Conclusions
- 4 Trial OlympiA survival data demonstrate superiority over placebo in high-risk human epidermal growth factor receptor receptor 2 negative early breast cancer in women with pathogenic or possibly pathogenic germline variants of the BRCA1 or BRCA2 (gBRCA1/2pv).
Why it matters
- This is the second prespecified interim analysis of olaparib’s benefits in high-risk early-stage breast cancer.
Study design
- Randomized, double-blind, placebo-controlled trial of 1,836 patients treated with olaparib or placebo after (neo)adjuvant chemotherapy, surgical treatment and radiotherapy, if indicated.
- In hormone receptor-positive tumours, endocrine therapy was administered concomitantly with olaparib or placebo.
- Primary outcome: overall survival (OS) with statistical significance set at P<0.015.
- Financing: NIH; AstraZeneca; Merck Sharp & Dohme.
Main results
- Median follow-up of 3.5 years.
- The olaparib group had better OS than placebo (HR=0.68; P=0.009).
- OS at 4 years was 89.8% in the olaparib group compared with 86.4% in the placebo group (difference of 3.4%; 95% CI, -0.1% to 6.8%).
- Invasive disease-free survival (IDFS) at 4 years was 82.7% and 75.4%, respectively (7.3% difference; 95% CI, 3.0%–11.5%).
- Distant disease-free survival (DDFS) at 4 years was 86.5% and 79.1%, respectively (7.4% difference; 95% CI, 3.6%–11.3%).
- Subgroup analysis for OS, IDFS, DDFS indicated a benefit of olaparib regardless of gBRCA1/2pv, hormone receptor status, prior platinum use, and type of chemotherapy (adjuvant chemotherapy versus neoadjuvant chemotherapy).
- Grade 3 or higher adverse events were reported in>1% of patients in the olaparib group alone: anaemia (8.7%), neutropenia (4.9%), leukopenia (3.0%), fatigue (1.8%) and lymphopenia (1.3%).
Limits
- None reported by the authors.
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