Multi-Institutional Phase II Study of High-Dose Hypofractionated Proton Beam Therapy in Patients With Localized, Unresectable Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma
Multi-Institutional Phase II Study of High-Dose Hypofractionated Proton Beam Therapy in Patients With Localized, Unresectable Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma
复制标题
DOI：
10.1200/jco.2015.64.2710
复制
发表时间：
2016-02-10
影响因子：
45.3
通讯作者：
Zhu, Andrew X.
中科院分区：
文献类型：
--
作者：
Hong, Theodore S.;Wo, Jennifer Y.;Zhu, Andrew X.
目的评价大剂量、大分割质子束治疗肝细胞癌（HCC）和肝内胆管细胞癌（ICC）的有效性和安全性。材料和方法在这项单臂、II期、多机构研究中，92例经活检证实的HCC或ICC患者，经多学科审查确定为不可切除，Child-Turcotte-Pugh评分（CTP）为A或B，ECOG体能状态为0 - 2，无肝外疾病，既往无放疗，接受了15次质子治疗，最大总剂量为67.5戈伊当量。计算样本量，以证明>80%的本地控制（LC）定义的反应评价标准在实体瘤（RECIST）1.0标准，在2年的HCC患者，与平行的目标，获得可接受的精度估计结果为ICC.ResultsEighty-three患者进行评估：44与HCC，37与ICC，和两个混合HCC/ICC。CTP评分为A的患者占79.5%，为B的患者占15.7%; 4.8%的患者无肝硬化。31.8%的HCC患者和61.5%的ICC患者接受过既往治疗。HCC患者的中位最大尺寸为5.0 cm（范围：1.9 - 12.0 cm），ICC患者为6.0 cm（范围：2.2 - 10.9 cm）。27.3%的HCC患者和12.8%的ICC患者存在多发性肿瘤。29.5%的HCC患者和28.2%的ICC患者存在肿瘤血管血栓形成。HCC和ICC患者的中位剂量为58.0戈伊。存活者的中位随访时间为19.5个月，HCC和ICC的2年LC率分别为94.8%和94.1%。在2年的总生存率为63.2%，HCC和46. 5% ICC.ConclusionHigh-dose hypofractionated质子治疗显示高LC率HCC和ICC安全，支持正在进行的III期试验的放射性肝癌和ICC。(C)2015年美国临床肿瘤学会
PurposeTo evaluate the efficacy and safety of high-dose, hypofractionated proton beam therapy for hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC).Materials and MethodsIn this single-arm, phase II, multi-institutional study, 92 patients with biopsy-confirmed HCC or ICC, determined to be unresectable by multidisciplinary review, with a Child-Turcotte-Pugh score (CTP) of A or B, ECOG performance status of 0 to 2, no extrahepatic disease, and no prior radiation received 15 fractions of proton therapy to a maximum total dose of 67.5 Gy equivalent. Sample size was calculated to demonstrate >80% local control (LC) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria at 2 years for HCC patients, with the parallel goal of obtaining acceptable precision for estimating outcomes for ICC.ResultsEighty-three patients were evaluable: 44 with HCC, 37 with ICC, and two with mixed HCC/ICC. The CTP score was A for 79.5% of patients and B for 15.7%; 4.8% of patients had no cirrhosis. Prior treatment had been given to 31.8% of HCC patients and 61.5% of ICC patients. The median maximum dimension was 5.0 cm (range, 1.9 to 12.0 cm) for HCC patients and 6.0 cm (range, 2.2 to 10.9 cm) for ICC patients. Multiple tumors were present in 27.3% of HCC patients and in 12.8% of ICC patients. Tumor vascular thrombosis was present in 29.5% of HCC patients and in 28.2% of ICC patients. The median dose delivered to both HCC and ICC patients was 58.0 Gy. With a median follow-up among survivors of 19.5 months, the LC rate at 2 years was 94.8% for HCC and 94.1% for ICC. The overall survival rate at 2 years was 63.2% for HCC and 46.5% ICC.ConclusionHigh-dose hypofractionated proton therapy demonstrated high LC rates for HCC and ICC safely, supporting ongoing phase III trials of radiation in HCC and ICC. (C) 2015 by American Society of Clinical Oncology