title: A Presurgical Study of Lecithin Formulation of Green Tea Extract in Women with Early Breast Cancer.
abstract: Epidemiologic data support an inverse association between green tea intake and breast cancer 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 circulating biomarkers in breast cancer patients. Twelve early breast cancer patients received GSP 300 mg, equivalent to 44.9 mg of EGCG, 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, breast cancer tissue, and surrounding normal breast tissue. Fasting blood samples were taken at baseline, before the last administration, and 2 hours later. Repeated administration of GSP achieved levels of total EGCG ranging from 17 to 121 ng/mL in plasma. Despite a high between-subject variability, total EGCG was detectable in all tumor tissue samples collected up to 8 ng/g. Median total EGCG concentration was higher in the tumor as compared with the adjacent normal tissue (3.18 ng/g vs. 0 ng/g,P= 0.02). Free EGCG concentrations ranged from 8 to 65.8 ng/mL in plasma (Pbetween last administration and 2 hours after <0.001). Free EGCG plasma levels showed a significant positive correlation with the Ki-67 decrease in tumor tissue (P= 0.02). No change in any other biomarkers was noted, except for a slight increase in testosterone levels after treatment. Oral GSP increases bioavailability of EGCG, which is detectable in breast tumor tissue and is associated with antiproliferative effects on breast cancer tissue.Cancer Prev Res; 10(6); 363-9. ©2017 AACR.
authors.affiliation: Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy. matteo.lazzeroni@ieo.it.
authors.forename: Matteo
authors.initials: M
authors.lastname: Lazzeroni
authors.affiliation: Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors.forename: Aliana
authors.initials: A
authors.lastname: Guerrieri-Gonzaga
authors.affiliation: Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Gandini
authors.affiliation: Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors.forename: Harriet
authors.initials: H
authors.lastname: Johansson
authors.affiliation: Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Serrano
authors.affiliation: Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Cazzaniga
authors.affiliation: Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Aristarco
authors.affiliation: Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors.forename: Debora
authors.initials: D
authors.lastname: Macis
authors.affiliation: Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors.forename: Serena
authors.initials: S
authors.lastname: Mora
authors.affiliation: Division of Senology, European Institute of Oncology, Milan, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Caldarella
authors.affiliation: Division of Senology, European Institute of Oncology, Milan, Italy.
authors.forename: Gianmatteo
authors.initials: G
authors.lastname: Pagani
authors.affiliation: Division of Pathology, European Institute of Oncology, Milan, Italy.|University of Milan, School of Medicine, Milan, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Pruneri
authors.affiliation: INDENA S.p.A, Milan, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Riva
authors.affiliation: INDENA S.p.A, Milan, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Petrangolini
authors.affiliation: INDENA S.p.A, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Morazzoni
authors.affiliation: Division of Medical Oncology, E.O. Ospedali Galliera, Genoa, Italy.|Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, United Kingdom.
authors.forename: Andrea
authors.initials: A
authors.lastname: DeCensi
authors.affiliation: Division of Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.
authors.forename: Bernardo
authors.initials: B
authors.lastname: Bonanni
mesh_terms: D000284:Administration, Oral; D016588:Anticarcinogenic Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use; D001682:Biological Availability; D014408:Biomarkers, Tumor / Q000097:blood; D001706:Biopsy; D001940:Breast / Q000473:pathology / Q000601:surgery; D001943:Breast Neoplasms / Q000097:blood / Q000628:therapy*; D028241:Camellia sinensis / Q000737:chemistry*; D002392:Catechin / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D049109:Cell Proliferation / Q000187:drug effects; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006801:Humans; D006868:Hydrolysis; D054709:Lecithins / Q000737:chemistry; D008408:Mastectomy; D008875:Middle Aged; D010865:Pilot Projects; D010936:Plant Extracts / Q000493:pharmacokinetics* / Q000627:therapeutic use; D053719:Tandem Mass Spectrometry; D013739:Testosterone / Q000097:blood; D014018:Tissue Distribution
chemical_list: D016588:Anticarcinogenic Agents; D014408:Biomarkers, Tumor; D054709:Lecithins; D010936:Plant Extracts; D013739:Testosterone; D002392:Catechin; C045651:epigallocatechin gallate