Replies to post #260913 on Avid Bioservices Inc (CDMO)

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Aflibercept and Docetaxel Versus Docetaxel Alone After Platinum Failure in Patients With Advanced or Metastatic Non–Small-Cell Lung Cancer: A Randomized, Controlled Phase III Trial

For reference, assumption was 7.5 vs 9.5 months, about 2-month difference in mOS, HR=0.78, 22% risk reduction.

Statistical Design and Analysis

A total of 687 deaths were required to detect a 22% HR reduction in OS for (ziv-)aflibercept and docetaxel compared with placebo and docetaxel, with 90% power using the two-sided log-rank test at an overall 5% significance level. Assuming a 7.5-month median survival time in the placebo arm, 18-month accrual, and 10-month follow-up, a total of 900 patients were to be accrued. One interim analysis for futility [?(-6) ß-spending function] and superiority (O'Brien-Fleming a-spending function, with P = .0015) was performed after 344 OS events. The final primary analysis was thus conducted with a one-sided a = .0245. To preserve a, a hierarchical step-down procedure was used, testing OS first, then PFS, followed by response rate; if the test for a parameter was negative, then subsequent tests could only be considered exploratory.

http://jco.ascopubs.org/content/30/29/3640.full