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Preventing Oral Mucositis in Cancer Treatment

Recombinant human intestinal trefoil factor produced encouraging results.

Chemotherapy- or radiation-induced oral mucositis (OM) can cause pain, difficulty in eating, and other complications that adversely affect quality of life; when severe, OM can interrupt treatment or necessitate treatment modifications. Unfortunately, few effective preventive or therapeutic approaches exist for OM. The mucosa of the gastrointestinal tract is naturally protected and repaired by intestinal trefoil factor (ITF), a peptide produced by mucin-secreting glands. In studies in which the mucosa was exposed to toxic substances, a new potential OM remedy — a recombinant human form of ITF (rhITF) — prevented mucosal breakdown and helped in its restoration. Now, in a phase II trial, investigators have examined the effects of rhITF administered in an oral spray to colorectal cancer patients who were at high risk for developing recurrent chemotherapy-associated OM.

Ninety-nine study participants — all of whom experienced WHO grade 2 OM during their first chemotherapy cycle that fully resolved before their second cycle — were randomized to one of three treatments: placebo spray, low-dose rhITF spray, or high-dose rhITF spray (each administered 8 times daily for 14 days). Patients began treatment on the first day of the second chemotherapy cycle and were assessed for the presence of grade 2 OM during this cycle. Grade 2 OM developed in 48.5%, 9.1%, and 9.1% of patients who received placebo, low-dose rhITF, and high-dose rhITF, respectively, and the proportions of patients without any signs of OM were 33.3%, 60.6%, and 69.7%. One patient who received high-dose rhITF developed grade 3 OM. Chemotherapy regimens and concomitant medications differed little among study groups. No clinically significant adverse events were associated with the sprays.

Comment: This study provides compelling preliminary data supporting the potential efficacy of orally administered rhITF for the prevention of OM. The rate of grade 2 OM decreased by 75% to 81% — a remarkable and clinically significant treatment effect — and treatment adherence was excellent (>97%) despite multiple daily dosing. Larger studies clearly are needed to confirm these findings. Although no dose-response effect with rhITF was evident here, such an effect might be more apparent in patients who tend to have more-profound OM, such as those who are treated for head and neck cancer or who undergo stem-cell transplantation; rhITF should be studied in these patients as well.

— Barbara A. Murphy, MD

Published in Journal Watch Oncology and Hematology October 27, 2009

Citation(s):

Peterson DE et al. 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. J Clin Oncol 2009 Sep 10; 27:4333.

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