Key clinical point: Scalp cooling therapy for chemotherapy-induced alopecia in patients with breast cancer is associated with 61% effectiveness, according to a meta-analysis.

Major finding: Scalp cooling therapy showed an effectiveness of 61% against hair loss. The region-specific efficacy was 65% in Europe and 53% in Asia.

Study details: Meta-analysis of 27 studies (3 randomized controlled trials, 12 cross-sectional, and 12 cohort studies) with 2,202 participants.

Disclosures: The study funding source was not identified. The authors declared no conflict of interests.

Source: Wang S et al. Support Care Cancer. 2021 Apr 13. doi: 10.1007/s00520-021-06188-8.

Key clinical point: Scalp cooling therapy for chemotherapy-induced alopecia in patients with breast cancer is associated with 61% effectiveness, according to a meta-analysis.

Major finding: Scalp cooling therapy showed an effectiveness of 61% against hair loss. The region-specific efficacy was 65% in Europe and 53% in Asia.

Study details: Meta-analysis of 27 studies (3 randomized controlled trials, 12 cross-sectional, and 12 cohort studies) with 2,202 participants.

Disclosures: The study funding source was not identified. The authors declared no conflict of interests.

Source: Wang S et al. Support Care Cancer. 2021 Apr 13. doi: 10.1007/s00520-021-06188-8.

Key clinical point: Scalp cooling therapy for chemotherapy-induced alopecia in patients with breast cancer is associated with 61% effectiveness, according to a meta-analysis.

Major finding: Scalp cooling therapy showed an effectiveness of 61% against hair loss. The region-specific efficacy was 65% in Europe and 53% in Asia.

Study details: Meta-analysis of 27 studies (3 randomized controlled trials, 12 cross-sectional, and 12 cohort studies) with 2,202 participants.

Disclosures: The study funding source was not identified. The authors declared no conflict of interests.

Source: Wang S et al. Support Care Cancer. 2021 Apr 13. doi: 10.1007/s00520-021-06188-8.

Interestingly the authors propose possible causative mechanisms. They note that normal pancreatic secretion is regulated by neural and endocrine control mechanisms that require intact gastro-pancreatico-duodenal anatomy. Disruptions to this include “extensive pancreatic denervation because of lymph node dissection and truncal vagotomy, the asynchronous release of pancreatic enzymes for food particles (pancreaticocibal-asynchrony) because of newly made reconstructions, and gastric reservoir and neural gastric stimulation losses.” They also include the possibility of effects of adjuvant therapies as well. 

While 64% of this patient population had some form of EPI, another study from this month’s selection by Sridhar et al out of Vellore, India tells a different story. In this cross-sectional study, they looked at symptomatic and biochemical evidence of EPI on pre and post questionnaires following gastric resection for adenocarcinoma. Of 27 patients that completed pre and post questionnaires, none of the patients on short-term follow-up (mean follow up of 3 months) had clinical symptoms of EPI following gastric resection. However, more than a third of the patients developed asymptomatic EPI after gastric resection, based on FE testing. The authors conclude that pancreatic supplementation might not be necessary following gastric resection, but perhaps their follow up window was much too short to draw such a conclusion. 

Interestingly the authors propose possible causative mechanisms. They note that normal pancreatic secretion is regulated by neural and endocrine control mechanisms that require intact gastro-pancreatico-duodenal anatomy. Disruptions to this include “extensive pancreatic denervation because of lymph node dissection and truncal vagotomy, the asynchronous release of pancreatic enzymes for food particles (pancreaticocibal-asynchrony) because of newly made reconstructions, and gastric reservoir and neural gastric stimulation losses.” They also include the possibility of effects of adjuvant therapies as well. 

While 64% of this patient population had some form of EPI, another study from this month’s selection by Sridhar et al out of Vellore, India tells a different story. In this cross-sectional study, they looked at symptomatic and biochemical evidence of EPI on pre and post questionnaires following gastric resection for adenocarcinoma. Of 27 patients that completed pre and post questionnaires, none of the patients on short-term follow-up (mean follow up of 3 months) had clinical symptoms of EPI following gastric resection. However, more than a third of the patients developed asymptomatic EPI after gastric resection, based on FE testing. The authors conclude that pancreatic supplementation might not be necessary following gastric resection, but perhaps their follow up window was much too short to draw such a conclusion. 

