Breast Cancer

Federal advisers have supported the efforts of pharmaceutical companies in four of six cases in which these firms are fighting to maintain cancer indications for approved drugs. The advisers voted against the companies in two cases.

The staff of the Food and Drug Administration will now consider these votes as they decide what to do regarding the six cases of what they have termed “dangling” accelerated approvals.

“One of the reasons I think we’re convening today is to prevent these accelerated approvals from dangling ad infinitum,” commented one of the members of the advisory panel.

In these cases, companies have been unable to prove the expected benefits that led the FDA to grant accelerated approvals for these indications.

These accelerated approvals, which are often based on surrogate endpoints, such as overall response rates, are granted on the condition that further findings show a clinical benefit – such as in progression-free survival or overall survival – in larger trials.

The FDA tasked its Oncologic Drugs Advisory Committee (ODAC) with conducting the review of the six accelerated approvals for cancer indications at a 3-day meeting (April 27-29).

These reviews were only for specific cancer indications and will not lead to the removal of drugs from the market. These drugs have already been approved for several cancer indications. For example, one of the drugs that was reviewed, pembrolizumab (Keytruda), is approved in the United States for 28 indications.

The FDA is facing growing pains in its efforts to manage the rapidly changing landscape for these immune checkpoint inhibitors. This field of medicine has experienced an “unprecedented level of drug development” in recent years, FDA officials said in briefing materials, owing in part to the agency’s willingness to accept surrogate markers for accelerated approvals. Although some companies have struggled with these, others have built strong cases for the use of their checkpoint inhibitors for these indications.

The ODAC panelists, for example, noted the emergence of nivolumab (Opdivo) as an option for patients with gastric cancer as a reason for seeking to withdraw an indication for pembrolizumab (Keytruda) for this disease.

Just weeks before the meeting, on April 16, the FDA approved nivolumab plus chemotherapy as a first-line treatment for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This was a full approval based on data showing an overall survival benefit from a phase 3 trial.
 

Votes by indication

On April 29, the last day of the meeting, the ODAC panel voted 6-2 against maintaining pembrolizumab’s indication as monotherapy for an advanced form of gastric cancer. This was an accelerated approval (granted in 2017) that was based on overall response rates from an open-label trial.

That last day of the meeting also saw another negative vote. On April 29, the ODAC panel voted 5-4 against maintaining an indication for nivolumab in patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib (Nexavar).

This accelerated approval for nivolumab was granted in 2017. The FDA said it had requested ODAC’s feedback on this indication because of the recent full approval of another checkpoint inhibitor for HCC, atezolizumab (Tecentriq), in combination with bevacizumab (Avastin) for patients with unresectable or metastatic diseases who have not received prior systemic therapy. This full approval (in May 2020) was based on an overall survival benefit.

There was one last vote on the third day of the meeting, and it was positive. The ODAC panel voted 8-0 in favor of maintaining the indication for the use of pembrolizumab as monotherapy for patients with HCC who have previously been treated with sorafenib.

The FDA altered the composition of the ODAC panel during the week, adding members in some cases who had expertise in particular cancers. That led to different totals for the week’s ODAC votes, as shown in the tallies summarized below.

On the first day of the meeting (April 27), the ODAC panel voted 7-2 in favor of maintaining a breast cancer indication for atezolizumab (Tecentriq). This covered use of the immunotherapy in combination with nab-paclitaxel for patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1.

The second day of the meeting (April 28) also saw two positive votes. The ODAC panel voted 10-1 for maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial. The panel also voted 5-3 for maintaining the indication for pembrolizumab in patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1.

The FDA is not bound to follow the voting and recommendations of its advisory panels, but it usually does so.
 

Managing shifts in treatment

In both of the cases in which ODAC voted against maintaining indications, Richard Pazdur, MD, the FDA’s top regulator for cancer medicines, jumped into the debate. Dr. Pazdur countered arguments put forward by representatives of the manufacturers as they sought to maintain indications for their drugs.

