BACKGROUND: In the United States (U.S.), lenvatinib monotherapy was approved in August 2018 for the first-line treatment of patients with unresectable hepatocellular carcinoma (uHCC) based on pivotal trial, REFLECT. However, real-world data are essential to assess if this efficacy translates into effectiveness when implemented into clinical practice. The main objective of our real-world data (RWD) study was to assess clinical characteristics and effectiveness of lenvatinib among patients treated in the U.S. clinical practices.
METHODS: A retrospective patient chart review study was conducted among adult patients (≥18 years) in the U.S. initiating lenvatinib monotherapy as first-line (1L) systemic therapy for uHCC between Aug 2018 and Sept 2019 and with ECOG status of 0 or 1. Data were extracted from individual patients’ electronic health records and captured in electronic case report forms. Clinical outcomes assessed included provider-reported real world best response, progression-free survival (PFS) and overall survival (OS). PFS and OS were estimated using Kaplan-Meier methods. For PFS, patients were censored at end of lenvatinib treatment or end of follow-up in case of ongoing treatment, while censoring occurred at end of follow-up for OS.
RESULTS: Among 233 patients treated with 1L lenvatinib monotherapy, median age was 63 years, majority were male (68%), and most were Caucasian (52%) or African American (25%). Median body weight was 76 kg168 pounds . The most common etiologies of liver disease were hepatitis C (36%), alcohol-related liver disease (28%), hepatitis B (16%) and non-alcoholic steatohepatitis (14%). Most patients had compensated cirrhosis at Lenvatinib initiation, with 5149% Child Pugh A and 413% Child Pugh B. All patients had unresectable HCC, with most having Barcelona Clinic Liver Cancer stage B (29%) or C (44%) disease. Portal vein invasion was reported in 19%, of whom7% had main portal vein involvement. The median starting dose of lenvatinib was 12 mg daily. Over a median follow-up period of 9 months from HCC diagnosis, median PFS and OS were not reached. Landmark PFS at 6 and 12 months was 85% and 65%, respectively. Landmark OS at 6 and 12 months was 92% and 73%, respectively. The provider-reported best response was complete response in 21%, partial response in 44% and stable disease in 26%. At the end of follow-up, average duration of lenvatinib treatment was 7.4 months (median: 6.7 months) with 61% of patients remaining on lenvatinib. Second line treatment was initiated in 32 patients, with the most common therapies being immunotherapy (44%), sorafenib (31%) and regorafenib (916%). Median time to 2nd line treatment from initiation of lenvatinib was approximately 8 months.
CONCLUSION: Results from this retrospective real-world study in the U.S. population demonstrate the clinical effectiveness of 1L lenvatinib monotherapy among patients with uHCC.
