Antitumor Activity
RECURRENCE
Of the first 18 patients enrolled, confirmed responses were noted in 12 patients, and the trial continued to full accrual.In the ITT set, 38 patients (65.5% [95% CI, 51.9 to 77.5]) achieved a confirmed objective response, with 13 CRs (22.4%) and 25 PRs (43.1%; Table Antitumor ActivityKaplan-Meier curves of the DoR, PFS, and OS. (A) The DoR was assessed in responders (n = 38). (B) PFS and (C) OS were assessed in the intention-to-treat population (n = 58). DoR, duration of response; NE, not evaluable; NR, not reached; OS, overall survival; PFS, progression-free survival.Patients who had locoregional recurrence only exhibited an ORR of 80.0%, while that for patients with metastatic lesions was 54.5% (