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| Home > Publications database > Clinical and molecular biomarkers for prediction of endocrine response after short preoperative endocrine therapy in the WSG ADAPT-HR+/HER2- and ADAPTcycle trials (N=7914). |
| Journal Article | DKFZ-2026-00920 |
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2026
Elsevier
Amsterdam [u.a.]
Abstract: Low Ki67 after short preoperative endocrine treatment (ET) indicates a favorable prognosis in HR+/HER2- early breast cancer (eBC). We investigated predictors of ET-response in the WSG ADAPT-HR+/HER2- and ADAPTcycle trials.ET-response (Ki67 ≤10%) after 2-4-week standard ET, recurrence score (RS), and nodal status were used for treatment allocation. In ADAPT-HR+/HER2-, clinical high-risk patients received ET-alone if N0-1 and RS 0-11 or RS 12-25 and ET-response. In ADAPTcycle, N0-1 patients with RS>25 and ET-response and those with RS<25 and e.g., ET-non-response, N2-3 patients with RS≤25 and ET-response, were randomized to (neo)adjuvant chemotherapy or aromatase inhibitor (AI)+ribociclib. Predictors of ET-response were identified through multivariable logistic regression models.3,675 patients from ADAPT-HR+/HER2- (≤50 years and premenopausal, ≤50y: N=1,250; >50 years or postmenopausal, >50y: N=2,425) and 4,239 from the ADAPTcycle screening cohort (≤50y: N=1,336; >50y: N=2,903) were analyzed. ET-response rates were higher after AI (ADAPT-HR+/HER2-/ADAPTcycle: 81.4%/76.7%) vs. tamoxifen (ADAPT-HR+/HER2-/ADAPTcycle: 40.1%/34.7%) in both age groups, with further improvement by ovarian function suppression (OFS) in premenopausal patients. Premenopausal patients with GnRH+AI had similar ET-response rates as postmenopausal patients. ET-response predictors included AI use (+OFS in premenopausal), age >50y, lower RS and baseline Ki67 levels, and higher expression of estrogen receptor (by immunohistochemistry) and HER2 (by Oncotype DX™). In ADAPT-HR+/HER2-, 5-year dDFS in ET-responders was markedly higher vs. non-responders even in chemotherapy-treated N0-1 patients with RS>25 (87.0 vs. 80.7%) and it was only slightly lower vs. RS 12-25 group.We observed similar ET-response rates in two large phase III trials. Postmenopausal patients (mostly receiving AI) had higher ET-response rates compared to younger patients. However, young patients with GnRH+AI had ET-response rates comparable to postmenopausal patients, suggesting that therapy rather than biology accounts for the difference. Combining ET-response and gene expression assessment could help more luminal eBC patients avoid chemotherapy.
Keyword(s): Biomarkers ; Breast Neoplasms ; Ki-67 Antigen ; Logistic Models ; Neoadjuvant Therapy ; Prognosis
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