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Annals of Oncology Advance Access published online on March 1, 2005
Annals of Oncology, doi:10.1093/annonc/mdi126
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© 2005 European Society for Medical Oncology
Received September 26, 2004
Revised November 25, 2004
Accepted December 3, 2004

Original article

Gemcitabine-docetaxel versus cisplatin-vinorelbine in advanced or metastatic non-small-cell lung cancer: a phase III study addressing the case for cisplatin

J.-L. Pujol 1*, J.-L. Breton 2, R. Gervais 3, P. Rebattu 4, A. Depierre 5, J.-F. Morère 6, B. Milleron 7, D. Debieuvre 8, D. Castéra 9, P.-J. Souquet 10, D. Moro-Sibilot 11, E. Lemarié 12, R. Kessler 13, H. Janicot 14, D. Braun 15, D. Spaeth 16, X. Quantin 1, and C. Clary 17

1 Montpellier University Hospital, Montpellier, France
2 Belfort Hospital, Belfort, France
3 Caen Cancer Institute, Caen, France
4 Lyon Cancer Institute, Lyon, France
5 Besançon University Hospital, Besançon, France
6 Bobigny Avicenne University Hospital, Bobigny, France
7 Paris Tenon University Hospital, Paris, France
8 Vesoul Hospital, Vesoul, France
9 Perpignan Saint Pierre Institute, Perpignan, France
10 Hospices Civils de Lyon, Lyon, France
11 Grenoble University Hospital, Grenoble, France
12 Tours University Hospital, Tours, France
13 Strasbourg Hautepierre University Hospital, Strasbourg, France
14 Clermont Ferrand University Hospital, Clermont Ferrand, France
15 Briey Hospital, Briey, France
16 Nancy Cancer Institute, Nancy, France
17 Nice University Hospital, Nice, France

* To whom correspondence should be addressed.
J.-L. Pujol, E-mail: pujol{at}cyber-sante.org


  Abstract

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.

Keywords: chemotherapy; non-platinum-containing regimen; non-small-cell lung cancer.
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