Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2-associated high-risk HER2-negative early breast cancer: updated results from the OlympiA phase III trial.
J E Garber, D Cameron, C Campbell et al.
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In 30 seconds
This updated analysis of the randomised, multicentre phase III OlympiA trial assessed one year of adjuvant olaparib versus placebo in patients with germline BRCA1/2 pathogenic variants and high-risk, HER2-negative early breast cancer after chemotherapy. At a median follow-up of 6.1 years, benefits in invasive and distant disease-free survival and overall survival were maintained. Six-year overall survival was 87.5% with olaparib versus 83.2% with placebo (difference 4.4%, 95% CI 0.9% to 6.7%).
Key findings
- Invasive disease-free survival benefit persisted with olaparib (HR 0.65, 95% CI 0.53-0.78).
- Distant disease-free survival benefit persisted (HR 0.65, 95% CI 0.53-0.81).
- Six-year overall survival was 87.5% versus 83.2% with olaparib versus placebo (difference 4.4%, 95% CI 0.9% to 6.7%).
- Adverse events of special interest occurred in 6.3% versus 9.3%; MDS/AML occurred in 0.4% versus 0.7%, with olaparib versus placebo.
Why it matters
The extended follow-up indicates that the survival and recurrence-related benefits observed with adjuvant olaparib were sustained beyond the treatment year in this genetically defined, high-risk population. The reported overall-survival difference and absence of an observed increase in MDS/AML provide clinically relevant longer-term efficacy and safety information for weighing adjuvant treatment.
What to keep in mind
This report presents descriptive analyses from a prespecified interim analysis; follow-up was a median of 6.1 years.