Navigation Links
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 mutations 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 rare mutations," he says.


'/>"/>

Contact: Karen Mallet
km463@georgetown.edu
Georgetown University Medical Center
Source:Eurekalert

Related medicine news :

1. First targeted nanomedicine to enter human clinical studies
2. First contact: Early intervention key in diagnosis and treatment of serious mental illness
3. Donor Kidney Re-Used in Second Patient After Failing in First
4. Many Who First Misuse Prescription Pills Get Them From Friends, Family: Report
5. First-of-its-kind Menopause Map helps women navigate treatment
6. First recipients of AcademyHealths Presidential Scholarship announced
7. Kessler Foundation researchers present at first International Congress on Cognition in MS
8. Whos the Dad? First-Trimester Blood Test May Tell
9. AGA releases first independently developed ABIM-approved Practice Improvement Module in GI
10. Dr. Yael Mosse will receive first Nachman Award in Pediatric Oncology at national conference
11. First study investigating possible link between sunscreen ingredient and endometriosis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer care, and ... in the eye of the beholder, according to experts who offered insights and commentary ... of Managed Care. For the full issue, click here . , For the ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the largest ... as the Medical Director of its new Mesquite-Samuell Farm facility. , “We are ... Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic ... Coating, Parenteral) - Global Forecast to 2021" report ... The global pharmaceutical excipients market is projected to ... of 6.1% in the forecast period 2016 to 2021. ...
Breaking Medicine Technology: