Roxanne Nelson, RN, BSN

Tamoxifen has long been used in breast cancer, both in the adjuvant and preventive setting, but uptake and adherence are notoriously low, mainly because of adverse events.

Using a much lower dose to reduce the incidence of side effects would be a “way forward,” reasoned Swedish researchers. They report that a substantially lower dose of tamoxifen (2.5 mg) may be as effective as the standard dose (20 mg), but reduced by half the incidence of severe vasomotor symptoms, including hot flashes, cold sweats, and night sweats.  

The research was published online March 18 in the Journal of Clinical Oncology.

The study involved 1,439 women (aged 40-74 years) who were participating in the Swedish mammography screening program and tested tamoxifen at various doses.  

“We performed a dose determination study that we hope will initiate follow-up studies that in turn will influence both adjuvant treatment and prevention of breast cancer,” said lead author Per Hall, MD, PhD, head of the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

The study measured the effects of the different doses (1, 2.5, 5, 10, and 20 mg) on mammographic breast density.

Dr. Hall emphasized that breast density was used as a proxy for therapy response. “We do not know how that translates to actual clinical effect,” he said in an interview. “This is step one.”

Previous studies have also used breast density changes as a proxy endpoint for tamoxifen therapy response, in both prophylactic and adjuvant settings, the authors note. There is some data to suggest that this does translate to a clinical effect. A recent study showed that tamoxifen at 5 mg/day taken for 3 years reduced the recurrence of breast intraepithelial neoplasia by 50% and contralateral breast cancer by 75%, with a symptom profile similar to placebo (J Clin Oncol.  2019;37:1629-1637).
 

Lower density, fewer symptoms

In the current study, Dr. Hall and colleagues found that the mammographic breast density (mean overall area) was decreased by 9.6% in the 20 mg tamoxifen group, and similar decreases were seen in the 2.5 and 10 mg dose groups, but not in the placebo and 1 mg dose groups.

These changes were driven primarily by changes observed among premenopausal women where the 20 mg mean decrease was 18.5% (P < .001 for interaction with menopausal status) with decreases of 13.4% in the 2.5 mg group, 19.6% in the 5 mg group, and 17% in the 10 mg group.

The results were quite different in postmenopausal participants, where those who received the 20 mg dose had a density mean decrease of 4%, which was not substantially different to the placebo, 1 mg, 2.5 mg, and 10 mg treatment arms.

The authors point out that the difference in density decrease between premenopausal and postmenopausal women was not dependent on differences in baseline density.

When reviewing adverse events with the various doses, the team found a large decrease in severe vasomotor symptoms with the lower doses of tamoxifen. These adverse events were reported by 34% of women taking 20 mg, 24.4% on 5 mg, 20.5% on 2.5 mg, 18.5% on 1 mg, and 13.7% of women taking placebo. There were no similar trends seen for gynecologic, sexual, or musculoskeletal symptoms.

Future studies should test whether 2.5 mg of tamoxifen reduces the risk of primary breast cancer, Dr. Hall commented.

“We are planning a trial now where women are offered risk assessment when attending mammography screening,” Dr. Hall said. “For those at very high risk, low-dose tamoxifen will be offered.”

The study received support from the Kamprad Foundation, Swedish Research Council, Marit and Hans Rausing’s Initiative Against Breast Cancer, Swedish Cancer Society, and Stockholm County Council.

Dr. Hall reports several relationships with industry, had a pending patent on compositions and methods for prevention of breast cancer with an option to license to Atossa Therapeutics, and has licensed an algorithm for risk prediction based on analyses of mammographic features to iCAD Travel. Several co-authors have also declared relationships with industry.

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

Tamoxifen has long been used in breast cancer, both in the adjuvant and preventive setting, but uptake and adherence are notoriously low, mainly because of adverse events.

Using a much lower dose to reduce the incidence of side effects would be a “way forward,” reasoned Swedish researchers. They report that a substantially lower dose of tamoxifen (2.5 mg) may be as effective as the standard dose (20 mg), but reduced by half the incidence of severe vasomotor symptoms, including hot flashes, cold sweats, and night sweats.  

The research was published online March 18 in the Journal of Clinical Oncology.

The study involved 1,439 women (aged 40-74 years) who were participating in the Swedish mammography screening program and tested tamoxifen at various doses.  

“We performed a dose determination study that we hope will initiate follow-up studies that in turn will influence both adjuvant treatment and prevention of breast cancer,” said lead author Per Hall, MD, PhD, head of the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

The study measured the effects of the different doses (1, 2.5, 5, 10, and 20 mg) on mammographic breast density.

Dr. Hall emphasized that breast density was used as a proxy for therapy response. “We do not know how that translates to actual clinical effect,” he said in an interview. “This is step one.”

Previous studies have also used breast density changes as a proxy endpoint for tamoxifen therapy response, in both prophylactic and adjuvant settings, the authors note. There is some data to suggest that this does translate to a clinical effect. A recent study showed that tamoxifen at 5 mg/day taken for 3 years reduced the recurrence of breast intraepithelial neoplasia by 50% and contralateral breast cancer by 75%, with a symptom profile similar to placebo (J Clin Oncol.  2019;37:1629-1637).
 

Lower density, fewer symptoms

In the current study, Dr. Hall and colleagues found that the mammographic breast density (mean overall area) was decreased by 9.6% in the 20 mg tamoxifen group, and similar decreases were seen in the 2.5 and 10 mg dose groups, but not in the placebo and 1 mg dose groups.

These changes were driven primarily by changes observed among premenopausal women where the 20 mg mean decrease was 18.5% (P < .001 for interaction with menopausal status) with decreases of 13.4% in the 2.5 mg group, 19.6% in the 5 mg group, and 17% in the 10 mg group.

The results were quite different in postmenopausal participants, where those who received the 20 mg dose had a density mean decrease of 4%, which was not substantially different to the placebo, 1 mg, 2.5 mg, and 10 mg treatment arms.

The authors point out that the difference in density decrease between premenopausal and postmenopausal women was not dependent on differences in baseline density.

When reviewing adverse events with the various doses, the team found a large decrease in severe vasomotor symptoms with the lower doses of tamoxifen. These adverse events were reported by 34% of women taking 20 mg, 24.4% on 5 mg, 20.5% on 2.5 mg, 18.5% on 1 mg, and 13.7% of women taking placebo. There were no similar trends seen for gynecologic, sexual, or musculoskeletal symptoms.

Future studies should test whether 2.5 mg of tamoxifen reduces the risk of primary breast cancer, Dr. Hall commented.

“We are planning a trial now where women are offered risk assessment when attending mammography screening,” Dr. Hall said. “For those at very high risk, low-dose tamoxifen will be offered.”

The study received support from the Kamprad Foundation, Swedish Research Council, Marit and Hans Rausing’s Initiative Against Breast Cancer, Swedish Cancer Society, and Stockholm County Council.

Dr. Hall reports several relationships with industry, had a pending patent on compositions and methods for prevention of breast cancer with an option to license to Atossa Therapeutics, and has licensed an algorithm for risk prediction based on analyses of mammographic features to iCAD Travel. Several co-authors have also declared relationships with industry.

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

Tamoxifen has long been used in breast cancer, both in the adjuvant and preventive setting, but uptake and adherence are notoriously low, mainly because of adverse events.

Using a much lower dose to reduce the incidence of side effects would be a “way forward,” reasoned Swedish researchers. They report that a substantially lower dose of tamoxifen (2.5 mg) may be as effective as the standard dose (20 mg), but reduced by half the incidence of severe vasomotor symptoms, including hot flashes, cold sweats, and night sweats.  

The research was published online March 18 in the Journal of Clinical Oncology.

The study involved 1,439 women (aged 40-74 years) who were participating in the Swedish mammography screening program and tested tamoxifen at various doses.  

“We performed a dose determination study that we hope will initiate follow-up studies that in turn will influence both adjuvant treatment and prevention of breast cancer,” said lead author Per Hall, MD, PhD, head of the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

The study measured the effects of the different doses (1, 2.5, 5, 10, and 20 mg) on mammographic breast density.

Dr. Hall emphasized that breast density was used as a proxy for therapy response. “We do not know how that translates to actual clinical effect,” he said in an interview. “This is step one.”

Previous studies have also used breast density changes as a proxy endpoint for tamoxifen therapy response, in both prophylactic and adjuvant settings, the authors note. There is some data to suggest that this does translate to a clinical effect. A recent study showed that tamoxifen at 5 mg/day taken for 3 years reduced the recurrence of breast intraepithelial neoplasia by 50% and contralateral breast cancer by 75%, with a symptom profile similar to placebo (J Clin Oncol.  2019;37:1629-1637).
 

Lower density, fewer symptoms

In the current study, Dr. Hall and colleagues found that the mammographic breast density (mean overall area) was decreased by 9.6% in the 20 mg tamoxifen group, and similar decreases were seen in the 2.5 and 10 mg dose groups, but not in the placebo and 1 mg dose groups.

These changes were driven primarily by changes observed among premenopausal women where the 20 mg mean decrease was 18.5% (P < .001 for interaction with menopausal status) with decreases of 13.4% in the 2.5 mg group, 19.6% in the 5 mg group, and 17% in the 10 mg group.

The results were quite different in postmenopausal participants, where those who received the 20 mg dose had a density mean decrease of 4%, which was not substantially different to the placebo, 1 mg, 2.5 mg, and 10 mg treatment arms.

The authors point out that the difference in density decrease between premenopausal and postmenopausal women was not dependent on differences in baseline density.

When reviewing adverse events with the various doses, the team found a large decrease in severe vasomotor symptoms with the lower doses of tamoxifen. These adverse events were reported by 34% of women taking 20 mg, 24.4% on 5 mg, 20.5% on 2.5 mg, 18.5% on 1 mg, and 13.7% of women taking placebo. There were no similar trends seen for gynecologic, sexual, or musculoskeletal symptoms.

Future studies should test whether 2.5 mg of tamoxifen reduces the risk of primary breast cancer, Dr. Hall commented.

“We are planning a trial now where women are offered risk assessment when attending mammography screening,” Dr. Hall said. “For those at very high risk, low-dose tamoxifen will be offered.”

The study received support from the Kamprad Foundation, Swedish Research Council, Marit and Hans Rausing’s Initiative Against Breast Cancer, Swedish Cancer Society, and Stockholm County Council.

Dr. Hall reports several relationships with industry, had a pending patent on compositions and methods for prevention of breast cancer with an option to license to Atossa Therapeutics, and has licensed an algorithm for risk prediction based on analyses of mammographic features to iCAD Travel. Several co-authors have also declared relationships with industry.

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

Most breast cancer screening centers in the United States are not following national guidelines, say researchers reporting on a new analysis.

They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.

This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.

The new analysis was published online in JAMA Internal Medicine.

This may be doing “more harm than good,” warn the authors of an accompanying editorial.

“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.

“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.

“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.

The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.

The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.

The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.

One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.

In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.

“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.

“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.

Details of the analysis

The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.

They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.

Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.

A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.

The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.

Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.

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

Most breast cancer screening centers in the United States are not following national guidelines, say researchers reporting on a new analysis.

They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.

This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.

The new analysis was published online in JAMA Internal Medicine.

This may be doing “more harm than good,” warn the authors of an accompanying editorial.

“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.

“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.

“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.

The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.

The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.

The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.

One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.

In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.

“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.

“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.

Details of the analysis

The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.

They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.

Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.

A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.

The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.

Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.

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

Most breast cancer screening centers in the United States are not following national guidelines, say researchers reporting on a new analysis.

They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.

This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.

The new analysis was published online in JAMA Internal Medicine.

This may be doing “more harm than good,” warn the authors of an accompanying editorial.

“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.

“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.

“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.

The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.

The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.

The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.

One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.

In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.

“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.

“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.

Details of the analysis

The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.

They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.

Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.

A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.

The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.

Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.

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

Worries about out-of-pocket costs of treatment they are receiving – so-called “financial toxicity” – may harm outcomes for patients with cancer, new research suggests.

The study found that patients with head and neck cancer who were worried about their finances had approximately double the risk of dying when compared to patients without such worries.

The findings were published in Oral Oncology.

“This is the first time that financial worry was shown to impact survival,” senior author Anurag Singh, MD, of Roswell Park Cancer Center, Buffalo, N.Y., told this news organization.

“The association we found was very strong and very concerning,” he said. “If you are worried about your finances, your risk of dying is roughly double.”

Dr. Singh emphasized that the risk of dying was not related to missing treatment due to financial concerns. Although it has been reported that as many as a quarter of all patients with cancer choose not to fill a prescription because of cost, this was not the case for the current study population.

“Our patients all finished on time and did not skip treatments,” Dr. Singh said.

Dr. Singh suggests these results could be extrapolated to the larger cancer population, as many cancer types require long treatments, expensive targeted agents, and surgery. “It is possible, and we are studying it in lung, breast, and prostate cancer patients,” he said.

The problem of financial toxicity has been widely reported. However, few solutions have emerged, especially those that can be implemented immediately. Dr. Singh said his institution has begun a referral program and plans to publish on this soon.

“We have been utilizing financial counselors for our head and neck patients for more than 3 years,” he said. “This has stabilized the amount of financial worry during the course of treatment – meaning it didn’t get worse while the patient was undergoing treatment.”

Financial worries linked to worse outcomes

In the article, Dr. Singh and colleagues explained that they studied patients with head and neck cancer because medical and out-of-pocket expenses are higher for this type of tumor compared with other malignancies.

Previous studies have shown that patients with head and neck cancer are at risk for worsening quality of life due to financial toxicity, and one study showed that more than two out of three such patients relied on cost-coping strategies, such as selling personal assets or taking credit card loans (J Onc Pract. 2017;13:e310-8).

