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.

A 66 Patient Multi-Institution Phase IV Post-Authorization Surveillance of ProThelial™ (High Potency Polymerized Cross-linked Sucralfate) -Single Agent Efficacy for the Prevention and Rapid Reversal of Chemo-radiation Induced Oral, Esophageal and Intestinal Mucositis.

Background: Standard potency sucralfate is not recommended by most clinical guidelines for prevention or treatment of oral and intestinal mucositis. However, its polymerized cross-linked (thereby high potency) formulation (HPPCLS) was cleared by the FDA for management of oral mucositis and has been associated with complete prevention and rapid reversal of oral, esophageal and intestinal mucositis. Statistically significant high quality evidence from a 66 patient multi-institution phase IV non-controlled observation study is reported here. Patients and Methods: In February 2014, as part of the Phase IV post-approval surveillance of HPPCLS, a non-interventional mucositis registry was established. The primary aim of the registry was the surveillance of patients’ tolerance of HPPCLS. A secondary aim was the observation of the prescribing pattern of oncologists using HPPCLS to manage chemo-radiation induced mucositis. Inclusion Criteria: Any cancer treatment patient who developed or was anticipated to develop oral mucositis and was prescribed HPPCLS. Exclusion Criteria: Allergies or prior adverse reactions to sucralfate. Conduct of Study: Patients identified by oncology clinical staff with mucositis or anticipated to develop mucositis, were prescribed a 75 ml single week-supply of HPPCLS as needed. Results: Thirty-nine oncologists from 32 institutions prescribed HPPCLS to 66 patients. No adverse reactions were reported. Five patients were lost to follow-up and 61 patients reported outcomes. Eight patients experienced successful prevention of mucositis averting placement of gastrostomy tube and the remaining 53 patients with WHO-Grade 1-3 mucositis involving the mouth, esophagus, small bowel & colon experienced reversal in 2-3 days. Though cleared for oral use only, 48 of 61 patients were instructed by oncologists to swallow HPPCLS following swish-and-gargle. Statistical Analysis: Quantitative Glasziou rate-ratio treatment effect beyond 10 (37-82 for HPPCLS) supported efficacy (p≤0.05). Conclusion: HPPCLS paste may offer oncologists a single-agent approach to manage chemo-radiation induced mucositis. To wit a protocol is offered for practical use.