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

IntroductionThis post hoc analysis investigated the relationship between tumor response and overall survival (OS) in pretreated advanced non-small cell lung cancer (NSCLC).MethodsWe 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.ResultsDisease 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).DiscussionDC 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.