamin D₃ is “estimated to lower the incidence of colorectal cancer by 50%,” according to Lidija Klampfer, PhD, formerly a molecular biologist and senior research scientist with the Southern Research Institute, Birmingham, Ala.

Dr. Klampfer, a founding partner of ProteXase Therapeutics, is the author of an article on vitamin D and colon cancer published in 2014 in the World Journal of Gastrointestinal Oncology.

“The levels of vitamin D3 appear to be an essential determinant for the development and progression of colon cancer and supplementation with vitamin D3 is effective in suppressing intestinal tumorigenesis in animal models,” she wrote. “Studies have shown that 1,25 dihydroxyvitamin D₃ can inhibit tumor-promoting inflammation leading to the development and progression of colon cancer.”
 

The hazards of a vitamin D deficiency

A severe vitamin D deficiency is associated with compromised bone and muscle health, calcium absorption, immunity, heart function and it can affect mood. Other studies have linked vitamin D deficiency to colorectal cancer, blood cancers, and bowel cancer.

Serum 25(OH)D is the primary circulating form of vitamin D and is considered the best marker for assessing vitamin D status, says Karin Amrein, MD, MSc, an endocrinologist with the Medical University of Graz (Austria). She was the lead author of a review on vitamin D deficiency published in January 2020 in the European Journal of Clinical Nutrition.

The Global Consensus Recommendations define vitamin D insufficiency as 12-20 ng/mL (30-50 nmol/L) and a deficiency as a serum 25OHD concentration less than 12 ng/mL (30 nmol/L). A deficiency in adults is usually treated with 50,000 IU of vitamin D2 or D3 once weekly for 8 weeks followed by maintenance dosages of cholecalciferol (vitamin D₃) at 800-1,000 IU daily from dietary and supplemental sources.

Screening is recommended for individuals who exhibit symptoms and conditions associated with a vitamin D deficiency, but there is little agreement on recommended serum levels because every individual is different, according to the U.S. Preventive Services Task Force which updated its vitamin D recommendations in April for the first time in 7 years.

In ongoing efforts to investigate a link between vitamin D and colorectal cancer, new research shows that women who consume higher levels of vitamin D – particularly from dietary sources – have a reduced risk of developing early-onset colorectal cancer, compared with those who have lower levels.

This is according to an observational study published in the journal Gastroenterology. The study included 94,205 women (aged 25-42 years) who were followed between 1991 and 2015 during which 111 incident cases of early-onset colorectal cancer were diagnosed. Among 29,186 women who had at least one lower endoscopy from 1991 to 2011, 1,439 newly diagnosed conventional adenomas and 1,878 serrated polyps were found.

Women who consumed the highest average levels of total vitamin D of 450 IU per day, compared with those consuming less than 300 IU per day, showed a significantly reduced risk of early-onset colorectal cancer. Consuming 400 IU each day was associated with a 54% reduced risk of early-onset colorectal cancer.

“If confirmed, our findings could potentially lead to recommendations for higher vitamin D intake as an inexpensive low-risk complement to colorectal cancer screening as a prevention strategy for adults younger than age 50,” wrote the study authors, led by Edward L. Giovannucci, MD, ScD, of the Harvard School of Public Health, Boston.

Associations between vitamin D levels and colorectal cancer have been documented in review articles over the years. The link is the subject of 10 recently completed or ongoing clinical trials. Few studies have focused on early colorectal cancer and vitamin D intake. Unlike advanced colorectal cancer, the early-onset form of the disease is not as strongly associated with the traditional risk factors of a family history of colorectal cancer and it is therefore believed to be more strongly linked to other factors, such as lifestyle and diet – including vitamin D supplementation.
 

The evidence is in, but it’s incomplete

In addition to the new study in Gastroenterology, other observational studies, as well as laboratory and animal studies, suggest that vitamin D plays a role in inhibiting carcinogenesis. Vitamin D, researchers theorize, contains anti-inflammatory, immunomodulatory, and tumor angiogenesis properties that can slow the growth of tumors, but the evidence is mixed.

A meta-analysis of 137,567 patients published in 2013 in Preventive Medicine found an inverse association between 25-hydroxyvitamin D (25[OH]D) and total cancer mortality in women, but not among men. Three meta-analyses published in 2014 and 2019 found that vitamin D supplementation does not affect cancer incidence but does significantly reduce total cancer mortality rates by 12%-13%.

In 2019, researchers led by Marjorie McCullough, ScD, RD, senior scientific director of epidemiology research for the American Cancer Society, described a causal relationship between circulating vitamin D and colorectal cancer risk among 17 cohorts from a pooled analysis. “Our study suggests that optimal circulating 25(OH)D concentrations for colorectal cancer risk reduction are 75-100 nmol/L, [which is] higher than current Institute of Medicine recommendations for bone health,” she and colleagues wrote. Their findings were published in the Journal of the National Cancer Institute.

The Vitamin D and Omega-3 Trial (VITAL) published in 2019 in the New England Journal of Medicine, showed no significant effect of vitamin D₃ supplementation of 2,000 IU/day in lowering the risk of invasive cancer or cardiovascular events.

Despite the mixed results, studies offer valuable insights into cancer risks, said Scott Kopetz, MD, PhD, codirector of the colorectal cancer moon shot research program at the University of Texas MD Anderson Cancer Center, Houston.