For their study, Dr. Singh and colleagues conducted a retrospective review of 284 patients treated at Roswell Park Comprehensive Cancer Center with definitive or postoperative radiation therapy between 2013 and 2017. The median age of patients was 61 years, and more than three-quarters were men (77.5%).

Of this group, 204 patients (71.8%) received definitive radiation, and 80 patients (28.2%) were treated with adjuvant radiation. Chemotherapy was used for 237 patients (83.5%), usually cisplatin. The median follow-up was 39.9 months.

At baseline, 41 (14.4%) patients reported a high level of financial difficulties, and the rate of relapse was higher among these patients.

In the group of patients with financial difficulties, 14 of 41 (33%) patients had a relapse (7 distant, 7 local). Subsequent treatments included none (n = 6, 42.9%), systemic therapy (n = 5, 35.7%), and surgery (n = 3, 21.4%). Three patients (21.4%) received immunotherapy at some point during treatment.

Among patients who reported low financial difficulty at baseline, 50 of 243 patients (20.6%) had a relapse (34 distant, 16 local). Subsequent treatments included none (n = 15, 30%), systemic therapy (n = 25, 50%), and surgery (n = 10, 20%). Fourteen patients (28%) received immunotherapy at some point during treatment.

The researchers noted there was no significant association between financial difficulties and receipt of additional treatments (P = .36) or immunotherapy (P = .62).

However, on multivariable analysis, they found a significant association between financial difficulties and worse overall survival (hazard ratio [HR], 1.75; P = .03) and cancer-specific survival (HR, 2.28; P = .003).

When the team narrowed their focus to 66 patients matched with well-balanced baseline characteristics, the significant association was even more pronounced. A high level of financial difficulties remained associated with worse overall survival (HR, 2.72; P = .04) and cancer-specific survival (HR, 3.75; P = .02).

The team noted that an earlier study (J Clin Oncol. 2016;34:980-6) found a higher risk of death among patients with cancer who filed for bankruptcy than among those who hadn’t. The adjusted mortality among cancer patients who filed for bankruptcy was nearly double (HR, 1.79; 95% confidence interval, 1.64-1.96). Colorectal, prostate, and thyroid cancers had the highest hazard ratios.

The hazard ratios for overall survival in the overall and matched-pair populations in the current study (1.75 and 2.72) are consistent with the overall cohort hazard ratio of 1.79 reported in the 2016 study, according to Dr. Singh and colleagues.

“If confirmed in other cohorts, this would suggest that relatively mild financial toxicity at baseline may have the same impact on mortality as an extreme consequence like post-therapy bankruptcy,” Dr. Singh and colleagues wrote.

Their study was supported by the National Cancer Institute Cancer Center. The authors declared no disclosures.

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

Worries about out-of-pocket costs of treatment they are receiving – so-called “financial toxicity” – may harm outcomes for patients with cancer, new research suggests.

The study found that patients with head and neck cancer who were worried about their finances had approximately double the risk of dying when compared to patients without such worries.

The findings were published in Oral Oncology.

“This is the first time that financial worry was shown to impact survival,” senior author Anurag Singh, MD, of Roswell Park Cancer Center, Buffalo, N.Y., told this news organization.

“The association we found was very strong and very concerning,” he said. “If you are worried about your finances, your risk of dying is roughly double.”

Dr. Singh emphasized that the risk of dying was not related to missing treatment due to financial concerns. Although it has been reported that as many as a quarter of all patients with cancer choose not to fill a prescription because of cost, this was not the case for the current study population.

“Our patients all finished on time and did not skip treatments,” Dr. Singh said.

Dr. Singh suggests these results could be extrapolated to the larger cancer population, as many cancer types require long treatments, expensive targeted agents, and surgery. “It is possible, and we are studying it in lung, breast, and prostate cancer patients,” he said.

The problem of financial toxicity has been widely reported. However, few solutions have emerged, especially those that can be implemented immediately. Dr. Singh said his institution has begun a referral program and plans to publish on this soon.

“We have been utilizing financial counselors for our head and neck patients for more than 3 years,” he said. “This has stabilized the amount of financial worry during the course of treatment – meaning it didn’t get worse while the patient was undergoing treatment.”

Financial worries linked to worse outcomes

In the article, Dr. Singh and colleagues explained that they studied patients with head and neck cancer because medical and out-of-pocket expenses are higher for this type of tumor compared with other malignancies.

Previous studies have shown that patients with head and neck cancer are at risk for worsening quality of life due to financial toxicity, and one study showed that more than two out of three such patients relied on cost-coping strategies, such as selling personal assets or taking credit card loans (J Onc Pract. 2017;13:e310-8).

For their study, Dr. Singh and colleagues conducted a retrospective review of 284 patients treated at Roswell Park Comprehensive Cancer Center with definitive or postoperative radiation therapy between 2013 and 2017. The median age of patients was 61 years, and more than three-quarters were men (77.5%).

Of this group, 204 patients (71.8%) received definitive radiation, and 80 patients (28.2%) were treated with adjuvant radiation. Chemotherapy was used for 237 patients (83.5%), usually cisplatin. The median follow-up was 39.9 months.

At baseline, 41 (14.4%) patients reported a high level of financial difficulties, and the rate of relapse was higher among these patients.

In the group of patients with financial difficulties, 14 of 41 (33%) patients had a relapse (7 distant, 7 local). Subsequent treatments included none (n = 6, 42.9%), systemic therapy (n = 5, 35.7%), and surgery (n = 3, 21.4%). Three patients (21.4%) received immunotherapy at some point during treatment.

Among patients who reported low financial difficulty at baseline, 50 of 243 patients (20.6%) had a relapse (34 distant, 16 local). Subsequent treatments included none (n = 15, 30%), systemic therapy (n = 25, 50%), and surgery (n = 10, 20%). Fourteen patients (28%) received immunotherapy at some point during treatment.

The researchers noted there was no significant association between financial difficulties and receipt of additional treatments (P = .36) or immunotherapy (P = .62).

However, on multivariable analysis, they found a significant association between financial difficulties and worse overall survival (hazard ratio [HR], 1.75; P = .03) and cancer-specific survival (HR, 2.28; P = .003).

When the team narrowed their focus to 66 patients matched with well-balanced baseline characteristics, the significant association was even more pronounced. A high level of financial difficulties remained associated with worse overall survival (HR, 2.72; P = .04) and cancer-specific survival (HR, 3.75; P = .02).

The team noted that an earlier study (J Clin Oncol. 2016;34:980-6) found a higher risk of death among patients with cancer who filed for bankruptcy than among those who hadn’t. The adjusted mortality among cancer patients who filed for bankruptcy was nearly double (HR, 1.79; 95% confidence interval, 1.64-1.96). Colorectal, prostate, and thyroid cancers had the highest hazard ratios.

The hazard ratios for overall survival in the overall and matched-pair populations in the current study (1.75 and 2.72) are consistent with the overall cohort hazard ratio of 1.79 reported in the 2016 study, according to Dr. Singh and colleagues.

“If confirmed in other cohorts, this would suggest that relatively mild financial toxicity at baseline may have the same impact on mortality as an extreme consequence like post-therapy bankruptcy,” Dr. Singh and colleagues wrote.

Their study was supported by the National Cancer Institute Cancer Center. The authors declared no disclosures.

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

Worries about out-of-pocket costs of treatment they are receiving – so-called “financial toxicity” – may harm outcomes for patients with cancer, new research suggests.

The study found that patients with head and neck cancer who were worried about their finances had approximately double the risk of dying when compared to patients without such worries.

The findings were published in Oral Oncology.

“This is the first time that financial worry was shown to impact survival,” senior author Anurag Singh, MD, of Roswell Park Cancer Center, Buffalo, N.Y., told this news organization.

“The association we found was very strong and very concerning,” he said. “If you are worried about your finances, your risk of dying is roughly double.”

Dr. Singh emphasized that the risk of dying was not related to missing treatment due to financial concerns. Although it has been reported that as many as a quarter of all patients with cancer choose not to fill a prescription because of cost, this was not the case for the current study population.

“Our patients all finished on time and did not skip treatments,” Dr. Singh said.

Dr. Singh suggests these results could be extrapolated to the larger cancer population, as many cancer types require long treatments, expensive targeted agents, and surgery. “It is possible, and we are studying it in lung, breast, and prostate cancer patients,” he said.

The problem of financial toxicity has been widely reported. However, few solutions have emerged, especially those that can be implemented immediately. Dr. Singh said his institution has begun a referral program and plans to publish on this soon.

“We have been utilizing financial counselors for our head and neck patients for more than 3 years,” he said. “This has stabilized the amount of financial worry during the course of treatment – meaning it didn’t get worse while the patient was undergoing treatment.”

Financial worries linked to worse outcomes

In the article, Dr. Singh and colleagues explained that they studied patients with head and neck cancer because medical and out-of-pocket expenses are higher for this type of tumor compared with other malignancies.

Previous studies have shown that patients with head and neck cancer are at risk for worsening quality of life due to financial toxicity, and one study showed that more than two out of three such patients relied on cost-coping strategies, such as selling personal assets or taking credit card loans (J Onc Pract. 2017;13:e310-8).

For their study, Dr. Singh and colleagues conducted a retrospective review of 284 patients treated at Roswell Park Comprehensive Cancer Center with definitive or postoperative radiation therapy between 2013 and 2017. The median age of patients was 61 years, and more than three-quarters were men (77.5%).

Of this group, 204 patients (71.8%) received definitive radiation, and 80 patients (28.2%) were treated with adjuvant radiation. Chemotherapy was used for 237 patients (83.5%), usually cisplatin. The median follow-up was 39.9 months.

At baseline, 41 (14.4%) patients reported a high level of financial difficulties, and the rate of relapse was higher among these patients.

In the group of patients with financial difficulties, 14 of 41 (33%) patients had a relapse (7 distant, 7 local). Subsequent treatments included none (n = 6, 42.9%), systemic therapy (n = 5, 35.7%), and surgery (n = 3, 21.4%). Three patients (21.4%) received immunotherapy at some point during treatment.

Among patients who reported low financial difficulty at baseline, 50 of 243 patients (20.6%) had a relapse (34 distant, 16 local). Subsequent treatments included none (n = 15, 30%), systemic therapy (n = 25, 50%), and surgery (n = 10, 20%). Fourteen patients (28%) received immunotherapy at some point during treatment.

The researchers noted there was no significant association between financial difficulties and receipt of additional treatments (P = .36) or immunotherapy (P = .62).

However, on multivariable analysis, they found a significant association between financial difficulties and worse overall survival (hazard ratio [HR], 1.75; P = .03) and cancer-specific survival (HR, 2.28; P = .003).

When the team narrowed their focus to 66 patients matched with well-balanced baseline characteristics, the significant association was even more pronounced. A high level of financial difficulties remained associated with worse overall survival (HR, 2.72; P = .04) and cancer-specific survival (HR, 3.75; P = .02).

The team noted that an earlier study (J Clin Oncol. 2016;34:980-6) found a higher risk of death among patients with cancer who filed for bankruptcy than among those who hadn’t. The adjusted mortality among cancer patients who filed for bankruptcy was nearly double (HR, 1.79; 95% confidence interval, 1.64-1.96). Colorectal, prostate, and thyroid cancers had the highest hazard ratios.

The hazard ratios for overall survival in the overall and matched-pair populations in the current study (1.75 and 2.72) are consistent with the overall cohort hazard ratio of 1.79 reported in the 2016 study, according to Dr. Singh and colleagues.

“If confirmed in other cohorts, this would suggest that relatively mild financial toxicity at baseline may have the same impact on mortality as an extreme consequence like post-therapy bankruptcy,” Dr. Singh and colleagues wrote.

Their study was supported by the National Cancer Institute Cancer Center. The authors declared no disclosures.

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

The U.S. Preventive Services Task Force has expanded the criteria for lung cancer screening. The updated final recommendations have lowered the age at which screening starts from 55 to 50 years and have reduced the criterion regarding smoking history from 30 to 20 pack-years.

“This is great news because it means that nearly twice as many people are eligible to be screened, which we hope will allow clinicians to save more lives and help people remain healthy longer,” commented John Wong, MD, chief science officer, vice chair for clinical affairs, and chief of the Division of Clinical Decision Making at USPSTF.

The updated final recommendations were published online on March 9 in JAMA.

The USPSTF recommends annual screening with low-dose CT for adults aged 50-80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.

This updates guidance issued in 2013, which recommended annual screening for lung cancer for adults aged 55-80 years who had a 30 pack-year smoking history and who were either current smokers or had quit within the past 15 years.

The move will nearly double the number of people are now eligible for screening, up to 14.5 million individuals – an increase of 81% (6.4 million adults) from the 2013 recommendations.

The expanded criteria may help increase screening among Black individuals and women. Data show that both groups tend to smoke fewer cigarettes than White men and that Black persons are at higher risk for lung cancer than White persons. In addition, research has shown that about one-third of Black patients with lung cancer were diagnosed before the age of 55 years, which means they would not have been recommended for screening under the previous guidelines.

Uptake has been limited

To date, uptake of lung cancer screening has been very limited, from 6% to 18% of individuals who meet the eligibility criteria.

The new recommendations will open up screening to many more people, but challenges to implementation remain.

“The science is clear that lung cancer screening has the potential to save lives,” Dr. Wong told this news organization. “We recognize that there are existing barriers to screening everyone who is eligible, but clinicians and patients both deserve to know that screening can detect lung cancer early, when treatment has the best chance of being beneficial.”

He added that the hope is that these recommendations will encourage clinicians to examine the barriers to effective lung cancer screening in their communities and to do what they can to improve implementation. “We also hope to encourage patients to have conversations with their clinicians about whether they are eligible for screening and to discuss smoking cessation treatments if they are still smoking,” Dr. Wong added.

