Treatment Outcomes of Metastatic Colorectal Cancer Patients Treated with Regorafenib as Third-Line Setting-A Multicenter Study.

Introduction: The clinical benefit of regorafenib therapy in metastatic colorectal cancer (mCRC) patients, who were previously treated with 5-fluorouracil (5-FU), irinotecan, or oxaliplatine based regimens with or without a biologic agent such as vascular endothelial growth factor (anti-VEGF) or anti epidermal growth factor receptor (anti-EGFR), has been shown in several previous phase III studies. In this study, we aimed to analyze the efficacy and toxicity profile of regorafenib in patients with mCRC. Methods: This was a retrospective study of 23 mCRC patients from two different centers in Turkey. All patients were treated with regorafenib as third line setting after failure of two standard consecutive therapies including 5-FU, irinotecan, or oxaliplatine with or without anti-VEGF or anti-EGFR agent. Treatment outcomes along with drug efficacy and safety were analyzed retrospectively. Results: Of the 23 patients, 13 were male (56.5%). Median age was 62 (35-76) years. The rates of RAS wild-type and RAS-mutated tumor were 43.5% and 56.5%, respectively. Eighteen patients (78.2%) received bevacizumab as first-line setting, whereas only five patients (28.8%) were given a prior anti-EGFR agent. Among the 23 patients, only one patient (4.3%) had a partial response. Median progression-free survival was 3.02 (2.6-3.37) months and median overall survival was 6.4 (2.6-10.1) months. There was no prognostic factor associated with survival. Grade 3-4 toxicities were observed in 30.4% of the patients, with hand-foot skin reaction being the most frequent adverse event (42.8%). Conclusion: Although clinical and survival benefits of regorafenib have been demonstrated in previous studies, this advantage seems to be questionable in our study, with a significant toxicity profile making its use challenging. A treatment decision should be made considering the risk of mortality and toxicity profile. [ABSTRACT FROM AUTHOR]