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Original Investigation |

Adjuvant Intraoperative Photodynamic Therapy in Head and Neck Cancer

Nestor R. Rigual, MD1,2,3; Gal Shafirstein, DSc1,2,3; Jennifer Frustino, PhD4; Mukund Seshadri, PhD5; Michele Cooper, RN3; Gregory Wilding, PhD6; Maureen A. Sullivan, DDS7; Barbara Henderson, PhD2,3
[+] Author Affiliations
1Department of Head and Neck Surgery, Roswell Park Cancer Institute, Buffalo, New York
2Department of Cell Stress Biology, Roswell Park Cancer Institute, Buffalo, New York
3Photodynamic Therapy Center, Roswell Park Cancer Institute, Buffalo, New York
4Division of Oral Medicine and Dentistry, Brigham and Women’s Hospital, Boston, Massachusetts
5Department of Pharmacology and Therapeutics, Roswell Park Cancer Institute, Buffalo, New York
6Department of Biostatistics and Bioinformatics, Roswell Park Cancer Institute, Center of Excellence, Buffalo, New York
7Dentistry and Maxillofacial Prosthetics, Roswell Park Cancer Institute, Buffalo, New York
JAMA Otolaryngol Head Neck Surg. 2013;139(7):706-711. doi:10.1001/jamaoto.2013.3387.
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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  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.

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  Intravenous injection of HPPH (4.0 mg/m2), followed by activation with 665-nm laser light in the surgical bed immediately after tumor resection.

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  The adjuvant use of HPPH-photodynamic therapy and surgery for head and neck squamous cell carcinoma seems safe and deserves further study.

Trial Registration  clinicaltrials.gov Identifier: NCT00470496

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Figure 1.
Photodynamic Therapy Illustrated by Process Layout

Photodynamic therapy requires the 3 elements of light, photosensitizer, and oxygen. Light of a specific wavelength activates a specific photosensitizer. This activation results in the creation of singlet oxygen, which in turn destroys tissue by intracellular oxidation, shutdown of the microvasculature, and concomitant upregulated immune response at the tumor site and humorally.

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Figure 2.
Finger and Nail Burn From Prolonged Exposure to Red Pulse Oximeter Light
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