Annals of Oncology Advance Access originally published online on March 1, 2005
Annals of Oncology 2005 16(4):602-610; doi:10.1093/annonc/mdi126
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© 2005 European Society for Medical Oncology
Original articles |
Gemcitabine–docetaxel versus cisplatin–vinorelbine in advanced or metastatic non-small-cell lung cancer: a phase III study addressing the case for cisplatin
1 Montpellier University Hospital, Montpellier; 2 Belfort Hospital, Belfort; 3 Caen Cancer Institute, Caen; 4 Lyon Cancer Institute, Lyon; 5 Besançon University Hospital, Besançon; 6 Bobigny Avicenne University Hospital, Bobigny; 7 Paris Tenon University Hospital, Paris; 8 Vesoul Hospital, Vesoul; 9 Perpignan Saint Pierre Institute, Perpignan; 10 Hospices Civils de Lyon, Lyon; 11 Grenoble University Hospital, Grenoble; 12 Tours University Hospital, Tours; 13 Strasbourg Hautepierre University Hospital, Strasbourg; 14 Clermont Ferrand University Hospital, Clermont Ferrand; 15 Briey Hospital, Briey; 16 Nancy Cancer Institute, Nancy; 17 Nice University Hospital, Nice, France
* Correspondence to: Dr J.-L. Pujol, Montpellier Academic Hospital, Hôpital Arnaud de Villeneuve, 34295 Montpellier Cedex 5, France. Tel/Fax: +33-4-67-33-61-36; Email: pujol{at}cyber-sante.org
Background: This multicenter, randomized, phase III study compared the efficacy, including progression-free survival (PFS), and safety of gemcitabine–docetaxel (GD) combination versus cisplatin–vinorelbine (CV) in the treatment of advanced non-small-cell lung cancer (NSCLC).
Patients and methods: Chemonaïve patients with stage IIIB or IV NSCLC were treated with GD (gemcitabine 1000 mg/m2 days 1 and 8 plus docetaxel 85 mg/m2 day 8, every 3 weeks for eight cycles) or CV (cisplatin 100 mg/m2 day 1 plus vinorelbine 30 mg/m2, days 1, 8, 15 and 22, every 4 weeks for six cycles).
Results: A total of 311 patients were enrolled (155 GD and 156 CV). Neither PFS nor overall survival differed significantly between the two arms (median PFS 4.2 and 4 months; median survival 11.1 and 9.6 months; 1-year survival 46% and 42%, for GD and CV, respectively). For the GD arm compared with the CV arm, the hazard ratio for PFS was 1.04 [95% confidence interval (CI) 0.83–1.32], and for overall survival, it was 0.90 (95% CI 0.70–1.16). Objective response rates did not differ significantly (31% for GD, 35.9% for CV). Myelosupression, emesis and frequency of febrile neutropenia were less pronounced on the GD arm, whereas fluid retention and pulmonary events were more pronounced. The CV arm experienced a higher number of serious adverse events and a lower compliance with the protocol. There was no quality of life (QoL) difference between arms. Median time to definite impairment of health-related QoL was 153 and 168 days in GD and CV arms, respectively.
Conclusions: There was no advantage in PFS with GD compared with CV; however, the CV regimen had higher rate of toxic events, mainly myelosuppression. The herein, non-platinum-containing regimen could be considered as a rational alternative to the cisplatin-based doublet.
Key words: chemotherapy, non-platinum-containing regimen, non-small-cell lung cancer
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