439P - Randomized controlled trial evaluating efficacy of topical urea-based cream for capecitabine-associated hand-foot syndrome prevention

Background

Hand-foot syndrome (HFS) is one of the most common adverse events of capecitabine leading to treatment interruption or delay which may result in unfavorable oncologic outcomes. Topical urea cream could reduce degree of sorafenib induced hand-foot skin reaction. Although urea cream could not prevent HFS during early capecitabine use, the long-term results of urea cream for HFS prevention is limited. The aim of this study is to evaluate the efficacy of urea cream as a prophylaxis of HFS throughout the period of capecitabine use.

Methods

Cancer patients who received capecitabine at the dosage of at least 2,000 mg/m2/day for 14 days of the treatment cycle were randomized 1:1 to receive standard measures (avoid trauma of hands/feet and keep moisture) or urea-based cream (apply to hand/foot twice daily with standard measures) for HFS prevention. Incidence and severity of HFS were assessed by physician and by patient’s self-report at day 1 of every capecitabine cycle until 4-week following capecitabine discontinuation. Primary endpoint was proportion of patients who developed any grade HFS. Secondary endpoints include proportion of severe (> grade 3) HFS, modifications of capecitabine due to HFS and HFS onset.

Results

At median capecitabine cycle of 6, 68 out of 109 patients (62.4%) with standard measures and 60 out of 107 patients (56%) with urea cream reported any grade HFS (p=0.36). Grade 3 HFS was found in 52 (47.7%) and 44 patients (41.1%) receiving standard measures and urea cream, respectively (p=0.34). Capecitabine modification due to HFS was required in 20 patients (18.3%) with standard measures and 17 patients (15.9%) receiving urea cream prophylaxis (p=0.89). HFS resulting in capecitabine discontinuation rate and HFS onset were similar between two groups.

Conclusions

Urea-based cream could not prevent occurrence of capecitabine associated HFS, lessen HFS severity or reduce capecitabine modification as well as delay HFS onset. Topical urea cream as a HFS prophylactic measure is not routinely recommended for all patients receiving capecitabine.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

S. Ithimakin.

Funding

Siriraj hospital.

Disclosure

All authors have declared no conflicts of interest.