The Gastroenterology study is noteworthy because it focuses on early-onset colorectal cancer, he said.

“[The authors] demonstrate for the first time that there is an association of vitamin D intake with early-onset colorectal incidence, especially in the left side of the colon and rectum where the increase in early onset colorectal cancer manifests,” Dr. Kopetz said. “The analysis suggests that it may require long-term vitamin D intake to derive the benefit, which may explain why some shorter-term randomized studies failed to demonstrate.”

In animal models, vitamin D₃ is “estimated to lower the incidence of colorectal cancer by 50%,” according to Lidija Klampfer, PhD, formerly a molecular biologist and senior research scientist with the Southern Research Institute, Birmingham, Ala.

Dr. Klampfer, a founding partner of ProteXase Therapeutics, is the author of an article on vitamin D and colon cancer published in 2014 in the World Journal of Gastrointestinal Oncology.

“The levels of vitamin D3 appear to be an essential determinant for the development and progression of colon cancer and supplementation with vitamin D3 is effective in suppressing intestinal tumorigenesis in animal models,” she wrote. “Studies have shown that 1,25 dihydroxyvitamin D₃ can inhibit tumor-promoting inflammation leading to the development and progression of colon cancer.”
 

The hazards of a vitamin D deficiency

A severe vitamin D deficiency is associated with compromised bone and muscle health, calcium absorption, immunity, heart function and it can affect mood. Other studies have linked vitamin D deficiency to colorectal cancer, blood cancers, and bowel cancer.

Serum 25(OH)D is the primary circulating form of vitamin D and is considered the best marker for assessing vitamin D status, says Karin Amrein, MD, MSc, an endocrinologist with the Medical University of Graz (Austria). She was the lead author of a review on vitamin D deficiency published in January 2020 in the European Journal of Clinical Nutrition.

The Global Consensus Recommendations define vitamin D insufficiency as 12-20 ng/mL (30-50 nmol/L) and a deficiency as a serum 25OHD concentration less than 12 ng/mL (30 nmol/L). A deficiency in adults is usually treated with 50,000 IU of vitamin D2 or D3 once weekly for 8 weeks followed by maintenance dosages of cholecalciferol (vitamin D₃) at 800-1,000 IU daily from dietary and supplemental sources.

Screening is recommended for individuals who exhibit symptoms and conditions associated with a vitamin D deficiency, but there is little agreement on recommended serum levels because every individual is different, according to the U.S. Preventive Services Task Force which updated its vitamin D recommendations in April for the first time in 7 years.

A new study suggests that tiny, clear nematodes can sniff out early-stage pancreatic cancer.

Research shows Caenorhabditis elegans are attracted to the odor certain chemicals give off – a behavior known as attractive chemotaxis – and early evidence indicates these scents may include human cancer cell secretions, cancer tissues, and urine from patients with colorectal, gastric, and breast cancers.

According to the recent analysis, published in Oncotarget, these small worms may be hot on the trail of pancreatic cancer–related compounds too. The researchers found that C. elegans were significantly more attracted to patients with early-stage pancreatic cancer versus healthy controls.

There is a huge need for research like this that explores strategies to detect pancreatic cancer early, but it’s far too soon to tell how, or if, this particular approach will be clinically relevant, according to Neeha Zaidi, MD, assistant professor of oncology and a medical oncologist specializing in pancreatic cancer at John Hopkins Medicine, Baltimore, who was not involved in the current analysis.

Right now, few diagnostic markers exist for identifying pancreatic ductal adenocarcinomas (PDACs), which account for 90% of pancreatic cancers. PDACs remain one of the deadliest cancers, with a 5-year survival rate of 9%.

A combination of surgical resection and chemotherapy is the only curative treatment, and just 20% of patients are eligible, Dr. Zaidi said. The majority are identified after the disease has metastasized.

However, patients’ 5-year survival rate improves markedly – as high as 85% – if the condition is caught sooner.

In the current study, the researchers first exposed C. elegans to the urine of 83 patients from cancer centers across Japan who had various stages of pancreatic cancer before and after undergoing surgical resection. Using an assay, which takes 30 minutes and 50-100 nematodes per test, C. elegans showed significantly higher chemotaxis toward preoperative urine, compared with postoperative urine.

In a second, closed-labeled arm, the nematodes were exposed to the urine of 28 randomized participants – 11 of whom had early-stage pancreatic cancer (0 or IA), plus 17 healthy volunteers. In this instance as well, C. elegans showed significantly higher chemotaxis in patients with early-stage pancreatic cancer, compared with healthy volunteers (P = .034). 

According to the authors, C. elegans “had a higher sensitivity for detecting early pancreatic cancer compared to existing diagnostic markers.” And while this strategy needs to be further validated, they believe early detection of pancreatic cancer using C. elegans “can certainly be expected in the near future.”

The study aligns with previous research, showing that wild-type C. elegans are sensitive to scent and that these critters can smell cancer. Other studies have also found that sniffer canines can detect volatile organic compounds – including biomarkers of certain cancers – in the urine and breath of cancer patients. But training an adequate number of these canines for the clinic isn’t feasible, while C. elegans are far more compact and affordable.

According to Dr. Zaidi, a scent test using C. elegans “seems pretty feasible” and cost effective, but whether this approach will “change our care has yet to be determined.”

