Vinorelbine plus cisplatin versus docetaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III randomized trial
| Autor: | Stylianos Kakolyris, Nikolaos Samaras, Dora Chatzidaki, Ourania Anagnostopoulou, X. Tsiafaki, Michael Toubis, Penelope Mixalopoulou, Nikolaos Androulakis, A. Agelidou, Kostas N. Syrigos, George Samonis, Vassilis Georgoulias, Alexandros Ardavanis, Anna Christou, P. Ziotopoulos, Aris Polyzos, Charalambos Kouroussis |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Lung Neoplasms Injections Subcutaneous Docetaxel Neutropenia Vinorelbine Vinblastine Gastroenterology Deoxycytidine Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor medicine Humans Lung cancer Infusions Intravenous Aged business.industry Middle Aged medicine.disease Survival Analysis Gemcitabine Surgery Regimen Oncology Tolerability Quality of Life Female Taxoids Cisplatin business Febrile neutropenia medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 23(13) |
| ISSN: | 0732-183X |
| Popis: | Purpose To compare the activity and tolerability of docetaxel/gemcitabine (DG) and vinorelbine/cisplatin (VC) combinations in chemotherapy-naïve non-small-cell lung cancer (NSCLC) patients. Patients and Methods Patients with advanced NSCLC were randomly assigned to receive either DG (gemcitabine 1,000 mg/m2 [days 1 and 8] plus docetaxel 100 mg/m2 [day 8]) or VC (vinorelbine 30 mg/m2 [days 1 and 8] plus cisplatin 80 mg/m2 [day 8]) and prophylactic recombinant human granulocyte colony-stimulating factor (150 μg/m2 subcutaneously [day 9 through 15]) every 3 weeks. Results A total of 413 randomly assigned patients were analyzed for response and toxicity (DG, n = 197; VC, n = 192). Median survival was 9.0 and 9.7 months (P = .965) for DG and VC arms, respectively; the corresponding 1-year survival rates were 34.3% and 40.8%, respectively. Overall response rate was 30% (95% CI, 23.9% to 36.3%) and 39.2% (95% CI, 32.5% to 45.9%; P = .053) for DG and VC, respectively. Toxicity was as follows (DG v VC): grade 2 to 4 anemia, 34% v 55% (P = .0001); grade 3 to 4 neutropenia, 16% v 37% (P = .0001); febrile neutropenia, 6% v 11% (P = .009); and grade 3 to 4 nausea and vomiting, 1% v 15% (P = .003). Nephrotoxicity occurred in 8% and ototoxicity in 2% of VC-treated patients. There were five and six treatment-related deaths in the DG and VC arms, respectively. Quality of life was improved in DG but not in VC patients. Conclusion Although the two regimens produced comparable overall survival, the DG regimen had a better toxicity profile. Therefore, DG could be used in the first-line setting of advanced NSCLC, especially for patients who cannot tolerate cisplatin. |
| Databáze: | OpenAIRE |
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