RANDOMIZED TRIAL OF HYPERFRACTIONATED RADIATION-THERAPY WITH OR WITHOUT CONCURRENT CHEMOTHERAPY FOR STAGE-III NON-SMALL-CELL LUNG-CANCER

Purpose: To investigate the efficacy of combined hyperfractionated radiation therapy (HFX RT) and concurrent chemotherapy (CHT) in stage IIIA or IIIB non-small-cell lung cancer (NSCLC) compared with that of HFX RT alone. Patients and Methods: Between January 1988 and December 1989, 169 patients were divided randomly into the following groups: group I, HFX PT with 1.2 Gy twice daily to a total dose of 64.8 Gy (n = 61); group II, same HFX RT with CHT consisting of 100 mg of carboplatin (CBDCA) on days 1 and 2 and 100 mg of etoposide (VP-16) on days 1 to 3 of each week during the RT course (9 = 52); and group III, same HFX RT with CHT consisting of 200 mg of CBDCA on days 1 and 2 and 100 mg of VP-16 on days 1 to 5 of the first, third, and fifth weeks of the RT course (n = 56). Results: The median survival time (MST) was 8 months for group I, 18 months for group II, and 13 months for group III. The 3-year survival rates were 6.6%, 23%, and 16%, respectively. There was a significant difference in the survival rate between groups I and II (P=.0027, log-rank test), but not between groups I and III (P=.17) or between groups II and III (P=.14), The relapse-free survival rate in group II was also higher than that in group I (P=.0024), which was largely due to improved local control in group II patients, Patients in groups II and III showed a higher incidence of acute and/or late high-grade toxicity compared with group I patients, but no patient died of treatment-related toxicity. Conclusion: The combination of HFX PT and continuous CBDCA/VP-16 CHT was tolerable and substantially increased the survival rate.