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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Date
2023-07-01ICR Author
Author
Yamauchi, H
Toi, M
Takayama, S
Nakamura, S
Takano, T
Cui, K
Campbell, C
De Vos, L
Geyer, C
Tutt, A
Type
Journal Article
Metadata
Show full item recordAbstract
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.
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Subject
Science & Technology
Life Sciences & Biomedicine
Oncology
Obstetrics & Gynecology
Adjuvant
Early breast cancer
BRCA
Olaparib
PARP inhibitor
CHEMOTHERAPY
CAPECITABINE
PEMBROLIZUMAB
SURVIVAL
EFFICACY
Research team
Directorate Breast Canc
Language
eng
Date accepted
2023-03-05
License start date
2023-07-01
Citation
Breast Cancer, 2023, 30 (4), pp. 596 - 605
Publisher
SPRINGER JAPAN KK