A randomized trial of postoperative adjuvant therapy in patients with completely resected stage II or IIIa non-small-cell lung cancer.

Background: We conducted a randomized trial to determine whether combinatio n chemotherapy plus thoracic radiotherapy is superior to thoracic radiother apy alone in prolonging survival and preventing local recurrence in patient s with completely resected stage II or IIIa non-small-cell lung cancer. Methods: After surgical staging and resection of the tumor (usually by lobe ctomy or pneumonectomy), the patients were randomly assigned to receive eit her 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 intrav enously 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 to tal of 50.4 Gy, given in 28 daily fractions). Results: Of the 488 patients who were enrolled in the study, 242 were assig ned to receive radiotherapy alone and 246 were assigned to receive chemothe rapy and radiotherapy. The median duration of follow-up was 44 months. Trea tment-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 month s in the group given chemotherapy and radiotherapy (P= 0.56 by the log-rank test). The relative likelihood of survival among patients assigned to rece ive chemotherapy and radiotherapy, as compared with those assigned to recei ve radiotherapy alone, was 0.93 (95 percent confidence interval, 0.74 to 1. 18). Intrathoracic disease recurred within the radiation field in 30 of 234 patients (13 percent) in the group given radiotherapy and in 28 of 236 pat ients (12 percent) in the group given chemotherapy and radiotherapy (P=0.84 ); data on recurrence were not available for 18 patients. Conclusions: As compared with radiotherapy alone, adjuvant radiotherapy and chemotherapy with cisplatin and etoposide does not decrease the risk of in trathoracic recurrence or prolong survival in patients with completely rese cted stage II or IIIa non-small-cell lung cancer.