In an accompanying editorial, Louise M. Henderson, PhD, M. Patricia Rivera, MD, FCCP, and Ethan Basch, MD, all from the University of North Carolina at Chapel Hill, address some of the current challenges in implementation.

They note that reimbursement for lung cancer screening by Medicare requires submission of data to a Centers for Medicare & Medicaid Services–approved registry, and this can present problems for facilities serving less affluent communities or that have limited resources.

Medicaid coverage is also uneven. As of September 2020, lung cancer screening was covered by 38 Medicaid programs, but not by 9. For three programs, data on coverage were not available.

“With the new recommendations lowering the screening-eligible age to 50 years, many eligible individuals who are uninsured or who are receiving Medicaid and living in states that do not cover screening will have financial barriers to undergo screening,” they write.

In addition, many individuals in at-risk populations lack adequate geographic access to comprehensive lung cancer screening programs.

Expanding eligibility criteria is important, the editorialists point out, but barriers to screening, which include lack of insurance coverage and limited physical access to high-quality screening programs, highlight the complex problems with implementation that need to be addressed.

“A concerted effort to increase the reach of lung cancer screening is needed,” they write. “The 2021 USPSTF recommendation statement represents a leap forward in evidence and offers promise to prevent more cancer deaths and address screening disparities. But the greatest work lies ahead to ensure this promise is actualized.”

Advocacy needed

When approached for comment, Jianjun Zhang, MD, PhD, from the department of thoracic/head and neck medical oncology, University of Texas MD Anderson Cancer Center, Houston, said he supports the new guidelines, and they will lower mortality. “The data are pretty strong overall,” he said in an interview.

Although the uptake of screening is currently very low, he pointed out that, even if uptake remains the same, more lives will be saved because eligibility has been expanded. “More people will be getting screened, so it’s a start,” he said.

Aside from factors such as insurance and access, another problem involves primary care. “Time is very limited in primary care,” he said. “You have about 15 minutes, and it can be really hard to fit everything into a visit. Screening may get left out or may only get a brief mention.”

Advocacy is needed, Dr. Zhang pointed out. “Breast cancer has strong voices and advocacy, and people are more aware of mammography,” he said. “The information is disseminated out into the community. We need the same for lung cancer.”

Dr. Zhang emphasized that, even with the expanded criteria, many individuals will still be missed. “There are other risk factors besides smoking,” he said. “About 10% of lung cancers occur in never-smokers.”

Other risk factors include a family history of lung cancer, exposure to certain materials and chemicals, working in the mining industry, and genetics.

“We will move on to more personalized screening at some point,” he said. “But right now, we can’t make it too complicated for patients and doctors. We need to concentrate on increasing screening rates within these current criteria.”

The updated guidelines have been given a B recommendation, meaning the USPSTF recommends that clinicians provide the service to eligible patients, there is at least fair evidence that this service improves important health outcomes, and benefits outweigh harms.

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF. All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings. The original article lists relevant financial relationships of task force members. Dr. Zhang has received grants from Johnson & Johnson and Merck, and adversary/consulting/honoraria fees from AstraZeneca, Bristol-Myers Squibb, GenePlus, Innovent, OrigMed, and Roche.

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

The U.S. Preventive Services Task Force has expanded the criteria for lung cancer screening. The updated final recommendations have lowered the age at which screening starts from 55 to 50 years and have reduced the criterion regarding smoking history from 30 to 20 pack-years.

“This is great news because it means that nearly twice as many people are eligible to be screened, which we hope will allow clinicians to save more lives and help people remain healthy longer,” commented John Wong, MD, chief science officer, vice chair for clinical affairs, and chief of the Division of Clinical Decision Making at USPSTF.

The updated final recommendations were published online on March 9 in JAMA.

The USPSTF recommends annual screening with low-dose CT for adults aged 50-80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.

This updates guidance issued in 2013, which recommended annual screening for lung cancer for adults aged 55-80 years who had a 30 pack-year smoking history and who were either current smokers or had quit within the past 15 years.

The move will nearly double the number of people are now eligible for screening, up to 14.5 million individuals – an increase of 81% (6.4 million adults) from the 2013 recommendations.

The expanded criteria may help increase screening among Black individuals and women. Data show that both groups tend to smoke fewer cigarettes than White men and that Black persons are at higher risk for lung cancer than White persons. In addition, research has shown that about one-third of Black patients with lung cancer were diagnosed before the age of 55 years, which means they would not have been recommended for screening under the previous guidelines.

Uptake has been limited

To date, uptake of lung cancer screening has been very limited, from 6% to 18% of individuals who meet the eligibility criteria.

The new recommendations will open up screening to many more people, but challenges to implementation remain.

“The science is clear that lung cancer screening has the potential to save lives,” Dr. Wong told this news organization. “We recognize that there are existing barriers to screening everyone who is eligible, but clinicians and patients both deserve to know that screening can detect lung cancer early, when treatment has the best chance of being beneficial.”

He added that the hope is that these recommendations will encourage clinicians to examine the barriers to effective lung cancer screening in their communities and to do what they can to improve implementation. “We also hope to encourage patients to have conversations with their clinicians about whether they are eligible for screening and to discuss smoking cessation treatments if they are still smoking,” Dr. Wong added.

In an accompanying editorial, Louise M. Henderson, PhD, M. Patricia Rivera, MD, FCCP, and Ethan Basch, MD, all from the University of North Carolina at Chapel Hill, address some of the current challenges in implementation.

They note that reimbursement for lung cancer screening by Medicare requires submission of data to a Centers for Medicare & Medicaid Services–approved registry, and this can present problems for facilities serving less affluent communities or that have limited resources.

Medicaid coverage is also uneven. As of September 2020, lung cancer screening was covered by 38 Medicaid programs, but not by 9. For three programs, data on coverage were not available.

“With the new recommendations lowering the screening-eligible age to 50 years, many eligible individuals who are uninsured or who are receiving Medicaid and living in states that do not cover screening will have financial barriers to undergo screening,” they write.

In addition, many individuals in at-risk populations lack adequate geographic access to comprehensive lung cancer screening programs.

Expanding eligibility criteria is important, the editorialists point out, but barriers to screening, which include lack of insurance coverage and limited physical access to high-quality screening programs, highlight the complex problems with implementation that need to be addressed.

“A concerted effort to increase the reach of lung cancer screening is needed,” they write. “The 2021 USPSTF recommendation statement represents a leap forward in evidence and offers promise to prevent more cancer deaths and address screening disparities. But the greatest work lies ahead to ensure this promise is actualized.”

Advocacy needed

When approached for comment, Jianjun Zhang, MD, PhD, from the department of thoracic/head and neck medical oncology, University of Texas MD Anderson Cancer Center, Houston, said he supports the new guidelines, and they will lower mortality. “The data are pretty strong overall,” he said in an interview.

Although the uptake of screening is currently very low, he pointed out that, even if uptake remains the same, more lives will be saved because eligibility has been expanded. “More people will be getting screened, so it’s a start,” he said.

Aside from factors such as insurance and access, another problem involves primary care. “Time is very limited in primary care,” he said. “You have about 15 minutes, and it can be really hard to fit everything into a visit. Screening may get left out or may only get a brief mention.”

Advocacy is needed, Dr. Zhang pointed out. “Breast cancer has strong voices and advocacy, and people are more aware of mammography,” he said. “The information is disseminated out into the community. We need the same for lung cancer.”

Dr. Zhang emphasized that, even with the expanded criteria, many individuals will still be missed. “There are other risk factors besides smoking,” he said. “About 10% of lung cancers occur in never-smokers.”

Other risk factors include a family history of lung cancer, exposure to certain materials and chemicals, working in the mining industry, and genetics.

“We will move on to more personalized screening at some point,” he said. “But right now, we can’t make it too complicated for patients and doctors. We need to concentrate on increasing screening rates within these current criteria.”

The updated guidelines have been given a B recommendation, meaning the USPSTF recommends that clinicians provide the service to eligible patients, there is at least fair evidence that this service improves important health outcomes, and benefits outweigh harms.

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF. All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings. The original article lists relevant financial relationships of task force members. Dr. Zhang has received grants from Johnson & Johnson and Merck, and adversary/consulting/honoraria fees from AstraZeneca, Bristol-Myers Squibb, GenePlus, Innovent, OrigMed, and Roche.

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

The U.S. Preventive Services Task Force has expanded the criteria for lung cancer screening. The updated final recommendations have lowered the age at which screening starts from 55 to 50 years and have reduced the criterion regarding smoking history from 30 to 20 pack-years.

“This is great news because it means that nearly twice as many people are eligible to be screened, which we hope will allow clinicians to save more lives and help people remain healthy longer,” commented John Wong, MD, chief science officer, vice chair for clinical affairs, and chief of the Division of Clinical Decision Making at USPSTF.

The updated final recommendations were published online on March 9 in JAMA.

The USPSTF recommends annual screening with low-dose CT for adults aged 50-80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.

This updates guidance issued in 2013, which recommended annual screening for lung cancer for adults aged 55-80 years who had a 30 pack-year smoking history and who were either current smokers or had quit within the past 15 years.

The move will nearly double the number of people are now eligible for screening, up to 14.5 million individuals – an increase of 81% (6.4 million adults) from the 2013 recommendations.

The expanded criteria may help increase screening among Black individuals and women. Data show that both groups tend to smoke fewer cigarettes than White men and that Black persons are at higher risk for lung cancer than White persons. In addition, research has shown that about one-third of Black patients with lung cancer were diagnosed before the age of 55 years, which means they would not have been recommended for screening under the previous guidelines.

Uptake has been limited

To date, uptake of lung cancer screening has been very limited, from 6% to 18% of individuals who meet the eligibility criteria.

The new recommendations will open up screening to many more people, but challenges to implementation remain.

“The science is clear that lung cancer screening has the potential to save lives,” Dr. Wong told this news organization. “We recognize that there are existing barriers to screening everyone who is eligible, but clinicians and patients both deserve to know that screening can detect lung cancer early, when treatment has the best chance of being beneficial.”

He added that the hope is that these recommendations will encourage clinicians to examine the barriers to effective lung cancer screening in their communities and to do what they can to improve implementation. “We also hope to encourage patients to have conversations with their clinicians about whether they are eligible for screening and to discuss smoking cessation treatments if they are still smoking,” Dr. Wong added.

In an accompanying editorial, Louise M. Henderson, PhD, M. Patricia Rivera, MD, FCCP, and Ethan Basch, MD, all from the University of North Carolina at Chapel Hill, address some of the current challenges in implementation.

They note that reimbursement for lung cancer screening by Medicare requires submission of data to a Centers for Medicare & Medicaid Services–approved registry, and this can present problems for facilities serving less affluent communities or that have limited resources.

Medicaid coverage is also uneven. As of September 2020, lung cancer screening was covered by 38 Medicaid programs, but not by 9. For three programs, data on coverage were not available.

“With the new recommendations lowering the screening-eligible age to 50 years, many eligible individuals who are uninsured or who are receiving Medicaid and living in states that do not cover screening will have financial barriers to undergo screening,” they write.

In addition, many individuals in at-risk populations lack adequate geographic access to comprehensive lung cancer screening programs.

Expanding eligibility criteria is important, the editorialists point out, but barriers to screening, which include lack of insurance coverage and limited physical access to high-quality screening programs, highlight the complex problems with implementation that need to be addressed.

“A concerted effort to increase the reach of lung cancer screening is needed,” they write. “The 2021 USPSTF recommendation statement represents a leap forward in evidence and offers promise to prevent more cancer deaths and address screening disparities. But the greatest work lies ahead to ensure this promise is actualized.”

Advocacy needed

When approached for comment, Jianjun Zhang, MD, PhD, from the department of thoracic/head and neck medical oncology, University of Texas MD Anderson Cancer Center, Houston, said he supports the new guidelines, and they will lower mortality. “The data are pretty strong overall,” he said in an interview.

Although the uptake of screening is currently very low, he pointed out that, even if uptake remains the same, more lives will be saved because eligibility has been expanded. “More people will be getting screened, so it’s a start,” he said.

Aside from factors such as insurance and access, another problem involves primary care. “Time is very limited in primary care,” he said. “You have about 15 minutes, and it can be really hard to fit everything into a visit. Screening may get left out or may only get a brief mention.”

Advocacy is needed, Dr. Zhang pointed out. “Breast cancer has strong voices and advocacy, and people are more aware of mammography,” he said. “The information is disseminated out into the community. We need the same for lung cancer.”

Dr. Zhang emphasized that, even with the expanded criteria, many individuals will still be missed. “There are other risk factors besides smoking,” he said. “About 10% of lung cancers occur in never-smokers.”

Other risk factors include a family history of lung cancer, exposure to certain materials and chemicals, working in the mining industry, and genetics.

“We will move on to more personalized screening at some point,” he said. “But right now, we can’t make it too complicated for patients and doctors. We need to concentrate on increasing screening rates within these current criteria.”

The updated guidelines have been given a B recommendation, meaning the USPSTF recommends that clinicians provide the service to eligible patients, there is at least fair evidence that this service improves important health outcomes, and benefits outweigh harms.

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF. All members of the USPSTF receive travel reimbursement and an honorarium for participating in USPSTF meetings. The original article lists relevant financial relationships of task force members. Dr. Zhang has received grants from Johnson & Johnson and Merck, and adversary/consulting/honoraria fees from AstraZeneca, Bristol-Myers Squibb, GenePlus, Innovent, OrigMed, and Roche.

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

It’s now confirmed: What you eat does affect your risk of developing colorectal cancer (CRC).

An umbrella review of studies and meta-analyses found “convincing evidence of an association between a lower CRC risk and higher intakes of dietary fiber, dietary calcium, and yogurt and lower intakes of alcohol and red meat.”

However, more research is needed to address the link between CRC and other foods, including dairy products, whole grains, processed meat, and specific dietary patterns, the authors conclude.

