Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer
Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer
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DOI：
10.1056/nejmoa031644
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发表时间：
2004-01-22
影响因子：
158.5
通讯作者：
Wedel, H
中科院分区：
文献类型：
--
作者：
Le Chevalier, T;Arriagada, R;Wedel, H
背景：在先前荟萃分析的基础上，国际辅助肺癌试验旨在评估以顺铂为基础的辅助化疗对非小细胞肺癌完全切除后生存的影响。方法：我们将患者随机分配到以顺铂为基础的3或4个化疗周期或观察组。随机化前，各中心确定纳入的病理分期、化疗方案（顺铂剂量及与顺铂联合用药）、术后放疗方案。主要终点为总生存期。结果：共有1867名患者接受了随机分组；36.5%为病理性I期，24.2%为II期，39.3%为III期。与顺铂配用的药物是依托泊苷（56.5%）、长春瑞滨（26.8%）、长春碱（11.0%）和长春地辛（5.8%）。在932名接受化疗的患者中，73.8%的患者接受了每平方米体表面积至少240毫克的顺铂。中位随访时间为56个月。化疗组患者的生存率明显高于观察组患者(5年生存率44.5% vs 40.4%[469例死亡vs 504例死亡]；死亡风险比0.86；95%可信区间0.76 ~ 0.98；P
BACKGROUND:On the basis of a previous meta-analysis, the International Adjuvant Lung Cancer Trial was designed to evaluate the effect of cisplatin-based adjuvant chemotherapy on survival after complete resection of non-small-cell lung cancer.METHODS:We randomly assigned patients either to three or four cycles of cisplatin-based chemotherapy or to observation. Before randomization, each center determined the pathological stages to include, its policy for chemotherapy (the dose of cisplatin and the drug to be combined with cisplatin), and its postoperative radiotherapy policy. The main end point was overall survival.RESULTS:A total of 1867 patients underwent randomization; 36.5 percent had pathological stage I disease, 24.2 percent stage II, and 39.3 percent stage III. The drug allocated with cisplatin was etoposide in 56.5 percent of patients, vinorelbine in 26.8 percent, vinblastine in 11.0 percent, and vindesine in 5.8 percent. Of the 932 patients assigned to chemotherapy, 73.8 percent received at least 240 mg of cisplatin per square meter of body-surface area. The median duration of follow-up was 56 months. Patients assigned to chemotherapy had a significantly higher survival rate than those assigned to observation (44.5 percent vs. 40.4 percent at five years [469 deaths vs. 504]; hazard ratio for death, 0.86; 95 percent confidence interval, 0.76 to 0.98; P