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Evidence still lacking that vitamins prevent CVD, cancer: USPSTF
There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.
However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.
These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.
“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.
“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.
“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.
Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.
“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.
The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.
“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.
On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.
However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.
“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.
But he noted that the task force did not find any significant harms from taking multivitamins.
“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.
Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.
“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
‘Any benefit likely to be small’
In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.
The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.
They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).
“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.
The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.
However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.
The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
Possible benefit for older adults?
Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.
“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”
However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.
She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.
“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.
“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”
A version of this article first appeared on Medscape.com.
There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.
However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.
These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.
“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.
“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.
“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.
Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.
“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.
The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.
“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.
On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.
However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.
“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.
But he noted that the task force did not find any significant harms from taking multivitamins.
“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.
Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.
“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
‘Any benefit likely to be small’
In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.
The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.
They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).
“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.
The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.
However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.
The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
Possible benefit for older adults?
Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.
“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”
However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.
She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.
“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.
“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”
A version of this article first appeared on Medscape.com.
There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.
However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.
These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.
“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.
“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.
“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.
Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.
“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.
The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.
“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.
On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.
However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.
“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.
But he noted that the task force did not find any significant harms from taking multivitamins.
“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.
Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.
“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
‘Any benefit likely to be small’
In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.
The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.
They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).
“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.
The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.
However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.
The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
Possible benefit for older adults?
Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.
“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”
However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.
She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.
“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.
“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”
A version of this article first appeared on Medscape.com.
FROM JAMA
ER+/HER2− BC: Age and Ki-67 index predict nodal response to NAC
Key clinical point: In estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) neoadjuvant chemotherapy (NAC) should be considered to enable axillary conservation in patients aged <50 years with Ki67 ≥20%.
Major finding: Both Ki67 ≥20% (adjusted odds ratio [aOR] 2.60; P = .04) and age <50 years (aOR 2.44; P = .01) were significant independent predictors of nodal pathological complete response (pCR). Younger patients (<50 years) had a higher nodal pCR when Ki67 index was ≥20% vs. <20% (35.8% vs. 14.3%; P = .02), whereas older patients (≥50 years) had an extremely low nodal pCR when Ki67 was <20% vs. ≥20% (2.6% vs. 21%; P = .008).
Study details: This study included 315 patients with node-positive, stage I-III, ER+/HER2− BC who were treated with NAC followed by surgery.
Disclosures: This work was partly supported by the National Institutes of Health Mayo Clinic Breast SPORE grant. Dr. Goetz and Dr. Boughey declared having research collaboration and receiving grants, funding, personal fees, or consulting fees from several sources.
Source: Boughey JC et al. Neoadjuvant chemotherapy and nodal response rates in luminal breast cancer: effects of age and tumor Ki67. Ann Surg Oncol. 2022 (May 15). Doi: 10.1245/s10434-022-11871-z
Key clinical point: In estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) neoadjuvant chemotherapy (NAC) should be considered to enable axillary conservation in patients aged <50 years with Ki67 ≥20%.
Major finding: Both Ki67 ≥20% (adjusted odds ratio [aOR] 2.60; P = .04) and age <50 years (aOR 2.44; P = .01) were significant independent predictors of nodal pathological complete response (pCR). Younger patients (<50 years) had a higher nodal pCR when Ki67 index was ≥20% vs. <20% (35.8% vs. 14.3%; P = .02), whereas older patients (≥50 years) had an extremely low nodal pCR when Ki67 was <20% vs. ≥20% (2.6% vs. 21%; P = .008).
Study details: This study included 315 patients with node-positive, stage I-III, ER+/HER2− BC who were treated with NAC followed by surgery.
Disclosures: This work was partly supported by the National Institutes of Health Mayo Clinic Breast SPORE grant. Dr. Goetz and Dr. Boughey declared having research collaboration and receiving grants, funding, personal fees, or consulting fees from several sources.
Source: Boughey JC et al. Neoadjuvant chemotherapy and nodal response rates in luminal breast cancer: effects of age and tumor Ki67. Ann Surg Oncol. 2022 (May 15). Doi: 10.1245/s10434-022-11871-z
Key clinical point: In estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC) neoadjuvant chemotherapy (NAC) should be considered to enable axillary conservation in patients aged <50 years with Ki67 ≥20%.
