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

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.

Actual duration of patient-reported mucositis: Far longer than 2 to 4 weeks and may be avoidable altogether

The impression that oral mucositis is a brief 14–28 day-consequence of chemoradiation is misguided. Clinically significant patient-reported oral mucositis may last 46 to 102 days depending on the treatment schedule and the modality used. The process of mucositis can occur in the epithelium throughout the entire GI tract and may possibly be avoided with the prescribed use of high potency polymerized cross-linked sucralfate (HPPCLS). Literature review of patient-reported mucositis occuring in the three common schedules of cancer treatment administration: daily radiation therapy, induction-based hematopoietic stem cell transplantation (HSCT), and multi-cycle chemo/immunotherapy (CT-IT). Review articles published in last 15 years focused on treatment-induced oral mucositis. The author reviewed 56 articles published in 15 years from 1999–2014 that focused primarily on treatment-induced oral mucositis. Only 6 were found to meet the criteria of providing patient-reported data from the beginning, throughout and following cancer treatment. For HSCT, radiation therapy, and CT-IT, despite active anti-mucositis treatment, patient-reported oral mucositis lasted 46–60 days, 70–84 days, and 68–102 days, respectively. Mucositis caused by cancer treatment, regardless of modality, lasts far longer than the oft quoted 2–4 weeks (range, 14–28 days). Patient reported mucositis persists from 46 to 102 days. This patient-based experience is the primary cause of treatment interruptions, delays or cancellations. It may be avoidable with HPPCLS that both prevents and rapidly reverses mucositis anywhere it occurs within the gastrointestinal tract.