Merck officials and representatives argued for pembrolizumab, saying that maintaining the gastric cancer indication might help patients whose disease has progressed despite earlier treatment.

Dr. Pazdur emphasized that the agency would help Merck and physicians to have access to pembrolizumab for these patients even if this one indication were to be withdrawn. But Dr. Pazdur and ODAC members also noted the recent shift in the landscape for gastric cancer, with the recent approval of a new indication for nivolumab.

“I want to emphasize to the patient community out there [that] we firmly believe in the role of checkpoint inhibitors in this disease,” Dr. Pazdur said during the discussion of the indication for pembrolizumab for gastric cancer. “We have to be cognizant of what is the appropriate setting for that, and it currently is in the first line.”

Dr. Pazdur noted that two studies had failed to confirm the expected benefit from pembrolizumab for patients with more advanced disease. Still, if “small numbers” of patients with advanced disease wanted access to Merck’s drug, the FDA and the company could accommodate them. The FDA could delay the removal of the gastric indication to allow patients to continue receiving it. The FDA also could work with physicians on other routes to provide the medicine, such as through single-patient investigational new drug applications or an expanded access program.

“Or Merck can alternatively give the drug gratis to patients,” Dr. Pazdur said.
 

#ProjectFacilitate for expanded access

One of Merck’s speakers at the ODAC meeting, Peter Enzinger, MD, of the Dana-Farber Cancer Institute, Boston, objected to Dr. Pazdur’s plan.

A loss of the gastric indication for pembrolizumab would result in patients with advanced cancer missing out on a chance to try this therapy. Some patients will not have had a chance to try a checkpoint inhibitor earlier in their treatment, and a loss of the indication would cost them that opportunity, he said.

“An expanded-access program sounds very nice, but the reality is that our patients are incredibly sick and that weeks matter,” Dr. Enzinger said, citing administrative hurdles as a barrier to treatment.

“Our patients just don’t have the time for that, and therefore I don’t think an expanded access program is the way to go,” Dr. Enzinger said.

Dr. Pazdur responded to these objections by highlighting an initiative called Project Facilitate at the FDA’s Oncology Center for Excellence. During the meeting, Dr. Pazdur’s division used its @FDAOncology Twitter handle to draw attention to this project.

ODAC panelist Diane Reidy-Lagunes, MD, of Memorial Sloan Kettering Cancer Center, New York, said she had struggled with this vote. She was one of the two panelists to vote in favor of keeping the indication.

“This is also incredibly hard for me. I actually changed it at the last minute,” she said of her vote.

But Dr. Reidy-Lagunes said she was concerned that some patients with advanced disease might not be able to get a checkpoint inhibitor.

“With disparities in healthcare and differences in the way that patients are treated throughout our country, I was nervous that they may not be able to get treated,” she said, noting that she shared her fellow panelists’ doubts about use of pembrolizumab as third-line treatment, owing to negative results in trials.

ODAC member David Mitchell, who served as a consumer representative, also said he found the vote on the gastric indication for pembrolizumab to be a difficult decision.

“As a patient with incurable cancer who’s now being given all three major classes of drugs to treat my disease in combination, these issues really cut close to home,” Mr. Mitchell said.

He said the expectation that the FDA’s expanded access program could help patients with advanced disease try pembrolizumab helped him decide to vote with the 6-2 majority against maintaining this gastric cancer approval.

His vote was based on “the changing treatment landscape.” There is general agreement that the patients in question should receive checkpoint inhibitors as first-line treatment, not third-line treatment, Mr. Mitchell said. The FDA should delay a withdrawal of the approval for pembrolizumab in this case and should allow a transition for those who missed out on treatment with a checkpoint inhibitor earlier in the disease course, he suggested.

“To protect the safety and well-being of patients, we have to base decisions on data,” Mr. Mitchell said. “The data don’t support maintaining the indication” for pembrolizumab.

 

Close split on nivolumab

In contrast to the 6-2 vote against maintaining the pembrolizumab indication, the ODAC panel split more closely, 5-4, on the question of maintaining an indication for the use as monotherapy of nivolumab in HCC.