Major finding: Both Ki67 ≥20% (adjusted odds ratio [aOR] 2.60; P = .04) and age <50 years (aOR 2.44; P = .01) were significant independent predictors of nodal pathological complete response (pCR). Younger patients (<50 years) had a higher nodal pCR when Ki67 index was ≥20% vs. <20% (35.8% vs. 14.3%; P = .02), whereas older patients (≥50 years) had an extremely low nodal pCR when Ki67 was <20% vs. ≥20% (2.6% vs. 21%; P = .008).
Study details: This study included 315 patients with node-positive, stage I-III, ER+/HER2− BC who were treated with NAC followed by surgery.
Disclosures: This work was partly supported by the National Institutes of Health Mayo Clinic Breast SPORE grant. Dr. Goetz and Dr. Boughey declared having research collaboration and receiving grants, funding, personal fees, or consulting fees from several sources.
Source: Boughey JC et al. Neoadjuvant chemotherapy and nodal response rates in luminal breast cancer: effects of age and tumor Ki67. Ann Surg Oncol. 2022 (May 15). Doi: 10.1245/s10434-022-11871-z
Similar prognosis in pregnant vs. nonpregnant BC patients receiving chemotherapy
Key clinical point: Patients with breast cancer (BC) treated with standard chemotherapy during pregnancy show comparable prognosis to young nonpregnant patients with BC, supporting chemotherapy initiation in pregnant women with BC as indicated.
Major finding: Median follow-up was 66.3 months. Disease-free survival (hazard ratio [HR] 1.024; P = .830) and overall survival (HR 1.082; P = .592) were not significantly different between pregnant and nonpregnant patients receiving chemotherapy.
Study details: Findings are from a large cohort study including 2081 nonpregnant women aged <45 years and 662 pregnant women, all of whom were diagnosed with stage I-III BC and received standard chemotherapy.
Disclosures: This study was funded by German Breast Group and other sources. Some authors declared receiving grants, honoraria, personal fees, or speaking fees from several sources.
Source: Amant F et al. Outcome of breast cancer patients treated with chemotherapy during pregnancy compared with non-pregnant controls. Eur J Cancer. 2022;170:54-63 (May 17). Doi: 10.1016/j.ejca.2022.04.014
Key clinical point: Patients with breast cancer (BC) treated with standard chemotherapy during pregnancy show comparable prognosis to young nonpregnant patients with BC, supporting chemotherapy initiation in pregnant women with BC as indicated.
Major finding: Median follow-up was 66.3 months. Disease-free survival (hazard ratio [HR] 1.024; P = .830) and overall survival (HR 1.082; P = .592) were not significantly different between pregnant and nonpregnant patients receiving chemotherapy.
Study details: Findings are from a large cohort study including 2081 nonpregnant women aged <45 years and 662 pregnant women, all of whom were diagnosed with stage I-III BC and received standard chemotherapy.
Disclosures: This study was funded by German Breast Group and other sources. Some authors declared receiving grants, honoraria, personal fees, or speaking fees from several sources.
Source: Amant F et al. Outcome of breast cancer patients treated with chemotherapy during pregnancy compared with non-pregnant controls. Eur J Cancer. 2022;170:54-63 (May 17). Doi: 10.1016/j.ejca.2022.04.014
Key clinical point: Patients with breast cancer (BC) treated with standard chemotherapy during pregnancy show comparable prognosis to young nonpregnant patients with BC, supporting chemotherapy initiation in pregnant women with BC as indicated.
Major finding: Median follow-up was 66.3 months. Disease-free survival (hazard ratio [HR] 1.024; P = .830) and overall survival (HR 1.082; P = .592) were not significantly different between pregnant and nonpregnant patients receiving chemotherapy.
Study details: Findings are from a large cohort study including 2081 nonpregnant women aged <45 years and 662 pregnant women, all of whom were diagnosed with stage I-III BC and received standard chemotherapy.
Disclosures: This study was funded by German Breast Group and other sources. Some authors declared receiving grants, honoraria, personal fees, or speaking fees from several sources.
Source: Amant F et al. Outcome of breast cancer patients treated with chemotherapy during pregnancy compared with non-pregnant controls. Eur J Cancer. 2022;170:54-63 (May 17). Doi: 10.1016/j.ejca.2022.04.014
Male infertility and breast cancer: Is there a link?
