Survival benefit of hyperthermia in a prospective randomized trial of brachytherapy boost ±hyperthermia for glioblastoma multiforme
Survival benefit of hyperthermia in a prospective randomized trial of brachytherapy boost ±hyperthermia for glioblastoma multiforme
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DOI：
10.1016/s0360-3016(97)00731-1
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发表时间：
1998-01-15
影响因子：
7
通讯作者：
Gutin, PH
中科院分区：
文献类型：
--
作者：
Sneed, PK;Stauffer, PR;Gutin, PH
目的：要确定是否辅助间质热疗（HT）显着提高生存率的胶质母细胞瘤患者接受近距离放射治疗后，常规radiotherapy.Methods和材料：成人新诊断的，局灶性，幕上胶质母细胞瘤直径小于或等于5厘米，术后登记的II/III期随机试验和治疗部分脑放疗，以59.4戈伊口服羟基脲。那些肿瘤在远距离放射治疗后仍然可植入的患者被随机分配到近距离放射治疗增强（60戈伊，0.40-0.60戈伊/h）+/- HT 30分钟，在近距离放射治疗之前和之后立即进行。使用Kaplan-Meier方法估计疾病进展时间（TTP）和诊断日期后的生存率。结果：从1990年至1995年，112例符合条件的患者进入试验。患者年龄范围为21-78岁（中位数，54岁），KPS范围为70-100（中位数，90）。最常见的原因是肿瘤进展或患者拒绝，33例患者从未接受随机化。在这些患者中，39例被随机分配到近距离放射治疗（“无热”）组，40例被随机分配到近距离放射治疗+ HT（“热”）组。通过意向治疗，“热”的TTP和生存期显著长于“无热”（p = 0.04和p = 0.04）。对于接受近距离放射治疗加强的33例“无热”患者和35例“热”患者，“热”的TTP和生存期显著长于“无热”（分别为p 0.045和p = 0.02;中位生存期85周vs. 76周; 2年生存期31% vs. 15%）。对这68例患者进行了多变量分析，调整了年龄和KPS，结果显示，生存率的提高与随机分配至“热”组显著相关（p = 0.008;风险比0.51）。没有5级毒性，2级4级毒性（每组1例），7级3级毒性（1例“无热”，6例“热”臂）。结论：常规放疗后，在近距离放射治疗增强之前和之后给予辅助间质脑HT，可显著提高局灶性胶质母细胞瘤患者的生存率，毒性可接受。(C)1998年爱思唯尔科学公司
Purpose: To determine if adjuvant interstitial hyperthermia (HT) significantly improves survival of patients with glioblastoma undergoing brachytherapy boost after conventional radiotherapy.Methods and Materials: Adults with newly-diagnosed, focal, supratentorial glioblastoma less than or equal to 5 cm in diameter were registered postoperatively on a Phase II/III randomized trial and treated with partial brain radiotherapy to 59.4 Gy with oral hydroxyurea. Those patients whose tumor was still implantable after teletherapy were randomized to brachytherapy boost (60 Gy at 0.40-0.60 Gy/h) +/- HT for 30 min immediately before and after brachytherapy. Time to progression (TTP) and survival from date of diagnosis were estimated using the Kaplan-Meier method.Results: From 1990 to 1995, 112 eligible patients were entered in the trial. Patient ages ranged from 21-78 years (median, 54 years) and KPS ranged from 70-100 (median, 90). Most commonly due to tumor progression or patient refusal, 33 patients were never randomized. Of the patients, 39 were randomized to brachytherapy ("no heat") and 40 to brachytherapy + HT ("heat"). By intent to treat, TTP and survival were significantly longer for "heat" than "no heat" (p = 0.04 and p = 0.04). For the 33 "no heat" patients and 35 "heat" patients who underwent brachytherapy boost, TTP and survival were significantly longer for "heat" than "no heat" (p 0.045 and p = 0.02, respectively; median survival 85 weeks vs. 76 weeks; 2-year survival 31% vs. 15%). A multivariate analysis for these 68 patients adjusting for age and KPS showed that improved survival was significantly associated with randomization to "heat" (p = 0.008; hazard ratio 0.51). There were no Grade 5 toxicities, 2 Grade 4 toxicities (1 on each arm), and 7 Grade 3 toxicities (1 on "no heat" and 6 on the "heat" arm).Conclusion: Adjuvant interstitial brain HT, given before and after brachytherapy boost, after conventional radiotherapy significantly improves survival of patients with focal glioblastoma, with acceptable toxicity. (C) 1998 Elsevier Science Inc.