Kang, W Kim, YJ Kim, SU Seo, YS Kim, JW Kim, JH Park, SY Baek, YH Kim, KM Lee, HL Yoon, KT Kim, H Cheong, JY Hwang, JS Kim, JH Kim, KM Sung, PS Kim, J Kim, DY 2024-12-26T06:01:46Z 2024-12-26T06:01:46Z 2024 1479-6694 http://repository.ajou.ac.kr/handle/201003/33534 Aim: This post-marketing surveillance study evaluated the safety and effectiveness of lenvatinib as first-line treatment for unresectable hepatocellular carcinoma in Korea. Materials & methods: Adverse drug reactions (ADRs) and other safety and effectiveness end points were assessed in patients who initiated lenvatinib according to the approved label in republic of Korea. Results: Among 658 lenvatinib-treated patients, ADRs were reported in 57.8%; ADRs grade ≥3 in 13.5%. The most common grade ≥3 ADRs were asthenia (1.2%) and hepatic encephalopathy (1.2%). Physician-reported tumor responses (n = 511) were complete (1.0%) or partial (12.9%) response and stable (45.2%) or progressive disease (40.9%); objective response rates were higher with longer lenvatinib treatment duration (p < 0.001). Conclusion: Lenvatinib was generally well tolerated and effective in real-world clinical practice in Korea. Clinical trial registration:ClinicalTrials.govNCT05225207. en Adult Aged Aged, 80 and over Antineoplastic Agents Carcinoma, Hepatocellular Female Humans Liver Neoplasms Male Middle Aged Phenylurea Compounds Product Surveillance, Postmarketing Protein Kinase Inhibitors Quinolines Republic of Korea Treatment Outcome Real-world safety and effectiveness of lenvatinib in unresectable hepatocellular carcinoma in Korea: post-marketing study Article 39320906 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11572195 effectiveness hepatocellular carcinoma Korean population lenvatinib real-world practice REFLECT trial safety Cheong, JY Journal Papers 10.1080/14796694.2024.2397328 Future oncology (London, England) 20 37 2024 2949 2959 Future oncology (London, England), 20(37). : 2949-2959, 2024 1744-8301 J014796694