Statistics
In this single‐arm open‐label study, the primary endpoint of PFS was determined using Kaplan–Meier method for survival.Due to slower than expected accrual, a prospective, but initially unplanned interim analysis for futility of achieving the projected PFS increase from 15 to 30 months by continuing to enroll the additional 24 patients evaluable for PFS was performed after 13 evaluable patients were enrolled using the Weibull distribution