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Perfusion MRI in the early clinical development of antivascular drugs: decorations or decision making tools?
Martin Zweifel1, Anwar R Padhani
1Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, Middlesex, UK.
Introduction:
Classically, the first step in the clinical development of drugs in oncology involves assessments of dose limiting toxicity (DLT) and maximum tolerated dose (MTD). New paradigms are needed for antiangiogenic drugs and vascular disrupting agents (VDAs) as they are active at doses well below the MTD and as single agents their use might not translate into anti-tumour efficacy. MRI is able to assess the antivascular effects of antivascular drugs via changes in functional kinetic parameters; however, the usefulness of MRI in decision making has been questioned by many.
Objectives:
Our aim is to review the experience of using dynamic contrast-enhanced MRI (DCE-MRI) in early clinical development of vascular directed anticancer therapies over the last decade. Thirty-nine phase I and II studies including data on more than 700 patients have been published as abstracts and/or papers, documenting DCE-MRI changes after the administration of antiangiogenic drugs and VDAs.
Discussion:
Perfusion MRI is helpful in assessing whether mechanistic goals are achieved, in assisting dose selection for phase II studies, in selecting subpopulations enriched for response and in predicting patient benefit. Imaging tools are increasingly available. Future challenges for imaging include correlation with clinical measures of efficacy and determining relationships with blood and serum biomarkers.
Insights
Dynamic contrast-enhanced MRI (DCE-MRI) aids in evaluating anti-cancer therapies targeting tumor vasculature. This imaging technique helps assess drug efficacy and patient response in early clinical trials.
Area of Science:
- Oncology
- Radiology
- Pharmacodynamics
Background:
- Traditional oncology drug development relies on dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
- Antiangiogenic drugs and vascular disrupting agents (VDAs) require new assessment paradigms due to their efficacy at sub-MTD doses.
- Dynamic contrast-enhanced MRI (DCE-MRI) can evaluate antivascular effects, but its clinical utility is debated.
Purpose of the Study:
- To review the application of DCE-MRI in the early clinical development of vascular-targeting anticancer agents over the past decade.
- To synthesize findings from Phase I and II studies utilizing DCE-MRI for antiangiogenic drugs and VDAs.
Main Methods:
- Systematic review of 39 Phase I and II clinical studies.
- Analysis of published abstracts and papers documenting DCE-MRI changes in over 700 patients.
- Focus on DCE-MRI assessments following administration of antiangiogenic drugs and VDAs.
Main Results:
- DCE-MRI demonstrates changes in functional kinetic parameters reflecting antivascular effects.
- Data from 700+ patients across 39 studies were analyzed.
- Documented DCE-MRI changes indicate the impact of vascular-targeting agents.
Conclusions:
- Perfusion MRI (DCE-MRI) is valuable for confirming mechanistic goals and guiding dose selection for Phase II studies.
- DCE-MRI aids in identifying patient subpopulations likely to respond to treatment.
- Future research should correlate imaging findings with clinical efficacy and biomarkers.
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