β-Carotene Produces Sustained Remissions in Patients With Oral Leukoplakia&lt;subtitle&gt;Results of a Multicenter Prospective Trial&lt;/subtitle&gt;

Garewal, Harinder S.; Katz, R. V.; Meyskens, Frank L.; Pitcock, James J.; Morse, Donald R.; Friedman, S.; Peng, Yitian; Pendrys, David G.; Mayne, Susan T.; Alberts, David S.; Kiersch, Theodore A.; Graver, Ellen

doi:10.1001/archotol.125.12.1305

Cited by 77 publications

(44 citation statements)

References 30 publications

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“…The main reason for the high drop-out rate is thought to be related to the information provided at the time of entry to the trial, that the supplement may increase the risk of lung cancer. The overall response rate of 17.4% (95%, CI 1.9-32.9%) in this study is lower compared with the outcomes reported in previous studies (Table 4) [22][23][24][27][28][29] . This might be related to the lower dose of beta-carotene used here.…”

Section: Discussioncontrasting

confidence: 88%

“…It appears that the reported outcomes are not necessarily related to the dosage of supplements used, lengths of trials, or due to a combination of antioxidants. There were five RCTs on oral leukoplakia using betacarotene with or without additional chemopreventive agents, [22][23][24]27,29 and these achieved nearly 50% of overall response rate by the variety of trial designs. However, the timing of assessment for the clinical response was not discussed clearly and none of the studies followed up beyond 15 months.…”

Section: Discussionmentioning

confidence: 99%

“…Based on three earlier studies [22][23][24] that used beta-carotene for the treatment of oral leukoplakia, the anticipated overall response rate (CR1PR) in the experimental arm was estimated at 50% and 10% in the control arm. The sample size required for the trial was estimated to be 20…”

Section: Power and Sample Calculationmentioning

confidence: 99%

See 2 more Smart Citations

Treatment of oral leukoplakia with a low‐dose of beta‐carotene and vitamin C supplements: A randomized controlled trial

Nagao

Warnakulasuriya

Nakamura

et al. 2014

Intl Journal of Cancer

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Management of oral leukoplakia-a potentially malignant disorder-is currently not evidence-based. Of the few randomized trials that have been reported, most have negative data. Therefore, a multi-centre, randomized, double-blind controlled trial (RCT) was undertaken to evaluate the use of low-dose beta-carotene combined with vitamin C supplements for the treatment and to prevent malignant transformation of oral leukoplakia. 46 Japanese participants with oral leukoplakia were allocated randomly either to an experimental arm (10 mg day 21 of beta-carotene and 500 mg day 21 of vitamin C) or placebo arm (50 mg day 21 of vitamin C). Current or ex-smokers within 3 months of cessation were excluded. The supplements were continued over a period of 1 year. The primary endpoint was clinical remission at 1-year and the likelihood of malignant transformation during a 5-year follow-up period as a secondary endpoint. The overall clinical response rate in the experimental arm was 17.4% (4/23) and 4.3% (1/23) in the placebo arm (p 5 0.346). During the median 60-month follow-up period, two subjects in the experimental arm and three in the control arm developed oral cancer. Under the intention-to-treat principle, relative risk by supplementing with beta-carotene and vitamin C was 0.77 (95%CI: 0.28-1.89) (p 5 0.580) by the Cox proportional hazards model. No unfavorable side-effects were noted. Beta-carotene (10 mg day 21 ) and vitamin C were neither effective for clinical remission, nor for protection against the development of cancer. Data from this RCT does not support the hypothesis that chemoprevention with this treatment is effective for oral leukoplakia.Oral leukoplakia-a potentially malignant disorder of the oral cavity-is associated with an increased risk of oral cancer. 1 Although a number of options for treatment of oral leukoplakia are available, 2 there is a lack of consensus on the most appropriate method of management and ways to minimize malignant transformation. 3 Tobacco and alcohol misuse are significant risk factors for the development of oral leukoplakia. 4 While it is possible to treat tobacco dependence, 5 the compliance of users and resources offered by healthcare delivery systems have been disappointing. Surgical and laser treatment of oral leukoplakia, although reducing the risk of malignant transformation, is at times associated with recurrences. 6 In this context, a medical treatment for leukoplakia is attractive, particularly if a chemopreventive agent that is effective and safe, and produces lasting benefit, can be found. 7,8 In 1981, Peto et al. hypothesized that high dietary intake of carotenoids may reduce cancer among humans. 9 Observational studies on diet suggest that its role in cancer prevention is mainly related to antioxidants in foods and/or beverages. 10,11 The incidence of a number of cancer types (i.e. lung, oral, pharyngeal and stomach) are inversely related to beta-carotene intake or blood concentrations. 12,13 A Japanese population study reported that high serum beta-carotene levels wer...