Key clinical point: Male-origin infertility was associated with an increased risk for breast cancer (BC) in men.
Major finding: Risk for BC was significantly higher in men diagnosed with infertility (odds ratio [OR] 2.03; P = .01), those diagnosed with infertility or low sperm count (OR 2.17; P = .004), and those who had not fathered any children (OR 1.50; P < .001).
Study details: Findings are from a case-control study including 1998 men diagnosed with in situ or invasive BC at <80 years of age and 1597 matched male controls.
Disclosures: This study was supported by Breast Cancer Now, formerly Breakthrough Breast Cancer, and the John Tridgell family. The authors declared no conflicts of interest.
Source: Swerdlow AJ et al. Infertility and risk of breast cancer in men: a national case–control study in England and Wales. Breast Cancer Res. 2022;24:29 (May 17). Doi: 10.1186/s13058-022-01517-z
Key clinical point: Male-origin infertility was associated with an increased risk for breast cancer (BC) in men.
Major finding: Risk for BC was significantly higher in men diagnosed with infertility (odds ratio [OR] 2.03; P = .01), those diagnosed with infertility or low sperm count (OR 2.17; P = .004), and those who had not fathered any children (OR 1.50; P < .001).
Study details: Findings are from a case-control study including 1998 men diagnosed with in situ or invasive BC at <80 years of age and 1597 matched male controls.
Disclosures: This study was supported by Breast Cancer Now, formerly Breakthrough Breast Cancer, and the John Tridgell family. The authors declared no conflicts of interest.
Source: Swerdlow AJ et al. Infertility and risk of breast cancer in men: a national case–control study in England and Wales. Breast Cancer Res. 2022;24:29 (May 17). Doi: 10.1186/s13058-022-01517-z
Key clinical point: Male-origin infertility was associated with an increased risk for breast cancer (BC) in men.
Major finding: Risk for BC was significantly higher in men diagnosed with infertility (odds ratio [OR] 2.03; P = .01), those diagnosed with infertility or low sperm count (OR 2.17; P = .004), and those who had not fathered any children (OR 1.50; P < .001).
Study details: Findings are from a case-control study including 1998 men diagnosed with in situ or invasive BC at <80 years of age and 1597 matched male controls.
Disclosures: This study was supported by Breast Cancer Now, formerly Breakthrough Breast Cancer, and the John Tridgell family. The authors declared no conflicts of interest.
Source: Swerdlow AJ et al. Infertility and risk of breast cancer in men: a national case–control study in England and Wales. Breast Cancer Res. 2022;24:29 (May 17). Doi: 10.1186/s13058-022-01517-z
Breast cancer: Epigallocatechin-3-gallate prevents dermatitis in patients receiving radiotherapy
Key clinical point: Patients who received adjuvant radiotherapy for breast cancer (BC) experienced a significant reduction in radiation-induced dermatitis (RID) incidence and severity after the prophylactic use of epigallocatechin-3-gallate (EGCG) solution.
Major finding: Incidence rates of grade ≥2 RID (50.5% vs. 72.2%; P = .008), the mean RID index of patients (5.22 vs. 6.21; P < .001), and RID-related symptoms, such as pain (P = .03), burning sensation (P = .001), itching (P < .001), and tenderness (P = .002), were significantly lower in the EGCG vs. placebo group. No severe EGCG solution/placebo-related adverse events were observed.
Study details: Findings are from a double-blind, phase 2 study including 165 women with histologically confirmed BC who received postoperative radiotherapy and were randomly assigned to receive EGCG solution or placebo.
Disclosures: Z Zhou, J Yu, and H Zhao received funding from the National Natural Science Foundation of China, Jinan Science and Technology Plan Project, and other sources. The authors declared no conflicts of interest.
Source: Zhao H et al. Efficacy of epigallocatechin-3-gallate in preventing dermatitis in patients with breast cancer receiving postoperative radiotherapy: A double-blind, placebo-controlled, phase 2 randomized clinical trial. JAMA Dermatol. 2022 (Jun 1). Doi: 10.1001/jamadermatol.2022.1736
Key clinical point: Patients who received adjuvant radiotherapy for breast cancer (BC) experienced a significant reduction in radiation-induced dermatitis (RID) incidence and severity after the prophylactic use of epigallocatechin-3-gallate (EGCG) solution.
