Cisplatin-Based Adjuvant Chemotherapy in Patients with Completely Resected Non–Small-Cell Lung Cancer

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International Adjuvant Lung Cancer Trial Collaborative Group..

Cisplatin-based adjuvant chemotherapy in patients with completely
resected non-small-cell lung cancer.

N Engl J Med 2004;350,351-360
BackgroundOn the basis of a previous meta-analysis, the International Adjuvant Lung Cancer Trialwas designed to evaluate the effect of cisplatin-based adjuvant chemotherapy on survivalafter complete resection of non–small-cell lung cancer.
MethodsWe randomly assigned patients either to three or four cycles of cisplatin-based chemotherapyor to observation. Before randomization, each center determined the pathologicalstages to include, its policy for chemotherapy (the dose of cisplatin and the drug tobe combined with cisplatin), and its postoperative radiotherapy policy. The main endpoint was overall survival.
ResultsA total of 1867 patients underwent randomization; 36.5 percent had pathological stageI disease, 24.2 percent stage II, and 39.3 percent stage III. The drug allocated with cisplatinwas etoposide in 56.5 percent of patients, vinorelbine in 26.8 percent, vinblastine in11.0 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-surfacearea. The median duration of follow-up was 56 months. Patients assigned to chemotherapyhad a significantly higher survival rate than those assigned to observation (44.5 percentvs. 40.4 percent at five years [469 deaths vs. 504]; hazard ratio for death, 0.86; 95percent confidence interval, 0.76 to 0.98; P<0.03). Patients assigned to chemotherapyalso 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 interactionswith prespecified factors. Seven patients (0.8 percent) died of chemotherapyinducedtoxic effects.
ConclusionsCisplatin-based adjuvant chemotherapy improves survival among patients with completelyresected non–small-cell lung cancer.