Randomized Clinical Trial Comparing Proton Beam Radiation Therapy with Transarterial Chemoembolization for Hepatocellular Carcinoma: Results of an Interim Analysis
Randomized Clinical Trial Comparing Proton Beam Radiation Therapy with Transarterial Chemoembolization for Hepatocellular Carcinoma: Results of an Interim Analysis
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DOI：
10.1016/j.ijrobp.2016.02.027
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发表时间：
2016-05-01
影响因子：
7
通讯作者：
de Vera, Michael E.
中科院分区：
文献类型：
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作者：
Bush, David A.;Smith, Jason C.;de Vera, Michael E.
目的：描述一项前瞻性随机临床试验的中期分析结果，该试验旨在比较新诊断肝细胞癌（HCC）患者的治疗结局。方法和材料：符合条件的受试者具有HCC的临床或病理诊断，符合米兰或旧金山弗朗西斯科移植标准。患者被随机分配接受经动脉化疗栓塞（TACE）或质子束放射治疗。随机分配至TACE组的患者接受了至少1次TACE，并因持续性疾病接受了额外的TACE。质子束放射治疗在3周内每天15次，对所有严重疾病区域进行总剂量为70.2戈伊的放射治疗。主要终点是无进展生存期，与总生存期，局部肿瘤控制，治疗相关的毒性为代表的治疗后住院天数的次要终点。其中，36例被随机分配至TACE组，33例被随机分配至质子组。TACE/质子治疗30天内的总住院天数分别为166天和24天（P
Purpose: To describe results of a planned interim analysis of a prospective, randomized clinical trial developed to compare treatment outcomes among patients with newly diagnosed hepatocellular carcinoma (HCC).Methods and Materials: Eligible subjects had either clinical or pathologic diagnosis of HCC and met either Milan or San Francisco transplant criteria. Patients were randomly assigned to transarterial chemoembolization (TACE) or to proton beam radiation therapy. Patients randomized to TACE received at least 1 TACE with additional TACE for persistent disease. Proton beam radiation therapy was delivered to all areas of gross disease to a total dose of 70.2 Gy in 15 daily fractions over 3 weeks. The primary endpoint was progression-free survival, with secondary endpoints of overall survival, local tumor control, and treatment-related toxicities as represented by posttreatment days of hospitalization.Results: At the time of this analysis 69 subjects were available for analysis. Of these, 36 were randomized to TACE and 33 to proton. Total days of hospitalization within 30 days of TACE/proton was 166 and 24 days, respectively (P