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.
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Embargo End Date
ICR Authors
Authors
Yamauchi, H
Toi, M
Takayama, S
Nakamura, S
Takano, T
Cui, K
Campbell, C
De Vos, L
Geyer, C
Tutt, A
Toi, M
Takayama, S
Nakamura, S
Takano, T
Cui, K
Campbell, C
De Vos, L
Geyer, C
Tutt, A
Document Type
Journal Article
Date
2023-07-01
Date Accepted
2023-03-05
Abstract
BACKGROUND: The efficacy and safety of olaparib compared with placebo in the subset of patients from Japan in the phase 3 OlympiA trial (NCT02032823) are reported here and contextualized with reference to the global OlympiA population. METHODS: Patients with germline BRCA1 and/or BRCA2 pathogenic variants and HER2-negative, high-risk early breast cancer who had received neoadjuvant or adjuvant chemotherapy and completed local treatment were eligible. Patients were randomized 1:1 to receive olaparib or placebo for 1 year. PRIMARY ENDPOINT: invasive disease-free survival (IDFS). Secondary endpoints: distant disease-free survival (DDFS), overall survival (OS), and safety. Data are reported from the first pre-specified interim analysis (data cut-off [DCO] March 27, 2020) and the second, event driven, pre-specified interim analysis of OS (DCO July 12, 2021) in patients from Japan. RESULTS: 140 patients were randomized in Japan (olaparib, n = 64; placebo, n = 76). At the first pre-specified interim analysis (median follow-up: 2.9 years), hazard ratios (HRs) for adjuvant olaparib compared with placebo were 0.5 for IDFS (95% confidence interval [CI] 0.18-1.24) and 0.41 for DDFS (95% CI 0.11-1.16). At the second pre-specified interim analysis of OS, three deaths occurred in the olaparib group versus six deaths in the placebo group (HR, 0.62 [95% CI 0.13-2.36]). Findings were consistent with those for the global population. No new safety signals were observed. CONCLUSIONS: While this analysis in a Japanese subset of patients was not powered to detect population-related treatment differences, efficacy and safety analysis results were consistent with the global OlympiA population, suggesting the findings from the global study are generalizable to clinical practice in Japan.
Citation
Breast Cancer, 2023, 30 (4), pp. 596 - 605
Source Title
Breast Cancer
Publisher
SPRINGER JAPAN KK
ISSN
1340-6868
eISSN
1880-4233
1880-4233
1880-4233
Collections
Research Team
Directorate Breast Canc