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First prospective trial shows molecular profiling timely for tailoring therapy
Date:5/15/2013

WASHINGTON A clinical trial has shown that patients, and their physicians, are eager to jump into next-era cancer care analysis of an individual's tumor to find and target genetic mutations that drive the cancer. Results of the study, CUSTOM, are being presented at the 2013 annual meeting of the American Society of Clinical Oncology years before investigators thought they would be ready.

CUSTOM is the first completed prospective clinical trial that used genetic analysis alone to assign cancer treatment for patients with one of three different cancers.

"We expected it would take five years to enroll 600 patients into CUSTOM. But in less than two years, 668 patients were recruited," says the study's lead investigator, Giuseppe Giaccone, MD, PhD, associate director for clinical research at Georgetown Lombardi Comprehensive Cancer Center.

"This was a surprise to all of us, especially since patients with advanced cancer who already had biopsies needed to undergo an additional biopsy for the study. But we found patients and their doctors are quite interested in this type of personalized medicine. They know that the molecular profile of the tumor is important," says Giaconne, who is also director of clinical research for the MedStar Georgetown Cancer Network, a regional oncology affiliation between MedStar Health and Georgetown Lombardi.

CUSTOM has proved to be a model for more efficient clinical trials, he adds. It showed that patients want to participate in this kind of research, and that it is feasible to do extensive genetic testing on a tumor biopsy in a timely manner in this case, taking only two weeks to complete. It also demonstrated that it is safe to take new biopsy from patients with advanced cancer to provide the tissue needed for the analysis.

One of the other endpoints of the study, however, was not achieved. Researchers discovered that, in many cases, they did not have enough patients with rare cancer mutatio
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Contact: Karen Mallet
km463@georgetown.edu
Georgetown University Medical Center
Source:Eurekalert

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