Interestingly the authors propose possible causative mechanisms. They note that normal pancreatic secretion is regulated by neural and endocrine control mechanisms that require intact gastro-pancreatico-duodenal anatomy. Disruptions to this include “extensive pancreatic denervation because of lymph node dissection and truncal vagotomy, the asynchronous release of pancreatic enzymes for food particles (pancreaticocibal-asynchrony) because of newly made reconstructions, and gastric reservoir and neural gastric stimulation losses.” They also include the possibility of effects of adjuvant therapies as well. 

While 64% of this patient population had some form of EPI, another study from this month’s selection by Sridhar et al out of Vellore, India tells a different story. In this cross-sectional study, they looked at symptomatic and biochemical evidence of EPI on pre and post questionnaires following gastric resection for adenocarcinoma. Of 27 patients that completed pre and post questionnaires, none of the patients on short-term follow-up (mean follow up of 3 months) had clinical symptoms of EPI following gastric resection. However, more than a third of the patients developed asymptomatic EPI after gastric resection, based on FE testing. The authors conclude that pancreatic supplementation might not be necessary following gastric resection, but perhaps their follow up window was much too short to draw such a conclusion. 

Key clinical point: Increasing body mass index (BMI) among survivors of early breast cancer is associated with a higher risk of developing a second primary cancer.

Major finding: At a mean follow-up of 88.0 months, 12.7% of patients developed a second primary cancer. For every 5 kg/m² increase in the BMI, the risk for any second cancer diagnosis increased by 7% and for obesity-related cancers by 13%. The risk for a second breast cancer and second estrogen receptor-positive breast cancer increased by 11% and 15%, respectively, for every 5 kg/m² increase in the BMI.

Study details: A retrospective cohort study of 6,481 women with early-stage primary breast cancer, wherein 33.4% of patients were overweight, and 33.8% were obese.

Disclosures: This work was supported in part by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics of the US National Cancer Institute, and American Cancer Society. The authors disclosed no conflict of interests.

Source: Feigelson HS et al. J Natl Cancer Inst. 2021 Apr 5. doi: 10.1093/jnci/djab053.

Key clinical point: Increasing body mass index (BMI) among survivors of early breast cancer is associated with a higher risk of developing a second primary cancer.

Major finding: At a mean follow-up of 88.0 months, 12.7% of patients developed a second primary cancer. For every 5 kg/m² increase in the BMI, the risk for any second cancer diagnosis increased by 7% and for obesity-related cancers by 13%. The risk for a second breast cancer and second estrogen receptor-positive breast cancer increased by 11% and 15%, respectively, for every 5 kg/m² increase in the BMI.

Study details: A retrospective cohort study of 6,481 women with early-stage primary breast cancer, wherein 33.4% of patients were overweight, and 33.8% were obese.

Disclosures: This work was supported in part by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics of the US National Cancer Institute, and American Cancer Society. The authors disclosed no conflict of interests.

Source: Feigelson HS et al. J Natl Cancer Inst. 2021 Apr 5. doi: 10.1093/jnci/djab053.

Key clinical point: Increasing body mass index (BMI) among survivors of early breast cancer is associated with a higher risk of developing a second primary cancer.

Major finding: At a mean follow-up of 88.0 months, 12.7% of patients developed a second primary cancer. For every 5 kg/m² increase in the BMI, the risk for any second cancer diagnosis increased by 7% and for obesity-related cancers by 13%. The risk for a second breast cancer and second estrogen receptor-positive breast cancer increased by 11% and 15%, respectively, for every 5 kg/m² increase in the BMI.

Study details: A retrospective cohort study of 6,481 women with early-stage primary breast cancer, wherein 33.4% of patients were overweight, and 33.8% were obese.

Disclosures: This work was supported in part by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics of the US National Cancer Institute, and American Cancer Society. The authors disclosed no conflict of interests.

