Disease control as a predictor of survival with gefitinib and docetaxel in a phase III study (V-15-32) in advanced non-small cell lung cancer patients.

摘要

INTRODUCTION: This post hoc analysis investigated the relationship between tumor response and overall survival (OS) in pretreated advanced non-small cell lung cancer (NSCLC). METHODS: We conducted landmark survival analyses of V-15-32, a phase III study comparing gefitinib with docetaxel in pretreated advanced NSCLC. Best response at weeks 8, 12, 16, and 20, and visit response at week 4, were evaluated. RESULTS: Disease control (DC; complete response [CR], partial response [PR], or stable disease) was a better predictor of OS than CR/PR at all time points. The strongest predictor of OS for both gefitinib and docetaxel was DC at week 8 (hazard ratio [HR] DC versus non-DC: 0.30, 95% confidence interval [CI] 0.20-0.45, p < 0.001 for both treatments). DC at week 4 was also associated with longer survival compared with non-DC for both treatments (HR 0.33, 95% CI 0.23-0.49, p < 0.001 for gefitinib; HR 0.30, 95% CI 0.19-0.47, p < 0.001 for docetaxel). DISCUSSION: DC is a better predictor of OS with gefitinib and docetaxel than CR/PR in advanced pretreated NSCLC, with a best response of DC at week 8 the strongest predictor.