Daniela Katz, Ilan Feldhamer, Yael Wolff-Sagy, Hadar Goldvaser, Ariel Hammerman, Daniel A Goldstein
{"title":"21 基因复发评分较高（> 25 分）的 T1a/bN0 乳腺癌辅助化疗：真实世界队列的 10 年随访。","authors":"Daniela Katz, Ilan Feldhamer, Yael Wolff-Sagy, Hadar Goldvaser, Ariel Hammerman, Daniel A Goldstein","doi":"10.1007/s12282-024-01652-9","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In ER + /HER2- early breast cancer (BC), 21-Gene Recurrence Score (RS) > 25 indicates high-risk of distant-recurrence and predicts benefit from adjuvant chemotherapy (aCT) regardless of tumor-size. However, T1a/b (≤ 1 cm) node-negative (N0) tumors, regarded as of low risk of recurrence, were under-represented in the RS trials. We therefore aimed to investigate the benefit of aCT in patients with T1a/bN0 BC, RS > 25, where clinical and genomic risk indicators are discordant.</p><p><strong>Methods: </strong>This retrospective observational cohort study utilized Israel's national Oncotest database to identify Clalit Health Services (CHS) members, diagnosed with T1a/bN0 HR + /HER2- BC, who underwent RS testing between February 2006, and December 2019. Patients with RS > 25 who received aCT were matched 1:1 by propensity-scoring to similar patients receiving no aCT. Invasive disease-free survival (iDFS) and distant recurrence were the study endpoints. Patient demographic and clinical data were obtained from CHS's centralized database. Kaplan--Meier analysis with log-rank testing was used for comparing outcomes.</p><p><strong>Results: </strong>During the study period, high-risk RS result (> 25) was identified in 156/9858 patients of the study cohort. aCT was administered to 74 (47.4%) and median follow-up was 121 months. Within the 148 matched-cases, eighteen iDFS-events occurred, nine (12.1%) in each group (χ<sup>2</sup> = 0.72, p = 0.39). Four (5.4%) of the aCT treated and three (4.0%) of the untreated patients were diagnosed with distant recurrence (χ<sup>2</sup> = 0.22, p = 0.64).</p><p><strong>Conclusions: </strong>In this study cohort, patients with T1a/bN0 BC, RS > 25 that received aCT, did not have improved outcomes and the 21-Gene RS > 25 was not found to be predictive, possibly due to the low number of events observed.</p>","PeriodicalId":56083,"journal":{"name":"Breast Cancer","volume":" ","pages":""},"PeriodicalIF":4.0000,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Adjuvant chemotherapy in T1a/bN0 breast cancer with a high 21-gene recurrence score (> 25): a 10-year follow-up in a real-world cohort.\",\"authors\":\"Daniela Katz, Ilan Feldhamer, Yael Wolff-Sagy, Hadar Goldvaser, Ariel Hammerman, Daniel A Goldstein\",\"doi\":\"10.1007/s12282-024-01652-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>In ER + /HER2- early breast cancer (BC), 21-Gene Recurrence Score (RS) > 25 indicates high-risk of distant-recurrence and predicts benefit from adjuvant chemotherapy (aCT) regardless of tumor-size. However, T1a/b (≤ 1 cm) node-negative (N0) tumors, regarded as of low risk of recurrence, were under-represented in the RS trials. We therefore aimed to investigate the benefit of aCT in patients with T1a/bN0 BC, RS > 25, where clinical and genomic risk indicators are discordant.</p><p><strong>Methods: </strong>This retrospective observational cohort study utilized Israel's national Oncotest database to identify Clalit Health Services (CHS) members, diagnosed with T1a/bN0 HR + /HER2- BC, who underwent RS testing between February 2006, and December 2019. Patients with RS > 25 who received aCT were matched 1:1 by propensity-scoring to similar patients receiving no aCT. Invasive disease-free survival (iDFS) and distant recurrence were the study endpoints. Patient demographic and clinical data were obtained from CHS's centralized database. Kaplan--Meier analysis with log-rank testing was used for comparing outcomes.</p><p><strong>Results: </strong>During the study period, high-risk RS result (> 25) was identified in 156/9858 patients of the study cohort. aCT was administered to 74 (47.4%) and median follow-up was 121 months. Within the 148 matched-cases, eighteen iDFS-events occurred, nine (12.1%) in each group (χ<sup>2</sup> = 0.72, p = 0.39). Four (5.4%) of the aCT treated and three (4.0%) of the untreated patients were diagnosed with distant recurrence (χ<sup>2</sup> = 0.22, p = 0.64).</p><p><strong>Conclusions: </strong>In this study cohort, patients with T1a/bN0 BC, RS > 25 that received aCT, did not have improved outcomes and the 21-Gene RS > 25 was not found to be predictive, possibly due to the low number of events observed.</p>\",\"PeriodicalId\":56083,\"journal\":{\"name\":\"Breast Cancer\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2024-11-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Breast Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s12282-024-01652-9\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breast Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s12282-024-01652-9","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Adjuvant chemotherapy in T1a/bN0 breast cancer with a high 21-gene recurrence score (> 25): a 10-year follow-up in a real-world cohort.
Background: In ER + /HER2- early breast cancer (BC), 21-Gene Recurrence Score (RS) > 25 indicates high-risk of distant-recurrence and predicts benefit from adjuvant chemotherapy (aCT) regardless of tumor-size. However, T1a/b (≤ 1 cm) node-negative (N0) tumors, regarded as of low risk of recurrence, were under-represented in the RS trials. We therefore aimed to investigate the benefit of aCT in patients with T1a/bN0 BC, RS > 25, where clinical and genomic risk indicators are discordant.
Methods: This retrospective observational cohort study utilized Israel's national Oncotest database to identify Clalit Health Services (CHS) members, diagnosed with T1a/bN0 HR + /HER2- BC, who underwent RS testing between February 2006, and December 2019. Patients with RS > 25 who received aCT were matched 1:1 by propensity-scoring to similar patients receiving no aCT. Invasive disease-free survival (iDFS) and distant recurrence were the study endpoints. Patient demographic and clinical data were obtained from CHS's centralized database. Kaplan--Meier analysis with log-rank testing was used for comparing outcomes.
Results: During the study period, high-risk RS result (> 25) was identified in 156/9858 patients of the study cohort. aCT was administered to 74 (47.4%) and median follow-up was 121 months. Within the 148 matched-cases, eighteen iDFS-events occurred, nine (12.1%) in each group (χ2 = 0.72, p = 0.39). Four (5.4%) of the aCT treated and three (4.0%) of the untreated patients were diagnosed with distant recurrence (χ2 = 0.22, p = 0.64).
Conclusions: In this study cohort, patients with T1a/bN0 BC, RS > 25 that received aCT, did not have improved outcomes and the 21-Gene RS > 25 was not found to be predictive, possibly due to the low number of events observed.
期刊介绍：
Breast Cancer, the official journal of the Japanese Breast Cancer Society, publishes articles that contribute to progress in the field, in basic or translational research and also in clinical research, seeking to develop a new focus and new perspectives for all who are concerned with breast cancer. The journal welcomes all original articles describing clinical and epidemiological studies and laboratory investigations regarding breast cancer and related diseases. The journal will consider five types of articles: editorials, review articles, original articles, case reports, and rapid communications. Although editorials and review articles will principally be solicited by the editors, they can also be submitted for peer review, as in the case of original articles. The journal provides the best of up-to-date information on breast cancer, presenting readers with high-impact, original work focusing on pivotal issues.
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