Phase II study of radiotherapy employing proton beam for hepatocellular carcinoma
Phase II study of radiotherapy employing proton beam for hepatocellular carcinoma
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DOI：
10.1200/jco.2005.00.620
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发表时间：
2005-03-20
影响因子：
45.3
通讯作者：
Ogino, T
中科院分区：
文献类型：
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作者：
Kawashima, M;Furuse, J;Ogino, T
目的评价质子束放射治疗（PRT）治疗肝细胞癌的安全性和有效性。患者和方法本研究的入选标准为：孤立性肝细胞癌（HCC）;无手术或局部消融治疗指征;无腹水;年龄≥ 20岁; Zubrod体力状态0 ~ 2;无肝硬化以外的严重合并症;知情同意书。PRT以76钴灰色当量的剂量分20次给药，持续5周。没有患者接受经动脉化疗栓塞或局部消融结合PRT.Results 30例患者在1999年5月至2003年2月期间入组。男20例，女10例，中位年龄70岁。最大肿瘤直径范围为25至82 mm（中位数45 mm）。所有患者均为肝硬化，肝功能Child-Pugh A级20例，B级10例。PRT的急性反应耐受性良好，所有患者均按计划完成PRT。术后6 ~ 9个月4例死于肝功能不全，无肿瘤复发。这4名患者中有3名在15分钟时的预处理吲哚菁绿色留存率超过50%。中位随访31个月（16 ~ 54个月）后，仅1例患者发生原发肿瘤复发，2年精算局部无进展率为96%（95%CI，88%~ 100%）。2年生存率为66%（48%~ 84%）。结论PRT对原发肿瘤有良好的控制作用，急性毒性小。进一步的研究是必要的，以审查适当的患者选择，以最大限度地提高这种有前途的方式生存的好处。(c)2005年，美国临床肿瘤学会。
Purpose To evaluate the safety and efficacy of proton beam radiotherapy (PRT) for hepatocellular carcinoma.Patients and Methods Eligibility criteria for this study were: solitary hepatocellular carcinoma (HCC); no indication for surgery or local ablation therapy; no ascites; age >= 20 years; Zubrod performance status of 0 to 2; no serious comorbidities other than liver cirrhosis; written informed consent. PRT was administered in doses of 76 cobalt gray equivalent in 20 fractions for 5 weeks. No patients received transarterial chemoembolization or local ablation in combination with PRT.Results Thirty patients were enrolled between May 1999 and February 2003. There were 20 male and 10 female patients, with a median age of 70 years. Maximum tumor diameter ranged from 25 to 82 mm (median 45 mm). All patients had liver cirrhosis the degree of which was,, Child-Pugh class A in 20, and class B in 10 patients. Acute reactions of PRT were well tolerated, and PRT was completed as planned in all patients. Four patients died of hepatic insufficiency without tumor recurrence at 6 to 9 months. Three of these four patients had pretreatment indocyanine green retention rate at 15 minutes of more than 50%. After a median follow-up period of 31 months (16 to 54 months), only one patient experienced recurrence of the primary tumor, and 2-year actuarial local progression-free rate was 96% (95% CI, 88% to 100%). Actuarial overall survival rate at 2 years was 66% (48% to 84%).Conclusion PRT showed excellent control of the primary tumor, with minimal acute toxicity. Further study is warranted to scrutinize adequate patient selection in order to maximize survival benefit of this promising modality. (c) 2005 by American Society of Clinical Oncology.