German Study Shows Urea Cream Better Than Antioxidant Ointment in Preventing Capecitabine-Associated Hand-Foot Syndrome
In a phase III study reported in the Journal of Clinical Oncology, Hofheinz et al found that 10% urea cream was better at preventing capecitabine-related hand-foot syndrome than a new ointment (Mapisal) available in Germany that contains several antioxidants and exhibits high radical protection.
Study Details
In the open-label trial, 152 evaluable patients with gastrointestinal or breast cancer treated with capecitabine were randomly assigned to receive urea cream (n = 76) or the new ointment (n = 76) three times a day for 6 weeks. The primary endpoint was prevention of hand-foot syndrome of any grade within 6 weeks of treatment.
Incidence of Hand-Foot Syndrome
Hand-foot syndrome occurred in 30 (39.5%) of 76 patients receiving the ointment (grade 3 in two) and in 17 (22.4%) of 76 patients given the urea cream (grade 3 in one; odds ratio = 2.37, P = .02). Time to hand-foot syndrome > grade 1 was comparable in the two groups (P = .68), but time to any-grade hand-foot syndrome was significantly longer in the urea group (P = .03).
Capecitabine dose intensity, time under study, and percentage of days with correct administration of study medication did not differ between groups, and no difference between groups was observed in adverse events other than hand-foot syndrome.
Quality of Life
There were no differences between groups in functional or symptom scales or global health status on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30. Skin-related quality of life, measured by the Dermatology Life Quality Index, was significantly worse in the new ointment group at the end of study treatment.
The investigators concluded: “This trial demonstrated that 10% urea cream was superior to the new ointment at preventing [hand-foot syndrome] over the first 6 weeks of treatment with capecitabine.”
Ralf-Dieter Hofheinz, MD, of Universität Heidelberg, is the corresponding author for the Journal of Clinical Oncology article.
Supported by Medac Gesellschaft für klinische Spezialpräparate. For full disclosures of the study authors, visit jco.ascopubs.org.
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®.
