Originally published as JCO Early Release 10.1200/JCO.2008.21.2381 on July 27 2009

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Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Recombinant Human Intestinal Trefoil Factor Oral Spray for Prevention of Oral Mucositis in Patients With Colorectal Cancer Who Are Receiving Fluorouracil-Based Chemotherapy

From the Department of Oral Health and Diagnostic Sciences, School of Dental Medicine, and Head and Neck/Oral Oncology Program, Neag Comprehensive Cancer Center, University of Connecticut Health Center, Farmington, CT; The GI Company, Framingham, MA; Asubio Pharmaceuticals, Rochelle Park, NJ; City Oncology Dispensary, Kazan; Kirov Regional Clinical Oncology Dispensary, Kirov; Oncology Dispensary, Krasnodar; Regional Oncology Dispensary, Engels (Saratov Region); Ivanovo Regional Oncology Dispensary, Ivanovo; Lipetsk Regional Oncology Dispensary, Lipetsk; Samara Regional Oncology Dispensary, Samara; Ryazan Regional Clinical Oncology Dispensary, Ryazan; Scientific-Research Oncology Institute, St Petersburg; InnoPharm, Smolensk; and Ingenik; and ClinStar, Moscow, Russia.

Corresponding author: Douglas E. Peterson, DMD, PhD, Division of Oral and Maxillofacial Diagnostic Sciences, Department of Oral Health and Diagnostic Sciences, School of Dental Medicine, Head and Neck/Oral Oncology Program, Neag Comprehensive Cancer Center, University of Connecticut Health Center, 263 Farmington Ave, Farmington, CT 06030-1605; e-mail: peterson{at}nso.uchc.edu.

Purpose This study evaluated the safety and efficacy of recombinant human intestinal trefoil factor (rhITF) administered as topical oral spray for prevention and treatment of chemotherapy-induced oral mucositis (OM).

Patients and Methods Ninety-nine patients with colorectal cancer who had moderate to severe OM (WHO grade 2) in the first cycle of chemotherapy were randomly assigned to receive either placebo, rhITF 10 mg/mL (ie, low dose), or rhITF 80 mg/mL (ie, high dose) by oral spray (300 µL, eight times each day) for 14 consecutive days in the second chemotherapy cycle. Patients were assessed on days 1, 3, 5, 7, 10, 12, 14, and 21 (± 2 days for the last assessment) for safety and for OM incidence and severity.

Results Treatment of patients at high risk for developing OM with low- or high-dose rhITF significantly reduced the amount of incidence (75% to 81%; low-dose rhITF P < .001; high-dose rhITF P = .002). Frequencies of WHO grade 2 OM in the placebo, low-dose rhITF, and high-dose rhITF groups were 48.5%, 9.1%, and 12.1%, respectively. Assessment of the area under the curve revealed statistically significant reductions in OM severity in the rhITF-treated groups versus placebo. Only a minority of patients (6.1%) reported treatment-emergent adverse events (TEAEs), all of which were mild to moderate in intensity and resolved without sequelae. The incidence of TEAEs was not significantly different among treatment groups.

Conclusion rhITF oral spray formulation was safe and effective when used for the reduction of chemotherapy-associated OM in patients with colorectal cancer. Patients exhibited high compliance in dosing administration. Future clinical study is planned to develop this drug for use in OM management in patients with cancer.

Funded by The GI Company.

Presented in part at the 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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