Advanced prostate cancer - patient survival and potential impact of enzalutamide and other emerging therapies.

61 The study’s primary end point of OS did not reach statistical significance with a median OS of 11.2 months (95% CI 9.5–12.7) for ipilimumab and 10.0 months (95% CI 8.3–11.0) for placebo (HR 0.85; 95% CI 0.72–1.00; P =0.053).

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25 The co-primary end points of this trial were radiographic progression-free survival (rPFS) and OS, which was met for rPFS, showing benefit in the abirater-one group (16.5 months versus 8.2 months, P <0.0001) but not for OS, though a strong trend toward improved survival was seen, but did not cross the O’Brien-Fleming efficacy boundary for statistical significance or the pre-specified statistical efficacy boundary (alpha-level: 0.0035). 26 Similar to the earlier study, unblinding was carried out after interim analysis and cross-over was allowed.

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