Source: Feigelson HS et al. J Natl Cancer Inst. 2021 Apr 5. doi: 10.1093/jnci/djab053.

Key clinical point: High rates of sentinel lymph node biopsy (SLNB) and radiotherapy (RT) do not show benefit in older women with early estrogen receptor-positive (ER+) breast cancer.

Major finding: Among all patients, 65.3% received SLNB and 54.4% received adjuvant RT. No association was found between SLNB and locoregional recurrence-free survival (LRFS; P = .71) or disease-free survival (DFS; P = .11). RT showed no association with LRFS (P = .10) or DFS (P = .97).

Study details: A retrospective cohort study of 3,361 consecutive patients aged 70 years or older with early ER+ breast cancer.

Disclosures: This study was funded by UPMC Health Services Division and Shear Family Foundation. The authors declared receiving consulting fees, personal fees and/or research funding outside this work.

Source: Carleton N et al. JAMA Netw Open. 2021 Apr 1. doi: 10.1001/jamanetworkopen.2021.6322.

Key clinical point: High rates of sentinel lymph node biopsy (SLNB) and radiotherapy (RT) do not show benefit in older women with early estrogen receptor-positive (ER+) breast cancer.

Major finding: Among all patients, 65.3% received SLNB and 54.4% received adjuvant RT. No association was found between SLNB and locoregional recurrence-free survival (LRFS; P = .71) or disease-free survival (DFS; P = .11). RT showed no association with LRFS (P = .10) or DFS (P = .97).

Study details: A retrospective cohort study of 3,361 consecutive patients aged 70 years or older with early ER+ breast cancer.

Disclosures: This study was funded by UPMC Health Services Division and Shear Family Foundation. The authors declared receiving consulting fees, personal fees and/or research funding outside this work.

Source: Carleton N et al. JAMA Netw Open. 2021 Apr 1. doi: 10.1001/jamanetworkopen.2021.6322.

Key clinical point: High rates of sentinel lymph node biopsy (SLNB) and radiotherapy (RT) do not show benefit in older women with early estrogen receptor-positive (ER+) breast cancer.

Major finding: Among all patients, 65.3% received SLNB and 54.4% received adjuvant RT. No association was found between SLNB and locoregional recurrence-free survival (LRFS; P = .71) or disease-free survival (DFS; P = .11). RT showed no association with LRFS (P = .10) or DFS (P = .97).

Study details: A retrospective cohort study of 3,361 consecutive patients aged 70 years or older with early ER+ breast cancer.

Disclosures: This study was funded by UPMC Health Services Division and Shear Family Foundation. The authors declared receiving consulting fees, personal fees and/or research funding outside this work.

Source: Carleton N et al. JAMA Netw Open. 2021 Apr 1. doi: 10.1001/jamanetworkopen.2021.6322.

Key clinical point: The addition of oral alisertib to a reduced dose of weekly paclitaxel improves progression-free survival (PFS) compared with paclitaxel alone in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Major finding: At a median follow-up of 22 months, the median PFS was 10.2 months with paclitaxel plus alisertib vs. 7.1 months with paclitaxel alone (hazard ratio, 0.56; P = .005) in the patients with ER+, HER2-negative disease. Grade 3-4 adverse event rate was higher with paclitaxel plus alisertib vs. paclitaxel alone (84.8% vs. 48.6%).

Study details: A phase 2, open-label, randomized study of 139 patients with metastatic breast cancer who received either paclitaxel or paclitaxel plus alisertib.

Disclosures: The study was supported by a research grant from Takeda Pharmaceuticals. Dr. O’Shaughnessy and Dr. Andorsky declared receiving personal fees, consulting and/or serving on steering committee meetings for various sources.

Source: O'Shaughnessy J et al. JAMA Netw Open. 2021 Apr 20. doi: 10.1001/jamanetworkopen.2021.4103.

Key clinical point: The addition of oral alisertib to a reduced dose of weekly paclitaxel improves progression-free survival (PFS) compared with paclitaxel alone in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Major finding: At a median follow-up of 22 months, the median PFS was 10.2 months with paclitaxel plus alisertib vs. 7.1 months with paclitaxel alone (hazard ratio, 0.56; P = .005) in the patients with ER+, HER2-negative disease. Grade 3-4 adverse event rate was higher with paclitaxel plus alisertib vs. paclitaxel alone (84.8% vs. 48.6%).

