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    Sunitinib in urothelial cancer: clinical, pharmacokinetic, and immunohistochemical study of predictors of response.

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    Authors
    Gallagher, David J
    Al-Ahmadie, Hikmat
    Ostrovnaya, Irina
    Gerst, Scott R
    Regazzi, Ashley
    Garcia-Grossman, Ilana
    Riches, Jamie
    Gounder, Sivaraman K
    Flaherty, Anne-Marie
    Trout, Alisa
    Milowsky, Matthew I
    Bajorin, Dean F
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    Affiliation
    Department of Medical Oncology, The Mater Hospital, Dublin, Ireland.
    Issue Date
    2012-02-01T11:08:47Z
    MeSH
    Adaptor Proteins, Signal Transducing/analysis
    Angiogenesis Inhibitors/administration & dosage/adverse effects/*pharmacokinetics
    Blood Pressure/drug effects
    Carcinoma, Transitional Cell/chemistry/*drug therapy/pathology
    Drug Administration Schedule
    Humans
    Hypertension/chemically induced
    Hypoxia-Inducible Factor 1, alpha Subunit/analysis
    *Immunohistochemistry
    Indoles/administration & dosage/adverse effects/*pharmacokinetics
    Logistic Models
    New York City
    Phosphoproteins/analysis
    Phosphorylation
    Pyrroles/administration & dosage/adverse effects/*pharmacokinetics
    Retrospective Studies
    Risk Assessment
    Risk Factors
    TOR Serine-Threonine Kinases/analysis
    Tissue Array Analysis
    Treatment Outcome
    Tumor Markers, Biological/analysis/*antagonists & inhibitors
    Urologic Neoplasms/chemistry/*drug therapy/pathology
    Urothelium/chemistry/*drug effects/pathology
    Vascular Endothelial Growth Factor Receptor-2/analysis/*antagonists & inhibitors
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    Citation
    Eur Urol. 2011 Aug;60(2):344-9. Epub 2011 May 25.
    Journal
    European urology
    URI
    http://hdl.handle.net/10147/207841
    DOI
    10.1016/j.eururo.2011.05.034
    PubMed ID
    21645967
    Abstract
    BACKGROUND: Sunitinib has activity in patients with metastatic urothelial cancer (UC), but most patients do not respond. OBJECTIVE: To identify predictors of response to sunitinib. DESIGN, SETTING, AND PARTICIPANTS: Seventy-seven patients with advanced UC received sunitinib on one of two schedules at a single institution. Blood pressure (BP), immunohistochemistry (IHC), and pharmacokinetic (PK) results were correlated with response to sunitinib. MEASUREMENTS: BP was assessed on day 1 and 28 of each cycle and on day 14 of cycle 1. IHC was performed on 55 samples from 38 cases using mammalian target of rapamycin and hypoxia-inducible factor (HIF) pathway marker antibodies. Blood samples for PK analysis were collected from 15 patients at three time points. Response was assessed using Response Evaluation Criteria in Solid Tumors criteria. RESULTS AND LIMITATIONS: Sunitinib-induced hypertension predicted improved response when hypertension was categorized as a discrete (p = 0.02) or continuous variable (p = 0.005 [systolic BP] and p = 0.007 [diastolic BP]). The odds ratio of response was 12.5 (95% confidence interval, 1.95-246.8) for grade 3/4 hypertension compared with grade 0. Response was associated with low HIF-1alpha expression in primary (p = 0.07) tissue. A nonstatistically significant trend was seen for an association between greater drug concentration and best response. A correlation between expression markers within the same pathways was identified, phosphorylated-4EBP1 and phosphorylated-S6 (p = 6.5 x 10(-9)), and vascular endothelial growth factor receptor 2 and HIF-1alpha (p = 0.008). Results are limited by small numbers. CONCLUSIONS: Clinical and molecular biomarkers of response to sunitinib may have clinical relevance and require prospective validation. There is an urgent need for predictive biomarkers to guide the management of UC.
    Language
    eng
    ISSN
    1873-7560 (Electronic)
    0302-2838 (Linking)
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.eururo.2011.05.034
    Scopus Count
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    Mater Misericordiae Hospital

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