{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T04:36:07Z","timestamp":1787027767257,"version":"build-2736575974"},"reference-count":32,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2025,2,1]],"date-time":"2025-02-01T00:00:00Z","timestamp":1738368000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Eisai Co., Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background\/objectives: The real-world survival of patients with unresectable hepatocellular carcinoma (uHCC) treated with lenvatinib has been explored retrospectively with a small sample size. We conducted a prospective observational 2-year extension study (510 study) of a 1-year observational post-marketing study of lenvatinib (504 study) to evaluate the long-term overall survival (OS) of patients with uHCC treated with lenvatinib and associated factors with a large sample size. Methods: Patients with uHCC included (July 2018 to January 2019) in the 504 study and who consented were eligible for the 510 study and were followed for up to 3 years after lenvatinib treatment initiation. Using the data from the 504 study and 510 study of the 504 study analysis set, we estimated the OS, the time from the first lenvatinib dose to all-cause death by the Kaplan\u2013Meier method (ClinicalTrials.Gov Registration ID, 504 study: NCT03663114; 510 study: NCT04008082). Results: The 703 patients included in the analysis were followed for a median period (min, max) of 12.5 months (0.1, 44.8). The median OS (95% confidence interval) was 16.6 months (15.4, 18.5). OS was significantly (p &lt; 0.05) associated with bile duct invasion (hazard ratio [HR]: 1.621), portal vein invasion (HR: 1.365), \u2265 4 intrahepatic lesions (HR: 1.437), extrahepatic lesions (HR: 1.357), Child\u2013Pugh B\/C (HR: 1.515), mALBI Grade 2a (HR: 1.331), and Grade \u2265 2b (HR: 1.811). Conclusions: This large-scale, prospective, real-world study demonstrated a long OS, comparable to that reported in the global Phase III REFLECT trial. More advanced-stage tumors and worse hepatic function have been suggested as OS-associated factors, consistent with previous reports.<\/jats:p>","DOI":"10.3390\/cancers17030479","type":"journal-article","created":{"date-parts":[[2025,2,3]],"date-time":"2025-02-03T09:35:07Z","timestamp":1738575307000},"page":"479","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Long-Term Survival of Patients with Unresectable Hepatocellular Carcinoma Treated with Lenvatinib in Real-World Clinical Practice"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0663-6117","authenticated-orcid":false,"given":"Junji","family":"Furuse","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Kanagawa Cancer Center, Yokohama 241-8515, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Namiki","family":"Izumi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Musashino 180-8610, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7515-099X","authenticated-orcid":false,"given":"Kenta","family":"Motomura","sequence":"additional","affiliation":[{"name":"Department of Hepatology, Aso Iizuka Hospital, Iizuka 820-8505, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0850-6327","authenticated-orcid":false,"given":"Yoshitaka","family":"Inaba","sequence":"additional","affiliation":[{"name":"Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshio","family":"Katamura","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Onomichi General Hospital, Onomichi 722-8508, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5935-4346","authenticated-orcid":false,"given":"Yasuteru","family":"Kondo","sequence":"additional","affiliation":[{"name":"Department of Hepatology, Sendai Tokushukai Hospital, Sendai 981-3116, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhisa","family":"Yabushita","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Fukuyama City Hospital, Fukuyama 721-8511, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3583-2993","authenticated-orcid":false,"given":"Toshiyuki","family":"Matsuoka","sequence":"additional","affiliation":[{"name":"Eisai Co., Ltd., Bunkyo-ku 112-8088, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuaki","family":"Motoyoshi","sequence":"additional","affiliation":[{"name":"Eisai Co., Ltd., Bunkyo-ku 112-8088, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4102-3474","authenticated-orcid":false,"given":"Masatoshi","family":"Kudo","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama 589-8511, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,2,1]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization, and International Agency for Research on Cancer (2024, March 07). 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