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

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. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03212625).

Recent blood pressure trends in adolescents from China, Korea, Seychelles and the United States of America, 1997-2012.

OBJECTIVE: Although the prevalence of obesity is increasing worldwide, secular trends in elevated blood pressure (BP) differ across populations. We aimed to compare recent BP and obesity trends in adolescents aged 10-19 years in China, Korea, Seychelles and the United States of America. METHODS: Data in adolescents aged 10-19 years came from China (1997-2011, n = 8025), Korea (1998-2012, n = 10 119), Seychelles (1998-2012, n = 27 569) and the United States of America (1999-2012, n = 14 580). Elevated BP was defined as SBP or DBP equal to or above the referent sex, age and height-specific 95th percentile of the US Fourth Report. Overweight and obesity were defined using criteria of the International Obesity Task Force. RESULTS: Between 1997-2000 and 2011-2012, the prevalence of elevated BP decreased in Korea and did not change substantially in China and in the United States of America. The prevalence of elevated BP increased in Seychelles. In 2011-2012, the prevalence of elevated BP was 1.7% in the United States of America, 3.8% in China, 3.7% in Korea and 14.3% in Seychelles. The prevalence of overweight and obesity increased over time and reached in 2011-2012 41.2% in the United States of America, 18.6% in China, 25.2% in Korea and 27.4% in Seychelles. Elevated BP was strongly associated with obesity in all countries. CONCLUSION: Although the prevalence of obesity increased markedly in the four countries, secular BP trends in adolescents differed in countries of different regions.