[Pooled Analysis of the Trials of Erlotinib Monotherapy for Epidermal Growth Factor Receptor (EGFR)-mutant Advanced Non-small Cell Lung Cancer.].

BACKGROUND: Erlotinib has been approved worldwide for second- and third-line treatment of advanced NSCLC. Clinical trials showed that patients with EGFR mutations treated with erlotinib has better clinical outcomes. The aim of this study is to evaluate the effects of erlotinib monotherapy in EGFR-mutated advanced NSCLC. METHODS: Search the published trials involving EGFR-mutant patients and erlotinib in following database: MEDLINE (2004-2009), CBMdic (2004-2008), CNKI (2004-2008). Search the references cited by the included studies. Identify the included trials. Extract and pooled data from the included trials. RESULTS: Seven studies were identified including 463 advanced NSCLC patients. Based on the available evidence, erlotinib monotherapy showed active effect in EGFR-mutated advanced NSCLC. The response rate reached 66%. 1-year survival and 2-year survival were approximately 73% and 53%. Median survival was more than 23 months while the progression free survival was more than 8.6 months. CONCLUSIONS: Based on the available evidence, erlotinib monotherapy leads to objective response and prolongs survival in most advanced NSCLC patients with EGFR mutations. Small molecule TKI, erlotinib, should be recommended as the first-line treatment of EGFR-mutant NSCLC.