Breast Cancer

Adding atezolizumab to chemotherapy in patients with anti–programmed death ligand 1 (PD-L1)–positive triple-negative breast cancer (TNBC) who have relapsed within 12 months of their last curative treatment does not improve their survival, results of the IMpassion132 trial show.

Our results “highlight the importance of recognizing TNBC heterogeneity, especially in the first-line setting” said Rebecca A. Dent, MD, MSc, National Cancer Center Singapore and Duke-NUS Medical School, Singapore, who presented the study at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.

“These patients have a dismal prognosis and represent a high unmet need,” she added. 

The current findings follow those from the IMpassion130 trial, which showed that the combination of atezolizumab with nab-paclitaxel chemotherapy offered no survival benefit in previously untreated locally advanced or metastatic TNBC despite a progression-free survival benefit on interim analysis.

Rapidly relapsing TNBC “represents one of most challenging clinical situations” because it is aggressive and “intrinsically resistant to standard therapies,” said Dr. Dent. It is also more common in younger patients with large primary tumors and no BRCA alterations.

“Most importantly, however, is that most trials actually exclude these patients,” she noted, “posing a real challenge for us in clinical practice.”

IMpassion132 enrolled 594 patients with unresectable locally advanced or metastatic TNBC who had experienced disease progression more than 12 months after their last treatment for early TNBC with curative intent.

Patients had received prior anthracycline and taxane therapy for but no prior chemotherapy for advanced disease.

Study participants were randomly assigned to chemotherapy with carboplatin-gemcitabine or capecitabine plus atezolizumab or placebo, with treatment continued until disease progression or unacceptable toxicity. The primary endpoint was overall survival.

Initially, all patients with TNBC who met the study criteria were enrolled in the randomized, phase 3, double-blinded trial; however, the trial was then amended to include only PD-L1–positive patients after the results of IMpassion130 “clearly showed us that the benefits of immune checkpoint inhibition were largely driven by those patients,” Dr. Dent explained.

The 354 patients with PD-L1–positive disease were “young,” she added, with a median age of 48 years. The youngest was 23 years old.

The majority (66%-69%) had a disease-free interval of less than 6 months after treatment with curative intent. Lung and/or liver metastases were present in 60%-62% of patients, and 18% had previously received platinum-based chemotherapy.

After a median follow-up of 9.8 months, overall survival was a median of 12.1 months in the atezolizumab group vs 11.2 months with placebo, at a hazard ratio of 0.93 (P = .59).

A similar result was seen when looking at the modified intention-to-treat population, and when stratifying the patients by prespecified subgroup.

Dr. Dent pointed out that in the placebo group, patients treated with capecitabine had a median overall survival of 12.6 months vs 9.9 months in those given carboplatin-gemcitabine , which she described as “hypothesis generating” because “prior therapy may trigger a variety of resistance mechanisms.”

The disease-free interval also seemed to play a role in the placebo group. Patients who had a disease-free interval of 6 or more months prior to study enrollment had a median overall survival of 12.8 months vs 9.4 months in those with an interval of less than 6 months.

There were no significant differences in progression-free survival or duration of overall response between the atezolizumab and placebo groups.

“In terms of the safety data, clearly we’re getting better at identifying immune checkpoint inhibition toxicities and initiating therapies for these toxicities earlier,” Dr. Dent said, because there were “no new safety signals.”

The rate of treatment-related grade 3 or 4 adverse events was similar between patients given atezolizumab and those assigned to placebo, at 65% vs 62%. Rates of grade 5 events were identical, at 1%.

Commenting on the study, Sara M. Tolaney, MD, MPH, chief, Division of Breast Oncology, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute, Boston, questioned the role for immunotherapy in patients with TNBC who experience early relapse. 

This is not the first trial to fail to show a benefit in this space, she said. Collectively, these results make “me think that these tumors are pretty immunologically cold, making them less likely to benefit from checkpoint inhibition.” 

The patients that do relapse, “have highly treatment refractory disease,” and “we need to think about other novel therapeutic strategies for this population,” she told this news organization.

IMpassion132 nevertheless represents a “unique opportunity to better understand the biology of these rapidly relapsing tumors, and hopefully use this information to develop more novel treatment approaches for this population,” she said.

“That being said, I do think that this is going to become an even more challenging area,” Dr. Tolaney said. “In the modern era, these patients are receiving multi-agent chemotherapy with preoperative checkpoint inhibition, and many then go on to receive additional systemic treatment in the adjuvant setting.”

The study was sponsored by Hoffmann-La Roche.

Dr. Dent declares relationships with AstraZeneca, Roche, Eisai, Lilly, MSD, Novartis, and Pfizer. Dr. Tolaney declares relationships with Novartis, Pfizer, Merck, Lilly, AstraZeneca, Genentech/Roche, Eisai, Sanofi, Bristol Myers Squib, Seattle Genetics, CytomX Therapeutics, Daiichi Sankyo, Gilead, Ellipses Pharma, 4D Pharma, OncoSec Medical Inc, BeyondSpring Pharmaceuticals, OncXerna, Zymeworks, Zentalis, Blueprint Medicines, Reveal Genomics, ARC Therapeutics, Myovant, Zetagen, Umoja Biopharma, Menarini/Stemline, Aadi Biopharma, Bayer, Jazz Pharmaceuticals, Exelixis, Novartis, Nanonstring, and Cyclacel.

A version of this article appeared on Medscape.com .

Adding atezolizumab to chemotherapy in patients with anti–programmed death ligand 1 (PD-L1)–positive triple-negative breast cancer (TNBC) who have relapsed within 12 months of their last curative treatment does not improve their survival, results of the IMpassion132 trial show.

Our results “highlight the importance of recognizing TNBC heterogeneity, especially in the first-line setting” said Rebecca A. Dent, MD, MSc, National Cancer Center Singapore and Duke-NUS Medical School, Singapore, who presented the study at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.

“These patients have a dismal prognosis and represent a high unmet need,” she added. 

The current findings follow those from the IMpassion130 trial, which showed that the combination of atezolizumab with nab-paclitaxel chemotherapy offered no survival benefit in previously untreated locally advanced or metastatic TNBC despite a progression-free survival benefit on interim analysis.

Rapidly relapsing TNBC “represents one of most challenging clinical situations” because it is aggressive and “intrinsically resistant to standard therapies,” said Dr. Dent. It is also more common in younger patients with large primary tumors and no BRCA alterations.

“Most importantly, however, is that most trials actually exclude these patients,” she noted, “posing a real challenge for us in clinical practice.”

IMpassion132 enrolled 594 patients with unresectable locally advanced or metastatic TNBC who had experienced disease progression more than 12 months after their last treatment for early TNBC with curative intent.

Patients had received prior anthracycline and taxane therapy for but no prior chemotherapy for advanced disease.

Study participants were randomly assigned to chemotherapy with carboplatin-gemcitabine or capecitabine plus atezolizumab or placebo, with treatment continued until disease progression or unacceptable toxicity. The primary endpoint was overall survival.

Initially, all patients with TNBC who met the study criteria were enrolled in the randomized, phase 3, double-blinded trial; however, the trial was then amended to include only PD-L1–positive patients after the results of IMpassion130 “clearly showed us that the benefits of immune checkpoint inhibition were largely driven by those patients,” Dr. Dent explained.

The 354 patients with PD-L1–positive disease were “young,” she added, with a median age of 48 years. The youngest was 23 years old.

The majority (66%-69%) had a disease-free interval of less than 6 months after treatment with curative intent. Lung and/or liver metastases were present in 60%-62% of patients, and 18% had previously received platinum-based chemotherapy.

After a median follow-up of 9.8 months, overall survival was a median of 12.1 months in the atezolizumab group vs 11.2 months with placebo, at a hazard ratio of 0.93 (P = .59).

A similar result was seen when looking at the modified intention-to-treat population, and when stratifying the patients by prespecified subgroup.

Dr. Dent pointed out that in the placebo group, patients treated with capecitabine had a median overall survival of 12.6 months vs 9.9 months in those given carboplatin-gemcitabine , which she described as “hypothesis generating” because “prior therapy may trigger a variety of resistance mechanisms.”

The disease-free interval also seemed to play a role in the placebo group. Patients who had a disease-free interval of 6 or more months prior to study enrollment had a median overall survival of 12.8 months vs 9.4 months in those with an interval of less than 6 months.

There were no significant differences in progression-free survival or duration of overall response between the atezolizumab and placebo groups.

“In terms of the safety data, clearly we’re getting better at identifying immune checkpoint inhibition toxicities and initiating therapies for these toxicities earlier,” Dr. Dent said, because there were “no new safety signals.”

The rate of treatment-related grade 3 or 4 adverse events was similar between patients given atezolizumab and those assigned to placebo, at 65% vs 62%. Rates of grade 5 events were identical, at 1%.

Commenting on the study, Sara M. Tolaney, MD, MPH, chief, Division of Breast Oncology, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute, Boston, questioned the role for immunotherapy in patients with TNBC who experience early relapse. 

This is not the first trial to fail to show a benefit in this space, she said. Collectively, these results make “me think that these tumors are pretty immunologically cold, making them less likely to benefit from checkpoint inhibition.” 

The patients that do relapse, “have highly treatment refractory disease,” and “we need to think about other novel therapeutic strategies for this population,” she told this news organization.

