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Randomized phase II study of erlotinib as first-line or second-line therapy for EGFR mutation-positive advanced lung adenocarcinoma patients

Wei Zhao, Xingchen Liu, Qing Tian, Yan Chang, Zhen Yang, Liangan Chen

Epidermal Growth Factor Receptor (EGFR) mutation in patients with Non-Small Cell Lung Cancer (NSCLC) in Asian population could benefit in survival to Tyrosine Kinase Inhibitor (TKI) treatment. Standard chemotherapy was the mainstay for advanced NSCLC. In this randomized, single center, phase 2 studies, we investigated erlotinib as first-line therapy plus docetaxel and cisplatin as second-line therapy compared to docetaxel and cisplatin as first-line therapy plus erlotinib as second-line therapy in treat naïve patients with advanced lung adenocarcinoma. 81 patients were randomized to receive erlotinib+chemotherapy (E+C group, n=43) and chemotherapy+erlotinib (C+E group, n=38). The primary objective was Overall Survival (OS) and secondary objective was objective response rate. The data showed the median OS in E+C group and C+E group were 23.7 months and 24.2 months, respectively (p=0.652). The objective response rate differed in the two groups (p<0.001). Our results indicated that sequential usage of erlotinib plus chemotherapy and chemotherapy plus erlotinib did not showed difference in OS.