Benefit substantial for homologous-recombination deficiency positive tumors with, without BRCA mutations
WEDNESDAY, Dec. 18, 2019 (HealthDay News) — Compared with placebo, the addition of olaparib to maintenance therapy with bevacizumab is associated with a significant progression-free survival benefit for patients with advanced ovarian cancer, according to a study published in the Dec. 19 issue of the New England Journal of Medicine.
Isabelle Ray-Coquard, M.D., Ph.D., from the Centre Léon Bérard in Lyon, France, and colleagues conducted a randomized, phase 3 trial involving patients with newly diagnosed, advanced, high-grade ovarian cancer who had a response after first-line platinum-taxane chemotherapy plus bevacizumab. Eligibility was not linked to patients’ surgical outcome or BRCA mutation status. Overall, 806 patients were randomly assigned to receive either olaparib or placebo in a 2:1 ratio for up to 24 months (537 and 269, respectively); all patients received bevacizumab.
The researchers found that the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab after a median follow-up of 22.9 months (hazard ratio for disease progression or death, 0.59). For disease progression or death, the hazard ratios were 0.33 and 0.43 for patients with tumors positive for homologous-recombination deficiency, including tumors that had BRCA mutations (median progression-free survival, 37.2 versus 17.7 months) and tumors that did not have BRCA mutations (median progression-free survival, 28.1 versus 16.6 months).
“The trial met its primary objective by showing a significant progression-free survival benefit in the intention-to-treat population,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including AstraZeneca (the manufacturer of olaparib), Merck Sharp & Dohme, and F. Hoffmann-La Roche, which partially funded the study.
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