“We can say that the existing recommendations for diet in the primary prevention of colorectal cancer is confirmed,” said lead author Nathorn Chaiyakunapruk, PharmD, PhD, professor of pharmacology at the University of Utah, Salt Lake City.

“It makes sense to encourage healthy diet, including those rich in fruits, vegetables, grains, and low-fat dairy, and reducing red meat and alcohol intake,” he said in an interview. “However, some of them may not yet have convincing evidence to fully support the claim.”

Other lifestyle factors, including excess weight and physical inactivity, also play a role in cancer risk. Dr. Chaiyakunapruk pointed out that their review was focused only on diet and that they had set out to confirm factors for which there was strong and convincing evidence.

The review was published online in JAMA Network Open.

The umbrella review of 45 meta-analyses found 109 associations. Overall, 35 of these 109 associations (32.1%) were nominally statistically significant, as determined on the basis of random-effects meta-analysis models, the researchers explained.

Convincing evidence was found for an increase in the risk for CRC with higher versus lower red meat consumption and with heavy alcohol intake (defined as more than four drinks per day, compared with no drinks per day or occasional drinks).

In addition, convincing evidence was found for three inverse associations: a decrease in the risk for CRC was associated with higher versus lower intake of total dietary fiber, calcium, and yogurt.

The researchers noted that, although not completely convincing, there was highly suggestive evidence for another association: a link between diet and CRC incidence. A higher intake of total dairy products (e.g., milk, cheese, and yogurt) was associated with significant risk reduction, in comparison with lower intake. A moderate intake of alcohol (from one to three drinks but not more than four per day) was associated with an increase in incidence in comparison with no drinks or an occasional drink.

Evidence suggested a reduced risk in association with several lifestyle behaviors, including adherence to a Mediterranean diet, a healthy diet, a pesco-vegetarian or semivegetarian diet, and the intake of whole grains, nonfermented milk, and supplemental calcium.

The evidence suggested that adherence to a Western diet and intake of processed meat were associated with an increased risk for CRC.

There was weak or no evidence for the remaining associations.
 

Existing cancer prevention guidelines

The findings support the existing cancer prevention dietary guidance and recommendations from the American Institute for Cancer Research, commented the institute’s director of nutrition programs, Sheena Swanner Patel, MS, RDN. The study confirms that dietary factors play a strong role in lowering CRC risk.

“AICR’s report found strong evidence for whole grains, foods containing dietary fiber, dairy products, and calcium supplements decreasing risk for colorectal cancer,” she said. “Specifically, eating 90 g or three servings of whole grains per day is associated with a 17% decrease in colorectal cancer risk.”

Ms. Patel added that the AICR’s report also suggested there was strong evidence that eating large amounts of red and processed meat, drinking alcohol excessively, and carrying extra body weight increased the risk for CRC.

Many previous studies have suggested a link between diet and CRC risk. One recent study suggested that, among all cancers, CRC has the highest proportion of diet-related cases (38.3%). The next highest were cancers of the mouth, pharynx, and larynx, for which almost 26% of cases were linked to diet, followed by endometrial cancer, postmenopausal breast cancer, and cancers of the kidney, stomach, liver, pancreas, and esophagus.

Neither Dr. Chaiyakunapruk and coauthors nor Ms. Patel disclosed any relevant financial relationships.

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

Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

It’s now confirmed: What you eat does affect your risk of developing colorectal cancer (CRC).

An umbrella review of studies and meta-analyses found “convincing evidence of an association between a lower CRC risk and higher intakes of dietary fiber, dietary calcium, and yogurt and lower intakes of alcohol and red meat.”

However, more research is needed to address the link between CRC and other foods, including dairy products, whole grains, processed meat, and specific dietary patterns, the authors conclude.

“We can say that the existing recommendations for diet in the primary prevention of colorectal cancer is confirmed,” said lead author Nathorn Chaiyakunapruk, PharmD, PhD, professor of pharmacology at the University of Utah, Salt Lake City.

“It makes sense to encourage healthy diet, including those rich in fruits, vegetables, grains, and low-fat dairy, and reducing red meat and alcohol intake,” he said in an interview. “However, some of them may not yet have convincing evidence to fully support the claim.”

Other lifestyle factors, including excess weight and physical inactivity, also play a role in cancer risk. Dr. Chaiyakunapruk pointed out that their review was focused only on diet and that they had set out to confirm factors for which there was strong and convincing evidence.

The review was published online in JAMA Network Open.

The umbrella review of 45 meta-analyses found 109 associations. Overall, 35 of these 109 associations (32.1%) were nominally statistically significant, as determined on the basis of random-effects meta-analysis models, the researchers explained.

Convincing evidence was found for an increase in the risk for CRC with higher versus lower red meat consumption and with heavy alcohol intake (defined as more than four drinks per day, compared with no drinks per day or occasional drinks).

In addition, convincing evidence was found for three inverse associations: a decrease in the risk for CRC was associated with higher versus lower intake of total dietary fiber, calcium, and yogurt.

The researchers noted that, although not completely convincing, there was highly suggestive evidence for another association: a link between diet and CRC incidence. A higher intake of total dairy products (e.g., milk, cheese, and yogurt) was associated with significant risk reduction, in comparison with lower intake. A moderate intake of alcohol (from one to three drinks but not more than four per day) was associated with an increase in incidence in comparison with no drinks or an occasional drink.

Evidence suggested a reduced risk in association with several lifestyle behaviors, including adherence to a Mediterranean diet, a healthy diet, a pesco-vegetarian or semivegetarian diet, and the intake of whole grains, nonfermented milk, and supplemental calcium.

The evidence suggested that adherence to a Western diet and intake of processed meat were associated with an increased risk for CRC.

There was weak or no evidence for the remaining associations.
 

Existing cancer prevention guidelines

The findings support the existing cancer prevention dietary guidance and recommendations from the American Institute for Cancer Research, commented the institute’s director of nutrition programs, Sheena Swanner Patel, MS, RDN. The study confirms that dietary factors play a strong role in lowering CRC risk.

“AICR’s report found strong evidence for whole grains, foods containing dietary fiber, dairy products, and calcium supplements decreasing risk for colorectal cancer,” she said. “Specifically, eating 90 g or three servings of whole grains per day is associated with a 17% decrease in colorectal cancer risk.”

Ms. Patel added that the AICR’s report also suggested there was strong evidence that eating large amounts of red and processed meat, drinking alcohol excessively, and carrying extra body weight increased the risk for CRC.

Many previous studies have suggested a link between diet and CRC risk. One recent study suggested that, among all cancers, CRC has the highest proportion of diet-related cases (38.3%). The next highest were cancers of the mouth, pharynx, and larynx, for which almost 26% of cases were linked to diet, followed by endometrial cancer, postmenopausal breast cancer, and cancers of the kidney, stomach, liver, pancreas, and esophagus.

Neither Dr. Chaiyakunapruk and coauthors nor Ms. Patel disclosed any relevant financial relationships.

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

Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

It’s now confirmed: What you eat does affect your risk of developing colorectal cancer (CRC).

An umbrella review of studies and meta-analyses found “convincing evidence of an association between a lower CRC risk and higher intakes of dietary fiber, dietary calcium, and yogurt and lower intakes of alcohol and red meat.”

However, more research is needed to address the link between CRC and other foods, including dairy products, whole grains, processed meat, and specific dietary patterns, the authors conclude.

“We can say that the existing recommendations for diet in the primary prevention of colorectal cancer is confirmed,” said lead author Nathorn Chaiyakunapruk, PharmD, PhD, professor of pharmacology at the University of Utah, Salt Lake City.

“It makes sense to encourage healthy diet, including those rich in fruits, vegetables, grains, and low-fat dairy, and reducing red meat and alcohol intake,” he said in an interview. “However, some of them may not yet have convincing evidence to fully support the claim.”

Other lifestyle factors, including excess weight and physical inactivity, also play a role in cancer risk. Dr. Chaiyakunapruk pointed out that their review was focused only on diet and that they had set out to confirm factors for which there was strong and convincing evidence.

The review was published online in JAMA Network Open.

The umbrella review of 45 meta-analyses found 109 associations. Overall, 35 of these 109 associations (32.1%) were nominally statistically significant, as determined on the basis of random-effects meta-analysis models, the researchers explained.

Convincing evidence was found for an increase in the risk for CRC with higher versus lower red meat consumption and with heavy alcohol intake (defined as more than four drinks per day, compared with no drinks per day or occasional drinks).

In addition, convincing evidence was found for three inverse associations: a decrease in the risk for CRC was associated with higher versus lower intake of total dietary fiber, calcium, and yogurt.

The researchers noted that, although not completely convincing, there was highly suggestive evidence for another association: a link between diet and CRC incidence. A higher intake of total dairy products (e.g., milk, cheese, and yogurt) was associated with significant risk reduction, in comparison with lower intake. A moderate intake of alcohol (from one to three drinks but not more than four per day) was associated with an increase in incidence in comparison with no drinks or an occasional drink.

Evidence suggested a reduced risk in association with several lifestyle behaviors, including adherence to a Mediterranean diet, a healthy diet, a pesco-vegetarian or semivegetarian diet, and the intake of whole grains, nonfermented milk, and supplemental calcium.

The evidence suggested that adherence to a Western diet and intake of processed meat were associated with an increased risk for CRC.

There was weak or no evidence for the remaining associations.
 

Existing cancer prevention guidelines

The findings support the existing cancer prevention dietary guidance and recommendations from the American Institute for Cancer Research, commented the institute’s director of nutrition programs, Sheena Swanner Patel, MS, RDN. The study confirms that dietary factors play a strong role in lowering CRC risk.

“AICR’s report found strong evidence for whole grains, foods containing dietary fiber, dairy products, and calcium supplements decreasing risk for colorectal cancer,” she said. “Specifically, eating 90 g or three servings of whole grains per day is associated with a 17% decrease in colorectal cancer risk.”

Ms. Patel added that the AICR’s report also suggested there was strong evidence that eating large amounts of red and processed meat, drinking alcohol excessively, and carrying extra body weight increased the risk for CRC.

Many previous studies have suggested a link between diet and CRC risk. One recent study suggested that, among all cancers, CRC has the highest proportion of diet-related cases (38.3%). The next highest were cancers of the mouth, pharynx, and larynx, for which almost 26% of cases were linked to diet, followed by endometrial cancer, postmenopausal breast cancer, and cancers of the kidney, stomach, liver, pancreas, and esophagus.

Neither Dr. Chaiyakunapruk and coauthors nor Ms. Patel disclosed any relevant financial relationships.

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

Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

It’s now confirmed: What you eat does affect your risk of developing colorectal cancer (CRC).

An umbrella review of studies and meta-analyses found “convincing evidence of an association between a lower CRC risk and higher intakes of dietary fiber, dietary calcium, and yogurt and lower intakes of alcohol and red meat.”

However, more research is needed to address the link between CRC and other foods, including dairy products, whole grains, processed meat, and specific dietary patterns, the authors conclude.

“We can say that the existing recommendations for diet in the primary prevention of colorectal cancer is confirmed,” said lead author Nathorn Chaiyakunapruk, PharmD, PhD, professor of pharmacology at the University of Utah, Salt Lake City.

“It makes sense to encourage healthy diet, including those rich in fruits, vegetables, grains, and low-fat dairy, and reducing red meat and alcohol intake,” he said in an interview. “However, some of them may not yet have convincing evidence to fully support the claim.”

Other lifestyle factors, including excess weight and physical inactivity, also play a role in cancer risk. Dr. Chaiyakunapruk pointed out that their review was focused only on diet and that they had set out to confirm factors for which there was strong and convincing evidence.

The review was published online in JAMA Network Open.

The umbrella review of 45 meta-analyses found 109 associations. Overall, 35 of these 109 associations (32.1%) were nominally statistically significant, as determined on the basis of random-effects meta-analysis models, the researchers explained.

Convincing evidence was found for an increase in the risk for CRC with higher versus lower red meat consumption and with heavy alcohol intake (defined as more than four drinks per day, compared with no drinks per day or occasional drinks).

In addition, convincing evidence was found for three inverse associations: a decrease in the risk for CRC was associated with higher versus lower intake of total dietary fiber, calcium, and yogurt.

The researchers noted that, although not completely convincing, there was highly suggestive evidence for another association: a link between diet and CRC incidence. A higher intake of total dairy products (e.g., milk, cheese, and yogurt) was associated with significant risk reduction, in comparison with lower intake. A moderate intake of alcohol (from one to three drinks but not more than four per day) was associated with an increase in incidence in comparison with no drinks or an occasional drink.

Evidence suggested a reduced risk in association with several lifestyle behaviors, including adherence to a Mediterranean diet, a healthy diet, a pesco-vegetarian or semivegetarian diet, and the intake of whole grains, nonfermented milk, and supplemental calcium.

The evidence suggested that adherence to a Western diet and intake of processed meat were associated with an increased risk for CRC.

There was weak or no evidence for the remaining associations.
 

Existing cancer prevention guidelines

The findings support the existing cancer prevention dietary guidance and recommendations from the American Institute for Cancer Research, commented the institute’s director of nutrition programs, Sheena Swanner Patel, MS, RDN. The study confirms that dietary factors play a strong role in lowering CRC risk.

“AICR’s report found strong evidence for whole grains, foods containing dietary fiber, dairy products, and calcium supplements decreasing risk for colorectal cancer,” she said. “Specifically, eating 90 g or three servings of whole grains per day is associated with a 17% decrease in colorectal cancer risk.”

Ms. Patel added that the AICR’s report also suggested there was strong evidence that eating large amounts of red and processed meat, drinking alcohol excessively, and carrying extra body weight increased the risk for CRC.

