title: Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy.
abstract: OBJECTIVE
  To characterize the efficacy and safety of palifermin in reducing the incidence of oral mucositis (OM) and diarrhea when administered to patients with metastatic colorectal cancer (CRC) receiving fluorouracil/leucovorin (FU/LV) chemotherapy.
  
  
  METHODS
  Patients (N = 64) were randomly assigned to receive either placebo or palifermin (40 microg/kg for 3 consecutive days) before each of two consecutive cycles of chemotherapy with FU/LV. The incidence of OM and diarrhea, safety, disease progression, and survival were evaluated.
  
  
  RESULTS
  Thirty-six patients received placebo and 28 patients received palifermin. The incidence of WHO grade 2 or higher OM was lower in patients who received palifermin compared with placebo (29% v 61% in cycle 1; 11% v 47% in cycle 2). FU dose reductions in the second chemotherapy cycle were more frequent in the placebo group (31%) than in the palifermin group (14%). Investigators reported lower mucositis scores and patients reported less severe symptoms with palifermin. There were no statistically significant differences in the incidence or severity of diarrhea or in overall survival between the groups. Overall, palifermin was safe and well tolerated.
  
  
  CONCLUSIONS
  Palifermin administered at the indicated dosing regimen (40 microg/kg for 3 consecutive days) before chemotherapy was well tolerated and resulted in a statistically significant and clinically meaningful reduction in the incidence of WHO grade 2 or higher OM in patients with metastatic CRC.
authors.affiliation: Premiere Oncology, John Wayne Cancer Institute, St John's Health Center, Santa Monica, CA 90404, USA. lrosen@premiereoncology.com
authors.forename: Lee S
authors.initials: LS
authors.lastname: Rosen
authors.forename: Ehtesham
authors.initials: E
authors.lastname: Abdi
authors.forename: Ian D
authors.initials: ID
authors.lastname: Davis
authors.forename: John
authors.initials: J
authors.lastname: Gutheil
authors.forename: Frederick M
authors.initials: FM
authors.lastname: Schnell
authors.forename: John
authors.initials: J
authors.lastname: Zalcberg
authors.forename: Alessandra
authors.initials: A
authors.lastname: Cesano
authors.forename: Urte
authors.initials: U
authors.lastname: Gayko
authors.forename: Mon-Gy
authors.initials: MG
authors.lastname: Chen
authors.forename: Stephen
authors.initials: S
authors.lastname: Clarke
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003967:Diarrhea / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D004334:Drug Administration Schedule; D005260:Female; D051523:Fibroblast Growth Factor 7 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005472:Fluorouracil / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects*; D012720:Severity of Illness Index; D013280:Stomatitis / Q000139:chemically induced / Q000188:drug therapy* / Q000517:prevention & control; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D051523:Fibroblast Growth Factor 7; D002955:Leucovorin; D005472:Fluorouracil