title: Adjuvant intraoperative photodynamic therapy in head and neck cancer.
abstract: OBJECTIVE
  There is an immediate need to develop local intraoperative adjuvant treatment strategies to improve outcomes in patients with cancer who undergo head and neck surgery.
  
  
  OBJECTIVE
  To determine the safety of photodynamic therapy with 2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a (HPPH) in combination with surgery in patients with head and neck squamous cell carcinoma.
  
  
  METHODS
  Nonrandomized, single-arm, single-site, phase 1 study at a comprehensive cancer center among 16 adult patients (median age, 65 years) with biopsy-proved primary or recurrent resectable head and neck squamous cell carcinoma.
  
  
  METHODS
  Intravenous injection of HPPH (4.0 mg/m2), followed by activation with 665-nm laser light in the surgical bed immediately after tumor resection.
  
  
  METHODS
  Adverse events and highest laser light dose.
  
  
  RESULTS
  Fifteen patients received the full course of treatment, and 1 patient received HPPH without intraoperative laser light because of an unrelated myocardial infarction. Disease sites included larynx (7 patients), oral cavity (6 patients), skin (1 patient), ear canal (1 patient), and oropharynx (1 patient, who received HPPH only). The most frequent adverse events related to photodynamic therapy were mild to moderate edema (9 patients) and pain (3 patients). One patient developed a grade 3 fistula after salvage laryngectomy, and another patient developed a grade 3 wound infection and mandibular fracture. Phototoxicity reactions included 1 moderate photophobia and 2 mild to moderate skin burns (2 due to operating room spotlights and 1 due to the pulse oximeter). The highest laser light dose was 75 J/cm2.
  
  
  CONCLUSIONS
  The adjuvant use of HPPH-photodynamic therapy and surgery for head and neck squamous cell carcinoma seems safe and deserves further study.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00470496.
authors.affiliation: Department of Head and Neck Surgery, Roswell Park Cancer Institute, Buffalo, New York, USA. nestor.rigual@roswellpark.org
authors.forename: Nestor R
authors.initials: NR
authors.lastname: Rigual
authors.forename: Gal
authors.initials: G
authors.lastname: Shafirstein
authors.forename: Jennifer
authors.initials: J
authors.lastname: Frustino
authors.forename: Mukund
authors.initials: M
authors.lastname: Seshadri
authors.forename: Michele
authors.initials: M
authors.lastname: Cooper
authors.forename: Gregory
authors.initials: G
authors.lastname: Wilding
authors.forename: Maureen A
authors.initials: MA
authors.lastname: Sullivan
authors.forename: Barbara
authors.initials: B
authors.lastname: Henderson
mesh_terms: D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002734:Chlorophyll / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D007430:Intraoperative Care; D007834:Lasers; D008297:Male; D010778:Photochemotherapy / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D002734:Chlorophyll; C083998:2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a