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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.
- 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.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Carcinoma, Non-Small-Cell Lung secondary
Cisplatin adverse effects
Deoxycytidine administration & dosage
Deoxycytidine adverse effects
Docetaxel
Female
Hematologic Diseases chemically induced
Humans
Lung Neoplasms secondary
Male
Middle Aged
Survival Analysis
Taxoids administration & dosage
Taxoids adverse effects
Vinblastine administration & dosage
Vinblastine adverse effects
Vinorelbine
Gemcitabine
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Carcinoma, Non-Small-Cell Lung drug therapy
Cisplatin administration & dosage
Deoxycytidine analogs & derivatives
Lung Neoplasms drug therapy
Vinblastine analogs & derivatives
Subjects
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