IMpassion132 nevertheless represents a “unique opportunity to better understand the biology of these rapidly relapsing tumors, and hopefully use this information to develop more novel treatment approaches for this population,” she said.

“That being said, I do think that this is going to become an even more challenging area,” Dr. Tolaney said. “In the modern era, these patients are receiving multi-agent chemotherapy with preoperative checkpoint inhibition, and many then go on to receive additional systemic treatment in the adjuvant setting.”

The study was sponsored by Hoffmann-La Roche.

Dr. Dent declares relationships with AstraZeneca, Roche, Eisai, Lilly, MSD, Novartis, and Pfizer. Dr. Tolaney declares relationships with Novartis, Pfizer, Merck, Lilly, AstraZeneca, Genentech/Roche, Eisai, Sanofi, Bristol Myers Squib, Seattle Genetics, CytomX Therapeutics, Daiichi Sankyo, Gilead, Ellipses Pharma, 4D Pharma, OncoSec Medical Inc, BeyondSpring Pharmaceuticals, OncXerna, Zymeworks, Zentalis, Blueprint Medicines, Reveal Genomics, ARC Therapeutics, Myovant, Zetagen, Umoja Biopharma, Menarini/Stemline, Aadi Biopharma, Bayer, Jazz Pharmaceuticals, Exelixis, Novartis, Nanonstring, and Cyclacel.

A version of this article appeared on Medscape.com .

Adding atezolizumab to chemotherapy in patients with anti–programmed death ligand 1 (PD-L1)–positive triple-negative breast cancer (TNBC) who have relapsed within 12 months of their last curative treatment does not improve their survival, results of the IMpassion132 trial show.

Our results “highlight the importance of recognizing TNBC heterogeneity, especially in the first-line setting” said Rebecca A. Dent, MD, MSc, National Cancer Center Singapore and Duke-NUS Medical School, Singapore, who presented the study at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress.

“These patients have a dismal prognosis and represent a high unmet need,” she added. 

The current findings follow those from the IMpassion130 trial, which showed that the combination of atezolizumab with nab-paclitaxel chemotherapy offered no survival benefit in previously untreated locally advanced or metastatic TNBC despite a progression-free survival benefit on interim analysis.

Rapidly relapsing TNBC “represents one of most challenging clinical situations” because it is aggressive and “intrinsically resistant to standard therapies,” said Dr. Dent. It is also more common in younger patients with large primary tumors and no BRCA alterations.

“Most importantly, however, is that most trials actually exclude these patients,” she noted, “posing a real challenge for us in clinical practice.”

IMpassion132 enrolled 594 patients with unresectable locally advanced or metastatic TNBC who had experienced disease progression more than 12 months after their last treatment for early TNBC with curative intent.

Patients had received prior anthracycline and taxane therapy for but no prior chemotherapy for advanced disease.

Study participants were randomly assigned to chemotherapy with carboplatin-gemcitabine or capecitabine plus atezolizumab or placebo, with treatment continued until disease progression or unacceptable toxicity. The primary endpoint was overall survival.

Initially, all patients with TNBC who met the study criteria were enrolled in the randomized, phase 3, double-blinded trial; however, the trial was then amended to include only PD-L1–positive patients after the results of IMpassion130 “clearly showed us that the benefits of immune checkpoint inhibition were largely driven by those patients,” Dr. Dent explained.

The 354 patients with PD-L1–positive disease were “young,” she added, with a median age of 48 years. The youngest was 23 years old.

The majority (66%-69%) had a disease-free interval of less than 6 months after treatment with curative intent. Lung and/or liver metastases were present in 60%-62% of patients, and 18% had previously received platinum-based chemotherapy.

After a median follow-up of 9.8 months, overall survival was a median of 12.1 months in the atezolizumab group vs 11.2 months with placebo, at a hazard ratio of 0.93 (P = .59).

A similar result was seen when looking at the modified intention-to-treat population, and when stratifying the patients by prespecified subgroup.

Dr. Dent pointed out that in the placebo group, patients treated with capecitabine had a median overall survival of 12.6 months vs 9.9 months in those given carboplatin-gemcitabine , which she described as “hypothesis generating” because “prior therapy may trigger a variety of resistance mechanisms.”

The disease-free interval also seemed to play a role in the placebo group. Patients who had a disease-free interval of 6 or more months prior to study enrollment had a median overall survival of 12.8 months vs 9.4 months in those with an interval of less than 6 months.

There were no significant differences in progression-free survival or duration of overall response between the atezolizumab and placebo groups.

“In terms of the safety data, clearly we’re getting better at identifying immune checkpoint inhibition toxicities and initiating therapies for these toxicities earlier,” Dr. Dent said, because there were “no new safety signals.”

The rate of treatment-related grade 3 or 4 adverse events was similar between patients given atezolizumab and those assigned to placebo, at 65% vs 62%. Rates of grade 5 events were identical, at 1%.

Commenting on the study, Sara M. Tolaney, MD, MPH, chief, Division of Breast Oncology, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute, Boston, questioned the role for immunotherapy in patients with TNBC who experience early relapse. 

This is not the first trial to fail to show a benefit in this space, she said. Collectively, these results make “me think that these tumors are pretty immunologically cold, making them less likely to benefit from checkpoint inhibition.” 

The patients that do relapse, “have highly treatment refractory disease,” and “we need to think about other novel therapeutic strategies for this population,” she told this news organization.

IMpassion132 nevertheless represents a “unique opportunity to better understand the biology of these rapidly relapsing tumors, and hopefully use this information to develop more novel treatment approaches for this population,” she said.

“That being said, I do think that this is going to become an even more challenging area,” Dr. Tolaney said. “In the modern era, these patients are receiving multi-agent chemotherapy with preoperative checkpoint inhibition, and many then go on to receive additional systemic treatment in the adjuvant setting.”

The study was sponsored by Hoffmann-La Roche.

Dr. Dent declares relationships with AstraZeneca, Roche, Eisai, Lilly, MSD, Novartis, and Pfizer. Dr. Tolaney declares relationships with Novartis, Pfizer, Merck, Lilly, AstraZeneca, Genentech/Roche, Eisai, Sanofi, Bristol Myers Squib, Seattle Genetics, CytomX Therapeutics, Daiichi Sankyo, Gilead, Ellipses Pharma, 4D Pharma, OncoSec Medical Inc, BeyondSpring Pharmaceuticals, OncXerna, Zymeworks, Zentalis, Blueprint Medicines, Reveal Genomics, ARC Therapeutics, Myovant, Zetagen, Umoja Biopharma, Menarini/Stemline, Aadi Biopharma, Bayer, Jazz Pharmaceuticals, Exelixis, Novartis, Nanonstring, and Cyclacel.

A version of this article appeared on Medscape.com .

Large language models (LLM) such as ChatGPT have shown mixed results in the quality of their responses to consumer questions about cancer.

One recent study found AI chatbots to churn out incomplete, inaccurate, or even nonsensical cancer treatment recommendations, while another found them to generate largely accurate — if technical — responses to the most common cancer questions.

While researchers have seen success with purpose-built chatbots created to address patient concerns about specific cancers, the consensus to date has been that the generalized models like ChatGPT remain works in progress and that physicians should avoid pointing patients to them, for now.

Yet new findings suggest that these chatbots may do better than individual physicians, at least on some measures, when it comes to answering queries about cancer. For research published May 16 in JAMA Oncology (doi: 10.1001/jamaoncol.2024.0836), David Chen, a medical student at the University of Toronto, and his colleagues, isolated a random sample of 200 questions related to cancer care addressed to doctors on the public online forum Reddit. They then compared responses from oncologists with responses generated by three different AI chatbots. The blinded responses were rated for quality, readability, and empathy by six physicians, including oncologists and palliative and supportive care specialists.

Mr. Chen and colleagues’ research was modeled after a 2023 study that measured the quality of physician responses compared with chatbots for general medicine questions addressed to doctors on Reddit. That study found that the chatbots produced more empathetic-sounding answers, something Mr. Chen’s study also found. The best-performing chatbot in Mr. Chen and colleagues’ study, Claude AI, performed significantly higher than the Reddit physicians on all the domains evaluated: quality, empathy, and readability.
 

Q&A With Author of New Research

Mr. Chen discussed his new study’s implications during an interview with this news organization.

Question: What is novel about this study?

Mr. Chen: We’ve seen many evaluations of chatbots that test for medical accuracy, but this study occurs in the domain of oncology care, where there are unique psychosocial and emotional considerations that are not precisely reflected in a general medicine setting. In effect, this study is putting these chatbots through a harder challenge.



Question: Why would chatbot responses seem more empathetic than those of physicians?

Mr. Chen: With the physician responses that we observed in our sample data set, we saw that there was very high variation of amount of apparent effort [in the physician responses]. Some physicians would put in a lot of time and effort, thinking through their response, and others wouldn’t do so as much. These chatbots don’t face fatigue the way humans do, or burnout. So they’re able to consistently provide responses with less variation in empathy.



Question: Do chatbots just seem empathetic because they are chattier?

Mr. Chen: We did think of verbosity as a potential confounder in this study. So we set a word count limit for the chatbot responses to keep it in the range of the physician responses. That way, verbosity was no longer a significant factor.



