Lung Cancer

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

Learn More

New therapies developed to treat non-small cell lung cancer are not reaching all patients with this disease. Human-created barriers bar the way for those experiencing real or perceived stigma and those who reside in remote places or live on little income. 

In this supplement, Abbie Begnaud, MD, FCCP, hones in on this human-created dichotomy and discusses the problems and possible solutions, along with diagnostic and treatment options.

Learn more

Learn More

New therapies developed to treat non-small cell lung cancer are not reaching all patients with this disease. Human-created barriers bar the way for those experiencing real or perceived stigma and those who reside in remote places or live on little income. 

In this supplement, Abbie Begnaud, MD, FCCP, hones in on this human-created dichotomy and discusses the problems and possible solutions, along with diagnostic and treatment options.

Learn more

Learn More

New therapies developed to treat non-small cell lung cancer are not reaching all patients with this disease. Human-created barriers bar the way for those experiencing real or perceived stigma and those who reside in remote places or live on little income. 

In this supplement, Abbie Begnaud, MD, FCCP, hones in on this human-created dichotomy and discusses the problems and possible solutions, along with diagnostic and treatment options.

Learn more

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

Women are at higher risk of severe adverse events (AEs) from cancer therapy than men, and this is seen with chemotherapy, targeted agents, and especially with immunotherapy.

The finding comes from a review of more than 23,000 participants across 202 trials of various cancers (excluding sex-related cancers) that has been conducted over the past 40 years.

The investigators found a 34% increased risk of severe AEs among women, compared with men, climbing to a 49% higher risk with immunotherapy.

Women had a substantially greater risk of severe symptomatic AEs, including with immune checkpoint inhibitors and targeted tyrosine kinase inhibitors, and were more likely to experience severe hematologic AEs with chemotherapy and immunotherapy.

The particularly large sex differences with immunotherapy suggest “that studying AEs from these agents is a priority,” the investigators comment.

The article was published online on Feb. 4 in the Journal of Clinical Oncology.

“It has been understood that women have more toxicity from chemotherapy than men, but almost no research has aimed to understand whether that pattern held for novel treatments like immunotherapy or targeted therapies. We found similar large differences, especially for immune treatments,” said lead investigator Joseph Unger, PhD, a biostatistician and health services researcher at the Fred Hutchinson Cancer Research Center, Seattle, in an institutional press release.

A “better understanding of the nature of the underlying mechanisms could potentially lead to interventions or delivery modifications to reduce toxicity in women,” the investigators comment in their article.

Among a sea of possible explanations for the finding, there could be differences in how men and women metabolize cancer therapies or differences in how they perceive symptoms. Women may also receive relatively higher doses because of their body size or have higher adherence to treatment.

Whatever the case, as cancer treatment becomes increasingly individualized, “sex may be an important consideration,” Dr. Unger said.
 

Study details

The study involved 8,838 women and 14,458 men across the trials, which were phase 2 or 3 investigations conducted by the SWOG Cancer Research Network from 1980 to 2019. Trials including sex-related cancers were excluded. In the trials included in the review, the most common cancers were gastrointestinal and lung, followed by leukemia.

Seventy-five percent of the subjects received chemotherapy, and the rest received either targeted therapy or immunotherapy.

Two-thirds of the subjects had at least one grade 3 or higher AE; women had a 25% higher risk than men of having AEs of grade 5 or higher.

After adjusting for age, race, disease prognosis, and other factors, women were at increased risk of severe symptomatic AEs, such as nausea and pain, across all treatment lines and especially with immunotherapy, for which reports of symptomatic AEs were 66% higher.

Women also had a higher risk of symptomatic gastrointestinal AEs with all three treatments and a higher risk of sleep-related AEs with chemotherapy and immunotherapy, which “could be a function of hormonal effects interacting with cancer treatment,” the investigators said.

As for readily measurable AEs, women were at higher risk than men for objective hematologic AEs with chemotherapy, immunotherapy, and targeted therapy. There were no statistically significant sex differences in the risk of nonhematologic objective AEs.

The team notes that increased toxicity among women has been associated with improved survival, which may give AEs more time to develop. Higher rates of AEs might also signal increased delivery or efficacy of cancer treatments.

However, a previous study found that men may have a better response to immunotherapy than women. Immune checkpoint inhibitors were twice as effective as standard cancer therapies in the treatment of men with advanced solid tumors compared to their female counterparts, concluded a team that carried out a meta-analysis of 20 randomized controlled trials involving more than 11,351 patients.

The study was funded by the National Cancer Institute and others. Dr. Unger has disclosed no relevant financial relationships. Several coauthors have reported ties to a handful of companies, including Johnson & Johnson and Seattle Genetics. One is an employee of AIM Specialty Health.

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

The Centers for Medicare & Medicaid Services (CMS) will expand eligibility guidelines for lung cancer screening with low-dose computed tomography for Medicare recipients.

According to the final decision, announced February 10, CMS will lower the age for screening from 55 to 50 years up to 77 years and reduce criteria for tobacco smoking history from at least 30 pack-years to 20 pack-years. The expanded Medicare recommendation will address racial disparities associated with lung cancer, given evidence that one third of Black patients are diagnosed with lung cancer before age 55.

The updated CMS guidelines align closely with recommendations made by the U.S. Preventive Services Task Force (USPSTF) in March 2021. The USPSTF expanded its guidelines for screening to include individuals ages 50 to 80 years, as well as those who have a 20–pack-year smoking history and who currently smoke or have quit within the past 15 years.

Overall, the expanded guidelines will nearly double the number of individuals who are eligible for screening and have the potential to save significantly more lives by identifying cancers at an earlier, more treatable stage.

“Expanding coverage broadens access for lung cancer screening to at-risk populations,” said Lee Felisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, in a statement. “Today’s decision not only expands access to quality care but is also critical to improving health outcomes for people by helping to detect lung cancer earlier.”

CMS’s decision also simplifies requirements for counseling and shared decision-making visits and removes an initial requirement for the reading radiologist to document participation in continuing medical education, which will reduce administrative burden. CMS also added a requirement back to the National Coverage Determination criteria that requires radiology imaging facilities to use a standardized lung nodule identification, classification, and reporting system.

The American Lung Association applauds the decision to update eligibility.

“[The] announcement from CMS will give more people enrolled in Medicare access to lifesaving lung cancer screening. Screening for individuals at high risk is the only tool to catch this disease early when it is more curable,” Harold Wimmer, president and CEO of the American Lung Association, said in a statement. “Unfortunately, only 5.7% of people who are eligible have been screened, so it’s important that we talk with our friends and family who are at high risk about getting screened.”

While access to screening will significantly increase, the American Lung Association recommends CMS go a step further and expand eligibility to individuals up to 80 years of age, as the USPSTF recommendations do, as well as remove the recommendation that individuals cease screening once they have stopped smoking for 15 years.

Given the new guidelines, most private insurance plans will need to update screening coverage policies to reflect the updated guidelines for plan years beginning after March 31.

To read the final decision, visit the CMS website.

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

The Centers for Medicare & Medicaid Services (CMS) will expand eligibility guidelines for lung cancer screening with low-dose computed tomography for Medicare recipients.

According to the final decision, announced February 10, CMS will lower the age for screening from 55 to 50 years up to 77 years and reduce criteria for tobacco smoking history from at least 30 pack-years to 20 pack-years. The expanded Medicare recommendation will address racial disparities associated with lung cancer, given evidence that one third of Black patients are diagnosed with lung cancer before age 55.

The updated CMS guidelines align closely with recommendations made by the U.S. Preventive Services Task Force (USPSTF) in March 2021. The USPSTF expanded its guidelines for screening to include individuals ages 50 to 80 years, as well as those who have a 20–pack-year smoking history and who currently smoke or have quit within the past 15 years.

Overall, the expanded guidelines will nearly double the number of individuals who are eligible for screening and have the potential to save significantly more lives by identifying cancers at an earlier, more treatable stage.

“Expanding coverage broadens access for lung cancer screening to at-risk populations,” said Lee Felisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, in a statement. “Today’s decision not only expands access to quality care but is also critical to improving health outcomes for people by helping to detect lung cancer earlier.”

CMS’s decision also simplifies requirements for counseling and shared decision-making visits and removes an initial requirement for the reading radiologist to document participation in continuing medical education, which will reduce administrative burden. CMS also added a requirement back to the National Coverage Determination criteria that requires radiology imaging facilities to use a standardized lung nodule identification, classification, and reporting system.

The American Lung Association applauds the decision to update eligibility.

“[The] announcement from CMS will give more people enrolled in Medicare access to lifesaving lung cancer screening. Screening for individuals at high risk is the only tool to catch this disease early when it is more curable,” Harold Wimmer, president and CEO of the American Lung Association, said in a statement. “Unfortunately, only 5.7% of people who are eligible have been screened, so it’s important that we talk with our friends and family who are at high risk about getting screened.”

While access to screening will significantly increase, the American Lung Association recommends CMS go a step further and expand eligibility to individuals up to 80 years of age, as the USPSTF recommendations do, as well as remove the recommendation that individuals cease screening once they have stopped smoking for 15 years.

Given the new guidelines, most private insurance plans will need to update screening coverage policies to reflect the updated guidelines for plan years beginning after March 31.

To read the final decision, visit the CMS website.

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

The Centers for Medicare & Medicaid Services (CMS) will expand eligibility guidelines for lung cancer screening with low-dose computed tomography for Medicare recipients.

According to the final decision, announced February 10, CMS will lower the age for screening from 55 to 50 years up to 77 years and reduce criteria for tobacco smoking history from at least 30 pack-years to 20 pack-years. The expanded Medicare recommendation will address racial disparities associated with lung cancer, given evidence that one third of Black patients are diagnosed with lung cancer before age 55.

The updated CMS guidelines align closely with recommendations made by the U.S. Preventive Services Task Force (USPSTF) in March 2021. The USPSTF expanded its guidelines for screening to include individuals ages 50 to 80 years, as well as those who have a 20–pack-year smoking history and who currently smoke or have quit within the past 15 years.

Overall, the expanded guidelines will nearly double the number of individuals who are eligible for screening and have the potential to save significantly more lives by identifying cancers at an earlier, more treatable stage.

“Expanding coverage broadens access for lung cancer screening to at-risk populations,” said Lee Felisher, MD, CMS chief medical officer and director of the Center for Clinical Standards and Quality, in a statement. “Today’s decision not only expands access to quality care but is also critical to improving health outcomes for people by helping to detect lung cancer earlier.”

CMS’s decision also simplifies requirements for counseling and shared decision-making visits and removes an initial requirement for the reading radiologist to document participation in continuing medical education, which will reduce administrative burden. CMS also added a requirement back to the National Coverage Determination criteria that requires radiology imaging facilities to use a standardized lung nodule identification, classification, and reporting system.

The American Lung Association applauds the decision to update eligibility.

“[The] announcement from CMS will give more people enrolled in Medicare access to lifesaving lung cancer screening. Screening for individuals at high risk is the only tool to catch this disease early when it is more curable,” Harold Wimmer, president and CEO of the American Lung Association, said in a statement. “Unfortunately, only 5.7% of people who are eligible have been screened, so it’s important that we talk with our friends and family who are at high risk about getting screened.”

While access to screening will significantly increase, the American Lung Association recommends CMS go a step further and expand eligibility to individuals up to 80 years of age, as the USPSTF recommendations do, as well as remove the recommendation that individuals cease screening once they have stopped smoking for 15 years.

Given the new guidelines, most private insurance plans will need to update screening coverage policies to reflect the updated guidelines for plan years beginning after March 31.

To read the final decision, visit the CMS website.

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

This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Hello. This is Mark Kris from Memorial Sloan Kettering, talking today about circulating tumor DNA (ctDNA), an emerging technology for use in perioperative patients. Recently, there have been a number of presentations about the use of ctDNA measurements in patients receiving pre- or postoperative therapies. These are critical therapies because they are given with the intention of improving the chance for cure.

All three of the presentations I’m going to mention have one thing in common: They used the so-called tumor-informed panel. The investigators took the patients’ tumor tissue, looked for cancer-related genes in that tumor tissue, and then looked for those same genes in the patient’s blood. That technology is going to become very important, as shown in these presentations.

I made one of these presentations at the European Society for Medical Oncology Immuno-Oncology virtual meeting in Geneva. In our study, we were able to find genes in the majority of patients who had tumor tissue available. These patients were preoperative surgical candidates. In 72% of these, we were able to find and track ctDNA. When we tracked the DNA in the blood, we saw that the falling levels of DNA were associated with shrinkages of the cancer radiographically – the degree of shrinkage seen in this case in the neoadjuvant examination at the time of surgery and examining the resection specimen after neoadjuvant therapy. Ultimately, the major pathologic responses were associated with clearing or falling DNA as well. Perhaps the most interesting observation is that when you put this DNA information together with the major pathologic response information, all of the patients who had clearance of ctDNA and had a major pathologic response were disease free. I believe that eventually we will use this ctDNA data in conjunction with other measures of benefit to reach a more precise assessment of therapy benefit, and eventually it may be helpful for prognosis as well.