Many previous studies have suggested a link between diet and CRC risk. One recent study suggested that, among all cancers, CRC has the highest proportion of diet-related cases (38.3%). The next highest were cancers of the mouth, pharynx, and larynx, for which almost 26% of cases were linked to diet, followed by endometrial cancer, postmenopausal breast cancer, and cancers of the kidney, stomach, liver, pancreas, and esophagus.

Neither Dr. Chaiyakunapruk and coauthors nor Ms. Patel disclosed any relevant financial relationships.

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

It’s now confirmed: What you eat does affect your risk of developing colorectal cancer (CRC).

An umbrella review of studies and meta-analyses found “convincing evidence of an association between a lower CRC risk and higher intakes of dietary fiber, dietary calcium, and yogurt and lower intakes of alcohol and red meat.”

However, more research is needed to address the link between CRC and other foods, including dairy products, whole grains, processed meat, and specific dietary patterns, the authors conclude.

“We can say that the existing recommendations for diet in the primary prevention of colorectal cancer is confirmed,” said lead author Nathorn Chaiyakunapruk, PharmD, PhD, professor of pharmacology at the University of Utah, Salt Lake City.

“It makes sense to encourage healthy diet, including those rich in fruits, vegetables, grains, and low-fat dairy, and reducing red meat and alcohol intake,” he said in an interview. “However, some of them may not yet have convincing evidence to fully support the claim.”

Other lifestyle factors, including excess weight and physical inactivity, also play a role in cancer risk. Dr. Chaiyakunapruk pointed out that their review was focused only on diet and that they had set out to confirm factors for which there was strong and convincing evidence.

The review was published online in JAMA Network Open.

The umbrella review of 45 meta-analyses found 109 associations. Overall, 35 of these 109 associations (32.1%) were nominally statistically significant, as determined on the basis of random-effects meta-analysis models, the researchers explained.

Convincing evidence was found for an increase in the risk for CRC with higher versus lower red meat consumption and with heavy alcohol intake (defined as more than four drinks per day, compared with no drinks per day or occasional drinks).

In addition, convincing evidence was found for three inverse associations: a decrease in the risk for CRC was associated with higher versus lower intake of total dietary fiber, calcium, and yogurt.

The researchers noted that, although not completely convincing, there was highly suggestive evidence for another association: a link between diet and CRC incidence. A higher intake of total dairy products (e.g., milk, cheese, and yogurt) was associated with significant risk reduction, in comparison with lower intake. A moderate intake of alcohol (from one to three drinks but not more than four per day) was associated with an increase in incidence in comparison with no drinks or an occasional drink.

Evidence suggested a reduced risk in association with several lifestyle behaviors, including adherence to a Mediterranean diet, a healthy diet, a pesco-vegetarian or semivegetarian diet, and the intake of whole grains, nonfermented milk, and supplemental calcium.

The evidence suggested that adherence to a Western diet and intake of processed meat were associated with an increased risk for CRC.

There was weak or no evidence for the remaining associations.
 

Existing cancer prevention guidelines

The findings support the existing cancer prevention dietary guidance and recommendations from the American Institute for Cancer Research, commented the institute’s director of nutrition programs, Sheena Swanner Patel, MS, RDN. The study confirms that dietary factors play a strong role in lowering CRC risk.

“AICR’s report found strong evidence for whole grains, foods containing dietary fiber, dairy products, and calcium supplements decreasing risk for colorectal cancer,” she said. “Specifically, eating 90 g or three servings of whole grains per day is associated with a 17% decrease in colorectal cancer risk.”

Ms. Patel added that the AICR’s report also suggested there was strong evidence that eating large amounts of red and processed meat, drinking alcohol excessively, and carrying extra body weight increased the risk for CRC.

Many previous studies have suggested a link between diet and CRC risk. One recent study suggested that, among all cancers, CRC has the highest proportion of diet-related cases (38.3%). The next highest were cancers of the mouth, pharynx, and larynx, for which almost 26% of cases were linked to diet, followed by endometrial cancer, postmenopausal breast cancer, and cancers of the kidney, stomach, liver, pancreas, and esophagus.

Neither Dr. Chaiyakunapruk and coauthors nor Ms. Patel disclosed any relevant financial relationships.

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

It’s now confirmed: What you eat does affect your risk of developing colorectal cancer (CRC).

An umbrella review of studies and meta-analyses found “convincing evidence of an association between a lower CRC risk and higher intakes of dietary fiber, dietary calcium, and yogurt and lower intakes of alcohol and red meat.”

However, more research is needed to address the link between CRC and other foods, including dairy products, whole grains, processed meat, and specific dietary patterns, the authors conclude.

“We can say that the existing recommendations for diet in the primary prevention of colorectal cancer is confirmed,” said lead author Nathorn Chaiyakunapruk, PharmD, PhD, professor of pharmacology at the University of Utah, Salt Lake City.

“It makes sense to encourage healthy diet, including those rich in fruits, vegetables, grains, and low-fat dairy, and reducing red meat and alcohol intake,” he said in an interview. “However, some of them may not yet have convincing evidence to fully support the claim.”

Other lifestyle factors, including excess weight and physical inactivity, also play a role in cancer risk. Dr. Chaiyakunapruk pointed out that their review was focused only on diet and that they had set out to confirm factors for which there was strong and convincing evidence.

The review was published online in JAMA Network Open.

The umbrella review of 45 meta-analyses found 109 associations. Overall, 35 of these 109 associations (32.1%) were nominally statistically significant, as determined on the basis of random-effects meta-analysis models, the researchers explained.

Convincing evidence was found for an increase in the risk for CRC with higher versus lower red meat consumption and with heavy alcohol intake (defined as more than four drinks per day, compared with no drinks per day or occasional drinks).

In addition, convincing evidence was found for three inverse associations: a decrease in the risk for CRC was associated with higher versus lower intake of total dietary fiber, calcium, and yogurt.

The researchers noted that, although not completely convincing, there was highly suggestive evidence for another association: a link between diet and CRC incidence. A higher intake of total dairy products (e.g., milk, cheese, and yogurt) was associated with significant risk reduction, in comparison with lower intake. A moderate intake of alcohol (from one to three drinks but not more than four per day) was associated with an increase in incidence in comparison with no drinks or an occasional drink.

Evidence suggested a reduced risk in association with several lifestyle behaviors, including adherence to a Mediterranean diet, a healthy diet, a pesco-vegetarian or semivegetarian diet, and the intake of whole grains, nonfermented milk, and supplemental calcium.

The evidence suggested that adherence to a Western diet and intake of processed meat were associated with an increased risk for CRC.

There was weak or no evidence for the remaining associations.
 

Existing cancer prevention guidelines

The findings support the existing cancer prevention dietary guidance and recommendations from the American Institute for Cancer Research, commented the institute’s director of nutrition programs, Sheena Swanner Patel, MS, RDN. The study confirms that dietary factors play a strong role in lowering CRC risk.

“AICR’s report found strong evidence for whole grains, foods containing dietary fiber, dairy products, and calcium supplements decreasing risk for colorectal cancer,” she said. “Specifically, eating 90 g or three servings of whole grains per day is associated with a 17% decrease in colorectal cancer risk.”

Ms. Patel added that the AICR’s report also suggested there was strong evidence that eating large amounts of red and processed meat, drinking alcohol excessively, and carrying extra body weight increased the risk for CRC.

Many previous studies have suggested a link between diet and CRC risk. One recent study suggested that, among all cancers, CRC has the highest proportion of diet-related cases (38.3%). The next highest were cancers of the mouth, pharynx, and larynx, for which almost 26% of cases were linked to diet, followed by endometrial cancer, postmenopausal breast cancer, and cancers of the kidney, stomach, liver, pancreas, and esophagus.

Neither Dr. Chaiyakunapruk and coauthors nor Ms. Patel disclosed any relevant financial relationships.

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

A new technique in which near-infrared hyperspectral imaging (NIR-HSI) is combined with machine learning could be useful for detecting cancers deep within tissue, suggests a research team from Japan.

An example of such a cancer is gastrointestinal stromal tumor (GIST). These tumors are often located in the submucosal layer and are covered by mucosal tissue, making diagnosis by conventional endoscopy difficult.

In a study to assess the new technique, the researchers examined 12 GIST lesions that were surgically resected. Seven of these lesions were totally covered by a mucosal layer (thickness, 0.4-2.5 mm); three lesions were partially covered.

Using NIR-HSI with machine learning, the researchers found that GIST lesions appeared green and that normal tissue appeared yellow. Calculation of classified pixels showed that the technique detected the GISTs with a specificity of 73%, a sensitivity of 91.3%, and an accuracy of 86.1%.

The findings were published in Nature’s Scientific Reports.

“There are many situations where we need to be able to detect cancers deep in the tissue that are not visible during surgery or diagnosis,” said lead author Toshihiro Takamatsu, PhD, assistant professor, Tokyo University of Science. “Near-infrared hyperspectral imaging has a strong potential to detect deep lesions,” he said.

In this study, the imaging was performed ex vivo.

“The data presented in the paper were not obtained endoscopically but utilized surgical specimens to demonstrate proof of concept. Additional data would be required to demonstrate its feasibility with endoscopy,” noted Margaret von Mehren, MD, chief, division of sarcoma medical oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

Dr. Takamatsu said his team is currently developing prototypes of laparoscopes and endoscopes for NIR-HSI.

“This technology is being developed to be added onto endoscopy, and as such I think may well be feasible,” Dr. von Mehren commented.
 

Currently diagnosed by endoscopy and biopsy

GISTs are found predominantly in the stomach (60%) and the small intestine (30%). Although some are detected after the occurrence of symptoms such as pain, gastrointestinal bleeding, and bowel obstruction, most cases are asymptomatic.

The authors note that endoscopic examination is the primary tool for detecting GISTs. Lesions usually first appear as submucosal tumors. Direct observation cannot differentially diagnose these tumors, and biopsies may have a low diagnostic yield, because the lesions are often deep and not easily accessible.

Endoscopic ultrasound-guided fine-needle aspiration can be used for taking samples for biopsy, but it can be technically demanding, and making a definitive diagnosis of GIST requires time-consuming immunohistochemical procedures, the authors write. A high-throughput, simple diagnostic technique for identifying GISTs located under the mucosa is needed. They report on the potential of NIR-HSI for diagnosing submucosal tumors that present deep within organs.
 

Study details

For the study, the team worked on GIST lesions that had been surgically resected from 12 patients. The median size of the tumors was 41 mm (range, 24-80 mm).

The researchers imaged each specimen with an NIR hyperspectral camera from the aspect of the mucosal surface.

The site of the GIST was defined by a pathologist who used the NIR image to prepare training data for normal regions and regions with GISTs. A machine learning algorithm–support vector machine was then used to predict normal and GIST regions.

The results were displayed using color-coded regions. The team says the results from this small study show that the technique has “great potential” in the diagnosis of GISTs as well as other tumors that are located deep within tissue.

“I think the potential benefit of such a diagnostic tool is with small lesions when trying to differentiate benign findings, such as leiomyomas,” Dr. von Mehren commented.

She pointed out that this study comes from Japan, where endoscopy is routinely used for surveillance of gastric cancer. Thus, many cases of GIST may be diagnosed before symptoms occur and when lesions are small. Such a practice is less common in other parts of the world, she told this news organization.

Overall, she sees this technique as having the most utility in cases involving small lesions, inasmuch as larger lesions are easily assessed through biopsy with endoscopic ultrasound, and pathologic assessment is not a lengthy procedure. “In addition, as we now appreciate that GISTs with different molecular drivers require different therapeutic approaches, I continue to see a role for tissue biopsies in the diagnostic workup of GISTs,” she said.

“Current approaches using endoscopic ultrasound have defined criteria for lesions more likely to be GISTs rather than benign lesions,” she added. “I would want to see a comparison of near-infrared hyperspectral imaging data compared to endoscopic ultrasound to see if this provides additional benefit to our current approaches.”

The study was partially funded by the National Cancer Center Research and Development Fund. The authors and Dr. von Mehren have disclosed no relevant financial relationships.

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

A new technique in which near-infrared hyperspectral imaging (NIR-HSI) is combined with machine learning could be useful for detecting cancers deep within tissue, suggests a research team from Japan.

An example of such a cancer is gastrointestinal stromal tumor (GIST). These tumors are often located in the submucosal layer and are covered by mucosal tissue, making diagnosis by conventional endoscopy difficult.

In a study to assess the new technique, the researchers examined 12 GIST lesions that were surgically resected. Seven of these lesions were totally covered by a mucosal layer (thickness, 0.4-2.5 mm); three lesions were partially covered.

Using NIR-HSI with machine learning, the researchers found that GIST lesions appeared green and that normal tissue appeared yellow. Calculation of classified pixels showed that the technique detected the GISTs with a specificity of 73%, a sensitivity of 91.3%, and an accuracy of 86.1%.

The findings were published in Nature’s Scientific Reports.

“There are many situations where we need to be able to detect cancers deep in the tissue that are not visible during surgery or diagnosis,” said lead author Toshihiro Takamatsu, PhD, assistant professor, Tokyo University of Science. “Near-infrared hyperspectral imaging has a strong potential to detect deep lesions,” he said.

In this study, the imaging was performed ex vivo.

“The data presented in the paper were not obtained endoscopically but utilized surgical specimens to demonstrate proof of concept. Additional data would be required to demonstrate its feasibility with endoscopy,” noted Margaret von Mehren, MD, chief, division of sarcoma medical oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

Dr. Takamatsu said his team is currently developing prototypes of laparoscopes and endoscopes for NIR-HSI.

“This technology is being developed to be added onto endoscopy, and as such I think may well be feasible,” Dr. von Mehren commented.
 

Currently diagnosed by endoscopy and biopsy

GISTs are found predominantly in the stomach (60%) and the small intestine (30%). Although some are detected after the occurrence of symptoms such as pain, gastrointestinal bleeding, and bowel obstruction, most cases are asymptomatic.

