Abstract:
BACKGROUND:Dysplastic oral leukoplakia (DOL) has been the index lesion in prevention trials for upper aerodigestive tract squamous cell carcinoma (SCC). Vitamin A derivatives, including 13-cis retinoic acid (13-CRA), have been used to treat DOL and to reduce the risk of subsequent SCC. Results from a trial of 13-CRA in patients with DOL are presented here. Transforming growth factor-alpha (TGF-alpha) and the epidermal growth factor receptor messenger RNA (mRNA) expression were studied to validate their use as surrogate endpoint biomarkers in prevention trials for SCC. STUDY DESIGN:In a prospective, randomized, double-blind trial of 13-CRA in 28 patients with DOL, TGF-alpha and epidermal growth factor receptor mRNA expression were analyzed in sequential biopsy specimens of DOL and of adjacent normal-appearing mucosa, utilizing a quantitative, competitive, reverse transcriptase polymerase chain reaction and were compared using the Wilcoxon signed-rank test for paired comparisons. RESULTS:In biopsy specimens of DOL, TGF-alpha mRNA expression at baseline, but not baseline expression of epidermal growth factor receptor mRNA, was significantly elevated when compared with its expression in specimens from adjacent normal-appearing mucosa (p = 0.003). In patients randomized to 13-CRA who had > or = 50% clearance of DOL during treatment, significant modulation of TGF-alpha mRNA overexpression was seen after 6 months of treatment (p = 0.016). TGF-alpha mRNA overexpression at baseline predicted a subsequent response to 13-CRA (p 0.066). CONCLUSIONS:The full extent of the association between TGF-alpha overexpression and the development of SCC is unknown. Evidence is presented in this article that TGF-alpha overexpression mediates the relationship between 13-CRA and DOL, but there is no direct evidence that it mediates the relationship between 13-CRA and the prevention of SCC. Determination of the extent to which TGF-alpha overexpression mediates this relationship and complete validation of TGF-alpha's role as a surrogate endpoint biomarker await the results of animal and human trials that utilize reduction in the incidence of SCC as their endpoint.
journal_name
J Am Coll Surgjournal_title
Journal of the American College of Surgeonsauthors
Beenken SW,Hockett R Jr,Grizzle W,Weiss HL,Pickens A,Perloff M,Malone WF,Bland KIdoi
10.1016/s1072-7515(02)01219-xkeywords:
subject
Has Abstractpub_date
2002-08-01 00:00:00pages
149-58issue
2eissn
1072-7515issn
1879-1190pii
S1072-7515(02)01219-Xjournal_volume
195pub_type
临床试验,杂志文章,随机对照试验abstract:BACKGROUND:Acinetobacter calcoaceticus-baumannii complex (Acb) is recognized as an important cause of nosocomial infections. Although Acb can be associated with multidrug resistance, its impact on mortality in burn patients has not been fully elucidated. STUDY DESIGN:In a retrospective cohort study assessing medical r...
journal_title:Journal of the American College of Surgeons
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journal_title:Journal of the American College of Surgeons
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