ODAC panelist Philip C. Hoffman, MD, of the University of Chicago was among those who supported keeping the indication.

“There’s still an unmet need for second-line immunotherapy because there will always be some patients who are poor candidates for bevacizumab or who are not tolerating or responding to sorafenib,” he said.

ODAC panelist Mark A. Lewis, MD, of Intermountain Healthcare, Salt Lake City, said he voted “no” in part because he doubted that Bristol-Myers Squibb would be able to soon produce data for nivolumab that was needed to support this indication.

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

Federal advisers have supported the efforts of pharmaceutical companies in four of six cases in which these firms are fighting to maintain cancer indications for approved drugs. The advisers voted against the companies in two cases.

The staff of the Food and Drug Administration will now consider these votes as they decide what to do regarding the six cases of what they have termed “dangling” accelerated approvals.

“One of the reasons I think we’re convening today is to prevent these accelerated approvals from dangling ad infinitum,” commented one of the members of the advisory panel.

In these cases, companies have been unable to prove the expected benefits that led the FDA to grant accelerated approvals for these indications.

These accelerated approvals, which are often based on surrogate endpoints, such as overall response rates, are granted on the condition that further findings show a clinical benefit – such as in progression-free survival or overall survival – in larger trials.

The FDA tasked its Oncologic Drugs Advisory Committee (ODAC) with conducting the review of the six accelerated approvals for cancer indications at a 3-day meeting (April 27-29).

These reviews were only for specific cancer indications and will not lead to the removal of drugs from the market. These drugs have already been approved for several cancer indications. For example, one of the drugs that was reviewed, pembrolizumab (Keytruda), is approved in the United States for 28 indications.

The FDA is facing growing pains in its efforts to manage the rapidly changing landscape for these immune checkpoint inhibitors. This field of medicine has experienced an “unprecedented level of drug development” in recent years, FDA officials said in briefing materials, owing in part to the agency’s willingness to accept surrogate markers for accelerated approvals. Although some companies have struggled with these, others have built strong cases for the use of their checkpoint inhibitors for these indications.

The ODAC panelists, for example, noted the emergence of nivolumab (Opdivo) as an option for patients with gastric cancer as a reason for seeking to withdraw an indication for pembrolizumab (Keytruda) for this disease.

Just weeks before the meeting, on April 16, the FDA approved nivolumab plus chemotherapy as a first-line treatment for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This was a full approval based on data showing an overall survival benefit from a phase 3 trial.
 

Votes by indication

On April 29, the last day of the meeting, the ODAC panel voted 6-2 against maintaining pembrolizumab’s indication as monotherapy for an advanced form of gastric cancer. This was an accelerated approval (granted in 2017) that was based on overall response rates from an open-label trial.

That last day of the meeting also saw another negative vote. On April 29, the ODAC panel voted 5-4 against maintaining an indication for nivolumab in patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib (Nexavar).

This accelerated approval for nivolumab was granted in 2017. The FDA said it had requested ODAC’s feedback on this indication because of the recent full approval of another checkpoint inhibitor for HCC, atezolizumab (Tecentriq), in combination with bevacizumab (Avastin) for patients with unresectable or metastatic diseases who have not received prior systemic therapy. This full approval (in May 2020) was based on an overall survival benefit.

There was one last vote on the third day of the meeting, and it was positive. The ODAC panel voted 8-0 in favor of maintaining the indication for the use of pembrolizumab as monotherapy for patients with HCC who have previously been treated with sorafenib.

The FDA altered the composition of the ODAC panel during the week, adding members in some cases who had expertise in particular cancers. That led to different totals for the week’s ODAC votes, as shown in the tallies summarized below.

On the first day of the meeting (April 27), the ODAC panel voted 7-2 in favor of maintaining a breast cancer indication for atezolizumab (Tecentriq). This covered use of the immunotherapy in combination with nab-paclitaxel for patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1.

The second day of the meeting (April 28) also saw two positive votes. The ODAC panel voted 10-1 for maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial. The panel also voted 5-3 for maintaining the indication for pembrolizumab in patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1.

