title: Palifermin decreases severe oral mucositis of patients undergoing postoperative radiochemotherapy for head and neck cancer: a randomized, placebo-controlled trial.
abstract: OBJECTIVE
  Radiochemotherapy of head and neck cancer causes severe mucositis in most patients. We investigated whether palifermin reduces this debilitating sequela.
  
  
  METHODS
  We conducted a multicenter, double-blind, randomized, placebo-controlled trial in 186 patients with stages II to IVB carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Patients received 60 or 66 Gy after complete (R0) or incomplete resection (R1), respectively, at 2 Gy/fraction and five fractions per week. Cisplatin 100 mg/m(2) was administered on days 1 and 22 (and on day 43 with R1). Patients were randomly assigned to receive weekly palifermin 120 μg/kg or placebo from 3 days before and continuing throughout radiochemotherapy. Trained evaluators performed oral assessments twice weekly. The primary end point was the incidence of severe oral mucositis (WHO grades 3 to 4). Overall survival and time to locoregional progression were also assessed. Analysis was by intention to treat.
  
  
  RESULTS
  Severe oral mucositis was seen in 47 (51%) of 92 patients administered palifermin and 63 (67%) of 94 administered placebo (P = .027). Palifermin decreased the duration (median, 4.5 v 22.0 days) and prolonged the time to develop (median, 45 v 32 days) severe mucositis. Neither patient-reported mouth and throat soreness scores nor treatment breaks differed between treatment arms. After median follow-up of 32.8 months, 23 deaths (25%) had occurred in both treatment arms, and disease had recurred in 25 (27%) and 22 (24%) of palifermin- and placebo-treated patients, respectively.
  
  
  CONCLUSIONS
  Palifermin reduced the occurrence of severe oral mucositis in patients with head and neck cancer undergoing postoperative radiochemotherapy. Additional clinical exploration of palifermin with postoperative radiochemotherapy would be useful.
authors.affiliation: University Clinic Freiburg, Germany. henke@uni-freiburg.de
authors.forename: Michael
authors.initials: M
authors.lastname: Henke
authors.forename: Marc
authors.initials: M
authors.lastname: Alfonsi
authors.forename: Paolo
authors.initials: P
authors.lastname: Foa
authors.forename: Jordi
authors.initials: J
authors.lastname: Giralt
authors.forename: Etienne
authors.initials: E
authors.lastname: Bardet
authors.forename: Laura
authors.initials: L
authors.lastname: Cerezo
authors.forename: Michaela
authors.initials: M
authors.lastname: Salzwimmer
authors.forename: Richard
authors.initials: R
authors.lastname: Lizambri
authors.forename: Lara
authors.initials: L
authors.lastname: Emmerson
authors.forename: Mon-Gy
authors.initials: MG
authors.lastname: Chen
authors.forename: Dietmar
authors.initials: D
authors.lastname: Berger
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D002945:Cisplatin / Q000009:adverse effects; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D051523:Fibroblast Growth Factor 7 / Q000009:adverse effects / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control*; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D051523:Fibroblast Growth Factor 7; D002945:Cisplatin