β-Carotene produces sustained remissions in patients with oral leukoplakia. Results of a multicenter prospective trial

Harinder S. Garewal, R. V. Katz, F. Meyskens, J. Pitcock, D. Morse, S. Friedman, Y. Peng, D. G. Pendrys, S. Mayne, D. Alberts, T. Kiersch, E. Graver

Research output: Contribution to journalArticle

Abstract

Background: β-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 β-carotene. Methods: In this multicenter, double-blind, placebo- controlled trial, subjects were given β- carotene, 60 mg/d, for 6 months. At 6 months, responders were randomized to continue β-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 β-carotene arm and 2 (17%) of 12 in the placebo arm relapsed. Baseline biopsies were per- formed in all patients, with displasia 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. β-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 β-carotene therapy. Conclusions: The activity of β-carotene in patients with oral leukoplakia was confirmed. The responses produced were durable for 1 year.

Original languageEnglish (US)
Pages (from-to)1305-1310
Number of pages6
JournalArchives of Otolaryngology - Head and Neck Surgery
Volume125
Issue number12
DOIs
StatePublished - Dec 1999

ASJC Scopus subject areas

  • Surgery
  • Otorhinolaryngology

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