Study details: A phase 2, open-label, randomized study of 139 patients with metastatic breast cancer who received either paclitaxel or paclitaxel plus alisertib.

Disclosures: The study was supported by a research grant from Takeda Pharmaceuticals. Dr. O’Shaughnessy and Dr. Andorsky declared receiving personal fees, consulting and/or serving on steering committee meetings for various sources.

Source: O'Shaughnessy J et al. JAMA Netw Open. 2021 Apr 20. doi: 10.1001/jamanetworkopen.2021.4103.

Key clinical point: The addition of oral alisertib to a reduced dose of weekly paclitaxel improves progression-free survival (PFS) compared with paclitaxel alone in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

Major finding: At a median follow-up of 22 months, the median PFS was 10.2 months with paclitaxel plus alisertib vs. 7.1 months with paclitaxel alone (hazard ratio, 0.56; P = .005) in the patients with ER+, HER2-negative disease. Grade 3-4 adverse event rate was higher with paclitaxel plus alisertib vs. paclitaxel alone (84.8% vs. 48.6%).

Study details: A phase 2, open-label, randomized study of 139 patients with metastatic breast cancer who received either paclitaxel or paclitaxel plus alisertib.

Disclosures: The study was supported by a research grant from Takeda Pharmaceuticals. Dr. O’Shaughnessy and Dr. Andorsky declared receiving personal fees, consulting and/or serving on steering committee meetings for various sources.

Source: O'Shaughnessy J et al. JAMA Netw Open. 2021 Apr 20. doi: 10.1001/jamanetworkopen.2021.4103.

Two more cancer indications that had been granted accelerated approval by the Food and Drug Administration are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27-29) and follows a similar verdict from day 1.

Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indications for a number of immune checkpoint inhibitors, despite poor results in studies that were meant to confirm the benefit of these medicines for certain patients.

On the second day (April 28) of the FDA meeting, the Oncologic Drugs Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases of what top agency staff call “dangling accelerated approvals.”

ODAC voted 10-1 in favor of maintaining the indication for atezolizumab (Tecentriq) for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining accelerated approval for pembrolizumab (Keytruda) for first-line cisplatin- and carboplatin-ineligible patients with advanced/metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but it is not bound to do so. If the FDA were to decide to strip the indications in question from these PD-1 medicines, such decisions would not remove these drugs from the market. The three drugs have already been approved for a number of other cancer indications.

Off-label prescribing is not uncommon in oncology, but a loss of an approved indication would affect reimbursement for these medicines, Scot Ebbinghaus, MD, vice president of oncology clinical research at Merck (the manufacturer of pembrolizumab), told ODAC members during a discussion of the possible consequences of removing the indications in question.

“Access to those treatments may end up being substantially limited, and really the best way to ensure that there’s access is to maintain FDA approval,” Dr. Ebbinghaus said.

Another participant at the meeting asked the panel and the FDA to consider the burden on patients in paying for medicines that have not yet proved to be beneficial.

Diana Zuckerman, PhD, of the nonprofit National Center for Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in hopes that something will work,” she said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that isn’t proven to work?”

Rapid development of PD-1 drugs

Top officials at the FDA framed the challenges with accelerated approvals for immunotherapy drugs in an April 21 article in The New England Journal of Medicine. Over the course of about 6 years, the FDA approved six of these PD-1 or PD-L1 drugs for more than 75 indications in oncology, wrote Richard Pazdur, MD, and Julia A. Beaver, MD, of the FDA.

“Development of drugs in this class occurred more rapidly than that in any other therapeutic area in history,” they wrote.

In 10 cases, the required follow-up trials did not confirm the expected benefit, and yet marketing authorization for these drugs continued, leading Dr. Pazdur and Dr. Beaver to dub these “dangling” accelerated approvals. Four of these indications were voluntarily withdrawn. For the other six indications, the FDA sought feedback from ODAC during the 3-day meeting. Over the first 2 days of the meeting, ODAC recommended that three of these cancer indications remain. Three more will be considered on the last day of the meeting.

