Beta-carotene produces sustained remissions in patients with oral leukoplakia : results of a multicenter prospective trial

Auteur(s) :
Garewal HS., Katz RV., Meyskens F.
Date :
Déc, 1999
Source(s) :
ARCHIVES OF OTOLARYNGOLOGY-HEAD & NECK SURGERY. #125:12 p1305-1310
Adresse :
"GAREWAL HS,SO ARIZONA VET AFFAIRS HEALTHCARE SYST,SECT HEMATOL ONCOL 1 111D 3601 S 6TH AVE;TUCSON,AZ 85723 USA.hgarewal@azcc.arizona.edu"

Sommaire de l'article

Background:
Beta-carotene has been reported to produce regressions in patients with oral leukoplakia, a pre- malignant 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 beta-carotene.Methods: In this multicenter, double-blind, placebo-controlled trial, subjects were given beta-carotene, 60 mg/d, for 6 months. At 6 months, responders were randomized to continue beta-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 beta-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. Beta-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 beta-carotene therapy.

Conclusions:
The activity of beta-carotene in patients with oral leukoplakia was confirmed. The responses produced were durable for 1 year.

Source : Pubmed
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