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Section: Discussioncontrasting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

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Treatment of oral leukoplakia with a low‐dose of beta‐carotene and vitamin C supplements: A randomized controlled trial

Nagao

Warnakulasuriya

Nakamura

et al. 2014

Intl Journal of Cancer

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“…conservative treatment: Can be done by [26,27]. Recurrences were seen after treating the patients conservatively.…”

Section: Treatmentmentioning

confidence: 99%

Leuloplakia - Review of A Potentially Malignant Disorder

Abidullah

Grover²,

Gaddikeri

et al. 2014

JCDR

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“…There is extensive evidence that β-carotene can produce major changes in immune cellular marker expression in vivo in humans (Prabhala, 1991), and has in fact been studied as a chemopreventive agent in the treatment of several precancerous lesions like oral leukoplakia, cervical dysplasia, breast carcinoma and esophageal adenocarcinoma (Cameron, 1995;Katz, 1998;Terry, 2000;Mayne, 2001;Bosetti, 2004;Nkondjock, 2004;SolaymaniDodaran, 2004). Regression of oral leukoplakia and gastric dysplasia with β-carotene therapy has been demonstrated in several clinical trials (Stich, 1988;Sankaranarayanan, 1997;Garewal, 1999;Correa, 2000). In addition, several animal studies have demonstrated evidence for inhibition of hepatic and pancreatic carcinogenesis by β-carotene therapy (Tsuda, 1994;Sarkar, 1995;Appel, 1996;Dagli, 1998;Majima, 1998).…”

Section: Barrett's Esophagus and β-Carotene Therapy: Symptomatic Imprmentioning

confidence: 99%

Barrett's Esophagus and β-carotene Therapy: Symptomatic Improvement in GERD and Enhanced HSP70 Expression in Esophageal Mucosa

Dutta

Agrawal

Girotra

et al. 2012

Asian Pacific Journal of Cancer Prevention

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Introduction: Epidemiological studies suggest a protective role for β-carotene with several malignancies. Esophageal adenocarcinoma frequently arises from Barrett's esophagus (BE). We postulated that β-carotene therapy maybe protective in BE. Materials and Method: We conducted a prospective study in which 25 mg of β-carotene was administered daily for six-months to six patients. Each patient underwent upper endoscopy before and after therapy and multiple mucosal biopsies were obtained. Additionally, patients completed a gastroesophageal reflux disease (GERD) symptoms questionnaire before and after therapy and severity score was calculated. To study the effect of β-carotene at molecular level, tissue extracts of the esophageal mucosal biopsy were subjected to assessment of heat-shock protein 70 (HSP70). Results: A significant (p<0.05) reduction in mean GERD symptoms severity score from 7.0±2.4 to 2.7±1.7 following β-carotene therapy was noted. Measurement of Barrett's segment also revealed a significant reduction in mean length after therapy. In fact, two patients had complete disappearance of intestinal metaplasia. Furthermore, marked enhancement of HSP70 expression was demonstrated in biopsy specimens from Barrett's epithelium in four cases that were tested. Conclusions: Longterm β-carotene therapy realizes amelioration of GERD symptoms along with restitution of the histological and molecular changes in esophageal mucosa of patients with BE, associated with concurrent increase in mucosal HSP70 expression.

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β-Carotene Produces Sustained Remissions in Patients With Oral Leukoplakia<subtitle>Results of a Multicenter Prospective Trial</subtitle>

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

Cited by 77 publications

References 30 publications

Treatment of oral leukoplakia with a low‐dose of beta‐carotene and vitamin C supplements: A randomized controlled trial

Treatment of oral leukoplakia with a low‐dose of beta‐carotene and vitamin C supplements: A randomized controlled trial

Leuloplakia - Review of A Potentially Malignant Disorder

Barrett's Esophagus and β-carotene Therapy: Symptomatic Improvement in GERD and Enhanced HSP70 Expression in Esophageal Mucosa

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