Adjuvant olaparib in the subset of patients from Japan with BRCA1- or BRCA2-mutated high-risk early breast cancer from the phase 3 OlympiA trial

• DOI: 10.1007/s12282-023-01451-8
• Publication Date: 2023-04-03T07:09:58Z
• Authors: Hideko Yamauchi; Masakazu Toi; Shin Takayama; Seigo Nakamura; Toshimi Takano; Karen Cui; Christine Campbell; Liesbet De Vos; Charles Geyer; Andrew Tutt
• Keywords: Olaparib; Interim analysis

The efficacy and safety of olaparib compared with placebo in the subset patients from Japan phase 3 OlympiA trial (NCT02032823) are reported here contextualized reference to global population.Patients germline BRCA1 and/or BRCA2 pathogenic variants HER2-negative, high-risk early breast cancer who had received neoadjuvant or adjuvant chemotherapy completed local treatment were eligible. Patients randomized 1:1 receive for 1 year.invasive disease-free survival (IDFS). Secondary endpoints: distant (DDFS), overall (OS), safety. Data first pre-specified interim analysis (data cut-off [DCO] March 27, 2020) second, event driven, OS (DCO July 12, 2021) Japan.140 (olaparib, n = 64; placebo, 76). At (median follow-up: 2.9 years), hazard ratios (HRs) 0.5 IDFS (95% confidence interval [CI] 0.18-1.24) 0.41 DDFS CI 0.11-1.16). second OS, three deaths occurred group versus six (HR, 0.62 [95% 0.13-2.36]). Findings consistent those population. No new signals observed.While this a Japanese was not powered detect population-related differences, results population, suggesting findings study generalizable clinical practice Japan.