Abstract
290 Background: The study evaluated safety and efficacy of CBZ in Japanese patients (pts) with CRPC in real world settings. Methods: This prospective, observational study targeted all CRPC pts receiving CBZ in daily practice between September 2014 and June 2015. Observation period was 1 year after first dose of CBZ given. Adverse drug reactions (ADRs) were evaluated for safety by CTCAE 4.0. Overall survival (OS), time to treatment failure (TTF) and prostate specific antigen (PSA) response rate (≥30% PSA decrease) were the efficacy endpoints. Two groups, those given 25mg/m2 of CBZ as initial dose (C25) and those given 20mg/m2 of CBZ (C20), were comparatively analyzed. This study was supported by Sanofi. Results: Of 662 enrolled pts with CRPC treated with CBZ, 660 pts were analyzed. ADRs occurred in 511 pts (77.4%). Most frequent all grade ADRs were neutropenia (49.2%), febrile neutropenia (18.0%) and anemia (14.2%). Median OS and TTF were 319 and 116 days, respectively. Of 540 PSA evaluable pts, 158 (29.3%) achieved PSA response. Populations for post hoc analysis were 159 pts for C25 and 190 pts for C20. Patient characteristics were similar C25 and C20 groups. Statistical significant differences were observed between C25 and C20 groups for OS (Hazzard Ratio [HR] = 0.71) and TTF (HR = 0.78) in favor of C25 group. Initial dose of CBZ remained as the independent prognostic factor for OS and TTF in univariate and multivariate analysis. There was no significant difference for PSA response rate. ≥ Grade 3 ADRs with C25 and C20 occurred in 129 pts (81.1%) and 116 pts (61.1%), respectively. Conclusions: Safety profile of CBZ was generally consistent with clinical studies conducted before approval in Japan. Although there are some limitations of studies done in real world settings, there were significant differences for OS and TTF between C25 and C20. Less ADRs occurred with C20. [Table: see text]
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