Curran W J, Scott C B, Nelson J S, Weinstein A S, Phillips T L, Murray K, Fischbach A J, Yakar D, Schwade J G, Powlis W D
Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111.
Cancer. 1992 Dec 15;70(12):2909-17. doi: 10.1002/1097-0142(19921215)70:12<2909::aid-cncr2820701230>3.0.co;2-6.
The third and final randomization of Radiation Therapy Oncology Group (RTOG) 83-02 was performed to identify the maximal tolerated dose and potential efficacy of accelerated hyperfractionated radiation therapy (AHRT) in 1.6 Gy twice-daily fractions for adult malignant glioma.
From December 1987 to July 1989, 304 patients with malignant glioma were stratified by age, performance status, and histologic findings and randomized to receive total AHRT doses of 48.0 or 54.4 Gy, with 80 mg/m2 of bis-chloroethyl nitrosourea (BCNU) for 3 days every 8 weeks. Distribution of other prognostic factors, including neurologic function, extent of surgery, tumor size, and sex, was comparable in each treatment arm.
One Grade 5 radiation therapy (RT)-related toxic effect was reported (in the 54.4-Gy treatment arm), and the incidence of late Grade 3-5 RT-related toxic effects at 18 months was 1% at 48.0 Gy and 4% at 54.4 Gy. The median survival times (MST) for the 48.0 Gy and 54.4 Gy treatment arms were 11.7 and 10.8 months, respectively, comparable to the MST in prior RTOG trials with a similar proportion of patients with glioblastoma multiforme (79%). For the 123 patients who were 60 years of age or older, the MST for the 48.0 Gy and 54.4 Gy treatment arms were 8.9 and 10.4 months, respectively, and compare favorably with the MST of 6.0 months reported with standard RT and BCNU treatment used for 101 patients who were 60 years of age or older in two prior RTOG malignant glioma trials (74-01 and 79-18). Although these results differ significantly (P = 0.0015), this contrast is not significant when adjusted by performance status.
The maximum tolerated dose of AHRT has yet to be identified, and pursuit of this information may most benefit patients with malignant glioma who are 60 years of age or older.
放射治疗肿瘤学组（RTOG）83 - 02的第三次也是最后一次随机分组试验旨在确定成人恶性胶质瘤每日两次、每次1.6 Gy的加速超分割放射治疗（AHRT）的最大耐受剂量和潜在疗效。
1987年12月至1989年7月，304例恶性胶质瘤患者按年龄、体能状态和组织学结果进行分层，随机接受48.0或54.4 Gy的总AHRT剂量，每8周给予80 mg/m²的双氯乙基亚硝脲（BCNU），连用3天。各治疗组中其他预后因素的分布，包括神经功能、手术范围、肿瘤大小和性别，具有可比性。
报告了1例5级放射治疗（RT）相关毒性反应（在54.4 Gy治疗组），18个月时3 - 5级晚期RT相关毒性反应的发生率在48.0 Gy组为1%，在54.4 Gy组为4%。48.0 Gy和54.4 Gy治疗组的中位生存时间（MST）分别为11.7个月和10.8个月，与之前RTOG试验中多形性胶质母细胞瘤患者比例相似（79%）时的MST相当。对于123例60岁及以上的患者，48.0 Gy和54.4 Gy治疗组的MST分别为8.9个月和10.4个月，与之前两项RTOG恶性胶质瘤试验（74 - 01和79 - 18）中101例60岁及以上患者采用标准RT和BCNU治疗报告的6.0个月的MST相比更优。尽管这些结果差异显著（P = 0.0015），但经体能状态调整后，这种差异并不显著。
AHRT的最大耐受剂量尚未确定，获取这一信息可能对60岁及以上的恶性胶质瘤患者最为有益。
