| Title |
A phase I and pharmacokinetic study of silybin-phytosome in prostate cancer patients
|
|---|---|
| Published in |
Investigational New Drugs, November 2006
|
| DOI | 10.1007/s10637-006-9019-2 |
| Pubmed ID | |
| Authors |
Thomas W. Flaig, Daniel L. Gustafson, Lih-Jen Su, Joseph A. Zirrolli, Frances Crighton, Gail S. Harrison, A. Scott Pierson, Rajesh Agarwal, L. Michael Glodé |
| Abstract |
Silibinin is a polyphenolic flavonoid isolated from milk thistle with anti-neoplastic activity in several in vitro and in vivo models of cancer, including prostate cancer. Silybin-phytosome is a commercially available formulation containing silibinin. This trial was designed to assess the toxicity of high-dose silybin-phytosome and recommend a phase II dose. Silybin-phytosome was administered orally to prostate cancer patients, giving 2.5-20 g daily, in three divided doses. Each course was 4 weeks in duration. Thirteen patients received a total of 91 courses of silybin-phytosome. Baseline patient characteristics included: median age of 70 years, median baseline prostate specific antigen (PSA) of 4.3 ng/ml, and a median ECOG performance status of 0. The most prominent adverse event was hyperbilirubinemia, with grade 1-2 bilirubin elevations in 9 of the 13 patients. The only grade 3 toxicity observed was elevation of alanine aminotransferase (ALT) in one patient; no grade 4 toxicity was noted. No objective PSA responses were observed. We conclude that 13 g of oral silybin-phytosome daily, in 3 divided doses, appears to be well tolerated in patients with advanced prostate cancer and is the recommended phase II dose. Asymptomatic liver toxicity is the most commonly seen adverse event. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Spain | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 129 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | <1% |
| Egypt | 1 | <1% |
| Unknown | 127 | 98% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Ph. D. Student | 27 | 21% |
| Researcher | 20 | 16% |
| Student > Master | 13 | 10% |
| Student > Bachelor | 10 | 8% |
| Professor > Associate Professor | 7 | 5% |
| Other | 21 | 16% |
| Unknown | 31 | 24% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 23 | 18% |
| Agricultural and Biological Sciences | 16 | 12% |
| Pharmacology, Toxicology and Pharmaceutical Science | 15 | 12% |
| Biochemistry, Genetics and Molecular Biology | 14 | 11% |
| Chemistry | 9 | 7% |
| Other | 14 | 11% |
| Unknown | 38 | 29% |
Attention Score in Context
This research output has an Altmetric Attention Score of 4. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 02 July 2018.
All research outputs
#6,948,651
of 22,785,242 outputs
Outputs from Investigational New Drugs
#288
of 1,168 outputs
Outputs of similar age
#22,950
of 69,312 outputs
Outputs of similar age from Investigational New Drugs
#3
of 5 outputs
Altmetric has tracked 22,785,242 research outputs across all sources so far. This one has received more attention than most of these and is in the 68th percentile.
So far Altmetric has tracked 1,168 research outputs from this source. They receive a mean Attention Score of 4.7. This one has gotten more attention than average, scoring higher than 73% of its peers.
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We're also able to compare this research output to 5 others from the same source and published within six weeks on either side of this one. This one has scored higher than 2 of them.