Martin Robert, Irurzun Javier, Munchart Jordi, Trofimov Igor, Scupchenko Alexander, Tatum Cliff, Narayanan Govindarajan
Division of Surgical Oncology, Department of Surgery, University of Louisville College of Medicine, Louisville, KY 40202, USA.
Korean J Hepatol. 2011 Mar;17(1):51-60. doi: 10.3350/kjhep.2011.17.1.51.
BACKGROUND/AIMS: It has been shown that the drug-eluting beads loaded with doxorubicin (DEBDOX) are effective for the treatment of hepatocellular carcinoma (HCC). However, the optimal safety and efficacy still remain to be established by using various bead sizes, doxorubicin doses, and the degree of stasis.The aim of this study was to determine the optimal safety and efficacy of DEBDOX in the treatment of HCC.
Analysis of a 503-patient prospective, multicenter, multinational Bead Registry Database from 2007 to 2010 identified 206 patients who had been treated for HCC with DEBDOX. Primary endpoints were to compare safety, tolerance, response rates, and overall survival based on bead size (100-300, 300-500, 500-700, and 700-900 μm), number of vials, doxorubicin dose, and degree of stasis.
In total, 206 patients underwent 343 treatments. The use of all four bead sizes was similar based on Child-Pugh class and Okuda stage, with a significantly higher use (50%) of beads of size 100-300 μm in patients with portal vein thrombosis (P=0.05). Significant differences were seen for the number of median treatments, median doxorubicin dose, lobar infusion), and degree of complete stasis. The rate of adverse events was higher for larger beads than for smaller beads (28% vs. 16%; P=0.02).
Bead size and dose may vary according to disease distribution. Smaller beads offer the opportunity for repeated treatments, a larger cumulative dose delivery, a lesser degree of complete stasis, and fewer adverse events.
背景/目的：已表明载有多柔比星的药物洗脱微球（DEBDOX）对肝细胞癌（HCC）治疗有效。然而，通过使用各种微球尺寸、多柔比星剂量和栓塞程度，最佳安全性和疗效仍有待确定。本研究的目的是确定DEBDOX治疗HCC的最佳安全性和疗效。
对2007年至2010年的503例患者的前瞻性、多中心、跨国微球注册数据库进行分析，确定了206例接受DEBDOX治疗HCC的患者。主要终点是根据微球尺寸（100 - 300、300 - 500、500 - 700和700 - 900μm）、瓶数、多柔比星剂量和栓塞程度比较安全性、耐受性、缓解率和总生存期。
总共206例患者接受了343次治疗。根据Child-Pugh分级和奥田分期，所有四种微球尺寸的使用情况相似，门静脉血栓形成患者中100 - 300μm尺寸微球的使用显著更高（50%）（P = 0.05）。在中位治疗次数、中位多柔比星剂量、叶内灌注和完全栓塞程度方面存在显著差异。较大微球的不良事件发生率高于较小微球（28%对16%；P = 0.02）。
微球尺寸和剂量可能根据疾病分布而有所不同。较小的微球提供了重复治疗的机会、更大的累积剂量递送、更低的完全栓塞程度和更少的不良事件。
