Efficacy and Safety of Gefitinib or Platinum plus Taxane in Egfr-Mutant Advanced Non-Small Cell Lung Cancers: A Meta-Analysis of First-Line Randomized Controlled Trials

Purpose: The discovery of EGFR mutations renewed interest in lung cancer translational research since EGFR-dependent pathway plays an important role in the development and progression of human epithelial cancers, including nonsmall cell lung cancer (NSCLC). The present meta-analysis was performed to review the recent advances with the selective oral EGFR-TK inhibitor gefitinib among EGFR mutation positive patients with NSCLC. Methods: Using the keywords “gefitinib” and “lung cancer” MEDLINE was searched. The primary reports of interest were the randomized controlled trials in NSCL published in peer-reviewed journals. Three recent studies concerning the effect of gefitinib in NSCLC were identified to be relevant for the meta-analysis based on their similarity in terms of study design. PFS and objective response rate (ORR) in gefitinib and platinum/taxane combination were compared by the Hazard ratio (HR) or Odds Ratio (OR) of meta-analysis. Results: The HR (95% CI) of the meta-analysis of 0.41 (0.34 0.49) demonstrated that in patients EFGR mutation positive patients, PFS was significantly longer among those who received gefitinib compared to platin derivative/taxane combination. Furthermore, OR of the meta-analysis for ORR was 3.83 (2.72 5.40). While hematological toxicity was observed in the majority of the taxane/platinum group, major adverse events in gefitinib patients were skin rashes/acnea, dry skin, elevated liver enzymes and diarrhea. Conclusion: This meta-analysis strongly confirms the efficacy and better tolerability of gefitinib in EGFR positive NSCLC, and the importance of EGFR mutation testing in order to plan first-line treatment in routine clinical practice in NSCLC.