Effect of Urea Cream on Sorafenib-Associated Hand-Foot Skin Reaction in Patients with Hepatocellular Carcinoma: A Multicenter, Randomized, Double-Blind Controlled Study

2020 ◽  
Author(s):  
Young-Sun Lee ◽  
Young Kul Jung ◽  
Ji Hoon Kim ◽  
Sung Bum Cho ◽  
Do Young Kim ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Skin Reaction ◽  
Controlled Study ◽  
Double Blind ◽  
Hand Foot Skin Reaction

scholarly journals As Clinical Markers, Hand-Foot-Skin Reaction and Diarrhea Can Predict Better Outcomes for Hepatocellular Carcinoma Patients Receiving Transarterial Chemoembolization plus Sorafenib

2019 ◽  
Vol 2019 ◽  
pp. 1-7
Author(s):  
Lei Liu ◽  
Enxin Wang ◽  
Lin Li ◽  
Dongyu Chen ◽  
Kun Peng ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Combination Therapy ◽  
Skin Reaction ◽  
Transarterial Chemoembolization ◽  
Cox Regression ◽  
Time Dependent ◽  
Clinical Markers ◽  
Study Population ◽  
Hand Foot Skin Reaction

Background. Combination therapy of transarterial chemoembolization plus sorafenib (TACE-S) has been proven to be safe and effective for hepatocellular carcinoma (HCC); however, this combination therapy is associated with a high incidence of adverse events (AEs). Our study focused on the relationships between AEs and treatment outcomes and aimed to discover AE-based clinical markers that can predict the survival benefits of combination treatment. Methods. From January 2010 to June 2014, a total of 235 HCC patients treated with TACE-S were retrospectively enrolled. Major sorafenib-related AEs were prospectively recorded, and their correlations with overall survival (OS) were analysed using time-dependent covariate Cox regression analyses. Results. The majority of the patients (200, 85.1%) were male, and the median age was 51 years old. After two years of follow-up, the median OS of the study population reached 12.4 months. In all, 218 patients (92.8%) presented at least one AE, and 174 (74.0%) suffered AEs ≥2 grade. Based on time-dependent multivariate analyses, the development of hand-foot skin reaction (HFSR) ≥2 grade (HR = 0.43, 95% CI: 0.32–0.58, P<0.001) and diarrhoea ≥1 grade (HR = 0.72, 95% CI: 0.53–0.97, P=0.029) were identified as independent predictors of prolonged OS. Moreover, patients who developed both HFSR ≥2 grade and diarrhoea ≥1 grade achieved better outcomes than those patients who developed either or neither of these AEs (HR = 1.51, 95% CI: 1.11–2.06, P=0.009). Conclusions. The development of HFSR ≥2 grade or diarrhoea ≥1 grade during TACE-S treatment indicated prolonged OS, and these AEs should be considered important clinical markers for predicting patient prognoses.

scholarly journals Multikinase inhibitor-associated hand-foot skin reaction as a predictor of outcomes in patients with hepatocellular carcinoma treated with sorafenib

2018 ◽  
Vol 24 (28) ◽  
pp. 3155-3162 ◽  
Author(s):  
Masanori Ochi ◽  
Toshiro Kamoshida ◽  
Atsushi Ohkawara ◽  
Haruka Ohkawara ◽  
Nobushige Kakinoki ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Skin Reaction ◽  
Multikinase Inhibitor ◽  
Hand Foot Skin Reaction

The protective role of urea-containing cream on sorafenib-associated hand-foot skin reaction in patients with hepatocellular carcinoma

2020 ◽  
Vol 73 ◽  
pp. S384
Author(s):  
Young-Sun Lee ◽  
Ji Hoon Kim ◽  
Young Kul Jung ◽  
Yeon Seok Seo ◽  
Hyung Joon Yim ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Skin Reaction ◽  
Protective Role ◽  
Hand Foot Skin Reaction

A randomized controlled phase II study of the prophylactic effect of urea-based cream on the hand-foot skin reaction associated with sorafenib in advanced hepatocellular carcinoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4008-4008 ◽  
Author(s):  
Zhenggang Ren ◽  
Kangshun Zhu ◽  
Haiyan Kang ◽  
Minqiang Lu ◽  
Zengqiang Qu ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Skin Reaction ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Advanced Hepatocellular Carcinoma ◽  
Prophylactic Effect ◽  
Multikinase Inhibitor ◽  
Advanced Hcc ◽  
Randomized Controlled ◽  
Hand Foot Skin Reaction

4008 Background: Sorafenib (SOR) has become the standard treatment for advanced hepatocellular carcinoma (HCC). Hand-foot skin reaction (HFSR) is one of the most common adverse events associated with SOR and its occurrence can impact patient quality of life and lead to dose modification or interruption, both of which may negatively impact clinical outcomes. This randomized controlled trial is the first large prospective study to investigate the prophylactic effect of urea-based creams on HFSR associated with SOR. Methods: Patients with advanced HCC treated with SOR were randomly assigned 1:1 to receive prophylactic urea-based cream (Arm A) or best supportive care (BSC) following development of HFSR (Arm B). SOR was administered 800 mg daily. Urea-based cream was given twice daily for up to 12 weeks starting on Day 1. BSC was at the physician’s discretion and excluded urea-based creams. The primary endpoint was the incidence of all-grade HFSR in the first12 weeks. Results: Eight hundred sixty eight patients were enrolled; 439 patients in Arm A and 432 patients in Arm B. There was no difference of baseline characteristics between two arms. Over the 12 week period of study, the incidence of all-grade HFSR was significantly lower in Arm A compared to Arm B; n=246 (56.0%) patients in Arm A versus n=318 (73.6%) patients in Arm B, p<0.0001. The incidence of grade ≥2 HFSR tended to be lower in Arm A compared to Arm B, but did not reach statistical significance; n=96 (21.9%) patients Arm A versus n=126 (29.2%) patients in Arm B, p=0.1638. The median time to the first HFSR event was 2.5 fold longer in Arm A compared to Arm B; 84 days (95% CI 45-93 days) in Arm A and 34 days (95% CI 29-43 days) in Arm B (p<0.001). Conclusions: This is the first large prospective, randomized control trial examining the prophylactic use of urea-based creams for treatment of HFSR associated with a multikinase inhibitor. Compared to BSC, prophylactic topical use of a urea-based cream appears to be effective in preventing and/or delaying the incidence of HFSR associated with SOR treatment in patients with advanced HCC.

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