Two other studies also used this technology. One was earlier this year, presented by Patrick Forde at the American Association for Cancer Research meeting. They associated changes in ctDNA using another tumor-informed assay. In that study, using the Archer assay, they were able to show that the ctDNA clearance was associated with a complete pathologic response. So again, combining this information provides a more precise measurement of the benefit of therapy.

Another presentation at ESMO Immuno-Oncology, by Caicun Zhou, looked at the Natera assay, another tumor-informed assay, in a trial of adjuvant atezolizumab. This group showed that patients who had clearance of their ctDNA after surgery had the greatest benefit from subsequent atezolizumab therapy. And even those patients who did not have clearance experienced some benefit of the atezolizumab therapy. In addition, they assessed the degree of benefit associated with whether or not PD-L1 was present. Those patients who had PD-L1 expression experienced the greatest benefit from the atezolizumab. For patients who didn’t have PD-L1 expression, where you wouldn’t expect atezolizumab to have this greater benefit, they didn’t see it.

I believe that ctDNA-informed testing will become more and more useful, both in clinical trials and ultimately in the care of patients with early-stage lung cancers. These tumor-informed assays are going to be standards of care and provide physicians and patients a better estimate of the effectiveness of therapy going forward.

Dr. Kris is chief of the thoracic oncology service and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center in New York. He reported serving as a consultant and/or adviser for AstraZeneca, Daiichi Sankyo, and Pfizer, and has received payments for various services from Genentech.

This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Hello. This is Mark Kris from Memorial Sloan Kettering, talking today about circulating tumor DNA (ctDNA), an emerging technology for use in perioperative patients. Recently, there have been a number of presentations about the use of ctDNA measurements in patients receiving pre- or postoperative therapies. These are critical therapies because they are given with the intention of improving the chance for cure.

All three of the presentations I’m going to mention have one thing in common: They used the so-called tumor-informed panel. The investigators took the patients’ tumor tissue, looked for cancer-related genes in that tumor tissue, and then looked for those same genes in the patient’s blood. That technology is going to become very important, as shown in these presentations.

I made one of these presentations at the European Society for Medical Oncology Immuno-Oncology virtual meeting in Geneva. In our study, we were able to find genes in the majority of patients who had tumor tissue available. These patients were preoperative surgical candidates. In 72% of these, we were able to find and track ctDNA. When we tracked the DNA in the blood, we saw that the falling levels of DNA were associated with shrinkages of the cancer radiographically – the degree of shrinkage seen in this case in the neoadjuvant examination at the time of surgery and examining the resection specimen after neoadjuvant therapy. Ultimately, the major pathologic responses were associated with clearing or falling DNA as well. Perhaps the most interesting observation is that when you put this DNA information together with the major pathologic response information, all of the patients who had clearance of ctDNA and had a major pathologic response were disease free. I believe that eventually we will use this ctDNA data in conjunction with other measures of benefit to reach a more precise assessment of therapy benefit, and eventually it may be helpful for prognosis as well.

Two other studies also used this technology. One was earlier this year, presented by Patrick Forde at the American Association for Cancer Research meeting. They associated changes in ctDNA using another tumor-informed assay. In that study, using the Archer assay, they were able to show that the ctDNA clearance was associated with a complete pathologic response. So again, combining this information provides a more precise measurement of the benefit of therapy.

Another presentation at ESMO Immuno-Oncology, by Caicun Zhou, looked at the Natera assay, another tumor-informed assay, in a trial of adjuvant atezolizumab. This group showed that patients who had clearance of their ctDNA after surgery had the greatest benefit from subsequent atezolizumab therapy. And even those patients who did not have clearance experienced some benefit of the atezolizumab therapy. In addition, they assessed the degree of benefit associated with whether or not PD-L1 was present. Those patients who had PD-L1 expression experienced the greatest benefit from the atezolizumab. For patients who didn’t have PD-L1 expression, where you wouldn’t expect atezolizumab to have this greater benefit, they didn’t see it.

I believe that ctDNA-informed testing will become more and more useful, both in clinical trials and ultimately in the care of patients with early-stage lung cancers. These tumor-informed assays are going to be standards of care and provide physicians and patients a better estimate of the effectiveness of therapy going forward.

Dr. Kris is chief of the thoracic oncology service and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center in New York. He reported serving as a consultant and/or adviser for AstraZeneca, Daiichi Sankyo, and Pfizer, and has received payments for various services from Genentech.

This transcript has been edited for clarity. A version of this article first appeared on Medscape.com.

Hello. This is Mark Kris from Memorial Sloan Kettering, talking today about circulating tumor DNA (ctDNA), an emerging technology for use in perioperative patients. Recently, there have been a number of presentations about the use of ctDNA measurements in patients receiving pre- or postoperative therapies. These are critical therapies because they are given with the intention of improving the chance for cure.

All three of the presentations I’m going to mention have one thing in common: They used the so-called tumor-informed panel. The investigators took the patients’ tumor tissue, looked for cancer-related genes in that tumor tissue, and then looked for those same genes in the patient’s blood. That technology is going to become very important, as shown in these presentations.

I made one of these presentations at the European Society for Medical Oncology Immuno-Oncology virtual meeting in Geneva. In our study, we were able to find genes in the majority of patients who had tumor tissue available. These patients were preoperative surgical candidates. In 72% of these, we were able to find and track ctDNA. When we tracked the DNA in the blood, we saw that the falling levels of DNA were associated with shrinkages of the cancer radiographically – the degree of shrinkage seen in this case in the neoadjuvant examination at the time of surgery and examining the resection specimen after neoadjuvant therapy. Ultimately, the major pathologic responses were associated with clearing or falling DNA as well. Perhaps the most interesting observation is that when you put this DNA information together with the major pathologic response information, all of the patients who had clearance of ctDNA and had a major pathologic response were disease free. I believe that eventually we will use this ctDNA data in conjunction with other measures of benefit to reach a more precise assessment of therapy benefit, and eventually it may be helpful for prognosis as well.

Two other studies also used this technology. One was earlier this year, presented by Patrick Forde at the American Association for Cancer Research meeting. They associated changes in ctDNA using another tumor-informed assay. In that study, using the Archer assay, they were able to show that the ctDNA clearance was associated with a complete pathologic response. So again, combining this information provides a more precise measurement of the benefit of therapy.

Another presentation at ESMO Immuno-Oncology, by Caicun Zhou, looked at the Natera assay, another tumor-informed assay, in a trial of adjuvant atezolizumab. This group showed that patients who had clearance of their ctDNA after surgery had the greatest benefit from subsequent atezolizumab therapy. And even those patients who did not have clearance experienced some benefit of the atezolizumab therapy. In addition, they assessed the degree of benefit associated with whether or not PD-L1 was present. Those patients who had PD-L1 expression experienced the greatest benefit from the atezolizumab. For patients who didn’t have PD-L1 expression, where you wouldn’t expect atezolizumab to have this greater benefit, they didn’t see it.

I believe that ctDNA-informed testing will become more and more useful, both in clinical trials and ultimately in the care of patients with early-stage lung cancers. These tumor-informed assays are going to be standards of care and provide physicians and patients a better estimate of the effectiveness of therapy going forward.

Dr. Kris is chief of the thoracic oncology service and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center in New York. He reported serving as a consultant and/or adviser for AstraZeneca, Daiichi Sankyo, and Pfizer, and has received payments for various services from Genentech.

A 2021 update to the U.S. Preventive Services Task Force lung cancer screening guidelines eliminated racial disparities that were prevalent in the group’s 2013 guidance, according to a report in JAMA Oncology.

Fewer Black people qualified for screening in the earlier guideline of which the majority of its participants were White. In response, the group changed the screening eligibility age from 55 to 50 years and lowered the smoking pack by year requirement from 30 to 20 years.

The changes showed that Black smokers tend to develop lung cancer earlier and with fewer pack-years than White smokers.
 

The study details

To gauge the impact, investigators from Wayne State University, Detroit, reviewed 912 patients with lung cancer and 1,457 controls without lung cancer to see who would have qualified for screening under the 2013 and 2021 criteria.

They were participants in the Detroit-area INHALE (Inflammation, Health, Ancestry, and Lung Epidemiology) study from 2012 to 2018. Over 30% were Black.

“Lowering the age and smoking criteria successfully bridged the gap in racial disparity,” said investigators led by Chan Yeu Pu, MD, a lung cancer specialist at Wayne State University.

With the 2021 criteria, 65% of White patients and 63% of Black patients with lung cancer would have been eligible for screening. Under the 2013 guidance, 52% of White patients were eligible for screening, but only 42% of Black patients.

The update also eliminated racial disparities among controls. The new guidance excluded 48% of White controls without lung cancer from screening and 50% of Black controls. The 2013 criteria excluded fewer White controls (61%) than Black control subjects (70%).

“As expected, broader inclusion criteria increased sensitivity, but at the cost of decreased specificity,” the investigators wrote.
 

Why is screening important?

The hope of screening is to catch lung cancer early, when curative surgical resection is still possible, the team wrote, but although screening has increased over the years, uptake remains dismal, just 5% in 2018, for instance.

In an editorial, Philadelphia-area thoracic surgeons Jonathan Nitz, MD, and Cherie Erkmen, MD, wrote that “multiple and changing criteria” and “nebulous payment plans” have made “for a confusing message. ... We need standardized” guidelines to deliver “a clear message about lung cancer screening.”

The fact that nearly two-thirds of lung cancer patients wouldn’t have qualified for screening under current guidelines also needs to be addressed. “We need standardized practice guidelines based on evidence from diverse populations and policies to ensure equitable access for high-risk individuals. Although this study demonstrates improved, calculated sensitivity of the 2021 USPSTF guidelines to detect lung cancer, these refinements of criteria do not address the nearly two-thirds of patients with diagnosed lung cancer who are not eligible for screening. There is a pressing need to redefine screening criteria,” Dr. Nitz and Dr. Erkmen wrote.

Both the 2013 and 2021 guidelines were outperformed in the study by the 2012 modification of the model from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCOm2012 criteria), but only marginally so in the case of USPSTF’s 2021 guidance.

PLCOm2012 screening eligibility, however, are based on a complicated risk factor assessments that include race but also education level and other factors which might not be readily available in electronic records. USPSTF’s criteria “are much more straightforward to use in a clinical setting,” the investigators noted.

Study subjects were 21-89 years old and were in their early 60s, on average. Just over half were women. The analysis excluded lung cancer patients and controls who had never smoked.

The authors noted some limitations, including the retrospective nature of the study, plus, few lung cancers were diagnosed among the control group, which were not only small, but they did not include follow-ups with CT scans.

The work was funded by the National Institutes of Health and the Herrick Foundation. Dr. Pu didn’t have any commercial disclosures. One investigator disclosed personal fees from Takeda, AstraZeneca, Genentech/Roche, Pfizer, and other companies. Dr. Erkmen reported an American Cancer Society-Pfizer Award to address disparities.

A 2021 update to the U.S. Preventive Services Task Force lung cancer screening guidelines eliminated racial disparities that were prevalent in the group’s 2013 guidance, according to a report in JAMA Oncology.

Fewer Black people qualified for screening in the earlier guideline of which the majority of its participants were White. In response, the group changed the screening eligibility age from 55 to 50 years and lowered the smoking pack by year requirement from 30 to 20 years.

The changes showed that Black smokers tend to develop lung cancer earlier and with fewer pack-years than White smokers.
 

The study details

To gauge the impact, investigators from Wayne State University, Detroit, reviewed 912 patients with lung cancer and 1,457 controls without lung cancer to see who would have qualified for screening under the 2013 and 2021 criteria.

They were participants in the Detroit-area INHALE (Inflammation, Health, Ancestry, and Lung Epidemiology) study from 2012 to 2018. Over 30% were Black.

“Lowering the age and smoking criteria successfully bridged the gap in racial disparity,” said investigators led by Chan Yeu Pu, MD, a lung cancer specialist at Wayne State University.

With the 2021 criteria, 65% of White patients and 63% of Black patients with lung cancer would have been eligible for screening. Under the 2013 guidance, 52% of White patients were eligible for screening, but only 42% of Black patients.

The update also eliminated racial disparities among controls. The new guidance excluded 48% of White controls without lung cancer from screening and 50% of Black controls. The 2013 criteria excluded fewer White controls (61%) than Black control subjects (70%).

“As expected, broader inclusion criteria increased sensitivity, but at the cost of decreased specificity,” the investigators wrote.
 

Why is screening important?

The hope of screening is to catch lung cancer early, when curative surgical resection is still possible, the team wrote, but although screening has increased over the years, uptake remains dismal, just 5% in 2018, for instance.

In an editorial, Philadelphia-area thoracic surgeons Jonathan Nitz, MD, and Cherie Erkmen, MD, wrote that “multiple and changing criteria” and “nebulous payment plans” have made “for a confusing message. ... We need standardized” guidelines to deliver “a clear message about lung cancer screening.”

The fact that nearly two-thirds of lung cancer patients wouldn’t have qualified for screening under current guidelines also needs to be addressed. “We need standardized practice guidelines based on evidence from diverse populations and policies to ensure equitable access for high-risk individuals. Although this study demonstrates improved, calculated sensitivity of the 2021 USPSTF guidelines to detect lung cancer, these refinements of criteria do not address the nearly two-thirds of patients with diagnosed lung cancer who are not eligible for screening. There is a pressing need to redefine screening criteria,” Dr. Nitz and Dr. Erkmen wrote.