Question: How were quality and empathy measured by the reviewers?

Mr. Chen: For our study we used two teams of readers, each team composed of three physicians. In terms of the actual metrics we used, they were pilot metrics. There are no well-defined measurement scales or checklists that we could use to measure empathy. This is an emerging field of research. So we came up by consensus with our own set of ratings, and we feel that this is an area for the research to define a standardized set of guidelines.

Another novel aspect of this study is that we separated out different dimensions of quality and empathy. A quality response didn’t just mean it was medically accurate — quality also had to do with the focus and completeness of the response.

With empathy there are cognitive and emotional dimensions. Cognitive empathy uses critical thinking to understand the person’s emotions and thoughts and then adjusting a response to fit that. A patient may not want the best medically indicated treatment for their condition, because they want to preserve their quality of life. The chatbot may be able to adjust its recommendation with consideration of some of those humanistic elements that the patient is presenting with.

Emotional empathy is more about being supportive of the patient’s emotions by using expressions like ‘I understand where you’re coming from.’ or, ‘I can see how that makes you feel.’



Question: Why would physicians, not patients, be the best evaluators of empathy?

Mr. Chen: We’re actually very interested in evaluating patient ratings of empathy. We are conducting a follow-up study that evaluates patient ratings of empathy to the same set of chatbot and physician responses,to see if there are differences.



Question: Should cancer patients go ahead and consult chatbots?

Mr. Chen: Although we did observe increases in all of the metrics compared with physicians, this is a very specialized evaluation scenario where we’re using these Reddit questions and responses.

Naturally, we would need to do a trial, a head to head randomized comparison of physicians versus chatbots.

This pilot study does highlight the promising potential of these chatbots to suggest responses. But we can’t fully recommend that they should be used as standalone clinical tools without physicians.

This Q&A was edited for clarity.

Large language models (LLM) such as ChatGPT have shown mixed results in the quality of their responses to consumer questions about cancer.

One recent study found AI chatbots to churn out incomplete, inaccurate, or even nonsensical cancer treatment recommendations, while another found them to generate largely accurate — if technical — responses to the most common cancer questions.

While researchers have seen success with purpose-built chatbots created to address patient concerns about specific cancers, the consensus to date has been that the generalized models like ChatGPT remain works in progress and that physicians should avoid pointing patients to them, for now.

Yet new findings suggest that these chatbots may do better than individual physicians, at least on some measures, when it comes to answering queries about cancer. For research published May 16 in JAMA Oncology (doi: 10.1001/jamaoncol.2024.0836), David Chen, a medical student at the University of Toronto, and his colleagues, isolated a random sample of 200 questions related to cancer care addressed to doctors on the public online forum Reddit. They then compared responses from oncologists with responses generated by three different AI chatbots. The blinded responses were rated for quality, readability, and empathy by six physicians, including oncologists and palliative and supportive care specialists.

Mr. Chen and colleagues’ research was modeled after a 2023 study that measured the quality of physician responses compared with chatbots for general medicine questions addressed to doctors on Reddit. That study found that the chatbots produced more empathetic-sounding answers, something Mr. Chen’s study also found. The best-performing chatbot in Mr. Chen and colleagues’ study, Claude AI, performed significantly higher than the Reddit physicians on all the domains evaluated: quality, empathy, and readability.
 

Q&A With Author of New Research

Mr. Chen discussed his new study’s implications during an interview with this news organization.

Question: What is novel about this study?

Mr. Chen: We’ve seen many evaluations of chatbots that test for medical accuracy, but this study occurs in the domain of oncology care, where there are unique psychosocial and emotional considerations that are not precisely reflected in a general medicine setting. In effect, this study is putting these chatbots through a harder challenge.



Question: Why would chatbot responses seem more empathetic than those of physicians?

Mr. Chen: With the physician responses that we observed in our sample data set, we saw that there was very high variation of amount of apparent effort [in the physician responses]. Some physicians would put in a lot of time and effort, thinking through their response, and others wouldn’t do so as much. These chatbots don’t face fatigue the way humans do, or burnout. So they’re able to consistently provide responses with less variation in empathy.



Question: Do chatbots just seem empathetic because they are chattier?

Mr. Chen: We did think of verbosity as a potential confounder in this study. So we set a word count limit for the chatbot responses to keep it in the range of the physician responses. That way, verbosity was no longer a significant factor.



Question: How were quality and empathy measured by the reviewers?

Mr. Chen: For our study we used two teams of readers, each team composed of three physicians. In terms of the actual metrics we used, they were pilot metrics. There are no well-defined measurement scales or checklists that we could use to measure empathy. This is an emerging field of research. So we came up by consensus with our own set of ratings, and we feel that this is an area for the research to define a standardized set of guidelines.

Another novel aspect of this study is that we separated out different dimensions of quality and empathy. A quality response didn’t just mean it was medically accurate — quality also had to do with the focus and completeness of the response.

With empathy there are cognitive and emotional dimensions. Cognitive empathy uses critical thinking to understand the person’s emotions and thoughts and then adjusting a response to fit that. A patient may not want the best medically indicated treatment for their condition, because they want to preserve their quality of life. The chatbot may be able to adjust its recommendation with consideration of some of those humanistic elements that the patient is presenting with.

Emotional empathy is more about being supportive of the patient’s emotions by using expressions like ‘I understand where you’re coming from.’ or, ‘I can see how that makes you feel.’



Question: Why would physicians, not patients, be the best evaluators of empathy?

Mr. Chen: We’re actually very interested in evaluating patient ratings of empathy. We are conducting a follow-up study that evaluates patient ratings of empathy to the same set of chatbot and physician responses,to see if there are differences.



Question: Should cancer patients go ahead and consult chatbots?

Mr. Chen: Although we did observe increases in all of the metrics compared with physicians, this is a very specialized evaluation scenario where we’re using these Reddit questions and responses.

Naturally, we would need to do a trial, a head to head randomized comparison of physicians versus chatbots.

This pilot study does highlight the promising potential of these chatbots to suggest responses. But we can’t fully recommend that they should be used as standalone clinical tools without physicians.

This Q&A was edited for clarity.

Large language models (LLM) such as ChatGPT have shown mixed results in the quality of their responses to consumer questions about cancer.

One recent study found AI chatbots to churn out incomplete, inaccurate, or even nonsensical cancer treatment recommendations, while another found them to generate largely accurate — if technical — responses to the most common cancer questions.

While researchers have seen success with purpose-built chatbots created to address patient concerns about specific cancers, the consensus to date has been that the generalized models like ChatGPT remain works in progress and that physicians should avoid pointing patients to them, for now.

Yet new findings suggest that these chatbots may do better than individual physicians, at least on some measures, when it comes to answering queries about cancer. For research published May 16 in JAMA Oncology (doi: 10.1001/jamaoncol.2024.0836), David Chen, a medical student at the University of Toronto, and his colleagues, isolated a random sample of 200 questions related to cancer care addressed to doctors on the public online forum Reddit. They then compared responses from oncologists with responses generated by three different AI chatbots. The blinded responses were rated for quality, readability, and empathy by six physicians, including oncologists and palliative and supportive care specialists.

Mr. Chen and colleagues’ research was modeled after a 2023 study that measured the quality of physician responses compared with chatbots for general medicine questions addressed to doctors on Reddit. That study found that the chatbots produced more empathetic-sounding answers, something Mr. Chen’s study also found. The best-performing chatbot in Mr. Chen and colleagues’ study, Claude AI, performed significantly higher than the Reddit physicians on all the domains evaluated: quality, empathy, and readability.
 

Q&A With Author of New Research

Mr. Chen discussed his new study’s implications during an interview with this news organization.

Question: What is novel about this study?

Mr. Chen: We’ve seen many evaluations of chatbots that test for medical accuracy, but this study occurs in the domain of oncology care, where there are unique psychosocial and emotional considerations that are not precisely reflected in a general medicine setting. In effect, this study is putting these chatbots through a harder challenge.



Question: Why would chatbot responses seem more empathetic than those of physicians?

Mr. Chen: With the physician responses that we observed in our sample data set, we saw that there was very high variation of amount of apparent effort [in the physician responses]. Some physicians would put in a lot of time and effort, thinking through their response, and others wouldn’t do so as much. These chatbots don’t face fatigue the way humans do, or burnout. So they’re able to consistently provide responses with less variation in empathy.



Question: Do chatbots just seem empathetic because they are chattier?

Mr. Chen: We did think of verbosity as a potential confounder in this study. So we set a word count limit for the chatbot responses to keep it in the range of the physician responses. That way, verbosity was no longer a significant factor.



Question: How were quality and empathy measured by the reviewers?

Mr. Chen: For our study we used two teams of readers, each team composed of three physicians. In terms of the actual metrics we used, they were pilot metrics. There are no well-defined measurement scales or checklists that we could use to measure empathy. This is an emerging field of research. So we came up by consensus with our own set of ratings, and we feel that this is an area for the research to define a standardized set of guidelines.

Another novel aspect of this study is that we separated out different dimensions of quality and empathy. A quality response didn’t just mean it was medically accurate — quality also had to do with the focus and completeness of the response.

