Randomized Controlled Trial of the Prophylactic Effect of Urea-Based Cream on Sorafenib-Associated Hand-Foot Skin Reactions in Patients With Advanced Hepatocellular Carcinoma

Ren, Zheng; Zhu, Kang; Kang, Hai Yan; Lu, Min; Qu, Zeng; Lu, Lixuan; Song, Tongtong; Zhou, Wei; Wang, Hui; Yang, Wei; Wang, Xuan; Yang, Yong; Shi, Le; Bai, Yu; Xiao, Guo; Ye, Sheng Long

doi:10.1200/jco.2013.52.9651

Cited by 123 publications

(121 citation statements)

References 30 publications

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“…Regular use of topical agents is recommended Bellmunt et al 2011]. A large randomized, controlled phase II study (N = 868) of patients with HCC treated with sorafenib demonstrated that prophylaxis with urea-based cream over a 12-week period significantly reduced the incidence of all grades of HFSR compared with best supportive care in patients treated with sorafenib (56% versus 74%; p < 0.0001) Ren et al 2012]. In another study of patients with HCC receiving sorafenib, use of a corticosteroid ointment significantly improved HFSR score, and the need for treatment modifications was reduced [Lu et al 2013].…”

Section: Case Studiesmentioning

confidence: 99%

Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer

Worden

2014

Ther Adv Med Oncol

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Until recently, no truly effective treatment options have existed for patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), a serious disease with poor prognosis. In November 2013, the targeted multikinase inhibitor, sorafenib, was approved for use in these patients based on substantially improved progression-free survival compared with placebo. A number of other targeted agents, including lenvatinib, are being investigated in phase II and phase III trials. With the advent of these new treatment options, practitioners are faced with making important decisions in determining which patients are candidates for systemic treatment and the optimal timing for treatment initiation. Since patients may remain asymptomatic for a protracted period of time, tumor size and growth rate are the primary considerations for making these choices. Proactive management of side effects is also critical in optimizing the effectiveness of treatment. Here we review targeted systemic agents that are either in use or are under investigation for RAI-refractory DTC and provide recommendations on the rationale for initiating systemic treatment and on managing adverse events. Four illustrative case studies are provided.

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Section: Case Studiesmentioning

confidence: 99%

Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer

Worden

2014

Ther Adv Med Oncol

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“…Of 868 patients treated with sorafenib for hepatocellular carcinoma, a reduction was seen in the incidence of all-grade HFSR (56% in treatment arm vs. 73.6% in controls; p < 0.0001), and a 2.5-fold increase in the median time-tofirst onset of HFSR (84 days in the treatment arm vs. 34 days in controls; p < 0.001), with the preventive daily use of ureabased cream (58) . Figures 4 (55) and 5 (38) provide recommendations for the prevention of HFSR and acneiform rash respectively.…”

Section: Managementmentioning

confidence: 99%

Overview and Management of Dermatologic Events Associated with Targeted Therapies for Medullary Thyroid Cancer

Lacouture

Ciccolini

Kloos

et al. 2014

Thyroid

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“…Ren and coworkers confirmed superiority of urea over standard local treatment as prophylaxis of HFSR in 871 patients with hepatocellular carcinoma treated with sorafenib [12]. During the 12 week study period 56.0% of the patients in the urea arm and 73.6% of the patients in the best standard local treatment arm suffered from HFSR of any grade (p<0.001).…”

mentioning

confidence: 93%

Strategies for Prevention and Treatment of Chemotherapy-Induced Hand-Foot- Skin-Reaction (HFSR)

Gencer¹,

Hofheinz²

2016

J Clin Exp Dermatol Res

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DescriptionHand-foot-skin-reaction (HFSR), also known as palmoplantar erythrodysesthesia, is a frequently occurring side effect of many antineoplastic therapies. Interruption, dose reduction or even discontinuation of anti-tumor therapy due to missing strategies in prevention or treatment of HFSR can be the consequence. According to severity grade of HFSR restrictions in activities of daily life can occur, which can lead to an impairment of quality of life (QOL). Especially skin-related QOL, which actually can be assessed by a variety of different questionnaires, often decreases when HFSR occurs, which can be underlined by some lately published investigations. Nardone and coworkers used the skindex-16 questionnaire to measure the skin-related QOL of patients treated with sunitinib and sorafenib. Patients with higher grades of HFSR showed lower results in the symptoms and emotions scores of the skindex-16 [1]. Chan et al. report in a lately published review that CTCAE grading of HFSR seems to correlate well with skin-related QOL, irrespective of the available questionnaires used for assessment [2].Main agents potentially causing HFSR are tyrosine kinase inhibitors such as sorafenib, sunitinib or regorafenib as well as cytostatic agents like pegylated liposomal doxorubicin (PLD), taxanes and pyrimidine analogues (infusional 5-Fluorouracil or capecitabine). The overall incidence rate of HFSR differs from 20% to 60%, depending on trialdesigns and analyzed anti-cancer drugs [3][4][5][6][7][8].The pathomechanism of HFSR actually seems not to be sufficiently explained. Almost 20 years ago the observed skin reaction in patients treated with a high-dosed chemotherapy led to one of the leading theories for development of HFSR [9]. According to this theory, toxic active metabolites resulting from the applied chemotherapy were eliminated over the eccrine sweat glands of the skin and caused severe damage. Especially at the palms of the hands and the planta of the feet as well as intertrigineous areas the count of sweat glands is highest in human body. Additionally, the thick stratum corneum of the skin in these areas serves as a reservoir for the toxic metabolites leading to severe skin reaction. Recently, other potential pathomechanism were suggested by Lademann and coworkers. New optical methods were used to detect fluorescent substances such as anthracyclines on the skin surface and around the sweat glands during or after administration [10]. As a consequence the excretion of toxic metabolites over the sweat glands results in formation of free radicals and hence in damaging cellular components. Thus, a prevention of HFSR using antioxidant agents seemed reasonable.PROCAPP, an open label randomized phase III trial was conducted to compare the prophylactic effect of Mapisal and urea-cream in patients receiving capecitabine therapy [11]. Mapisal is a medical device containing a huge variety of antioxidants and other nourishing ingredients. Patients with gastrointestinal or breast cancer not pretreated with tyrosine kinase inh...

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Randomized Controlled Trial of the Prophylactic Effect of Urea-Based Cream on Sorafenib-Associated Hand-Foot Skin Reactions in Patients With Advanced Hepatocellular Carcinoma

Cited by 123 publications

References 30 publications

Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer

Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer

Overview and Management of Dermatologic Events Associated with Targeted Therapies for Medullary Thyroid Cancer

Strategies for Prevention and Treatment of Chemotherapy-Induced Hand-Foot- Skin-Reaction (HFSR)

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