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Originally published as JCO Early Release 10.1200/JCO.2003.08.092 on September 29 2003

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Journal of Clinical Oncology, Vol 21, Issue 21 (November), 2003: 3955-3964
© 2003 American Society for Clinical Oncology

Dynamic Contrast-Enhanced Magnetic Resonance Imaging As a Biomarker for the Pharmacological Response of PTK787/ZK 222584, an Inhibitor of the Vascular Endothelial Growth Factor Receptor Tyrosine Kinases, in Patients With Advanced Colorectal Cancer and Liver Metastases: Results From Two Phase I Studies

Bruno Morgan, Anne L. Thomas, Joachim Drevs, Juergen Hennig, Martin Buchert, Asvina Jivan, Mark A. Horsfield, Klauss Mross, Howard A. Ball, Lucy Lee, William Mietlowski, Stefan Fuxius, Clemens Unger, Ken O’Byrne, Andrew Henry, Graham R. Cherryman, Dirk Laurent, Margaret Dugan, Dieter Marmé, William P. Steward

From the University of Leicester, Leicester, United Kingdom; Tumor Biology Center and Freiburg University, Freiburg, and Schering AG, Berlin, Germany; and Novartis Pharmaceuticals, East Hanover, NJ.

Address reprint requests to Bruno Morgan, MD, Academic Department of Radiology, Leicester Royal Infirmary, Leicester LE1 5WW, United Kingdom; e-mail: bruno.morgan{at}uhl-tr.nhs.uk.

Purpose: PTK787/ZK 222584 (PTK/ZK), an orally active inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases, inhibits VEGF-mediated angiogenesis. The pharmacodynamic effects of PTK/ZK were evaluated by assessing changes in contrast-enhancement parameters of metastatic liver lesions using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in patients with advanced colorectal cancer treated in two ongoing, dose-escalating phase I studies.

Patients and Methods: Twenty-six patients had DCE-MRI performed at baseline, day 2, and at the end of each 28-day cycle. Doses of oral PTK/ZK ranged from 50 to 2000 mg once daily. Tumor permeability and vascularity were assessed by calculating the bidirectional transfer constant (Ki). The percentage of baseline Ki (% of baseline Ki) at each time point was compared with pharmacokinetic and clinical end points.

Results: A significant negative correlation exists between the % of baseline Ki and increase in PTK/ZK oral dose and plasma levels (P = .01 for oral dose; P = .0001 for area under the plasma concentration curve at day 2). Patients with a best response of stable disease had a significantly greater reduction in Ki at both day 2 and at the end of cycle 1 compared with progressors (mean difference in % of baseline Ki, 47%, P = .004%; and 51%, P = .006; respectively). The difference in % of baseline Ki remained statistically significant after adjusting for baseline WHO performance status.

Conclusion: These findings should help to define a biologically active dose of PTK/ZK. These results suggest that DCE-MRI may be a useful biomarker for defining the pharmacological response and dose of angiogenesis inhibitiors, such as PTK/ZK, for further clinical development.

Research support provided by Novartis Pharmaceuticals, East Hanover, NJ, and Schering AG, Berlin, Germany. Authors’ disclosures of potential conflicts of interest are found at the end of this article.




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