Major finding: Incidence rates of grade ≥2 RID (50.5% vs. 72.2%; P = .008), the mean RID index of patients (5.22 vs. 6.21; P < .001), and RID-related symptoms, such as pain (P = .03), burning sensation (P = .001), itching (P < .001), and tenderness (P = .002), were significantly lower in the EGCG vs. placebo group. No severe EGCG solution/placebo-related adverse events were observed.
Study details: Findings are from a double-blind, phase 2 study including 165 women with histologically confirmed BC who received postoperative radiotherapy and were randomly assigned to receive EGCG solution or placebo.
Disclosures: Z Zhou, J Yu, and H Zhao received funding from the National Natural Science Foundation of China, Jinan Science and Technology Plan Project, and other sources. The authors declared no conflicts of interest.
Source: Zhao H et al. Efficacy of epigallocatechin-3-gallate in preventing dermatitis in patients with breast cancer receiving postoperative radiotherapy: A double-blind, placebo-controlled, phase 2 randomized clinical trial. JAMA Dermatol. 2022 (Jun 1). Doi: 10.1001/jamadermatol.2022.1736
Key clinical point: Patients who received adjuvant radiotherapy for breast cancer (BC) experienced a significant reduction in radiation-induced dermatitis (RID) incidence and severity after the prophylactic use of epigallocatechin-3-gallate (EGCG) solution.
Major finding: Incidence rates of grade ≥2 RID (50.5% vs. 72.2%; P = .008), the mean RID index of patients (5.22 vs. 6.21; P < .001), and RID-related symptoms, such as pain (P = .03), burning sensation (P = .001), itching (P < .001), and tenderness (P = .002), were significantly lower in the EGCG vs. placebo group. No severe EGCG solution/placebo-related adverse events were observed.
Study details: Findings are from a double-blind, phase 2 study including 165 women with histologically confirmed BC who received postoperative radiotherapy and were randomly assigned to receive EGCG solution or placebo.
Disclosures: Z Zhou, J Yu, and H Zhao received funding from the National Natural Science Foundation of China, Jinan Science and Technology Plan Project, and other sources. The authors declared no conflicts of interest.
Source: Zhao H et al. Efficacy of epigallocatechin-3-gallate in preventing dermatitis in patients with breast cancer receiving postoperative radiotherapy: A double-blind, placebo-controlled, phase 2 randomized clinical trial. JAMA Dermatol. 2022 (Jun 1). Doi: 10.1001/jamadermatol.2022.1736
Metastatic BC and brain metastases: Etirinotecan pegol fails to improve survival in phase 3
Key clinical point: Etirinotecan pegol failed to prolong survival compared with chemotherapy in patients with metastatic breast cancer (BC) and stable pretreated brain metastases (BM).
Major finding: The median overall survival (hazard ratio [HR] 0.90; P = .60) and median progression-free survival for non-central nervous system (CNS; HR 0.72; P = .18) or CNS (HR 0.59; P = .07) metastases were similar in the etirinotecan pegol and chemotherapy groups, with overall safety profiles of the two treatments being largely comparable.
Study details: Findings are from the phase 3 ATTAIN study including 178 patients with metastatic BC and a history of stable pretreated BM who were randomly assigned to receive etirinotecan pegol or chemotherapy.
Disclosures: This study was funded by Nektar Therapeutics. Dr. Hoch and Dr. Tagliaferri declared being employees of Nektar Therapeutics, and the other authors reported ties with several sources, including Nektar Therapeutics.
Source: Tripathy D et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: Final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022 (May 12). Doi: 10.1001/jamaoncol.2022.0514
Key clinical point: Etirinotecan pegol failed to prolong survival compared with chemotherapy in patients with metastatic breast cancer (BC) and stable pretreated brain metastases (BM).
Major finding: The median overall survival (hazard ratio [HR] 0.90; P = .60) and median progression-free survival for non-central nervous system (CNS; HR 0.72; P = .18) or CNS (HR 0.59; P = .07) metastases were similar in the etirinotecan pegol and chemotherapy groups, with overall safety profiles of the two treatments being largely comparable.
Study details: Findings are from the phase 3 ATTAIN study including 178 patients with metastatic BC and a history of stable pretreated BM who were randomly assigned to receive etirinotecan pegol or chemotherapy.
