Chemotherapy for elderly patients with advanced non-small-cell lung cancer:: The Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial
Chemotherapy for elderly patients with advanced non-small-cell lung cancer:: The Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial
复制标题
DOI：
10.1093/jnci/95.5.362
复制
发表时间：
2003-03-05
影响因子：
10.3
通讯作者：
Gebbia, V
中科院分区：
文献类型：
--
作者：
Gridelli, C;Perrone, F;Gebbia, V
研究背景：长春瑞滨可延长老年晚期非小细胞肺癌（NSCLC）患者的生存期，改善患者的生活质量。一些研究还表明，吉西他滨在这类患者中耐受性良好且有效。在一项开放标签、随机III期临床试验中，我们比较了长春瑞滨联合吉西他滨与单独给药的有效性和毒性。方法：1997年12月至2000年11月，年龄在70岁及以上的患者被随机分配接受静脉注射长春瑞滨（30 mg/m(2)体表面积）、吉西他滨（1200 mg/m(2)）或长春瑞滨（25 mg/m(2)）加吉西他滨（1000 mg/m(2)）。所有治疗均在第1天和第8天每3周进行一次，最多6个周期。主要终点是生存期。采用Kaplan-Meier法绘制生存曲线，并采用Mantel-Haenszel检验进行分析。次要终点为生活质量和毒性。结果：在698例可用于意向治疗分析的患者中，233例接受长春瑞滨，233例接受吉西他滨，232例接受长春瑞滨加吉西他滨。与单药治疗相比，联合治疗没有提高生存率。联合治疗组的死亡风险比为长春瑞滨组的1.17(95%可信区间[CI] = 0.95 ~ 1.44)，吉西他滨组的1.06 （95% CI = 0.86 ~ 1.29）。虽然三个治疗组的生活质量相似，但联合治疗比单独使用两种药物的毒性更大。结论：长春瑞滨联合吉西他滨治疗老年晚期非小细胞肺癌并不比单药长春瑞滨或吉西他滨更有效。
Background: Vinorelbine prolongs survival and improves quality of life in elderly patients with advanced non-small-cell lung cancer (NSCLC). Some studies have also suggested that gemcitabine is well tolerated and effective in such patients. We compared the effectiveness and toxicity of the combination of vinorelbine plus gemcitabine with those of each drug given alone in an open-label, randomized phase III trial in elderly patients with advanced NSCLC. Methods: Patients aged 70 years and older, enrolled between December 1997 and November 2000, were randomly assigned to receive intravenous vinorelbine (30 mg/m(2) of body surface area), gemcitabine (1200 mg/m(2)), or vinorelbine (25 mg/m(2)) plus gemcitabine (1000 mg/m(2)). All treatments were delivered on days 1 and 8 every 3 weeks for a maximum of six cycles. The primary endpoint was survival. Survival curves were drawn using the Kaplan-Meier method and analyzed by the Mantel-Haenszel test. Secondary endpoints were quality of life and toxicity. Results: Of 698 patients available for intention-to-treat analysis, 233 were assigned to receive vinorelbine, 233 to gemcitabine, and 232 to vinorelbine plus gemcitabine. Compared with each single drug, the combination treatment did not improve survival. The hazard ratio of death for patients receiving the combination treatment was 1.17 (95% confidence interval [CI] = 0.95 to 1.44) that of patients receiving vinorelbine and 1.06 (95% CI = 0.86 to 1.29) that of patients receiving gemcitabine. Although quality of life was similar across the three treatment arms, the combination treatment was more toxic than the two drugs given singly. Conclusion: The combination of vinorelbine plus gemcitabine is not more effective than single-agent vinorelbine or gemcitabine in the treatment of elderly patients with advanced NSCLC.