Arriagada Rodrigo, Bergman Bengt, Dunant Ariane, Le Chevalier Thierry, Pignon Jean-Pierre, Vansteenkiste Johan
Instituto de Radiomedicina, Santiago, Chile.
N Engl J Med. 2004 Jan 22;350(4):351-60. doi: 10.1056/NEJMoa031644.
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.
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.
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<0.03). Patients assigned to chemotherapy also had a significantly higher disease-free survival rate than those assigned to observation (39.4 percent vs. 34.3 percent at five years [518 events vs. 577]; hazard ratio, 0.83; 95 percent confidence interval, 0.74 to 0.94; P<0.003). There were no significant interactions with prespecified factors. Seven patients (0.8 percent) died of chemotherapy-induced toxic effects.
Cisplatin-based adjuvant chemotherapy improves survival among patients with completely resected non-small-cell lung cancer.
基于之前的一项荟萃分析，国际辅助性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术后生存率的影响。
我们将患者随机分为接受三或四个周期的以顺铂为基础的化疗组或观察组。在随机分组前，每个中心确定纳入的病理分期、其化疗策略（顺铂剂量及与顺铂联合使用的药物）以及其术后放疗策略。主要终点为总生存期。
共有1867例患者接受随机分组；36.5%为病理I期疾病，24.2%为II期，39.3%为III期。与顺铂联合使用的药物，56.5%的患者为依托泊苷，26.8%为长春瑞滨，11.0%为长春碱，5.8%为长春地辛。在分配至化疗组的932例患者中，73.8%的患者每平方米体表面积接受至少240mg顺铂。中位随访时间为56个月。分配至化疗组的患者生存率显著高于分配至观察组的患者（五年时分别为44.5%对40.4%[469例死亡对504例]；死亡风险比为0.86；95%置信区间为0.76至0.98；P<0.03）。分配至化疗组的患者无病生存率也显著高于分配至观察组的患者（五年时分别为39.4%对34.3%[518例事件对577例]；风险比为0.83；95%置信区间为0.74至0.94；P<0.003）。与预先设定的因素无显著交互作用。7例患者（0.8%）死于化疗引起的毒性作用。
以顺铂为基础的辅助化疗可提高完全切除的非小细胞肺癌患者的生存率。