Disclosures: This study was funded by Nektar Therapeutics. Dr. Hoch and Dr. Tagliaferri declared being employees of Nektar Therapeutics, and the other authors reported ties with several sources, including Nektar Therapeutics.
Source: Tripathy D et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: Final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022 (May 12). Doi: 10.1001/jamaoncol.2022.0514
Key clinical point: Etirinotecan pegol failed to prolong survival compared with chemotherapy in patients with metastatic breast cancer (BC) and stable pretreated brain metastases (BM).
Major finding: The median overall survival (hazard ratio [HR] 0.90; P = .60) and median progression-free survival for non-central nervous system (CNS; HR 0.72; P = .18) or CNS (HR 0.59; P = .07) metastases were similar in the etirinotecan pegol and chemotherapy groups, with overall safety profiles of the two treatments being largely comparable.
Study details: Findings are from the phase 3 ATTAIN study including 178 patients with metastatic BC and a history of stable pretreated BM who were randomly assigned to receive etirinotecan pegol or chemotherapy.
Disclosures: This study was funded by Nektar Therapeutics. Dr. Hoch and Dr. Tagliaferri declared being employees of Nektar Therapeutics, and the other authors reported ties with several sources, including Nektar Therapeutics.
Source: Tripathy D et al. Treatment with etirinotecan pegol for patients with metastatic breast cancer and brain metastases: Final results from the phase 3 ATTAIN randomized clinical trial. JAMA Oncol. 2022 (May 12). Doi: 10.1001/jamaoncol.2022.0514
Adjuvant radiotherapy less toxic in prone vs. supine position in BC patients with heavy breasts
Key clinical point: Adjuvant breast intensity-modulated radiotherapy (IMRT) in the prone vs. supine position was less toxic in women with large breast size and early-stage breast cancer (BC) who underwent breast-conserving surgery (BCS).
Major finding: IMRT in the supine vs. prone position was significantly associated with higher rates of desquamation anywhere in the breast and grade 3 desquamation in the overall cohort (odds ratio [OR] 1.78; P = .002, and OR 2.09; P < .001, respectively) and among women receiving extended fractionation (OR 1.92 and OR 2.76, respectively; both P < .001). The quality of life outcomes were similar between both treatment arms.
Study details: This phase 3 study included 357 women with large breast size and early-stage BC who underwent BCS and were randomly assigned to receive adjuvant IMRT in the supine or prone position.
Disclosures: This study was supported by Canadian Cancer Society. Dr. Rakovitch declared receiving grants and personal fees from some sources, and Dr. Pignol declared being employed by Accuray Inc.
Source: Vesprini D et al. Effect of supine vs prone breast radiotherapy on acute toxic effects of the skin among women with large breast size: A randomized clinical trial. JAMA Oncol. 2022 (May 26). Doi: 10.1001/jamaoncol.2022.1479
Key clinical point: Adjuvant breast intensity-modulated radiotherapy (IMRT) in the prone vs. supine position was less toxic in women with large breast size and early-stage breast cancer (BC) who underwent breast-conserving surgery (BCS).
Major finding: IMRT in the supine vs. prone position was significantly associated with higher rates of desquamation anywhere in the breast and grade 3 desquamation in the overall cohort (odds ratio [OR] 1.78; P = .002, and OR 2.09; P < .001, respectively) and among women receiving extended fractionation (OR 1.92 and OR 2.76, respectively; both P < .001). The quality of life outcomes were similar between both treatment arms.
Study details: This phase 3 study included 357 women with large breast size and early-stage BC who underwent BCS and were randomly assigned to receive adjuvant IMRT in the supine or prone position.
Disclosures: This study was supported by Canadian Cancer Society. Dr. Rakovitch declared receiving grants and personal fees from some sources, and Dr. Pignol declared being employed by Accuray Inc.
Source: Vesprini D et al. Effect of supine vs prone breast radiotherapy on acute toxic effects of the skin among women with large breast size: A randomized clinical trial. JAMA Oncol. 2022 (May 26). Doi: 10.1001/jamaoncol.2022.1479
Key clinical point: Adjuvant breast intensity-modulated radiotherapy (IMRT) in the prone vs. supine position was less toxic in women with large breast size and early-stage breast cancer (BC) who underwent breast-conserving surgery (BCS).