Both the 2013 and 2021 guidelines were outperformed in the study by the 2012 modification of the model from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCOm2012 criteria), but only marginally so in the case of USPSTF’s 2021 guidance.

PLCOm2012 screening eligibility, however, are based on a complicated risk factor assessments that include race but also education level and other factors which might not be readily available in electronic records. USPSTF’s criteria “are much more straightforward to use in a clinical setting,” the investigators noted.

Study subjects were 21-89 years old and were in their early 60s, on average. Just over half were women. The analysis excluded lung cancer patients and controls who had never smoked.

The authors noted some limitations, including the retrospective nature of the study, plus, few lung cancers were diagnosed among the control group, which were not only small, but they did not include follow-ups with CT scans.

The work was funded by the National Institutes of Health and the Herrick Foundation. Dr. Pu didn’t have any commercial disclosures. One investigator disclosed personal fees from Takeda, AstraZeneca, Genentech/Roche, Pfizer, and other companies. Dr. Erkmen reported an American Cancer Society-Pfizer Award to address disparities.

A 2021 update to the U.S. Preventive Services Task Force lung cancer screening guidelines eliminated racial disparities that were prevalent in the group’s 2013 guidance, according to a report in JAMA Oncology.

Fewer Black people qualified for screening in the earlier guideline of which the majority of its participants were White. In response, the group changed the screening eligibility age from 55 to 50 years and lowered the smoking pack by year requirement from 30 to 20 years.

The changes showed that Black smokers tend to develop lung cancer earlier and with fewer pack-years than White smokers.
 

The study details

To gauge the impact, investigators from Wayne State University, Detroit, reviewed 912 patients with lung cancer and 1,457 controls without lung cancer to see who would have qualified for screening under the 2013 and 2021 criteria.

They were participants in the Detroit-area INHALE (Inflammation, Health, Ancestry, and Lung Epidemiology) study from 2012 to 2018. Over 30% were Black.

“Lowering the age and smoking criteria successfully bridged the gap in racial disparity,” said investigators led by Chan Yeu Pu, MD, a lung cancer specialist at Wayne State University.

With the 2021 criteria, 65% of White patients and 63% of Black patients with lung cancer would have been eligible for screening. Under the 2013 guidance, 52% of White patients were eligible for screening, but only 42% of Black patients.

The update also eliminated racial disparities among controls. The new guidance excluded 48% of White controls without lung cancer from screening and 50% of Black controls. The 2013 criteria excluded fewer White controls (61%) than Black control subjects (70%).

“As expected, broader inclusion criteria increased sensitivity, but at the cost of decreased specificity,” the investigators wrote.
 

Why is screening important?

The hope of screening is to catch lung cancer early, when curative surgical resection is still possible, the team wrote, but although screening has increased over the years, uptake remains dismal, just 5% in 2018, for instance.

In an editorial, Philadelphia-area thoracic surgeons Jonathan Nitz, MD, and Cherie Erkmen, MD, wrote that “multiple and changing criteria” and “nebulous payment plans” have made “for a confusing message. ... We need standardized” guidelines to deliver “a clear message about lung cancer screening.”

The fact that nearly two-thirds of lung cancer patients wouldn’t have qualified for screening under current guidelines also needs to be addressed. “We need standardized practice guidelines based on evidence from diverse populations and policies to ensure equitable access for high-risk individuals. Although this study demonstrates improved, calculated sensitivity of the 2021 USPSTF guidelines to detect lung cancer, these refinements of criteria do not address the nearly two-thirds of patients with diagnosed lung cancer who are not eligible for screening. There is a pressing need to redefine screening criteria,” Dr. Nitz and Dr. Erkmen wrote.

Both the 2013 and 2021 guidelines were outperformed in the study by the 2012 modification of the model from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCOm2012 criteria), but only marginally so in the case of USPSTF’s 2021 guidance.

PLCOm2012 screening eligibility, however, are based on a complicated risk factor assessments that include race but also education level and other factors which might not be readily available in electronic records. USPSTF’s criteria “are much more straightforward to use in a clinical setting,” the investigators noted.

Study subjects were 21-89 years old and were in their early 60s, on average. Just over half were women. The analysis excluded lung cancer patients and controls who had never smoked.

The authors noted some limitations, including the retrospective nature of the study, plus, few lung cancers were diagnosed among the control group, which were not only small, but they did not include follow-ups with CT scans.

The work was funded by the National Institutes of Health and the Herrick Foundation. Dr. Pu didn’t have any commercial disclosures. One investigator disclosed personal fees from Takeda, AstraZeneca, Genentech/Roche, Pfizer, and other companies. Dr. Erkmen reported an American Cancer Society-Pfizer Award to address disparities.

Catching all solid cancers before they metastasize could prevent 26% to 32% of cancer deaths in women and 18% to 24% in men within 10 years of diagnosis, researchers in Australia estimate.

Those figures translate to 2,064 to 2,677 fewer cancer deaths annually in the state of New South Wales between 2005 and 2014, the most recent period studied.

“While it is well established that diagnosing cancers at an earlier stage is ‘better,’ our study is unique in that it quantifies what that ‘better’ might look like in terms of how many deaths would be avoided within 10 years of diagnosis,” the authors write in an article published online Jan. 17 in the International Journal of Cancer. “By doing so, it is hoped that these results will provide continued motivation to develop more effective strategies to diagnose cancers at an earlier stage.”

Of course, achieving such a “stage-shift in practice is difficult,” study author Xue Qin Yu, PhD, of The Daffodil Centre in Sydney and colleagues, acknowledge. First, Dr. Yu and colleagues note, “diagnosis at an earlier stage can be challenging due to the nonspecific nature of many common symptoms which may not be recognized by either patients or doctors.” Plus, they add, a challenge for diagnosing cancers at an earlier stage “is the overall low uptake of screening.”

For their study, the researchers used data from a cohort of more than 716,000 people aged 15 to 89 years diagnosed with a solid cancer in New South Wales between 1985 and 2014 and followed through 2015.

To estimate how many deaths could be avoided if tumors were caught earlier, the authors looked at two scenarios. In scenario 1, they assumed all known cases of distant cancer were instead diagnosed at the regional stage, and in scenario 2, they assumed half of the cases were diagnosed as regional and half as localized disease.

Under the conservative scenario 1, about 18% of the observed cancer deaths in males and 26% in females could be avoided. In total, this corresponded to 21% of observed deaths.

Colorectal cancer topped the list of avoidable deaths in both men (27%) and women (33%), followed by prostate cancer in men (19%), breast cancer in women (18%), and melanoma in women (16%) and men (13%).

Under scenario 2, 24% of cancer deaths in males and 32% in females – or 28% overall – were avoidable.

The researchers caution that their study is limited by a high proportion of cases of unknown stage. Still, they say their findings are consistent with results from the United States indicating 15% to 25% of cancer-related deaths were potentially avoidable if tumors were detected before metastasizing.

“Given our study cohort was sourced from a population-based cancer registry with complete enumeration of cancers diagnosed during the study period, it is likely that our study findings, particularly in terms of the population rate of avoidable deaths, would be generalizable to other populations with similar characteristics,” Dr. Yu and colleagues write. “However, results may be different in countries that have a different mix of cancer types or distribution of stage at diagnosis.”

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

Catching all solid cancers before they metastasize could prevent 26% to 32% of cancer deaths in women and 18% to 24% in men within 10 years of diagnosis, researchers in Australia estimate.

Those figures translate to 2,064 to 2,677 fewer cancer deaths annually in the state of New South Wales between 2005 and 2014, the most recent period studied.

“While it is well established that diagnosing cancers at an earlier stage is ‘better,’ our study is unique in that it quantifies what that ‘better’ might look like in terms of how many deaths would be avoided within 10 years of diagnosis,” the authors write in an article published online Jan. 17 in the International Journal of Cancer. “By doing so, it is hoped that these results will provide continued motivation to develop more effective strategies to diagnose cancers at an earlier stage.”

Of course, achieving such a “stage-shift in practice is difficult,” study author Xue Qin Yu, PhD, of The Daffodil Centre in Sydney and colleagues, acknowledge. First, Dr. Yu and colleagues note, “diagnosis at an earlier stage can be challenging due to the nonspecific nature of many common symptoms which may not be recognized by either patients or doctors.” Plus, they add, a challenge for diagnosing cancers at an earlier stage “is the overall low uptake of screening.”

For their study, the researchers used data from a cohort of more than 716,000 people aged 15 to 89 years diagnosed with a solid cancer in New South Wales between 1985 and 2014 and followed through 2015.

To estimate how many deaths could be avoided if tumors were caught earlier, the authors looked at two scenarios. In scenario 1, they assumed all known cases of distant cancer were instead diagnosed at the regional stage, and in scenario 2, they assumed half of the cases were diagnosed as regional and half as localized disease.

Under the conservative scenario 1, about 18% of the observed cancer deaths in males and 26% in females could be avoided. In total, this corresponded to 21% of observed deaths.

Colorectal cancer topped the list of avoidable deaths in both men (27%) and women (33%), followed by prostate cancer in men (19%), breast cancer in women (18%), and melanoma in women (16%) and men (13%).

Under scenario 2, 24% of cancer deaths in males and 32% in females – or 28% overall – were avoidable.

The researchers caution that their study is limited by a high proportion of cases of unknown stage. Still, they say their findings are consistent with results from the United States indicating 15% to 25% of cancer-related deaths were potentially avoidable if tumors were detected before metastasizing.

“Given our study cohort was sourced from a population-based cancer registry with complete enumeration of cancers diagnosed during the study period, it is likely that our study findings, particularly in terms of the population rate of avoidable deaths, would be generalizable to other populations with similar characteristics,” Dr. Yu and colleagues write. “However, results may be different in countries that have a different mix of cancer types or distribution of stage at diagnosis.”

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

Catching all solid cancers before they metastasize could prevent 26% to 32% of cancer deaths in women and 18% to 24% in men within 10 years of diagnosis, researchers in Australia estimate.

Those figures translate to 2,064 to 2,677 fewer cancer deaths annually in the state of New South Wales between 2005 and 2014, the most recent period studied.

“While it is well established that diagnosing cancers at an earlier stage is ‘better,’ our study is unique in that it quantifies what that ‘better’ might look like in terms of how many deaths would be avoided within 10 years of diagnosis,” the authors write in an article published online Jan. 17 in the International Journal of Cancer. “By doing so, it is hoped that these results will provide continued motivation to develop more effective strategies to diagnose cancers at an earlier stage.”

Of course, achieving such a “stage-shift in practice is difficult,” study author Xue Qin Yu, PhD, of The Daffodil Centre in Sydney and colleagues, acknowledge. First, Dr. Yu and colleagues note, “diagnosis at an earlier stage can be challenging due to the nonspecific nature of many common symptoms which may not be recognized by either patients or doctors.” Plus, they add, a challenge for diagnosing cancers at an earlier stage “is the overall low uptake of screening.”

For their study, the researchers used data from a cohort of more than 716,000 people aged 15 to 89 years diagnosed with a solid cancer in New South Wales between 1985 and 2014 and followed through 2015.

To estimate how many deaths could be avoided if tumors were caught earlier, the authors looked at two scenarios. In scenario 1, they assumed all known cases of distant cancer were instead diagnosed at the regional stage, and in scenario 2, they assumed half of the cases were diagnosed as regional and half as localized disease.

Under the conservative scenario 1, about 18% of the observed cancer deaths in males and 26% in females could be avoided. In total, this corresponded to 21% of observed deaths.

Colorectal cancer topped the list of avoidable deaths in both men (27%) and women (33%), followed by prostate cancer in men (19%), breast cancer in women (18%), and melanoma in women (16%) and men (13%).

Under scenario 2, 24% of cancer deaths in males and 32% in females – or 28% overall – were avoidable.

The researchers caution that their study is limited by a high proportion of cases of unknown stage. Still, they say their findings are consistent with results from the United States indicating 15% to 25% of cancer-related deaths were potentially avoidable if tumors were detected before metastasizing.

“Given our study cohort was sourced from a population-based cancer registry with complete enumeration of cancers diagnosed during the study period, it is likely that our study findings, particularly in terms of the population rate of avoidable deaths, would be generalizable to other populations with similar characteristics,” Dr. Yu and colleagues write. “However, results may be different in countries that have a different mix of cancer types or distribution of stage at diagnosis.”

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

Use of e-cigarettes was not more effective than other methods at helping cigarette smokers quit, authors of new research found.

From 2013 to 2017, e-cigarette sales in the United States nearly doubled, driven by a rapid uptake of use by adolescents, wrote Riufeng Chen, MD, of the University of California, San Diego, and colleagues, in their paper published in Tobacco Control. However, the subsequent effect of increased e-cigarette use on smoking cessation have not been examined, they said.