The FDA is not bound to follow the voting and recommendations of its advisory panels, but it usually does so.
 

Managing shifts in treatment

In both of the cases in which ODAC voted against maintaining indications, Richard Pazdur, MD, the FDA’s top regulator for cancer medicines, jumped into the debate. Dr. Pazdur countered arguments put forward by representatives of the manufacturers as they sought to maintain indications for their drugs.

Merck officials and representatives argued for pembrolizumab, saying that maintaining the gastric cancer indication might help patients whose disease has progressed despite earlier treatment.

Dr. Pazdur emphasized that the agency would help Merck and physicians to have access to pembrolizumab for these patients even if this one indication were to be withdrawn. But Dr. Pazdur and ODAC members also noted the recent shift in the landscape for gastric cancer, with the recent approval of a new indication for nivolumab.

“I want to emphasize to the patient community out there [that] we firmly believe in the role of checkpoint inhibitors in this disease,” Dr. Pazdur said during the discussion of the indication for pembrolizumab for gastric cancer. “We have to be cognizant of what is the appropriate setting for that, and it currently is in the first line.”

Dr. Pazdur noted that two studies had failed to confirm the expected benefit from pembrolizumab for patients with more advanced disease. Still, if “small numbers” of patients with advanced disease wanted access to Merck’s drug, the FDA and the company could accommodate them. The FDA could delay the removal of the gastric indication to allow patients to continue receiving it. The FDA also could work with physicians on other routes to provide the medicine, such as through single-patient investigational new drug applications or an expanded access program.

“Or Merck can alternatively give the drug gratis to patients,” Dr. Pazdur said.
 

#ProjectFacilitate for expanded access

One of Merck’s speakers at the ODAC meeting, Peter Enzinger, MD, of the Dana-Farber Cancer Institute, Boston, objected to Dr. Pazdur’s plan.

A loss of the gastric indication for pembrolizumab would result in patients with advanced cancer missing out on a chance to try this therapy. Some patients will not have had a chance to try a checkpoint inhibitor earlier in their treatment, and a loss of the indication would cost them that opportunity, he said.

“An expanded-access program sounds very nice, but the reality is that our patients are incredibly sick and that weeks matter,” Dr. Enzinger said, citing administrative hurdles as a barrier to treatment.

“Our patients just don’t have the time for that, and therefore I don’t think an expanded access program is the way to go,” Dr. Enzinger said.

Dr. Pazdur responded to these objections by highlighting an initiative called Project Facilitate at the FDA’s Oncology Center for Excellence. During the meeting, Dr. Pazdur’s division used its @FDAOncology Twitter handle to draw attention to this project.

ODAC panelist Diane Reidy-Lagunes, MD, of Memorial Sloan Kettering Cancer Center, New York, said she had struggled with this vote. She was one of the two panelists to vote in favor of keeping the indication.

“This is also incredibly hard for me. I actually changed it at the last minute,” she said of her vote.

But Dr. Reidy-Lagunes said she was concerned that some patients with advanced disease might not be able to get a checkpoint inhibitor.

“With disparities in healthcare and differences in the way that patients are treated throughout our country, I was nervous that they may not be able to get treated,” she said, noting that she shared her fellow panelists’ doubts about use of pembrolizumab as third-line treatment, owing to negative results in trials.

ODAC member David Mitchell, who served as a consumer representative, also said he found the vote on the gastric indication for pembrolizumab to be a difficult decision.

“As a patient with incurable cancer who’s now being given all three major classes of drugs to treat my disease in combination, these issues really cut close to home,” Mr. Mitchell said.

He said the expectation that the FDA’s expanded access program could help patients with advanced disease try pembrolizumab helped him decide to vote with the 6-2 majority against maintaining this gastric cancer approval.

His vote was based on “the changing treatment landscape.” There is general agreement that the patients in question should receive checkpoint inhibitors as first-line treatment, not third-line treatment, Mr. Mitchell said. The FDA should delay a withdrawal of the approval for pembrolizumab in this case and should allow a transition for those who missed out on treatment with a checkpoint inhibitor earlier in the disease course, he suggested.