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

Two more cancer indications that had been granted accelerated approval by the Food and Drug Administration are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27-29) and follows a similar verdict from day 1.

Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indications for a number of immune checkpoint inhibitors, despite poor results in studies that were meant to confirm the benefit of these medicines for certain patients.

On the second day (April 28) of the FDA meeting, the Oncologic Drugs Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases of what top agency staff call “dangling accelerated approvals.”

ODAC voted 10-1 in favor of maintaining the indication for atezolizumab (Tecentriq) for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining accelerated approval for pembrolizumab (Keytruda) for first-line cisplatin- and carboplatin-ineligible patients with advanced/metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but it is not bound to do so. If the FDA were to decide to strip the indications in question from these PD-1 medicines, such decisions would not remove these drugs from the market. The three drugs have already been approved for a number of other cancer indications.

Off-label prescribing is not uncommon in oncology, but a loss of an approved indication would affect reimbursement for these medicines, Scot Ebbinghaus, MD, vice president of oncology clinical research at Merck (the manufacturer of pembrolizumab), told ODAC members during a discussion of the possible consequences of removing the indications in question.

“Access to those treatments may end up being substantially limited, and really the best way to ensure that there’s access is to maintain FDA approval,” Dr. Ebbinghaus said.

Another participant at the meeting asked the panel and the FDA to consider the burden on patients in paying for medicines that have not yet proved to be beneficial.

Diana Zuckerman, PhD, of the nonprofit National Center for Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in hopes that something will work,” she said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that isn’t proven to work?”

Rapid development of PD-1 drugs

Top officials at the FDA framed the challenges with accelerated approvals for immunotherapy drugs in an April 21 article in The New England Journal of Medicine. Over the course of about 6 years, the FDA approved six of these PD-1 or PD-L1 drugs for more than 75 indications in oncology, wrote Richard Pazdur, MD, and Julia A. Beaver, MD, of the FDA.

“Development of drugs in this class occurred more rapidly than that in any other therapeutic area in history,” they wrote.

In 10 cases, the required follow-up trials did not confirm the expected benefit, and yet marketing authorization for these drugs continued, leading Dr. Pazdur and Dr. Beaver to dub these “dangling” accelerated approvals. Four of these indications were voluntarily withdrawn. For the other six indications, the FDA sought feedback from ODAC during the 3-day meeting. Over the first 2 days of the meeting, ODAC recommended that three of these cancer indications remain. Three more will be considered on the last day of the meeting.

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

Two more cancer indications that had been granted accelerated approval by the Food and Drug Administration are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27-29) and follows a similar verdict from day 1.

Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indications for a number of immune checkpoint inhibitors, despite poor results in studies that were meant to confirm the benefit of these medicines for certain patients.

On the second day (April 28) of the FDA meeting, the Oncologic Drugs Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases of what top agency staff call “dangling accelerated approvals.”

ODAC voted 10-1 in favor of maintaining the indication for atezolizumab (Tecentriq) for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining accelerated approval for pembrolizumab (Keytruda) for first-line cisplatin- and carboplatin-ineligible patients with advanced/metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but it is not bound to do so. If the FDA were to decide to strip the indications in question from these PD-1 medicines, such decisions would not remove these drugs from the market. The three drugs have already been approved for a number of other cancer indications.

Off-label prescribing is not uncommon in oncology, but a loss of an approved indication would affect reimbursement for these medicines, Scot Ebbinghaus, MD, vice president of oncology clinical research at Merck (the manufacturer of pembrolizumab), told ODAC members during a discussion of the possible consequences of removing the indications in question.

“Access to those treatments may end up being substantially limited, and really the best way to ensure that there’s access is to maintain FDA approval,” Dr. Ebbinghaus said.

Another participant at the meeting asked the panel and the FDA to consider the burden on patients in paying for medicines that have not yet proved to be beneficial.

Diana Zuckerman, PhD, of the nonprofit National Center for Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in hopes that something will work,” she said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that isn’t proven to work?”

