title: Oral pirfenidone in patients with chronic fibrosis resulting from radiotherapy: a pilot study.
abstract: BACKGROUND
  Fibrosis is a common side effect after treatment with ionizing radiation. Several methods to ameliorate debilitating fibrosis have been employed but without consistent results. The goal of this pilot study is to determine if Pirfenidone, a novel regulator of cytokine gene expression, has the potential to ameliorate established radiation-induced fibrosis.
  
  
  METHODS
  Open label, prospective pilot study of 800 mg three times/day, orally administered Pirfenidone was administered to enrolled patients who were had completed radiation therapy and who had established radiation-induced fibrosis. Range of motion (ROM) was assessed using standard measures, and subjective measures of pain, fatigue, disability and global health were measured every three months.
  
  
  RESULTS
  Seven patients were enrolled of whom 3 had ROM assessments of 1 site and 2 had ROM assessments of 2 sites. Of these assessments, 6 revealed increased ROM during drug intervention while 1 revealed a decreased ROM. There was an overall improvement in the mental composite score of the SF36 while physical composite score was decreased and the vitality score was unchanged. Two patients were removed from the study because of syncopal episodes.
  
  
  CONCLUSIONS
  Several patients experienced improved function of at least 25% and reported subjective improvement. Pirfenidone may benefit patients with radiation-induced fibrosis and is worthy of a larger well controlled trial.
authors.affiliation: Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, 9000 Rockville Pike, Building 10-CRC, Room B2-3561, Bethesda, Maryland 20892, USA. simonen@mail.nih.gov
authors.forename: Nicole L
authors.initials: NL
authors.lastname: Simone
authors.forename: Benjamin P
authors.initials: BP
authors.lastname: Soule
authors.forename: Lynn
authors.initials: L
authors.lastname: Gerber
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Augustine
authors.forename: Sharon
authors.initials: S
authors.lastname: Smith
authors.forename: Rosemary M
authors.initials: RM
authors.lastname: Altemus
authors.forename: James B
authors.initials: JB
authors.lastname: Mitchell
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Camphausen
mesh_terms: D000284:Administration, Oral; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D015331:Cohort Studies; D005355:Fibrosis / Q000188:drug therapy* / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010865:Pilot Projects; D011446:Prospective Studies; D011728:Pyridones / Q000008:administration & dosage*; D011832:Radiation Injuries / Q000188:drug therapy*; D011878:Radiotherapy / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011728:Pyridones; C093844:pirfenidone