Major finding: IMRT in the supine vs. prone position was significantly associated with higher rates of desquamation anywhere in the breast and grade 3 desquamation in the overall cohort (odds ratio [OR] 1.78; P = .002, and OR 2.09; P < .001, respectively) and among women receiving extended fractionation (OR 1.92 and OR 2.76, respectively; both P < .001). The quality of life outcomes were similar between both treatment arms.
Study details: This phase 3 study included 357 women with large breast size and early-stage BC who underwent BCS and were randomly assigned to receive adjuvant IMRT in the supine or prone position.
Disclosures: This study was supported by Canadian Cancer Society. Dr. Rakovitch declared receiving grants and personal fees from some sources, and Dr. Pignol declared being employed by Accuray Inc.
Source: Vesprini D et al. Effect of supine vs prone breast radiotherapy on acute toxic effects of the skin among women with large breast size: A randomized clinical trial. JAMA Oncol. 2022 (May 26). Doi: 10.1001/jamaoncol.2022.1479
Elacestrant prolongs survival in previously treated ER+/HER2− advanced BC
Key clinical point: Elacestrant significantly improved progression-free survival (PFS) compared with standard-of-care (SOC) endocrine monotherapy in previously treated patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) with a manageable safety.
Major finding: Elacestrant vs. SOC prolonged PFS in the overall cohort (hazard ratio [HR] 0.70; P = .002) and in patients with estrogen receptor 1 mutation (HR 0.55; P = .0005). Grade 3/4 adverse events occurred in 27.0% vs. 20.5% of patients receiving elacestrant vs. SOC therapy, respectively.
Study details: Findings are from the phase 3 EMERALD study including 477 patients with ER+/HER2− metastatic BC who progressed after the first- or second-line treatment with endocrine therapy + cyclin-dependent kinase 4/6 inhibitor and ≤1 rounds of chemotherapy treatment and were randomly assigned to receive elacestrant or SOC endocrine monotherapy.
Disclosures: This study was sponsored by Radius Health, Inc. The authors declared owning stock options or patents, receiving research funding, travel, accommodation expenses, or honoraria from, or serving as consultants, advisors, and in speakers’ bureaus for several sources, including Radius Health.
Source: Bidard FC et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Results from the randomized phase III EMERALD Trial. J Clin Oncol. 2022 (May 18). Doi: 10.1200/JCO.22.00338
Key clinical point: Elacestrant significantly improved progression-free survival (PFS) compared with standard-of-care (SOC) endocrine monotherapy in previously treated patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) with a manageable safety.
Major finding: Elacestrant vs. SOC prolonged PFS in the overall cohort (hazard ratio [HR] 0.70; P = .002) and in patients with estrogen receptor 1 mutation (HR 0.55; P = .0005). Grade 3/4 adverse events occurred in 27.0% vs. 20.5% of patients receiving elacestrant vs. SOC therapy, respectively.
Study details: Findings are from the phase 3 EMERALD study including 477 patients with ER+/HER2− metastatic BC who progressed after the first- or second-line treatment with endocrine therapy + cyclin-dependent kinase 4/6 inhibitor and ≤1 rounds of chemotherapy treatment and were randomly assigned to receive elacestrant or SOC endocrine monotherapy.
Disclosures: This study was sponsored by Radius Health, Inc. The authors declared owning stock options or patents, receiving research funding, travel, accommodation expenses, or honoraria from, or serving as consultants, advisors, and in speakers’ bureaus for several sources, including Radius Health.
Source: Bidard FC et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Results from the randomized phase III EMERALD Trial. J Clin Oncol. 2022 (May 18). Doi: 10.1200/JCO.22.00338
Key clinical point: Elacestrant significantly improved progression-free survival (PFS) compared with standard-of-care (SOC) endocrine monotherapy in previously treated patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (BC) with a manageable safety.
Major finding: Elacestrant vs. SOC prolonged PFS in the overall cohort (hazard ratio [HR] 0.70; P = .002) and in patients with estrogen receptor 1 mutation (HR 0.55; P = .0005). Grade 3/4 adverse events occurred in 27.0% vs. 20.5% of patients receiving elacestrant vs. SOC therapy, respectively.
Study details: Findings are from the phase 3 EMERALD study including 477 patients with ER+/HER2− metastatic BC who progressed after the first- or second-line treatment with endocrine therapy + cyclin-dependent kinase 4/6 inhibitor and ≤1 rounds of chemotherapy treatment and were randomly assigned to receive elacestrant or SOC endocrine monotherapy.
