Abstract CT122: A presurgical study of lecithin formulation of green tea extract in women with early breast cancer
Authors: Lazzeroni Matteo , Guerrieri-Gonzaga Aliana , Gandini Sara , Johansson Harriet , Serrano Davide , Caldarella Pietro , Pagani Gianmatteo , Arnone Paolo , Pruneri Giancarlo , Aristarco Valentina , Puccio Antonella , Mora Serena , Riva Antonella , Petrangolini Giovanna , Morazzoni Paolo , Bonanni Bernardo 
Published: July 2016

Abstract
Background: Epidemiologic data support an inverse association between green tea intake and breast cancer (BC) risk. Greenselect® Phytosome® (GSP) is a lecithin formulation of a caffeine-free green tea catechin extract. The purpose of the study was to determine the tissue distribution of Epigallocatechin 3-O-gallate (EGCG) and its effect on cell proliferation and other biomarkers in BC patients undergoing surgery. Methods: Twelve early BC patients received GSP, 300 mg daily for 4 weeks prior to surgery. The EGCG levels were measured before (free-) and after (total-) enzymatic hydrolysis by HPLC-MS/MS in plasma, urine, BC tissue and surrounding normal tissue. Fasting blood samples were taken at baseline, before the last administration and 2 hours later. Women were asked to avoid any tea for at least 14 days prior the beginning of the study and for the entire duration of the study. Results: All patients were fully compliant and completed the treatment program. No toxicity was observed. Free-EGCG and Total-EGCG were undetectable in baseline samples except for 1 patient with total-EGCG of 1 ng/mL in plasma. Despite a high between-subject variability, total EGCG was detectable in all tumor tissue samples collected (n = 8). Repeated administration of GSP achieved levels of total-EGCG ranging from 17 to 121 ng/mL in plasma, and up to 8 ng/g in BC tissue. Median total-EGCG concentration was higher in the tumor as compared to the adjacent normal tissue (P = 0.01).Urine EGCG levels correlated inversely with concentration in normal tissue (P = 0.01). Free-EGCG concentrations ranged from 8 to 65 ng/mL in plasma, but were under the limit of quantitation in tumor tissue and present in traces in adjacent normal breast tissue. Conclusions: Compared to other green tea extracts, GSP taken orally, appears to increase bioavailability of EGCG which selectively accumulates in breast tumor tissue. Biomarkers of activity will be presented at the conference. Median (Q1-Q3) concentrations after supplementation:Urine-final ng/mLPlasma-end ng/mLPlasma-end-2h ng/mLBreast-K ng/gBreast-N ng/gTotal-EGCG4.7 (3.3, 5.4)20.3 (14.7, 30.7)89.0 (50.9, 111.4)3.2 (2.7, 4.6)0.50 (0.5,2.3)end: before the last administration; end-2h: 2 hours after the last administration; value below the detectable level were imputed as 0.5. K: cancer tissue; N: normal tissue; P-value from Wilcoxon-rank test.
Citation Format: Matteo Lazzeroni, Aliana Guerrieri-Gonzaga, Sara Gandini, Harriet Johansson, Davide Serrano, Pietro Caldarella, Gianmatteo Pagani, Paolo Arnone, Giancarlo Pruneri, Valentina Aristarco, Antonella Puccio, Serena Mora, Antonella Riva, Giovanna Petrangolini, Paolo Morazzoni, Bernardo Bonanni. A presurgical study of lecithin formulation of green tea extract in women with early breast cancer. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr CT122.