Jagadeswara R. Earla, Allison W. Kurian, Kalé Kponee-Shovein, Malena Mahendran, Yan Song, Qi Hua, Annalise Hilts, Yezhou Sun, Kim M. Hirshfield, Mark Robson, Jaime A. Mejia
{"title":"早期 HER2 阴性乳腺癌老年患者无病生存期终点与总生存期之间的相关性：SEER-Medicare 分析。","authors":"Jagadeswara R. Earla, Allison W. Kurian, Kalé Kponee-Shovein, Malena Mahendran, Yan Song, Qi Hua, Annalise Hilts, Yezhou Sun, Kim M. Hirshfield, Mark Robson, Jaime A. Mejia","doi":"10.1007/s12325-024-03074-7","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Recent trial-level meta-analyses have established disease-free survival (DFS) as a valid surrogate for overall survival (OS) in human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), irrespective of disease stage, and in early-stage hormone receptor-positive (HR+)/HER2− BC. To advance the understanding of the association between additional DFS endpoints and OS, this study assessed the patient-level correlations between DFS and OS, invasive DFS (IDFS) and OS, and distant DFS (DDFS) and OS in Medicare beneficiaries with early-stage HER2− BC, overall and in subgroups of patients with HR+/HER2− BC and triple-negative BC (TNBC).</p><h3>Methods</h3><p>Patients with stages I–III HER2− BC aged ≥ 66 years were identified from SEER-Medicare data (2010–2019). DFS, IDFS, DDFS, and OS were assessed using Kaplan–Meier analyses. Normal scores rank correlation was estimated between each DFS endpoint and OS, overall and separately in patients with HR+/HER2− BC and TNBC.</p><h3>Results</h3><p>Of 28,655 patients, 90.4% had HR+/HER2− BC and 9.6% had TNBC (median follow-up 4 years). Median DFS, IDFS, and DDFS were 4.5, 5.9, and 6.3 years, respectively, in HR+/HER2− BC and 3.0, 3.8, and 4.4 years, respectively, in TNBC. Median OS was not reached (5-year OS, HR+/HER2− BC 83.7%; TNBC 67.7%). A significant positive correlation was observed between each DFS endpoint and OS across cohorts, with the strongest correlation observed between DDFS and OS in HR+/HER2− BC (correlation coefficient 0.60; 95% confidence interval 0.57–0.62; <i>p</i> < 0.001) and in TNBC (0.69; 0.65–0.71; <i>p</i> < 0.001).</p><h3>Conclusion</h3><p>We observed significant positive patient-level correlations between DFS and OS, IDFS and OS, and DDFS and OS in early-stage HER2− BC. Our IDFS and DDFS findings advance the understanding of the role of these DFS endpoints as predictors of OS, and their potential utility as surrogate endpoints in clinical trials of early-stage HER2− BC, given additional validation in trial-level meta-analyses.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 2","pages":"886 - 903"},"PeriodicalIF":3.4000,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-024-03074-7.pdf","citationCount":"0","resultStr":"{\"title\":\"Correlation Between Disease-Free Survival Endpoints and Overall Survival in Elderly Patients with Early-Stage HER2-Negative Breast Cancer: A SEER-Medicare Analysis\",\"authors\":\"Jagadeswara R. Earla, Allison W. Kurian, Kalé Kponee-Shovein, Malena Mahendran, Yan Song, Qi Hua, Annalise Hilts, Yezhou Sun, Kim M. Hirshfield, Mark Robson, Jaime A. Mejia\",\"doi\":\"10.1007/s12325-024-03074-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Recent trial-level meta-analyses have established disease-free survival (DFS) as a valid surrogate for overall survival (OS) in human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), irrespective of disease stage, and in early-stage hormone receptor-positive (HR+)/HER2− BC. To advance the understanding of the association between additional DFS endpoints and OS, this study assessed the patient-level correlations between DFS and OS, invasive DFS (IDFS) and OS, and distant DFS (DDFS) and OS in Medicare beneficiaries with early-stage HER2− BC, overall and in subgroups of patients with HR+/HER2− BC and triple-negative BC (TNBC).</p><h3>Methods</h3><p>Patients with stages I–III HER2− BC aged ≥ 66 years were identified from SEER-Medicare data (2010–2019). DFS, IDFS, DDFS, and OS were assessed using Kaplan–Meier analyses. Normal scores rank correlation was estimated between each DFS endpoint and OS, overall and separately in patients with HR+/HER2− BC and TNBC.