A randomized phase II study evaluating the use of prydoxine to prevent hand-foot syndrome associated with capecitabine therapy for advanced or metastatic breast cancer.

9610 Background: Pyridoxine (Pyr) is a drug of activated vitamin B6 and usually used for allergic dermatitis. Pyr is frequently used to prevent the HFS, although the evidence of benefit is lacking in Japan. The aim of this is to determine whether Pyr could reduce capecitabine (Cap)-induced HFS in advanced or metastatic breast cancer patients. This study is an open label, multicenter, randomized phase II study conducted by Tokai Breast Cancer Research Group (TBCRG) in Japan. Methods: All patients were received either concomitant pyridoxine (60mg P.O per day) or none with Cap containing regimens (Cap monotherapy, Cap plus cyclophosphamide, Cap plus weekly paclitaxel). Patients were stratified by chemotherapy regimens, line of therapy after metastases, and institutes. The study treatment was given until grade 2 HFS or incidence of other severe adverse events or progression disease. Primary endpoint is the period until the incidence of grade 2 or worse HFS from start of protocol treatment. The key secondary e...