Single Center Real Life Experience with Regorafenib in Patients with Metastatic Colorectal Cancer

Abstract

Objective: To evaluate the clinical benefit of regorafenib in routine clinical practice. Material and Methods: We retrospectively evaluated the data of 45 metastatic colorectal cancer (mCRC) patients who received regorafenib between January 2016 and November 2018. Results: The median age of all patients was 54 years, and 66.7% of the patients were male. Performance status of 20 patients (44.4%) was 2, whereas in 25 patients (55.6%) it was 0-1. Thirty-six patients (80%) were performed primary tumor resection and KRAS mutation was detected in 53.3% of patients. Regorafenib was started at a dose of 160 mg in all patients, and a dose reduction was observed in 28.9% of patients. Line of regorafenib treatment was 3 rd in 66.7% of patients, whereas in 33.3% of patients it was ≥ 4 th. Best response was progressive disease (46.7%) and stable disease (35.6%). The median progression free survival (PFS) was 3.1 months (95% CI: 2.2-4.0) and overall survival (OS) was 6.4 months (95% CI: 3.2-9.5). Primary tumor resection status and using regorafenib ≥ 4 treatment line were significantly associated with both PFS and OS in multivariate analysis. Conclusion: Regorafenib was associated with survival durations similar to those reported in both randomized controlled trials and in the real-life setting, and was generally well tolerated. Patients who had primary tumor resected and using regorafenib as the ≥ 4 th treatment line (primary resected vs nonresected: PFS: 3.8 vs. 1.6 months, p: 0.006; OS: 6.1 vs. 3.1 months, p: 0.018, 3 rd vs. 4 th or more: PFS: 2.7 vs. 4.6 months, p:0.001; OS: 3.8 vs. 11.4 months, p:0.001) were associated with better PFS and OS. However, in order to explain the better survival with regorafenib in patients with primary tumor resected, this information must be confirmed with further studies.