OlympiA: Adjuvant Olaparib for HER2-Negative Early Breast Cancer With BRCA1 or BRCA2 Germline Mutation
Posted: Monday, December 13, 2021
Patients who have HER2-negative early breast cancer with BRCA1 or BRCA2 pathogenic variants may benefit from adjuvant olaparib, according to updated results from the phase III OlympiA trial. In particular, survival without invasive or distant disease was found to be longer in patients treated with the PARP inhibitor compared with placebo, according to Charles E. Geyer, Jr, MD, of Weill Cornell Medical College, Houston, and colleagues. The findings of this international, double-blind, randomized trial were published in The New England Journal of Medicine.
“The OlympiA trial showed that 1 year of adjuvant olaparib can meaningfully reduce recurrence risk and prevent progression to metastatic disease among patients with high-risk early breast cancer and germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants, with high adherence rates and primarily a low-grade toxicity profile,” stated the study investigators.
Patients were randomly assigned to receive oral olaparib or placebo for 1 year following completion of local treatment and neoadjuvant or adjuvant chemotherapy (n = 1,836). Eligible patients had completed all local therapy at least 2 weeks and not 12 weeks prior to study commencement and at least 6 cycles of nonplatinum chemotherapy.
At the median follow-up of 2.5 years, the 3-year invasive disease–free survival rates were found 85.9% in patients who received olaparib compared with 77.1% in those given placebo (95% confidence interval [CI] = 4.5–13.0, hazard ratio [HR] = 0.58, P < .001). The olaparib group also appeared to have higher levels of 3-year distant disease–free survival (87.5%) compared with the placebo group (80.4%, CI = 3.0–11.1, HR = 0.57, P < .001). Although there was a trend toward a decrease in deaths following olaparib treatment (n = 59) compared with placebo (n = 86, P = .02), it was not considered to be significantly different, with an interim-analysis boundary of P < .01.
Disclosure: For full disclosures of the study authors, visit nejm.org.