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The value of Botox-A in acute radiation proctitis: results from a phase I/II study using a three-dimensional scoring system.

Author(s): Vuong T, Waschke K, Niazi T, Richard C, Parent J, Liberman S, Mayrand S, Loungnarath R, Stein B, Devic S

Affiliation(s): Department of Radiation Oncology, McGill University, Montreal, Canada. tvuong@jgh.mcgill.ca

Publication date & source: 2011-08-01, Int J Radiat Oncol Biol Phys., 80(5):1505-11. Epub 2010 Jul 23.

Publication type: Clinical Trial, Phase I; Clinical Trial, Phase II

PURPOSE: Acute radiation proctitis (ARP) is a common side effect of pelvic radiotherapy, and its management is challenging in daily practice. The present phase I/II study evaluates the safety and efficacy of the botulinum toxin A (BTX-A) in ARP treatment for rectal cancer patients undergoing neoadjuvant high-dose-rate endorectal brachytherapy (HDREBT). METHODS AND MATERIALS: Fifteen patients, treated with neoadjuvant HDREBT, 26-Gy in 4 fractions, received the study treatment that consisted of a single injection of BTX-A into the rectal wall. The injection was performed post-HDREBT and prior to the development of ARP. The control group, 20 such patients, did not receive the BTX-A injection. Both groups had access to standard treatment with hydrocortisone rectal aerosol foam (Cortifoam) and anti-inflammatory and narcotic medication. The ARP was clinically evaluated by self-administered daily questionnaires using visual analog scores to document frequency and urgency of bowel movements, rectal burning/tenesmus, and pain symptoms before and after HDREBT. RESULTS: At the time of this analysis, there was no observed systemic toxicity. Patient compliance with the self-administered questionnaire was 100% from week 1 to 4, 70% during week 5, and 40% during week 6. The maximum tolerated dose was established at the 100-U dose level, and noticeable mean differences were observed in bowel frequency (p = 0.016), urgency (p = 0.007), and pain (p = 0.078). CONCLUSIONS: This study confirms the feasibility and efficacy of BTX-A intervention at 100-U dose level for study patients compared to control patients. A phase III study with this dose level is planned to validate these results. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Page last updated: 2011-12-09

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