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Randomized Controlled Trial
. 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

P G Corrie  1 , R Bulusu, C B Wilson, G Armstrong, S Bond, R Hardy, S Lao-Sirieix, D Parashar, A Ahmad, F Daniel, M Hill, G Wilson, C Blesing, A M Moody, K McAdam, M Osborne
Affiliations
Randomized Controlled Trial

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

P G Corrie et al. Br J Cancer. .

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.

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Figures

Figure 1
Figure 1
Kaplan-Meier estimates of the time to first dose modification.
See this image and copyright information in PMC

References

    1. Beveridge RA, Kales AN, Binder RA, Miller JA, Virts SG (1990) Pyridoxine (B6) and amelioration of hand/foot syndrome. Proc Am Soc Clin Oncol 9: 102a (abstr 393)
    1. Chalermchai T, Tantiphlachiva K, Suwanrusme H, Voravud N, Sriuranpong V (2010) Randomized trial of two different doses of pyridoxine in the prevention of capecitabine-associated palmar-plantar erythrodysesthesia. Asia-Pacific J Clin Oncol 6: 155–160 - PubMed
    1. Fabian CJ, Molina R, Slavik M, Dahlberg S, Giri S, Stephens R (1990) Pyridoxine therapy for palmar-plantar erythrodysesthesia associated with continuous 5-fluorouracil infusion. Invest New Drugs 8: 57–63 - PubMed
    1. Gressett SM, Stanford BL, Hardwicke F (2006) Management of hand-foot syndrome induced by capecitabine. J Oncol Pharm Pract 12: 131–141 - PubMed
    1. Kang YK, Lee SS, Yoon DH, Lee SY, Chun YJ, Kim MS, Ryu MH, Chang HM, Lee JL, Kim TW (2010) Pyridoxine is not effective to prevent hand-foot syndrome associated with capecitabine therapy: results of a randomized, double-blind, placebo-controlled study. J Clin Oncol 28: 3824–3829 - PubMed

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