Disclosures: This study was sponsored by Radius Health, Inc. The authors declared owning stock options or patents, receiving research funding, travel, accommodation expenses, or honoraria from, or serving as consultants, advisors, and in speakers’ bureaus for several sources, including Radius Health.
Source: Bidard FC et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: Results from the randomized phase III EMERALD Trial. J Clin Oncol. 2022 (May 18). Doi: 10.1200/JCO.22.00338
Metformin disappoints in high-risk operable breast cancer
Key clinical point: In patients with high-risk operable breast cancer (BC) and without diabetes, adding metformin to standard BC treatment did not improve the invasive disease-free survival (iDFS) rate, regardless of estrogen receptor/progesterone receptor (ER/PgR) status.
Major finding: The incidence rates of iDFS events were similar between the metformin and placebo groups in patients with ER/PgR+ BC (2.78 vs. 2.74 per 100 patient-years; P = .93) and ER/PgR− BC (3.58 vs. 3.60 per 100 patient-years; P = .92). Grade ≥3 nonhematological adverse events were more frequent in the metformin vs. placebo group (21.5% vs. 17.5%; P = .003).
Study details: Findings are from the phase 3 MA.32 study including 3649 patients with high-risk operable BC and without diabetes who were randomly assigned to receive metformin or placebo after undergoing complete resection.
Disclosures: This study was funded by the Canadian Cancer Society Research Institute and other sources. The authors declared serving on advisory boards, as consultants, or were employees or received grants, nonfinancial support, or travel expenses from several sources.
Source: Goodwin PJ et al. Effect of metformin vs placebo on invasive disease–free survival in patients with breast cancer: The MA.32 Randomized Clinical Trial. JAMA. 2022;327(20):1963–1973 (May 24). Doi: 10.1001/jama.2022.6147
Key clinical point: In patients with high-risk operable breast cancer (BC) and without diabetes, adding metformin to standard BC treatment did not improve the invasive disease-free survival (iDFS) rate, regardless of estrogen receptor/progesterone receptor (ER/PgR) status.
Major finding: The incidence rates of iDFS events were similar between the metformin and placebo groups in patients with ER/PgR+ BC (2.78 vs. 2.74 per 100 patient-years; P = .93) and ER/PgR− BC (3.58 vs. 3.60 per 100 patient-years; P = .92). Grade ≥3 nonhematological adverse events were more frequent in the metformin vs. placebo group (21.5% vs. 17.5%; P = .003).
Study details: Findings are from the phase 3 MA.32 study including 3649 patients with high-risk operable BC and without diabetes who were randomly assigned to receive metformin or placebo after undergoing complete resection.
Disclosures: This study was funded by the Canadian Cancer Society Research Institute and other sources. The authors declared serving on advisory boards, as consultants, or were employees or received grants, nonfinancial support, or travel expenses from several sources.
Source: Goodwin PJ et al. Effect of metformin vs placebo on invasive disease–free survival in patients with breast cancer: The MA.32 Randomized Clinical Trial. JAMA. 2022;327(20):1963–1973 (May 24). Doi: 10.1001/jama.2022.6147
Key clinical point: In patients with high-risk operable breast cancer (BC) and without diabetes, adding metformin to standard BC treatment did not improve the invasive disease-free survival (iDFS) rate, regardless of estrogen receptor/progesterone receptor (ER/PgR) status.
Major finding: The incidence rates of iDFS events were similar between the metformin and placebo groups in patients with ER/PgR+ BC (2.78 vs. 2.74 per 100 patient-years; P = .93) and ER/PgR− BC (3.58 vs. 3.60 per 100 patient-years; P = .92). Grade ≥3 nonhematological adverse events were more frequent in the metformin vs. placebo group (21.5% vs. 17.5%; P = .003).
Study details: Findings are from the phase 3 MA.32 study including 3649 patients with high-risk operable BC and without diabetes who were randomly assigned to receive metformin or placebo after undergoing complete resection.
Disclosures: This study was funded by the Canadian Cancer Society Research Institute and other sources. The authors declared serving on advisory boards, as consultants, or were employees or received grants, nonfinancial support, or travel expenses from several sources.
