Abstract | IMPORTANCE: 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. OBJECTIVES: DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: MAIN OUTCOMES AND MEASURES: 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 AND RELEVANCE: TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00470496.
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Authors | Nestor R Rigual, Gal Shafirstein, Jennifer Frustino, Mukund Seshadri, Michele Cooper, Gregory Wilding, Maureen A Sullivan, Barbara Henderson |
Journal | JAMA otolaryngology-- head & neck surgery
(JAMA Otolaryngol Head Neck Surg)
Vol. 139
Issue 7
Pg. 706-11
(Jul 2013)
ISSN: 2168-619X [Electronic] United States |
PMID | 23868427
(Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, N.I.H., Extramural)
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Chemical References |
- Chlorophyll
- 2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a
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Topics |
- Aged
- Carcinoma, Squamous Cell
(drug therapy, surgery)
- Chemotherapy, Adjuvant
- Chlorophyll
(analogs & derivatives, therapeutic use)
- Female
- Head and Neck Neoplasms
(drug therapy, surgery)
- Humans
- Intraoperative Care
- Lasers
- Male
- Photochemotherapy
(methods)
- Treatment Outcome
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