Back to Search Start Over

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

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

Authors :
Pujol JL
Breton JL
Gervais R
Rebattu P
Depierre A
Morère JF
Milleron B
Debieuvre D
Castéra D
Souquet PJ
Moro-Sibilot D
Lemarié E
Kessler R
Janicot H
Braun D
Spaeth D
Quantin X
Clary C
Source :
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2005 Apr; Vol. 16 (4), pp. 602-10. Date of Electronic Publication: 2005 Mar 01.
Publication Year :
2005

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).<br />Patients and Methods: Chemonaive patients with stage IIIB or IV NSCLC were treated with GD (gemcitabine 1000 mg/m(2) days 1 and 8 plus docetaxel 85 mg/m(2) day 8, every 3 weeks for eight cycles) or CV (cisplatin 100 mg/m(2) day 1 plus vinorelbine 30 mg/m(2), days 1, 8, 15 and 22, every 4 weeks for six cycles).<br />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.<br />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.

Details

Language :
English
ISSN :
0923-7534
Volume :
16
Issue :
4
Database :
MEDLINE
Journal :
Annals of oncology : official journal of the European Society for Medical Oncology
Publication Type :
Academic Journal
Accession number :
15741225
Full Text :
https://doi.org/10.1093/annonc/mdi126