In their study, Dr. Chen and colleagues analyzed data from 3,578 previous-year smokers with a recent quit attempt and 1,323 recent former smokers who were part of the PATH cohort in 2017. The participants reported using e-cigarettes or other products to quit cigarette smoking. The primary outcomes were at least 12 months of cigarette abstinence, and tobacco abstinence in 2019. In 2017, 32.8% of established smokers reported trying to quit. Of these, 12.6% used e-cigarettes to help them quit. Cigarette abstinence for at least 12 months for these individuals was 9.9%, which was lower than for those who used either nicotine replacement therapy or a pharmaceutical aid only (15.2%), and about half of the 18.6% abstinence in those who used no products to help them quit.

“In our study, e-cigarettes resulted in seven fewer successful quitters than those who used pharmaceutical aids,” emphasized corresponding author, John P. Pierce, PhD, of the University of California, San Diego.

Among smokers attempting to quit, the adjusted risk difference for cigarette abstinence for a least 12 months with e-cigarettes vs. pharmaceutical aids was –7.3%, and –7.7% for e-cigarettes vs. other smoking cessation methods.

*“Among recent former smokers who had switched to daily use of e-cigarettes in 2017, 43.2% had successfully quit cigarette smoking by 2019, which was similar to those who used e-cigarettes on a nondaily basis (34.6%) or to those who switched to another tobacco product, whether daily (43.6%) or nondaily (44.7%),” the researchers wrote.

The rapid growth in e-cigarette use between 2014 and 2017 has been attributed in part to aggressive marketing of high-nicotine e-cigarettes, they said. “The high-nicotine JUUL e-cigarette has been noted as the closest match to cigarettes in both nicotine delivery and user satisfaction, which should make it one of the best candidates as a product to which smokers could switch in order to maintain their nicotine habit,” they said in their discussion of the findings.

More research needed

The researchers acknowledged the need to review more recent data.

“When we looked ahead to 2019, recent former smokers had started using high-nicotine e-cigarettes. The effectiveness of high-nicotine e-cigarettes at preventing relapse will require another follow-up PATH survey,” they said.

Among recent former smokers, 2.2% reported switching to a high-nicotine e-cigarette. Although individuals who switched to e-cigarettes showed a higher rate of relapse to cigarettes than those who did not switch to other tobacco or e-cigarette products, this difference was not significant.

The study findings were limited by several factors including the observational design and inability to control for all potential confounding factors, the researchers noted. However, the results were strengthened by the use of a large and representative study population, and the inclusion of biological samples to validate self-reported smoking, they said.
 

Several findings surprised study author

Dr. Pierce said he was surprised by several aspects of the study findings.

“First of all, contrary to what we expected, there was a 25% decline in using e-cigarettes to quit, compared to the previous year (not the 40% increase that was expected from the increase in e-cigarette sales) and almost no smokers were using high-nicotine JUUL products to help them quit,” he said. “In this study, e-cigarettes were much less helpful (7 less successful quitters per 100) than pharmaceutical cessation aids in helping people quit,” he added.

“The fact that the proportion of smokers using e-cigarettes for cessation dropped from 17% to 12% was unexpected, and it suggests that the belief that they are a cessation aid is declining,” he said.

The implication for clinical practice is that e-cigarettes are not a useful tool for smoking cessation, Dr. Pierce said. “We are not finding any evidence in this very large nationally representative study that smokers who switch to getting their nicotine from e-cigarettes are less likely to relapse back to cigarette smoking,” he said.

“We don’t know about the high-nicotine versions,” he added. 
 

New review advises against e-cigarettes for cessation

A recent review article published in JAMA supported the use of pharmacotherapy and behavioral support for smokers wanting to quit. In the review, Nancy A. Rigotti, MD, of Massachusetts General Hospital, Boston, and colleagues summarized the evidence for managing tobacco smoking in clinical practice.

“The health risk from cigarette smoking is primarily due to chemicals produced by the burning of tobacco and not to nicotine,” they noted. However, the physical dependence on nicotine makes quitting a challenge, but it is one worth pursuing, the authors said.

The authors of this review identified 30 reviews, 12 randomized clinical trials, and 7 recent guidelines and evidence reviews. Their key message: Pharmacotherapy and behavioral support are effective when used alone, but even more effective when combined. Pharmacotherapy helps reduce the symptoms of nicotine withdrawal, while behavioral intervention tackles the challenge of changing learned behaviors associated with smoking, the researchers said.

Although combining medications, such as varenicline and nicotine replacement therapy or bupropion might improve successful quit rates, these combinations have not been well studied, they noted.

With regard to e-cigarettes, the researchers cited a 2021 Cochrane review of 16,759 individuals who used e-cigarettes for smoking cessation, which found no evidence of harm, but insufficient evidence to asses the balance of risks vs. benefits.

In addition to the lack of randomized trials, “the FDA regulates e-cigarettes as tobacco products, not as medical products and has not evaluated any e-cigarette for medical use as a cessation aid,” the authors of the new review noted.

The review was limited by several factors, including the lack of quality assessment for the selected studies and the exclusion of pharmacotherapy not licensed in the United States.

Commenting on the JAMA paper, Dr. Pierce said, “This review looks like a number of Cochrane Reports that have been published recently. Of course, it only considers randomized trials and not population evidence.”

“If public health had limited itself to this form of evidence, then we still would not know that smoking caused cancer,” he noted. “Randomized trials are very important for testing new drugs; they use selected populations and provide considerable support that is not available in the real world. Sometimes they do not generalize to the population.”
 

Findings may guide patient conversations

The Tobacco Control study was important, because few studies on e-cigarettes have been conducted, said Linda Girgis, MD, a family physician in private practice in South River, N.J., in an interview.

“As clinicians, we do not have a lot of data available in order to make clinical decisions that are evidence based. Also, getting patients to quit smoking is often very difficult, and having more tools available is a great benefit; however, we need to have the evidence that these tools are effective,” she said.

Dr. Girgis also said she was not surprised by the findings.

“Patients still have the same concerns from e-cigarettes regarding nicotine exposure, but just to a lesser degree; and we still don’t know the long-term effects of e-cigarette use, she said. Based on these studies, recommending e-cigarettes for smokers looking to quit may not be the best method, she noted.

“While it may seem reasonable that exposing lungs to lower doses of nicotine will reduce harm, we need to see actual evidence of this. Also, we also need to study the additives that are frequently used in e-cigs, such as artificial flavorings, to see what harms they may pose, she emphasized.

With regard to the JAMA review, Dr. Girgis said she agreed with the recommendations for pharmacotherapy and behavior therapy as first-line treatments for smoking cessation. “There is evidence regarding the efficacy and safety of these methods, and they have been used for decades,” she said.

Dr. Girgis added that there is a role for e-cigarettes in smoking cessation strategies as a method of harm reduction, but pointed out the problem of many people thinking these products are safe and not understanding the hazards they pose.

“They think they can replace smoking with e-cigarettes and be safe from the health risks associated with smoking. I think if the plan were to switch to e-cigarettes for a short period and then quit, there would be a role,” Dr. Girgis said. “However, replacing one risk for another may reduce harm, but doesn’t eliminate it.”

“To continue to use e-cigarettes indefinitely should not be the goal,” she added.

The Tobacco Control study was funded by the National Institutes of Health and the Tobacco-Related Disease Research Program of the University of California. The researchers had no financial conflicts to disclose.

The JAMA study was funded in part by a grant from the National Institute for Health Research, via Cochrane Infrastructure funds to the Cochrane Tobacco Addiction Group. Lead author Dr. Rigotti disclosed funding from the National Heart, Lung, and Blood Institute and Achieve Life Sciences and personal fees from UpToDate and Achieve Life Sciences. Dr. Girgis had no financial conflicts to disclose.

*This article was updated on 2/28/2022.

Use of e-cigarettes was not more effective than other methods at helping cigarette smokers quit, authors of new research found.

From 2013 to 2017, e-cigarette sales in the United States nearly doubled, driven by a rapid uptake of use by adolescents, wrote Riufeng Chen, MD, of the University of California, San Diego, and colleagues, in their paper published in Tobacco Control. However, the subsequent effect of increased e-cigarette use on smoking cessation have not been examined, they said.

In their study, Dr. Chen and colleagues analyzed data from 3,578 previous-year smokers with a recent quit attempt and 1,323 recent former smokers who were part of the PATH cohort in 2017. The participants reported using e-cigarettes or other products to quit cigarette smoking. The primary outcomes were at least 12 months of cigarette abstinence, and tobacco abstinence in 2019. In 2017, 32.8% of established smokers reported trying to quit. Of these, 12.6% used e-cigarettes to help them quit. Cigarette abstinence for at least 12 months for these individuals was 9.9%, which was lower than for those who used either nicotine replacement therapy or a pharmaceutical aid only (15.2%), and about half of the 18.6% abstinence in those who used no products to help them quit.

“In our study, e-cigarettes resulted in seven fewer successful quitters than those who used pharmaceutical aids,” emphasized corresponding author, John P. Pierce, PhD, of the University of California, San Diego.

Among smokers attempting to quit, the adjusted risk difference for cigarette abstinence for a least 12 months with e-cigarettes vs. pharmaceutical aids was –7.3%, and –7.7% for e-cigarettes vs. other smoking cessation methods.

*“Among recent former smokers who had switched to daily use of e-cigarettes in 2017, 43.2% had successfully quit cigarette smoking by 2019, which was similar to those who used e-cigarettes on a nondaily basis (34.6%) or to those who switched to another tobacco product, whether daily (43.6%) or nondaily (44.7%),” the researchers wrote.

The rapid growth in e-cigarette use between 2014 and 2017 has been attributed in part to aggressive marketing of high-nicotine e-cigarettes, they said. “The high-nicotine JUUL e-cigarette has been noted as the closest match to cigarettes in both nicotine delivery and user satisfaction, which should make it one of the best candidates as a product to which smokers could switch in order to maintain their nicotine habit,” they said in their discussion of the findings.

More research needed

The researchers acknowledged the need to review more recent data.

“When we looked ahead to 2019, recent former smokers had started using high-nicotine e-cigarettes. The effectiveness of high-nicotine e-cigarettes at preventing relapse will require another follow-up PATH survey,” they said.

Among recent former smokers, 2.2% reported switching to a high-nicotine e-cigarette. Although individuals who switched to e-cigarettes showed a higher rate of relapse to cigarettes than those who did not switch to other tobacco or e-cigarette products, this difference was not significant.

The study findings were limited by several factors including the observational design and inability to control for all potential confounding factors, the researchers noted. However, the results were strengthened by the use of a large and representative study population, and the inclusion of biological samples to validate self-reported smoking, they said.
 

Several findings surprised study author

Dr. Pierce said he was surprised by several aspects of the study findings.

“First of all, contrary to what we expected, there was a 25% decline in using e-cigarettes to quit, compared to the previous year (not the 40% increase that was expected from the increase in e-cigarette sales) and almost no smokers were using high-nicotine JUUL products to help them quit,” he said. “In this study, e-cigarettes were much less helpful (7 less successful quitters per 100) than pharmaceutical cessation aids in helping people quit,” he added.

“The fact that the proportion of smokers using e-cigarettes for cessation dropped from 17% to 12% was unexpected, and it suggests that the belief that they are a cessation aid is declining,” he said.

The implication for clinical practice is that e-cigarettes are not a useful tool for smoking cessation, Dr. Pierce said. “We are not finding any evidence in this very large nationally representative study that smokers who switch to getting their nicotine from e-cigarettes are less likely to relapse back to cigarette smoking,” he said.

“We don’t know about the high-nicotine versions,” he added. 
 

New review advises against e-cigarettes for cessation

A recent review article published in JAMA supported the use of pharmacotherapy and behavioral support for smokers wanting to quit. In the review, Nancy A. Rigotti, MD, of Massachusetts General Hospital, Boston, and colleagues summarized the evidence for managing tobacco smoking in clinical practice.

“The health risk from cigarette smoking is primarily due to chemicals produced by the burning of tobacco and not to nicotine,” they noted. However, the physical dependence on nicotine makes quitting a challenge, but it is one worth pursuing, the authors said.

The authors of this review identified 30 reviews, 12 randomized clinical trials, and 7 recent guidelines and evidence reviews. Their key message: Pharmacotherapy and behavioral support are effective when used alone, but even more effective when combined. Pharmacotherapy helps reduce the symptoms of nicotine withdrawal, while behavioral intervention tackles the challenge of changing learned behaviors associated with smoking, the researchers said.

Although combining medications, such as varenicline and nicotine replacement therapy or bupropion might improve successful quit rates, these combinations have not been well studied, they noted.

With regard to e-cigarettes, the researchers cited a 2021 Cochrane review of 16,759 individuals who used e-cigarettes for smoking cessation, which found no evidence of harm, but insufficient evidence to asses the balance of risks vs. benefits.

In addition to the lack of randomized trials, “the FDA regulates e-cigarettes as tobacco products, not as medical products and has not evaluated any e-cigarette for medical use as a cessation aid,” the authors of the new review noted.

The review was limited by several factors, including the lack of quality assessment for the selected studies and the exclusion of pharmacotherapy not licensed in the United States.

Commenting on the JAMA paper, Dr. Pierce said, “This review looks like a number of Cochrane Reports that have been published recently. Of course, it only considers randomized trials and not population evidence.”

