Abstract | OBJECTIVE: DESIGN: 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. SETTING: Tertiary medical centers. PATIENTS: 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. INTERVENTION: MAIN OUTCOME MEASURES: 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.
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Authors | Mark J Shikowitz, Allan L Abramson, Bettie M Steinberg, James DeVoti, Vincent R Bonagura, Virginia Mullooly, May Nouri, Avigdor M Ronn, Andrew Inglis, John McClay, Kathrine Freeman |
Journal | Archives of otolaryngology--head & neck surgery
(Arch Otolaryngol Head Neck Surg)
Vol. 131
Issue 2
Pg. 99-105
(Feb 2005)
ISSN: 0886-4470 [Print] United States |
PMID | 15723939
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Mesoporphyrins
- Photosensitizing Agents
- temoporfin
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Topics |
- Adolescent
- Adult
- Child
- Child, Preschool
- Female
- Humans
- Laryngeal Neoplasms
(drug therapy)
- Male
- Mesoporphyrins
(therapeutic use)
- Middle Aged
- Papilloma
(drug therapy)
- Photochemotherapy
- Photosensitizing Agents
(therapeutic use)
- Remission Induction
- Treatment Outcome
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