Key clinical point: Adjuvant olaparib prolongs invasive disease-free survival and distant disease-free survival in patients with high-risk BRCA1/2-mutated human epidermal growth factor 2 (HER2)-negative early breast cancer who received local treatment and adjuvant/neoadjuvant chemotherapy.
Major finding: Adjuvant olaparib significantly improved invasive disease-free survival (hazard ratio, 0.58; P less than .001) and distant disease-free survival (hazard ratio, 0.57; P less than .001). The serious adverse event rate was 8.7% in the olaparib group and 8.4% in the placebo group.
Study details: A phase 3 double-blind, randomized OlympiA trial evaluated 1,836 patients with high-risk BRCA1/2-mutated HER2-negative early breast cancer who received local treatment and adjuvant/neoadjuvant chemotherapy. Patients were randomly assigned to olaparib or placebo.
Disclosures: The study received funding from the National Cancer Institute and AstraZeneca. The authors reported receiving grants, honoraria, advisory/speaker/consulting fees, financial/nonfinancial support, and travel expense from various sources and/or owning stocks in pharmaceutical companies. Dr. SJ Hollingsworth, Dr. A Fielding, and Dr. N Baker were employees at AstraZeneca.
Source: Tutt ANJ et al. New Eng J Med. 2021 Jun 3. doi: 10.1056/NEJMoa2105215.