</p><h3>Results</h3><p>Of 28,655 patients, 90.4% had HR+/HER2− BC and 9.6% had TNBC (median follow-up 4 years). Median DFS, IDFS, and DDFS were 4.5, 5.9, and 6.3 years, respectively, in HR+/HER2− BC and 3.0, 3.8, and 4.4 years, respectively, in TNBC. Median OS was not reached (5-year OS, HR+/HER2− BC 83.7%; TNBC 67.7%). A significant positive correlation was observed between each DFS endpoint and OS across cohorts, with the strongest correlation observed between DDFS and OS in HR+/HER2− BC (correlation coefficient 0.60; 95% confidence interval 0.57–0.62; <i>p</i> < 0.001) and in TNBC (0.69; 0.65–0.71; <i>p</i> < 0.001).</p><h3>Conclusion</h3><p>We observed significant positive patient-level correlations between DFS and OS, IDFS and OS, and DDFS and OS in early-stage HER2− BC. Our IDFS and DDFS findings advance the understanding of the role of these DFS endpoints as predictors of OS, and their potential utility as surrogate endpoints in clinical trials of early-stage HER2− BC, given additional validation in trial-level meta-analyses.</p></div>\",\"PeriodicalId\":7482,\"journal\":{\"name\":\"Advances in Therapy\",\"volume\":\"42 2\",\"pages\":\"886 - 903\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-12-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://link.springer.com/content/pdf/10.1007/s12325-024-03074-7.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s12325-024-03074-7\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Therapy","FirstCategoryId":"3","ListUrlMain":"https://link.springer.com/article/10.1007/s12325-024-03074-7","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Correlation Between Disease-Free Survival Endpoints and Overall Survival in Elderly Patients with Early-Stage HER2-Negative Breast Cancer: A SEER-Medicare Analysis
Introduction
Recent trial-level meta-analyses have established disease-free survival (DFS) as a valid surrogate for overall survival (OS) in human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), irrespective of disease stage, and in early-stage hormone receptor-positive (HR+)/HER2− BC. To advance the understanding of the association between additional DFS endpoints and OS, this study assessed the patient-level correlations between DFS and OS, invasive DFS (IDFS) and OS, and distant DFS (DDFS) and OS in Medicare beneficiaries with early-stage HER2− BC, overall and in subgroups of patients with HR+/HER2− BC and triple-negative BC (TNBC).
Methods
Patients with stages I–III HER2− BC aged ≥ 66 years were identified from SEER-Medicare data (2010–2019). DFS, IDFS, DDFS, and OS were assessed using Kaplan–Meier analyses. Normal scores rank correlation was estimated between each DFS endpoint and OS, overall and separately in patients with HR+/HER2− BC and TNBC.
Results
Of 28,655 patients, 90.4% had HR+/HER2− BC and 9.6% had TNBC (median follow-up 4 years). Median DFS, IDFS, and DDFS were 4.5, 5.9, and 6.3 years, respectively, in HR+/HER2− BC and 3.0, 3.8, and 4.4 years, respectively, in TNBC. Median OS was not reached (5-year OS, HR+/HER2− BC 83.7%; TNBC 67.7%). A significant positive correlation was observed between each DFS endpoint and OS across cohorts, with the strongest correlation observed between DDFS and OS in HR+/HER2− BC (correlation coefficient 0.60; 95% confidence interval 0.57–0.62; p < 0.001) and in TNBC (0.69; 0.65–0.71; p < 0.001).
Conclusion
We observed significant positive patient-level correlations between DFS and OS, IDFS and OS, and DDFS and OS in early-stage HER2− BC. Our IDFS and DDFS findings advance the understanding of the role of these DFS endpoints as predictors of OS, and their potential utility as surrogate endpoints in clinical trials of early-stage HER2− BC, given additional validation in trial-level meta-analyses.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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