“To protect the safety and well-being of patients, we have to base decisions on data,” Mr. Mitchell said. “The data don’t support maintaining the indication” for pembrolizumab.

 

Close split on nivolumab

In contrast to the 6-2 vote against maintaining the pembrolizumab indication, the ODAC panel split more closely, 5-4, on the question of maintaining an indication for the use as monotherapy of nivolumab in HCC.

ODAC panelist Philip C. Hoffman, MD, of the University of Chicago was among those who supported keeping the indication.

“There’s still an unmet need for second-line immunotherapy because there will always be some patients who are poor candidates for bevacizumab or who are not tolerating or responding to sorafenib,” he said.

ODAC panelist Mark A. Lewis, MD, of Intermountain Healthcare, Salt Lake City, said he voted “no” in part because he doubted that Bristol-Myers Squibb would be able to soon produce data for nivolumab that was needed to support this indication.

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

Federal advisers have supported the efforts of pharmaceutical companies in four of six cases in which these firms are fighting to maintain cancer indications for approved drugs. The advisers voted against the companies in two cases.

The staff of the Food and Drug Administration will now consider these votes as they decide what to do regarding the six cases of what they have termed “dangling” accelerated approvals.

“One of the reasons I think we’re convening today is to prevent these accelerated approvals from dangling ad infinitum,” commented one of the members of the advisory panel.

In these cases, companies have been unable to prove the expected benefits that led the FDA to grant accelerated approvals for these indications.

These accelerated approvals, which are often based on surrogate endpoints, such as overall response rates, are granted on the condition that further findings show a clinical benefit – such as in progression-free survival or overall survival – in larger trials.

The FDA tasked its Oncologic Drugs Advisory Committee (ODAC) with conducting the review of the six accelerated approvals for cancer indications at a 3-day meeting (April 27-29).

These reviews were only for specific cancer indications and will not lead to the removal of drugs from the market. These drugs have already been approved for several cancer indications. For example, one of the drugs that was reviewed, pembrolizumab (Keytruda), is approved in the United States for 28 indications.

The FDA is facing growing pains in its efforts to manage the rapidly changing landscape for these immune checkpoint inhibitors. This field of medicine has experienced an “unprecedented level of drug development” in recent years, FDA officials said in briefing materials, owing in part to the agency’s willingness to accept surrogate markers for accelerated approvals. Although some companies have struggled with these, others have built strong cases for the use of their checkpoint inhibitors for these indications.

The ODAC panelists, for example, noted the emergence of nivolumab (Opdivo) as an option for patients with gastric cancer as a reason for seeking to withdraw an indication for pembrolizumab (Keytruda) for this disease.

Just weeks before the meeting, on April 16, the FDA approved nivolumab plus chemotherapy as a first-line treatment for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This was a full approval based on data showing an overall survival benefit from a phase 3 trial.
 

Votes by indication

On April 29, the last day of the meeting, the ODAC panel voted 6-2 against maintaining pembrolizumab’s indication as monotherapy for an advanced form of gastric cancer. This was an accelerated approval (granted in 2017) that was based on overall response rates from an open-label trial.

That last day of the meeting also saw another negative vote. On April 29, the ODAC panel voted 5-4 against maintaining an indication for nivolumab in patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib (Nexavar).

This accelerated approval for nivolumab was granted in 2017. The FDA said it had requested ODAC’s feedback on this indication because of the recent full approval of another checkpoint inhibitor for HCC, atezolizumab (Tecentriq), in combination with bevacizumab (Avastin) for patients with unresectable or metastatic diseases who have not received prior systemic therapy. This full approval (in May 2020) was based on an overall survival benefit.

There was one last vote on the third day of the meeting, and it was positive. The ODAC panel voted 8-0 in favor of maintaining the indication for the use of pembrolizumab as monotherapy for patients with HCC who have previously been treated with sorafenib.

