397PBenefits of prophylactic use of personalized insoles for patients treated with regorafenib

Abstract Background: Regorafenib is an oral multi-kinase inhibitor that was approved for treatment of colorectal cancer in Japan in 2013. It has characteristic side effects of skin damage, especially of hands and feet, which can lead to suspension of treatment. We had one patient who suffered from severe foot damage and we managed to relieve her symptoms using personalized insoles. These insoles allowed us to continue her Regorafenib treatment for over six months without foot damage. Based on this case, we started a study to evaluate the benefits of prophylactic use of personalized insoles. Aim: To evaluate the benefits of prophylactic use of personalized insoles for patients treated with Regorafenib. Method: We prepared personalized insoles before the start of the treatment. The quality of fit of the insoles was evaluated and adjusted by baropodometry; a system for measurement of plantar pressure. The insoles were to be worn all the time, outside as well as at home. Foot damage in all patients who could complete more than 1 course of Regorafenib treatment was evaluated using the CTCAE v4.0 scale. Results: Since Nov. 2013, 10 patients with metastatic colorectal cancer participated in this study. 2 patients stopped Regorafenib during the 1st course due to intolerable toxicities other than foot damage. Foot damage was evaluated in the 8 remaining Patients: all could walk normally during the whole treatment and none had foot damage CTCAE grade 2 or higher. Conclusion: Personalized insoles could prevent foot damage by Regorafenib and could increase its compliance and so also the efficacy of treatment.