The authors, for instance, don’t specify how the scent test will be used, though Dr. Zaidi suspects it would be most relevant for following patients with a higher risk of pancreatic cancer. Alternatively, it could be used as a screening test, but that’s a massive undertaking and “this is way too early to tell if it’s going to be helpful to use this test on a broad scale,” Dr. Zaidi said.

To validate the approach, researchers would also need to know what exactly the C. elegans are smelling and to test it in a much larger number of patients, Dr. Zaidi said. The mere 11 patients with cancer in the blinded portion of the study are not sufficient to draw any major conclusions.

The study also claims a high sensitivity, but what about specificity, Dr. Zaidi said. In other words, are there a lot of false positives? 

In addition, a deeper look at the participants shows the two groups – early PDAC and healthy volunteers – were not adequately balanced. The median age of the diseased patients was 70, and the healthy volunteers was 39.

“This is a big difference,” Eithne Costello, PhD, professor of molecular oncology at Liverpool (England) University, said in an interview. “It [also] appears the controls are all of one sex (either all male or all female), while the cancer group is mixed.”

The authors attributed these shortcomings to the small population they had to work with: There simply aren’t many patients whose pancreatic cancer is detected early. Dr. Zaidi agreed that patients with pancreatic cancer stage 0 or IA are extremely difficult to come by.

Even still, researchers need to understand the mechanisms behind this approach and see it work in a much larger group of patients, Dr. Zaidi said.

The study was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology. The authors reported institutional endowments received from Hirotsu Bio Science, Kinshu-kai Medical, IDEA Consultants, Ono Pharmaceutical, and others. Two coauthors are employees of Hirotsu Bio Science.

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

A new study suggests that tiny, clear nematodes can sniff out early-stage pancreatic cancer.

Research shows Caenorhabditis elegans are attracted to the odor certain chemicals give off – a behavior known as attractive chemotaxis – and early evidence indicates these scents may include human cancer cell secretions, cancer tissues, and urine from patients with colorectal, gastric, and breast cancers.

According to the recent analysis, published in Oncotarget, these small worms may be hot on the trail of pancreatic cancer–related compounds too. The researchers found that C. elegans were significantly more attracted to patients with early-stage pancreatic cancer versus healthy controls.

There is a huge need for research like this that explores strategies to detect pancreatic cancer early, but it’s far too soon to tell how, or if, this particular approach will be clinically relevant, according to Neeha Zaidi, MD, assistant professor of oncology and a medical oncologist specializing in pancreatic cancer at John Hopkins Medicine, Baltimore, who was not involved in the current analysis.

Right now, few diagnostic markers exist for identifying pancreatic ductal adenocarcinomas (PDACs), which account for 90% of pancreatic cancers. PDACs remain one of the deadliest cancers, with a 5-year survival rate of 9%.

A combination of surgical resection and chemotherapy is the only curative treatment, and just 20% of patients are eligible, Dr. Zaidi said. The majority are identified after the disease has metastasized.

However, patients’ 5-year survival rate improves markedly – as high as 85% – if the condition is caught sooner.

In the current study, the researchers first exposed C. elegans to the urine of 83 patients from cancer centers across Japan who had various stages of pancreatic cancer before and after undergoing surgical resection. Using an assay, which takes 30 minutes and 50-100 nematodes per test, C. elegans showed significantly higher chemotaxis toward preoperative urine, compared with postoperative urine.

In a second, closed-labeled arm, the nematodes were exposed to the urine of 28 randomized participants – 11 of whom had early-stage pancreatic cancer (0 or IA), plus 17 healthy volunteers. In this instance as well, C. elegans showed significantly higher chemotaxis in patients with early-stage pancreatic cancer, compared with healthy volunteers (P = .034). 

According to the authors, C. elegans “had a higher sensitivity for detecting early pancreatic cancer compared to existing diagnostic markers.” And while this strategy needs to be further validated, they believe early detection of pancreatic cancer using C. elegans “can certainly be expected in the near future.”

The study aligns with previous research, showing that wild-type C. elegans are sensitive to scent and that these critters can smell cancer. Other studies have also found that sniffer canines can detect volatile organic compounds – including biomarkers of certain cancers – in the urine and breath of cancer patients. But training an adequate number of these canines for the clinic isn’t feasible, while C. elegans are far more compact and affordable.

According to Dr. Zaidi, a scent test using C. elegans “seems pretty feasible” and cost effective, but whether this approach will “change our care has yet to be determined.”

The authors, for instance, don’t specify how the scent test will be used, though Dr. Zaidi suspects it would be most relevant for following patients with a higher risk of pancreatic cancer. Alternatively, it could be used as a screening test, but that’s a massive undertaking and “this is way too early to tell if it’s going to be helpful to use this test on a broad scale,” Dr. Zaidi said.

To validate the approach, researchers would also need to know what exactly the C. elegans are smelling and to test it in a much larger number of patients, Dr. Zaidi said. The mere 11 patients with cancer in the blinded portion of the study are not sufficient to draw any major conclusions.

The study also claims a high sensitivity, but what about specificity, Dr. Zaidi said. In other words, are there a lot of false positives? 

In addition, a deeper look at the participants shows the two groups – early PDAC and healthy volunteers – were not adequately balanced. The median age of the diseased patients was 70, and the healthy volunteers was 39.

