Olaparib Tablets Prolong Progression-free Survival in Ovarian Cancer
Maintenance treatment with olaparib tablets may prolong PFS without negatively affecting quality of life among patients with relapsed ovarian cancer.
Maintenance treatment with olaparib tablets may prolong progression-free survival (PFS) without negatively affecting quality of life among patients with relapsed ovarian cancer, according to a study published in The Lancet Oncology.1
For the phase 3 study SOLO2/ENGOT-Ov21 (ClinicalTrials.gov Identifier: NCT01874353), researchers enrolled 295 patients with relapsed ovarian cancer sensitive to platinum therapy who had received at least 2 lines of prior chemotherapy and who had a BRCA1/2 mutation. These patients were randomly assigned 2:1 to receive olaparib 300 mg tablets twice daily or placebo.
Study participants in the olaparib group had a significantly longer investigator-assessed PFS, with 19.1 months (95% CI, 16.3-25.7) with olaparib vs 5.5 months (95% CI, 5.2-5.8) for placebo (hazard ratio [HR], 0.30; 95% CI, 0.22-0.41; P < .0001).
Median time to first subsequent therapy was 27.9 months (95% CI, 22.6 to not calculable) in the olaparib group vs 7.1 months (95% CI, 6.3-8.3) for placebo. Median time to second progression was not reached in the olaparib arm vs 18.4 months (95% CI, 15.4-22.8) in the placebo arm. Median time to second subsequent therapy was not reached in the olaparib arm vs 18.2 months (95% CI, 15.0-20.5) in the placebo arm.
The most frequently reported grade 3 or worse adverse events (AEs) were anemia (19% olaparib vs 2% placebo), asthenia or fatigue (4% vs 2%), and neutropenia (5% vs 4%).
One patient in the olaparib arm developed treatment-related acute myeloid leukemia, which led to death.
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The authors concluded that “olaparib can achieve a significant prolongation of progression-free survival in this patient population with no appreciable detrimental effect observed for patients' quality of life.”
- Pujade-Lauraine E, Ledermann JA, Selle F, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomized, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Jul 25. doi: 10.1016/S1470-2045(17)30469-2 [Epub ahead of print]