Rapid development of PD-1 drugs

Top officials at the FDA framed the challenges with accelerated approvals for immunotherapy drugs in an April 21 article in The New England Journal of Medicine. Over the course of about 6 years, the FDA approved six of these PD-1 or PD-L1 drugs for more than 75 indications in oncology, wrote Richard Pazdur, MD, and Julia A. Beaver, MD, of the FDA.

“Development of drugs in this class occurred more rapidly than that in any other therapeutic area in history,” they wrote.

In 10 cases, the required follow-up trials did not confirm the expected benefit, and yet marketing authorization for these drugs continued, leading Dr. Pazdur and Dr. Beaver to dub these “dangling” accelerated approvals. Four of these indications were voluntarily withdrawn. For the other six indications, the FDA sought feedback from ODAC during the 3-day meeting. Over the first 2 days of the meeting, ODAC recommended that three of these cancer indications remain. Three more will be considered on the last day of the meeting.

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

Key clinical point: The detrimental effects of chemotherapy on quality of life (QoL) are significant at 12 months in older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer treated with either chemotherapy plus trastuzumab vs. trastuzumab monotherapy. There was no difference in QoL after 36 months between treatments.

Major finding: At 12 months, the proportion of patients showing QoL deterioration was significantly lower in the trastuzumab monotherapy vs. trastuzumab plus chemotherapy group (19% vs. 38%; P = .009). A significantly higher number of patients showed improvement in QoL with trastuzumab monotherapy at 12 months (43% vs. 25%; P = .021). No difference was reported in any QoL items at 36 months between the 2 treatment groups.

Study details: The QoL analysis of phase 3, randomized RESPECT trial included 231 older patients with HER2-positive breast cancer who received either trastuzumab monotherapy (mean age, 73.9 years) or trastuzumab plus chemotherapy (mean age, 73.7 years).

Disclosures: The analysis was supported by the Comprehensive Support Project for Oncology Research of the Public Health Research Foundation, Japan. The authors received consulting fees, honoraria, and research funding outside this work.

Source: Taira N et al. J Clin Oncol. 2021 Apr 9. doi: 10.1200/JCO.20.02751.

Key clinical point: The detrimental effects of chemotherapy on quality of life (QoL) are significant at 12 months in older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer treated with either chemotherapy plus trastuzumab vs. trastuzumab monotherapy. There was no difference in QoL after 36 months between treatments.

Major finding: At 12 months, the proportion of patients showing QoL deterioration was significantly lower in the trastuzumab monotherapy vs. trastuzumab plus chemotherapy group (19% vs. 38%; P = .009). A significantly higher number of patients showed improvement in QoL with trastuzumab monotherapy at 12 months (43% vs. 25%; P = .021). No difference was reported in any QoL items at 36 months between the 2 treatment groups.

Study details: The QoL analysis of phase 3, randomized RESPECT trial included 231 older patients with HER2-positive breast cancer who received either trastuzumab monotherapy (mean age, 73.9 years) or trastuzumab plus chemotherapy (mean age, 73.7 years).

Disclosures: The analysis was supported by the Comprehensive Support Project for Oncology Research of the Public Health Research Foundation, Japan. The authors received consulting fees, honoraria, and research funding outside this work.

Source: Taira N et al. J Clin Oncol. 2021 Apr 9. doi: 10.1200/JCO.20.02751.

Key clinical point: The detrimental effects of chemotherapy on quality of life (QoL) are significant at 12 months in older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer treated with either chemotherapy plus trastuzumab vs. trastuzumab monotherapy. There was no difference in QoL after 36 months between treatments.

Major finding: At 12 months, the proportion of patients showing QoL deterioration was significantly lower in the trastuzumab monotherapy vs. trastuzumab plus chemotherapy group (19% vs. 38%; P = .009). A significantly higher number of patients showed improvement in QoL with trastuzumab monotherapy at 12 months (43% vs. 25%; P = .021). No difference was reported in any QoL items at 36 months between the 2 treatment groups.

