Olaparib maintenance therapy in patients with platinum-sensitive, relapsed serous ovarian cancer and a BRCA mutation: Overall survival adjusted for postprogression poly(adenosine diphosphate ribose) polymerase inhibitor therapy

摘要: BACKGROUND Maintenance treatment with the oral poly(adenosine diphosphate ribose) polymerase (PARP) inhibitor olaparib (Lynparza) in Study 19 (study number, D0810C00019; ClinicalTrials.gov identifier, NCT00753545) significantly improved progression-free survival comparison a placebo for patients platinum-sensitive, relapsed serous ovarian cancer BRCA1/2 mutation (BRCAm), but an interim analysis revealed no statistically significant overall (OS) benefit. However, 23% of receiving switched to PARP after progression. To investigate whether this had confounding effect on OS, article reports exploratory post hoc that excluded all from sites where 1 or more received postprogression treatment. METHODS In 19, 136 265 BRCAm. Sixteen treated at 11 82 investigational progression; these were analysis, and 97 BRCAm 50 included. OS was assessed Cox proportional hazards model analogous primary study analysis. A supporting rank-preserving structural failure time (RPSFT) undertaken patients. RESULTS The hazard ratio (HR) 0.52 (95% confidence interval [CI], 0.28-0.97) patients, whereas it 0.73 CI, 0.45-1.17). The supportive RPSFT HR approximately 0.66. CONCLUSIONS The numerical improvement suggests influence patients. There is degree uncertainty due small sample size lack data maturity. Cancer 2016;122:1844–52. © 2016 American Society.