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


CONCLUSIONS
Pyridoxine may reduce the need for capecitabine dose modifications and the incidence of severe HFS, but does not impact on antitumour effect.
Oncology Division, Addenbrooke's Hospital, Hills Road, Cambridge CB2 0QQ, UK. pippa.corrie@addenbrookes.nhs.uk
P G
PG
Corrie
R
R
Bulusu
C B
CB
Wilson
G
G
Armstrong
S
S
Bond
R
R
Hardy
S
S
Lao-Sirieix
D
D
Parashar
A
A
Ahmad
F
F
Daniel
M
M
Hill
G
G
Wilson
C
C
Blesing
A M
AM
Moody
K
K
McAdam
M
M
Osborne
D000293:Adolescent; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D060831:Hand-Foot Syndrome / Q000150:complications; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011736:Pyridoxine / Q000009:adverse effects / Q000627:therapeutic use*
D010919:Placebos; D003841:Deoxycytidine; D000069287:Capecitabine; D011736:Pyridoxine; D005472:Fluorouracil