A randomized phase II study evaluating pyridoxine for the prevention of hand-foot syndrome associated with capecitabine therapy for advanced or metastatic breast cancer.

BACKGROUND

Pyridoxine, an activated form of vitamin B6 used to treat allergic dermatitis, may prevent capecitabine-associated hand-foot syndrome (HFS), although evidence of the benefit of prophylactic pyridoxine is lacking. The aim of this open-label, multicenter, randomized phase II study was to determine whether prophylactic pyridoxine could delay the onset of capecitabine-induced HFS in patients with advanced or metastatic breast cancer.

METHODS

Patients received either concomitant pyridoxine (60 mg per day; pyridoxine group), or no pyridoxine but treatment with capecitabine-containing regimens (no pyridoxine group). Study treatment was administered until the development of grade 2 or worse HFS or disease progression. The primary endpoint was the time to onset of grade 2 or worse HFS from the start of protocol treatment.

RESULTS

A total of 135 patients were randomized to the pyridoxine (n = 67) or no pyridoxine (n = 68) groups. Grade 2 or worse HFS developed in 19 of 66 patients (28.8%) versus 21 of 67 patients (31.3%) in the pyridoxine and no pyridoxine groups, respectively. The median time to onset of grade 2 or worse HFS was 13.6 and 10.6 months in the pyridoxine and no pyridoxine groups, respectively [hazard ratio = 0.75 (80% confidence interval 0.50-1.13), one-sided P = 0.18].

CONCLUSIONS

Prophylactic pyridoxine was not shown to have an effect on the onset of capecitabine-associated HFS in this study.