Adjuvant Lenvatinib Prevents Recurrence of High-risk Patients With Hepatitis B Virus-related Hepatocellular Carcinoma Following Liver Transplantation: a Retrospective Case Control Study

The investigators retrospectively reviewed 23 Chinese HCC patients with HBV infection, who underwent LT in our hospital from June 2018 to December 2019. All donor grafts were allocated by the China Organ Transplant Response System. All these patients were diagnosed by histology and were defined as "high-risk" for recurrence.

The participants were divided into lenvatinib group and control group according to their willingness to take lenvatinib as adjuvant therapy after LT. Of the 23 patients, 14 pantients in lenvatinib group began to take lenvatinib about a month after LT except for routine treatment, while the other 9 patients in control group received routine treatment and follow-up after transplantation. Clinical data and demographic characteristics was obtained. This study was conducted according to the 1975 Declaration of Helsinki and approved by Ethics Committee of Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (No. XHEC-D-2020-068). All patients enrolled in this study provided informed consent.

Usage of lenvatinib and immunosuppressants The participants in lenvatinib group received oral lenvatinib (Eisai, Japan) 12 mg/day (for bodyweight (BW) ≥60 kg) or 8 mg/day (for BW <60 kg) in 28-day cycles until HCC recurrence or serious adverse events (SAEs) or voluntary withdrawal. Dose interruptions followed by reductions for lenvatinib-related toxicities (to 8 mg and 4 mg/day, or 4 mg every other day) were permitted. All 14 patients took lenvatinib for more than 3 cycles.

The induction immunosuppression strategies for all participants enrolled in the study involved IV infusion of 20mg of basiliximab within 2 hours prior to operation and a second dose 4 days later, oral tacrolimus started on the fourth day after LT at a dose of 0.04mg/kg (BW) and adjusted according to its plasma concentration, taking mycophenolate mofetil (MMF) from the next day after surgery at a dose of 500mg/kg(BW), and rapid withdrawal of glucocorticoids with the initial dose of 500mg. Maintenance immunosuppression which was started about one month after LT included sirolimus (4 mg/M2 per day) plus oral tacrolimus with the plasma concentration maintained at 5-8 ng/ml.

All patients were followed up monthly within six months after LT and every three months within two years. During each follow-up, complete blood count, urinalysis, serum AFP level, liver and kidney function test, and blood concentration of FK506 were recorded. Chest and abdominal computed tomography was implemented at 3 months, 6 months, 12 months, and annually thereafter. Other radiological examinations such as radionuclide bone scan, magnetic resonance imaging (MRI) and positron emission tomography (PET) were obtained when local recurrence or distant metastasis was suspected.