title: Pyridoxine is not effective to prevent hand-foot syndrome associated with capecitabine therapy: results of a randomized, double-blind, placebo-controlled study.
abstract: OBJECTIVE
  To determine whether concurrent pyridoxine therapy can prevent the development of hand-foot syndrome (HFS) in patients being treated with capecitabine.
  
  
  METHODS
  Chemotherapy-naive patients with GI tract cancers scheduled for capecitabine-containing chemotherapy were randomly assigned to concurrent oral pyridoxine (200 mg/d) or placebo. Patients were stratified by chemotherapy regimen and monitored until development of National Cancer Institute Common Toxicity Criteria grade 2 or worse HFS or capecitabine-containing chemotherapy ended. Patients in the placebo group who developed grade 2 or worse HFS were randomly assigned again to receive pyridoxine or placebo in the next chemotherapy cycle to determine whether pyridoxine could improve HFS.
  
  
  RESULTS
  The median number of chemotherapy cycles to grade 2 or worse HFS was three in both groups. Grade 2 or worse HFS developed in 55 (30.6%) of 180 placebo-treated patients and in 57 (31.7%) of 180 pyridoxine patients. The cumulative dose of capecitabine to grade 2 or worse HFS was not different between the two groups (median not reached in either group; hazard ratio [HR] = 0.95; P = .788). Randomization of the 44 patients in the placebo group with grade 2 or worse HFS to placebo or pyridoxine for the next cycle resulted in no significant difference in the proportion showing improvement of HFS (42.9% v 47.8%; HR = 1.12; P = .94). By multivariate analysis, age > or = 56 years (HR = 1.768; 95% CI, 1.190 to 2.628; P = .005) was an independent risk factor for grade 2 or worse HFS, and combined use of docetaxel (HR = 2.046; 95% CI, 0.880 to 4.755; P = .096) was of borderline significance.
  
  
  CONCLUSIONS
  Pyridoxine is not effective in prevention of capecitabine-associated HFS.
authors.affiliation: Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Songpa-gu, Seoul, 138-736 Korea. ykkang@amc.seoul.kr
authors.forename: Yoon-Koo
authors.initials: YK
authors.lastname: Kang
authors.forename: Sung Sook
authors.initials: SS
authors.lastname: Lee
authors.forename: Dok Hyun
authors.initials: DH
authors.lastname: Yoon
authors.forename: So Young
authors.initials: SY
authors.lastname: Lee
authors.forename: Young Ju
authors.initials: YJ
authors.lastname: Chun
authors.forename: Min Sun
authors.initials: MS
authors.lastname: Kim
authors.forename: Min-Hee
authors.initials: MH
authors.lastname: Ryu
authors.forename: Heung-Moon
authors.initials: HM
authors.lastname: Chang
authors.forename: Jae-Lyun
authors.initials: JL
authors.lastname: Lee
authors.forename: Tae Won
authors.initials: TW
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005533:Foot Dermatoses / Q000139:chemically induced / Q000188:drug therapy* / Q000517:prevention & control*; D006229:Hand Dermatoses / Q000139:chemically induced / Q000188:drug therapy* / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011736:Pyridoxine / Q000627:therapeutic use*; D013577:Syndrome; D017211:Treatment Failure; D014803:Vitamin B Complex / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D014803:Vitamin B Complex; D000069287:Capecitabine; D011736:Pyridoxine; D005472:Fluorouracil