Featured Research

from universities, journals, and other organizations

First prospective trial shows molecular profiling timely for tailoring therapy

Date:
May 15, 2013
Source:
Georgetown University Medical Center
Summary:
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. Findings suggest 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.

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.

Related Articles


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.


Story Source:

The above story is based on materials provided by Georgetown University Medical Center. Note: Materials may be edited for content and length.


Cite This Page:

Georgetown University Medical Center. "First prospective trial shows molecular profiling timely for tailoring therapy." ScienceDaily. ScienceDaily, 15 May 2013. <www.sciencedaily.com/releases/2013/05/130515203044.htm>.
Georgetown University Medical Center. (2013, May 15). First prospective trial shows molecular profiling timely for tailoring therapy. ScienceDaily. Retrieved December 20, 2014 from www.sciencedaily.com/releases/2013/05/130515203044.htm
Georgetown University Medical Center. "First prospective trial shows molecular profiling timely for tailoring therapy." ScienceDaily. www.sciencedaily.com/releases/2013/05/130515203044.htm (accessed December 20, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Saturday, December 20, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

The Best Tips to Curb Holiday Carbs

The Best Tips to Curb Holiday Carbs

Buzz60 (Dec. 19, 2014) It's hard to resist those delicious but fattening carbs we all crave during the winter months, but there are some ways to stay satisfied without consuming the extra calories. Vanessa Freeman (@VanessaFreeTV) has the details. Video provided by Buzz60
Powered by NewsLook.com
Sierra Leone Bikers Spread the Message to Fight Ebola

Sierra Leone Bikers Spread the Message to Fight Ebola

AFP (Dec. 19, 2014) More than 100 motorcyclists hit the road to spread awareness messages about Ebola. Nearly 7,000 people have now died from the virus, almost all of them in west Africa, according to the World Health Organization. Video provided by AFP
Powered by NewsLook.com
Researchers Test Colombian Village With High Alzheimer's Rates

Researchers Test Colombian Village With High Alzheimer's Rates

AFP (Dec. 19, 2014) In Yarumal, a village in N. Colombia, Alzheimer's has ravaged a disproportionately large number of families. A genetic "curse" that may pave the way for research on how to treat the disease that claims a new victim every four seconds. Duration: 02:42 Video provided by AFP
Powered by NewsLook.com
The Best Protein-Filled Foods to Energize You for the New Year

The Best Protein-Filled Foods to Energize You for the New Year

Buzz60 (Dec. 19, 2014) The new year is coming and nothing will energize you more for 2015 than protein-filled foods. Fitness and nutrition expert John Basedow (@JohnBasedow) gives his favorite high protein foods that will help you build muscle, lose fat and have endless energy. Video provided by Buzz60
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins