Final overall survival results of NEJ002, a phase III trial comparing gefitinib to carboplatin (CBDCA) plus paclitaxel (TXL) as the first-line treatment for advanced non-small cell lung cancer (NSCLC) with EGFR mutations.

Abstract

7519 Background: NEJ002 have demonstrated a significant superiority of gefitinib on progression-free survival compared with CBDCA plus PTX (CP) as the first-line treatment for EGFR-mutated advanced NSCLC. Since the result of overall survival (OS) was immature at the time of previous report, final evaluation of the updated OS was performed. Methods: OS at the final data-cut-off point (November 2010) was evaluated for the entire ITT population in NEJ002 (n=228). Subgroup analysis of OS for gender, smoking status, and type of mutation and detail examination for second or later-line chemotherapy on each patient were also performed. Results: The updated maturity of OS data was 60% compared to 36% at the previous cut-off point in November 2008. The median survival time and 2-year survival rate were 27.7 months and 57.9% in gefitinib group, and 26.6 months and 53.7% in CP group (HR 0.887; 95% CI 0.634-1.241; p=0.483). No significant difference in OS was observed between groups from any subset analysis. In gefitnib group, OS of patients with exon 19 deletion and that of patients with L858R were similar (28.9 months vs 28.0months). Eleven patients were still responding to the first-line gefitinib. Regarding the second-line treatment, 90% of patients in gefitinib group received chemotherapy and 96% of patients in CP group received gefitinib. Conclusions: No statistical difference in OS was observed in NEJ002 from this matured analysis, which is possibly due to high cross-over use of gefitinib in the CP group. Considering a risk-benefit balance and the results of QOL investigation in NEJ002, gefitinib should be considered as one of the standard first-line treatment for EGFR-mutated advanced NSCLC.