Source: Goodwin PJ et al. Effect of metformin vs placebo on invasive disease–free survival in patients with breast cancer: The MA.32 Randomized Clinical Trial. JAMA. 2022;327(20):1963–1973 (May 24). Doi: 10.1001/jama.2022.6147
Advanced TNBC: Camrelizumab + apatinib and eribulin shows promise in heavily pretreated patients
Key clinical point: The combination of camrelizumab, apatinib, and eribulin demonstrated a favorable efficacy and a manageable safety profile in patients with heavily pretreated advanced triple negative breast cancer (TNBC).
Major finding: The objective response rate (ORR), disease control rate, and median progression-free survival in the overall cohort were 37.0% (95% CI 23.2%-52.5%), 87.0% (95% CI 73.7%-95.1%), and 8.1 months (95% CI 4.6-10.3 months), respectively, whereas the ORR in patients who progressed on previous treatment with checkpoint inhibitor + chemotherapy was 25.0% (95% CI 3.2%-65.1%). Grade 3/4 treatment-related adverse events occurred in 41.3% of patients.
Study details: Findings are from a multicenter, phase 2 study including 46 patients with pretreated advanced TNBC who received camrelizumab on day 1, apatinib daily, and eribulin on days 1 and 8 of a 21-day cycle.
Disclosures: This work was supported by grants from the Natural Science Foundation of China, Guangdong Science and Technology Department, and other sources. The authors declared no conflicts of interest.
Source: Liu J et al. Multicenter phase II trial of camrelizumab combined with apatinib and eribulin in heavily pretreated patients with advanced triple-negative breast cancer. Nat Commun. 2022;13:3011 (May 31). Doi: 10.1038/s41467-022-30569-0
Key clinical point: The combination of camrelizumab, apatinib, and eribulin demonstrated a favorable efficacy and a manageable safety profile in patients with heavily pretreated advanced triple negative breast cancer (TNBC).
Major finding: The objective response rate (ORR), disease control rate, and median progression-free survival in the overall cohort were 37.0% (95% CI 23.2%-52.5%), 87.0% (95% CI 73.7%-95.1%), and 8.1 months (95% CI 4.6-10.3 months), respectively, whereas the ORR in patients who progressed on previous treatment with checkpoint inhibitor + chemotherapy was 25.0% (95% CI 3.2%-65.1%). Grade 3/4 treatment-related adverse events occurred in 41.3% of patients.
Study details: Findings are from a multicenter, phase 2 study including 46 patients with pretreated advanced TNBC who received camrelizumab on day 1, apatinib daily, and eribulin on days 1 and 8 of a 21-day cycle.
Disclosures: This work was supported by grants from the Natural Science Foundation of China, Guangdong Science and Technology Department, and other sources. The authors declared no conflicts of interest.
Source: Liu J et al. Multicenter phase II trial of camrelizumab combined with apatinib and eribulin in heavily pretreated patients with advanced triple-negative breast cancer. Nat Commun. 2022;13:3011 (May 31). Doi: 10.1038/s41467-022-30569-0
Key clinical point: The combination of camrelizumab, apatinib, and eribulin demonstrated a favorable efficacy and a manageable safety profile in patients with heavily pretreated advanced triple negative breast cancer (TNBC).
Major finding: The objective response rate (ORR), disease control rate, and median progression-free survival in the overall cohort were 37.0% (95% CI 23.2%-52.5%), 87.0% (95% CI 73.7%-95.1%), and 8.1 months (95% CI 4.6-10.3 months), respectively, whereas the ORR in patients who progressed on previous treatment with checkpoint inhibitor + chemotherapy was 25.0% (95% CI 3.2%-65.1%). Grade 3/4 treatment-related adverse events occurred in 41.3% of patients.
Study details: Findings are from a multicenter, phase 2 study including 46 patients with pretreated advanced TNBC who received camrelizumab on day 1, apatinib daily, and eribulin on days 1 and 8 of a 21-day cycle.
Disclosures: This work was supported by grants from the Natural Science Foundation of China, Guangdong Science and Technology Department, and other sources. The authors declared no conflicts of interest.
Source: Liu J et al. Multicenter phase II trial of camrelizumab combined with apatinib and eribulin in heavily pretreated patients with advanced triple-negative breast cancer. Nat Commun. 2022;13:3011 (May 31). Doi: 10.1038/s41467-022-30569-0