title: Therapeutic effect of recombinant human epidermal growth factor (RhEGF) on mucositis in patients undergoing radiotherapy, with or without chemotherapy, for head and neck cancer: a double-blind placebo-controlled prospective phase 2 multi-institutional clinical trial.
abstract: BACKGROUND
  We evaluated the efficacy of topically applied human recombinant epidermal growth factor (rhEGF) for the treatment of oral mucositis induced by radiotherapy (RT), with or without chemotherapy, in patients with head and neck cancer.
  
  
  METHODS
  Patients receiving definitive chemoradiotherapy, definitive RT, or postoperative RT to the oral cavity or oropharynx were recruited from 6 institutions and enrolled in a randomized, double-blind, placebo-controlled phase 2 trial. Patients were assigned to a placebo group or to 1 of 3 EGF-treatment groups (10, 50, or 100 microg/mL doses, delivered in a spray, twice daily). The grade of mucositis was evaluated using the Radiation Therapy Oncology Group (RTOG) scoring criteria. Responders to EGF were defined as having an RTOG grade of 2 or lower at the fourth- or fifth-week examinations during RT, but an enduring RTOG grade 2 for 2 weeks was an exception.
  
  
  RESULTS
  Of the 113 patients included in the study, 28 received placebo and 29 received EGF at 10 microg/mL, 29 at 50 microg/mL, and 27 at 100 microg/mL. EGF significantly reduced the incidence of severe oral mucositis at the primary endpoint (a 64% response was observed with 50 microg/mL EGF vs a 37% response in the control group; P = .0246).
  
  
  CONCLUSIONS
  The EGF oral spray may have potential benefit for oral mucositis in patients undergoing RT for head and neck cancer. Phase 3 studies are ongoing to confirm these results.
authors.affiliation: Department of Radiation Oncology and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Hong Gyun
authors.initials: HG
authors.lastname: Wu
authors.forename: Si Yeol
authors.initials: SY
authors.lastname: Song
authors.forename: Yeon Sil
authors.initials: YS
authors.lastname: Kim
authors.forename: Young Taek
authors.initials: YT
authors.lastname: Oh
authors.forename: Chang Geol
authors.initials: CG
authors.lastname: Lee
authors.forename: Ki Chang
authors.initials: KC
authors.lastname: Keum
authors.forename: Yong Chan
authors.initials: YC
authors.lastname: Ahn
authors.forename: Sang-wook
authors.initials: SW
authors.lastname: Lee
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004815:Epidermal Growth Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006258:Head and Neck Neoplasms / Q000150:complications / Q000188:drug therapy / Q000532:radiotherapy*; D006801:Humans; D008875:Middle Aged; D010919:Placebos; D011832:Radiation Injuries / Q000188:drug therapy; D011994:Recombinant Proteins / Q000627:therapeutic use; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology
chemical_list: D010919:Placebos; D011994:Recombinant Proteins; D004815:Epidermal Growth Factor