Annals of oncology : official journal of the European Society for Medical Oncology · 2000
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.
Клиническое исследованиеКлиническое исследование II фазыСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Kubota K, Tamura T, Fukuoka M, Furuse K, Ikegami H, Ariyoshi Y, Kurita Y, Saijo N
Аннотация
BACKGROUND: Although chemoradiotherapy is standard treatment for unresectable stage III non-small-cell lung cancer (NSCLC), few long-term survival data exist.
PATIENTS AND METHODS: Between October 1989 and December 1991, 74 patients with histologically or cytologically proven NSCLC, unresectable stage IIIA or IIIB, were entered into this study. Seventy patients were eligible and evaluable for response, toxicity, and survival analysis. Chemotherapy consisted of cisplatin (100 mg/m2 on days 1, 29, and 57) and vindesine (3 mg/m2 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 the 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 (> or = grade 3, 93%). Other toxicities > or = 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.
PATIENTS AND METHODS: Between October 1989 and December 1991, 74 patients with histologically or cytologically proven NSCLC, unresectable stage IIIA or IIIB, were entered into this study. Seventy patients were eligible and evaluable for response, toxicity, and survival analysis. Chemotherapy consisted of cisplatin (100 mg/m2 on days 1, 29, and 57) and vindesine (3 mg/m2 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 the 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 (> or = grade 3, 93%). Other toxicities > or = 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.