Regorafenib as Salvage Treatment in Korean Patients with Refractory Metastatic Colorectal Cancer

Abstract

Purpose Regorafenib, an oral multi-targeted tyrosine k nase inhibitor, is considered the new standard of care in patients with chemotherapy-refractory colorectal cancers (CRCs). However, there are no data on this drug in Korean patients. Materials and Methods We evaluated patients who received oral regorafenib 160 mg once daily du ing the first 3 weeks of each 4-week cycle between August 2013 and September 2013. All patients had previously progressed fluorouracil, irinotecan, and oxaliplatin with or without biologic agents such as cetuximab or bevacizumab. Results Thirty-two patients were enrolled (median age, 57 years; male female ratio, 20:12; Eastern Cooperative Oncology Group performance status [0-1:2], 31:1; colon rectum, 2111). The overall response rate was 3.1% and the disease control rate was 50.0% (95% confidence interval [Cl]) with one partial response and 15 patients with stable disease. The median progression-free survival was 4.2 months (95% Cl, 3.1 to 5.2 months) and the median overall survival has not yet been reached. The most common adverse events of grade two or 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 toxicities included LET abnormalities (9%), abdominal pain (9%), rash (6%), anemia (3%), leukopenia (3%), neutropenic fever (3%), and fatigue (3%). There was no treatment-related death. Conclusion Regorafenib appears to have promising activity and tolerable toxicity profiles in Korean patients with refractory CRC, consistent with the CORRECT trial findings.