Abstract 198P
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.
Resources from the same session
101P - The coexistence of TP53 gain-of-function mutation and hypermethylation as a poor prognostic factor in BRAF wild-type metastatic colorectal cancer
Presenter: Kota Ouchi
Session: Poster Display
Resources:
Abstract
102P - Enhancing colorectal cancer prevention in high-risk populations through faecal immunochemical test surveillance
Presenter: Li Xie
Session: Poster Display
Resources:
Abstract
103P - Anlotinib plus chemotherapy as first-line therapy for gastrointestinal tumor patients with unresectable liver metastasis: Updated results from a multi-cohort, multi-center phase II trial ALTER-G-001-cohort A
Presenter: Junwei Wu
Session: Poster Display
Resources:
Abstract
104P - The value of functional MR-imaging signature model for early prediction of chemotherapy response and its guidance for regimen adjustment to improve efficacy
Presenter: Wenhua Li
Session: Poster Display
Resources:
Abstract
105P - A single-arm, phase II, multicenter study of iparomlimab (QL1604) in patients (pts) with unresectable/metastatic deficient mismatch repair (dMMR)/microsatellite instability high (MSI-H) solid tumors
Presenter: Weijian Guo
Session: Poster Display
Resources:
Abstract
106P - Efficacy and safety of IBI351 (GFH925) monotherapy in metastatic colorectal cancer harboring KRASG12C mutation: Updated results from a pooled analysis of two phase I studies
Presenter: Ying Yuan
Session: Poster Display
Resources:
Abstract
107P - Tumor-stromal ratio in a new age fibroblast activated protein PET imaging as a biomarker for prediction of response to neoadjuvant chemoradiotherapy in carcinoma rectum
Presenter: swetha Suresh
Session: Poster Display
Resources:
Abstract
108P - Detection of HER2 overexpression in colorectal cancer: Comparison of a HANDLE classic NGS panel with standard IHC/FISH
Presenter: Lijuan Luan
Session: Poster Display
Resources:
Abstract
109P - Early onset metastatic colorectal cancer: Clinical-prognostic characteristics and correlation to molecular status
Presenter: Andrea Pretta
Session: Poster Display
Resources:
Abstract
110P - The correlation between multi-dimensional characteristics of circulating tumor cells (CTC) and treatment response in patients with initially unresectable metastatic colorectal cancer
Presenter: Yu Liu
Session: Poster Display
Resources:
Abstract