Vitale A, Boccagni P, Kertusha X, Zanus G, D'Amico F, Lodo E, Pastorelli D, Ramirez Morales R, Lombardi G, Senzolo M, Burra P, Cillo U
Unità di Chirurgia Epatobiliare e Trapianto Epatico, Azienda - Università di Padova, Padova, Italy.
Transplant Proc. 2012 Sep;44(7):1989-91. doi: 10.1016/j.transproceed.2012.06.046.
There are scarce data on the use of sorafenib for the treatment of recurrent hepatocellular carcinoma (HCC) after orthotopic liver transplantation (OLT).
Ten patients were treated with sorafenib after OLT following the Italian Drug Agency guidelines: they had well-compensated liver function (Child-Pugh class A in the case of cirrhosis), intermediate-or advanced-stage HCC, good general condition (performance status 0), and not suitable for loco-regional therapies. Patients with HCC recurrence after OLT were treated with sorafenib (400 mg twice daily). Adverse events (AEs) were assessed using National Cancer Institute Common Toxicity Criteria of Adverse Events (NCI-CTCAE) v3.0 with tumor responses evaluated acording to modified Response Evaluation Criteria in Select Tumors) criteria.
Median duration of treatment was 10 months (range, 2-18). Seven patients (70%) received an additionally targeted therapy with mTOR inhibitors as part of their immunosuppressive regimen. Most common grade 3 AEs included diarrhea (50%), hand-foot skin reaction (30%), and fatigue (20%). Sorafenib had to be discontinued in 3 patients (30%) due to AEs and 4 additional patients (40%) required a dose adjustment. No deterioration of liver graft function occurred. Three patients (30%) stopped treatment due to radiological progression of HCC, whereas 3 are still using the drug. Median time to progression was 8 months (range, 2-16). Median survival from start of therapy was 18 months (range, 4- 36).
Our preliminary results suggest that sorafenib is a safe effective therapy for recurrent HCC after OLT.
关于索拉非尼用于原位肝移植（OLT）后复发性肝细胞癌（HCC）治疗的数据稀缺。
10例患者在OLT后按照意大利药品管理局指南接受索拉非尼治疗：他们肝功能代偿良好（肝硬化患者为Child-Pugh A级），HCC处于中期或晚期，一般状况良好（体能状态0），且不适合局部区域治疗。OLT后HCC复发的患者接受索拉非尼治疗（每日两次，每次400mg）。使用美国国立癌症研究所不良事件通用毒性标准（NCI-CTCAE）v3.0评估不良事件（AE），根据改良的实体瘤疗效评价标准评估肿瘤反应。
中位治疗持续时间为10个月（范围2 - 18个月）。7例患者（70%）在免疫抑制方案中额外接受了mTOR抑制剂靶向治疗。最常见的3级AE包括腹泻（50%）、手足皮肤反应（30%）和疲劳（20%）。3例患者（30%）因AE不得不停用索拉非尼，另外4例患者（40%）需要调整剂量。肝移植功能未恶化。3例患者（30%）因HCC影像学进展停止治疗，而3例仍在使用该药物。中位进展时间为8个月（范围2 - 16个月）。从治疗开始的中位生存期为18个月（范围4 - 36个月）。
我们的初步结果表明，索拉非尼是OLT后复发性HCC的一种安全有效的治疗方法。
