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 -Carotene Produces Sustained Remissions in Patients With Oral Leukoplakia
Results of a Multicenter Prospective Trial
H. S. Garewal, MD, PhD;
R. V. Katz, DMD, PhD;
F. Meyskens, MD;
J. Pitcock, MD;
D. Morse, DMD;
S. Friedman, RN;
Y. Peng, PhD;
D. G. Pendrys, DDS, PhD;
S. Mayne, PhD;
D. Alberts, MD;
T. Kiersch, DDS;
E. Graver, MS
Arch Otolaryngol Head Neck Surg. 1999;125:1305-1310.
Background  -Carotene has been reported to produce regressions in patients with oral leukoplakia, a premalignant lesion. However, previous studies have all been of short duration, with clinical response as the end point.
Objective To evaluate the duration of response and the need for maintenance therapy in subjects who respond to -carotene.
Methods In this multicenter, double-blind, placebo-controlled trial, subjects were given -carotene, 60 mg/d, for 6 months. At 6 months, responders were randomized to continue -carotene or placebo therapy for 12 additional months.
Results Fifty-four subjects were enrolled in the trial, with 50 being evaluable. At 6 months, 26 subjects (52%) had a clinical response. Twenty-three of the 26 responders completed the second, randomized phase. Only 2 (18%) of 11 in the -carotene arm and 2 (17%) of 12 in the placebo arm relapsed. Baseline biopsies were performed in all patients, with dysplasia being present in 19 (38%) of the 50 evaluable patients. A second biopsy was obtained at 6 months in 23 subjects who consented to this procedure. There was improvement of at least 1 grade of dysplasia in 9 (39%), with no change in 14 (61%). Nutritional intake was assessed using food frequency questionnaires. There was no change in carotenoid intake during the trial. Responders had a lower intake of dietary fiber, fruits, folate, and vitamin E supplements than did nonresponders. -Carotene levels were measured in plasma and oral cavity cells. Marked increases occurred during the 6-month induction. However, baseline levels were not restored in subjects taking placebo for 6 to 9 months after discontinuation of -carotene therapy.
Conclusions The activity of -carotene in patients with oral leukoplakia was confirmed. The responses produced were durable for 1 year.
From the Arizona Cancer Center (Drs Garewal, Peng, and Alberts, and Mss Friedman and Graver), the Arizona Health Sciences Center (Dr Kiersch), University of Arizona, and the Southern Arizona Veterans' Affairs Healthcare System (Dr Garewal and Ms Friedman), Tucson; the Departments of Behavioral Sciences and Dental Medicine (Drs Katz, Morse, and Pendrys), the University of Connecticut, Farmington; Cancer Center, the University of California, Irvine (Drs Meyskens and Pitcock); and the Department of Behavioral Science, Yale University School of Medicine, New Haven, Conn (Dr Mayne).
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