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Purpose Regorafenib, an oral multi-targeted tyrosine kinase inhibitor, is considered the new standardof care in patients with chemotherapy-refractory colorectal cancers (CRCs). However, thereare no data on this drug in Korean patients. Materials and MethodsWe evaluated patients who received oral regorafenib 160 mg once daily during the first 3weeks of each 4-week cycle between August 2013 and September 2013. All patients hadpreviously progressed fluorouracil, irinotecan, and oxaliplatin with or without biologic agentssuch as cetuximab or bevacizumab. ResultsThirty-two patients were enrolled (median age, 57 years; male:female ratio, 20:12; EasternCooperative Oncology Group performance status [0-1:2], 31:1; colon:rectum, 21:11). Theoverall response rate was 3.1% and the disease control rate was 50.0% (95% confidenceinterval [CI]) with one partial response and 15 patients with stable disease. The medianprogression-free survival was 4.2 months (95% CI, 3.1 to 5.2 months) and the medianoverall survival has not yet been reached. The most common adverse events of grade twoor higher related to regorafenib were hand-foot skin reaction (25%), mucositis (19%),abdominal pain (9%), and liver function test (LFT) abnormalities (9%). Grade 3 or 4 toxicitiesincluded LFT abnormalities (9%), abdominal pain (9%), rash (6%), anemia (3%), leukopenia(3%), neutropenic fever (3%), and fatigue (3%). There was no treatment-related death. ConclusionRegorafenib appears to have promising activity and tolerable toxicity profiles in Koreanpatients with refractory CRC, consistent with the CORRECT trial findings.

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