1. ¹Institute of Clinical Medicine, University of Tromsø and Department of Oncology, University Hospital of Northern Norway, 9038 Tromsø, Norway
2. ²Department of Oncology, St Olavs University Hospital, 7030 Trondheim, Norway
3. ³Department of Pulmonology, University Hospital of Northern Norway and Institute of Clinical Medicine, University of Tromsø, 9038 Tromsø, Norway
4. ⁴Department of Oncology, Rikshospitalet-Radiumhospitalet HF, Ullernch. 70, 0310 Oslo, Norway
5. ⁵Department of Thoracic Medicine, Haukeland University Hospital and Institute of Medicine, University of Bergen, Jonas Lies vei, 5021 Bergen, Norway
6. ⁶Department of Pulmonology, St Olavs University Hospital, 7030 Trondheim, Norway
7. ⁷Thoracic Department, Division of Internal Medicine, Stavanger University Hospital, 4010 Stavanger, Norway
8. ⁸Department of Pulmonology, University Hospital of Akershus, Sykehusv. 27, 1474 Nordbyhagen, Norway

Correspondence: Dr N Helbekkmo, E-mail: nina.helbekkmo@fagmed.uit.no

Received 30 March 2007; Revised 30 May 2007; Accepted 4 June 2007; Published online 26 June 2007.

Abstract

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 mg m^-2 or gemcitabine 1000 mg m^-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.