Pooled analysis of clinical outcome for EGFR TKI ‐treated patients with EGFR mutation‐positive NSCLC

Patients with non‐small‐cell lung cancer ( NSCLC ) appear to gain particular benefit from treatment with epidermal growth factor receptor ( EGFR ) tyrosine‐kinase inhibitors ( TKI ) if their disease tests positive for EGFR activating mutations. Recently, several large, controlled, phase III studies have been published in NSCLC patients with EGFR mutation‐positive tumours. Given the increased patient dataset now available, a comprehensive literature search for EGFR TKI s or chemotherapy in EGFR mutation‐positive NSCLC was undertaken to update the results of a previously published pooled analysis. Pooling eligible progression‐free survival ( PFS ) data from 27 erlotinib studies ( n  = 731), 54 gefitinib studies ( n  = 1802) and 20 chemotherapy studies ( n  = 984) provided median PFS values for each treatment. The pooled median PFS was: 12.4 months (95% accuracy intervals [ AI ] 11.6–13.4) for erlotinib‐treated patients; 9.4 months (95% AI 9.0–9.8) for gefitinib‐treated patients; and 5.6 months (95% AI 5.3–6.0) for chemotherapy. Both erlotinib and gefitinib resulted in significantly longer PFS than chemotherapy (permutation testing; P  = 0.000 and P  = 0.000, respectively). Data on more recent TKI s (afatinib, dacomitinib and icotinib) were insufficient at this time‐point to carry out a pooled PFS analysis on these compounds. The results of this updated pooled analysis suggest a substantial clear PFS benefit of treating patients with EGFR mutation‐positive NSCLC with erlotinib or gefitinib compared with chemotherapy.