The authors note that endoscopic examination is the primary tool for detecting GISTs. Lesions usually first appear as submucosal tumors. Direct observation cannot differentially diagnose these tumors, and biopsies may have a low diagnostic yield, because the lesions are often deep and not easily accessible.

Endoscopic ultrasound-guided fine-needle aspiration can be used for taking samples for biopsy, but it can be technically demanding, and making a definitive diagnosis of GIST requires time-consuming immunohistochemical procedures, the authors write. A high-throughput, simple diagnostic technique for identifying GISTs located under the mucosa is needed. They report on the potential of NIR-HSI for diagnosing submucosal tumors that present deep within organs.
 

Study details

For the study, the team worked on GIST lesions that had been surgically resected from 12 patients. The median size of the tumors was 41 mm (range, 24-80 mm).

The researchers imaged each specimen with an NIR hyperspectral camera from the aspect of the mucosal surface.

The site of the GIST was defined by a pathologist who used the NIR image to prepare training data for normal regions and regions with GISTs. A machine learning algorithm–support vector machine was then used to predict normal and GIST regions.

The results were displayed using color-coded regions. The team says the results from this small study show that the technique has “great potential” in the diagnosis of GISTs as well as other tumors that are located deep within tissue.

“I think the potential benefit of such a diagnostic tool is with small lesions when trying to differentiate benign findings, such as leiomyomas,” Dr. von Mehren commented.

She pointed out that this study comes from Japan, where endoscopy is routinely used for surveillance of gastric cancer. Thus, many cases of GIST may be diagnosed before symptoms occur and when lesions are small. Such a practice is less common in other parts of the world, she told this news organization.

Overall, she sees this technique as having the most utility in cases involving small lesions, inasmuch as larger lesions are easily assessed through biopsy with endoscopic ultrasound, and pathologic assessment is not a lengthy procedure. “In addition, as we now appreciate that GISTs with different molecular drivers require different therapeutic approaches, I continue to see a role for tissue biopsies in the diagnostic workup of GISTs,” she said.

“Current approaches using endoscopic ultrasound have defined criteria for lesions more likely to be GISTs rather than benign lesions,” she added. “I would want to see a comparison of near-infrared hyperspectral imaging data compared to endoscopic ultrasound to see if this provides additional benefit to our current approaches.”

The study was partially funded by the National Cancer Center Research and Development Fund. The authors and Dr. von Mehren have disclosed no relevant financial relationships.

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

A new technique in which near-infrared hyperspectral imaging (NIR-HSI) is combined with machine learning could be useful for detecting cancers deep within tissue, suggests a research team from Japan.

An example of such a cancer is gastrointestinal stromal tumor (GIST). These tumors are often located in the submucosal layer and are covered by mucosal tissue, making diagnosis by conventional endoscopy difficult.

In a study to assess the new technique, the researchers examined 12 GIST lesions that were surgically resected. Seven of these lesions were totally covered by a mucosal layer (thickness, 0.4-2.5 mm); three lesions were partially covered.

Using NIR-HSI with machine learning, the researchers found that GIST lesions appeared green and that normal tissue appeared yellow. Calculation of classified pixels showed that the technique detected the GISTs with a specificity of 73%, a sensitivity of 91.3%, and an accuracy of 86.1%.

The findings were published in Nature’s Scientific Reports.

“There are many situations where we need to be able to detect cancers deep in the tissue that are not visible during surgery or diagnosis,” said lead author Toshihiro Takamatsu, PhD, assistant professor, Tokyo University of Science. “Near-infrared hyperspectral imaging has a strong potential to detect deep lesions,” he said.

In this study, the imaging was performed ex vivo.

“The data presented in the paper were not obtained endoscopically but utilized surgical specimens to demonstrate proof of concept. Additional data would be required to demonstrate its feasibility with endoscopy,” noted Margaret von Mehren, MD, chief, division of sarcoma medical oncology, Fox Chase Cancer Center, Philadelphia, who was approached for comment.

Dr. Takamatsu said his team is currently developing prototypes of laparoscopes and endoscopes for NIR-HSI.

“This technology is being developed to be added onto endoscopy, and as such I think may well be feasible,” Dr. von Mehren commented.
 

Currently diagnosed by endoscopy and biopsy

GISTs are found predominantly in the stomach (60%) and the small intestine (30%). Although some are detected after the occurrence of symptoms such as pain, gastrointestinal bleeding, and bowel obstruction, most cases are asymptomatic.

The authors note that endoscopic examination is the primary tool for detecting GISTs. Lesions usually first appear as submucosal tumors. Direct observation cannot differentially diagnose these tumors, and biopsies may have a low diagnostic yield, because the lesions are often deep and not easily accessible.

Endoscopic ultrasound-guided fine-needle aspiration can be used for taking samples for biopsy, but it can be technically demanding, and making a definitive diagnosis of GIST requires time-consuming immunohistochemical procedures, the authors write. A high-throughput, simple diagnostic technique for identifying GISTs located under the mucosa is needed. They report on the potential of NIR-HSI for diagnosing submucosal tumors that present deep within organs.
 

Study details

For the study, the team worked on GIST lesions that had been surgically resected from 12 patients. The median size of the tumors was 41 mm (range, 24-80 mm).

The researchers imaged each specimen with an NIR hyperspectral camera from the aspect of the mucosal surface.

The site of the GIST was defined by a pathologist who used the NIR image to prepare training data for normal regions and regions with GISTs. A machine learning algorithm–support vector machine was then used to predict normal and GIST regions.

The results were displayed using color-coded regions. The team says the results from this small study show that the technique has “great potential” in the diagnosis of GISTs as well as other tumors that are located deep within tissue.

“I think the potential benefit of such a diagnostic tool is with small lesions when trying to differentiate benign findings, such as leiomyomas,” Dr. von Mehren commented.

She pointed out that this study comes from Japan, where endoscopy is routinely used for surveillance of gastric cancer. Thus, many cases of GIST may be diagnosed before symptoms occur and when lesions are small. Such a practice is less common in other parts of the world, she told this news organization.

Overall, she sees this technique as having the most utility in cases involving small lesions, inasmuch as larger lesions are easily assessed through biopsy with endoscopic ultrasound, and pathologic assessment is not a lengthy procedure. “In addition, as we now appreciate that GISTs with different molecular drivers require different therapeutic approaches, I continue to see a role for tissue biopsies in the diagnostic workup of GISTs,” she said.

“Current approaches using endoscopic ultrasound have defined criteria for lesions more likely to be GISTs rather than benign lesions,” she added. “I would want to see a comparison of near-infrared hyperspectral imaging data compared to endoscopic ultrasound to see if this provides additional benefit to our current approaches.”

The study was partially funded by the National Cancer Center Research and Development Fund. The authors and Dr. von Mehren have disclosed no relevant financial relationships.

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

Patients with multiple myeloma that has continued to progress despite many lines of therapy have shown deep and durable responses to a new chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel, under development by Bristol-Myers Squibb and Bluebird Bio).

An expert not involved in the trial described the results as “phenomenal.”

Krina Patel, MD, an associate professor in the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center, Houston, said that “the response rate of 73% in a patient population with a median of six lines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal.”

“We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed/refractory patients,” Dr. Patel said.

The new data on ide-cell, from a trial in 128 patients, were published Feb. 25 in the New England Journal of Medicine.

Lead investigator of the study Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, said: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

Both experts highlighted the poor prognosis for this population of relapsed/refractory patients. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. Nevertheless, in some patients, the disease continues to progress. For patients who have failed all three classes of drugs, the median progression-free survival is about 3-4 months, with a median overall survival of 8-9 months.
 

Product is awaiting approval

Ide-cel is currently awaiting FDA approval, with a decision date slated for March 27.

Several CAR T-cell products are already marketed for use in certain leukemias and lymphomas, and there is another for use in multiple myeloma, ciltacabtagene autoleucel (cilta-cel, under development by Janssen), that is awaiting approval in Europe.
 

Strong and sustained responses

The trial involved 128 patients treated with ide-cel infusions. At the time of data cutoff for this report (Jan. 14, 2020), 62 patients remained in the primary study. Of the 128 treated patients, the median age was 61 years and the median time since diagnosis was 6 years. About half (51%) had a high tumor burden (≥50% bone marrow plasma cells), 39% had extramedullary disease, 16% had stage III disease, and 35% had a high-risk cytogenetic abnormality, defined as del(17p), t(4;14), or t(14;16).

Patients in the cohort had received a median of six previous antimyeloma regimens (range, 3-16), and most of the patients (120, 94%) had undergone autologous hematopoietic stem cell transplants. In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta refractory.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001), with 42 (33%) showing a complete or stringent complete response, and 67 patients (52%) showing a “very good partial response or better.”

Overall median progression-free survival was 8.8 months at the 450×106 dose but more than double that (20.2 months) for patients who achieved a complete or stringent complete response. Estimated median overall survival was 19.4 months, with an overall survival of 78% at 12 months. The authors noted that overall survival data are not yet mature.

After experiencing disease progression, 28 patients were retreated with ide-cel, with 6 patients showing a second response. The durations of response ranged from 1.9 to 6.8 months.

All patients in the cohort experienced adverse events, primarily grade 3 or 4 events that occurred in 127 patients (99%). The most common events reported were hematologic toxicities, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion, the authors note. Cytokine-release syndrome occurred in 107 patients (84%), primarily grade 1 or 2.

“Results of the KarMMa study support substantial antitumor activity for ide-cel across a target dose range of 150×106 to 450×106 CAR+ T cells,” the authors conclude. “The 450×106 dose appeared to be somewhat more effective than the other doses.”
 

New option?

“What this study further highlights is that higher cell dose tends to increase cell expansion, which correlates to improved response and duration of response,” said Dr. Patel.

Importantly, multiple vulnerable subgroups experienced impressive outcomes, such as those who are older or with high risk or extramedullary disease, she noted.

“My patients who have undergone this therapy, albeit on other clinical trials, all say that their quality of life during this time of remission is priceless,” Dr. Patel added. “The is the first therapy in the relapsed/refractory setting that allows patients to have a significant chemo-free period. We need to find more ways to do this for our patients.”

The study was supported by Bluebird Bio and Bristol-Myers Squibb. Dr. Patel has served on the advisory board for Janssen and Bristol-Myers Squibb. She also reports a speaking engagement with Oncopeptides. Dr. Munshi acts as a consultant for several pharmaceutical companies, and many coauthors also have relationships with industry, as listed in the original article.

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

Patients with multiple myeloma that has continued to progress despite many lines of therapy have shown deep and durable responses to a new chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel, under development by Bristol-Myers Squibb and Bluebird Bio).

An expert not involved in the trial described the results as “phenomenal.”

Krina Patel, MD, an associate professor in the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center, Houston, said that “the response rate of 73% in a patient population with a median of six lines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal.”

“We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed/refractory patients,” Dr. Patel said.

The new data on ide-cell, from a trial in 128 patients, were published Feb. 25 in the New England Journal of Medicine.

Lead investigator of the study Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, said: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

Both experts highlighted the poor prognosis for this population of relapsed/refractory patients. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. Nevertheless, in some patients, the disease continues to progress. For patients who have failed all three classes of drugs, the median progression-free survival is about 3-4 months, with a median overall survival of 8-9 months.
 

Product is awaiting approval

Ide-cel is currently awaiting FDA approval, with a decision date slated for March 27.

Several CAR T-cell products are already marketed for use in certain leukemias and lymphomas, and there is another for use in multiple myeloma, ciltacabtagene autoleucel (cilta-cel, under development by Janssen), that is awaiting approval in Europe.
 

Strong and sustained responses

The trial involved 128 patients treated with ide-cel infusions. At the time of data cutoff for this report (Jan. 14, 2020), 62 patients remained in the primary study. Of the 128 treated patients, the median age was 61 years and the median time since diagnosis was 6 years. About half (51%) had a high tumor burden (≥50% bone marrow plasma cells), 39% had extramedullary disease, 16% had stage III disease, and 35% had a high-risk cytogenetic abnormality, defined as del(17p), t(4;14), or t(14;16).

Patients in the cohort had received a median of six previous antimyeloma regimens (range, 3-16), and most of the patients (120, 94%) had undergone autologous hematopoietic stem cell transplants. In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta refractory.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001), with 42 (33%) showing a complete or stringent complete response, and 67 patients (52%) showing a “very good partial response or better.”

Overall median progression-free survival was 8.8 months at the 450×106 dose but more than double that (20.2 months) for patients who achieved a complete or stringent complete response. Estimated median overall survival was 19.4 months, with an overall survival of 78% at 12 months. The authors noted that overall survival data are not yet mature.

After experiencing disease progression, 28 patients were retreated with ide-cel, with 6 patients showing a second response. The durations of response ranged from 1.9 to 6.8 months.

All patients in the cohort experienced adverse events, primarily grade 3 or 4 events that occurred in 127 patients (99%). The most common events reported were hematologic toxicities, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion, the authors note. Cytokine-release syndrome occurred in 107 patients (84%), primarily grade 1 or 2.

“Results of the KarMMa study support substantial antitumor activity for ide-cel across a target dose range of 150×106 to 450×106 CAR+ T cells,” the authors conclude. “The 450×106 dose appeared to be somewhat more effective than the other doses.”
 

New option?

“What this study further highlights is that higher cell dose tends to increase cell expansion, which correlates to improved response and duration of response,” said Dr. Patel.

Importantly, multiple vulnerable subgroups experienced impressive outcomes, such as those who are older or with high risk or extramedullary disease, she noted.

“My patients who have undergone this therapy, albeit on other clinical trials, all say that their quality of life during this time of remission is priceless,” Dr. Patel added. “The is the first therapy in the relapsed/refractory setting that allows patients to have a significant chemo-free period. We need to find more ways to do this for our patients.”

