药物洗脱微球与传统化疗栓塞术治疗不可切除肝细胞癌的对比

Drug-eluting beads versus conventional chemoembolization for the treatment of unresectable hepatocellular carcinoma.

作者信息

Facciorusso Antonio, Mariani Luigi, Sposito Carlo, Spreafico Carlo, Bongini Marco, Morosi Carlo, Cascella Tommaso, Marchianò Alfonso, Camerini Tiziana, Bhoori Sherrie, Brunero Federica, Barone Michele, Mazzaferro Vincenzo

机构信息

Gastroenterology, Surgery and Liver Transplantation Unit, Fondazione Istituto Nazionale Tumori IRCCS-National Cancer Institute, Milan, Italy.

Trial Office and Biomedical Statistics, Fondazione Istituto Nazionale Tumori IRCCS-National Cancer Institute, Milan, Italy.

出版信息

J Gastroenterol Hepatol. 2016 Mar;31(3):645-53. doi: 10.1111/jgh.13147.

DOI:10.1111/jgh.13147

PMID:26331807

Abstract

BACKGROUND AND AIM

Solid demonstrations of superior efficacy of drug-eluting beads transarterial chemoembolization with respect to conventional chemoembolization in hepatocellular carcinoma patients are lacking. The aim of the study was to compare these two techniques in two large cohorts of unresectable hepatocellular carcinoma patients.

METHODS

A single center series of 249 early/intermediate hepatocellular carcinoma patients who underwent "on demand" chemoembolization in the period 2007-2011 was analyzed. Overall survival, time to progression, tumor response rate, and safety were compared between 104 patients who underwent conventional chemoembolization and 145 who underwent drug-eluting beads chemoembolization. Time-to-event data were analyzed using the Cox univariate and multivariate regression.

RESULTS

The two cohorts resulted balanced for liver function and tumor stages. Objective response rate was 85.3% after conventional and 74.8% after drug-eluting beads chemoembolization (P = 0.039), and median time to progression was 17 (95% confidence interval: 14-21) versus 11 months (9-12), respectively (P < 0.001). Treatment regimen was the sole independent predictor of progression at multivariate analysis (hazard ratio = 2.01; 1.45-2.80; P < 0.001). Median survival was 39 (32-47) and 32 (24-39) months in the two groups, respectively (hazard ratio = 1.33; 0.94-1.87; P = 0.10), but conventional chemoembolization was significantly associated with a survival advantage in patients with bilobar neoplasia, portal hypertension and alpha fetoprotein above normal limits. No significant differences in severe adverse events were found.

CONCLUSION

In a large series of Western hepatocellular carcinoma patients, drug-eluting beads chemoembolization with 100-300 µm particles did not seem to improve survival in comparison with conventional chemoembolization, which in turn provided better tumor responses and time to progression.

摘要

背景与目的

缺乏确凿证据表明在肝细胞癌患者中，载药微球经动脉化疗栓塞术相较于传统化疗栓塞术具有更优疗效。本研究旨在比较两组大型不可切除肝细胞癌患者的这两种技术。

方法

分析了单中心2007年至2011年期间接受“按需”化疗栓塞术的249例早期/中期肝细胞癌患者。比较了104例接受传统化疗栓塞术患者与145例接受载药微球化疗栓塞术患者的总生存期、疾病进展时间、肿瘤反应率和安全性。采用Cox单因素和多因素回归分析生存时间数据。

结果

两组患者在肝功能和肿瘤分期方面达到平衡。传统化疗栓塞术后客观缓解率为85.3%，载药微球化疗栓塞术后为74.8%（P = 0.039），疾病进展的中位时间分别为17个月（95%置信区间：14 - 21）和11个月（9 - 12）（P < 0.001）。多因素分析中，治疗方案是疾病进展的唯一独立预测因素（风险比 = 2.01；1.45 - 2.80；P < 0.001）。两组患者的中位生存期分别为39个月（32 - 47）和32个月（24 - 39）（风险比 = 1.33；0.94 - 1.87；P = 0.10），但传统化疗栓塞术在双叶肿瘤、门静脉高压和甲胎蛋白高于正常范围的患者中与生存优势显著相关。严重不良事件无显著差异。