Cancer Prevention Research CM8 AM No Deadline
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Cancer Prevention Research 2, 931, November 1, 2009. doi: 10.1158/1940-6207.CAPR-09-0121
© 2009 American Association for Cancer Research
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Research Articles

Phase II Randomized, Placebo-Controlled Trial of Green Tea Extract in Patients with High-Risk Oral Premalignant Lesions

Anne S. Tsao1, Diane Liu2, Jack Martin3, Xi-ming Tang1,4, J. Jack Lee2, Adel K. El-Naggar4, Ignacio Wistuba1,4, Kirk S. Culotta5, Li Mao1, Ann Gillenwater6, Yuko M. Sagesaka7, Waun K. Hong1 and Vassiliki Papadimitrakopoulou1

Authors' Affiliations: Departments of 1 Thoracic/Head and Neck Medical Oncology, 2 Biostatistics, 3 Dental Oncology, 4 Pathology, 5 Pharmacy-Pharmacology Research, and 6 Head and Neck Surgery, The University of Texas M. D. Anderson Cancer Center, Houston, Texas and 7 Ito En Ltd., Central Research Institute, Tokyo, Japan

Requests for reprints: Vassiliki Papadimitrakopoulou, Department of Thoracic/Head and Neck Medical Oncology, M. D. Anderson Cancer Center, Unit 432, 1515 Holcombe Boulevard, Houston, TX 77030. Phone: 713-792-6363; Fax: 713-792-1220; E-mail: vpapadim{at}mdanderson.org.

Epidemiologic and preclinical data support the oral cancer prevention potential of green tea extract (GTE). We randomly assigned patients with high-risk oral premalignant lesions (OPL) to receive GTE at 500, 750, or 1,000 mg/m2 or placebo thrice daily for 12 weeks, evaluating biomarkers in baseline and 12-week biopsies. The OPL clinical response rate was higher in all GTE arms (n = 28; 50%) versus placebo (n = 11; 18.2%; P = 0.09) but did not reach statistical significance. However, the two higher-dose GTE arms [58.8% (750 and 1,000 mg/m2), 36.4% (500 mg/m2), and 18.2% (placebo); P = 0.03] had higher responses, suggesting a dose-response effect. GTE treatment also improved histology (21.4% versus 9.1%; P = 0.65), although not statistically significant. GTE was well tolerated, although higher doses increased insomnia/nervousness but produced no grade 4 toxicity. Higher mean baseline stromal vascular endothelial growth factor (VEGF) correlated with a clinical (P = 0.04) but not histologic response. Baseline scores of other biomarkers (epithelial VEGF, p53, Ki-67, cyclin D1, and p16 promoter methylation) were not associated with a response or survival. Baseline p16 promoter methylation (n = 5) was associated with a shorter cancer-free survival. Stromal VEGF and cyclin D1 expression were downregulated in clinically responsive GTE patients and upregulated in nonresponsive patients at 12 weeks (versus at baseline). An extended (median, 27.5 months) follow-up showed a median time to oral cancer of 46.4 months. GTE may suppress OPLs, in part through reducing angiogenic stimulus (stromal VEGF). Higher doses of GTE may improve short-term (12-week) OPL outcome. The present results support longer-term clinical testing of GTE for oral cancer prevention.

Key Words: green tea extract • oral premalignant lesions • chemoprevention


Commentary

Oral Cancer Prevention Advances with a Translational Trial of Green Tea
Dong M. Shin
Cancer Prevention Research 2009 2: 919-921. [Abstract] [Full Text] [PDF]



This article has been cited by other articles:


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D. M. Shin
Oral Cancer Prevention Advances with a Translational Trial of Green Tea
Cancer Prevention Research, November 1, 2009; 2(11): 919 - 921.
[Abstract] [Full Text] [PDF]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
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Molecular Cancer Research Cancer Prevention Research
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Annual Meeting Education Book Meeting Abstracts Online
Copyright © 2009 by the American Association for Cancer Research.