多柔比星洗脱微球与单纯微球栓塞治疗肝细胞癌的肝动脉栓塞随机试验
Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone.
作者信息
Brown Karen T, Do Richard K, Gonen Mithat, Covey Anne M, Getrajdman George I, Sofocleous Constantinos T, Jarnagin William R, D'Angelica Michael I, Allen Peter J, Erinjeri Joseph P, Brody Lynn A, O'Neill Gerald P, Johnson Kristian N, Garcia Alessandra R, Beattie Christopher, Zhao Binsheng, Solomon Stephen B, Schwartz Lawrence H, DeMatteo Ronald, Abou-Alfa Ghassan K
机构信息
Karen T. Brown, Richard K. Do, Mithat Gonen, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Gerald P. O'Neill, Kristian N. Johnson, Alessandra R. Garcia, Christopher Beattie, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Memorial Sloan Kettering Cancer Center; Binsheng Zhao and Lawrence H. Schwartz, Columbia University College of Physicians and Surgeons; and Karen T. Brown, Richard K. Do, Anne M. Covey, George I. Getrajdman, Constantinos T. Sofocleous, William R. Jarnagin, Michael I. D'Angelica, Peter J. Allen, Joseph P. Erinjeri, Lynn A. Brody, Stephen B. Solomon, Ronald DeMatteo, and Ghassan K. Abou-Alfa, Weill Cornell Medical College, New York, NY.
出版信息
J Clin Oncol. 2016 Jun 10;34(17):2046-53. doi: 10.1200/JCO.2015.64.0821. Epub 2016 Feb 1.
PURPOSE
Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres.
MATERIALS AND METHODS
At a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual.
RESULTS
Between December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, -0.1%; 95% CI, -9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively.
CONCLUSION
There was no apparent difference between the treatment arms. These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC.
目的
经动脉化疗栓塞术是肝细胞癌（HCC）的公认治疗方法。尚无随机试验证明化疗栓塞术优于单纯栓塞术，化疗的作用仍不明确。本随机试验比较了单纯使用微球栓塞与使用阿霉素洗脱微球进行化疗栓塞的疗效。
材料与方法
在一家三级转诊中心，将HCC患者随机分为两组，一组单纯使用微球栓塞（Bead Block [BB]），另一组使用载有150 mg阿霉素的微球（LC Bead [LCB]）。随机分组按完成治疗所需的栓塞次数进行分层，分组由机构数据库中的置换区组产生。主要终点是根据实体瘤疗效评价标准（RECIST）1.0，在治疗后2至3周以及之后每季度进行多期计算机断层扫描评估的反应，评估者对治疗分配情况不知情。次要目标包括安全性和耐受性、疾病进展时间、无进展生存期和总生存期。该试验目前已停止入组。
结果
2007年12月至2012年4月期间，101例患者被随机分组：51例接受BB治疗，50例接受LCB治疗。人口统计学特征具有可比性：中位年龄67岁；77%为男性；巴塞罗那临床肝癌分期A期占22%，B期或C期占78%。两组不良事件发生频率相似：BB组51例患者中有19例（38%），LCB组50例患者中有20例（40%；P = 0.48），RECIST反应无差异：BB组为5.9%，LCB组为6.0%（差异为 -0.1%；95% CI，-9%至9%）。BB组和LCB组的中位无进展生存期分别为6.2个月和2.8个月（风险比，1.36；95% CI，0.91至2.05；P = 0.11），总生存期分别为19.6个月和20.8个月（风险比，1.11；95% CI，0.71至1.76；P = 0.64）。
结论
两组治疗效果无明显差异。这些结果对阿霉素洗脱微球用于HCC化疗栓塞术提出了挑战。
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