What question did this study set out to answer?

To validate transforming growth factor-alpha (TGF-alpha) and epidermal growth factor receptor (EGFR) mRNA expression as surrogate endpoint biomarkers in oral leukoplakia chemoprevention trials.

August 1, 2002Journal of the American College of Surgeons

Transforming Growth Factor-α: A Surrogate Endpoint Biomarker?1

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To validate transforming growth factor-alpha (TGF-alpha) and epidermal growth factor receptor (EGFR) mRNA expression as surrogate endpoint biomarkers in oral leukoplakia chemoprevention trials.
Conducted a prospective, randomized, double-blind trial evaluating 13-cis retinoic acid (13-CRA) in N=28 patients with dysplastic oral leukoplakia (DOL).
Measured TGF-alpha and EGFR mRNA expression in sequential biopsies of DOL lesions and adjacent normal mucosa using quantitative competitive reverse transcriptase-PCR, analyzed with Wilcoxon signed-rank tests.
Baseline TGF-alpha mRNA was significantly elevated in DOL lesions compared with adjacent normal-appearing mucosa (p = 0.003), whereas baseline EGFR mRNA was not significantly altered.
Patients receiving 13-CRA with ≥50% clearance of DOL exhibited significant down-modulation of TGF-alpha mRNA overexpression after 6 months (p = 0.016), and baseline overexpression tended to predict clinical response (p = 0.066).

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Implication

Randomized double-blind trial demonstrates that 13-cis retinoic acid modulates elevated TGF-alpha expression in dysplastic oral leukoplakia, suggesting its utility as a response biomarker.

Cite This Study

Beenken et al. (2002) studied this question.

synapsesocial.com/papers/6a9e3b290bfbee156fd6f235 https://doi.org/10.1016/s1072-7515(02)01219-x

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Implication

Randomized double-blind trial demonstrates that 13-cis retinoic acid modulates elevated TGF-alpha expression in dysplastic oral leukoplakia, suggesting its utility as a response biomarker.

Transforming Growth Factor-α: A Surrogate Endpoint Biomarker?1

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Discussion

Implication

Cite This Study

Transforming Growth Factor-α: A Surrogate Endpoint Biomarker?1

Key Points

Discussion

Implication

Cite This Study

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