Predictors of hand-foot syndrome (HFS) in randomised double-blind, placebo-controlled trial of pyridoxine for prevention of capecitabine induced HFS.

9596 Background: Hand-foot syndrome (HFS)is a common side effect of capecitabine, although East Asian patients appear to have better tolerability. Methods: This study aimed to evaluate the incidence of grade ≥ 2 HFS in patients receiving pyridoxine versus placebo (primary objective), compare the time to onset of grade ≥ 2 HFS, and identify biomarkers predictive of HFS, including baseline folate and vitamin B12 levels, plus genetic polymorphisms (secondary objectives). Patients starting capecitabine single-agent chemotherapy for breast, colorectal and other cancers in National Cancer Centre Singapore were randomized to receive concurrent pyridoxine (200mg) or placebo daily for a maximum of 8 cycles of capecitabine, with stratification by gender and use in adjuvant/neoadjuvant versus palliative setting. Patients were withdrawn from the study upon development of grade ≥ 2 HFS or cessation of capecitabine. Results: The trial was terminated before reaching the original target of 296 patients due to slow accrua...