Laurent Mathiot, Olivier Kerdraon, Florent Le Borgne, Véronique Verriele, Anne Patsouris, Marie Robert, Jérôme Chetritt, Delphine Loussouarn, Mario Campone, François Bocquet, Jean-Sébastien Frenel
{"title":"HR+/HER2-转移性乳腺癌中HER2-超低的现实世界分析：患病率和一线化疗结果","authors":"Laurent Mathiot, Olivier Kerdraon, Florent Le Borgne, Véronique Verriele, Anne Patsouris, Marie Robert, Jérôme Chetritt, Delphine Loussouarn, Mario Campone, François Bocquet, Jean-Sébastien Frenel","doi":"10.1177/17588359251378863","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>HER2-ultralow is an emerging subgroup of metastatic breast cancer (mBC). However, despite an increasing interest, limited data exist on its prevalence and outcomes, especially among patients receiving standard first-line chemotherapy.</p><p><strong>Objectives: </strong>This study assessed the prevalence and outcomes of HER2-ultralow mBC in a real-world cohort of hormone receptor-positive (HR+)/HER2-negative patients receiving first-line standard-of-care (SOC) chemotherapy.</p><p><strong>Design: </strong>A retrospective, single-center cohort study.</p><p><strong>Methods: </strong>We included HR+/HER2-negative mBC patients treated with SOC between January 2016 and February 2023. Patient data were reviewed from electronic health records. HER2-zero tumors (immunohistochemistry 0) were rescored by expert pathologists using the American Society of Clinical Oncology/College of American Pathologists guidelines to distinguish HER2-ultralow from HER2-null cases. Real-world progression-free survival (rwPFS) and real-world overall survival (rwOS) were estimated using Kaplan-Meier and multivariable Cox regression models.</p><p><strong>Results: </strong>Among 320 patients (median age, 62.4 years), 72.8% had visceral metastases, and 17.5% had bone-only disease. Previous CDK4/6 inhibitor treatment was reported in 43.4%. Rescoring identified 15.6% with HER2-ultralow, 61.9% with HER2-low, and 22.5% with HER2-null tumors. The median follow-up was 39.4 months (95% confidence interval (CI), 37.1-47.6). Median rwPFS was 7.9 months (95% CI, 4.6-19.0), 7.3 months (95% CI, 6.4-9.1), and 6.2 months (95% CI, 4.6-8.9) for HER2-ultralow, HER2-low, and HER2-null groups, respectively. Median rwOS was 19.5 months (95% CI, 10.7-33.4), 21.5 months (95% CI, 19.0-25.8), and 16.6 months (95% CI, 11.9-23.6). In patients previously treated with CDK4/6 inhibitors, median rwPFS was 4.6 months (95% CI, 2.7-21.4), 6.1 months (95% CI, 5.5-7.3), and 5.6 months (95% CI, 3.8-8.7).</p><p><strong>Conclusion: </strong>HER2-ultralow accounts for 15.6% of HR+/HER2-negative mBC cases and demonstrates outcomes comparable to HER2-low with SOC chemotherapy.</p>","PeriodicalId":23053,"journal":{"name":"Therapeutic Advances in Medical Oncology","volume":"17 ","pages":"17588359251378863"},"PeriodicalIF":4.2000,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477358/pdf/","citationCount":"0","resultStr":"{\"title\":\"Real-world analysis of HER2-ultralow in HR+/HER2- metastatic breast cancer: prevalence and first-line chemotherapy outcomes.\",\"authors\":\"Laurent Mathiot, Olivier Kerdraon, Florent Le Borgne, Véronique Verriele, Anne Patsouris, Marie Robert, Jérôme Chetritt, Delphine Loussouarn, Mario Campone, François Bocquet, Jean-Sébastien Frenel\",\"doi\":\"10.1177/17588359251378863\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>HER2-ultralow is an emerging subgroup of metastatic breast cancer (mBC). However, despite an increasing interest, limited data exist on its prevalence and outcomes, especially among patients receiving standard first-line chemotherapy.</p><p><strong>Objectives: </strong>This study assessed the prevalence and outcomes of HER2-ultralow mBC in a real-world cohort of hormone receptor-positive (HR+)/HER2-negative patients receiving first-line standard-of-care (SOC) chemotherapy.</p><p><strong>Design: </strong>A retrospective, single-center cohort study.</p><p><strong>Methods: </strong>We included HR+/HER2-negative mBC patients treated with SOC between January 2016 and February 2023. Patient data were reviewed from electronic health records. HER2-zero tumors (immunohistochemistry 0) were rescored by expert pathologists using the American Society of Clinical Oncology/College of American Pathologists guidelines to distinguish HER2-ultralow from HER2-null cases. Real-world progression-free survival (rwPFS) and real-world overall survival (rwOS) were estimated using Kaplan-Meier and multivariable Cox regression models.