A randomized multicenter phase II trial on efficacy of high-slip skin care pad for hand-foot skin reaction caused by sorafenib in patients with renal cell carcinoma.

Abstract

TPS233 Background: Hand-foot skin reaction (HFSR) is the most clinically significant dermatologic toxicity in patients (pts) with metastatic renal cell carcinoma (mRCC) who receive sorafenib. HFSR was found to occur in 72 of 131 Japanese pts (Akaza et al, JJCO, 2007). Since HFSR is reported to be associated with significant tenderness affecting function and quality of life (especially difficulty in walking), prevention and management of HFSR would be mandatory. Although treatment with topical urea cream is frequently performed, the control of pain is not completely established. HFSR may be attributed to keratinous disorders of the skin and tends to develop in particular in areas on the soles of the feet subject for strong pressure. Since high-slip skin care pad (Remois pad) is a protective dressing on pressure ulcer to reduce surface pressure and to result in the prevention of skin damage, the characteristics of this material may prevent the development and worsening of HFSR. The purpose of the study is to investigate the usefulness of a high-slip skin care pad for HFSR on the soles. Methods: This randomized, prospective, open-label trial intends to enroll 100 pts with mRCC who received 400 mg bid of sorafenib. Eligibility criteria include pts with confirmed RCC, within 8 weeks after the initiation of sorafenib treatment, with ECOG-PS 0 or 1, and with grade 1 HFSR on their sole. Exclusion criteria are pts who had previously treated with other molecular targeted drugs, with a systemic dermatological disease, or with > grade 3 adverse events other than HFSR. Pts are randomized into two groups: high-slip skin care pad group versus 10% urea cream group. High slip skin care pad is recommended to change every 2-3 days, and 10% urea cream is ordered to apply and rub to affected sites 2 or 3 times per day. Their subsequent progress will be monitored every 2 weeks by 4 weeks after the initiation of these supportive therapy. Primary endpoint is incidence of Grade 2 or 3 HFSR during these supportive therapy. Secondary endpoints are treatment compliance (dose reduction/discontinuation of sorafenib), pain assessment (visual analogue scale), and safety. Currently 19 pts have enrolled.