“If public health had limited itself to this form of evidence, then we still would not know that smoking caused cancer,” he noted. “Randomized trials are very important for testing new drugs; they use selected populations and provide considerable support that is not available in the real world. Sometimes they do not generalize to the population.”
 

Findings may guide patient conversations

The Tobacco Control study was important, because few studies on e-cigarettes have been conducted, said Linda Girgis, MD, a family physician in private practice in South River, N.J., in an interview.

“As clinicians, we do not have a lot of data available in order to make clinical decisions that are evidence based. Also, getting patients to quit smoking is often very difficult, and having more tools available is a great benefit; however, we need to have the evidence that these tools are effective,” she said.

Dr. Girgis also said she was not surprised by the findings.

“Patients still have the same concerns from e-cigarettes regarding nicotine exposure, but just to a lesser degree; and we still don’t know the long-term effects of e-cigarette use, she said. Based on these studies, recommending e-cigarettes for smokers looking to quit may not be the best method, she noted.

“While it may seem reasonable that exposing lungs to lower doses of nicotine will reduce harm, we need to see actual evidence of this. Also, we also need to study the additives that are frequently used in e-cigs, such as artificial flavorings, to see what harms they may pose, she emphasized.

With regard to the JAMA review, Dr. Girgis said she agreed with the recommendations for pharmacotherapy and behavior therapy as first-line treatments for smoking cessation. “There is evidence regarding the efficacy and safety of these methods, and they have been used for decades,” she said.

Dr. Girgis added that there is a role for e-cigarettes in smoking cessation strategies as a method of harm reduction, but pointed out the problem of many people thinking these products are safe and not understanding the hazards they pose.

“They think they can replace smoking with e-cigarettes and be safe from the health risks associated with smoking. I think if the plan were to switch to e-cigarettes for a short period and then quit, there would be a role,” Dr. Girgis said. “However, replacing one risk for another may reduce harm, but doesn’t eliminate it.”

“To continue to use e-cigarettes indefinitely should not be the goal,” she added.

The Tobacco Control study was funded by the National Institutes of Health and the Tobacco-Related Disease Research Program of the University of California. The researchers had no financial conflicts to disclose.

The JAMA study was funded in part by a grant from the National Institute for Health Research, via Cochrane Infrastructure funds to the Cochrane Tobacco Addiction Group. Lead author Dr. Rigotti disclosed funding from the National Heart, Lung, and Blood Institute and Achieve Life Sciences and personal fees from UpToDate and Achieve Life Sciences. Dr. Girgis had no financial conflicts to disclose.

*This article was updated on 2/28/2022.

Use of e-cigarettes was not more effective than other methods at helping cigarette smokers quit, authors of new research found.

From 2013 to 2017, e-cigarette sales in the United States nearly doubled, driven by a rapid uptake of use by adolescents, wrote Riufeng Chen, MD, of the University of California, San Diego, and colleagues, in their paper published in Tobacco Control. However, the subsequent effect of increased e-cigarette use on smoking cessation have not been examined, they said.

In their study, Dr. Chen and colleagues analyzed data from 3,578 previous-year smokers with a recent quit attempt and 1,323 recent former smokers who were part of the PATH cohort in 2017. The participants reported using e-cigarettes or other products to quit cigarette smoking. The primary outcomes were at least 12 months of cigarette abstinence, and tobacco abstinence in 2019. In 2017, 32.8% of established smokers reported trying to quit. Of these, 12.6% used e-cigarettes to help them quit. Cigarette abstinence for at least 12 months for these individuals was 9.9%, which was lower than for those who used either nicotine replacement therapy or a pharmaceutical aid only (15.2%), and about half of the 18.6% abstinence in those who used no products to help them quit.

“In our study, e-cigarettes resulted in seven fewer successful quitters than those who used pharmaceutical aids,” emphasized corresponding author, John P. Pierce, PhD, of the University of California, San Diego.

Among smokers attempting to quit, the adjusted risk difference for cigarette abstinence for a least 12 months with e-cigarettes vs. pharmaceutical aids was –7.3%, and –7.7% for e-cigarettes vs. other smoking cessation methods.

*“Among recent former smokers who had switched to daily use of e-cigarettes in 2017, 43.2% had successfully quit cigarette smoking by 2019, which was similar to those who used e-cigarettes on a nondaily basis (34.6%) or to those who switched to another tobacco product, whether daily (43.6%) or nondaily (44.7%),” the researchers wrote.

The rapid growth in e-cigarette use between 2014 and 2017 has been attributed in part to aggressive marketing of high-nicotine e-cigarettes, they said. “The high-nicotine JUUL e-cigarette has been noted as the closest match to cigarettes in both nicotine delivery and user satisfaction, which should make it one of the best candidates as a product to which smokers could switch in order to maintain their nicotine habit,” they said in their discussion of the findings.

More research needed

The researchers acknowledged the need to review more recent data.

“When we looked ahead to 2019, recent former smokers had started using high-nicotine e-cigarettes. The effectiveness of high-nicotine e-cigarettes at preventing relapse will require another follow-up PATH survey,” they said.

Among recent former smokers, 2.2% reported switching to a high-nicotine e-cigarette. Although individuals who switched to e-cigarettes showed a higher rate of relapse to cigarettes than those who did not switch to other tobacco or e-cigarette products, this difference was not significant.

The study findings were limited by several factors including the observational design and inability to control for all potential confounding factors, the researchers noted. However, the results were strengthened by the use of a large and representative study population, and the inclusion of biological samples to validate self-reported smoking, they said.
 

Several findings surprised study author

Dr. Pierce said he was surprised by several aspects of the study findings.

“First of all, contrary to what we expected, there was a 25% decline in using e-cigarettes to quit, compared to the previous year (not the 40% increase that was expected from the increase in e-cigarette sales) and almost no smokers were using high-nicotine JUUL products to help them quit,” he said. “In this study, e-cigarettes were much less helpful (7 less successful quitters per 100) than pharmaceutical cessation aids in helping people quit,” he added.

“The fact that the proportion of smokers using e-cigarettes for cessation dropped from 17% to 12% was unexpected, and it suggests that the belief that they are a cessation aid is declining,” he said.

The implication for clinical practice is that e-cigarettes are not a useful tool for smoking cessation, Dr. Pierce said. “We are not finding any evidence in this very large nationally representative study that smokers who switch to getting their nicotine from e-cigarettes are less likely to relapse back to cigarette smoking,” he said.

“We don’t know about the high-nicotine versions,” he added. 
 

New review advises against e-cigarettes for cessation

A recent review article published in JAMA supported the use of pharmacotherapy and behavioral support for smokers wanting to quit. In the review, Nancy A. Rigotti, MD, of Massachusetts General Hospital, Boston, and colleagues summarized the evidence for managing tobacco smoking in clinical practice.

“The health risk from cigarette smoking is primarily due to chemicals produced by the burning of tobacco and not to nicotine,” they noted. However, the physical dependence on nicotine makes quitting a challenge, but it is one worth pursuing, the authors said.

The authors of this review identified 30 reviews, 12 randomized clinical trials, and 7 recent guidelines and evidence reviews. Their key message: Pharmacotherapy and behavioral support are effective when used alone, but even more effective when combined. Pharmacotherapy helps reduce the symptoms of nicotine withdrawal, while behavioral intervention tackles the challenge of changing learned behaviors associated with smoking, the researchers said.

Although combining medications, such as varenicline and nicotine replacement therapy or bupropion might improve successful quit rates, these combinations have not been well studied, they noted.

With regard to e-cigarettes, the researchers cited a 2021 Cochrane review of 16,759 individuals who used e-cigarettes for smoking cessation, which found no evidence of harm, but insufficient evidence to asses the balance of risks vs. benefits.

In addition to the lack of randomized trials, “the FDA regulates e-cigarettes as tobacco products, not as medical products and has not evaluated any e-cigarette for medical use as a cessation aid,” the authors of the new review noted.

The review was limited by several factors, including the lack of quality assessment for the selected studies and the exclusion of pharmacotherapy not licensed in the United States.

Commenting on the JAMA paper, Dr. Pierce said, “This review looks like a number of Cochrane Reports that have been published recently. Of course, it only considers randomized trials and not population evidence.”

“If public health had limited itself to this form of evidence, then we still would not know that smoking caused cancer,” he noted. “Randomized trials are very important for testing new drugs; they use selected populations and provide considerable support that is not available in the real world. Sometimes they do not generalize to the population.”
 

Findings may guide patient conversations

The Tobacco Control study was important, because few studies on e-cigarettes have been conducted, said Linda Girgis, MD, a family physician in private practice in South River, N.J., in an interview.

“As clinicians, we do not have a lot of data available in order to make clinical decisions that are evidence based. Also, getting patients to quit smoking is often very difficult, and having more tools available is a great benefit; however, we need to have the evidence that these tools are effective,” she said.

Dr. Girgis also said she was not surprised by the findings.

“Patients still have the same concerns from e-cigarettes regarding nicotine exposure, but just to a lesser degree; and we still don’t know the long-term effects of e-cigarette use, she said. Based on these studies, recommending e-cigarettes for smokers looking to quit may not be the best method, she noted.

“While it may seem reasonable that exposing lungs to lower doses of nicotine will reduce harm, we need to see actual evidence of this. Also, we also need to study the additives that are frequently used in e-cigs, such as artificial flavorings, to see what harms they may pose, she emphasized.

With regard to the JAMA review, Dr. Girgis said she agreed with the recommendations for pharmacotherapy and behavior therapy as first-line treatments for smoking cessation. “There is evidence regarding the efficacy and safety of these methods, and they have been used for decades,” she said.

Dr. Girgis added that there is a role for e-cigarettes in smoking cessation strategies as a method of harm reduction, but pointed out the problem of many people thinking these products are safe and not understanding the hazards they pose.

“They think they can replace smoking with e-cigarettes and be safe from the health risks associated with smoking. I think if the plan were to switch to e-cigarettes for a short period and then quit, there would be a role,” Dr. Girgis said. “However, replacing one risk for another may reduce harm, but doesn’t eliminate it.”

“To continue to use e-cigarettes indefinitely should not be the goal,” she added.

The Tobacco Control study was funded by the National Institutes of Health and the Tobacco-Related Disease Research Program of the University of California. The researchers had no financial conflicts to disclose.

The JAMA study was funded in part by a grant from the National Institute for Health Research, via Cochrane Infrastructure funds to the Cochrane Tobacco Addiction Group. Lead author Dr. Rigotti disclosed funding from the National Heart, Lung, and Blood Institute and Achieve Life Sciences and personal fees from UpToDate and Achieve Life Sciences. Dr. Girgis had no financial conflicts to disclose.

*This article was updated on 2/28/2022.

A new tracer for use in PET imaging can detect more metastases in patients with cancer than the standard tracer, leading to predictions of a “paradigm shift” in this field.

The new tracer, 68Ga-FAPI (fibroblast activation protein inhibitor), detected more metastases in patients with lung cancer than the standard tracer, 18F-FDG (fluorodeoxyglucose), which has been in use for years.

The study by Chinese researchers was published in Radiology.

The team imaged 34 lung cancer patients with both 68Ga-FAPI and 18F-FDG. Performance was similar for primary tumors and for lung, liver, and adrenal gland metastases. However, FAPI imaging detected more metastases in the lymph nodes (356 vs. 320), brain (23 vs. 10), bone (109 vs. 91), and pleura (66 vs. 35). However, neither modality outperformed MRI for brain metastases, the researchers note.

An accompanying editorial concluded that 68Ga-FAPI PET/CT scanning marks “an important paradigm shift to more specific identification and characterization of a variety of cancers.”

“This may also mark the arrival of a new era in nuclear medicine where molecular imaging helps visualize and characterize the entire tumor burden in one setting,” write editorialists Francine Jacobson, MD, and Annick Van den Abbeele, MD, from Harvard University and Brigham and Women’s Hospital and the Dana Farber Cancer Center, in Boston.

This study was the one of the latest in a fast-growing body of literature reporting that tracers targeting FAP with a small-molecule inhibitor (FAPI) outperform FDG tracers, not just in lung cancer but across a broad range of cancers, including breast, hepatic, gastrointestinal, head-neck, gynecologic, and many other tumor types.

The possibilities aren’t limited to imaging, either. Several companies are planning trials to target FAP with radiopharmaceuticals.

FAP is associated with wound repair and is highly expressed by the fibroblasts tightly packed in with cancer cells, particularly in stroma-dense tumors. FAP is rarely expressed by healthy tissue.

The underlying idea is to deliver a radionuclide to cancer-associated fibroblasts, using either a positron emitter, such as gallium-68 (68Ga), for PET imaging or a beta particle or other short-radiation emitter to kill nearby cancer cells as part of treatment.

Targeting FAP holds the promise of PET imaging that is more selective for cancer than FDG. FDG resolution depends on glucose uptake, which is high in active tumors but is also high in inflamed tissues as well as in the brain, gastrointestinal tract, and other areas. Uptake by background tissue can make it difficult to distinguish tumors from their surroundings. FDG uptake can also be lower in small and indolent tumors.

