Korean J Clin Oncol.  2017 Jun;13(1):10-24. 10.14216/kjco.17002.

Elimination of unplanned treatment breaks and dose reductions caused by mucositis: Positive implications for survival outcomes and cost reductions using high potency polymerized cross-linked sucralfate in 55 patients undergoing radiation for head and neck cancer with and without chemotherapy

• McCullough RW

• KMID: 2387994
• DOI: http://doi.org/10.14216/kjco.17002

Abstract

PURPOSE
Annually 27,855 patients in Korea develop treatment-induced mucositis nearly doubling the cost of cancer care. It is an emergency medical condition causing unplanned treatment breaks in 4,998 patients. The subsequent reduction in optimal dose-intensity causes premature deaths due to lower 5-year survival. An additional 216 patients die from mucositis-mediated sepsis and infection. Thus complete elimination of mucositis will immediately reduce the cost of care while simultaneously eliminating 5,214 mucositis-associated deaths. High potency polymerized cross-linked sucralfate (HPPCLS) cleared by the US Food and Drug Administration has been associated with the elimination of mucositis.
METHODS
Observational, self-reporting, practice-based mucositis registry. Inclusion criteria: any patient with chemoradiation-induced mucositis. Exclusion criteria: previous adverse reaction to sucralfate products. Primary outcome: rapid reversal or complete prevention. Conduct of study: 28 radiation oncologists from 21 different institutions prescribed HPPCLS to 55 patients undergoing chemoradiation for squamous cell carcinoma of head and neck and esophagus to eliminate mucositis-associated treatment breaks.
RESULTS
All patients with World Health Organization grade 1 (n=6), grade 2 (n=23), grade 3 (n=16) oral mucositis, and grade 2 esophageal mucositis (n=2) experienced complete reversal of mucositis. Within 2-3 days both mucosa and swallowing normalized. Anticipated grade 3/4 mucositis was prevented in 8 out of 8 elderly patients aged 78-93 avoiding gastrostomy tube placement. Statistical analysis of outcomes: Outcomes qualified as a positive Glasziou treatment effect that was statistically significant (P<0.05).
CONCLUSION
HPPCLS eliminated mucositis by rapid reversal or complete prevention, thereby eliminating unplanned treatment breaks. It may likely reduce mucositis-associated increased cost of care and premature deaths.

Keyword

Polymerized-Sucralfate; ProThelial; Mucositis; Unplanned-treatment-breaks; High potency polymerized cross-linked sucralfate

MeSH Terms

Aged
Carcinoma, Squamous Cell
Deglutition
Drug Therapy*
Emergencies
Esophagus
Gastrostomy
Head and Neck Neoplasms*
Head*
Humans
Korea
Mortality, Premature
Mucositis*
Mucous Membrane
Neck
Polymers*
Sepsis
Stomatitis
Sucralfate*
United States Food and Drug Administration
World Health Organization
Polymers
Sucralfate