Nations First Cancer Trial Combining Multiple Drugs to Attack Blood Vessel Formation in Patients with Kidney Cancer
In addition to these patients, the results from the trial will inform care in many other types of cancer, including breast, lung, and colon cancer. Penn scientists will also use an experimental imaging technique to measure the effectiveness of the treatments.
The BeST trial stands for bevacizumab(Avastin), sorafenib(Nexavar), and temsirolimus(Torisel), Researchers have previously shown these drugs to slow the progression of metastatic cancer when used alone by starving the cells of the oxygenated blood required for growth.
This trial takes these three proven drugs, and combines them into two drug combinations, said Keith Flaherty, MD, Assistant Professor of Medicine, who is the primary investigator for the trial. They all seem to attack blood vessel formation in somewhat unique ways, so we think we could get a more profound effect by combining them.
In my mind, kidney cancer is truly the anvil on which we will hammer out the issues of anti-angiogenic therapy because it is the disease where we dont give chemotherapy or any other type of drug at the same time and we can still see benefit. It is in this setting that we are going to work out which combinations make sense, are safe, and efficacious. And then move those into other cancers, Flaherty said.
Flaherty and colleagues will determine which of the drug treatments sorafenib plus bevacizumab, sorafenib plus temsirolimus, temsirolimus plus bevacizumab, or bevacizumab alone is most effective by looking at how long it takes patients tumors to start growing again on treatment. The longer the progression-free survival is, the better the combination.
In addition to this standard measure of effectiveness, Mark Rosen, MD, PhD, Assistant Professor of Radiology, will lead the imaging portion of the trial to test the value of a relatively new imaging technique in evaluating anti-angiogenic therapy. The technique, called dynamic contrast-enhanced-magnetic resonance imaging, or DCE-MRI, relies on a series of rapidly collected images that allow the investigators to calculate the rate of movement of a contrast agent through the blood vessels and into the tumor. Using this information they can estimate the amount and rate of blood flow. Researchers may be able to use that information to learn within a few days or weeks whether a patient is responding to anti-angiogenic therapy, rather than having to wait months to see if a patients disease worsens or gets better.
When Rosen tested DCE-MRI in a small group of patients that Flaherty treated in a pilot study with sorafenib, he identified tumor characteristics that predict response to therapy. We want to know if these characteristics remain predictive in a larger patient population, Rosen said. Also, we want to see if we can get high quality DCE-MRI data from multiple institutions. It is one thing to succeed in a small group of patients here, but DCE-MRI is not something that one can get by pushing a button on a machine. Obtaining high quality DCE-MRI results when the imaging is performed across multiple institutions may be more difficult, but is a crucial step in defining the applicability of the DCE-MRI technique in the routine clinical setting.
The BeST trial is sponsored by the Eastern Cooperative Oncology Group and supported by grants from the National Cancer Institute. The imaging portion of the trial is supported by the National Cancer Institute as part of the I-2 initiative to improve imaging techniques in cancer care.
For more information on the study and how to enroll, please visit the study website at the National Institutes of Health: http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=499788&version=patient&protocolsearchid=3677344
This release is available at www.pennhealth.com/news
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