“This is a big difference,” Eithne Costello, PhD, professor of molecular oncology at Liverpool (England) University, said in an interview. “It [also] appears the controls are all of one sex (either all male or all female), while the cancer group is mixed.”

The authors attributed these shortcomings to the small population they had to work with: There simply aren’t many patients whose pancreatic cancer is detected early. Dr. Zaidi agreed that patients with pancreatic cancer stage 0 or IA are extremely difficult to come by.

Even still, researchers need to understand the mechanisms behind this approach and see it work in a much larger group of patients, Dr. Zaidi said.

The study was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology. The authors reported institutional endowments received from Hirotsu Bio Science, Kinshu-kai Medical, IDEA Consultants, Ono Pharmaceutical, and others. Two coauthors are employees of Hirotsu Bio Science.

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

A new study suggests that tiny, clear nematodes can sniff out early-stage pancreatic cancer.

Research shows Caenorhabditis elegans are attracted to the odor certain chemicals give off – a behavior known as attractive chemotaxis – and early evidence indicates these scents may include human cancer cell secretions, cancer tissues, and urine from patients with colorectal, gastric, and breast cancers.

According to the recent analysis, published in Oncotarget, these small worms may be hot on the trail of pancreatic cancer–related compounds too. The researchers found that C. elegans were significantly more attracted to patients with early-stage pancreatic cancer versus healthy controls.

There is a huge need for research like this that explores strategies to detect pancreatic cancer early, but it’s far too soon to tell how, or if, this particular approach will be clinically relevant, according to Neeha Zaidi, MD, assistant professor of oncology and a medical oncologist specializing in pancreatic cancer at John Hopkins Medicine, Baltimore, who was not involved in the current analysis.

Right now, few diagnostic markers exist for identifying pancreatic ductal adenocarcinomas (PDACs), which account for 90% of pancreatic cancers. PDACs remain one of the deadliest cancers, with a 5-year survival rate of 9%.

A combination of surgical resection and chemotherapy is the only curative treatment, and just 20% of patients are eligible, Dr. Zaidi said. The majority are identified after the disease has metastasized.

However, patients’ 5-year survival rate improves markedly – as high as 85% – if the condition is caught sooner.

In the current study, the researchers first exposed C. elegans to the urine of 83 patients from cancer centers across Japan who had various stages of pancreatic cancer before and after undergoing surgical resection. Using an assay, which takes 30 minutes and 50-100 nematodes per test, C. elegans showed significantly higher chemotaxis toward preoperative urine, compared with postoperative urine.

In a second, closed-labeled arm, the nematodes were exposed to the urine of 28 randomized participants – 11 of whom had early-stage pancreatic cancer (0 or IA), plus 17 healthy volunteers. In this instance as well, C. elegans showed significantly higher chemotaxis in patients with early-stage pancreatic cancer, compared with healthy volunteers (P = .034). 

According to the authors, C. elegans “had a higher sensitivity for detecting early pancreatic cancer compared to existing diagnostic markers.” And while this strategy needs to be further validated, they believe early detection of pancreatic cancer using C. elegans “can certainly be expected in the near future.”

The study aligns with previous research, showing that wild-type C. elegans are sensitive to scent and that these critters can smell cancer. Other studies have also found that sniffer canines can detect volatile organic compounds – including biomarkers of certain cancers – in the urine and breath of cancer patients. But training an adequate number of these canines for the clinic isn’t feasible, while C. elegans are far more compact and affordable.

According to Dr. Zaidi, a scent test using C. elegans “seems pretty feasible” and cost effective, but whether this approach will “change our care has yet to be determined.”

The authors, for instance, don’t specify how the scent test will be used, though Dr. Zaidi suspects it would be most relevant for following patients with a higher risk of pancreatic cancer. Alternatively, it could be used as a screening test, but that’s a massive undertaking and “this is way too early to tell if it’s going to be helpful to use this test on a broad scale,” Dr. Zaidi said.

To validate the approach, researchers would also need to know what exactly the C. elegans are smelling and to test it in a much larger number of patients, Dr. Zaidi said. The mere 11 patients with cancer in the blinded portion of the study are not sufficient to draw any major conclusions.

The study also claims a high sensitivity, but what about specificity, Dr. Zaidi said. In other words, are there a lot of false positives? 

In addition, a deeper look at the participants shows the two groups – early PDAC and healthy volunteers – were not adequately balanced. The median age of the diseased patients was 70, and the healthy volunteers was 39.

“This is a big difference,” Eithne Costello, PhD, professor of molecular oncology at Liverpool (England) University, said in an interview. “It [also] appears the controls are all of one sex (either all male or all female), while the cancer group is mixed.”

The authors attributed these shortcomings to the small population they had to work with: There simply aren’t many patients whose pancreatic cancer is detected early. Dr. Zaidi agreed that patients with pancreatic cancer stage 0 or IA are extremely difficult to come by.

Even still, researchers need to understand the mechanisms behind this approach and see it work in a much larger group of patients, Dr. Zaidi said.

The study was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology. The authors reported institutional endowments received from Hirotsu Bio Science, Kinshu-kai Medical, IDEA Consultants, Ono Pharmaceutical, and others. Two coauthors are employees of Hirotsu Bio Science.