With empathy there are cognitive and emotional dimensions. Cognitive empathy uses critical thinking to understand the person’s emotions and thoughts and then adjusting a response to fit that. A patient may not want the best medically indicated treatment for their condition, because they want to preserve their quality of life. The chatbot may be able to adjust its recommendation with consideration of some of those humanistic elements that the patient is presenting with.

Emotional empathy is more about being supportive of the patient’s emotions by using expressions like ‘I understand where you’re coming from.’ or, ‘I can see how that makes you feel.’



Question: Why would physicians, not patients, be the best evaluators of empathy?

Mr. Chen: We’re actually very interested in evaluating patient ratings of empathy. We are conducting a follow-up study that evaluates patient ratings of empathy to the same set of chatbot and physician responses,to see if there are differences.



Question: Should cancer patients go ahead and consult chatbots?

Mr. Chen: Although we did observe increases in all of the metrics compared with physicians, this is a very specialized evaluation scenario where we’re using these Reddit questions and responses.

Naturally, we would need to do a trial, a head to head randomized comparison of physicians versus chatbots.

This pilot study does highlight the promising potential of these chatbots to suggest responses. But we can’t fully recommend that they should be used as standalone clinical tools without physicians.

This Q&A was edited for clarity.

Only about 3% to 5% of patients with metastatic colorectal cancer have tumors that are positive for human epidermal growth factor receptor 2 (HER2), and until recently there was no treatment approved by the US Food and Drug Administration (FDA) for this subset of patients.

That all changed, in January of 2023. At that time, the FDA granted accelerated approval to tucatinib (Tukysa) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

The combination was the first FDA-approved treatment for this patient population.

The only other FDA-approved therapy for metastatic HER2-positive CRC is the antibody-drug conjugate trastuzumab deruxtecan (Enhertu). That drug received accelerated approval from the FDA for metastatic HER2-positive CRC for which no other suitable therapeutic option exists, on April 5, 2024. This FDA action represented an expansion of the drug’s earlier approvals for treating several cancer types, including certain patients with unresectable or metastatic HER2-positive breast cancer and adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who had received a prior trastuzumab-based regimen.

More than a year after tucatinib-trastuzumab’s approval, the dual HER2 blockade is bringing substantial clinical benefits to a population with few therapeutic options.
 

Drug Combo’s Use With Capecitabine in Breast Cancer

Tucatinib is a potent oral tyrosine kinase inhibitor (TKI) that has been shown to be highly selective for HER2. Prior to approval of the colorectal cancer indication, tucatinib had received FDA approval (in April 2020) in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who had received one or more prior anti-HER2-based regimens in the metastatic setting.

In these patients the combination was associated with significant improvements in both progression-free survival (PFS) and overall survival compared with trastuzumab and capecitabine.

Approval for the colorectal cancer indication was based on results of the phase 2 MOUNTAINEER trial, which were published in The Lancet Oncology.
 

Real-World Setting

Clinical experience with the combination in a real-world setting is still limited due to the relatively uncommon RAS wild-type HER2-positive CRC subtype, so most of what’s known about the efficacy and safety of tucatinib plus trastuzumab comes from clinical trials. But oncologists interviewed for this article emphasized that the tucatinib-trastuzumab combination nonetheless represents a major breakthrough.

“The population of RAS wild-type HER2-positive is small in colorectal cancer, but the benefit of this treatment is really remarkable. With this combination therapy there was a 38% response rate, and there was a very respectable duration of response. So the population is small, but the benefit of the treatment is by no means small,” said Afsaneh Barzi, MD, PhD, a medical oncologist specializing in gastrointestinal cancers at City of Hope in Duarte, California.

Another medical oncologist interviewed for this piece, who treats patients with HER2-positive metastatic CRC, said that the performance of tucatinib in the real-world setting is in keeping with the efficacy seen in clinical trials.

“There is a group of patients who have a very good response to HER2 [targeted] therapy. Often these are patients who have higher degrees of HER2 amplification, and they do not have concomitant other mutations that activate the pathway, such as RAS mutations,” said Kanwal PS Raghav, MD, MBBS, from the University of Texas MD Anderson Cancer Center in Houston.
 

Why It Works

In an interview, MOUNTAINEER coinvestigator Tanios S. Bekaii-Saab, MD, from the Mayo Clinic Comprehensive Cancer Center in Phoenix, Arizona, explained why dual HER2 blockade with tucatinib and trastuzumab is an important breakthrough for this population.

“HER2 as a target was already well established in breast cancer and in gastric cancer. In colon cancer we had signals [of anti-HER2 efficacy] but these signals were primarily with dual targeted therapy,” he said.

“What’s unique about tucatinib versus neratinib [Nerlynx], lapatinib [Tykerb] and some of the others is that this is a highly selective tyrosine kinase inhibitor, meaning it is potent just against HER2 and has limited activity against other receptors, classically EGFR, which also goes by the name of HER1,” said MOUNTAINEER trial chair John H. Strickler, MD, of Duke Cancer Center in Durham, North Carolina.

“The reason why that’s valuable is that when you inhibit other receptors like HER1 or EGFR, you can cause significant skin rash and other symptoms that can limit tolerability, which limits your ability to give the full dose. With tucatinib you can more completely inhibit HER2 with fewer side effects,” Dr. Strickler said in an interview.

Dr. Raghav noted that the primary adverse events of therapy with tucatinib have been diarrhea and fatigue, and other common side effects include abdominal pain, fever, nausea, rash, and infusion reactions.
 

Barriers to Treatment

Dr. Barzi pointed out that in the day-to-day practice setting there are two potential barriers to treatment with tucatinib and trastuzumab for patients with HER2-positive colorectal cancer, hurdles that they would not encounter if they were enrolled in clinical trials.

The first barrier is the requirement for HER2 testing, either through immunohistochemistry or fluorescence in situ hybridization.

“The adoption of HER2 testing in colorectal cancer lags behind other molecular testing, such as testing for KRAS or BRAF, so the provider needs to be aware that HER2 positivity is a possibility,” she said.

The second and more difficult-to-surmount barrier is imposed by the healthcare system. Although the combination is included in National Comprehensive Cancer Network guidelines and, therefore, should not be subject to restrictions or denials by insurers, “the challenge is that this is an oral and IV drug combination,” Dr. Barzi said.

While patients in real-world settings receive intravenous drugs such as trastuzumab in treatment centers, the oral drug component, tucatinib, is dispensed by pharmacies, and patients are often required to shell out high copays for such agents.

Dr. Barzi cited as an example the case of one of her patients who was receiving an oral agent — not tucatinib — for treatment of a different type of colorectal cancer.

“He has very good insurance, and after insurance his out-of-pocket cost on a monthly basis to obtain the drug is $275,” she said.
 

What’s Next

In colorectal cancer the combination of tucatinib and trastuzumab is approved only in the metastatic setting, but it is also being explored as a first-line therapy in combination with the mFOLFOX6 regimen (5-Fluorouracil, leucovorin, and oxaliplatin) in the MOUNTAINEER-03 trial, which is currently recruiting.

MOUNTAINEER was sponsored by Seagen and Merck. Dr. Strickler reported support from Seagen for the Lancet Oncology manuscript; institutional grants, consulting fees, and travel support from Seagen, and similar relationships with other companies. Dr. Bekaii-Saab reported institutional research and consulting fees from various companies, including Merck, personal consulting fees from various companies, and independent monitoring board/scientific advisory board activities. Dr. Raghav disclosed honoraria and an advisory/consulting role for Seagen and others. Dr. Barzi reported no relevant conflicts of interest.

Only about 3% to 5% of patients with metastatic colorectal cancer have tumors that are positive for human epidermal growth factor receptor 2 (HER2), and until recently there was no treatment approved by the US Food and Drug Administration (FDA) for this subset of patients.

That all changed, in January of 2023. At that time, the FDA granted accelerated approval to tucatinib (Tukysa) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

The combination was the first FDA-approved treatment for this patient population.

The only other FDA-approved therapy for metastatic HER2-positive CRC is the antibody-drug conjugate trastuzumab deruxtecan (Enhertu). That drug received accelerated approval from the FDA for metastatic HER2-positive CRC for which no other suitable therapeutic option exists, on April 5, 2024. This FDA action represented an expansion of the drug’s earlier approvals for treating several cancer types, including certain patients with unresectable or metastatic HER2-positive breast cancer and adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who had received a prior trastuzumab-based regimen.

More than a year after tucatinib-trastuzumab’s approval, the dual HER2 blockade is bringing substantial clinical benefits to a population with few therapeutic options.
 

Drug Combo’s Use With Capecitabine in Breast Cancer

Tucatinib is a potent oral tyrosine kinase inhibitor (TKI) that has been shown to be highly selective for HER2. Prior to approval of the colorectal cancer indication, tucatinib had received FDA approval (in April 2020) in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who had received one or more prior anti-HER2-based regimens in the metastatic setting.

In these patients the combination was associated with significant improvements in both progression-free survival (PFS) and overall survival compared with trastuzumab and capecitabine.

Approval for the colorectal cancer indication was based on results of the phase 2 MOUNTAINEER trial, which were published in The Lancet Oncology.
 

Real-World Setting

Clinical experience with the combination in a real-world setting is still limited due to the relatively uncommon RAS wild-type HER2-positive CRC subtype, so most of what’s known about the efficacy and safety of tucatinib plus trastuzumab comes from clinical trials. But oncologists interviewed for this article emphasized that the tucatinib-trastuzumab combination nonetheless represents a major breakthrough.

