Comparison of gefitinib and docetaxel in patients with pretreated advanced non-small cell lung cancer (NSCLC): Meta-analysis from four clinical trials

8011 Background: Four open-label, randomized trials evaluated gefitinib (G) vs docetaxel (D) in unselected patients with pre-treated advanced NSCLC: INTEREST (Lancet 2008; 372: 1809), V-15–32 (J Clin Oncol 2008; 26: 4244), ISTANA (J Clin Oncol 2008; 26: Abs 8025), SIGN (Anticancer Drugs 2006; 17: 401). Reported here is a meta-analysis using the patient data from each of these trials. Methods: The meta-analysis compared efficacy of G (250 mg/day) and D (75 mg/m2 [V-15–32 60 mg/m2]) using appropriate analysis populations from INTEREST (1466 patients randomized), V-15–32 (489), ISTANA (161) and SIGN (141). Meta-analyses (unadjusted and adjusted for covariates) were performed by Cox proportional hazards for OS and PFS, and by logistic regression for ORR. Results: G demonstrated similar OS and PFS and superior ORR to D in the primary analyses. Secondary analyses demonstrated similar results. Conclusions: Results were consistent with those of the individual studies. Given the similar/superior efficacy demonstra...