On the therapy side, there’s hope that FAP targeting will lead to radiopharmaceuticals that work across tumor types, not just in specific cancers.
 

High interest in FAP

Overall, FAP “is a target of high interest for the whole medical oncology community. The preliminary data are good, but this will take a while” to get to market, said Jeremie Calais, MD, a nuclear medicine specialist and FAP researcher at the University of California, Los Angeles.

Interest in FAP as a radiopharmaceutical target is being driven by the success of two agents that have served as a kind of proof of concept, Dr. Calais said.

The first is Novartis’s 177Lu-PSMA-617, which was granted priority review by the U.S. Food and Drug Administration in September 2021 following phase 3 results that showed a progression-free survival benefit of about 5 months when added to standard of care for metastatic castration-resistant prostate cancer, as well as an overall survival benefit of 4 months.

PSMA-617 binds prostate cancer cells that express prostate-specific membrane antigen. The lutetium-177 (177Lu) bombards them with beta particles and gamma radiation.

FAP researchers are also encouraged by the success of 177Lu dotatate (Lutathera), from Advanced Accelerator Applications, which delivers the radionucleotide to gastroenteropancreatic neuroendocrine tumors that express somatostatin receptors.

The FDA approved this agent in 2018 in part on the basis of phase 3 results that found a 20-month progression-free survival of 65.2% when Lutathera was added to octreotide for metastatic disease vs. 10.8% when it wasn’t.

Novartis is now looking into developing FAP-targeted radiopharmaceuticals, along with Clovis and Point Biopharma, among others.

“That’s the key goal” of industry research, “more so than FAP as a diagnostic tool,” Dr. Calais commented to this news organization. There’s “huge potential” if it works out, he said, in part because it won’t be limited to one tumor type.

Clovis recently launched a phase 1/2 trial of its candidate, 177Lu-FAP-2286, for advanced/metastatic solid tumors.

In the company’s “luMIERE” trial, subjects will be infused with 68Ga-FAP-2286 to image the tumor. Once uptake is confirmed, they’ll be infused with 177Lu-FAP-2286 for treatment.

The two-step process – uptake confirmation, then treatment – is dubbed “theranostics” and is the standard approach for radiopharmaceutical therapy, Dr. Calais said.

His own team is working to confirm that imaging accurately reflects FAP expression in tumors by comparing preoperative imaging results with FAP expression on surgical specimens. So far, his team has found that they are strongly correlated.

FAPI PET imaging research is much farther along than therapeutic applications, with almost 200 research articles listed on PubMed in 2021, up from just 3 in 2018. One 2019 paper reported “remarkably high uptake and image contrast” across 28 cancers in 80 patients, including breast, esophagus, lung, pancreatic, head-neck, and colorectal tumors.

Imaging studies so far have tended to be small, with many currently focused on identifying the optimal molecule for targeting FAP and the best positron emitter to combine with it.

FAPI tracers are not available yet commercially, so researchers are creating them themselves. One team recently reported it’s recipe for automated synthesis using commercially available synthesis modules.

Sofie, a maker of FDG and other tracers, hopes to change that and is working to bring FAP tracers to market. The company announced in November 2021 a phase 2 study of 68Ga FAPI-46 to image pancreatic ductal adenocarcinoma. It’s the first step in a broader development program for oncologic and nononcologic indications, Sofie said in a press release.

Dr. Calais sees potential for indications where FAPI has already outperformed FDG in the literature, particularly for gastrointestinal cancers. He doesn’t think it will ever replace FDG for indications such as lymphoma, where it “works perfectly well.”

“On the other hand, you have lesions located in a tissue that has some background level” of FDG uptake. “These things are okay with FDG, but I think maybe FAP can help” because of the improved signal-to-noise ratio, Dr. Calais commented. Unlike FDG, “you mostly never see background uptake with FAP-imaging agents,” he said.

Other pluses include quicker distribution throughout the body than FDG, so scan times are shorter, and also patients do not need to fast beforehand.

Dr. Calais predicts that FAPI tracers will reach the market within 5 years.

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

A new tracer for use in PET imaging can detect more metastases in patients with cancer than the standard tracer, leading to predictions of a “paradigm shift” in this field.

The new tracer, 68Ga-FAPI (fibroblast activation protein inhibitor), detected more metastases in patients with lung cancer than the standard tracer, 18F-FDG (fluorodeoxyglucose), which has been in use for years.

The study by Chinese researchers was published in Radiology.

The team imaged 34 lung cancer patients with both 68Ga-FAPI and 18F-FDG. Performance was similar for primary tumors and for lung, liver, and adrenal gland metastases. However, FAPI imaging detected more metastases in the lymph nodes (356 vs. 320), brain (23 vs. 10), bone (109 vs. 91), and pleura (66 vs. 35). However, neither modality outperformed MRI for brain metastases, the researchers note.

An accompanying editorial concluded that 68Ga-FAPI PET/CT scanning marks “an important paradigm shift to more specific identification and characterization of a variety of cancers.”

“This may also mark the arrival of a new era in nuclear medicine where molecular imaging helps visualize and characterize the entire tumor burden in one setting,” write editorialists Francine Jacobson, MD, and Annick Van den Abbeele, MD, from Harvard University and Brigham and Women’s Hospital and the Dana Farber Cancer Center, in Boston.

This study was the one of the latest in a fast-growing body of literature reporting that tracers targeting FAP with a small-molecule inhibitor (FAPI) outperform FDG tracers, not just in lung cancer but across a broad range of cancers, including breast, hepatic, gastrointestinal, head-neck, gynecologic, and many other tumor types.

The possibilities aren’t limited to imaging, either. Several companies are planning trials to target FAP with radiopharmaceuticals.

FAP is associated with wound repair and is highly expressed by the fibroblasts tightly packed in with cancer cells, particularly in stroma-dense tumors. FAP is rarely expressed by healthy tissue.

The underlying idea is to deliver a radionuclide to cancer-associated fibroblasts, using either a positron emitter, such as gallium-68 (68Ga), for PET imaging or a beta particle or other short-radiation emitter to kill nearby cancer cells as part of treatment.

Targeting FAP holds the promise of PET imaging that is more selective for cancer than FDG. FDG resolution depends on glucose uptake, which is high in active tumors but is also high in inflamed tissues as well as in the brain, gastrointestinal tract, and other areas. Uptake by background tissue can make it difficult to distinguish tumors from their surroundings. FDG uptake can also be lower in small and indolent tumors.

On the therapy side, there’s hope that FAP targeting will lead to radiopharmaceuticals that work across tumor types, not just in specific cancers.
 

High interest in FAP

Overall, FAP “is a target of high interest for the whole medical oncology community. The preliminary data are good, but this will take a while” to get to market, said Jeremie Calais, MD, a nuclear medicine specialist and FAP researcher at the University of California, Los Angeles.

Interest in FAP as a radiopharmaceutical target is being driven by the success of two agents that have served as a kind of proof of concept, Dr. Calais said.

The first is Novartis’s 177Lu-PSMA-617, which was granted priority review by the U.S. Food and Drug Administration in September 2021 following phase 3 results that showed a progression-free survival benefit of about 5 months when added to standard of care for metastatic castration-resistant prostate cancer, as well as an overall survival benefit of 4 months.

PSMA-617 binds prostate cancer cells that express prostate-specific membrane antigen. The lutetium-177 (177Lu) bombards them with beta particles and gamma radiation.

FAP researchers are also encouraged by the success of 177Lu dotatate (Lutathera), from Advanced Accelerator Applications, which delivers the radionucleotide to gastroenteropancreatic neuroendocrine tumors that express somatostatin receptors.

The FDA approved this agent in 2018 in part on the basis of phase 3 results that found a 20-month progression-free survival of 65.2% when Lutathera was added to octreotide for metastatic disease vs. 10.8% when it wasn’t.

Novartis is now looking into developing FAP-targeted radiopharmaceuticals, along with Clovis and Point Biopharma, among others.

“That’s the key goal” of industry research, “more so than FAP as a diagnostic tool,” Dr. Calais commented to this news organization. There’s “huge potential” if it works out, he said, in part because it won’t be limited to one tumor type.

Clovis recently launched a phase 1/2 trial of its candidate, 177Lu-FAP-2286, for advanced/metastatic solid tumors.

In the company’s “luMIERE” trial, subjects will be infused with 68Ga-FAP-2286 to image the tumor. Once uptake is confirmed, they’ll be infused with 177Lu-FAP-2286 for treatment.

The two-step process – uptake confirmation, then treatment – is dubbed “theranostics” and is the standard approach for radiopharmaceutical therapy, Dr. Calais said.

His own team is working to confirm that imaging accurately reflects FAP expression in tumors by comparing preoperative imaging results with FAP expression on surgical specimens. So far, his team has found that they are strongly correlated.

FAPI PET imaging research is much farther along than therapeutic applications, with almost 200 research articles listed on PubMed in 2021, up from just 3 in 2018. One 2019 paper reported “remarkably high uptake and image contrast” across 28 cancers in 80 patients, including breast, esophagus, lung, pancreatic, head-neck, and colorectal tumors.

Imaging studies so far have tended to be small, with many currently focused on identifying the optimal molecule for targeting FAP and the best positron emitter to combine with it.

FAPI tracers are not available yet commercially, so researchers are creating them themselves. One team recently reported it’s recipe for automated synthesis using commercially available synthesis modules.

Sofie, a maker of FDG and other tracers, hopes to change that and is working to bring FAP tracers to market. The company announced in November 2021 a phase 2 study of 68Ga FAPI-46 to image pancreatic ductal adenocarcinoma. It’s the first step in a broader development program for oncologic and nononcologic indications, Sofie said in a press release.

Dr. Calais sees potential for indications where FAPI has already outperformed FDG in the literature, particularly for gastrointestinal cancers. He doesn’t think it will ever replace FDG for indications such as lymphoma, where it “works perfectly well.”

“On the other hand, you have lesions located in a tissue that has some background level” of FDG uptake. “These things are okay with FDG, but I think maybe FAP can help” because of the improved signal-to-noise ratio, Dr. Calais commented. Unlike FDG, “you mostly never see background uptake with FAP-imaging agents,” he said.

Other pluses include quicker distribution throughout the body than FDG, so scan times are shorter, and also patients do not need to fast beforehand.

Dr. Calais predicts that FAPI tracers will reach the market within 5 years.

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

A new tracer for use in PET imaging can detect more metastases in patients with cancer than the standard tracer, leading to predictions of a “paradigm shift” in this field.

The new tracer, 68Ga-FAPI (fibroblast activation protein inhibitor), detected more metastases in patients with lung cancer than the standard tracer, 18F-FDG (fluorodeoxyglucose), which has been in use for years.

The study by Chinese researchers was published in Radiology.

The team imaged 34 lung cancer patients with both 68Ga-FAPI and 18F-FDG. Performance was similar for primary tumors and for lung, liver, and adrenal gland metastases. However, FAPI imaging detected more metastases in the lymph nodes (356 vs. 320), brain (23 vs. 10), bone (109 vs. 91), and pleura (66 vs. 35). However, neither modality outperformed MRI for brain metastases, the researchers note.

An accompanying editorial concluded that 68Ga-FAPI PET/CT scanning marks “an important paradigm shift to more specific identification and characterization of a variety of cancers.”

“This may also mark the arrival of a new era in nuclear medicine where molecular imaging helps visualize and characterize the entire tumor burden in one setting,” write editorialists Francine Jacobson, MD, and Annick Van den Abbeele, MD, from Harvard University and Brigham and Women’s Hospital and the Dana Farber Cancer Center, in Boston.

This study was the one of the latest in a fast-growing body of literature reporting that tracers targeting FAP with a small-molecule inhibitor (FAPI) outperform FDG tracers, not just in lung cancer but across a broad range of cancers, including breast, hepatic, gastrointestinal, head-neck, gynecologic, and many other tumor types.

The possibilities aren’t limited to imaging, either. Several companies are planning trials to target FAP with radiopharmaceuticals.

FAP is associated with wound repair and is highly expressed by the fibroblasts tightly packed in with cancer cells, particularly in stroma-dense tumors. FAP is rarely expressed by healthy tissue.

The underlying idea is to deliver a radionuclide to cancer-associated fibroblasts, using either a positron emitter, such as gallium-68 (68Ga), for PET imaging or a beta particle or other short-radiation emitter to kill nearby cancer cells as part of treatment.

Targeting FAP holds the promise of PET imaging that is more selective for cancer than FDG. FDG resolution depends on glucose uptake, which is high in active tumors but is also high in inflamed tissues as well as in the brain, gastrointestinal tract, and other areas. Uptake by background tissue can make it difficult to distinguish tumors from their surroundings. FDG uptake can also be lower in small and indolent tumors.

On the therapy side, there’s hope that FAP targeting will lead to radiopharmaceuticals that work across tumor types, not just in specific cancers.
 

High interest in FAP

Overall, FAP “is a target of high interest for the whole medical oncology community. The preliminary data are good, but this will take a while” to get to market, said Jeremie Calais, MD, a nuclear medicine specialist and FAP researcher at the University of California, Los Angeles.

Interest in FAP as a radiopharmaceutical target is being driven by the success of two agents that have served as a kind of proof of concept, Dr. Calais said.

