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索拉非尼作为肝移植受者高危肝细胞癌辅助治疗的可行性和疗效

Sorafenib as adjuvant therapy for high-risk hepatocellular carcinoma in liver transplant recipients: feasibility and efficacy.

作者信息

Saab Sammy, McTigue Michael, Finn Richard S, Busuttil Ronald W

机构信息

Departments of Medicine, the University of California at Los Angeles, Los Angeles, CA, USA.

出版信息

Exp Clin Transplant. 2010 Dec;8(4):307-13.

PMID:21143097
Abstract

OBJECTIVES

Liver transplant can be a definitive treatment for hepatocellular carcinoma. However, recurrence limits long-term survival. Sorafenib is the first agent to improve survival for patients with advanced hepatocellular carcinoma.

MATERIALS AND METHODS

A retrospective, case-control match analysis was performed, along with assessment of safety and tolerability. The endpoints of the study were recurrence incidence, episodes of rejection, and disease-free overall survival. Eight patients who underwent liver transplant for hepatocellular carcinoma between May 2007 and April 2009, and tolerated adjuvant therapy with sorafenib were matched with patients who did not receive sorafenib according to age, sex, year of transplant, tumor burden, and presence of vascular invasion.

RESULTS

During follow-up, there were no episodes of rejection in either group. Eight patients were able to tolerate a predetermined duration of therapy. During a mean (± standard deviation [SD]) follow-up of 17.75 ± 6.26 months, 1 of 8 patients (12.5%) treated with sorafenib developed hepatocellular carcinoma recurrence. During a mean (± SD) follow-up of 31.63 months (± 22.30 months), 4 of 8 matched controls (50.0%) developed hepatocellular carcinoma recurrence. Disease-free 1-year survival for sorafenib and control group was 85.7% and 57.1%. Overall, 1-year survival for sorafenib and control group was 87.5% and 62.5%.

CONCLUSIONS

Our study demonstrates the safety and potential benefit of sorafenib in reducing the incidence of hepatocellular carcinoma recurrence and in extending disease-free and overall survival for high-risk liver transplant recipients. A prospective trial is needed to fully assess the role sorafenib as prophylaxis against hepatocellular carcinoma recurrence.

摘要

目的

肝移植可作为肝细胞癌的一种确定性治疗方法。然而,复发限制了长期生存率。索拉非尼是首个可提高晚期肝细胞癌患者生存率的药物。

材料与方法

进行了一项回顾性病例对照匹配分析,并评估了安全性和耐受性。研究的终点为复发发生率、排斥反应发作次数以及无病总生存期。将2007年5月至2009年4月期间因肝细胞癌接受肝移植且耐受索拉非尼辅助治疗的8例患者,按照年龄、性别、移植年份、肿瘤负荷和血管侵犯情况与未接受索拉非尼治疗的患者进行匹配。

结果

随访期间,两组均未发生排斥反应发作。8例患者能够耐受预定疗程的治疗。在平均(±标准差[SD])17.75±6.26个月的随访中,接受索拉非尼治疗的8例患者中有1例(12.5%)发生肝细胞癌复发。在平均(±SD)31.63个月(±22.30个月)的随访中,8例匹配对照中有4例(50.0%)发生肝细胞癌复发。索拉非尼组和对照组的1年无病生存率分别为85.7%和57.1%。总体而言,索拉非尼组和对照组的1年生存率分别为87.5%和62.5%。

结论

我们的研究证明了索拉非尼在降低高危肝移植受者肝细胞癌复发率以及延长无病生存期和总生存期方面的安全性和潜在益处。需要进行一项前瞻性试验以全面评估索拉非尼作为预防肝细胞癌复发的作用。

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