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Effect of urea cream on sorafenib-associated hand-foot skin reaction in patients with hepatocellular carcinoma: A multicenter, randomised, double-blind controlled study

Authors
Lee, Young SunJung, Young KulKim, Ji HoonCho, Sung B.Kim, Do Y.Kim, Moon Y.Kim, Hyung J.Seo, Yeon SeokYoon, Ki T.Hong, Young M.Lee, Jeong-HoonLee, Hyun W.Yim, Hyung JoonJang, Byoung K.Jang, Eun S.Jang, Jae Y.Hwang, Sang Y.
Issue Date
Nov-2020
Publisher
ELSEVIER SCI LTD
Keywords
Hepatocellular; carcinoma; Hand-foot skin reaction; Urea cream
Citation
European Journal of Cancer, v.140, pp.19 - 27
Indexed
SCIE
SCOPUS
Journal Title
European Journal of Cancer
Volume
140
Start Page
19
End Page
27
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/49217
DOI
10.1016/j.ejca.2020.09.012
ISSN
0959-8049
Abstract
Background: Hand-foot skin reaction (HFSR) is the most common adverse event during sorafenib treatment in patients with hepatocellular carcinoma (HCC). In the present study, we aimed to investigate the role of urea cream in the prevention of HFSR or amelioration of HFSR severity. Patients and methods: Patients with HCC were treated with either placebo cream or urea cream for 12 weeks concomitantly with sorafenib treatment. HFSR development, the Hand-Foot Skin Reaction and Quality of Life (HF-QoL) questionnaire score, and adverse events were assessed at 2, 4, 8 and 12 weeks. Results: Of the 288 patients, 247 patients, with 117 patients in the placebo control group and 130 patients in the urea cream group, were analysed. The urea cream group showed a trend towards a lower cumulative incidence of any-grade HFSR (log-rank, P = 0.247) and severe HFSR of grade II or higher (log-rank, P = 0.394) without statistical significance. In the incidence by time point, the incidence of severe HFSR of grade II or higher was significantly lower in the urea cream group than in the placebo control group at 2 weeks (13.8% versus 23.9%, P = 0.042). The urea cream group showed a significantly better HF-QoL questionnaire score than the placebo control group (11.8 versus 19.7, P = 0.014) at 12 weeks. Conclusions: Treatment with urea cream showed a lower incidence of severe sorafenib-induced HFSR at 2 weeks and reduced the tendency of HFSR development in HCC patients. Therefore, treatment with urea cream may be considered for prophylaxis or improvement of HFSR grade in HCC patients treated with sorafenib. (C) 2020 Elsevier Ltd. All rights reserved.
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Yim, Hyung Joon
Ansan Hospital (Department of Gastroenterology and Hepatology, Ansan Hospital)
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