Bunn P A, Lichter A S, Makuch R W, Cohen M H, Veach S R, Matthews M J, Anderson A J, Edison M, Glatstein E, Minna J D
Ann Intern Med. 1987 May;106(5):655-62. doi: 10.7326/0003-4819-106-5-655.
To determine the effect of concurrent chest radiation therapy on response rate, recurrence, and treatment toxicity among patients with limited stage small cell lung cancer who are receiving combination chemotherapy.
Randomized trial with a median follow-up of 57 months.
A single government institution--the National Cancer Institute.
Consecutive sample of 96 patients with histologically confirmed small cell lung cancer that was confined to the hemithorax of origin or mediastinal and supraclavicular nodes, and which could be encompassed within a tolerable radiation portal ("limited stage"). All patients were followed until death or the end of the study period.
Chemotherapy: Cyclophosphamide, methotrexate, and lomustine in 6-week cycles alternating with vincristine, adriamycin, and procarbazine in 6-week cycles, for a total of 48 weeks. Radiation therapy: Chest irradiation to 40 Gy in 15 fractions over 3 weeks, given simultaneously with the first chemotherapy cycle.
The combined therapy led to a significantly higher response rate (complete responses, 81%, compared with partial responses, 43%; 95% Cl for the difference, 20% to 56%), significantly improved local control of the chest tumor (p less than 0.001), and significantly longer survival (p less than 0.035) (median, 15.0 months, compared with 11.6 for chemotherapy alone). The combined therapy produced significantly more myelosuppression, weight loss, esophagitis, and pulmonary dysfunction. There were more infections and deaths from toxicity in the combined treatment group, but the differences between groups were not statistically significant.
A regimen of combined chemotherapy and chest radiation therapy given concurrently is superior to chemotherapy given alone in inducing remission and prolonging survival in patients with limited stage small cell lung cancer, and the benefit of combined therapy is reduced by its greater toxicity.
确定同步胸部放疗对接受联合化疗的局限期小细胞肺癌患者的缓解率、复发率及治疗毒性的影响。
中位随访时间为57个月的随机试验。
单一政府机构——美国国立癌症研究所。
连续纳入96例经组织学确诊的小细胞肺癌患者，肿瘤局限于原半侧胸腔或纵隔及锁骨上淋巴结，且可纳入可耐受的放疗野内（“局限期”）。所有患者均随访至死亡或研究期结束。
化疗：环磷酰胺、甲氨蝶呤和洛莫司汀每6周为1周期，与长春新碱、阿霉素和丙卡巴肼每6周为1周期交替使用，共48周。放疗：在3周内分15次给予胸部照射，剂量为40 Gy，与第1个化疗周期同时进行。
联合治疗组的缓解率显著更高（完全缓解率为81%，部分缓解率为43%；两者差异的95%可信区间为20%至56%），胸部肿瘤的局部控制显著改善（p<0.001），生存期显著延长（p<0.035）（中位生存期为15.0个月，单纯化疗组为11.6个月）。联合治疗导致的骨髓抑制、体重减轻、食管炎和肺功能障碍明显更多。联合治疗组的感染和毒性死亡更多，但两组间差异无统计学意义。
对于局限期小细胞肺癌患者，同步进行联合化疗和胸部放疗的方案在诱导缓解和延长生存期方面优于单纯化疗，但其更大的毒性降低了联合治疗的益处。