“The population of RAS wild-type HER2-positive is small in colorectal cancer, but the benefit of this treatment is really remarkable. With this combination therapy there was a 38% response rate, and there was a very respectable duration of response. So the population is small, but the benefit of the treatment is by no means small,” said Afsaneh Barzi, MD, PhD, a medical oncologist specializing in gastrointestinal cancers at City of Hope in Duarte, California.

Another medical oncologist interviewed for this piece, who treats patients with HER2-positive metastatic CRC, said that the performance of tucatinib in the real-world setting is in keeping with the efficacy seen in clinical trials.

“There is a group of patients who have a very good response to HER2 [targeted] therapy. Often these are patients who have higher degrees of HER2 amplification, and they do not have concomitant other mutations that activate the pathway, such as RAS mutations,” said Kanwal PS Raghav, MD, MBBS, from the University of Texas MD Anderson Cancer Center in Houston.
 

Why It Works

In an interview, MOUNTAINEER coinvestigator Tanios S. Bekaii-Saab, MD, from the Mayo Clinic Comprehensive Cancer Center in Phoenix, Arizona, explained why dual HER2 blockade with tucatinib and trastuzumab is an important breakthrough for this population.

“HER2 as a target was already well established in breast cancer and in gastric cancer. In colon cancer we had signals [of anti-HER2 efficacy] but these signals were primarily with dual targeted therapy,” he said.

“What’s unique about tucatinib versus neratinib [Nerlynx], lapatinib [Tykerb] and some of the others is that this is a highly selective tyrosine kinase inhibitor, meaning it is potent just against HER2 and has limited activity against other receptors, classically EGFR, which also goes by the name of HER1,” said MOUNTAINEER trial chair John H. Strickler, MD, of Duke Cancer Center in Durham, North Carolina.

“The reason why that’s valuable is that when you inhibit other receptors like HER1 or EGFR, you can cause significant skin rash and other symptoms that can limit tolerability, which limits your ability to give the full dose. With tucatinib you can more completely inhibit HER2 with fewer side effects,” Dr. Strickler said in an interview.

Dr. Raghav noted that the primary adverse events of therapy with tucatinib have been diarrhea and fatigue, and other common side effects include abdominal pain, fever, nausea, rash, and infusion reactions.
 

Barriers to Treatment

Dr. Barzi pointed out that in the day-to-day practice setting there are two potential barriers to treatment with tucatinib and trastuzumab for patients with HER2-positive colorectal cancer, hurdles that they would not encounter if they were enrolled in clinical trials.

The first barrier is the requirement for HER2 testing, either through immunohistochemistry or fluorescence in situ hybridization.

“The adoption of HER2 testing in colorectal cancer lags behind other molecular testing, such as testing for KRAS or BRAF, so the provider needs to be aware that HER2 positivity is a possibility,” she said.

The second and more difficult-to-surmount barrier is imposed by the healthcare system. Although the combination is included in National Comprehensive Cancer Network guidelines and, therefore, should not be subject to restrictions or denials by insurers, “the challenge is that this is an oral and IV drug combination,” Dr. Barzi said.

While patients in real-world settings receive intravenous drugs such as trastuzumab in treatment centers, the oral drug component, tucatinib, is dispensed by pharmacies, and patients are often required to shell out high copays for such agents.

Dr. Barzi cited as an example the case of one of her patients who was receiving an oral agent — not tucatinib — for treatment of a different type of colorectal cancer.

“He has very good insurance, and after insurance his out-of-pocket cost on a monthly basis to obtain the drug is $275,” she said.
 

What’s Next

In colorectal cancer the combination of tucatinib and trastuzumab is approved only in the metastatic setting, but it is also being explored as a first-line therapy in combination with the mFOLFOX6 regimen (5-Fluorouracil, leucovorin, and oxaliplatin) in the MOUNTAINEER-03 trial, which is currently recruiting.

MOUNTAINEER was sponsored by Seagen and Merck. Dr. Strickler reported support from Seagen for the Lancet Oncology manuscript; institutional grants, consulting fees, and travel support from Seagen, and similar relationships with other companies. Dr. Bekaii-Saab reported institutional research and consulting fees from various companies, including Merck, personal consulting fees from various companies, and independent monitoring board/scientific advisory board activities. Dr. Raghav disclosed honoraria and an advisory/consulting role for Seagen and others. Dr. Barzi reported no relevant conflicts of interest.

Only about 3% to 5% of patients with metastatic colorectal cancer have tumors that are positive for human epidermal growth factor receptor 2 (HER2), and until recently there was no treatment approved by the US Food and Drug Administration (FDA) for this subset of patients.

That all changed, in January of 2023. At that time, the FDA granted accelerated approval to tucatinib (Tukysa) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

The combination was the first FDA-approved treatment for this patient population.

The only other FDA-approved therapy for metastatic HER2-positive CRC is the antibody-drug conjugate trastuzumab deruxtecan (Enhertu). That drug received accelerated approval from the FDA for metastatic HER2-positive CRC for which no other suitable therapeutic option exists, on April 5, 2024. This FDA action represented an expansion of the drug’s earlier approvals for treating several cancer types, including certain patients with unresectable or metastatic HER2-positive breast cancer and adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who had received a prior trastuzumab-based regimen.

More than a year after tucatinib-trastuzumab’s approval, the dual HER2 blockade is bringing substantial clinical benefits to a population with few therapeutic options.
 

Drug Combo’s Use With Capecitabine in Breast Cancer

Tucatinib is a potent oral tyrosine kinase inhibitor (TKI) that has been shown to be highly selective for HER2. Prior to approval of the colorectal cancer indication, tucatinib had received FDA approval (in April 2020) in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who had received one or more prior anti-HER2-based regimens in the metastatic setting.

In these patients the combination was associated with significant improvements in both progression-free survival (PFS) and overall survival compared with trastuzumab and capecitabine.

Approval for the colorectal cancer indication was based on results of the phase 2 MOUNTAINEER trial, which were published in The Lancet Oncology.
 

Real-World Setting

Clinical experience with the combination in a real-world setting is still limited due to the relatively uncommon RAS wild-type HER2-positive CRC subtype, so most of what’s known about the efficacy and safety of tucatinib plus trastuzumab comes from clinical trials. But oncologists interviewed for this article emphasized that the tucatinib-trastuzumab combination nonetheless represents a major breakthrough.

“The population of RAS wild-type HER2-positive is small in colorectal cancer, but the benefit of this treatment is really remarkable. With this combination therapy there was a 38% response rate, and there was a very respectable duration of response. So the population is small, but the benefit of the treatment is by no means small,” said Afsaneh Barzi, MD, PhD, a medical oncologist specializing in gastrointestinal cancers at City of Hope in Duarte, California.

Another medical oncologist interviewed for this piece, who treats patients with HER2-positive metastatic CRC, said that the performance of tucatinib in the real-world setting is in keeping with the efficacy seen in clinical trials.

“There is a group of patients who have a very good response to HER2 [targeted] therapy. Often these are patients who have higher degrees of HER2 amplification, and they do not have concomitant other mutations that activate the pathway, such as RAS mutations,” said Kanwal PS Raghav, MD, MBBS, from the University of Texas MD Anderson Cancer Center in Houston.
 

Why It Works

In an interview, MOUNTAINEER coinvestigator Tanios S. Bekaii-Saab, MD, from the Mayo Clinic Comprehensive Cancer Center in Phoenix, Arizona, explained why dual HER2 blockade with tucatinib and trastuzumab is an important breakthrough for this population.

“HER2 as a target was already well established in breast cancer and in gastric cancer. In colon cancer we had signals [of anti-HER2 efficacy] but these signals were primarily with dual targeted therapy,” he said.

“What’s unique about tucatinib versus neratinib [Nerlynx], lapatinib [Tykerb] and some of the others is that this is a highly selective tyrosine kinase inhibitor, meaning it is potent just against HER2 and has limited activity against other receptors, classically EGFR, which also goes by the name of HER1,” said MOUNTAINEER trial chair John H. Strickler, MD, of Duke Cancer Center in Durham, North Carolina.

“The reason why that’s valuable is that when you inhibit other receptors like HER1 or EGFR, you can cause significant skin rash and other symptoms that can limit tolerability, which limits your ability to give the full dose. With tucatinib you can more completely inhibit HER2 with fewer side effects,” Dr. Strickler said in an interview.

Dr. Raghav noted that the primary adverse events of therapy with tucatinib have been diarrhea and fatigue, and other common side effects include abdominal pain, fever, nausea, rash, and infusion reactions.
 

Barriers to Treatment

Dr. Barzi pointed out that in the day-to-day practice setting there are two potential barriers to treatment with tucatinib and trastuzumab for patients with HER2-positive colorectal cancer, hurdles that they would not encounter if they were enrolled in clinical trials.

The first barrier is the requirement for HER2 testing, either through immunohistochemistry or fluorescence in situ hybridization.

“The adoption of HER2 testing in colorectal cancer lags behind other molecular testing, such as testing for KRAS or BRAF, so the provider needs to be aware that HER2 positivity is a possibility,” she said.

