Preliminary experience on safety of regorafenib after sorafenib failure in recurrent hepatocellular carcinoma after liver transplantation
Preliminary experience on safety of regorafenib after sorafenib failure in recurrent hepatocellular carcinoma after liver transplantation
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DOI：
10.1111/ajt.15551
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发表时间：
2019-09-03
影响因子：
8.8
通讯作者：
Reig, Maria
中科院分区：
文献类型：
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作者：
Iavarone, Massimo;Invernizzi, Federica;Reig, Maria
瑞非尼是肝细胞癌（HCC）二线治疗的一种选择，可改善进展的索拉非尼耐受患者的总生存期（OS）。我们的目的是评估瑞非尼作为肝移植（LT）后HCC复发的二线治疗的安全性和结果。这是一项回顾性、多中心、国际研究，包括瑞非尼治疗的LT患者（2015-2018），分析了索拉非尼/瑞非尼治疗期间的基线特征和进化事件。纳入28例LT患者（57岁，7%肝硬化，54%表现状态1）。从LT到瑞非尼起始治疗的中位时间为3.9年（1.1-18.5年）；从索拉非尼停药到瑞非尼的中位时间为11.3（0.7-76.4）个月，14（1-591）天。在regorafenib治疗期间（6.3个月），所有患者至少发生一次不良事件（AE），最常见的3/4级AE是疲劳（n = 7）和皮肤反应（n = 5）。虽然没有观察到肝排斥反应，但5例患者的血浆免疫抑制药物水平升高。24例患者出现进展（38%肝外生长，33%新的肝外病变/血管侵犯）。瑞非尼起始治疗的中位OS为12.9 (95% CI, 6.7-19.1)，索拉非尼起始治疗的中位OS为38.4个月（95% CI, 18.5-58.4）。这是首个证明肝移植后瑞非尼安全性的研究，为肝移植后复发的索拉非尼耐受患者在临床决策时考虑瑞非尼提供了依据。
Regorafenib is one option for second-line treatment of hepatocellular carcinoma (HCC), improving overall survival (OS) of sorafenib-tolerant patients who develop progression. We aim to evaluate the safety and outcomes of regorafenib as second-line treatment for HCC recurrence after liver transplantation (LT). This is a retrospective, multicenter, international study including regorafenib-treated LT patients (2015-2018), with analysis of baseline characteristics and evolutionary events during sorafenib/regorafenib treatment. Twenty-eight LT patients (57 years, 7% cirrhotics, 54% performance status 1) were included. Median time from LT to regorafenib initiation was 3.9 (1.1-18.5) years; median time on sorafenib was 11.3 (0.7-76.4) months and 14 (1-591) days from sorafenib discontinuation to regorafenib. During regorafenib (6.3 months), all patients had at least one adverse event (AE), the most common grade 3/4 AEs were fatigue (n = 7) and dermatological reaction (n = 5). While no liver rejection was observed, plasma levels of immunosuppressive drugs increased in five. Twenty-four patients developed progression (38% extrahepatic growth, 33% new extrahepatic lesions/vascular invasion). Median OS from regorafenib initiation was 12.9 (95% CI, 6.7-19.1) and 38.4 months (95% CI, 18.5-58.4) for the sorafenib initiation. This is the first study showing safety of regorafenib after LT, thus providing the rational of considering regorafenib in the clinical decision-making in sorafenib-tolerant patients with HCC recurrence after LT.