The study was supported by Bluebird Bio and Bristol-Myers Squibb. Dr. Patel has served on the advisory board for Janssen and Bristol-Myers Squibb. She also reports a speaking engagement with Oncopeptides. Dr. Munshi acts as a consultant for several pharmaceutical companies, and many coauthors also have relationships with industry, as listed in the original article.

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

Patients with multiple myeloma that has continued to progress despite many lines of therapy have shown deep and durable responses to a new chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel, under development by Bristol-Myers Squibb and Bluebird Bio).

An expert not involved in the trial described the results as “phenomenal.”

Krina Patel, MD, an associate professor in the department of lymphoma/myeloma at the University of Texas MD Anderson Cancer Center, Houston, said that “the response rate of 73% in a patient population with a median of six lines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal.”

“We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed/refractory patients,” Dr. Patel said.

The new data on ide-cell, from a trial in 128 patients, were published Feb. 25 in the New England Journal of Medicine.

Lead investigator of the study Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, said: “The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients.”

Both experts highlighted the poor prognosis for this population of relapsed/refractory patients. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. Nevertheless, in some patients, the disease continues to progress. For patients who have failed all three classes of drugs, the median progression-free survival is about 3-4 months, with a median overall survival of 8-9 months.
 

Product is awaiting approval

Ide-cel is currently awaiting FDA approval, with a decision date slated for March 27.

Several CAR T-cell products are already marketed for use in certain leukemias and lymphomas, and there is another for use in multiple myeloma, ciltacabtagene autoleucel (cilta-cel, under development by Janssen), that is awaiting approval in Europe.
 

Strong and sustained responses

The trial involved 128 patients treated with ide-cel infusions. At the time of data cutoff for this report (Jan. 14, 2020), 62 patients remained in the primary study. Of the 128 treated patients, the median age was 61 years and the median time since diagnosis was 6 years. About half (51%) had a high tumor burden (≥50% bone marrow plasma cells), 39% had extramedullary disease, 16% had stage III disease, and 35% had a high-risk cytogenetic abnormality, defined as del(17p), t(4;14), or t(14;16).

Patients in the cohort had received a median of six previous antimyeloma regimens (range, 3-16), and most of the patients (120, 94%) had undergone autologous hematopoietic stem cell transplants. In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta refractory.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001), with 42 (33%) showing a complete or stringent complete response, and 67 patients (52%) showing a “very good partial response or better.”

Overall median progression-free survival was 8.8 months at the 450×106 dose but more than double that (20.2 months) for patients who achieved a complete or stringent complete response. Estimated median overall survival was 19.4 months, with an overall survival of 78% at 12 months. The authors noted that overall survival data are not yet mature.

After experiencing disease progression, 28 patients were retreated with ide-cel, with 6 patients showing a second response. The durations of response ranged from 1.9 to 6.8 months.

All patients in the cohort experienced adverse events, primarily grade 3 or 4 events that occurred in 127 patients (99%). The most common events reported were hematologic toxicities, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion, the authors note. Cytokine-release syndrome occurred in 107 patients (84%), primarily grade 1 or 2.

“Results of the KarMMa study support substantial antitumor activity for ide-cel across a target dose range of 150×106 to 450×106 CAR+ T cells,” the authors conclude. “The 450×106 dose appeared to be somewhat more effective than the other doses.”
 

New option?

“What this study further highlights is that higher cell dose tends to increase cell expansion, which correlates to improved response and duration of response,” said Dr. Patel.

Importantly, multiple vulnerable subgroups experienced impressive outcomes, such as those who are older or with high risk or extramedullary disease, she noted.

“My patients who have undergone this therapy, albeit on other clinical trials, all say that their quality of life during this time of remission is priceless,” Dr. Patel added. “The is the first therapy in the relapsed/refractory setting that allows patients to have a significant chemo-free period. We need to find more ways to do this for our patients.”

The study was supported by Bluebird Bio and Bristol-Myers Squibb. Dr. Patel has served on the advisory board for Janssen and Bristol-Myers Squibb. She also reports a speaking engagement with Oncopeptides. Dr. Munshi acts as a consultant for several pharmaceutical companies, and many coauthors also have relationships with industry, as listed in the original article.

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

Axillary adenopathy, or swelling under the armpit, has been reported by women after receiving the Pfizer-BioNTech and Moderna COVID-19 vaccines, but it is also a common symptom of breast cancer.

Clinicians should therefore consider recent COVID-19 vaccination history in the differential diagnosis of patients who present with unilateral axillary adenopathy, according to a new article.

“We noticed an increasing number of patients with swollen lymph nodes on just one side/one underarm who presented for routine screening mammography or ultrasound, and some women who actually felt these swollen nodes,” said author Katerina Dodelzon, MD, assistant professor of clinical radiology at Weill Cornell Medicine, New York.

“Historically, swollen lymph nodes on just one side are relatively rare and are an uncommon occurrence on screening mammography – seen only 0.02%-0.04% of the time – and is a sign that alerts a radiologist to exclude the presence of breast malignancy on that side,” she added.

In an article published in Clinical Imaging, Dr. Dodelzon and colleagues described four cases involving women who received a COVID-19 vaccine and then sought breast screening. In describing these cases, the authors sought “to inform the medical community to consider this benign and self-resolving diagnosis in the setting of what can be alarming presentation of unilateral axillary adenopathy.”

They hope they will decrease unnecessary biopsies and help reassure patients.

Adenopathy has been reported in association with other vaccines, such as the bacille Calmette-Guérin vaccine, influenza vaccines, and the human papillomavirus vaccine, commented Jessica W. T. Leung, MD, president of the Society of Breast Imaging.

“It’s too early to say if there is something different about the COVID-19 vaccines,” said Dr. Leung, who is also professor of diagnostic radiology and deputy chair of breast imaging at the University of Texas MD Anderson Cancer Center, Houston.

“The two vaccines that are currently in use – Pfizer and Moderna – are both mRNA vaccines, and it is unknown if those will give a stronger immune response,” she said. “If the Johnson & Johnson and AstraZeneca vaccines do become available, it will be interesting to see if they elicit as strong a response, since they are not mRNA vaccines. At this time, we have no data to say one way or the other.”

Dr. Leung also noted that these latest vaccine reactions may be getting more attention because “it is COVID-19 related, and everything related to COVID-19 gets more attention.

“It may also be more noticeable because of the large number of people getting vaccinated within a short period of time in an effort to contain the pandemic, and this is not the case with the other vaccines,” she said.
 

New recommendations from SBI

The SBI recently issued recommendations to clinicians that women who experience axillary adenopathy and who have recently been vaccinated on the same side on which the adenopathy occurs be followed for a few weeks to see whether the lymph nodes return to normal, rather than undergo biopsy.

“Many practices are now routinely inquiring about history of recent vaccination and on which side it was given,” Dr. Dodelzon said. She emphasized that women should feel empowered to share that history if they are not asked.

“Letting your mammography technologist or breast imager know that you have recently been vaccinated, and on which side, will provide the breast imager more accurate context within which to interpret the results,” she said.

In addition, the SBI recommends that, if feasible, women schedule routine screening mammography either before the first dose of the COVID-19 vaccine or 4-6 weeks after the second dose to avoid a false-positive finding.

“We want to emphasize that screening mammography is very important, and if possible, to schedule it around the vaccine,” commented Dr. Leung. “But that may not be possible, as most of us don’t have a choice when to get the vaccine.”

If it is not possible to reschedule either the mammogram or the vaccine, Dr. Leung recommends that women inform the facility that they have recently received a COVID-19 vaccine. “Currently, we recommend a follow-up in 4-12 weeks,” she said. “The swelling could subside sooner, perhaps even within 1-2 weeks, but we generally recommend waiting at least 4 weeks to capture the majority of women.”
 

Differences between the vaccines?

The frequency with which axillary adenopathy occurs as a side effect differs with the two COVID-19 vaccines, according to reports from the Centers for Disease Control and Prevention.

For the Moderna vaccine, axillary adenopathy ipsilateral to the vaccination arm was the second most frequently reported local reaction, with 11.6% of recipients aged 18-64 years reporting it after the first dose, and 16.0% reporting it after the second. The average duration of this adenopathy was 1-2 days.

For the Pfizer-BioNTech COVID-19 vaccine, the CDC notes that reports of adenopathy were imbalanced between the vaccine and placebo groups and concluded that adenopathy was plausibly related to the vaccine.

The average duration of adenopathy was approximately 10 days.

Adenopathy was reported within 2-4 days after vaccination for both vaccine groups, the CDC noted.

However, details from the cases reported by Dr. Dodelzon and colleagues paint a somewhat different picture. For example, in case 1, the patient self-detected unilateral axillary adenopathy 9 days after receiving the first dose of the Pfizer-BioNTech vaccine. In case 3, the time between receiving the Moderna vaccine and detection of adenopathy was 13 days.

In both of these cases, the time was much longer than the average duration of 1-2 days noted by the CDC. The authors suggest that in taking the patient’s vaccination history, radiologists understand that the side effect may occur up to several weeks following the COVID-19 vaccination.

In cases 2 and 4, the axillary adenopathy was incidentally noted during mammography, so it is unclear when the onset of this reaction occurred after receiving the COVID-19 vaccine.

The authors and Dr. Leung have disclosed no relevant financial relationships.

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

Axillary adenopathy, or swelling under the armpit, has been reported by women after receiving the Pfizer-BioNTech and Moderna COVID-19 vaccines, but it is also a common symptom of breast cancer.

Clinicians should therefore consider recent COVID-19 vaccination history in the differential diagnosis of patients who present with unilateral axillary adenopathy, according to a new article.

“We noticed an increasing number of patients with swollen lymph nodes on just one side/one underarm who presented for routine screening mammography or ultrasound, and some women who actually felt these swollen nodes,” said author Katerina Dodelzon, MD, assistant professor of clinical radiology at Weill Cornell Medicine, New York.

“Historically, swollen lymph nodes on just one side are relatively rare and are an uncommon occurrence on screening mammography – seen only 0.02%-0.04% of the time – and is a sign that alerts a radiologist to exclude the presence of breast malignancy on that side,” she added.

In an article published in Clinical Imaging, Dr. Dodelzon and colleagues described four cases involving women who received a COVID-19 vaccine and then sought breast screening. In describing these cases, the authors sought “to inform the medical community to consider this benign and self-resolving diagnosis in the setting of what can be alarming presentation of unilateral axillary adenopathy.”

They hope they will decrease unnecessary biopsies and help reassure patients.

Adenopathy has been reported in association with other vaccines, such as the bacille Calmette-Guérin vaccine, influenza vaccines, and the human papillomavirus vaccine, commented Jessica W. T. Leung, MD, president of the Society of Breast Imaging.

“It’s too early to say if there is something different about the COVID-19 vaccines,” said Dr. Leung, who is also professor of diagnostic radiology and deputy chair of breast imaging at the University of Texas MD Anderson Cancer Center, Houston.

“The two vaccines that are currently in use – Pfizer and Moderna – are both mRNA vaccines, and it is unknown if those will give a stronger immune response,” she said. “If the Johnson & Johnson and AstraZeneca vaccines do become available, it will be interesting to see if they elicit as strong a response, since they are not mRNA vaccines. At this time, we have no data to say one way or the other.”

Dr. Leung also noted that these latest vaccine reactions may be getting more attention because “it is COVID-19 related, and everything related to COVID-19 gets more attention.

“It may also be more noticeable because of the large number of people getting vaccinated within a short period of time in an effort to contain the pandemic, and this is not the case with the other vaccines,” she said.
 

New recommendations from SBI

The SBI recently issued recommendations to clinicians that women who experience axillary adenopathy and who have recently been vaccinated on the same side on which the adenopathy occurs be followed for a few weeks to see whether the lymph nodes return to normal, rather than undergo biopsy.

“Many practices are now routinely inquiring about history of recent vaccination and on which side it was given,” Dr. Dodelzon said. She emphasized that women should feel empowered to share that history if they are not asked.

“Letting your mammography technologist or breast imager know that you have recently been vaccinated, and on which side, will provide the breast imager more accurate context within which to interpret the results,” she said.

In addition, the SBI recommends that, if feasible, women schedule routine screening mammography either before the first dose of the COVID-19 vaccine or 4-6 weeks after the second dose to avoid a false-positive finding.

“We want to emphasize that screening mammography is very important, and if possible, to schedule it around the vaccine,” commented Dr. Leung. “But that may not be possible, as most of us don’t have a choice when to get the vaccine.”

If it is not possible to reschedule either the mammogram or the vaccine, Dr. Leung recommends that women inform the facility that they have recently received a COVID-19 vaccine. “Currently, we recommend a follow-up in 4-12 weeks,” she said. “The swelling could subside sooner, perhaps even within 1-2 weeks, but we generally recommend waiting at least 4 weeks to capture the majority of women.”
 

Differences between the vaccines?

The frequency with which axillary adenopathy occurs as a side effect differs with the two COVID-19 vaccines, according to reports from the Centers for Disease Control and Prevention.

For the Moderna vaccine, axillary adenopathy ipsilateral to the vaccination arm was the second most frequently reported local reaction, with 11.6% of recipients aged 18-64 years reporting it after the first dose, and 16.0% reporting it after the second. The average duration of this adenopathy was 1-2 days.

For the Pfizer-BioNTech COVID-19 vaccine, the CDC notes that reports of adenopathy were imbalanced between the vaccine and placebo groups and concluded that adenopathy was plausibly related to the vaccine.

The average duration of adenopathy was approximately 10 days.

Adenopathy was reported within 2-4 days after vaccination for both vaccine groups, the CDC noted.