The FDA altered the composition of the ODAC panel during the week, adding members in some cases who had expertise in particular cancers. That led to different totals for the week’s ODAC votes, as shown in the tallies summarized below.

On the first day of the meeting (April 27), the ODAC panel voted 7-2 in favor of maintaining a breast cancer indication for atezolizumab (Tecentriq). This covered use of the immunotherapy in combination with nab-paclitaxel for patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1.

The second day of the meeting (April 28) also saw two positive votes. The ODAC panel voted 10-1 for maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial. The panel also voted 5-3 for maintaining the indication for pembrolizumab in patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1.

The FDA is not bound to follow the voting and recommendations of its advisory panels, but it usually does so.
 

Managing shifts in treatment

In both of the cases in which ODAC voted against maintaining indications, Richard Pazdur, MD, the FDA’s top regulator for cancer medicines, jumped into the debate. Dr. Pazdur countered arguments put forward by representatives of the manufacturers as they sought to maintain indications for their drugs.

Merck officials and representatives argued for pembrolizumab, saying that maintaining the gastric cancer indication might help patients whose disease has progressed despite earlier treatment.

Dr. Pazdur emphasized that the agency would help Merck and physicians to have access to pembrolizumab for these patients even if this one indication were to be withdrawn. But Dr. Pazdur and ODAC members also noted the recent shift in the landscape for gastric cancer, with the recent approval of a new indication for nivolumab.

“I want to emphasize to the patient community out there [that] we firmly believe in the role of checkpoint inhibitors in this disease,” Dr. Pazdur said during the discussion of the indication for pembrolizumab for gastric cancer. “We have to be cognizant of what is the appropriate setting for that, and it currently is in the first line.”

Dr. Pazdur noted that two studies had failed to confirm the expected benefit from pembrolizumab for patients with more advanced disease. Still, if “small numbers” of patients with advanced disease wanted access to Merck’s drug, the FDA and the company could accommodate them. The FDA could delay the removal of the gastric indication to allow patients to continue receiving it. The FDA also could work with physicians on other routes to provide the medicine, such as through single-patient investigational new drug applications or an expanded access program.

“Or Merck can alternatively give the drug gratis to patients,” Dr. Pazdur said.
 

#ProjectFacilitate for expanded access

One of Merck’s speakers at the ODAC meeting, Peter Enzinger, MD, of the Dana-Farber Cancer Institute, Boston, objected to Dr. Pazdur’s plan.

A loss of the gastric indication for pembrolizumab would result in patients with advanced cancer missing out on a chance to try this therapy. Some patients will not have had a chance to try a checkpoint inhibitor earlier in their treatment, and a loss of the indication would cost them that opportunity, he said.

“An expanded-access program sounds very nice, but the reality is that our patients are incredibly sick and that weeks matter,” Dr. Enzinger said, citing administrative hurdles as a barrier to treatment.

“Our patients just don’t have the time for that, and therefore I don’t think an expanded access program is the way to go,” Dr. Enzinger said.

Dr. Pazdur responded to these objections by highlighting an initiative called Project Facilitate at the FDA’s Oncology Center for Excellence. During the meeting, Dr. Pazdur’s division used its @FDAOncology Twitter handle to draw attention to this project.

ODAC panelist Diane Reidy-Lagunes, MD, of Memorial Sloan Kettering Cancer Center, New York, said she had struggled with this vote. She was one of the two panelists to vote in favor of keeping the indication.

“This is also incredibly hard for me. I actually changed it at the last minute,” she said of her vote.

But Dr. Reidy-Lagunes said she was concerned that some patients with advanced disease might not be able to get a checkpoint inhibitor.

“With disparities in healthcare and differences in the way that patients are treated throughout our country, I was nervous that they may not be able to get treated,” she said, noting that she shared her fellow panelists’ doubts about use of pembrolizumab as third-line treatment, owing to negative results in trials.

ODAC member David Mitchell, who served as a consumer representative, also said he found the vote on the gastric indication for pembrolizumab to be a difficult decision.

