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A Presurgical Study of Oral Silybin-Phosphatidylcholine in Patients with Early Breast Cancer.
- Source :
-
Cancer prevention research (Philadelphia, Pa.) [Cancer Prev Res (Phila)] 2016 Jan; Vol. 9 (1), pp. 89-95. Date of Electronic Publication: 2015 Nov 02. - Publication Year :
- 2016
-
Abstract
- Silybin-phosphatidylcholine is an orally bioavailable complex of silybin, a polyphenolic flavonolignan derived from milk thistle, endowed with potential anticancer activity in preclinical models. The purpose of this window of opportunity trial was to determine, for the first time in early breast cancer patients, the breast tissue distribution of silybin. Twelve breast cancer patients received silybin-phosphatidylcholine, 2.8 g daily for 4 weeks prior to surgery. Silybin levels were measured before (SIL) and after (TOT-SIL) enzymatic hydrolysis by high-performance liquid chromatography (HPLC)-MS/MS in biologic samples (plasma, urine, breast cancer, and surrounding normal tissue). Fasting blood samples were taken at baseline, before the last administration, and 2 hours later. All patients were fully compliant and completed the treatment program. No toxicity was observed. SIL and TOT-SIL were undetectable in baseline samples. Despite a high between-subject variability, repeated administration of Siliphos achieved levels of TOT-SIL of 31,121 to 7,654 ng/mL in the plasma and up to 1,375 ng/g in breast cancer tissue. SIL concentrations ranged from 10,861 to 1,818 ng/mL in plasma and up to 177 ng/g in breast cancer tissue. Median TOT-SIL concentration was higher in the tumor as compared with the adjacent normal tissue (P = 0.018). No significant change in either blood levels of IGF-I and nitric oxide or Ki-67 in tumors was noted. Silybin-phosphatidylcholine, taken orally, can deliver high blood concentrations of silybin, which selectively accumulates in breast tumor tissue. These findings provide the basis for a future phase II biomarker trial in breast cancer prevention.<br /> (©2015 American Association for Cancer Research.)
- Subjects :
- Administration, Oral
Antineoplastic Agents pharmacokinetics
Biological Availability
Biomarkers, Tumor
Breast Neoplasms immunology
Chromatography, High Pressure Liquid
Enzyme-Linked Immunosorbent Assay
Female
Humans
Hydrolysis
Middle Aged
Phosphatidylcholines pharmacokinetics
Reproducibility of Results
Silybin
Silymarin pharmacokinetics
Tandem Mass Spectrometry
Antineoplastic Agents administration & dosage
Breast Neoplasms drug therapy
Phosphatidylcholines administration & dosage
Silymarin administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1940-6215
- Volume :
- 9
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Cancer prevention research (Philadelphia, Pa.)
- Publication Type :
- Academic Journal
- Accession number :
- 26526990
- Full Text :
- https://doi.org/10.1158/1940-6207.CAPR-15-0123