Study details: The QoL analysis of phase 3, randomized RESPECT trial included 231 older patients with HER2-positive breast cancer who received either trastuzumab monotherapy (mean age, 73.9 years) or trastuzumab plus chemotherapy (mean age, 73.7 years).

Disclosures: The analysis was supported by the Comprehensive Support Project for Oncology Research of the Public Health Research Foundation, Japan. The authors received consulting fees, honoraria, and research funding outside this work.

Source: Taira N et al. J Clin Oncol. 2021 Apr 9. doi: 10.1200/JCO.20.02751.

Key clinical point: Pembrolizumab plus eribulin shows activity in patients with heavily pretreated, hormone-receptor–positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative, locally recurrent, or metastatic breast cancer.

Major finding: The clinical benefit rate was 56.8%, and the objective response rate was 40.9%. The median progression-free survival was 6.0 months. The serious adverse event rate was 31.8%, and 25.0% of patients experienced immune-related adverse events.

Study details: Phase 2 study of 44 previously treated patients with HR+, HER-negative, inoperable, locally recurrent breast cancer received pembrolizumab plus eribulin.

Disclosures: The study was supported by MSD Spain. Some of the authors declared receiving consulting fees, honoraria, travel expenses and/or research funding from various sources.

Source: Pérez-García JM et al. Eur J Cancer. 2021 Mar 29. doi: 10.1016/j.ejca.2021.02.028.

Key clinical point: Pembrolizumab plus eribulin shows activity in patients with heavily pretreated, hormone-receptor–positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative, locally recurrent, or metastatic breast cancer.

Major finding: The clinical benefit rate was 56.8%, and the objective response rate was 40.9%. The median progression-free survival was 6.0 months. The serious adverse event rate was 31.8%, and 25.0% of patients experienced immune-related adverse events.

Study details: Phase 2 study of 44 previously treated patients with HR+, HER-negative, inoperable, locally recurrent breast cancer received pembrolizumab plus eribulin.

Disclosures: The study was supported by MSD Spain. Some of the authors declared receiving consulting fees, honoraria, travel expenses and/or research funding from various sources.

Source: Pérez-García JM et al. Eur J Cancer. 2021 Mar 29. doi: 10.1016/j.ejca.2021.02.028.

Key clinical point: Pembrolizumab plus eribulin shows activity in patients with heavily pretreated, hormone-receptor–positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative, locally recurrent, or metastatic breast cancer.

Major finding: The clinical benefit rate was 56.8%, and the objective response rate was 40.9%. The median progression-free survival was 6.0 months. The serious adverse event rate was 31.8%, and 25.0% of patients experienced immune-related adverse events.

Study details: Phase 2 study of 44 previously treated patients with HR+, HER-negative, inoperable, locally recurrent breast cancer received pembrolizumab plus eribulin.

Disclosures: The study was supported by MSD Spain. Some of the authors declared receiving consulting fees, honoraria, travel expenses and/or research funding from various sources.

Source: Pérez-García JM et al. Eur J Cancer. 2021 Mar 29. doi: 10.1016/j.ejca.2021.02.028.

Key clinical point: Long-term data show similar local control rates with 10-Gy intraoperative electron radiotherapy (IOERT) vs. external beam radiotherapy (EBRT).

Major finding: The cumulative risk for in-breast true recurrences at 10 years was 4.3% after IOERT vs. 5.3% after EBRT boost (P = .493). The cumulative risk for out-field local recurrence at 10 years was 7.9% for IOERT vs. 10.3% for EBRT (P = .611).

Study details: Phase 3 randomized study of 245 patients with early-stage breast cancer who underwent breast-conserving surgery with either 10-Gy IOERT or EBRT boost.

Disclosures: An author received a study grant from IntraOp Medical. The authors declared no conflict of interests.

Source: Ciabattoni A et al. Breast Can Res. 2021 Apr 13. doi: 10.1186/s13058-021-01424-9.

Key clinical point: Long-term data show similar local control rates with 10-Gy intraoperative electron radiotherapy (IOERT) vs. external beam radiotherapy (EBRT).

