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Br J Cancer. 2012 Aug 7;107(4):585-7. doi: 10.1038/bjc.2012.318. Epub 2012 Jul 19.

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

Author information

1
Oncology Division, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0QQ, UK. pippa.corrie@addenbrookes.nhs.uk

Abstract

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.

PMID:
22814578
PMCID:
PMC3419962
DOI:
10.1038/bjc.2012.318
[Indexed for MEDLINE]
Free PMC Article
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