Urea-Based Cream Prevents Sorafenib-Associated Hand-Foot Skin Reactions in Chinese Patients With Advanced Hepatocellular Carcinoma
In a Chinese study reported in the Journal of Clinical Oncology, Ren et al found that prophylactic use of urea-based cream reduced the incidence of sorafenib (Nexavar)–associated hand-foot skin reactions in patients with advanced hepatocellular carcinoma. Urea-based creams are used to treat hyperkeratotic conditions.
In this open-label trial, 871 patients with advanced hepatocellular carcinoma were randomly assigned to treatment with 10% urea-based cream three times daily plus best supportive care (n = 439) or best supportive care alone (excluding all creams; n = 432) starting on day 1 of sorafenib treatment for up to 12 weeks.
Reduced Incidence
The 12-week incidence of any grade hand-foot skin reaction was 56.0% in the cream group vs 73.6% in the control group (odds ratio [OR] = 0.457, P < .001). The incidence of grade ≥ 2 hand-foot skin reaction was 20.7% vs 29.2% (OR = 0.635, P = .004). Median time to first occurrence of hand-foot skin reaction was 84 vs 34 days (hazard ratio [HR] = 0.658, P < .001). An elevated aspartate aminotransferase level was associated with an increased risk of hand-foot skin reaction (HR = 1.949, P < .001), but there was no significant difference in the risk of the reaction among patients in the cream group with vs without an elevated aspartate aminotransferase level (P = .0732).
Other Outcomes
There was no difference between the cream and control groups with regard to the rate of sorafenib dose reduction or interruption (9.1% vs 11.8%, P = .1937), response rate (11.1% vs 10.1%, P = .6674), or disease control rate (98.8% vs 98.2%, P = .5350) at week 12. Assessment with the Hand-Foot Reaction Quality-of-Life questionnaire showed lower symptom scores from week 4 to week 14 and improved daily activity scores at weeks 6 and 8 among patients in the cream group.
The investigators concluded: “[Urea-based cream] prophylaxis in patients with advanced [hepatocellular carcinoma] starting sorafenib reduced [hand-foot skin reaction] rates, extended the time to first occurrence of [hand-foot skin reaction], and improved patient quality of life compared with [best supportive care]. Blinded, randomized, placebo-controlled trials to determine the role of [urea-based cream] on the incidence and severity of [hand-foot skin reaction] are warranted.”
Sheng-Long Ye, MD, of Fudan University, Shanghai, is the corresponding author of the Journal of Clinical Oncology article.
The study was supported by the Chinese Anti-Cancer Association and Bayer HealthCare. Dr. Ye has received research funding from Bayer.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