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

In the first study of its kind, women with a breast cancer diagnosis who recalled eating nuts were found to have a significantly better disease-free survival over a 10-year study period, compared with those who said they had not eaten nuts.

PxHere

There was also an improvement in overall survival, but this was not statistically significant.

The finding comes from a study of more than 3,000 patients conducted in China, published online in the International Journal of Cancer. Patients were queried about nut consumption on only one occasion, 5 years after their breast cancer diagnosis. 

The investigators report a dose-response pattern between nut eating and the risk of both breast cancer recurrence and overall mortality, with those consuming the largest amounts having the lowest risks.

“Nuts are important components of healthy diets. Promoting this modifiable lifestyle factor should be emphasized in breast cancer survivor guidelines,” conclude Xiao-Ou Shu, MD, PhD, of Vanderbilt University, Nashville, Tenn., and colleagues in the study.

“The association for disease-free survival is quite strong and robust,” Dr. Shu told this news organization.

However, as with all observational studies, this report shows an association and not causation.

“Based upon this study alone, the evidence is weak,” said Wendy Chen, MD, MPH, a breast oncologist at Dana-Farber Cancer Institute in Boston, who was approached for comment.  

The people who consumed nuts generally had more education, higher income, lower body mass index, earlier-stage cancers, and more physically active lives – all factors associated with better breast cancer survival, she observed. “The authors tried to control for these factors,” Dr. Chen acknowledged. But it’s hard to know whether nut consumption was “truly” the difference maker, she said.

Furthermore, the study population is also “a bit unusual” because people had to survive 5 years after diagnosis to be included in the analysis – and thus is not representative of breast cancer survivors, she noted.

Erin Van Blarigan, PhD, an epidemiologist at the University of California, San Francisco, described the overall evidence of the beneficial relationship between nut eating and breast cancer – including this study – as “limited.” She previously led a study that observed benefits of nut intake for patients with colon cancer.

Dr. Van Blarigan also noted that nut intake in this study was “very low” – with the median intake less than one serving per week.

She also offered some general advice about eating nuts.  

“Nuts are an energy-dense food, so portion sizes should be kept small,” she said, explaining a portion should be about 1 ounce or 1/4 cup of nuts or 1-2 tablespoons of nut butter.

A little may go a long way, she suggested, as research to date “suggests only small amounts may be needed to gain potential benefits.”

The level of nut consumption was low in the Chinese study population (median = 17.3 grams/week) compared with the 42.5 grams/week recommended by the American Heart Association, the study authors acknowledge.

“Nuts, particularly tree nuts, are expensive in China. Traditionally, nut consumption level has been low among Chinese, particularly in the old generation,” commented Dr. Shu.
 

Study authors did an adjusted analysis

The new study was conducted among 3,449 participants of the Shanghai Breast Cancer Survival Study.

Nut consumption (including peanuts and tree nuts such as walnuts) was assessed with a food questionnaire at 5 years post-diagnosis.

An analysis was conducted at 10 years post-diagnosis (and 5 years after the diet questionnaire). At this 10-year mark, there were 252 breast cancer-specific deaths. Among 3,274 survivors without previous recurrence at the dietary assessment, 209 went on to develop breast cancer-specific events – either recurrence, metastasis, or breast cancer mortality.

Nut consumers had higher overall survival (93.7% vs. 89%; P = .003) and disease-free survival (94.1% vs. 86.2%; P <.001) rates than nonconsumers.

However, the two groups had many differences, as noted by the authors and outside experts.

The consumers had a younger age at diagnosis, lower BMI, higher total energy intake, higher diet quality score, and higher soy food intake. In addition, nut consumers were more likely to have a higher education, personal income, and physical activity level (≥7.5 metabolic equivalent of task-hour/week) as well as to have received immunotherapy.

So the investigators adjusted for many of those variables and found that nut consumption was associated with significantly better disease-free survival (hazard ratio, 0.52; 95% confidence interval, 0.35-0.75), but a nonsignificantly improved overall survival (HR, 0.90; 95% CI, 0.66-1.23), as noted above.

Analyses by amount of nut intake showed a dose-response relationship for both overall survival (P trend = .022) and disease-free survival (P trend = .003).

The authors say that “there has been no strong evidence to support individual food items in favor of breast cancer survival,” citing a 2018 report entitled “Diet, Nutrition, Physical Activity and Breast Cancer Survivors” from the World Cancer Research Fund/American Institute for Cancer Research.

The new study provides evidence that nuts may be such a food, they say, while also calling for studies to confirm their findings.

Study limitations include that fact that the statuses of recurrence and metastasis were self-reported. Misclassification, particularly regarding the event date, is likely, the team says.

The study authors and Dr. Van Blarigan and Dr. Chen have disclosed no relevant financial relationships.

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

In the first study of its kind, women with a breast cancer diagnosis who recalled eating nuts were found to have a significantly better disease-free survival over a 10-year study period, compared with those who said they had not eaten nuts.

PxHere

There was also an improvement in overall survival, but this was not statistically significant.

The finding comes from a study of more than 3,000 patients conducted in China, published online in the International Journal of Cancer. Patients were queried about nut consumption on only one occasion, 5 years after their breast cancer diagnosis. 

The investigators report a dose-response pattern between nut eating and the risk of both breast cancer recurrence and overall mortality, with those consuming the largest amounts having the lowest risks.

