Clinical trial of photodynamic therapy with meso-tetra (hydroxyphenyl) chlorin for respiratory papillomatosis.

Abstract

OBJECTIVE:

To determine the efficacy of photodynamic therapy (PDT) with meso-tetra (hydroxyphenyl) chlorin (m-THPC) photosensitizer for recurrent respiratory papillomatosis.

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:

Intravenous administration of m-THPC 6 days before direct endoscopic PDT with 80 to 100 J of light for adults and 60 to 80 J for children.

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.

• 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.)

Chemical References

• Mesoporphyrins
• Photosensitizing Agents
• temoporfin

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