A randomised study evaluating the use of pyridoxine to avoid capecitabine dose modifications

作者：Corrie P G^*; Bulusu R; Wilson C B; Armstrong G; Bond S; Hardy R; Lao Sirieix S; Parashar D; Ahmad A; Daniel F; Hill M; Wilson G; Blesing C; Moody A M; McAdam K; O**orne M

来源：British Journal of Cancer, 2012, 107(4): 585-587.

DOI：10.1038/bjc.2012.318

• capecitabine
• pyridoxine
• hand-foot syndrome
• randomised trial

BACKGROUND: Pyridoxine is frequently used to treat capecitabine-induced hand-foot syndrome (HFS), although the evidence of benefit is lacking. We performed a randomised placebo-controlled trial to determine whether pyridoxine could avoid the need for capecitabine dose modifications and improve outcomes.
METHODS: A total of 106 patients planned for palliative single-agent capecitabine (53 in each arm, 65%/35% colorectal/breast cancer) were randomised to receive either concomitant pyridoxine (50 mg po) or matching placebo three times daily.
RESULTS: Compared with placebo, pyridoxine use was associated with an increased rate of avoiding capecitabine dose modifications (37% vs 23%, relative risk 0.59, 95% CI 0.29, 1.20, P = 0.15) and fewer grade 3/4 HFS-related adverse events (9% vs 17%, odds ratio 0.51, 95% CI 0.15-1.6, P = 0.26). Use of pyridoxine did not improve response rate or progression-free survival.
CONCLUSION: Pyridoxine may reduce the need for capecitabine dose modifications and the incidence of severe HFS, but does not impact on antitumour effect. British Journal of Cancer (2012) 107, 585-587. doi: 10.1038/bjc.2012.318 www.bjcancer.

• 出版日期2012-8-7