“Nuts are important components of healthy diets. Promoting this modifiable lifestyle factor should be emphasized in breast cancer survivor guidelines,” conclude Xiao-Ou Shu, MD, PhD, of Vanderbilt University, Nashville, Tenn., and colleagues in the study.

“The association for disease-free survival is quite strong and robust,” Dr. Shu told this news organization.

However, as with all observational studies, this report shows an association and not causation.

“Based upon this study alone, the evidence is weak,” said Wendy Chen, MD, MPH, a breast oncologist at Dana-Farber Cancer Institute in Boston, who was approached for comment.  

The people who consumed nuts generally had more education, higher income, lower body mass index, earlier-stage cancers, and more physically active lives – all factors associated with better breast cancer survival, she observed. “The authors tried to control for these factors,” Dr. Chen acknowledged. But it’s hard to know whether nut consumption was “truly” the difference maker, she said.

Furthermore, the study population is also “a bit unusual” because people had to survive 5 years after diagnosis to be included in the analysis – and thus is not representative of breast cancer survivors, she noted.

Erin Van Blarigan, PhD, an epidemiologist at the University of California, San Francisco, described the overall evidence of the beneficial relationship between nut eating and breast cancer – including this study – as “limited.” She previously led a study that observed benefits of nut intake for patients with colon cancer.

Dr. Van Blarigan also noted that nut intake in this study was “very low” – with the median intake less than one serving per week.

She also offered some general advice about eating nuts.  

“Nuts are an energy-dense food, so portion sizes should be kept small,” she said, explaining a portion should be about 1 ounce or 1/4 cup of nuts or 1-2 tablespoons of nut butter.

A little may go a long way, she suggested, as research to date “suggests only small amounts may be needed to gain potential benefits.”

The level of nut consumption was low in the Chinese study population (median = 17.3 grams/week) compared with the 42.5 grams/week recommended by the American Heart Association, the study authors acknowledge.

“Nuts, particularly tree nuts, are expensive in China. Traditionally, nut consumption level has been low among Chinese, particularly in the old generation,” commented Dr. Shu.
 

Study authors did an adjusted analysis

The new study was conducted among 3,449 participants of the Shanghai Breast Cancer Survival Study.

Nut consumption (including peanuts and tree nuts such as walnuts) was assessed with a food questionnaire at 5 years post-diagnosis.

An analysis was conducted at 10 years post-diagnosis (and 5 years after the diet questionnaire). At this 10-year mark, there were 252 breast cancer-specific deaths. Among 3,274 survivors without previous recurrence at the dietary assessment, 209 went on to develop breast cancer-specific events – either recurrence, metastasis, or breast cancer mortality.

Nut consumers had higher overall survival (93.7% vs. 89%; P = .003) and disease-free survival (94.1% vs. 86.2%; P <.001) rates than nonconsumers.

However, the two groups had many differences, as noted by the authors and outside experts.

The consumers had a younger age at diagnosis, lower BMI, higher total energy intake, higher diet quality score, and higher soy food intake. In addition, nut consumers were more likely to have a higher education, personal income, and physical activity level (≥7.5 metabolic equivalent of task-hour/week) as well as to have received immunotherapy.

So the investigators adjusted for many of those variables and found that nut consumption was associated with significantly better disease-free survival (hazard ratio, 0.52; 95% confidence interval, 0.35-0.75), but a nonsignificantly improved overall survival (HR, 0.90; 95% CI, 0.66-1.23), as noted above.

Analyses by amount of nut intake showed a dose-response relationship for both overall survival (P trend = .022) and disease-free survival (P trend = .003).

The authors say that “there has been no strong evidence to support individual food items in favor of breast cancer survival,” citing a 2018 report entitled “Diet, Nutrition, Physical Activity and Breast Cancer Survivors” from the World Cancer Research Fund/American Institute for Cancer Research.

The new study provides evidence that nuts may be such a food, they say, while also calling for studies to confirm their findings.

Study limitations include that fact that the statuses of recurrence and metastasis were self-reported. Misclassification, particularly regarding the event date, is likely, the team says.

The study authors and Dr. Van Blarigan and Dr. Chen have disclosed no relevant financial relationships.

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

In the first study of its kind, women with a breast cancer diagnosis who recalled eating nuts were found to have a significantly better disease-free survival over a 10-year study period, compared with those who said they had not eaten nuts.

PxHere

There was also an improvement in overall survival, but this was not statistically significant.

The finding comes from a study of more than 3,000 patients conducted in China, published online in the International Journal of Cancer. Patients were queried about nut consumption on only one occasion, 5 years after their breast cancer diagnosis. 

The investigators report a dose-response pattern between nut eating and the risk of both breast cancer recurrence and overall mortality, with those consuming the largest amounts having the lowest risks.

“Nuts are important components of healthy diets. Promoting this modifiable lifestyle factor should be emphasized in breast cancer survivor guidelines,” conclude Xiao-Ou Shu, MD, PhD, of Vanderbilt University, Nashville, Tenn., and colleagues in the study.

“The association for disease-free survival is quite strong and robust,” Dr. Shu told this news organization.

However, as with all observational studies, this report shows an association and not causation.

“Based upon this study alone, the evidence is weak,” said Wendy Chen, MD, MPH, a breast oncologist at Dana-Farber Cancer Institute in Boston, who was approached for comment.  