The second and more difficult-to-surmount barrier is imposed by the healthcare system. Although the combination is included in National Comprehensive Cancer Network guidelines and, therefore, should not be subject to restrictions or denials by insurers, “the challenge is that this is an oral and IV drug combination,” Dr. Barzi said.

While patients in real-world settings receive intravenous drugs such as trastuzumab in treatment centers, the oral drug component, tucatinib, is dispensed by pharmacies, and patients are often required to shell out high copays for such agents.

Dr. Barzi cited as an example the case of one of her patients who was receiving an oral agent — not tucatinib — for treatment of a different type of colorectal cancer.

“He has very good insurance, and after insurance his out-of-pocket cost on a monthly basis to obtain the drug is $275,” she said.
 

What’s Next

In colorectal cancer the combination of tucatinib and trastuzumab is approved only in the metastatic setting, but it is also being explored as a first-line therapy in combination with the mFOLFOX6 regimen (5-Fluorouracil, leucovorin, and oxaliplatin) in the MOUNTAINEER-03 trial, which is currently recruiting.

MOUNTAINEER was sponsored by Seagen and Merck. Dr. Strickler reported support from Seagen for the Lancet Oncology manuscript; institutional grants, consulting fees, and travel support from Seagen, and similar relationships with other companies. Dr. Bekaii-Saab reported institutional research and consulting fees from various companies, including Merck, personal consulting fees from various companies, and independent monitoring board/scientific advisory board activities. Dr. Raghav disclosed honoraria and an advisory/consulting role for Seagen and others. Dr. Barzi reported no relevant conflicts of interest.

Key clinical point: Everolimus plus endocrine therapy (ET) led to promising survival outcomes in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC) who progressed on a CDK4/6 inhibitor.

Major finding: Everolimus + ET led to a median progression-free survival (mPFS) of 6 months (95% CI 5.3-7.8 months), with longer mPFS observed in patients previously treated with CDK4/6 inhibitors for >18 months (8.7 months; 95% CI 6.6-11.3 months), patients without visceral metastasis (8.0 months; 95% CI 5.8-10.5 months), and chemotherapy-naive patients (7.2 months; 95% CI 5.9-8.4 months).

Study details: This retrospective observational study included 161 patients with HR+/HER2− advanced BC who were previously treated with CDK4/6 inhibitors and received everolimus + ET.

Disclosures: This study did not receive any funding. Several authors declared receiving honoraria, research grants, or travel support from or having other ties with various sources.

Source: Sánchez-Bayona R, Lopez de Sa A, Jerez Gilarranz Y, et al. Everolimus plus endocrine therapy beyond CDK4/6 inhibitors progression for HR+ /HER2− advanced breast cancer: A real-world evidence cohort. Breast Cancer Res Treat. 2024 (May 4). doi: 10.1007/s10549-024-07324-8 Source

Key clinical point: Everolimus plus endocrine therapy (ET) led to promising survival outcomes in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC) who progressed on a CDK4/6 inhibitor.

Major finding: Everolimus + ET led to a median progression-free survival (mPFS) of 6 months (95% CI 5.3-7.8 months), with longer mPFS observed in patients previously treated with CDK4/6 inhibitors for >18 months (8.7 months; 95% CI 6.6-11.3 months), patients without visceral metastasis (8.0 months; 95% CI 5.8-10.5 months), and chemotherapy-naive patients (7.2 months; 95% CI 5.9-8.4 months).

Study details: This retrospective observational study included 161 patients with HR+/HER2− advanced BC who were previously treated with CDK4/6 inhibitors and received everolimus + ET.

Disclosures: This study did not receive any funding. Several authors declared receiving honoraria, research grants, or travel support from or having other ties with various sources.

Source: Sánchez-Bayona R, Lopez de Sa A, Jerez Gilarranz Y, et al. Everolimus plus endocrine therapy beyond CDK4/6 inhibitors progression for HR+ /HER2− advanced breast cancer: A real-world evidence cohort. Breast Cancer Res Treat. 2024 (May 4). doi: 10.1007/s10549-024-07324-8 Source

Key clinical point: Everolimus plus endocrine therapy (ET) led to promising survival outcomes in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC) who progressed on a CDK4/6 inhibitor.

Major finding: Everolimus + ET led to a median progression-free survival (mPFS) of 6 months (95% CI 5.3-7.8 months), with longer mPFS observed in patients previously treated with CDK4/6 inhibitors for >18 months (8.7 months; 95% CI 6.6-11.3 months), patients without visceral metastasis (8.0 months; 95% CI 5.8-10.5 months), and chemotherapy-naive patients (7.2 months; 95% CI 5.9-8.4 months).

Study details: This retrospective observational study included 161 patients with HR+/HER2− advanced BC who were previously treated with CDK4/6 inhibitors and received everolimus + ET.

Disclosures: This study did not receive any funding. Several authors declared receiving honoraria, research grants, or travel support from or having other ties with various sources.

Source: Sánchez-Bayona R, Lopez de Sa A, Jerez Gilarranz Y, et al. Everolimus plus endocrine therapy beyond CDK4/6 inhibitors progression for HR+ /HER2− advanced breast cancer: A real-world evidence cohort. Breast Cancer Res Treat. 2024 (May 4). doi: 10.1007/s10549-024-07324-8 Source

Key clinical point: Chemotherapy with anthracycline or trastuzumab increased the risk for cardiovascular diseases (CVD) in breast cancer (BC) survivors, with the risk persisting beyond 10 years after BC diagnosis and being high in women age < 65 years.

Major finding: Anthracycline or trastuzumab vs no chemotherapy was associated with a 53% higher risk for incident CVD (adjusted hazard ratio [aHR] 1.53; 95% CI 1.31-1.79), particularly in women age < 65 years (aHR 1.70; 95% CI ≥1.19 to ≤2.45). The risk for CVD was seen beyond 5 years after BC diagnosis (aHR_{5-<10 years} 1.85; 95% CI 1.44-2.39; aHR_{10+ years} 1.83; 95% CI 1.34-2.49).

Study details: This retrospective cohort study included 10,211 female BC survivors who received anthracycline or trastuzumab (n = 2712), other chemotherapies (n = 1185), or no chemotherapy (n = 6314), with a median follow-up period of 5.79 years.

Disclosures: This study was supported in part by the Intramural Research Program of the US National Cancer Institute. The authors declared no conflicts of interest.

Source: Vo JB, Ramin C, Veiga LHS, et al. Long-term cardiovascular disease risk after anthracycline and trastuzumab treatments in U.S. breast cancer survivors. J Natl Cancer Inst. 2024 (May 8). doi: 10.1093/jnci/djae107 Source

Key clinical point: Chemotherapy with anthracycline or trastuzumab increased the risk for cardiovascular diseases (CVD) in breast cancer (BC) survivors, with the risk persisting beyond 10 years after BC diagnosis and being high in women age < 65 years.

Major finding: Anthracycline or trastuzumab vs no chemotherapy was associated with a 53% higher risk for incident CVD (adjusted hazard ratio [aHR] 1.53; 95% CI 1.31-1.79), particularly in women age < 65 years (aHR 1.70; 95% CI ≥1.19 to ≤2.45). The risk for CVD was seen beyond 5 years after BC diagnosis (aHR_{5-<10 years} 1.85; 95% CI 1.44-2.39; aHR_{10+ years} 1.83; 95% CI 1.34-2.49).

Study details: This retrospective cohort study included 10,211 female BC survivors who received anthracycline or trastuzumab (n = 2712), other chemotherapies (n = 1185), or no chemotherapy (n = 6314), with a median follow-up period of 5.79 years.

Disclosures: This study was supported in part by the Intramural Research Program of the US National Cancer Institute. The authors declared no conflicts of interest.

Source: Vo JB, Ramin C, Veiga LHS, et al. Long-term cardiovascular disease risk after anthracycline and trastuzumab treatments in U.S. breast cancer survivors. J Natl Cancer Inst. 2024 (May 8). doi: 10.1093/jnci/djae107 Source

Key clinical point: Chemotherapy with anthracycline or trastuzumab increased the risk for cardiovascular diseases (CVD) in breast cancer (BC) survivors, with the risk persisting beyond 10 years after BC diagnosis and being high in women age < 65 years.

Major finding: Anthracycline or trastuzumab vs no chemotherapy was associated with a 53% higher risk for incident CVD (adjusted hazard ratio [aHR] 1.53; 95% CI 1.31-1.79), particularly in women age < 65 years (aHR 1.70; 95% CI ≥1.19 to ≤2.45). The risk for CVD was seen beyond 5 years after BC diagnosis (aHR_{5-<10 years} 1.85; 95% CI 1.44-2.39; aHR_{10+ years} 1.83; 95% CI 1.34-2.49).

Study details: This retrospective cohort study included 10,211 female BC survivors who received anthracycline or trastuzumab (n = 2712), other chemotherapies (n = 1185), or no chemotherapy (n = 6314), with a median follow-up period of 5.79 years.

Disclosures: This study was supported in part by the Intramural Research Program of the US National Cancer Institute. The authors declared no conflicts of interest.

