Assessment of Adjuvant Endocrine Therapy With Ovarian Function Suppression by Breast Cancer Index

作者：Ruth O’Regan, Yue Ren, Yi Zhang, Natalia Siuliukina, Catherine A. Schnabel, Roswitha Kammler, G. Viale, Patrizia Dell’Orto, Elisabetta Munzone, István Láng, Carlo Tondini, Henry Gómez, Claudio Chini, Stefania Vittoria Luisa Nicoletti, Fabio Puglisi, Khalil Zaman, Matthew P. Goetz, Vered Stearns, Silvana Martino, Muhammad Salim, Sibylle Loibl, Charles E. Geyer, Hervé Bonnefoi, Eva Ciruelos, Sherene Loi, Marco Colleoni, Gini F. Fleming, Prudence A. Francis, Barbara Walley, Olivia Pagani, Kai Treuner, Meredith M. Regan · 发表于：JAMA Network Open · 年份：2025 · DOI：10.1001/jamanetworkopen.2025.40931 · 被引用次数：2 · 研究领域：Estrogen and related hormone effects、Breast Cancer Treatment Studies、Cancer Risks and Factors

Importance: The Breast Cancer Index (BCI) previously identified premenopausal patients with tumors in which the ratio of expression of HOXB13 relative to IL17BR (hereafter, BCI [H/I]-low tumors) as likely to derive greatest benefit from ovarian function suppression (OFS)-containing adjuvant therapy in the Suppression of Ovarian Function Trial (SOFT) trial. Objectives: To assess BCI as a predictive biomarker of benefit from exemestane plus OFS vs tamoxifen plus OFS and to validate BCI as a prognostic biomarker for premenopausal patients. Design, Setting, and Participants: This prognostic study used a prospective-retrospective translational design within the Tamoxifen and Exemestane (TEXT) and SOFT trials (enrolled November 2003 to April 2011). Blinded BCI testing in all available tumor samples was completed in March 2024. Premenopausal women with hormone receptor-positive breast cancer randomized to tamoxifen plus OFS or exemestane plus OFS who had BCI assessed were included. Analysis occurred from March to August 2024. Exposure: 5 years of adjuvant tamoxifen plus OFS or exemestane plus OFS. Main Outcomes and Measures: The primary outcomes were breast cancer-free interval (BCFI) for predictive analyses and distant recurrence-free interval (DRFI) for prognostic analyses after a median follow-up of 13 years in the TEXT cohort. Secondary objectives examined the predictive performance of BCI (H/I) in the combined TEXT and SOFT cohort overall and in prespecified clinical subgroups....