Phase II study of concurrent chemotherapy and radiotherapy for unresectable stage III non-small-cell lung cancer: Long-term follow-up results. Japan Clinical Oncology Group Protocol 8902

Background: Although chemoradiotherapy is standard treatment for unresectab le stage III non-small-cell lung cancer (NSCLC), few long-term survival dat a exist. Patients and methods: Between October 1989 and December 1991, 74 patients w ith histologically or cytologically proven NSCLC, unresectable stage IIIA o r IIIB, were entered into this study. Seventy patients were eligible and ev aluable for response, toxicity, and survival analysis. Chemotherapy consist ed of cisplatin (100 mg/m(2) on days 1, 29, and 57) and vindesine (3 mg/m(2 ) on days 1, 8, 29, 36, 57, and 64). Thoracic radiotherapy was administered for two weeks (2 Gy given 10 times, five fractions per week), and after a 14-day rest period, the previous schedule of radiotherapy was repeated for two weeks. A 10-Gy to 20-Gy dose of radiotherapy was administered during th e third cycle of chemotherapy. Results: Of the 70 evaluable patients, 1 (1.4%) had a complete response (CR ) and 51 (72.9%) had a partial response (PR). The median survival time was 14.8 months, and the five-year survival rate was 14.8%. The major toxicity was leukopenia (greater than or equal to grade 3, 93%). Other toxicities gr eater than or equal to grade 3 included anemia (34%), nausea/vomiting (27%) , alopecia (7%), thrombocytopenia (4%), and serum creatinine elevation (1%) . Treatment related death occurred in two patients (2.8%). One patient died of pneumonia and pneumothorax, and the other of hemoptysis. Conclusions: Concurrent chemotherapy and radiotherapy has the potential to provide long-term survival with acceptable toxicities.