Source: Vo JB, Ramin C, Veiga LHS, et al. Long-term cardiovascular disease risk after anthracycline and trastuzumab treatments in U.S. breast cancer survivors. J Natl Cancer Inst. 2024 (May 8). doi: 10.1093/jnci/djae107 Source

Key clinical point: Neoadjuvant radiation therapy (NART) led to similar survival outcomes as postoperation radiation therapy (PORT) in patients with invasive ductal carcinoma (IDC) who underwent breast-conserving surgery (BCS) and were treated with neoadjuvant chemotherapy.

Major finding: NART vs PORT led to comparable breast cancer-specific survival (BCCS) and overall survival (OS) outcomes (both log-rank P > .05) in patients undergoing BCS or implant-based immediate breast reconstruction. However, NART vs PORT led to significantly lower BCCS (hazard ratio [HR] 1.407; log-rank P = .003) and OS (HR 1.383; log-rank P = .004) outcomes in those undergoing mastectomy.

Study details: This retrospective study included 14,515 women with IDC (age ≤ 80 years) from the Surveillance, Epidemiology, and End Results (SEER) database who were treated with neoadjuvant chemotherapy, of whom 386 and 14,129 patients underwent NART and PORT, respectively.

Disclosures: This study was supported by Shanghai Science and Technology Commission and Fudan University, China. The authors declared no conflicts of interest.

Source: Yuan J, Zhang M, Wang M, et al. Neoadjuvant radiochemotherapy is safe and feasible for breast conserving surgery or immediate reconstruction. Sci Rep. 2024;14:9208 (Apr 22). doi: 10.1038/s41598-024-59961-0 Source

Key clinical point: Neoadjuvant radiation therapy (NART) led to similar survival outcomes as postoperation radiation therapy (PORT) in patients with invasive ductal carcinoma (IDC) who underwent breast-conserving surgery (BCS) and were treated with neoadjuvant chemotherapy.

Major finding: NART vs PORT led to comparable breast cancer-specific survival (BCCS) and overall survival (OS) outcomes (both log-rank P > .05) in patients undergoing BCS or implant-based immediate breast reconstruction. However, NART vs PORT led to significantly lower BCCS (hazard ratio [HR] 1.407; log-rank P = .003) and OS (HR 1.383; log-rank P = .004) outcomes in those undergoing mastectomy.

Study details: This retrospective study included 14,515 women with IDC (age ≤ 80 years) from the Surveillance, Epidemiology, and End Results (SEER) database who were treated with neoadjuvant chemotherapy, of whom 386 and 14,129 patients underwent NART and PORT, respectively.

Disclosures: This study was supported by Shanghai Science and Technology Commission and Fudan University, China. The authors declared no conflicts of interest.

Source: Yuan J, Zhang M, Wang M, et al. Neoadjuvant radiochemotherapy is safe and feasible for breast conserving surgery or immediate reconstruction. Sci Rep. 2024;14:9208 (Apr 22). doi: 10.1038/s41598-024-59961-0 Source

Key clinical point: Neoadjuvant radiation therapy (NART) led to similar survival outcomes as postoperation radiation therapy (PORT) in patients with invasive ductal carcinoma (IDC) who underwent breast-conserving surgery (BCS) and were treated with neoadjuvant chemotherapy.

Major finding: NART vs PORT led to comparable breast cancer-specific survival (BCCS) and overall survival (OS) outcomes (both log-rank P > .05) in patients undergoing BCS or implant-based immediate breast reconstruction. However, NART vs PORT led to significantly lower BCCS (hazard ratio [HR] 1.407; log-rank P = .003) and OS (HR 1.383; log-rank P = .004) outcomes in those undergoing mastectomy.

Study details: This retrospective study included 14,515 women with IDC (age ≤ 80 years) from the Surveillance, Epidemiology, and End Results (SEER) database who were treated with neoadjuvant chemotherapy, of whom 386 and 14,129 patients underwent NART and PORT, respectively.

Disclosures: This study was supported by Shanghai Science and Technology Commission and Fudan University, China. The authors declared no conflicts of interest.

Source: Yuan J, Zhang M, Wang M, et al. Neoadjuvant radiochemotherapy is safe and feasible for breast conserving surgery or immediate reconstruction. Sci Rep. 2024;14:9208 (Apr 22). doi: 10.1038/s41598-024-59961-0 Source

Key clinical point: Use of a statin after breast cancer (BC) diagnosis improved survival in older women (age ≥ 66 years) with localized and regional stage disease, particularly in those with the hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2−) subtype.

Major finding: Use vs no use of a statin postdiagnosis was associated with a 15% reduced risk for BC-specific mortality (hazard ratio 0.85; 95% CI 0.75-0.96), with the effect being more pronounced women with HR+/HER2− BC (hazard ratio 0.71; 95% CI 0.57-0.88). There was no significant association between postdiagnosis statin use and the risk for BC recurrence (hazard ratio 1.05; 95% CI 0.91-1.21).

Study details: This retrospective cohort study included women with localized and regional stage BC from the Surveillance, Epidemiology, and End Results (SEER)–Medicare database who were assessed for mortality (n = 38,858) and recurrence (n = 28,522), of whom 8836 and 6475 used a statin postdiagnosis, respectively.

Disclosures: This study was supported by the US National Cancer Institute, National Institutes of Health. The authors declared no conflicts of interest.

Source: Guo H, Malone KE, Heckbert SR, Li CI. Statin use and risks of breast cancer recurrence and mortality. Cancer. 2024 (May 6). doi: 10.1002/cncr.35362 Source

Key clinical point: Use of a statin after breast cancer (BC) diagnosis improved survival in older women (age ≥ 66 years) with localized and regional stage disease, particularly in those with the hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2−) subtype.

Major finding: Use vs no use of a statin postdiagnosis was associated with a 15% reduced risk for BC-specific mortality (hazard ratio 0.85; 95% CI 0.75-0.96), with the effect being more pronounced women with HR+/HER2− BC (hazard ratio 0.71; 95% CI 0.57-0.88). There was no significant association between postdiagnosis statin use and the risk for BC recurrence (hazard ratio 1.05; 95% CI 0.91-1.21).

Study details: This retrospective cohort study included women with localized and regional stage BC from the Surveillance, Epidemiology, and End Results (SEER)–Medicare database who were assessed for mortality (n = 38,858) and recurrence (n = 28,522), of whom 8836 and 6475 used a statin postdiagnosis, respectively.

Disclosures: This study was supported by the US National Cancer Institute, National Institutes of Health. The authors declared no conflicts of interest.

Source: Guo H, Malone KE, Heckbert SR, Li CI. Statin use and risks of breast cancer recurrence and mortality. Cancer. 2024 (May 6). doi: 10.1002/cncr.35362 Source

Key clinical point: Use of a statin after breast cancer (BC) diagnosis improved survival in older women (age ≥ 66 years) with localized and regional stage disease, particularly in those with the hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2−) subtype.

Major finding: Use vs no use of a statin postdiagnosis was associated with a 15% reduced risk for BC-specific mortality (hazard ratio 0.85; 95% CI 0.75-0.96), with the effect being more pronounced women with HR+/HER2− BC (hazard ratio 0.71; 95% CI 0.57-0.88). There was no significant association between postdiagnosis statin use and the risk for BC recurrence (hazard ratio 1.05; 95% CI 0.91-1.21).

Study details: This retrospective cohort study included women with localized and regional stage BC from the Surveillance, Epidemiology, and End Results (SEER)–Medicare database who were assessed for mortality (n = 38,858) and recurrence (n = 28,522), of whom 8836 and 6475 used a statin postdiagnosis, respectively.

Disclosures: This study was supported by the US National Cancer Institute, National Institutes of Health. The authors declared no conflicts of interest.

Source: Guo H, Malone KE, Heckbert SR, Li CI. Statin use and risks of breast cancer recurrence and mortality. Cancer. 2024 (May 6). doi: 10.1002/cncr.35362 Source

Key clinical point: Sentinel lymph node biopsy (SLNB) performed before vs after neoadjuvant chemotherapy (NACT) showed a higher axillary lymph node dissection rate and no overall survival (OS) benefits in patients with clinically lymph node-negative (cN0) breast cancer (BC).

Major finding: The axillary lymph node dissection rate was significantly higher for SLNB performed before vs after NACT (29.9% vs 7.4%; P < .001; odds ratio 5.35; P = .002). Moreover, the 4-year overall survival rate was significantly compromised when SLNB was performed before vs after NACT (88.4% vs 95.7%; hazard ratio 0.21; P = .009).

Study details: This retrospective observational study included 310 patients with cN0 BC, of whom 107 and 203 patients underwent SLNB before and after NACT, respectively.

Disclosures: This study did not receive any specific funding except Open Access funding from Springer Nature. The authors declared no financial conflicts of interest. Two authors declared non-financial ties with various sources.

Source: Fernandez-Gonzalez S, Falo C, Pla MJ, et al. Sentinel lymph node biopsy before and after neoadjuvant chemotherapy in cN0 breast cancer patients: Impact on axillary morbidity and survival—A propensity score cohort study. Breast Cancer Res Treat. 2024 (Apr 18). doi: 10.1007/s10549-024-07274-1 Source

Key clinical point: Sentinel lymph node biopsy (SLNB) performed before vs after neoadjuvant chemotherapy (NACT) showed a higher axillary lymph node dissection rate and no overall survival (OS) benefits in patients with clinically lymph node-negative (cN0) breast cancer (BC).

