Vinorelbine/carboplatin vs gemcitabine/carboplatin in advanced NSCLC shows similar efficacy, but different impact of toxicity

This randomised phase III study in advanced non- small cell lung cancer ( NSCLC) patients was conducted to compare vinorelbine/ carboplatin ( VC) and gemcitabine/ carboplatin ( GC) regarding efficacy, health- related quality of life ( HRQOL) and toxicity. Chemonaive patients with NSCLC stage IIIB/ IV and WHO performance status 0 - 2 were eligible. No upper age limit was defined. Patients received vinorelbine 25 mgm(-2) or gemcitabine 1000 mgm(-2) on days 1 and 8 and carboplatin AUC4 on day 1 and three courses with 3- week cycles. HRQOL questionnaires were completed at baseline, before chemotherapy and every 8 weeks until 49 weeks. During 14 months, 432 patients were included ( VC, n= 218; GC, n= 214). Median survival was 7.3 vs 6.4 months, 1- year survival 28 vs 30% and 2- year survival 7 vs 7% in the VC and GC arm, respectively ( P= 0.89). HRQOL, represented by global QOL, nausea/ vomiting, dyspnoea and pain, showed no significant differences. More grade 3 - 4 anaemia ( P < 0.01), thrombocytopenia ( P < 0.01) and transfusions of blood ( P < 0.01) or platelets ( P < 0.01) were observed in the GC arm. There was more grade 3 - 4 leucopoenia ( P < 0.01) in the VC arm, but the rate of neutropenic infections was the same (P= 0.87). In conclusion, overall survival and HRQOL are similar, while grade 3 - 4 toxicity requiring interventions are less frequent when VC is compared to GC in advanced NSCLC.