Major finding: The cumulative risk for in-breast true recurrences at 10 years was 4.3% after IOERT vs. 5.3% after EBRT boost (P = .493). The cumulative risk for out-field local recurrence at 10 years was 7.9% for IOERT vs. 10.3% for EBRT (P = .611).

Study details: Phase 3 randomized study of 245 patients with early-stage breast cancer who underwent breast-conserving surgery with either 10-Gy IOERT or EBRT boost.

Disclosures: An author received a study grant from IntraOp Medical. The authors declared no conflict of interests.

Source: Ciabattoni A et al. Breast Can Res. 2021 Apr 13. doi: 10.1186/s13058-021-01424-9.

Key clinical point: Long-term data show similar local control rates with 10-Gy intraoperative electron radiotherapy (IOERT) vs. external beam radiotherapy (EBRT).

Major finding: The cumulative risk for in-breast true recurrences at 10 years was 4.3% after IOERT vs. 5.3% after EBRT boost (P = .493). The cumulative risk for out-field local recurrence at 10 years was 7.9% for IOERT vs. 10.3% for EBRT (P = .611).

Study details: Phase 3 randomized study of 245 patients with early-stage breast cancer who underwent breast-conserving surgery with either 10-Gy IOERT or EBRT boost.

Disclosures: An author received a study grant from IntraOp Medical. The authors declared no conflict of interests.

Source: Ciabattoni A et al. Breast Can Res. 2021 Apr 13. doi: 10.1186/s13058-021-01424-9.

Key clinical point: Sacituzumab govitecan improves survival vs. single-agent chemotherapy in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: Sacituzumab govitecan vs. chemotherapy showed 59% and 52% reduction in the risk for progression and mortality, respectively (P less than .001 for both). The objective response rate was 35% with sacituzumab govitecan and 5% with chemotherapy. Grade 3-4 adverse event rate was 64% and 47% in the sacituzumab govitecan and chemotherapy groups, respectively.

Study details: A phase 3 ASCENT study of patients with relapsed or refractory TNBC, randomly assigned to receive either sacituzumab govitecan or single-agent chemotherapy of physician’s choice.

Disclosures: The study was supported by Immunomedics, a subsidiary of Gilead Sciences. The authors received consulting fees outside this work.

Source: Bardia A et al. New Eng J Med. 2021 Apr 22. doi: 10.1056/NEJMoa2028485.

Key clinical point: Sacituzumab govitecan improves survival vs. single-agent chemotherapy in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: Sacituzumab govitecan vs. chemotherapy showed 59% and 52% reduction in the risk for progression and mortality, respectively (P less than .001 for both). The objective response rate was 35% with sacituzumab govitecan and 5% with chemotherapy. Grade 3-4 adverse event rate was 64% and 47% in the sacituzumab govitecan and chemotherapy groups, respectively.

Study details: A phase 3 ASCENT study of patients with relapsed or refractory TNBC, randomly assigned to receive either sacituzumab govitecan or single-agent chemotherapy of physician’s choice.

Disclosures: The study was supported by Immunomedics, a subsidiary of Gilead Sciences. The authors received consulting fees outside this work.

Source: Bardia A et al. New Eng J Med. 2021 Apr 22. doi: 10.1056/NEJMoa2028485.

Key clinical point: Sacituzumab govitecan improves survival vs. single-agent chemotherapy in patients with metastatic triple-negative breast cancer (TNBC).

Major finding: Sacituzumab govitecan vs. chemotherapy showed 59% and 52% reduction in the risk for progression and mortality, respectively (P less than .001 for both). The objective response rate was 35% with sacituzumab govitecan and 5% with chemotherapy. Grade 3-4 adverse event rate was 64% and 47% in the sacituzumab govitecan and chemotherapy groups, respectively.

Study details: A phase 3 ASCENT study of patients with relapsed or refractory TNBC, randomly assigned to receive either sacituzumab govitecan or single-agent chemotherapy of physician’s choice.

Disclosures: The study was supported by Immunomedics, a subsidiary of Gilead Sciences. The authors received consulting fees outside this work.

Source: Bardia A et al. New Eng J Med. 2021 Apr 22. doi: 10.1056/NEJMoa2028485.