Major finding: The axillary lymph node dissection rate was significantly higher for SLNB performed before vs after NACT (29.9% vs 7.4%; P < .001; odds ratio 5.35; P = .002). Moreover, the 4-year overall survival rate was significantly compromised when SLNB was performed before vs after NACT (88.4% vs 95.7%; hazard ratio 0.21; P = .009).

Study details: This retrospective observational study included 310 patients with cN0 BC, of whom 107 and 203 patients underwent SLNB before and after NACT, respectively.

Disclosures: This study did not receive any specific funding except Open Access funding from Springer Nature. The authors declared no financial conflicts of interest. Two authors declared non-financial ties with various sources.

Source: Fernandez-Gonzalez S, Falo C, Pla MJ, et al. Sentinel lymph node biopsy before and after neoadjuvant chemotherapy in cN0 breast cancer patients: Impact on axillary morbidity and survival—A propensity score cohort study. Breast Cancer Res Treat. 2024 (Apr 18). doi: 10.1007/s10549-024-07274-1 Source

Key clinical point: Sentinel lymph node biopsy (SLNB) performed before vs after neoadjuvant chemotherapy (NACT) showed a higher axillary lymph node dissection rate and no overall survival (OS) benefits in patients with clinically lymph node-negative (cN0) breast cancer (BC).

Major finding: The axillary lymph node dissection rate was significantly higher for SLNB performed before vs after NACT (29.9% vs 7.4%; P < .001; odds ratio 5.35; P = .002). Moreover, the 4-year overall survival rate was significantly compromised when SLNB was performed before vs after NACT (88.4% vs 95.7%; hazard ratio 0.21; P = .009).

Study details: This retrospective observational study included 310 patients with cN0 BC, of whom 107 and 203 patients underwent SLNB before and after NACT, respectively.

Disclosures: This study did not receive any specific funding except Open Access funding from Springer Nature. The authors declared no financial conflicts of interest. Two authors declared non-financial ties with various sources.

Source: Fernandez-Gonzalez S, Falo C, Pla MJ, et al. Sentinel lymph node biopsy before and after neoadjuvant chemotherapy in cN0 breast cancer patients: Impact on axillary morbidity and survival—A propensity score cohort study. Breast Cancer Res Treat. 2024 (Apr 18). doi: 10.1007/s10549-024-07274-1 Source

Key clinical point: Trastuzumab deruxtecan demonstrated superior efficacy over trastuzumab emtansine as second-line treatment in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases.

Major finding: Trastuzumab deruxtecan led to significantly longer median progression-free survival (15.0 vs 3.0 months; hazard ratio 0.25; 95% CI 0.13-0.45) and higher systemic (67.4% vs 20.5%) and intracranial (65.7% vs 34.3%) objective response rates than trastuzumab emtansine in patients with brain metastases. Outcomes were similar in patients without brain metastases.

Study details: This exploratory analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic BC with or without brain metastases who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed with trastuzumab and taxane treatment.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Six authors declared being current or former employees or holding stock or stock options of Daiichi Sankyo or AstraZeneca. Several authors declared having ties to various sources, including Daiichi Sankyo and AstraZeneca.

Source: Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer patients with brain metastases from the randomized DESTINY-Breast03 trial. ESMO Open. 2024;109294 (Apr 24). doi: 10.1016/j.esmoop.2024.102924 Source

Key clinical point: Trastuzumab deruxtecan demonstrated superior efficacy over trastuzumab emtansine as second-line treatment in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases.

Major finding: Trastuzumab deruxtecan led to significantly longer median progression-free survival (15.0 vs 3.0 months; hazard ratio 0.25; 95% CI 0.13-0.45) and higher systemic (67.4% vs 20.5%) and intracranial (65.7% vs 34.3%) objective response rates than trastuzumab emtansine in patients with brain metastases. Outcomes were similar in patients without brain metastases.

Study details: This exploratory analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic BC with or without brain metastases who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed with trastuzumab and taxane treatment.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Six authors declared being current or former employees or holding stock or stock options of Daiichi Sankyo or AstraZeneca. Several authors declared having ties to various sources, including Daiichi Sankyo and AstraZeneca.

Source: Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer patients with brain metastases from the randomized DESTINY-Breast03 trial. ESMO Open. 2024;109294 (Apr 24). doi: 10.1016/j.esmoop.2024.102924 Source

Key clinical point: Trastuzumab deruxtecan demonstrated superior efficacy over trastuzumab emtansine as second-line treatment in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases.

Major finding: Trastuzumab deruxtecan led to significantly longer median progression-free survival (15.0 vs 3.0 months; hazard ratio 0.25; 95% CI 0.13-0.45) and higher systemic (67.4% vs 20.5%) and intracranial (65.7% vs 34.3%) objective response rates than trastuzumab emtansine in patients with brain metastases. Outcomes were similar in patients without brain metastases.

Study details: This exploratory analysis of the phase 3 DESTINY-Breast03 trial included 524 patients with HER2+ metastatic BC with or without brain metastases who were randomly assigned to receive trastuzumab deruxtecan or trastuzumab emtansine after their disease progressed with trastuzumab and taxane treatment.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Six authors declared being current or former employees or holding stock or stock options of Daiichi Sankyo or AstraZeneca. Several authors declared having ties to various sources, including Daiichi Sankyo and AstraZeneca.

Source: Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer patients with brain metastases from the randomized DESTINY-Breast03 trial. ESMO Open. 2024;109294 (Apr 24). doi: 10.1016/j.esmoop.2024.102924 Source

Key clinical point: Axillary lymph node dissection (ALND) can be omitted in node-positive breast cancer (BC) as only 1% of patients who achieved nodal pathological complete response (pCR) with neoadjuvant chemotherapy reported axillary recurrence (AR) in 5 years.

Major finding: The AR rate was very low at 0.65% (95% CI 0.29%-1.30%) and 1.0% (95% CI 0.49%-2.00%) at 3 years and 5 years, respectively, in patients who omitted ALND and underwent targeted axillary dissection (TAD) or sentinel lymph node biopsy (SLNB). AR rates were comparable in both surgical cohorts at 3 years (P = .55).

Study details: This retrospective cohort study included 1144 patients with node-positive BC who achieved nodal pCR with neoadjuvant chemotherapy, of whom 58.2% and 41.8% underwent SLNB and TAD, respectively.

Disclosures: This study was supported in part by a US National Institutes of Health and US National Cancer Institute Cancer Center support grant. Several authors declared receiving personal fees, grants, or consulting fees from or having other ties with various sources.

Source: Montagna G, Mrdutt MM, Sun SX, et al. Omission of axillary dissection following nodal downstaging with neoadjuvant chemotherapy. JAMA Oncol. 2024 (Apr 25). doi: 10.1001/jamaoncol.2024.0578 Source

Key clinical point: Axillary lymph node dissection (ALND) can be omitted in node-positive breast cancer (BC) as only 1% of patients who achieved nodal pathological complete response (pCR) with neoadjuvant chemotherapy reported axillary recurrence (AR) in 5 years.

Major finding: The AR rate was very low at 0.65% (95% CI 0.29%-1.30%) and 1.0% (95% CI 0.49%-2.00%) at 3 years and 5 years, respectively, in patients who omitted ALND and underwent targeted axillary dissection (TAD) or sentinel lymph node biopsy (SLNB). AR rates were comparable in both surgical cohorts at 3 years (P = .55).

Study details: This retrospective cohort study included 1144 patients with node-positive BC who achieved nodal pCR with neoadjuvant chemotherapy, of whom 58.2% and 41.8% underwent SLNB and TAD, respectively.

Disclosures: This study was supported in part by a US National Institutes of Health and US National Cancer Institute Cancer Center support grant. Several authors declared receiving personal fees, grants, or consulting fees from or having other ties with various sources.

Source: Montagna G, Mrdutt MM, Sun SX, et al. Omission of axillary dissection following nodal downstaging with neoadjuvant chemotherapy. JAMA Oncol. 2024 (Apr 25). doi: 10.1001/jamaoncol.2024.0578 Source

Key clinical point: Axillary lymph node dissection (ALND) can be omitted in node-positive breast cancer (BC) as only 1% of patients who achieved nodal pathological complete response (pCR) with neoadjuvant chemotherapy reported axillary recurrence (AR) in 5 years.

Major finding: The AR rate was very low at 0.65% (95% CI 0.29%-1.30%) and 1.0% (95% CI 0.49%-2.00%) at 3 years and 5 years, respectively, in patients who omitted ALND and underwent targeted axillary dissection (TAD) or sentinel lymph node biopsy (SLNB). AR rates were comparable in both surgical cohorts at 3 years (P = .55).

Study details: This retrospective cohort study included 1144 patients with node-positive BC who achieved nodal pCR with neoadjuvant chemotherapy, of whom 58.2% and 41.8% underwent SLNB and TAD, respectively.

Disclosures: This study was supported in part by a US National Institutes of Health and US National Cancer Institute Cancer Center support grant. Several authors declared receiving personal fees, grants, or consulting fees from or having other ties with various sources.

Source: Montagna G, Mrdutt MM, Sun SX, et al. Omission of axillary dissection following nodal downstaging with neoadjuvant chemotherapy. JAMA Oncol. 2024 (Apr 25). doi: 10.1001/jamaoncol.2024.0578 Source