Hyperfractionated Versus Conventional Radiotherapy Followed by Chemotherapy in Standard-Risk Medulloblastoma: Results From the Randomized Multicenter HIT-SIOP PNET 4 Trial
Hyperfractionated Versus Conventional Radiotherapy Followed by Chemotherapy in Standard-Risk Medulloblastoma: Results From the Randomized Multicenter HIT-SIOP PNET 4 Trial
复制标题
DOI：
10.1200/jco.2011.39.8719
复制
发表时间：
2012-09-10
影响因子：
45.3
通讯作者：
Kortmann, Rolf
中科院分区：
文献类型：
--
作者：
Lannering, Birgitta;Rutkowski, Stefan;Kortmann, Rolf
目的比较标准风险髓母细胞瘤儿童接受术后超分割或传统分割放疗随后维持化疗的无事件生存期 (EFS)、总生存期 (OS)、复发模式和听力损失。 患者和方法 来自 122 个欧洲中心的 340 名 4 至 21 岁儿童进行了术后分期并随机分配接受超分割治疗 放疗 (HFRT) 或标准（传统）分割放疗 (STRT)，随后采用由 8 个周期的顺铂、洛莫司汀和长春新碱组成的常见化疗方案。结果中位随访 4.8 年（范围为 0.1 至 8.3 年）后，两个治疗组之间的生存率没有显着差异：5 年 EFS 为 77% +/- 4% STRT 组和 HFRT 组为 78% +/- 4%；相应的 5 年 OS 分别为 87% +/- 3% 和 85% +/- 3%。术后残留肿瘤超过1.5 cm(2) 是最强的负面预后因素。具有所有参考评估且无大残留肿瘤的儿童 5 年时的 EFS 为 82% +/- 2%。延迟开始 RT 超过 7 周的患者预后较差。随访时两个治疗组的严重听力损失没有显着差异。结论在这项大型随机欧洲研究中，招募了来自 100 多个中心的标准风险髓母细胞瘤患者，术后没有大残留肿瘤且没有 RT 治疗延迟的患者获得了出色的生存率。 HFRT 的 EFS 和 OS 并不优于 STRT，因此仍然是该疾病的标准护理。 J 临床肿瘤杂志 30：3187-3193。 (C) 2012 年美国临床肿瘤学会
PurposeTo compare event-free survival (EFS), overall survival (OS), pattern of relapse, and hearing loss in children with standard-risk medulloblastoma treated by postoperative hyperfractionated or conventionally fractionated radiotherapy followed by maintenance chemotherapy.Patients and MethodsIn all, 340 children age 4 to 21 years from 122 European centers were postoperatively staged and randomly assigned to treatment with hyperfractionated radiotherapy (HFRT) or standard (conventional) fractionated radiotherapy (STRT) followed by a common chemotherapy regimen consisting of eight cycles of cisplatin, lomustine, and vincristine.ResultsAfter a median follow-up of 4.8 years (range, 0.1 to 8.3 years), survival rates were not significantly different between the two treatment arms: 5-year EFS was 77% +/- 4% in the STRT group and 78% +/- 4% in the HFRT group; corresponding 5-year OS was 87% +/- 3% and 85% +/- 3%, respectively. A postoperative residual tumor of more than 1.5 cm(2) was the strongest negative prognostic factor. EFS of children with all reference assessments and no large residual tumor was 82% +/- 2% at 5 years. Patients with a delay of more than 7 weeks to the start of RT had a worse prognosis. Severe hearing loss was not significantly different for the two treatment arms at follow-up.ConclusionIn this large randomized European study, which enrolled patients with standard-risk medulloblastoma from more than 100 centers, excellent survival rates were achieved in patients without a large postoperative residual tumor and without RT treatment delays. EFS and OS for HFRT was not superior to STRT, which therefore remains standard of care in this disease. J Clin Oncol 30:3187-3193. (C) 2012 by American Society of Clinical Oncology