The people who consumed nuts generally had more education, higher income, lower body mass index, earlier-stage cancers, and more physically active lives – all factors associated with better breast cancer survival, she observed. “The authors tried to control for these factors,” Dr. Chen acknowledged. But it’s hard to know whether nut consumption was “truly” the difference maker, she said.

Furthermore, the study population is also “a bit unusual” because people had to survive 5 years after diagnosis to be included in the analysis – and thus is not representative of breast cancer survivors, she noted.

Erin Van Blarigan, PhD, an epidemiologist at the University of California, San Francisco, described the overall evidence of the beneficial relationship between nut eating and breast cancer – including this study – as “limited.” She previously led a study that observed benefits of nut intake for patients with colon cancer.

Dr. Van Blarigan also noted that nut intake in this study was “very low” – with the median intake less than one serving per week.

She also offered some general advice about eating nuts.  

“Nuts are an energy-dense food, so portion sizes should be kept small,” she said, explaining a portion should be about 1 ounce or 1/4 cup of nuts or 1-2 tablespoons of nut butter.

A little may go a long way, she suggested, as research to date “suggests only small amounts may be needed to gain potential benefits.”

The level of nut consumption was low in the Chinese study population (median = 17.3 grams/week) compared with the 42.5 grams/week recommended by the American Heart Association, the study authors acknowledge.

“Nuts, particularly tree nuts, are expensive in China. Traditionally, nut consumption level has been low among Chinese, particularly in the old generation,” commented Dr. Shu.
 

Study authors did an adjusted analysis

The new study was conducted among 3,449 participants of the Shanghai Breast Cancer Survival Study.

Nut consumption (including peanuts and tree nuts such as walnuts) was assessed with a food questionnaire at 5 years post-diagnosis.

An analysis was conducted at 10 years post-diagnosis (and 5 years after the diet questionnaire). At this 10-year mark, there were 252 breast cancer-specific deaths. Among 3,274 survivors without previous recurrence at the dietary assessment, 209 went on to develop breast cancer-specific events – either recurrence, metastasis, or breast cancer mortality.

Nut consumers had higher overall survival (93.7% vs. 89%; P = .003) and disease-free survival (94.1% vs. 86.2%; P <.001) rates than nonconsumers.

However, the two groups had many differences, as noted by the authors and outside experts.

The consumers had a younger age at diagnosis, lower BMI, higher total energy intake, higher diet quality score, and higher soy food intake. In addition, nut consumers were more likely to have a higher education, personal income, and physical activity level (≥7.5 metabolic equivalent of task-hour/week) as well as to have received immunotherapy.

So the investigators adjusted for many of those variables and found that nut consumption was associated with significantly better disease-free survival (hazard ratio, 0.52; 95% confidence interval, 0.35-0.75), but a nonsignificantly improved overall survival (HR, 0.90; 95% CI, 0.66-1.23), as noted above.

Analyses by amount of nut intake showed a dose-response relationship for both overall survival (P trend = .022) and disease-free survival (P trend = .003).

The authors say that “there has been no strong evidence to support individual food items in favor of breast cancer survival,” citing a 2018 report entitled “Diet, Nutrition, Physical Activity and Breast Cancer Survivors” from the World Cancer Research Fund/American Institute for Cancer Research.

The new study provides evidence that nuts may be such a food, they say, while also calling for studies to confirm their findings.

Study limitations include that fact that the statuses of recurrence and metastasis were self-reported. Misclassification, particularly regarding the event date, is likely, the team says.

The study authors and Dr. Van Blarigan and Dr. Chen have disclosed no relevant financial relationships.

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

The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.

Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”

For what it says is the first time in the industry, Pfizer has issued a warranty on crizotinib (Xalkori) and will refund the cost that was paid for the medicine if it doesn’t work within the first 3 months of use.

“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.

Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.

In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.

Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
 

Pfizer pledge

Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.

Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.

“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”

This program is only available for patients who reside in the United States.

If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.

“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.

The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.

So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.

“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
 

Previous scheme ended in court

Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).

Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.

Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.

The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.

Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.

The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.

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

The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.

Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”

For what it says is the first time in the industry, Pfizer has issued a warranty on crizotinib (Xalkori) and will refund the cost that was paid for the medicine if it doesn’t work within the first 3 months of use.

“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.

Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.

In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.

Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
 

Pfizer pledge

Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.

Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.

“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”

This program is only available for patients who reside in the United States.

If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.

“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.

The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.

So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.

“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
 

Previous scheme ended in court

Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).

Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.

Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.

The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.

Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.

The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.

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

The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.

Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”

For what it says is the first time in the industry, Pfizer has issued a warranty on crizotinib (Xalkori) and will refund the cost that was paid for the medicine if it doesn’t work within the first 3 months of use.

“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.

Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.

In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.

Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
 

Pfizer pledge

Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.

Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.

“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”

This program is only available for patients who reside in the United States.

If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.

“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.

The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.

So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.

“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
 

Previous scheme ended in court

Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).

Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.

Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.

The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.

Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.

The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.

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

Untreated PD-L1 non–small cell lung cancer (NSCLC). Patients with previously untreated, PD-L1-selected, locally advanced, unresectable, or metastatic NSCLC are sought for a phase 3 trial comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.

Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.

Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.

Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.

Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.

Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).

