A Randomized Trial of Postoperative Adjuvant Therapy in Patients with Completely Resected Stage II or IIIa Non–Small-Cell Lung Cancer

作者：Steven M. Keller, Sudeshna Adak, Henry Wagner, Arnold M. Herskovic, Ritsuko R. Komaki, Burke J. Brooks, Michael C. Perry, Robert B. Livingston, David H. Johnson · 发表于：New England Journal of Medicine · 年份：2000 · DOI：10.1056/nejm200010263431703 · 被引用次数：450 · 研究领域：Lung Cancer Diagnosis and Treatment、Pleural and Pulmonary Diseases、Hepatocellular Carcinoma Treatment and Prognosis

BACKGROUND: We conducted a randomized trial to determine whether combination chemotherapy plus thoracic radiotherapy is superior to thoracic radiotherapy alone in prolonging survival and preventing local recurrence in patients with completely resected stage II or IIIa non-small-cell lung cancer. METHODS: After surgical staging and resection of the tumor (usually by lobectomy or pneumonectomy), the patients were randomly assigned to receive either four 28-day cycles of cisplatin (60 mg per square meter of body-surface area intravenously on day 1) and etoposide (120 mg per square meter intravenously on days 1, 2, and 3) administered concurrently with radiotherapy (a total of 50.4 Gy, given in 28 daily fractions) or radiotherapy alone (a total of 50.4 Gy, given in 28 daily fractions). RESULTS: Of the 488 patients who were enrolled in the study, 242 were assigned to receive radiotherapy alone and 246 were assigned to receive chemotherapy and radiotherapy. The median duration of follow-up was 44 months. Treatment-associated mortality was 1.2 percent in the group given radiotherapy alone and 1.6 percent in the group given chemotherapy and radiotherapy. The median survival was 39 months in the group given radiotherapy and 38 months in the group given chemotherapy and radiotherapy (P= 0.56 by the log-rank test). The relative likelihood of survival among patients assigned to receive chemotherapy and radiotherapy, as compared with those assigned to receive radiotherapy alone, was 0.93 ...