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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.

AbstractPURPOSE:
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.
AuthorsTe Vuong, Kevin Waschke, Tamim Niazi, Carole Richard, Josee Parent, Sender Liberman, Serge Mayrand, Rasmy Loungnarath, Barry Stein, Slobodan Devic
JournalInternational 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
PMID20656418 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article)
CopyrightCopyright © 2011 Elsevier Inc. All rights reserved.
Chemical References
  • Anti-Inflammatory Agents
  • Botulinum Toxins, Type A
  • Hydrocortisone
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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