Mortimer, J.E., Lauman, M.K., Tan, B., Dempsey, C.L., Shillington, A.C., & Hutchins, K.S. (2003). Pyridoxine treatment and prevention of hand-and-foot syndrome in patients receiving capecitabine. Journal of Oncology Pharmacy Practice, 9, 161–166.

DOI Link

Study Purpose

To evaluate the effectiveness of oral pyridoxine for preventing and treating palmar plantar erythrodysesthesia (PPE) associated with capecitabine

Intervention Characteristics/Basic Study Process

Of the patients receiving oral pyridoxine, 73 patients (74%) received it as prophylaxis, and the remainder (26%) received it as acute hand-foot syndrome (HFS) treatment. The median dose of pyridoxine was 200 mg/m2.

Sample Characteristics

  • N = 198–99 patients who were receiving capecitabine and pyridoxine and 99 patients who were receiving capecitabine and no pyridoxine

Setting

  • SITE: Multi-site
  • SETTING TYPE: Outpatient centers
  • LOCATION: Sentara Cancer Institute in Norfolk, VA

 

Study Design

  • Retrospective review of 198 charts

Measurement Instruments/Methods

  • National Cancer Institute Common Toxicity Criteria version 2.0

Results

The data did not support that vitamin B6 prophylaxis prevented overall PPE incidence in a greater proportion of patients compared with those who did not receive prophylaxis (60% versus 53%). However, when used as treatment, a greater proportion of patients receiving vitamin B6 reported symptom improvement (65% versus 12%, p < 0.001).

Conclusions

Pyridoxine is not recommended for prophylaxis but may provide some relief for patients with acute HFS.

Limitations

  • The data was obtained from chart review, which is subject to documentation bias and patient selection.
  • This was not a controlled trial.
  • A controlled trial of Xeloda® with and without vitamin B6 seems warranted.