The first is Novartis’s 177Lu-PSMA-617, which was granted priority review by the U.S. Food and Drug Administration in September 2021 following phase 3 results that showed a progression-free survival benefit of about 5 months when added to standard of care for metastatic castration-resistant prostate cancer, as well as an overall survival benefit of 4 months.

PSMA-617 binds prostate cancer cells that express prostate-specific membrane antigen. The lutetium-177 (177Lu) bombards them with beta particles and gamma radiation.

FAP researchers are also encouraged by the success of 177Lu dotatate (Lutathera), from Advanced Accelerator Applications, which delivers the radionucleotide to gastroenteropancreatic neuroendocrine tumors that express somatostatin receptors.

The FDA approved this agent in 2018 in part on the basis of phase 3 results that found a 20-month progression-free survival of 65.2% when Lutathera was added to octreotide for metastatic disease vs. 10.8% when it wasn’t.

Novartis is now looking into developing FAP-targeted radiopharmaceuticals, along with Clovis and Point Biopharma, among others.

“That’s the key goal” of industry research, “more so than FAP as a diagnostic tool,” Dr. Calais commented to this news organization. There’s “huge potential” if it works out, he said, in part because it won’t be limited to one tumor type.

Clovis recently launched a phase 1/2 trial of its candidate, 177Lu-FAP-2286, for advanced/metastatic solid tumors.

In the company’s “luMIERE” trial, subjects will be infused with 68Ga-FAP-2286 to image the tumor. Once uptake is confirmed, they’ll be infused with 177Lu-FAP-2286 for treatment.

The two-step process – uptake confirmation, then treatment – is dubbed “theranostics” and is the standard approach for radiopharmaceutical therapy, Dr. Calais said.

His own team is working to confirm that imaging accurately reflects FAP expression in tumors by comparing preoperative imaging results with FAP expression on surgical specimens. So far, his team has found that they are strongly correlated.

FAPI PET imaging research is much farther along than therapeutic applications, with almost 200 research articles listed on PubMed in 2021, up from just 3 in 2018. One 2019 paper reported “remarkably high uptake and image contrast” across 28 cancers in 80 patients, including breast, esophagus, lung, pancreatic, head-neck, and colorectal tumors.

Imaging studies so far have tended to be small, with many currently focused on identifying the optimal molecule for targeting FAP and the best positron emitter to combine with it.

FAPI tracers are not available yet commercially, so researchers are creating them themselves. One team recently reported it’s recipe for automated synthesis using commercially available synthesis modules.

Sofie, a maker of FDG and other tracers, hopes to change that and is working to bring FAP tracers to market. The company announced in November 2021 a phase 2 study of 68Ga FAPI-46 to image pancreatic ductal adenocarcinoma. It’s the first step in a broader development program for oncologic and nononcologic indications, Sofie said in a press release.

Dr. Calais sees potential for indications where FAPI has already outperformed FDG in the literature, particularly for gastrointestinal cancers. He doesn’t think it will ever replace FDG for indications such as lymphoma, where it “works perfectly well.”

“On the other hand, you have lesions located in a tissue that has some background level” of FDG uptake. “These things are okay with FDG, but I think maybe FAP can help” because of the improved signal-to-noise ratio, Dr. Calais commented. Unlike FDG, “you mostly never see background uptake with FAP-imaging agents,” he said.

Other pluses include quicker distribution throughout the body than FDG, so scan times are shorter, and also patients do not need to fast beforehand.

Dr. Calais predicts that FAPI tracers will reach the market within 5 years.

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

The names of health care professionals and patients cited within the dialogue text have been changed to protect their privacy.

Early in my career, before I had any notion that years later I would be doing palliative care consults in a cancer center, I heard a senior physician refer to palliative care as “the most misunderstood” medical specialty. I wasn’t sure what she meant at that time, but over the years I have come to realize that she was right – most people, including many within health care, don’t have a good appreciation of what palliative care is or how it can help patients and health care teams.

A recent national survey about cancer-related health information found that of more than 1,000 surveyed Americans, less than 30% professed any knowledge of palliative care. Of those who had some knowledge of palliative care, around 30% believed palliative care was synonymous with hospice.¹ Another 15% believed that a patient would have to give up cancer-directed treatments to receive palliative care.¹

It’s not giving up

This persistent belief that palliative care is equivalent to hospice, or is tantamount to “giving up,” is one of the most commonly held myths I encounter in everyday practice.

I knock on the exam door and walk in.
A small, trim woman in her late 50s is sitting in a chair, arms folded across her chest, face drawn in.

“Hi,” I start. “I’m Sarah, the palliative care nurse practitioner who works in this clinic. I work closely with Dr. Smith.”
Dr. Smith is the patient’s oncologist.

“I really didn’t want to meet you,” she says in a quiet voice, her eyes large with concern.

I don’t take it personally. Few patients really want to be in the position of needing to meet the palliative care team.

“I looked up palliative care on Google and saw the word hospice.”

“Yeah,” I say. “I hear that a lot. Well, I can reassure you that this isn’t hospice.
In this clinic, our focus is on your cancer symptoms, your treatment side effects, and your quality of life.”

She looks visibly relieved. “Quality of life,” she echoes. “I need more of that.”
“OK,” I say. “So, tell me what you’re struggling with the most right now.”

That’s how many palliative care visits start. I actually prefer if patients haven’t heard of palliative care because it allows me to frame it for them, rather than having to start by addressing a myth or a prior negative experience. Even when patients haven’t had a negative experience with palliative care per se, typically, if they’ve interacted with palliative care in the past, it’s usually because someone they loved died in a hospital setting and it is the memory of that terrible loss that becomes synonymous with their recollection of palliative care.

Many patients I meet have never seen another outpatient palliative care practitioner – and this makes sense – we are still too few and far between. Most established palliative care teams are hospital based and many patients seen in the community do not have easy access to palliative care teams where they receive oncologic care.² As an embedded practitioner, I see patients in the same exam rooms and infusion centers where they receive their cancer therapies, so I’m effectively woven into the fabric of their oncology experience. Just being there in the cancer center allows me to be in the right place at the right time for the right patients and their care teams.
 

More than pain management

Another myth I tend to dispel a lot is that palliative care is just a euphemism for “pain management.” I have seen this less lately, but still occasionally in the chart I’ll see documented in a note, “patient is seeing palliative/pain management,” when a patient is seeing me or one of my colleagues. Unfortunately, when providers have limited or outdated views of what palliative care is or the value it brings to patient-centered cancer care, referrals to palliative care tend to be delayed.³

“I really think Ms. Lopez could benefit from seeing palliative care,” an oncology nurse practitioner says to an oncologist.
I’m standing nearby, about to see another patient in one of the exam rooms in our clinic.
“But I don’t think she’s ready. And besides, she doesn’t have any pain,” he says.
He turns to me quizzically. “What do you think?”

“Tell me about the patient,” I ask, taking a few steps in their direction.

“Well, she’s a 64-year-old woman with metastatic cancer.
She has a really poor appetite and is losing some weight.
Seems a bit down, kind of pessimistic about things.
Her scan showed some new growth, so guess I’m not surprised by that.”

“I might be able to help her with the appetite and the mood changes. 
I can at least talk with her and see where she’s at,” I offer.

“Alright,” he says. “We’ll put the palliative referral in.”
He hesitates. “But are you sure you want to see her? 
She doesn’t have any pain.” He sounds skeptical.

“Yeah, I mean, it sounds like she has symptoms that are bothering her, so I’d be happy to see her. She sounds completely appropriate for palliative care.”

I hear this assumption a lot – that palliative care is somehow equivalent to pain management and that unless a patient’s pain is severe, it’s not worth referring the patient to palliative care. Don’t get me wrong – we do a lot of pain management, but at its heart, palliative care is an interdisciplinary specialty focused on improving or maintaining quality of life for people with serious illness. Because the goal is so broad, care can take many shapes.⁴

In addition to pain, palliative care clinicians commonly treat nausea, shortness of breath, constipation or diarrhea, poor appetite, fatigue, anxiety, depression, and insomnia.
 

Palliative care is more than medical or nursing care

A related misconception about palliative care held by many lay people and health care workers alike is that palliative care is primarily medical or nursing care focused mostly on alleviating physical symptoms such as pain or nausea. This couldn’t be further from the truth.

We’ve been talking for a while.
Ms. Lopez tells me about her struggles to maintain her weight while undergoing chemotherapy. She has low-grade nausea that is impacting her ability and desire to eat more and didn’t think that her weight loss was severe enough to warrant taking medication.
We talk about how she may be able to use antinausea medication sparingly to alleviate nausea while also limiting side effects from the medications—which was a big concern for her.

I ask her what else is bothering her.

She tells me that she has always been a strong Catholic and even when life has gotten tough, her faith was never shaken – until now.
She is struggling to understand why she ended up with metastatic cancer at such a relatively young age—why would God do this to her?
She had plans for retirement that have since evaporated in the face of a foreshortened life.
Why did this happen to her of all people? She was completely healthy until her diagnosis.
Her face is wet with tears.

We talk a little about how a diagnosis like this can change so much of a person’s life and identity. I try to validate her experience. She’s clearly suffering from a sense that her life is not what she expected, and she is struggling to integrate how her future looks at this point.

I ask her what conversations with her priest have been like.

At this point you may be wondering where this conversation is going. Why are we talking about Ms. Lopez’s religion? Palliative care is best delivered through high functioning interdisciplinary teams that can include other supportive people in a patient’s life. We work in concert to try to bring comfort to a patient and their family.⁴ That support network can include nurses, physicians, social workers, and chaplains. In this case, Ms. Lopez had not yet reached out to her priest. She hasn’t had the time or energy to contact her priest given her symptoms.
 

“Can I contact your priest for you?
Maybe he can visit or call and chat with you?”
She nods and wipes tears away.
“That would be really nice,” she says. “I’d love it if he could pray with me.”

A few hours after the visit, I call Ms. Lopez’s priest.
I ask him to reach out to her and about her request for prayer.
He says he’s been thinking about her and that her presence has been missed at weekly Mass. He thanks me for the call and says he’ll call her tomorrow.

I say my own small prayer for Ms. Lopez and head home, the day’s work completed.

Sarah D'Ambruoso was born and raised in Maine. She completed her undergraduate and graduate nursing education at New York University and UCLA, respectively, and currently works as a palliative care nurse practitioner in an oncology clinic in Los Angeles. 

References

1. Cheng BT et al. Patterns of palliative care beliefs among adults in the U.S.: Analysis of a National Cancer Database. J Pain Symptom Manage. 2019 Aug 10. doi: 10.1016/j.jpainsymman.2019.07.030.

2. Finlay E et al. Filling the gap: Creating an outpatient palliative care program in your institution. Am Soc Clin Oncol Educ Book. 2018 May 23. doi: 10.1200/EDBK_200775.

3. Von Roenn JH et al. Barriers and approaches to the successful integration of palliative care and oncology practice. J Natl Compr Canc Netw. 2013 Mar. doi: 10.6004/jnccn.2013.0209.

4. Ferrell BR et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2016.70.1474.

The names of health care professionals and patients cited within the dialogue text have been changed to protect their privacy.

Early in my career, before I had any notion that years later I would be doing palliative care consults in a cancer center, I heard a senior physician refer to palliative care as “the most misunderstood” medical specialty. I wasn’t sure what she meant at that time, but over the years I have come to realize that she was right – most people, including many within health care, don’t have a good appreciation of what palliative care is or how it can help patients and health care teams.

A recent national survey about cancer-related health information found that of more than 1,000 surveyed Americans, less than 30% professed any knowledge of palliative care. Of those who had some knowledge of palliative care, around 30% believed palliative care was synonymous with hospice.¹ Another 15% believed that a patient would have to give up cancer-directed treatments to receive palliative care.¹

It’s not giving up

This persistent belief that palliative care is equivalent to hospice, or is tantamount to “giving up,” is one of the most commonly held myths I encounter in everyday practice.

I knock on the exam door and walk in.
A small, trim woman in her late 50s is sitting in a chair, arms folded across her chest, face drawn in.

“Hi,” I start. “I’m Sarah, the palliative care nurse practitioner who works in this clinic. I work closely with Dr. Smith.”
Dr. Smith is the patient’s oncologist.

“I really didn’t want to meet you,” she says in a quiet voice, her eyes large with concern.

I don’t take it personally. Few patients really want to be in the position of needing to meet the palliative care team.

“I looked up palliative care on Google and saw the word hospice.”

“Yeah,” I say. “I hear that a lot. Well, I can reassure you that this isn’t hospice.
In this clinic, our focus is on your cancer symptoms, your treatment side effects, and your quality of life.”

She looks visibly relieved. “Quality of life,” she echoes. “I need more of that.”
“OK,” I say. “So, tell me what you’re struggling with the most right now.”

That’s how many palliative care visits start. I actually prefer if patients haven’t heard of palliative care because it allows me to frame it for them, rather than having to start by addressing a myth or a prior negative experience. Even when patients haven’t had a negative experience with palliative care per se, typically, if they’ve interacted with palliative care in the past, it’s usually because someone they loved died in a hospital setting and it is the memory of that terrible loss that becomes synonymous with their recollection of palliative care.

