Erlotinib in patients with advanced non-small-cell lung cancer: A meta-analysis.

Erlotinib is a potent reversible HER1/epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with single-agent activity in patients with non-small-cell lung cancer (NSCLC). In this article, we updated the evidence of erlotinib in treating advanced NSCLC by adding new results of RCTs published between January 2011 and May 2012 into a pooled analysis which had been published in 2011. Outcomes analyzed were objective response rate (ORR), progression free survival (PFS), overall survival (OS) and adverse events. Twenty trials including 9,005 patients were identified, and six of them were recently published. As first-line therapy compared to placebo or chemotherapy, there was a similar ORR (P=0.29 and 0.42), PFS (P=0.09 and 0.25) and OS (P=0.73 and 0.49). However, for the patients with EGFR mutations, erlotinib based regimens could significantly improve ORR (P<0.01), prolong PFS (P<0.0), but did not prolong OS (P=0.22). As maintenance therapy compared with placebo, erlotinib based regimens significantly increased ORR (P<0.01), prolonged PFS (P<0.01), but did not improve OS (P=0.22). As second/third-line therapy comparing with placebo, erlotinib based regimens also significantly increased ORR (P<0.01), prolonged PFS (P<0.01), and improved OS (P<0.01). As second/third-line therapy compared with chemotherapy, gefitinib, or vandetanib, the outcomes were similar between two arms. However, compared with PF299804, there was a decreased ORR (P=0.02), and shorten PFS (P=0.02). Meanwhile, The patients treated with erlotinib based regimens suffered from more diarrhea, rash, and less fatigue, neutropenia, and thrombocytopenia than other agent based regimens. Our meta analysis showed that erlotinib based regimens could significantly increase ORR, improve PFS as first-line maintenance therapy or second/third-line therapy comparing with placebo or PF299804.