Freeman C R, Krischer J, Sanford R A, Cohen M E, Burger P C, Kun L, Halperin E C, Crocker I, Wharam M
McGill Univeristy, Montreal, Quebec, Canada.
Cancer. 1991 Aug 1;68(3):474-81. doi: 10.1002/1097-0142(19910801)68:3<474::aid-cncr2820680305>3.0.co;2-7.
Between May 1986 and February 1988, 57 patients were accrued to the second dose level of a Phase I/II Pediatric Oncology Group (POG) study exploring the use of hyperfractionated radiation therapy (HRT) in children with high-risk brain stem tumors. Local fields were treated with fraction sizes of 117 cGy given twice daily, with a minimum interfraction interval of 6 hours, to a total dose of 7020 cGy in 60 fractions over 6 weeks. Information regarding clinical status during HRT was available for 55 patients (44 [80%] improved, 6 remained stable, and 5 deteriorated). Results of initial and follow-up computed tomography (CT) scan and/or magnetic resonance imaging (MRI) were available for review for 52 patients. One patient had a complete response (CR) to treatment, 3 had a partial response (PR) (more than 50% response), and 40 remained stable, for a total response rate (CR + PR + stable) of 77%. Median time to disease progression was 6 months. Median survival time was 10 months. Survival rate was 39.6% (standard error [SE] = 6.6%) at 1 year and 23% (SE = 5.8%) at 2 years. Complications of treatment included an enhanced skin reaction in six patients and otitis media and/or externa in nine. One patient bled into tumor shortly after completion of HRT, and three had intralesional necrosis. Five patients continued taking steroids for protracted periods in the face of improved clinical and/or radiologic findings. Complications related to the use of steroids included opportunistic infections, impaired glucose tolerance, hypertension, osteoporosis, and significant mood changes. In no patient was there evidence of any late injury attributable to HRT. When compared with results of treatment with HRT at a lower dose level (6600 cGy), there appears to be a trend toward improved survival at 7020 cGy despite a less favorable patient population at the higher dose level. A second dose escalation to 7560 cGy in 60 fractions over 6 weeks has been implemented as planned.
1986年5月至1988年2月期间,57例患者进入了一项I/II期儿科肿瘤学组(POG)研究的第二剂量水平,该研究探索超分割放射治疗(HRT)在高危脑干肿瘤儿童中的应用。局部野采用每次117 cGy的分割剂量,每天照射两次,两次照射间隔至少6小时,在6周内分60次给予总剂量7020 cGy。55例患者(44例[80%]病情改善,6例病情稳定,5例病情恶化)有HRT期间临床状态的相关信息。52例患者可获得初始及随访计算机断层扫描(CT)和/或磁共振成像(MRI)结果以供复查。1例患者治疗后完全缓解(CR),3例部分缓解(PR)(缓解率超过50%),40例病情稳定,总缓解率(CR + PR + 稳定)为77%。疾病进展的中位时间为6个月。中位生存时间为10个月。1年生存率为39.6%(标准误[SE]=6.6%),2年生存率为23%(SE = 5.8%)。治疗并发症包括6例患者皮肤反应加重,9例患者发生中耳炎和/或外耳炎。1例患者在HRT完成后不久肿瘤内出血,3例发生瘤内坏死。5例患者尽管临床和/或影像学表现改善,但仍长期服用类固醇。与使用类固醇相关的并发症包括机会性感染、糖耐量受损、高血压、骨质疏松症和明显的情绪变化。没有患者有任何归因于HRT的晚期损伤证据。与较低剂量水平(6600 cGy)的HRT治疗结果相比,尽管较高剂量水平的患者群体情况较差,但7020 cGy时似乎有生存改善的趋势。已按计划实施了第二次剂量递增,在6周内分60次给予7560 cGy。