Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: The TAX 326 study group
Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: The TAX 326 study group
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DOI：
10.1200/jco.2003.12.046
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发表时间：
2003-08-15
影响因子：
45.3
通讯作者：
Belani, CP
中科院分区：
文献类型：
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作者：
Fossella, F;Pereira, JR;Belani, CP
目的：研究多西他赛联合铂类方案与长春瑞滨联合顺铂作为一线化疗相比是否能改善晚期非小细胞肺癌（NSCLC）患者的生存率并影响生活质量（QoL）。（n = 1，218）IIIB至IV期NSCLC患者随机接受多西他赛75 mg/m2和顺铂75 mg/m2，每3周一次（DC）;多西他赛75 mg/m2，卡铂曲线下面积6 mg/mL。结果：接受DC治疗的患者中位生存期为11.3个月，而接受VC治疗的患者中位生存期为10.1个月（P = 0.044;风险比为1.183 [97.2%可信区间为0.989 ~ 1.416]）。DC治疗患者的2年生存率为21%，VC治疗患者的2年生存率为14%。DC治疗患者的总体缓解率为31.6%，VC治疗患者为24.5%（P = 0.029）。DCb的中位生存期（9.4 v9.9个月[VC]; P = 0.657;风险比，1.048 [97.2置信区间，0.877 - 1.253]）和缓解率（23.9%）与VC的结果相似。中性，。血小板减少症、感染和发热性中性粒细胞减少症在所有三种方案中相似。3 ~ 4级贫血、恶心、呕吐多见（P
Purpose: To investigate whether docetaxel plus platinum regimens improve survival and affect quality of life (QoL) in advanced non-small-cell lung cancer (NSCLC) compared with vinorelbine plus cisplatin as first-line chemotherapy.Patients and Methods: Patients (n = 1,218) with stage IIIB to IV NSCLC were randomly assigned to receive docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2) every 3 weeks (DC); docetaxel 75 mg/m(2) and carboplatin area under the curve of 6 mg/mL . min every 3 weeks (DCb); or vinorelbine 25 mg/ m(2)/wk and cisplatin 100 mg/m(2) every 4 weeks (VC).Results: Patients treated with DC had a median survival of 11.3 v 10.1 months for VC-treated patients (P =.044; hazard ratio, 1.183 [97.2% confidence interval, 0.989 to 1.416]). The 2-year survival rate was 21% for DC-treated patients and 14% for VC-treated patients. Overall response rate was 31.6% for DC-treated patients v 24.5% for VC-treated patients (P =.029). Median survival (9.4 v 9.9 months [for VC]; P =.657; hazard ratio, 1.048 [97.2 confidence interval, 0.877 to 1.253]) and response (23.9%) with DCb were similar to those results for VC. Neutropenia,. thrombocytopenia, infection, and febrile neutropenia were similar with all three regimens. Grade 3 to 4 anemia, nausea, and vomiting were more common (P