For the open-label study, researchers enrolled 871 patients with advanced hepatoceullar carcinoma throughout China and randomly assigned them to receive 10% urea-based cream three times daily plus best supportive care or best supportive care alone, beginning on day 1 of sorafenib treatment for up to 3 months.
Patients were assessed for hand-foot skin reactions every 2 weeks and at 14 weeks. Once a patient developed a hand-foot skin reaction, the patient was allowed to use any cream.1
Results showed that at 12 weeks, the incidence of any grade hand-foot skin reactions was significantly lower in the urea-based cream arm compared with the best supportive care alone arm (56.0% vs 73.6%; overall response (OR)=0.457; 95% CI 0.344,0.608; P<0.001).
The incidence of grade 2 or higher hand–foot skin reactions was also significantly lower in the urea-based cream arm (20.7% vs 29.2%; OR=0.635; 95% CI 0.466,0.866; P=0.004).
Furthermore, the median time to first occurrence of hand–foot skin reactions was 84 days in the urea-based cream compared with 34 days in the best supportive care alone arm (hazard ratio 0.658; 95% CI 0.541,0.799; P<0.001).1
Despite the urea-based cream’s beneficial effect on hand–foot skin reaction rates and time to first occurrence of hand–foot skin reactions, it did not affect the sorafenib dose interruption or dose reduction rate compared with best supportive care alone (9.1% vs. 11.8%; P=0.1937).
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In addition, the urea-based cream did not affect response rate (11.1% vs. 10.1%; P=0.6674) or disease control rate (98.8% vs. 98.2%; P=0.5350) versus best supportive care alone at week 12.1
The findings suggest that the onset of sorafenib-associated hand–foot skin reactions can be delayed by urea-based cream plus best supportive care in patients with advanced hepatocellular carcinoma, thereby improving their health-related quality of life; however, further blinded, placebo-controlled, randomized studies longer in duration are warranted to determine whether prophylactic urea-based cream reduces the rates and intensity of hand-foot skin reactions, and ultimately improves outcomes.1
- Ren ZG, Zhu KS, Kang HY, et al. Randomized controlled trial of the prophylactic effect of urea-based cream on sorafenib-associated hand-foot skin reactions in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2015;[Epub ahead of print].
- “How many people get liver cancer?” American Cancer Society. 13 Jan 2015. Web. 18 Feb 2015.
- NCCN Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers. Version 2.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed February 18, 2015.
- Nexavar (sorafenib) [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021923s008s009lbl.pdf.
- Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359:378-390.