Therapeutic efficacy
squamous or nonsquamous, tumor
EVENTS, TUMOR, SOLID TUMORS
During the follow‐up period, events occurred in 36 (92.3%) of 39 patients in group A and 35 (89.7%) of 39 patients in group B regarding the primary endpoint. Median PFS was 3.75 months (95% CI, 1.87–5.36) in group A and 3.71 months (95% CI, 2.23–5.85) in group B (Figure Investigator‐assessed progression‐free survival and overall survival. Kaplan–Meier plots for investigator‐assessed progression‐free survival (A) and overall survival (B) in the intention‐to‐treat (ITT) population. CI, confidence interval; HR, hazard ratio.The results for OS are shown in Figure The results of PFS and OS for subgroup analysis were consistent with those for the intention‐to‐treat population (Figure Investigator‐assessed progression‐free survival by number of prior cytotoxic chemotherapies and investigator‐assessed progression‐free survival by histologic subtype of tumor. Kaplan–Meier plots for subgroup analysis of investigator‐assessed progression‐free survival (A) and overall survival (B) in the intention‐to‐treat (ITT) population. Stratification factors for overall survival were the number of prior cytotoxic chemotherapy regimens (1 or ≧2), tumor histology (squamous or nonsquamous). CI, confidence interval; HR, hazard ratio.The ORR was assessed for 39 patients who had measurable tumor lesions. The ORR was 20.5% (95% CI, 9.3–36.5) in group A and 23.1% (95% CI, 11.1–39.3%) in group B (Table Response rates for enrolled patients and for histology‐based subsets.Objective response by investigator review per Response Evaluation Criteria in solid tumors, version 1.1.Response rates by number of previous cytotoxic chemotherapies.Objective response by investigator review per Response Evaluation Criteria in solid tumors, version 1.1.