title: Pyridoxine therapy for palmar-plantar erythrodysesthesia associated with continuous 5-fluorouracil infusion.
abstract: The limiting toxicity of low dose continuous infusion 5-fluorouracil (200-300 mg/m2/day) is often palmar-plantar erythrodysesthesia (PPE). PPE developed in 16/25 patients (exact 95% confidence interval of 42%-82%) with metastatic colon cancer enrolled in a phase II trial. In this trial, 5-FU was given continuously at a dose of 200 mg/m2/day until toxicity or progressive disease forced discontinuation. The first signs of the syndrome developed at a median of 2 months following infusion initiation and, unless treatment was interrupted, became progressively worse. The incidence of moderate to severe PPE was 71% in the 14 previously untreated patients (exact 95% confidence intervals of 42-92%). Seventy-eight percent of the responders in the no prior treatment group developed PPE. The incidence of moderate to severe PPE was only 27% in the 11 previously treated patients (exact 95% confidence intervals of 6-61%). The higher incidence of PPE in the previously untreated patients probably resulted from a longer total infusion time (median = 7.3 months) than the previously treated (median = 4.5 months). The longer infusion time in turn was a result of the higher response rates (64 vs 18%) in the previously untreated versus treated groups. Five previously untreated patients who developed PPE received 50 or 150 mg of pyridoxine/day when moderate PPE changes were noted. Reversal of PPE without interruption of the 5-FU was seen in 4/5 patients. Four of these patients who received pyridoxine had responded to 5-FU treatment. No adverse affect of pyridoxine on clinical response was noted.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: University of Kansas Medical Center, Division of Clinical Oncology, Kansas City 66102.
authors.forename: C J
authors.initials: CJ
authors.lastname: Fabian
authors.forename: R
authors.initials: R
authors.lastname: Molina
authors.forename: M
authors.initials: M
authors.lastname: Slavik
authors.forename: S
authors.initials: S
authors.lastname: Dahlberg
authors.forename: S
authors.initials: S
authors.lastname: Giri
authors.forename: R
authors.initials: R
authors.lastname: Stephens
mesh_terms: D003110:Colonic Neoplasms / Q000188:drug therapy; D004487:Edema / Q000139:chemically induced / Q000188:drug therapy; D004890:Erythema / Q000139:chemically induced / Q000188:drug therapy*; D005472:Fluorouracil / Q000009:adverse effects*; D005500:Follow-Up Studies; D005533:Foot Dermatoses / Q000139:chemically induced / Q000188:drug therapy*; D006229:Hand Dermatoses / Q000139:chemically induced / Q000188:drug therapy*; D006801:Humans; D007261:Infusions, Intra-Arterial; D008875:Middle Aged; D010292:Paresthesia / Q000139:chemically induced / Q000188:drug therapy*; D011736:Pyridoxine / Q000627:therapeutic use*
chemical_list: D011736:Pyridoxine; D005472:Fluorouracil