198P - Effectiveness of lenvatinib in patients with unresectable hepatocellular carcinoma: A multicenter observational study in Japan

Background

Lenvatinib is oral tyrosine kinase inhibitor (TKI) that has been available for treatment of unresectable hepatocellular carcinoma (uHCC) in Japan since March 2018. We conducted a multicenter prospective observational study to assess overall survival (OS) of lenvatinib treatment in real world practice.

Methods

This study enrolled patients initially receiving lenvatinib for uHCC as systemic therapy who gave informed consent from July 2018 through January 2019. Observation period for each patient was up to 3 years. Kaplan-Meier method was used to estimate OS, and Cox regression analysis was used to explore factors which were associated with OS. The factors were selected with p value <0.05.

Results

A total of 713 patients were registered at 137 clinical sites, and the effectiveness analysis set were 703 patients. Patient background characteristics in 703 patients included median age:73.0 years (25 to 94), male/female: 564/139, weight: <60/≥60 kg :323/380 ,HBV/HCV/alcohol/NAFLD or NASH :137/287/167/88, modified ALBI grade 1/2a/2b/3 :216/199/258/18, BCLC stage A/B/C/D :57/291/332/11, Vp 0/1/2/3/4 :520/31/52/60/22, with/without extrahepatic metastasis :229/450, AFP level <200/≥200 ng/mL :432/240. Treatment history for uHCC was with/without transcatheter arterial chemoembolization (TACE): 513/190, median number of TACE: 3.0 times (1 to 26), with/without TKI pretreatment: 131/572. The initial dose of lenvatinib were labeled dose in 80.5% of patients <60 kg (8 mg) and 68.2% of patients ≥60 kg (12 mg), respectively. The median (range) duration of treatment with lenvatinib was 186.0 days (2-1,099 days). The median OS (95% CI) was 1.38 years (1.29-1.54 years) and the number of deaths was 445 patients. As a result of multivariate analysis, low ECOG-PS, low modified ALBI grade, low AFP level, small number of intrahepatic lesions, no bile duct involvement, no portal vein involvement and no extrahepatic involvement at baseline were associated with longer median OS.

Conclusions

This analysis showed that the effectiveness of lenvatinib in real world practice were consistent with previous reports.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Eisai Co., Ltd.

Funding

Eisai Co., Ltd.

Disclosure

N. Izumi: Financial Interests, Personal, Speaker, Consultant, Advisor: Eisai, Chugai, Takeda, Lily. K. Motoyoshi: Financial Interests, Personal, Full or part-time Employment: eisai. J. Furuse: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, Bayer, Eisai, Eli Lilly Japan, MSD, Yakult Honsha, Chugai Pharma, Novartis Pharma, AstraZeneca, Pfizer, Takeda, Taiho Pharmaceutical, Sannofy, Mylan EPD, EA Pharma, Kyowa Hakko Kirin, Daiichi Sankyo, Teijin pharma, Servier Japan, Incy; Financial Interests, Personal, Advisory Board: Fuji film, Mudi Pharma, Onco Therapy Science, Merck Bio, Ono Pharmaceutical, MSD, Taiho Pharmaceutical, Chugai Pharma, Astellas, AstraZeneca, Takara bio, Delta-Fly-Pharma, Incyte Japan; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical, MSD, Merck Bio, J-Pharma, Taiho Pharmaceutical, Takeda, Chugai Pharma, AstraZeneca, Yakult Honsha, Eisai, Daiichi Sankyo, Mochida, Sanofy, Sumitomo Dainippon Bayer, Astellas, Incyte Japan; Financial Interests, Personal, Steering Committee Member: Merck Bio, Ono Pharmaceutical, MSD, Taiho Pharmaceutical, Astellas, AstraZeneca, Incyte Japan. All other authors have declared no conflicts of interest.