Many patients I meet have never seen another outpatient palliative care practitioner – and this makes sense – we are still too few and far between. Most established palliative care teams are hospital based and many patients seen in the community do not have easy access to palliative care teams where they receive oncologic care.² As an embedded practitioner, I see patients in the same exam rooms and infusion centers where they receive their cancer therapies, so I’m effectively woven into the fabric of their oncology experience. Just being there in the cancer center allows me to be in the right place at the right time for the right patients and their care teams.
 

More than pain management

Another myth I tend to dispel a lot is that palliative care is just a euphemism for “pain management.” I have seen this less lately, but still occasionally in the chart I’ll see documented in a note, “patient is seeing palliative/pain management,” when a patient is seeing me or one of my colleagues. Unfortunately, when providers have limited or outdated views of what palliative care is or the value it brings to patient-centered cancer care, referrals to palliative care tend to be delayed.³

“I really think Ms. Lopez could benefit from seeing palliative care,” an oncology nurse practitioner says to an oncologist.
I’m standing nearby, about to see another patient in one of the exam rooms in our clinic.
“But I don’t think she’s ready. And besides, she doesn’t have any pain,” he says.
He turns to me quizzically. “What do you think?”

“Tell me about the patient,” I ask, taking a few steps in their direction.

“Well, she’s a 64-year-old woman with metastatic cancer.
She has a really poor appetite and is losing some weight.
Seems a bit down, kind of pessimistic about things.
Her scan showed some new growth, so guess I’m not surprised by that.”

“I might be able to help her with the appetite and the mood changes. 
I can at least talk with her and see where she’s at,” I offer.

“Alright,” he says. “We’ll put the palliative referral in.”
He hesitates. “But are you sure you want to see her? 
She doesn’t have any pain.” He sounds skeptical.

“Yeah, I mean, it sounds like she has symptoms that are bothering her, so I’d be happy to see her. She sounds completely appropriate for palliative care.”

I hear this assumption a lot – that palliative care is somehow equivalent to pain management and that unless a patient’s pain is severe, it’s not worth referring the patient to palliative care. Don’t get me wrong – we do a lot of pain management, but at its heart, palliative care is an interdisciplinary specialty focused on improving or maintaining quality of life for people with serious illness. Because the goal is so broad, care can take many shapes.⁴

In addition to pain, palliative care clinicians commonly treat nausea, shortness of breath, constipation or diarrhea, poor appetite, fatigue, anxiety, depression, and insomnia.
 

Palliative care is more than medical or nursing care

A related misconception about palliative care held by many lay people and health care workers alike is that palliative care is primarily medical or nursing care focused mostly on alleviating physical symptoms such as pain or nausea. This couldn’t be further from the truth.

We’ve been talking for a while.
Ms. Lopez tells me about her struggles to maintain her weight while undergoing chemotherapy. She has low-grade nausea that is impacting her ability and desire to eat more and didn’t think that her weight loss was severe enough to warrant taking medication.
We talk about how she may be able to use antinausea medication sparingly to alleviate nausea while also limiting side effects from the medications—which was a big concern for her.

I ask her what else is bothering her.

She tells me that she has always been a strong Catholic and even when life has gotten tough, her faith was never shaken – until now.
She is struggling to understand why she ended up with metastatic cancer at such a relatively young age—why would God do this to her?
She had plans for retirement that have since evaporated in the face of a foreshortened life.
Why did this happen to her of all people? She was completely healthy until her diagnosis.
Her face is wet with tears.

We talk a little about how a diagnosis like this can change so much of a person’s life and identity. I try to validate her experience. She’s clearly suffering from a sense that her life is not what she expected, and she is struggling to integrate how her future looks at this point.

I ask her what conversations with her priest have been like.

At this point you may be wondering where this conversation is going. Why are we talking about Ms. Lopez’s religion? Palliative care is best delivered through high functioning interdisciplinary teams that can include other supportive people in a patient’s life. We work in concert to try to bring comfort to a patient and their family.⁴ That support network can include nurses, physicians, social workers, and chaplains. In this case, Ms. Lopez had not yet reached out to her priest. She hasn’t had the time or energy to contact her priest given her symptoms.
 

“Can I contact your priest for you?
Maybe he can visit or call and chat with you?”
She nods and wipes tears away.
“That would be really nice,” she says. “I’d love it if he could pray with me.”

A few hours after the visit, I call Ms. Lopez’s priest.
I ask him to reach out to her and about her request for prayer.
He says he’s been thinking about her and that her presence has been missed at weekly Mass. He thanks me for the call and says he’ll call her tomorrow.

I say my own small prayer for Ms. Lopez and head home, the day’s work completed.

Sarah D'Ambruoso was born and raised in Maine. She completed her undergraduate and graduate nursing education at New York University and UCLA, respectively, and currently works as a palliative care nurse practitioner in an oncology clinic in Los Angeles. 

References

1. Cheng BT et al. Patterns of palliative care beliefs among adults in the U.S.: Analysis of a National Cancer Database. J Pain Symptom Manage. 2019 Aug 10. doi: 10.1016/j.jpainsymman.2019.07.030.

2. Finlay E et al. Filling the gap: Creating an outpatient palliative care program in your institution. Am Soc Clin Oncol Educ Book. 2018 May 23. doi: 10.1200/EDBK_200775.

3. Von Roenn JH et al. Barriers and approaches to the successful integration of palliative care and oncology practice. J Natl Compr Canc Netw. 2013 Mar. doi: 10.6004/jnccn.2013.0209.

4. Ferrell BR et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2016.70.1474.

The names of health care professionals and patients cited within the dialogue text have been changed to protect their privacy.

Early in my career, before I had any notion that years later I would be doing palliative care consults in a cancer center, I heard a senior physician refer to palliative care as “the most misunderstood” medical specialty. I wasn’t sure what she meant at that time, but over the years I have come to realize that she was right – most people, including many within health care, don’t have a good appreciation of what palliative care is or how it can help patients and health care teams.

A recent national survey about cancer-related health information found that of more than 1,000 surveyed Americans, less than 30% professed any knowledge of palliative care. Of those who had some knowledge of palliative care, around 30% believed palliative care was synonymous with hospice.¹ Another 15% believed that a patient would have to give up cancer-directed treatments to receive palliative care.¹

It’s not giving up

This persistent belief that palliative care is equivalent to hospice, or is tantamount to “giving up,” is one of the most commonly held myths I encounter in everyday practice.

I knock on the exam door and walk in.
A small, trim woman in her late 50s is sitting in a chair, arms folded across her chest, face drawn in.

“Hi,” I start. “I’m Sarah, the palliative care nurse practitioner who works in this clinic. I work closely with Dr. Smith.”
Dr. Smith is the patient’s oncologist.

“I really didn’t want to meet you,” she says in a quiet voice, her eyes large with concern.

I don’t take it personally. Few patients really want to be in the position of needing to meet the palliative care team.

“I looked up palliative care on Google and saw the word hospice.”

“Yeah,” I say. “I hear that a lot. Well, I can reassure you that this isn’t hospice.
In this clinic, our focus is on your cancer symptoms, your treatment side effects, and your quality of life.”

She looks visibly relieved. “Quality of life,” she echoes. “I need more of that.”
“OK,” I say. “So, tell me what you’re struggling with the most right now.”

That’s how many palliative care visits start. I actually prefer if patients haven’t heard of palliative care because it allows me to frame it for them, rather than having to start by addressing a myth or a prior negative experience. Even when patients haven’t had a negative experience with palliative care per se, typically, if they’ve interacted with palliative care in the past, it’s usually because someone they loved died in a hospital setting and it is the memory of that terrible loss that becomes synonymous with their recollection of palliative care.

Many patients I meet have never seen another outpatient palliative care practitioner – and this makes sense – we are still too few and far between. Most established palliative care teams are hospital based and many patients seen in the community do not have easy access to palliative care teams where they receive oncologic care.² As an embedded practitioner, I see patients in the same exam rooms and infusion centers where they receive their cancer therapies, so I’m effectively woven into the fabric of their oncology experience. Just being there in the cancer center allows me to be in the right place at the right time for the right patients and their care teams.
 

More than pain management

Another myth I tend to dispel a lot is that palliative care is just a euphemism for “pain management.” I have seen this less lately, but still occasionally in the chart I’ll see documented in a note, “patient is seeing palliative/pain management,” when a patient is seeing me or one of my colleagues. Unfortunately, when providers have limited or outdated views of what palliative care is or the value it brings to patient-centered cancer care, referrals to palliative care tend to be delayed.³

“I really think Ms. Lopez could benefit from seeing palliative care,” an oncology nurse practitioner says to an oncologist.
I’m standing nearby, about to see another patient in one of the exam rooms in our clinic.
“But I don’t think she’s ready. And besides, she doesn’t have any pain,” he says.
He turns to me quizzically. “What do you think?”

“Tell me about the patient,” I ask, taking a few steps in their direction.

“Well, she’s a 64-year-old woman with metastatic cancer.
She has a really poor appetite and is losing some weight.
Seems a bit down, kind of pessimistic about things.
Her scan showed some new growth, so guess I’m not surprised by that.”

“I might be able to help her with the appetite and the mood changes. 
I can at least talk with her and see where she’s at,” I offer.

“Alright,” he says. “We’ll put the palliative referral in.”
He hesitates. “But are you sure you want to see her? 
She doesn’t have any pain.” He sounds skeptical.

“Yeah, I mean, it sounds like she has symptoms that are bothering her, so I’d be happy to see her. She sounds completely appropriate for palliative care.”

I hear this assumption a lot – that palliative care is somehow equivalent to pain management and that unless a patient’s pain is severe, it’s not worth referring the patient to palliative care. Don’t get me wrong – we do a lot of pain management, but at its heart, palliative care is an interdisciplinary specialty focused on improving or maintaining quality of life for people with serious illness. Because the goal is so broad, care can take many shapes.⁴

In addition to pain, palliative care clinicians commonly treat nausea, shortness of breath, constipation or diarrhea, poor appetite, fatigue, anxiety, depression, and insomnia.
 

Palliative care is more than medical or nursing care

A related misconception about palliative care held by many lay people and health care workers alike is that palliative care is primarily medical or nursing care focused mostly on alleviating physical symptoms such as pain or nausea. This couldn’t be further from the truth.

We’ve been talking for a while.
Ms. Lopez tells me about her struggles to maintain her weight while undergoing chemotherapy. She has low-grade nausea that is impacting her ability and desire to eat more and didn’t think that her weight loss was severe enough to warrant taking medication.
We talk about how she may be able to use antinausea medication sparingly to alleviate nausea while also limiting side effects from the medications—which was a big concern for her.

I ask her what else is bothering her.

She tells me that she has always been a strong Catholic and even when life has gotten tough, her faith was never shaken – until now.
She is struggling to understand why she ended up with metastatic cancer at such a relatively young age—why would God do this to her?
She had plans for retirement that have since evaporated in the face of a foreshortened life.
Why did this happen to her of all people? She was completely healthy until her diagnosis.
Her face is wet with tears.

We talk a little about how a diagnosis like this can change so much of a person’s life and identity. I try to validate her experience. She’s clearly suffering from a sense that her life is not what she expected, and she is struggling to integrate how her future looks at this point.

I ask her what conversations with her priest have been like.

At this point you may be wondering where this conversation is going. Why are we talking about Ms. Lopez’s religion? Palliative care is best delivered through high functioning interdisciplinary teams that can include other supportive people in a patient’s life. We work in concert to try to bring comfort to a patient and their family.⁴ That support network can include nurses, physicians, social workers, and chaplains. In this case, Ms. Lopez had not yet reached out to her priest. She hasn’t had the time or energy to contact her priest given her symptoms.
 

“Can I contact your priest for you?
Maybe he can visit or call and chat with you?”
She nods and wipes tears away.
“That would be really nice,” she says. “I’d love it if he could pray with me.”

A few hours after the visit, I call Ms. Lopez’s priest.
I ask him to reach out to her and about her request for prayer.
He says he’s been thinking about her and that her presence has been missed at weekly Mass. He thanks me for the call and says he’ll call her tomorrow.

I say my own small prayer for Ms. Lopez and head home, the day’s work completed.

Sarah D'Ambruoso was born and raised in Maine. She completed her undergraduate and graduate nursing education at New York University and UCLA, respectively, and currently works as a palliative care nurse practitioner in an oncology clinic in Los Angeles. 

References

1. Cheng BT et al. Patterns of palliative care beliefs among adults in the U.S.: Analysis of a National Cancer Database. J Pain Symptom Manage. 2019 Aug 10. doi: 10.1016/j.jpainsymman.2019.07.030.

2. Finlay E et al. Filling the gap: Creating an outpatient palliative care program in your institution. Am Soc Clin Oncol Educ Book. 2018 May 23. doi: 10.1200/EDBK_200775.

3. Von Roenn JH et al. Barriers and approaches to the successful integration of palliative care and oncology practice. J Natl Compr Canc Netw. 2013 Mar. doi: 10.6004/jnccn.2013.0209.

4. Ferrell BR et al. Integration of palliative care into standard oncology care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2016.70.1474.