“As a patient with incurable cancer who’s now being given all three major classes of drugs to treat my disease in combination, these issues really cut close to home,” Mr. Mitchell said.

He said the expectation that the FDA’s expanded access program could help patients with advanced disease try pembrolizumab helped him decide to vote with the 6-2 majority against maintaining this gastric cancer approval.

His vote was based on “the changing treatment landscape.” There is general agreement that the patients in question should receive checkpoint inhibitors as first-line treatment, not third-line treatment, Mr. Mitchell said. The FDA should delay a withdrawal of the approval for pembrolizumab in this case and should allow a transition for those who missed out on treatment with a checkpoint inhibitor earlier in the disease course, he suggested.

“To protect the safety and well-being of patients, we have to base decisions on data,” Mr. Mitchell said. “The data don’t support maintaining the indication” for pembrolizumab.

 

Close split on nivolumab

In contrast to the 6-2 vote against maintaining the pembrolizumab indication, the ODAC panel split more closely, 5-4, on the question of maintaining an indication for the use as monotherapy of nivolumab in HCC.

ODAC panelist Philip C. Hoffman, MD, of the University of Chicago was among those who supported keeping the indication.

“There’s still an unmet need for second-line immunotherapy because there will always be some patients who are poor candidates for bevacizumab or who are not tolerating or responding to sorafenib,” he said.

ODAC panelist Mark A. Lewis, MD, of Intermountain Healthcare, Salt Lake City, said he voted “no” in part because he doubted that Bristol-Myers Squibb would be able to soon produce data for nivolumab that was needed to support this indication.

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

Key clinical point: The addition of palbociclib to estrogen therapy for 1 year does not improve invasive disease-free survival (DFS) in high-risk patients with hormone-receptor–positive (HR+), human epidermal growth factor receptor (HER)-negative early breast cancer who had residual invasive disease after neoadjuvant chemotherapy.

Major finding: Palbociclib did not improve invasive DFS vs. placebo (stratified hazard ratio, 0.93; P = .525) after a median follow-up of 42.8 months. Incidences of grade 3-4 neutropenia and leukopenia were significantly higher in the palbociclib group. Eight fatal serious adverse events were reported.

Study details: A phase 3, double-blind, randomized PENELOPE-B study evaluated 1,250 high-risk patients with HR+, HER-negative early breast cancer who have residual invasive disease after neoadjuvant chemotherapy. Patients received estrogen therapy with either palbociclib or placebo.

Disclosures: The study was supported by Pfizer. The authors declared receiving consulting, honoraria, travel/accomodation expenses and research funding outside the study work. Some of the authors declared being employee of and/or stocks/ownership interests of various sources including Pfizer.

Source: Loibl S et al. J Clin Oncol. 2021 Apr 1. doi: 10.1200/JCO.20.03639.

Key clinical point: The addition of palbociclib to estrogen therapy for 1 year does not improve invasive disease-free survival (DFS) in high-risk patients with hormone-receptor–positive (HR+), human epidermal growth factor receptor (HER)-negative early breast cancer who had residual invasive disease after neoadjuvant chemotherapy.

Major finding: Palbociclib did not improve invasive DFS vs. placebo (stratified hazard ratio, 0.93; P = .525) after a median follow-up of 42.8 months. Incidences of grade 3-4 neutropenia and leukopenia were significantly higher in the palbociclib group. Eight fatal serious adverse events were reported.

Study details: A phase 3, double-blind, randomized PENELOPE-B study evaluated 1,250 high-risk patients with HR+, HER-negative early breast cancer who have residual invasive disease after neoadjuvant chemotherapy. Patients received estrogen therapy with either palbociclib or placebo.

Disclosures: The study was supported by Pfizer. The authors declared receiving consulting, honoraria, travel/accomodation expenses and research funding outside the study work. Some of the authors declared being employee of and/or stocks/ownership interests of various sources including Pfizer.

Source: Loibl S et al. J Clin Oncol. 2021 Apr 1. doi: 10.1200/JCO.20.03639.

