title: Clinical trial of photodynamic therapy with meso-tetra (hydroxyphenyl) chlorin for respiratory papillomatosis.
abstract: OBJECTIVE
  To determine the efficacy of photodynamic therapy (PDT) with meso-tetra (hydroxyphenyl) chlorin (m-THPC) photosensitizer for recurrent respiratory papillomatosis.
  
  
  METHODS
  Parallel-arm, randomized trial of patients requiring surgery at least 3 times yearly with single PDT 6 or 18 months after enrollment and 12-month follow-up. Disease extent was scored and papillomas were removed during direct endoscopy every 3 months after enrollment.
  
  
  METHODS
  Tertiary medical centers.
  
  
  METHODS
  Of 23 patients aged 4 to 60 years enrolled in the study, 15 patients, plus 2 in the late group without PDT owing to airway risk, completed the study. Six patients withdrew voluntarily after PDT.
  
  
  METHODS
  Intravenous administration of m-THPC 6 days before direct endoscopic PDT with 80 to 100 J of light for adults and 60 to 80 J for children.
  
  
  METHODS
  Difference in severity scores between the early and late groups and between pre- and post-PDT scores for all patients. Secondary measures were the associations between baseline characteristics and response and changes in immune response and the prevalence of latent viral DNA.
  
  
  RESULTS
  There were significant differences between groups, with marked improvement in laryngeal disease across time after PDT (P = .006). Five of 15 patients were in remission 12 to 15 months after treatment, but there was recurrence of disease after 3 to 5 years. Tracheal disease was not responsive to PDT. No change occurred in the prevalence of latent human papillomavirus DNA. The immune response to virus improved with clinical response.
  
  
  CONCLUSIONS
  Use of m-THPC PDT reduces the severity of laryngeal papillomas, possibly through an improved immune response. Failure to maintain remission with time suggests that this is not an optimal treatment.
authors.affiliation: Department of Otolaryngology and Communicative Disorders, Long Island Jewish Medical Center, New Hyde Park, NY 11040, USA. mshikowi@lij.edu
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Shikowitz
authors.forename: Allan L
authors.initials: AL
authors.lastname: Abramson
authors.forename: Bettie M
authors.initials: BM
authors.lastname: Steinberg
authors.forename: James
authors.initials: J
authors.lastname: DeVoti
authors.forename: Vincent R
authors.initials: VR
authors.lastname: Bonagura
authors.forename: Virginia
authors.initials: V
authors.lastname: Mullooly
authors.forename: May
authors.initials: M
authors.lastname: Nouri
authors.forename: Avigdor M
authors.initials: AM
authors.lastname: Ronn
authors.forename: Andrew
authors.initials: A
authors.lastname: Inglis
authors.forename: John
authors.initials: J
authors.lastname: McClay
authors.forename: Kathrine
authors.initials: K
authors.lastname: Freeman
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007822:Laryngeal Neoplasms / Q000188:drug therapy*; D008297:Male; D008652:Mesoporphyrins / Q000627:therapeutic use*; D008875:Middle Aged; D010212:Papilloma / Q000188:drug therapy*; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D008652:Mesoporphyrins; D017319:Photosensitizing Agents; C072269:temoporfin