Regorafenib as Salvage Treatment in Korean Patients with Refractory Metastatic Colorectal Cancer.
- Author:
Seung Tae KIM
1
;
Tae Won KIM
;
Kyu Pyo KIM
;
Tae You KIM
;
Sae Won HAN
;
Ji Yun LEE
;
Sung Hee LIM
;
Min Young LEE
;
Haesu KIM
;
Young Suk PARK
Author Information
- Publication Type:Original Article
- Keywords: Regorafenib; Korea; Colorectal neoplasms
- MeSH: Abdominal Pain; Anemia; Biological Factors; Colorectal Neoplasms*; Disease-Free Survival; Exanthema; Fatigue; Fever; Fluorouracil; Humans; Korea; Leukopenia; Liver Function Tests; Mucositis; Protein-Tyrosine Kinases; Skin; Standard of Care
- From:Cancer Research and Treatment 2015;47(4):790-795
- CountryRepublic of Korea
- Language:English
- Abstract: PURPOSE: Regorafenib, an oral multi-targeted tyrosine kinase 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 during 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, 21:11). The overall response rate was 3.1% and the disease control rate was 50.0% (95% confidence interval [CI]) with one partial response and 15 patients with stable disease. The median progression-free survival was 4.2 months (95% CI, 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 LFT 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.