Key clinical point: The addition of palbociclib to estrogen therapy for 1 year does not improve invasive disease-free survival (DFS) in high-risk patients with hormone-receptor–positive (HR+), human epidermal growth factor receptor (HER)-negative early breast cancer who had residual invasive disease after neoadjuvant chemotherapy.

Major finding: Palbociclib did not improve invasive DFS vs. placebo (stratified hazard ratio, 0.93; P = .525) after a median follow-up of 42.8 months. Incidences of grade 3-4 neutropenia and leukopenia were significantly higher in the palbociclib group. Eight fatal serious adverse events were reported.

Study details: A phase 3, double-blind, randomized PENELOPE-B study evaluated 1,250 high-risk patients with HR+, HER-negative early breast cancer who have residual invasive disease after neoadjuvant chemotherapy. Patients received estrogen therapy with either palbociclib or placebo.

Disclosures: The study was supported by Pfizer. The authors declared receiving consulting, honoraria, travel/accomodation expenses and research funding outside the study work. Some of the authors declared being employee of and/or stocks/ownership interests of various sources including Pfizer.

Source: Loibl S et al. J Clin Oncol. 2021 Apr 1. doi: 10.1200/JCO.20.03639.

Key clinical point: The hormone receptor (HR)-negative/ human epidermal growth factor receptor 2 (HER2)-positive subtype was associated with the highest axillary pathologic complete response (pCR) rate and luminal A subtype was associated with the lowest axillary pCR rate.

Major finding: The axillary pCR rates were 60% for HR-negative/HER2-positive, 59% for HER2-positive, 48% for triple-negative, 45% for HR-positive/HER2-positive, 35% for luminal B, 18% for HR-positive/HER2-negative, and 13% for luminal A breast cancer subtypes.

Study details: A meta-analysis of 33 studies including 57,531 patients with breast cancer who received neoadjuvant systemic therapy.

Disclosures: The study was supported by a grant from the Dutch Cancer Society and Alpe d’Huzes Foundation. The authors received grants and personal fees outside this work.

Source: Samiei S et al. JAMA Surg. 2021 Apr 21. doi: 10.1001/jamasurg.2021.0891.

Key clinical point: The hormone receptor (HR)-negative/ human epidermal growth factor receptor 2 (HER2)-positive subtype was associated with the highest axillary pathologic complete response (pCR) rate and luminal A subtype was associated with the lowest axillary pCR rate.

Major finding: The axillary pCR rates were 60% for HR-negative/HER2-positive, 59% for HER2-positive, 48% for triple-negative, 45% for HR-positive/HER2-positive, 35% for luminal B, 18% for HR-positive/HER2-negative, and 13% for luminal A breast cancer subtypes.

Study details: A meta-analysis of 33 studies including 57,531 patients with breast cancer who received neoadjuvant systemic therapy.

Disclosures: The study was supported by a grant from the Dutch Cancer Society and Alpe d’Huzes Foundation. The authors received grants and personal fees outside this work.

Source: Samiei S et al. JAMA Surg. 2021 Apr 21. doi: 10.1001/jamasurg.2021.0891.

Key clinical point: The hormone receptor (HR)-negative/ human epidermal growth factor receptor 2 (HER2)-positive subtype was associated with the highest axillary pathologic complete response (pCR) rate and luminal A subtype was associated with the lowest axillary pCR rate.

Major finding: The axillary pCR rates were 60% for HR-negative/HER2-positive, 59% for HER2-positive, 48% for triple-negative, 45% for HR-positive/HER2-positive, 35% for luminal B, 18% for HR-positive/HER2-negative, and 13% for luminal A breast cancer subtypes.

Study details: A meta-analysis of 33 studies including 57,531 patients with breast cancer who received neoadjuvant systemic therapy.

Disclosures: The study was supported by a grant from the Dutch Cancer Society and Alpe d’Huzes Foundation. The authors received grants and personal fees outside this work.

Source: Samiei S et al. JAMA Surg. 2021 Apr 21. doi: 10.1001/jamasurg.2021.0891.

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.

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.

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.