Olaparib efficacy in patients with germline BRCA ‐mutated, HER2 ‐negative metastatic breast cancer: Subgroup analyses from the phase III OlympiAD trial
Open accessAbstract
In the primary analysis of the phase III OlympiAD trial, olaparib significantly prolonged progression‐free survival (PFS) vs chemotherapy treatment of physician's choice (TPC) in patients with germline BRCA‐mutated (gBRCAm), HER2‐negative metastatic breast cancer (mBC). We report subgroup analyses for the final analysis at a median OS follow‐up of 18.9 months (olaparib) and 15.5 months (TPC). Patients (N = 302) with gBRCAm, HER2‐negative mBC and ≤2 previous lines of chemotherapy for mBC were randomized 2:1 to open‐label olaparib (300 mg twice daily) or TPC. All subgroup analyses were prespecified except site of metastases. Investigator‐assessed median PFS was 8.0 months (95% confidence interval [CI] 5.8‐8.4; 176/205 events) for olaparib and 3.8 months (95% CI 2.8‐4.2; 83/97 events) for TPC (hazard ratio 0.51, 95% CI 0.39‐0.66). In subgroup analyses, median PFS hazard ratios (95% CI) favored olaparib: hormone receptor status (triple‐negative: 0.47, 0.32‐0.69; hormone receptor‐positive: 0.52, 0.36‐0.75); gBRCAm ( BRCA1 : 0.49, 0.35‐0.71; BRCA2 : 0.49, 0.33‐0.74); site of metastases (visceral/CNS: 0.53, 0.40‐0.71; non‐visceral: 0.45, 0.23‐0.98); prior chemotherapy for mBC (yes: 0.51, 0.38‐0.70; no: 0.49, 0.30‐0.82); prior platinum‐based chemotherapy for BC (yes: 0.49, 0.30‐0.83; no: 0.50, 0.37‐0.69); progressive disease at randomization (yes: 0.48, 0.35‐0.65; no: 0.61, 0.36‐1.07). Investigator‐assessed objective response rates were higher across all subgroups with olaparib (35‐68%) vs TPC (5‐40%). Global health status/health‐related quality of life increased in all subgroups with olaparib vs decreased/no change with TPC. These data confirm the consistency of olaparib benefit across patient subgroups in OlympiAD.
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- Susan M. Domchek reports honoraria from AstraZeneca, Clovis Oncology, and Bristol- Myers Squibb and research funding to the University of Pennsylvania from AstraZeneca and Clovis Oncology. Pierfranco Conte reports speakers' bureaus with AstraZeneca, GlaxoSmithKline, Novartis, and Roche; travel, accommodation, and expenses from Celgene, GlaxoSmithKline, and Novartis; and research funding from Merck Serono, Novartis, and Roche. Seock-Ah Im reports consultancy for AstraZeneca, Idience, GSK, Hanmi, Lilly, MSD, Novartis, Pfizer, Daiichi-Sankyo, and Roche; and research funding from AstraZe- neca, Roche, Boryung Pharm, Daewoong Pharm, Pfizer, and Eisai. Binghe Xu reports consultancy for AstraZeneca and payment or honoraria for invited speaker from AstraZeneca and Novartis. Anne Armstrong reports receiving fees for serving on an advisory board from MSD, conference fees from MSD, conference fees and travel expenses from Novartis, research funding from AstraZeneca payed to the institution, and spousal shares from AstraZeneca. Norikazu Masuda reports honoraria from AstraZeneca, Chugai Pharma, Eisai, Eli Lilly, Pfizer, and Takeda; and institutional research funding from AstraZeneca, Chugai Pharma, Daiichi Sankyo, Eisai, Eli Lilly, Kyowa Hakka Kirin, MSD, Nippon-Kayaku, Novartis, Pfizer, and Sanofi.
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- Authors
- Senkus, E., Delaloge, S., Domchek, S. M., Conte, P., Im, S., Xu, B., Armstrong, A., Masuda, N., Fielding, A., Robson, M., & Tung, N.
- Affiliations
- Gdańsk Medical University (PL)
- Institut Gustave Roussy (FR)
- University of Pennsylvania (US)
- University of Padua (IT)
- Seoul National University (KR)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- University of Manchester (GB)
- Nagoya University (JP)
- AstraZeneca (United States) (US)
- Memorial Sloan Kettering Cancer Center (US)
- Beth Israel Deaconess Medical Center (US)
- Corresponding author
- Senkus, Elżbieta
- ORCID
- Venue
- International Journal of Cancer
- Publisher
- Wiley
- Published
- 2023-04-06
- Volume
- 153
- Issue
- 4
- Pages
- 803-814
- ISSN
- 0020-7136 (ISSN-L)
- 1097-0215
- OpenAlex
- W4361006679
- Cited by
- 39
- References
- 34
- Citations by year
- 2026: 13 · 2025: 11 · 2024: 11 · 2023: 4
- FWCI
- 4.76
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- International Journal of Cancer (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- AstraZeneca
- Topics
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › BRCA gene mutations in cancer
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
- Keywords
- olaparib, germline BRCA mutation, HER2-negative metastatic breast cancer, PARP inhibitors, progression-free survival, overall survival, subgroup analysis, BRCA1, BRCA2, hormone receptor status, triple-negative breast cancer, platinum-based chemotherapy, platinum-free chemotherapy
- MeSH terms
- Breast Neoplasms, Female, Humans, Ovarian Neoplasms, Phthalazines, Piperazines, Quality of Life, Germ-Line Mutation, BRCA1 Protein
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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