Gemcitabine with either paclitaxel or vinorelbine vs paclitaxel or gemcitabine alone for elderly or unfit advanced non-small-cell lung cancer patients

Abstract

The aim of this study was to assess whether a combination of gemcitabine (GEM) with either paclitaxel (PTX) or vinorelbine (VNR) could be more effective than GEM or PTX alone in elderly or unfit advanced non-small-cell lung cancer (NSCLC) patients. A total of 264 NSCLC patients aged > 70 years with ECOG performance status (PS) ≤ 2, or younger with PS = 2, were randomly treated with: GEM 1200 mg m-2 on days 1, 8 and 15 every 28 days; PTX 100 mg m-2 on days 1, 8 and 15 every 28 days; GEM 1000 mg m-2 plus PTX 80 mg m-2 (GT) on days 1 and 8 every 21 days; GEM 1000 mg m-2 plus VNR 25 mg m-2 (GV) on days 1 and 8 every 21 days. In all arms, an intra-patients dose escalation was applied over the first three courses, provided that no toxicity of WHO grade ≥ 2 had previously occurred. At present time, 217 (82%) patients had died. The median (months) and 1-year survival probability were 5.1 and 29% for GEM, 6.4 and 25% for PTX, 9.2 and 44% for GT, and 9.7 and 32% for GV. Multivariate analysis showed that PS ≤ 1 (hazard ratio (HR) =0.67; 95% CI 0.51-0.90), and doublet treatments (HR = 0.76; 95% CI 0.59-0.99) were significantly associated with longer survival. Doublets produced no more toxicity than single agents. GT should be considered a reference regimen for elderly NSCLC patients with PS ≤ 1. © 2004 Cancer Research UK.