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Randomized trial of vitamin B6 for preventing hand-foot syndrome from capecitabine chemotherapy.
J Community Support Oncol 2014; 12(2):65-70JC

Abstract

BACKGROUND

Capecitabine is an oral fluoropyrimidine that is used to treat various malignancies. Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine that can limit the use of this agent in some patients. Some investigators have observed that pyridoxine (vitamin B6) can ameliorate HFS that is caused by capecitabine. We designed a prospective trial to determine if pyridoxine can prevent HFS in patients who receive capecitabine.

METHODS

In our double-blind, placebo-controlled trial, we randomly assigned eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of HFS that occurred in both study arms.

RESULTS

Between 2008 and 2011, 77 patients were randomly assigned to receive either pyridoxine (n = 38) or placebo (n = 39). Dosages of capecitabine were equally matched between both arms of the study. HFS occurred after a median of 2 chemotherapy cycles in both groups. HFS developed in 10 of 38 (26%) patients in the pyridoxine group and in 8 of 39 (21%) patients in the placebo group (P = .547). Therefore, the risk of HFS was 5 percentage points higher in pyridoxine group (95% confdence interval [CI] for difference, -13 percentage points to +25 percentage points). Given our study results, a true benefit from pyridoxine can be excluded. No difference in HFS grades was observed.

LIMITATIONS

Single-institution study.

CONCLUSION

Prophylactic pyridoxine (vitamin B6), given concomitantly with capecitabine-containing chemotherapy, was not effective for the prevention of HFS.

Authors+Show Affiliations

Hematology and Oncology Division, John H Stroger Jr Hospital of Cook County, Chicago, IL USA Email: tareqbk410@hotmail.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24971407

Citation

Braik, Tareq, et al. "Randomized Trial of Vitamin B6 for Preventing Hand-foot Syndrome From Capecitabine Chemotherapy." The Journal of Community and Supportive Oncology, vol. 12, no. 2, 2014, pp. 65-70.
Braik T, Yim B, Evans AT, et al. Randomized trial of vitamin B6 for preventing hand-foot syndrome from capecitabine chemotherapy. J Community Support Oncol. 2014;12(2):65-70.
Braik, T., Yim, B., Evans, A. T., Kassem, M., Mullane, M., Lad, T., ... McDunn, S. (2014). Randomized trial of vitamin B6 for preventing hand-foot syndrome from capecitabine chemotherapy. The Journal of Community and Supportive Oncology, 12(2), pp. 65-70.
Braik T, et al. Randomized Trial of Vitamin B6 for Preventing Hand-foot Syndrome From Capecitabine Chemotherapy. J Community Support Oncol. 2014;12(2):65-70. PubMed PMID: 24971407.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized trial of vitamin B6 for preventing hand-foot syndrome from capecitabine chemotherapy. AU - Braik,Tareq, AU - Yim,Barbara, AU - Evans,Arthur T, AU - Kassem,Mohammed, AU - Mullane,Michael, AU - Lad,Thomas, AU - Hussein,Lily, AU - Cleveland,Barbara, AU - McDunn,Susan, PY - 2014/6/28/entrez PY - 2014/6/28/pubmed PY - 2014/6/28/medline SP - 65 EP - 70 JF - The Journal of community and supportive oncology JO - J Community Support Oncol VL - 12 IS - 2 N2 - BACKGROUND: Capecitabine is an oral fluoropyrimidine that is used to treat various malignancies. Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine that can limit the use of this agent in some patients. Some investigators have observed that pyridoxine (vitamin B6) can ameliorate HFS that is caused by capecitabine. We designed a prospective trial to determine if pyridoxine can prevent HFS in patients who receive capecitabine. METHODS: In our double-blind, placebo-controlled trial, we randomly assigned eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of HFS that occurred in both study arms. RESULTS: Between 2008 and 2011, 77 patients were randomly assigned to receive either pyridoxine (n = 38) or placebo (n = 39). Dosages of capecitabine were equally matched between both arms of the study. HFS occurred after a median of 2 chemotherapy cycles in both groups. HFS developed in 10 of 38 (26%) patients in the pyridoxine group and in 8 of 39 (21%) patients in the placebo group (P = .547). Therefore, the risk of HFS was 5 percentage points higher in pyridoxine group (95% confdence interval [CI] for difference, -13 percentage points to +25 percentage points). Given our study results, a true benefit from pyridoxine can be excluded. No difference in HFS grades was observed. LIMITATIONS: Single-institution study. CONCLUSION: Prophylactic pyridoxine (vitamin B6), given concomitantly with capecitabine-containing chemotherapy, was not effective for the prevention of HFS. SN - 2330-7749 UR - https://www.unboundmedicine.com/medline/citation/24971407/Randomized_trial_of_vitamin_B6_for_preventing_hand_foot_syndrome_from_capecitabine_chemotherapy_ L2 - http://www.oncologypractice.com/jcso/the-publication/past-issue-single-view/randomized-trial-of-vitamin-b6-for-preventing-hand-foot-syndrome-from-capecitabine-chemotherapy/fb53d21aa685d6950918c5bb33ee8192.html DB - PRIME DP - Unbound Medicine ER -