Role of radiation therapy in the combined-modality treatment of patients with extensive disease small-cell lung cancer: A randomized study

Purpose: To investigate the efficacy and toxicity of cisplatin/etoposide (PE) chemotherapy (CHT) with or without accelerated hyperfractionated radiation therapy (ACC HFX RT) and concurrent daily carboplatin/etoposide (CE) in patients with extensive-disease small-cell lung cancer. patients and Methods: A total of 210 patients were treated with three cycles of standard PE, Patients with a complete response (CR) at both the local and distant levels (CR/CR) or a partial response (PR) at the local level and CR at the distant level (PR/CR) received either thoracic ACC HFX RT with 54 Gy in 36 fractions over 13 treatment days in combination with CF followed by two cycles of PE (group 1, n = 55) or an additional four cycles of PE (group 2, n = 54). Patients who experienced less response were treated nonrandomly (groups 3, 4, and 5). All patients with a CR at the distant level received prophylactic cranial irradiation, Results: For 206 assessable patients, the median survival time (MST) was 9 months and the 5-year survival rate was 3.4%, Patients in group 1 had significantly better survival rates than those in group 2 (MST, 17 v 11 months; 5-year survival rate, 9.1% v 3.7%, respectively; P = .041), Local control was also better in group 1, hut the difference was: only marginally not significant(P = .062). There was no difference in distant metastasis free survival between groups 1 and 2, Acute high-grade toxicity war higher in group 2 than in group 1. Conclusion: The addition of ACC HFX PT to the treatment of the mort favorable subset of patients led to improved survival over that obtained with CHT alone. (C) 1999 by American Society of Clinical Oncology.