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

Untreated PD-L1 non–small cell lung cancer (NSCLC). Patients with previously untreated, PD-L1-selected, locally advanced, unresectable, or metastatic NSCLC are sought for a phase 3 trial comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.

Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.

Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.

Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.

Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.

Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).

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

Untreated PD-L1 non–small cell lung cancer (NSCLC). Patients with previously untreated, PD-L1-selected, locally advanced, unresectable, or metastatic NSCLC are sought for a phase 3 trial comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.

Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.

Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.

Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.

Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.

Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).

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

A mainstay of treatment for prostate cancer is to deprive it of androgens, the hormones that make it grow. The testes are the main source of these hormones, so treatment can consist of either surgical removal of these organs or use of drugs to block their hormone production.

Over time, some prostate cancers become resistant to these treatments and begin to expand again. As with many cancers that show these behaviors, finding exactly what makes them resistant can be tricky.

A culprit may be bacteria that live in the gut. Researchers found that in castrated mice and in people having androgen deprivation therapy, some of these gut bacteria start producing androgens that are easily taken into the bloodstream. According to these new findings,published in the journal Science, the androgens seem to support the growth of prostate cancer and its resistance to treatment.

This study is the first to show that bacteria can produce testosterone, although the investigators are not yet sure what triggers them to start doing that. Androgen deprivation treatment may also lead to more of these hormone-producing microbes in the gut, the results suggest. Fecal bacterial of people with treatment-resistant prostate cancer also showed a link to lower life expectancy.

Fecal transplants from mice with treatment-resistant prostate cancer could trigger resistance in animals with disease susceptible to these hormones. When these mice received fecal transplants from humans with resistant cancer, the effect was the same: a shift to treatment resistance.

But the converse also was true: Fecal transplants from mice or humans with hormone-susceptible cancer contributed to limiting tumor growth.

The findings may suggest new therapeutic targets: the microbes living in the gut. In mouse studies, the researchers found that when they wiped out these bacteria, the cancer was much slower to progress to treatment resistance. Authors of a commentary accompanying the study say there are other places to look for bacteria that might be making these hormones, too, including the urinary tract or even in the tumor itself.

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

A mainstay of treatment for prostate cancer is to deprive it of androgens, the hormones that make it grow. The testes are the main source of these hormones, so treatment can consist of either surgical removal of these organs or use of drugs to block their hormone production.

Over time, some prostate cancers become resistant to these treatments and begin to expand again. As with many cancers that show these behaviors, finding exactly what makes them resistant can be tricky.

A culprit may be bacteria that live in the gut. Researchers found that in castrated mice and in people having androgen deprivation therapy, some of these gut bacteria start producing androgens that are easily taken into the bloodstream. According to these new findings,published in the journal Science, the androgens seem to support the growth of prostate cancer and its resistance to treatment.

This study is the first to show that bacteria can produce testosterone, although the investigators are not yet sure what triggers them to start doing that. Androgen deprivation treatment may also lead to more of these hormone-producing microbes in the gut, the results suggest. Fecal bacterial of people with treatment-resistant prostate cancer also showed a link to lower life expectancy.

Fecal transplants from mice with treatment-resistant prostate cancer could trigger resistance in animals with disease susceptible to these hormones. When these mice received fecal transplants from humans with resistant cancer, the effect was the same: a shift to treatment resistance.

But the converse also was true: Fecal transplants from mice or humans with hormone-susceptible cancer contributed to limiting tumor growth.

The findings may suggest new therapeutic targets: the microbes living in the gut. In mouse studies, the researchers found that when they wiped out these bacteria, the cancer was much slower to progress to treatment resistance. Authors of a commentary accompanying the study say there are other places to look for bacteria that might be making these hormones, too, including the urinary tract or even in the tumor itself.

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

A mainstay of treatment for prostate cancer is to deprive it of androgens, the hormones that make it grow. The testes are the main source of these hormones, so treatment can consist of either surgical removal of these organs or use of drugs to block their hormone production.

Over time, some prostate cancers become resistant to these treatments and begin to expand again. As with many cancers that show these behaviors, finding exactly what makes them resistant can be tricky.

A culprit may be bacteria that live in the gut. Researchers found that in castrated mice and in people having androgen deprivation therapy, some of these gut bacteria start producing androgens that are easily taken into the bloodstream. According to these new findings,published in the journal Science, the androgens seem to support the growth of prostate cancer and its resistance to treatment.

This study is the first to show that bacteria can produce testosterone, although the investigators are not yet sure what triggers them to start doing that. Androgen deprivation treatment may also lead to more of these hormone-producing microbes in the gut, the results suggest. Fecal bacterial of people with treatment-resistant prostate cancer also showed a link to lower life expectancy.

Fecal transplants from mice with treatment-resistant prostate cancer could trigger resistance in animals with disease susceptible to these hormones. When these mice received fecal transplants from humans with resistant cancer, the effect was the same: a shift to treatment resistance.

But the converse also was true: Fecal transplants from mice or humans with hormone-susceptible cancer contributed to limiting tumor growth.

The findings may suggest new therapeutic targets: the microbes living in the gut. In mouse studies, the researchers found that when they wiped out these bacteria, the cancer was much slower to progress to treatment resistance. Authors of a commentary accompanying the study say there are other places to look for bacteria that might be making these hormones, too, including the urinary tract or even in the tumor itself.

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