Overall response rate as a surrogate of progression-free survival with molecular targeted agents: A meta-analysis of phase III trials in advanced non-small cell lung cancer.

e19142 Background: Development of molecular targeted agents (MTAs) is active in advanced non-small cell lung cancer (NSCLC). Some of them demonstrated high overall response rate (ORR), and durable progression-free survival (PFS). To screen MTAs effectively in early clinical trials, ORR is a candidate surrogate marker. Methods: We extracted phase III trials which were for advanced NSCLC using MTA as monotherapy, published between 2000 to 2014. The trials were categorized into 3 groups (genetically enriched, clinically enriched, and non-enriched). ORR and median PFS were analyzed using Spearman’s rank order correlation. Results: Twenty-five trials (27 arms) using 6 MTAs (afatinib, crizotinib, erlotinib, gefitinib, icotinib, and vandetanib) were identified. Total number of the patients was 7050, and median number of the patients per arm was 196 (range, 68-695). About half of the trials were for the first-line treatment. Ninety percent of participants had good performance status. Of 25 trials, 8 were genetica...