In the phase 3 SOLO-1 study, 391 ovarian cancer patients with a germline and/or somatic BRCA mutation who had a complete or partial clinical response after platinum-based chemotherapy were enrolled. The patients were randomly assigned to receive olaparib or placebo as frontline maintenance therapy. After a median follow-up of 41 months, the median PFS was not reached in the olaparib arm (n = 260), versus 13.8 months in the placebo arm (n = 131) (HR, 0.30; p <0.0001). The three-year progression-free survival rate was 60% in the olaparib group, as compared with 27% in the placebo group. These results suggested that the use of frontline maintenance therapy with olaparib provided a substantial benefit for patients with ovarian cancer and a BRCA1/2 mutation.
Source: N Engl J Med. 2018 Oct 21. [Epub ahead of print]