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

ns to provide an accurate statistical analysis of response to novel drugs, says Giaccone.

Giaccone led the clinical trial while at the National Cancer Institute where he was the Chief of the Medical Oncology Branch, before he joined Georgetown in January. Researchers at Oregon Health & Science University also participated.

CUSTOM enrolled patients diagnosed with advanced stage non-small cell lung cancer, small cell lung cancer or thymic cancer. Researchers used next-generation sequencing, which was novel at the time, to look at almost 200 genes. From this, patients were assigned to different treatment groups based on genetic mutations or amplification.

Results from the largest group patients with non-small cell lung cancer had either an EGFR or a KRAS mutation, and results showed that those with EGFR mutations had a very high response to the drug erlotinib. "This is nothing new; we essentially confirmed what was already known," Giaccone says. But they also discovered that patients with KRAS mutations did not benefit from the single agent investigational drug selumetinib, which is being studied for use in a number of cancers, including non-small cell lung cancer.

Results for the patients with small cell lung or thymic cancers were inconclusive, primarily because the investigated mutations were rare not enough patients had specific mutations to adequately test response to therapy. "When we started the study, we didn't know how frequently the mutations occurred," Giaccone says. "Now we know that many mutations represent only 1 to 2 percent of patients and to do this right, you need to screen thousands of patients. That is only possible with a global study that involves, potentially, hundreds of institutions.

"The CUSTOM trial demonstrates both the feasibility of the approach for common mutations that it is possible to have a real-time genetic analysis that guides treatment as well as the difficulty of studying treatment for
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Contact: Karen Mallet
km463@georgetown.edu
Georgetown University Medical Center
Source:Eurekalert

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