Effectiveness of Topical Steroid Therapy for Prevention of Regorafenib associatedHand-foot Skin Reaction

Introduction: Hand-foot Skin Reaction (HFSR) often hinders completion of Regorafenib therapy. No established prophylaxis exists against multikinase inhibitor-associated HFSR and further improvement of prophylaxis for HFSR is needed. Therefore, we offer multiagent therapy to prevent Regorafenib-associated HFSR comprising topical steroid (0.05% difluprednate) ointment and 20% urea-based cream. Methods: Subjects were unresectable or recurrent colorectal cancer patients who started Regorafenib therapy between May 2013 and March 2014 at the Shizuoka Cancer Center. Electronic medical records were retrospectively examined for HFSR incidence, CTCAE v3.0 grade of severest HFSR, time of HFSR onset, rate of therapy termination, delay and dose reduction. Results: Subjects were 55 patients and median treatment time 7.1 weeks. Overall and grade 3 HFSR incidence rate in this study (73 and 22%, respectively) was lower than in the CORRECT study Japanese subpopulation (80 and 28%, respectively). HFSR (grade ≥ 2) occurred in the first cycle or later in 42 and 11% of patients, respectively. HFSR accounted for 33 and 61% of first-cycle Regorafenib delay and dose reductions, respectively, and HFSR accounted for 40 and 53% in any cycle, respectively. Conclusion: Effectiveness of prophylactic topical steroids against Regorafenib-associated HFSR was shown in this study. Therefore, this prophylaxis is applicable in clinical settings.