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We aimed to assess the efficacy and tolerability of regorafenib and the predictors of treatment outcomes in Taiwanese patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We analyzed the survival, best overall response, predictors of treatment outcomes, and safety for uHCC patients who had tumor progression on sorafenib therapy and received regorafenib as salvage therapy between March 2018 and November 2020.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Eighty\u2010six patients with uHCC were enrolled (median age, 66.5\u00a0years; 76.7% male). The median regorafenib treatment duration was 4.0\u00a0months (95% confidence interval [CI], 3.6\u20134.6). The most frequently reported adverse events were hand\u2010foot skin reaction (44.2%), diarrhea (36.0%), and fatigue (29.1%). No unpredictable toxicity was observed during treatment. The median overall survival (OS) with regorafenib was 12.4\u00a0months (95% CI, 7.8\u201317.0) and the median progression\u2010free survival (PFS) was 4.2\u00a0months (95% CI, 3.7\u20134.7). Of 82 patients with regorafenib responses assessable, 4 patients (4.9%) achieved a partial response, and 33 (40.2%) had stable disease, leading to a disease control rate (DCR) of 45.1% (<jats:italic>n<\/jats:italic>\u00a0=\u00a037). Patients possessing baseline AFP\u00a0&lt;\u00a0400\u00a0ng\/ml exhibited a markedly longer median OS, median PFS, and higher DCR compared with their counterparts (15.7 vs. 8.1\u00a0months, 4.6 vs. 3.7\u00a0months, 60.9% vs. 27.5%, respectively). Despite possessing high baseline AFP levels, patients with early AFP response (&gt;10% reduction at 4\u00a0weeks or &gt;20% reduction at 8\u00a0weeks after regorafenib administration) exhibited comparable treatment outcomes to those with baseline AFP\u00a0&lt;\u00a0400\u00a0ng\/ml.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The results of this real\u2010world study verified the tolerability and efficacy of regorafenib treatment for uHCC patients who failed prior sorafenib therapy, especially for those with lower baseline AFP levels or with early AFP response.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.4430","type":"journal-article","created":{"date-parts":[[2021,11,17]],"date-time":"2021-11-17T07:59:22Z","timestamp":1637135962000},"page":"104-116","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Regorafenib for Taiwanese patients with unresectable hepatocellular carcinoma after sorafenib failure: Impact of alpha\u2010fetoprotein levels"],"prefix":"10.1002","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5443-7203","authenticated-orcid":false,"given":"Po\u2010Yao","family":"Hsu","sequence":"first","affiliation":[{"name":"Graduate Institute of Clinical Medicine College of Medicine Kaohsiung Medical University  Kaohsiung Taiwan"},{"name":"Hepatobiliary Division Department of Internal Medicine Kaohsiung Medical University Hospital Kaohsiung Medical University  Kaohsiung Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tzu\u2010Sheng","family":"Cheng","sequence":"additional","affiliation":[{"name":"Hepatobiliary Division Department of Internal Medicine Kaohsiung Medical University Hospital Kaohsiung Medical University  Kaohsiung Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shih\u2010Chang","family":"Chuang","sequence":"additional","affiliation":[{"name":"Department of Surgery Kaohsiung Medical 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