ERCC1 Expression-based Randomized Phase II Study of Gemcitabine/cisplatin Versus Irinotecan/cisplatin in Patients With Advanced Non-Small Cell Lung Cancer.

We evaluated the clinical utility of excision repair cross-complementation group 1 (ERCC1) expression as a predictive biomarker for platinum-based chemotherapy in advanced non-small cell lung cancer (NSCLC).,Eligible patients were randomly assigned to the GP (gemcitabine 1,250 mg/m2 on days 1 and 8, and cisplatin 75 mg/m2 on day 1 every 3 weeks) or IP (irinotecan 65 mg/m2 and cisplatin 30 mg/m2 on days 1 and 8 every 3 weeks) arm. The primary goal of this study was to compare the response rate (RR) of the GP and IP arms according to the ERCC1 expression level.,A total of 279 patients were randomly assigned to the GP (n=139) and IP (n=140) arms, among which 63% were ERCC1-positive and 268 patients were assessable for the RR. The GP and IP arms did not differ significantly with respect to the RR (29.8% vs. 27.0%, respectively; P=0.082), median progression-free survival (PFS; 4.5 vs. 3.9 months, respectively; P=0.117) and overall survival (OS; 16.5 vs. 16.7 months, respectively; P=0.313). When comparing the efficacy between the ERCC1-positive and ERCC1-negative groups, there was no significant difference in the RR (GP, 28.2% vs. 32.6%, respectively, P=0.509; IP, 30.2% vs. 21.6%, respectively, P=0.536), median PFS (GP, 4.6 vs. 5.0 months, respectively, P=0.506; IP, 3.9 vs. 3.7 months, respectively, P=0.748) or median OS (GP, 18.6 vs. 11.9 months, respectively, P=0.070; IP, 17.5 vs. 14.0 months, respectively, P=0.821).,Immunohistochemical analysis of the ERCC1 expression level did not differentiate the efficacy of platinum-based chemotherapy in advanced NSCLC (NCT01003964).