Lenvima May Offer Survival Benefit With Manageable Side Effects in Recurrent HCC After Liver Transplantation

Researchers observed this benefit in recurrent HCC after liver transplantation, which represents a patient population often excluded from clinical trials due to potential organ rejection.

Patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation who were treated with Lenvima (lenvatinib) obtained a benefit from the treatment with manageable side effects, recent study results demonstrated.

Results from this study were similar to a prior clinical trial that assessed Lenvima in patients with HCC, although it excluded patients who underwent a liver transplantation, a patient subset often withheld from clinical trials.

“(Lenvima) is approved for the use in patients with metastatic or recurrent hepatocellular carcinoma,” Dr. Kyunghye Bang, of the Department of Oncology at Asan Medical Center at the University of Uslan College of Medicine in Seoul, Korea, said during a presentation of the data at 2022 ASCO Gastrointestinal Cancers Symposium. “However, its clinical outcomes in patients experiencing HCC recurrence after liver transplantation remain unclear.”

Bang added, “Despite immunotherapeutic advances (Tecentriq plus bevacizumab, Keytruda and Opdivo) in the management of advanced HCC, patients with prior (liver transplantation) are not benefitted because of the risk of allograft (transplant of an organ from one patient to another who’s not an identical twin) rejection, and they are also excluded in most prospective clinical trials for novel agents.”

In this current study, treatment with Lenvima demonstrated an objective response rate (percentage of patients with a partial or complete response to treatment) of 13.6%. The median progression-free survival (length of time after treatment when a patient lives with cancer without disease worsening) was 6.6 months during a median follow-up of 5.2 months. Also, during follow-up, overall survival (the time that patients diagnosed with cancer are still alive) was 14.5 months. The six-month overall survival rate was 88.8%, and the six-month progression-free survival rate was 59.8%.

ALBI grade may be a predictor of overall survival, as patients with ALBI grade 2 had significantly poorer overall survival compared with those with ALBI grade 1 (11.1 months versus 14.5 months). Side effects that occurred with Lenvima included low platelet numbers in the blood (31.8%), high blood pressure (36.4%) and fatigue (27.3%).

In particular, researchers assessed the impact of Lenvima in 22 patients with recurrent HCC after liver transplantation who were treated in South Korea. Several factors of interest included a response to Lenvima, and side effects associated with the treatment.

Patients in the study had a median age of 58 years and 95.5% were men. The most common cause of HCC in patients was hepatitis B (81.8%). Recurrence after liver transplantation occurred at a median of 6.6 months. Before treatment with systemic therapy, the most used therapy for recurrent HCC after a liver transplant was trans-arterial embolization (54.5%), which is a procedure when blood supply to a tumor is blocked.

Most patients at the time of Lenvima initiation were Child-Pugh A (95.5%), meaning that patients did not have symptoms of liver disease. In addition, 68.2% of patients were classified as serum albumin and bilirubin (ALBI) grade 1 (lowest mortality risk) and 31.8% were classified as ALBI grade 2 (intermediate mortality risk). All patients in this study were at Barcelona Clinic Liver Cancer (BCLC) stage C, advanced-stage cancer. In addition, Lenvima was administered as either a first-line therapy in 19 patients or second-line therapy in three patients.

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