A randomized phase III study of combining erlotinib with bevacizumab and panitumumab versus erlotinib alone as second-line therapy for Chinese patients with non-small-cell lung cancer.

Abstract

In this phase III clinical study, we assessed the clinical outcomes of combining erlotinib with bevacizumab and panitumumab as second-line chemotherapy for patients with non-small-cell lung cancer (NSCLC). Chinese NSCLC patients, who received first-line platinum-based chemotherapy but still experienced disease progression, were assigned to receive second-line treatment of erlotinib plus bevacizumab and panitumumab (arm I), or erlotinib plus placebo (arm II). The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS) and response rates. 150 patients were enrolled in arm I, and 147 in arm II. Median PFS of arm I was 4.6 months (95% CI, 2.3-9.4 months), much longer than the median PFS in arm II (1.9 months, 95% CI 0.8-5.2 months) (P=0.003). The median OS of arm I was 10.4 months (95% CI, 7.5-13.1 months), also significantly longer than the median OS in arm II (8.9 months, 95% CI 3.3-10.9 months) (P=0.031). Partial response in arm I was 38%, significantly higher than the partial response rate of 15% in arm II (P=0.014). The occurrence rates of adverse events, including diarrhea, fatigue and rash, were higher in arm I than in arm II. Erlotinib plus bevacizumab and panitumumab is an efficient second-line treatment option for patients with NSCLC.