Vinorelbine plus cisplatin versus docetaxel plus gemcitabine in advanced non-small-cell lung cancer: A phase III randomized trial

被引:129
作者
Georgoulias, V
Ardavanis, A
Tsiafaki, X
Agelidou, A
Mixalopoulou, P
Anagnostopoulou, O
Ziotopoulos, P
Toubis, M
Syrigos, K
Samaras, N
Polyzos, A
Christou, A
Kakolyris, S
Kouroussis, C
Androulakis, N
Samonis, G
Chatzidaki, D
机构
[1] Univ Gen Hosp Heraklion, Dept Med Oncol, Iraklion 71110, Crete, Greece
[2] Agios Savas Anticanc Hosp, Dept Med Oncol 1, Athens, Greece
[3] Sismanoglio Gen Hosp, Dept Pulm Dis 1, Athens, Greece
[4] Sismanoglio Gen Hosp, Dept Pulm Dis 2, Athens, Greece
[5] Univ Athens, Sotiria Gen Hosp, Dept Internal Med 3, Athens, Greece
[6] Univ Athens, Sotiria Gen Hosp, Dept Pulm Dis 1, Athens, Greece
[7] Univ Athens, Sotiria Gen Hosp, Dept Pulm Dis 3, Athens, Greece
[8] Univ Athens, Sotiria Gen Hosp, Dept Pulm Dis 6, Athens, Greece
[9] Univ Athens, Sotiria Gen Hosp, Dept Pulm Dis 7, Athens, Greece
[10] Univ Athens, Sotiria Gen Hosp, Dept Pulm Dis 8, Athens, Greece
[11] Univ Athens, Sotiria Gen Hosp, Med Oncol Unit, Athens, Greece
[12] Papanicolaou Gen Hosp, Dept Pulm Dis 2, Thessaloniki, Greece
[13] Univ Athens, Laiko Gen Hosp, Med Oncol Unit, Dept Propedeut Med, Athens, Greece
关键词
D O I
10.1200/JCO.2005.04.016
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose To compare the activity and tolerability of docetaxel/gemcitabine (DG) and vinorelbine/cisplatin (VC) combinations in chemotherapy-naive 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/m(2) [days 1 and 8] plus docetaxel 100 mg/m(2) [day 8]) or VC (vinorelbine 30 mg/m(2) [days 1 and 8] plus cisplatin 80 mg/m(2) [day 8]) and prophylactic recombinant human granulocyte colony-stimulating factor (150 mu g/m(2) 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, In = 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.
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页码:2937 / 2945
页数:9
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