Hand-foot Syndrome Following Capecitabine (Xeloda(R)) Monotherapy for Colorectal Cancer

ABSTRACT

PURPOSE: Capecitabine (Xeloda(R)), which is a systemic prodrug of 5-fluorouracil, can be used in oral formulation for treatment of advanced colorectal cancer as a 1st line or an alternative modality to I.V. 5-fluorouracil-based chemotherapy. One of the most common side effects of this drug is hand-foot syndrome (HFS), palmar-plantar erythrodysesthesia syndrome. We planned this study to clarify the incidence and the clinical course of severe hand-foot syndrome (WHO classification, grade 3 or 4) following capecitabine monotherapy for adjuvant treatment of colorectal cancer. METHODS: From August 2006 to August 2008, 45 colorectal cancer patients were treated with capecitabine, 1,250 mg/m2, orally administered twice daily for 2 wk, followed by 1 wk of rest, given as 3-wk cycles. Seven of them discontinued the drug within 3rd cycle due to poor performance status, gastrointestinal troubles, or other causes. We retrospectively analyzed the remaining 38 patients' medical records and defined the incidence and the clinical course of HFS. RESULTS: Of the 38 patients, 17 (44.7%) suffered severe HFS after capecitabine monotherapy. Of those 17, 5 (29.4%) had severe symptoms after the 1st chemotherapy cycle, and 14 patients (82.4%) had severe symptoms within the 4th cycle. Three of the 14 female and 14 of the 24 male patients complained of severe HFS, showing a statistical male predominance (P=0.043). Eventually, we had to decrease capecitabine to 75% of the daily dose in 12 patients and to 50% in one patient, and to discontinue its use in 4 patients. CONCLUSION: Capecitabine monotherapy very frequently provokes severe HFS, especially in the early cycles of chemotherapy and in males.