Marcial V A, Pajak T F, Chang C, Tupchong L, Stetz J
Int J Radiat Oncol Biol Phys. 1987 Jan;13(1):41-7. doi: 10.1016/0360-3016(87)90258-6.
From August 1979 to June 1983, the RTOG conducted a prospective Phase III study that compared a standard schedule with five fractions per week of 180 to 200 cGy per day to a total dose of 6600-7380 cGy, with a hyperfractionation regimen consisting of two fractions of 120 cGy per day, separated by a rest period of 3 to 6 hours for a total of 6000 cGy. A total of 210 patients were entered, of which 187 are analyzed. Complete initial tumor clearance in the head and neck was achieved by radiotherapy in 61% of the patients assigned to the standard schedules and in 59% of those assigned to the continuous hyperfractionation schedule; surgical salvage contributed towards achieving complete response in 5% and 7% of patients, respectively. The Kaplan-Meier estimates for loco-regional control of tumor at 1 and 2 years was 39% and 29% for the standard schedules, and 43% and 30% for the hyperfractionation schedule. The endpoints examined to evaluate therapeutic effects do not indicate that the stated hyperfractionation schedule is different than the standard RTOG treatment schedule for head and neck cancer. Acute normal tissue reactions appear to be more severe with the hyperfractionation schedule but the incidence of late reactions is similar in both groups. There is a tendency toward more severe acute reactions when the interval between the two fractions per day is 4.5 hrs or less in comparison to intervals longer than 4.5 hrs.
1979年8月至1983年6月,放射治疗肿瘤学组(RTOG)开展了一项前瞻性III期研究,将每天5次、每次180至200 cGy、总剂量为6600 - 7380 cGy的标准放疗方案与一种超分割方案进行比较,后者为每天2次、每次120 cGy,间隔3至6小时,总剂量为6000 cGy。共有210例患者入组,其中187例接受分析。在接受标准放疗方案的患者中,61%通过放疗实现了头颈部肿瘤的初始完全清除,在接受持续超分割放疗方案的患者中这一比例为59%;手术挽救分别使5%和7%的患者实现了完全缓解。标准放疗方案组1年和2年的肿瘤局部区域控制率的Kaplan-Meier估计值分别为39%和29%,超分割放疗方案组则为43%和30%。用于评估治疗效果的观察终点并未表明所述的超分割放疗方案与RTOG针对头颈癌的标准治疗方案存在差异。超分割放疗方案的急性正常组织反应似乎更严重,但两组的晚期反应发生率相似。与间隔时间超过4.5小时相比,当每天两次放疗之间的间隔时间为4.5小时或更短时间时,急性反应有更严重的趋势。