This article is more than 5 years old. Information may no longer be current.
ULABTKA cream worsened symptoms of hand-foot syndrome
Click Here to Manage Email Alerts
Patients undergoing therapy with capecitabine who were assigned to a urea/lactic acid-based topical keratolytic agent did not see any relief from symptoms associated with hand-foot syndrome compared with patients assigned to placebo.
In a randomized, double blind phase 3 trial, 67 patients were assigned to a urea/lactic acid-based topical keratolytic agent (ULABTKA) and 60 were assigned to placebo. All patients were undergoing treatment with 2,000 mg/m2 to 2,500 mg/m2 daily capecitabine (Xeloda, Roche) from June 2006 to January 2009.
Patients were instructed to apply one-half to 1 teaspoon of a topical agent consisting of 12% urea/6% lactic acid to their palms and soles twice daily upon initiation of capecitabine treatment. Study treatment started within 3 days of initiation of capecitabine therapy.
Symptoms were scored on a 0 to 10 scale, with 10 representing the worst possible experience.
After the initial 3-week cycle of therapy, researchers said there was no statistically significant difference between the two arms for incidence of moderate to severe hand-foot syndrome symptoms. Researchers determined that moderate to severe hand-foot syndrome was more common in the ULABTKA arm, 13.6% vs. 10.2%.
The odds of experiencing moderate to severe hand-foot syndrome were 1.37 times greater for patients in the ULABTKA arm compared with patients in the placebo arm (95% CI, 0.37-5.76).
For more information:
- Wolf SL. J Clin Oncol. 2010;doi:10.1200/JCO.2010.31.1431.