Journal of Clinical Oncology, Vol 10, 1963-1968, Copyright © 1992 by American Society of Clinical Oncology
Clinical evaluation of MGI 209, an anesthetic, film-forming agent for relief from painful oral ulcers associated with chemotherapy
FG LeVeque, JB Parzuchowski, GC Farinacci, SW Redding, B Rodu, JT Johnson, GA Ferretti, PD Eisenberg and MB Zimmer
Harper Hospital, Detroit, MI 48201.
PURPOSE: This open-label, multicenter trial evaluated the efficacy of a
mucoadherent, anesthetic medication (MGI 209) for relief from painful oral
ulcers associated with cytotoxic chemotherapy. PATIENTS AND METHODS:
Twenty-eight eligible cancer patients who had up to five discrete oral
ulcers (total area < or = 5 cm2) completed this study. Mean age was 53.5
years (range, 21 to 81). Subjective assessments of oral discomfort before
and after an orange juice pain challenge (OJPC), which was measured using a
visual analog scale (VAS), and visual estimates of the amount of MGI 209
that remained on treated ulcers were collected at (1) baseline (before MGI
209 treatment); and (2) 30, 60, 120, and 180 minutes posttreatment.
RESULTS: Most subjects had low VAS scores (4 or less), which was indicative
of oral discomfort, at baseline before and after the OJPC. At 30, 60, 120,
and 180 minutes after MGI 209 treatment, most subjects had high VAS scores
before and after an OJPC compared with baseline scores, which was
indicative of a substantial increase in oral comfort; these differences
were statistically significant (P < .0001). Mean percent of MGI 209
estimated to remain on ulcers at the previously mentioned times was 93.7%,
90.3%, 79.6%, and 71.3% of the total amount applied, respectively.
CONCLUSION: Benzocaine hydrochloride in combination with the protective,
mucoadherent film-coating relieved discomfort for at least 3 hours even
with exposure to an irritating beverage. MGI 209 treatment should allow
patients with chemotherapy-induced oral ulcers to drink and eat with
significantly diminished pain or no pain.
