O2-5-3 - Safety and Efficacy of Regorafenib in National Cancer Center Hospital East (Ncche)

Abstract

Background: Regorafenib is an oral multi-kinase inhibitor that has recently demonstrated significant overall survival benefit vs placebo in CORRECT study. Since the number of Japanese patients enrolled for CORRECT study is limited, there is not enough information regarding tolerability and efficacy of regorafenib in Japan.Patients and methods: We retrospectively analyzed 62 patients with mCRC who received regorafenib in NCCHE between May 2013 and November 2013.Weekly monitoring for toxicities was performed during first cycle in almost all cases.Result: Among the 62 patients, number of prior line of chemotherapy was 2 in 34% of patients and 3 or more in 66% of patients. Fifty-four patients (87%) were initiated with 160 mg of regorafenib and other 8 patients were started with reduced dose (120 mg).Common grade >3 AEs (>5%) were hand-foot skin reaction (HFSR, 27.4%), hypertension (11.3%), and proteinuria (9.6%), which is compatible to those of Japanese subset of CORRECT study (27.7%, 10.8%, 6.2%, respectively). In contrast, the frequencies of grade >3 AST and ALT elevations were lower in our cohort (3.2 and 4.8%) than those of Japanese patients of CORRECT study (18.7 and 13.8%, respectively). Treatment discontinuation due to drug related AEs in our cohort was also relatively lower than that of Japanese subset of CORRECT study (7.8 vs. 13.8%). Dose reduction or interruption of regorafenib was required in 59.6% and 88.7% of patients, with more than half of these events occurred in the first visit (32 patients, 51.6%). The disease control rate and median PFS of our patients cohort was 38% and 61 days, respectively, which were also compatible to those of Japanese subset in the CORRECT trial (40% and 57 days, respectively).Conclusion: The safety and efficacy profile in NCCHE were similar to those of the Japanese subpopulation in the CORRECT trial. Weekly monitoring with early dose modification might be important to decrease treatment discontinuation with AEs.