However, details from the cases reported by Dr. Dodelzon and colleagues paint a somewhat different picture. For example, in case 1, the patient self-detected unilateral axillary adenopathy 9 days after receiving the first dose of the Pfizer-BioNTech vaccine. In case 3, the time between receiving the Moderna vaccine and detection of adenopathy was 13 days.

In both of these cases, the time was much longer than the average duration of 1-2 days noted by the CDC. The authors suggest that in taking the patient’s vaccination history, radiologists understand that the side effect may occur up to several weeks following the COVID-19 vaccination.

In cases 2 and 4, the axillary adenopathy was incidentally noted during mammography, so it is unclear when the onset of this reaction occurred after receiving the COVID-19 vaccine.

The authors and Dr. Leung have disclosed no relevant financial relationships.

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

Axillary adenopathy, or swelling under the armpit, has been reported by women after receiving the Pfizer-BioNTech and Moderna COVID-19 vaccines, but it is also a common symptom of breast cancer.

Clinicians should therefore consider recent COVID-19 vaccination history in the differential diagnosis of patients who present with unilateral axillary adenopathy, according to a new article.

“We noticed an increasing number of patients with swollen lymph nodes on just one side/one underarm who presented for routine screening mammography or ultrasound, and some women who actually felt these swollen nodes,” said author Katerina Dodelzon, MD, assistant professor of clinical radiology at Weill Cornell Medicine, New York.

“Historically, swollen lymph nodes on just one side are relatively rare and are an uncommon occurrence on screening mammography – seen only 0.02%-0.04% of the time – and is a sign that alerts a radiologist to exclude the presence of breast malignancy on that side,” she added.

In an article published in Clinical Imaging, Dr. Dodelzon and colleagues described four cases involving women who received a COVID-19 vaccine and then sought breast screening. In describing these cases, the authors sought “to inform the medical community to consider this benign and self-resolving diagnosis in the setting of what can be alarming presentation of unilateral axillary adenopathy.”

They hope they will decrease unnecessary biopsies and help reassure patients.

Adenopathy has been reported in association with other vaccines, such as the bacille Calmette-Guérin vaccine, influenza vaccines, and the human papillomavirus vaccine, commented Jessica W. T. Leung, MD, president of the Society of Breast Imaging.

“It’s too early to say if there is something different about the COVID-19 vaccines,” said Dr. Leung, who is also professor of diagnostic radiology and deputy chair of breast imaging at the University of Texas MD Anderson Cancer Center, Houston.

“The two vaccines that are currently in use – Pfizer and Moderna – are both mRNA vaccines, and it is unknown if those will give a stronger immune response,” she said. “If the Johnson & Johnson and AstraZeneca vaccines do become available, it will be interesting to see if they elicit as strong a response, since they are not mRNA vaccines. At this time, we have no data to say one way or the other.”

Dr. Leung also noted that these latest vaccine reactions may be getting more attention because “it is COVID-19 related, and everything related to COVID-19 gets more attention.

“It may also be more noticeable because of the large number of people getting vaccinated within a short period of time in an effort to contain the pandemic, and this is not the case with the other vaccines,” she said.
 

New recommendations from SBI

The SBI recently issued recommendations to clinicians that women who experience axillary adenopathy and who have recently been vaccinated on the same side on which the adenopathy occurs be followed for a few weeks to see whether the lymph nodes return to normal, rather than undergo biopsy.

“Many practices are now routinely inquiring about history of recent vaccination and on which side it was given,” Dr. Dodelzon said. She emphasized that women should feel empowered to share that history if they are not asked.

“Letting your mammography technologist or breast imager know that you have recently been vaccinated, and on which side, will provide the breast imager more accurate context within which to interpret the results,” she said.

In addition, the SBI recommends that, if feasible, women schedule routine screening mammography either before the first dose of the COVID-19 vaccine or 4-6 weeks after the second dose to avoid a false-positive finding.

“We want to emphasize that screening mammography is very important, and if possible, to schedule it around the vaccine,” commented Dr. Leung. “But that may not be possible, as most of us don’t have a choice when to get the vaccine.”

If it is not possible to reschedule either the mammogram or the vaccine, Dr. Leung recommends that women inform the facility that they have recently received a COVID-19 vaccine. “Currently, we recommend a follow-up in 4-12 weeks,” she said. “The swelling could subside sooner, perhaps even within 1-2 weeks, but we generally recommend waiting at least 4 weeks to capture the majority of women.”
 

Differences between the vaccines?

The frequency with which axillary adenopathy occurs as a side effect differs with the two COVID-19 vaccines, according to reports from the Centers for Disease Control and Prevention.

For the Moderna vaccine, axillary adenopathy ipsilateral to the vaccination arm was the second most frequently reported local reaction, with 11.6% of recipients aged 18-64 years reporting it after the first dose, and 16.0% reporting it after the second. The average duration of this adenopathy was 1-2 days.

For the Pfizer-BioNTech COVID-19 vaccine, the CDC notes that reports of adenopathy were imbalanced between the vaccine and placebo groups and concluded that adenopathy was plausibly related to the vaccine.

The average duration of adenopathy was approximately 10 days.

Adenopathy was reported within 2-4 days after vaccination for both vaccine groups, the CDC noted.

However, details from the cases reported by Dr. Dodelzon and colleagues paint a somewhat different picture. For example, in case 1, the patient self-detected unilateral axillary adenopathy 9 days after receiving the first dose of the Pfizer-BioNTech vaccine. In case 3, the time between receiving the Moderna vaccine and detection of adenopathy was 13 days.

In both of these cases, the time was much longer than the average duration of 1-2 days noted by the CDC. The authors suggest that in taking the patient’s vaccination history, radiologists understand that the side effect may occur up to several weeks following the COVID-19 vaccination.

In cases 2 and 4, the axillary adenopathy was incidentally noted during mammography, so it is unclear when the onset of this reaction occurred after receiving the COVID-19 vaccine.

The authors and Dr. Leung have disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved cemiplimab-rwlc (Libtayo) for the treatment of advanced non–small cell lung cancer (NSCLC).

Specifically, the indication is for first-line treatment as monotherapy for patients with locally advanced or metastatic disease who are not candidates for surgical resection or definitive chemoradiotherapy and whose tumors have a high expression of programmed death–ligand 1 (PD-L1) (Tumor Proportion Score >50%), as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations.

This is the third indication for cemiplimab-rlwc, a monoclonal antibody and PD-1 inhibitor.

In February, it was approved as the first immunotherapy to treat patients with locally advanced or metastatic basal cell carcinoma that was previously treated with a hedgehog pathway inhibitor or for whom a hedgehog inhibitor is inappropriate.

Cemiplimab-rlwc previously received FDA approval in 2018 for locally advanced or metastatic cutaneous squamous cell carcinoma for patients who were not eligible for curative surgery or radiotherapy. At the time, Karl Lewis, MD, a professor at the University of Colorado at Denver, Aurora, and a trial investigator, predicted that the drug “will change the treatment paradigm for patients with advanced basal cell carcinoma.”
 

Outperforms chemotherapy

The approval for use in NSCLC is based on results from the phase 3, open-label EMPOWER-Lung 1 trial, which randomly assigned 710 patients in a 1:1 ratio to receive either cemiplimab-rwlc or platinum-doublet chemotherapy. Patients had either locally advanced NSCLC and were not candidates for surgical resection or definitive chemoradiotherapy, or they had metastatic NSCLC.

Patients in the experimental arm received cemiplimab-rwlc 350 mg intravenously every 3 weeks. The primary efficacy outcome measures were overall survival (OS) and progression-free survival (PFS), determined on the basis of blinded independent central review.

Results showed statistically significant improvements in both outcomes. Median OS was 22.1 months with cemiplimab-rwlc versus 14.3 months with chemotherapy (hazard ratio, 0.68; P = .0022). Median PFS was 6.2 months versus 5.6 months (HR, 0.59; P < .0001).

The confirmed overall response rate was 37% for the cemiplimab arm versus 21% for the chemotherapy arm.

The most common adverse reactions (>10%) with cemiplimab-rlwc were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.

This approval “means physicians and patients have a potent new treatment option against this deadly disease,” said Naiyer Rizvi, MD, Price Family Professor of Medicine, director of thoracic oncology, and codirector of cancer immunotherapy at Columbia University Irving Medical Center, New York, in a statement. He was a steering committee member on the EMPOWER-Lung-1 Trial.

“Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases or who had locally advanced disease and were not candidates for definitive chemoradiation,” said Dr. Rizvi. “This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”

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

The Food and Drug Administration has approved cemiplimab-rwlc (Libtayo) for the treatment of advanced non–small cell lung cancer (NSCLC).

Specifically, the indication is for first-line treatment as monotherapy for patients with locally advanced or metastatic disease who are not candidates for surgical resection or definitive chemoradiotherapy and whose tumors have a high expression of programmed death–ligand 1 (PD-L1) (Tumor Proportion Score >50%), as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations.

This is the third indication for cemiplimab-rlwc, a monoclonal antibody and PD-1 inhibitor.

In February, it was approved as the first immunotherapy to treat patients with locally advanced or metastatic basal cell carcinoma that was previously treated with a hedgehog pathway inhibitor or for whom a hedgehog inhibitor is inappropriate.

Cemiplimab-rlwc previously received FDA approval in 2018 for locally advanced or metastatic cutaneous squamous cell carcinoma for patients who were not eligible for curative surgery or radiotherapy. At the time, Karl Lewis, MD, a professor at the University of Colorado at Denver, Aurora, and a trial investigator, predicted that the drug “will change the treatment paradigm for patients with advanced basal cell carcinoma.”
 

Outperforms chemotherapy

The approval for use in NSCLC is based on results from the phase 3, open-label EMPOWER-Lung 1 trial, which randomly assigned 710 patients in a 1:1 ratio to receive either cemiplimab-rwlc or platinum-doublet chemotherapy. Patients had either locally advanced NSCLC and were not candidates for surgical resection or definitive chemoradiotherapy, or they had metastatic NSCLC.

Patients in the experimental arm received cemiplimab-rwlc 350 mg intravenously every 3 weeks. The primary efficacy outcome measures were overall survival (OS) and progression-free survival (PFS), determined on the basis of blinded independent central review.

Results showed statistically significant improvements in both outcomes. Median OS was 22.1 months with cemiplimab-rwlc versus 14.3 months with chemotherapy (hazard ratio, 0.68; P = .0022). Median PFS was 6.2 months versus 5.6 months (HR, 0.59; P < .0001).

The confirmed overall response rate was 37% for the cemiplimab arm versus 21% for the chemotherapy arm.

The most common adverse reactions (>10%) with cemiplimab-rlwc were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.

This approval “means physicians and patients have a potent new treatment option against this deadly disease,” said Naiyer Rizvi, MD, Price Family Professor of Medicine, director of thoracic oncology, and codirector of cancer immunotherapy at Columbia University Irving Medical Center, New York, in a statement. He was a steering committee member on the EMPOWER-Lung-1 Trial.

“Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases or who had locally advanced disease and were not candidates for definitive chemoradiation,” said Dr. Rizvi. “This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”

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

The Food and Drug Administration has approved cemiplimab-rwlc (Libtayo) for the treatment of advanced non–small cell lung cancer (NSCLC).

Specifically, the indication is for first-line treatment as monotherapy for patients with locally advanced or metastatic disease who are not candidates for surgical resection or definitive chemoradiotherapy and whose tumors have a high expression of programmed death–ligand 1 (PD-L1) (Tumor Proportion Score >50%), as determined by an FDA-approved test, with no EGFR, ALK, or ROS1 aberrations.

This is the third indication for cemiplimab-rlwc, a monoclonal antibody and PD-1 inhibitor.

In February, it was approved as the first immunotherapy to treat patients with locally advanced or metastatic basal cell carcinoma that was previously treated with a hedgehog pathway inhibitor or for whom a hedgehog inhibitor is inappropriate.

Cemiplimab-rlwc previously received FDA approval in 2018 for locally advanced or metastatic cutaneous squamous cell carcinoma for patients who were not eligible for curative surgery or radiotherapy. At the time, Karl Lewis, MD, a professor at the University of Colorado at Denver, Aurora, and a trial investigator, predicted that the drug “will change the treatment paradigm for patients with advanced basal cell carcinoma.”
 

Outperforms chemotherapy

The approval for use in NSCLC is based on results from the phase 3, open-label EMPOWER-Lung 1 trial, which randomly assigned 710 patients in a 1:1 ratio to receive either cemiplimab-rwlc or platinum-doublet chemotherapy. Patients had either locally advanced NSCLC and were not candidates for surgical resection or definitive chemoradiotherapy, or they had metastatic NSCLC.

Patients in the experimental arm received cemiplimab-rwlc 350 mg intravenously every 3 weeks. The primary efficacy outcome measures were overall survival (OS) and progression-free survival (PFS), determined on the basis of blinded independent central review.

Results showed statistically significant improvements in both outcomes. Median OS was 22.1 months with cemiplimab-rwlc versus 14.3 months with chemotherapy (hazard ratio, 0.68; P = .0022). Median PFS was 6.2 months versus 5.6 months (HR, 0.59; P < .0001).

The confirmed overall response rate was 37% for the cemiplimab arm versus 21% for the chemotherapy arm.

The most common adverse reactions (>10%) with cemiplimab-rlwc were musculoskeletal pain, rash, anemia, fatigue, decreased appetite, pneumonia, and cough.

This approval “means physicians and patients have a potent new treatment option against this deadly disease,” said Naiyer Rizvi, MD, Price Family Professor of Medicine, director of thoracic oncology, and codirector of cancer immunotherapy at Columbia University Irving Medical Center, New York, in a statement. He was a steering committee member on the EMPOWER-Lung-1 Trial.

“Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases or who had locally advanced disease and were not candidates for definitive chemoradiation,” said Dr. Rizvi. “This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”

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