Abstract | 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.
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Authors | Te Vuong, Kevin Waschke, Tamim Niazi, Carole Richard, Josee Parent, Sender Liberman, Serge Mayrand, Rasmy Loungnarath, Barry Stein, Slobodan Devic |
Journal | International journal of radiation oncology, biology, physics
(Int J Radiat Oncol Biol Phys)
Vol. 80
Issue 5
Pg. 1505-11
(Aug 01 2011)
ISSN: 1879-355X [Electronic] United States |
PMID | 20656418
(Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article)
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Copyright | Copyright © 2011 Elsevier Inc. All rights reserved. |
Chemical References |
- Anti-Inflammatory Agents
- Botulinum Toxins, Type A
- Hydrocortisone
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Topics |
- Anti-Inflammatory Agents
(administration & dosage)
- Botulinum Toxins, Type A
(administration & dosage)
- Brachytherapy
(adverse effects, methods)
- Case-Control Studies
- Feasibility Studies
- Female
- Humans
- Hydrocortisone
(administration & dosage)
- Male
- Maximum Tolerated Dose
- Proctitis
(drug therapy)
- Radiation Injuries
(drug therapy)
- Rectal Neoplasms
(radiotherapy)
- Surveys and Questionnaires
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