Oncology Medical News about oral mucositis;recombinant human intestional Trefoil factor oral spray;colorectal cancer;Fluorouracil-based chemotherapy

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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
Journal of Clinical Oncology, 09/10/09

Peterson DE et al. – Recombinant human intestinal trefoil factor (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.

Methods

99 patients with CRC 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, 8 times qd) for 14 consecutive days in the second chemotherapy cycle
Patients were assessed on d1, 3, 5, 7, 10, 12, 14, and 21 for safety and for OM incidence and severity

Results

Tx 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; high-dose rhITF)
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

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