Photodynamic therapy for head and neck dysplasia and cancer.
OBJECTIVE
To determine the response of dysplasia, carcinoma in situ (CIS), and T1 carcinoma of the oral cavity and larynx to photodynamic therapy with porfimer sodium.


METHODS
Prospective trial.


METHODS
A National Cancer Institute-designated cancer institute.


METHODS
Patients with primary or recurrent moderate to severe oral or laryngeal dysplasia, CIS, or T1N0 carcinoma.


METHODS
Porfimer sodium, 2 mg/kg of body weight, was injected intravenously 48 hours before treatment. Light at 630 nm for photosensitizer activation was delivered from an argon laser or diode laser using lens or cylindrical diffuser fibers. The light dose was 50 J/cm(2) for dysplasia and CIS and 75 J/cm(2) for carcinoma.


METHODS
Response was evaluated at 1 week and at 1 month and then at 3-month intervals thereafter. Response options were complete (CR), partial (PR), and no (NR) response. Posttreatment biopsies were performed in all patients with persistent and recurrent visible lesions.


RESULTS
Thirty patients were enrolled, and 26 were evaluable. Mean follow-up was 15 months (range, 7-52 months). Twenty-four patients had a CR, 1 had a PR, and 1 had NR. Three patients with oral dysplasia with an initial CR experienced recurrence in the treatment field. All the patients with NR, a PR, or recurrence after an initial CR underwent salvage treatment. Temporary morbidities included edema, pain, hoarseness, and skin phototoxicity.


CONCLUSIONS
Photodynamic therapy with porfimer sodium is an effective treatment alternative, with no permanent sequelae, for oral and laryngeal dysplasia and early carcinoma.


BACKGROUND
clinicaltrials.gov Identifier: NCT00530088.
Rigual
Nestor R
NR
Department of Head and Neck Surgery/Plastic and Reconstructive Surgery, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. nestor.rigual@roswellpark.org
Thankappan
Krishnakumar
K
Cooper
Michele
M
Sullivan
Maureen A
MA
Dougherty
Thomas
T
Popat
Saurin R
SR
Loree
Thom R
TR
Biel
Merrill A
MA
Henderson
Barbara
B
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology; D017323:Dihematoporphyrin Ether / Q000008:administration & dosage*; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D028022:Low-Level Light Therapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010778:Photochemotherapy / Q000379:methods*; D017319:Photosensitizing Agents / Q000008:administration & dosage*; D011230:Precancerous Conditions / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D016896:Treatment Outcome
D017319:Photosensitizing Agents; D017323:Dihematoporphyrin Ether
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