Methylcobalamin Significantly Reduces Severe Hand-Foot Syndrome in HER2 Negative Early Breast Cancer Patients Receiving Capecitabine: Results from a Phase 3 Randomised Trial

Background

Hand-foot syndrome (HFS) is a common, dose-limiting adverse effect of capecitabine, an oral chemotherapeutic frequently used in adjuvant treatment of human epidermal growth factor receptor 2 (HER2) negative early breast cancer. Grade 2 or 3 HFS causes erythema, edema, neuropathic pain, dysesthesia, blistering, and ulceration of palms and soles, substantially impairing patients’ quality of life and treatment adherence. Despite its clinical significance, current preventive strategies, including pyridoxine, celecoxib, and urea-based creams, have limitations due to efficacy or safety concerns. There is an unmet need for effective, safe approaches to reduce the incidence and severity of capecitabine-induced HFS.

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