</p><p><strong>Results: </strong>Among 320 patients (median age, 62.4 years), 72.8% had visceral metastases, and 17.5% had bone-only disease. Previous CDK4/6 inhibitor treatment was reported in 43.4%. Rescoring identified 15.6% with HER2-ultralow, 61.9% with HER2-low, and 22.5% with HER2-null tumors. The median follow-up was 39.4 months (95% confidence interval (CI), 37.1-47.6). Median rwPFS was 7.9 months (95% CI, 4.6-19.0), 7.3 months (95% CI, 6.4-9.1), and 6.2 months (95% CI, 4.6-8.9) for HER2-ultralow, HER2-low, and HER2-null groups, respectively. Median rwOS was 19.5 months (95% CI, 10.7-33.4), 21.5 months (95% CI, 19.0-25.8), and 16.6 months (95% CI, 11.9-23.6). In patients previously treated with CDK4/6 inhibitors, median rwPFS was 4.6 months (95% CI, 2.7-21.4), 6.1 months (95% CI, 5.5-7.3), and 5.6 months (95% CI, 3.8-8.7).</p><p><strong>Conclusion: </strong>HER2-ultralow accounts for 15.6% of HR+/HER2-negative mBC cases and demonstrates outcomes comparable to HER2-low with SOC chemotherapy.</p>\",\"PeriodicalId\":23053,\"journal\":{\"name\":\"Therapeutic Advances in Medical Oncology\",\"volume\":\"17 \",\"pages\":\"17588359251378863\"},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2025-09-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477358/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Medical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17588359251378863\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Medical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17588359251378863","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
Real-world analysis of HER2-ultralow in HR+/HER2- metastatic breast cancer: prevalence and first-line chemotherapy outcomes.
Background: HER2-ultralow is an emerging subgroup of metastatic breast cancer (mBC). However, despite an increasing interest, limited data exist on its prevalence and outcomes, especially among patients receiving standard first-line chemotherapy.
Objectives: This study assessed the prevalence and outcomes of HER2-ultralow mBC in a real-world cohort of hormone receptor-positive (HR+)/HER2-negative patients receiving first-line standard-of-care (SOC) chemotherapy.
Design: A retrospective, single-center cohort study.
Methods: We included HR+/HER2-negative mBC patients treated with SOC between January 2016 and February 2023. Patient data were reviewed from electronic health records. HER2-zero tumors (immunohistochemistry 0) were rescored by expert pathologists using the American Society of Clinical Oncology/College of American Pathologists guidelines to distinguish HER2-ultralow from HER2-null cases. Real-world progression-free survival (rwPFS) and real-world overall survival (rwOS) were estimated using Kaplan-Meier and multivariable Cox regression models.
Results: Among 320 patients (median age, 62.4 years), 72.8% had visceral metastases, and 17.5% had bone-only disease. Previous CDK4/6 inhibitor treatment was reported in 43.4%. Rescoring identified 15.6% with HER2-ultralow, 61.9% with HER2-low, and 22.5% with HER2-null tumors. The median follow-up was 39.4 months (95% confidence interval (CI), 37.1-47.6). Median rwPFS was 7.9 months (95% CI, 4.6-19.0), 7.3 months (95% CI, 6.4-9.1), and 6.2 months (95% CI, 4.6-8.9) for HER2-ultralow, HER2-low, and HER2-null groups, respectively. Median rwOS was 19.5 months (95% CI, 10.7-33.4), 21.5 months (95% CI, 19.0-25.8), and 16.6 months (95% CI, 11.9-23.6). In patients previously treated with CDK4/6 inhibitors, median rwPFS was 4.6 months (95% CI, 2.7-21.4), 6.1 months (95% CI, 5.5-7.3), and 5.6 months (95% CI, 3.8-8.7).
Conclusion: HER2-ultralow accounts for 15.6% of HR+/HER2-negative mBC cases and demonstrates outcomes comparable to HER2-low with SOC chemotherapy.
期刊介绍：
Therapeutic Advances in Medical Oncology is an open access, peer-reviewed journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of cancer. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in medical oncology, providing a forum in print and online for publishing the highest quality articles in this area. This journal is a member of the Committee on Publication Ethics (COPE).
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