Pyridoxine treatment and prevention of hand-and-foot syndrome in patients receiving capecitabine

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Abstract
Background. Capecitabine is a novel fluoropyrimidine administered orally for treatment of gastrointestinal and breast malignancies. Toxicity described with capecitabine includes hand-and-foot syndrome (HFS), a potentially painful inflammation of the hands and feet. Pyridoxine has been reported to produce improvement in HFS symptoms. We conducted our study to determine the incidence and severity of HFS symptoms in capecitabine patients and to assess the effects of pyridoxine administered as prophylaxis or treatment. Patients and methods. We retrospectively reviewed 99 charts of capecitabine patients receiving pyridoxine and 99 charts of those who had not. Results. Of the 99 pyridoxine patients, 73 (74%) received it as prophylaxis, with the remainder receiving pyridoxine as acute HFS treatment. The median number of capecitabine cycles administered was five, with first-reported HFS onset at cycle 2 in those receiving pyridoxine prophylaxis versus 1.5 in those not (P 5 0.06). Incidence was significantly associated with capecitabine dose, with 76% of patients experiencing HFS in the highest dose ranges compared with 40% in the lowest (P B 0.01). The data did not support that pyridoxine prophylaxis prevented overall HFS incidence in a greater proportion of patients compared with those who did not receive prophylaxis (60% versus 53%, respectively, P 5 NS). However, when used as treatment, a greater proportion of patients receiving pyridoxine reported symptom improvement compared with those not receiving the agent (65% versus 12%, P B0.001). No differences in 12-week tumor response were seen. Conclusion. The data do not support the use of pyridoxine as prophylaxis as neither the incidence nor the severity of HFS was affected. Once HFS develops, however, pyridoxine may provide some relief of HFS symptoms. A controlled trial of capecitabine with and without pyridoxine seems warranted.