Phase II study of sunitinib in men with advanced prostate cancer

This study explored the efficacy and tolerability of sunitinib, an inhibitor of tyrosine kinase receptors, in men with castration-resistant prostate cancer (CRPC). Men with no prior chemotherapy (group A) and men with docetaxel (Taxotere)-resistant prostate cancer (group B) were treated with sunitin...

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Bibliographic Details
Published in:	Annals of oncology Vol. 20; no. 5; pp. 913 - 920
Main Authors:	Dror Michaelson, M., Regan, M.M., Oh, W.K., Kaufman, D.S., Olivier, K., Michaelson, S.Z., Spicer, B., Gurski, C., Kantoff, P.W., Smith, M.R.
Format:	Journal Article
Language:	English
Published:	Oxford Elsevier Ltd 01-05-2009 Oxford University Press Oxford Publishing Limited (England)
Subjects:	Adenocarcinoma - blood Adenocarcinoma - diagnostic imaging Adenocarcinoma - drug therapy Aged Aged, 80 and over angiogenesis Angiogenesis Inhibitors - adverse effects Angiogenesis Inhibitors - therapeutic use Angiogenic Proteins - blood Antineoplastic agents Antineoplastic Agents, Phytogenic - therapeutic use Biological and medical sciences castration Docetaxel Drug Resistance, Neoplasm Gynecology. Andrology. Obstetrics Humans Indoles - adverse effects Indoles - therapeutic use Male Male genital diseases Medical sciences Middle Aged Nephrology. Urinary tract diseases Original Pharmacology. Drug treatments Prostate-Specific Antigen - blood Prostatic Neoplasms - blood Prostatic Neoplasms - diagnostic imaging Prostatic Neoplasms - drug therapy Protein Kinase Inhibitors - adverse effects Protein Kinase Inhibitors - therapeutic use PSA Pyrroles - adverse effects Pyrroles - therapeutic use Radiography resistant Sunitinib Taxoids - therapeutic use Time Factors Treatment Outcome Tumors Tumors of the urinary system Urinary tract. Prostate gland resistant docetaxel angiogenesis castration PSA Antineoplastic agent Prostate disease Male Tumoral marker Prostate specific antigen Angiogenesis Sunitinib Castration Taxane derivatives Phase II trial Adult Advanced stage Neovascularization Antiangiogenic agent Antimitotic Male genital diseases Protein-tyrosine kinase Human Urinary system disease Enzyme Tyrosine kinase inhibitor Transferases Docetaxel Enzyme inhibitor Malignant tumor Resistance Treatment Multikinase inhibitor Prostate cancer Cancer
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Summary:	This study explored the efficacy and tolerability of sunitinib, an inhibitor of tyrosine kinase receptors, in men with castration-resistant prostate cancer (CRPC). Men with no prior chemotherapy (group A) and men with docetaxel (Taxotere)-resistant prostate cancer (group B) were treated with sunitinib. The primary end point was confirmed 50% prostate-specific antigen (PSA) decline. Secondary end points included objective response rate and safety. Serum-soluble biomarkers were measured. Seventeen men were enrolled in each group. One confirmed PSA response was observed in each group, and an additional eight men and seven men had stable PSA at week 12 in groups A and B, respectively. Improvements in imaging were observed in the absence of post-treatment PSA declines. Common adverse effects included fatigue, nausea, diarrhea, myelosuppression and transaminase elevation. Significant changes following sunitinib treatment were observed in serum-soluble biomarkers including soluble vascular endothelial growth factor receptor-2, platelet-derived growth factor aa, placental growth factor and leptin. Sunitinib monotherapy resulted in few confirmed 50% post-treatment declines in PSA in men with CRPC. Serum markers of angiogenesis confirmed on-target effects of sunitinib. Assessments of radiographic disease status were often discordant with changes in PSA, indicating that alternate end points are important in future trials.
Bibliography:	ark:/67375/HXZ-JQGFW7JW-T istex:E34640AF08DB6B5BE1470AC3D62F65F25A7C74D7
ISSN:	0923-7534 1569-8041
DOI:	10.1093/annonc/mdp111