First-line lenvatinib monotherapy is effective for unresectable hepatocellular carcinoma (HCC) in US clinical practice, according to results from a real-world study presented at the virtual 2021 ASCO Gastrointestinal Cancers Symposium.
“In the [US] lenvatinib monotherapy was approved in August 2018 for first-line treatment of patients with unresectable [HCC] based on the pivotal trial, REFLECT,” wrote Amit G Singal, MD, University of Texas Southwestern, Dallas, and colleagues.
“Real-world data are essential to assess if this efficacy translates into effectiveness in clinical practice,” they continued.
This study aimed to assess real-world clinical characteristics and effectiveness of lenvatinib among patients with HCC treated in US clinical practices.
Data from individual patients’ electronic health records were pulled and compiled into electronic case report forms. Provider-reported best response, progression-free survival. (PFS) and overall survival (OS) were assessed.
A total of 233 patients initiating lenvatinib monotherapy for unresectable HCC between August 2018 and September 2019 were included in the study.
The most common liver disease etiologies were hepatitis C (36%), alcohol-related liver disease (28%), hepatitis B (16%) and non-alcoholic steatohepatitis (14%). The majority of patients had compensated cirrhosis and Barcelona Clinical Liver Cancer stage B or C disease. Portal vein invasion was reported in 19% of patients, of whom 7% had main portal vein involvement.
The median starting dose of lenvatinib was 12 mg daily. After 9 months follow-up from diagnosis, median PFS and OS were not reached. At 6 months, PFS was 85% and OS was 92%. At 12 months, PFS was 65% and OS was 73%.
Overall, provider-reported best response was complete response (CR; 21%), partial response (PR; 44%), and stable disease (SD; 26%). Per RECIST 1.1 criteria in 125 patients, CR was achieved in 16% of patients, PR in 54%, and SD in 26%. Per mRECIST criteria in 11 patients, CR was achieved in 73% of patients and SD in 18%.
The average duration of treatment with lenvatinib was 7.4 months (median, 6.7 months), with 61% of patients remaining on treatment at the end of follow-up.
A total of 32 patients initiated second-line treatment. The most common second-line treatments were immunotherapy (50%), sorafenib (31%), and regorafenib (9%). Median time to second-line treatment from lenvatinib initiation was roughly 8 months.
“Results from this retrospective real-world study in an US population affirm the clinical effectiveness of [first-line] lenvatinib monotherapy among patients with [unresectable] HCC,” Dr Singal and colleagues concluded.—Janelle Bradley
Singal A, Nagar SP, Hitchen A, et al. Real-world effectiveness of lenvatinib monotherapy among unresectable hepatocellular carcinoma patients treated in United States clinical practices. Presented at: the virtual 2021 ASCO Gastrointestinal Cancers Symposium; January 15-17, 2021. Abstract 273.
