title: Palifermin reduces severe mucositis in definitive chemoradiotherapy of locally advanced head and neck cancer: a randomized, placebo-controlled study.
abstract: OBJECTIVE
  Oral mucositis (OM) is a debilitating toxicity of chemoradiotherapy for head and neck cancer (HNC). This randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of palifermin to reduce OM associated with definitive chemoradiotherapy for locally advanced HNC.
  
  
  METHODS
  Patients receiving conventionally fractionated radiotherapy (2.0 Gy/d, 5 days/wk to 70 Gy) with cisplatin (100 mg/m(2) on days 1, 22, and 43) received palifermin (180 μg/kg) or placebo before starting chemoradiotherapy and then once weekly for 7 weeks. The primary end point was the incidence of severe, observable, and functional OM (WHO grade 3 to 4).
  
  
  RESULTS
  The palifermin (n = 94) and placebo (n = 94) arms were well balanced. The incidence of severe OM was significantly lower for palifermin than for placebo (54% v 69%; P = .041). In the palifermin arm, median time to severe OM was delayed (47 v 35 days), median duration of severe OM was shortened (5 v 26 days), and the incidence of xerostomia grade ≥ 2 was lower (67% v 80%), favoring palifermin; however, the differences were not significant after multiplicity adjustment. Opioid analgesic use, average mouth and throat soreness scores, and chemoradiotherapy compliance were not significantly different between treatment arms. Adverse events were similar between arms (98%, palifermin; 93%, placebo). The most common study drug-related adverse events were rash, flushing, and dysgeusia. After median follow-up of 25.8 months, overall survival and progression-free survival were similar between treatment arms.
  
  
  CONCLUSIONS
  Although palifermin reduced severe functional OM, its role in the management of locally advanced HNC during chemoradiotherapy remains to be elucidated.
authors.affiliation: Department of Radiation Oncology, Stanford University, Stanford, CA 94305, USA. qle@stanford.edu
authors.forename: Quynh-Thu
authors.initials: QT
authors.lastname: Le
authors.forename: Harold E
authors.initials: HE
authors.lastname: Kim
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Schneider
authors.forename: Györgyi
authors.initials: G
authors.lastname: Muraközy
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Skladowski
authors.forename: Sabine
authors.initials: S
authors.lastname: Reinisch
authors.forename: Yuhchyau
authors.initials: Y
authors.lastname: Chen
authors.forename: Michael
authors.initials: M
authors.lastname: Hickey
authors.forename: May
authors.initials: M
authors.lastname: Mo
authors.forename: Mon-Gy
authors.initials: MG
authors.lastname: Chen
authors.forename: Dietmar
authors.initials: D
authors.lastname: Berger
authors.forename: Richard
authors.initials: R
authors.lastname: Lizambri
authors.forename: Michael
authors.initials: M
authors.lastname: Henke
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects; D002945:Cisplatin / Q000009:adverse effects; D003131:Combined Modality Therapy / 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; 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