Validation of the predictive ability for recurrence and the clinical utility of the 95-gene classifier (95GC) through an integrated analysis of five studies.
{"title":"Validation of the predictive ability for recurrence and the clinical utility of the 95-gene classifier (95GC) through an integrated analysis of five studies.","authors":"Aya Imai, Ryo Tsunashima, Yu Hidaka, Sae Kitano, Chikage Kato, Akira Watanabe, Midori Morita, Koichi Sakaguchi, Yoshiaki Sota, Masahiko Suzuki, Takayuki Kinoshita, Seiichi Imanishi, Masahiro Oikawa, Yoshihiko Kamada, Ken-Ichi Ito, Takaaki Oba, Shin Takayama, Fumine Tsukamoto, Mina Takahashi, Yutaka Hatanaka, Naoto T Ueno, Kenzo Shimazu, Satoshi Morita, Yasuto Naoi","doi":"10.1007/s12282-025-01734-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In recent years, multigene assays have become indispensable tools for predicting the recurrence risk of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer and guiding adjuvant chemotherapy decisions. Curebest™ 95GC Breast (95GC), developed in 2011 as a domestically produced multigene assay for postoperative recurrence prediction, has been commercially available since 2013. Since 2021, five validation studies evaluating the predictive performance 95GC have been published. This study presents an integrated analysis of these studies to validate the prognostic utility of 95GC further.</p><p><strong>Methods: </strong>The integrated analysis included 719 real-world cases of luminal-type node-negative breast cancer patients who underwent adjuvant hormone therapy alone without extended endocrine treatment. In addition, an expanded cohort incorporating 294 cases from Western patients within the GEO public database was analyzed, resulting in a total of 1013 cases.</p><p><strong>Results: </strong>Among the 719 real-world cases, 550 (76.5%) were classified into the 95GC Low-risk group, demonstrating a significantly superior prognosis compared to the High-risk group (P < 1.00e-12). The 5-year distant recurrence-free survival (DRFS) rate in the Low-risk group was approximately 98%, with consistent findings observed in the expanded cohort. Furthermore, an analysis of 754 CEL files using 21GC (a proxy for Oncotype DX®) identified 318 cases (42.2%) as the 21GC intermediate risk. 95GC successfully stratified these cases into two prognostically distinct subgroups.</p><p><strong>Conclusions: </strong>These findings underscore the clinical utility of 95GC in safely omitting chemotherapy for Low-risk patients with good prognosis and in further stratifying the 21GC Intermediate-risk cases, thereby contributing to personalized treatment strategies.</p>","PeriodicalId":520574,"journal":{"name":"Breast cancer (Tokyo, Japan)","volume":" ","pages":"1075-1087"},"PeriodicalIF":2.9000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breast cancer (Tokyo, Japan)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s12282-025-01734-2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/6/25 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background: In recent years, multigene assays have become indispensable tools for predicting the recurrence risk of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer and guiding adjuvant chemotherapy decisions. Curebest™ 95GC Breast (95GC), developed in 2011 as a domestically produced multigene assay for postoperative recurrence prediction, has been commercially available since 2013. Since 2021, five validation studies evaluating the predictive performance 95GC have been published. This study presents an integrated analysis of these studies to validate the prognostic utility of 95GC further.
Methods: The integrated analysis included 719 real-world cases of luminal-type node-negative breast cancer patients who underwent adjuvant hormone therapy alone without extended endocrine treatment. In addition, an expanded cohort incorporating 294 cases from Western patients within the GEO public database was analyzed, resulting in a total of 1013 cases.
Results: Among the 719 real-world cases, 550 (76.5%) were classified into the 95GC Low-risk group, demonstrating a significantly superior prognosis compared to the High-risk group (P < 1.00e-12). The 5-year distant recurrence-free survival (DRFS) rate in the Low-risk group was approximately 98%, with consistent findings observed in the expanded cohort. Furthermore, an analysis of 754 CEL files using 21GC (a proxy for Oncotype DX®) identified 318 cases (42.2%) as the 21GC intermediate risk. 95GC successfully stratified these cases into two prognostically distinct subgroups.
Conclusions: These findings underscore the clinical utility of 95GC in safely omitting chemotherapy for Low-risk patients with good prognosis and in further stratifying the 21GC Intermediate-risk cases, thereby contributing to personalized treatment strategies.
背景:近年来,多基因检测已成为预测雌激素受体(ER)阳性、人表皮生长因子受体2 (HER2)阴性早期乳腺癌复发风险和指导辅助化疗决策不可或缺的工具。currebest™95GC Breast (95GC)于2011年开发,是一种用于术后复发预测的国产多基因检测方法,自2013年以来已上市。自2021年以来,已经发表了5项评估95GC预测性能的验证研究。本研究对这些研究进行了综合分析,以进一步验证95GC的预后效用。方法:综合分析719例光型淋巴结阴性乳腺癌患者,这些患者单独接受辅助激素治疗,不接受扩展的内分泌治疗。此外,对GEO公共数据库中包含294例西方患者的扩大队列进行了分析,总共有1013例病例。结果:在719例真实病例中,550例(76.5%)被划分为95GC低危组,预后明显优于高危组(P)。结论:这些发现强调了95GC在预后良好的低危患者安全免化疗以及进一步对21GC中危患者进行分层的临床应用,从而有助于制定个性化的治疗策略。