Featured Research

from universities, journals, and other organizations

Experimental graft-versus-host disease treatment equivalent to standard care in phase 3 trial

Date:
December 10, 2012
Source:
Dana-Farber Cancer Institute
Summary:
Researchers found an experimental drug combination for preventing graft-versus-host disease (GVHD) was not significantly better than the standard regimen of care, but that the new combination could provide an alternative that could be preferable in certain scenarios.

An experimental drug combination for preventing graft-versus-host disease (GVHD) was not significantly better than the standard regimen on key endpoints, according to a report of a phase 3 trial at the American Society of Hematology annual meeting. The combination of two immunosuppressive compounds -- tacrolimus plus sirolimus -- did not provide a statistically significant, GVHD-free survival benefit over the long-used standard of care, tacrolimus plus methotrexate, said researchers from Dana-Farber Cancer Institute who led the multi-center trial.

However, there were some "upsides" of the tacrolimus/sirolimus treatment that could prove advantageous for certain patients, said Corey Cutler, MD, MPH, first author of the report. Among them: patients engrafted slightly more rapidly and suffered much less from mucositis, a common and painful side-effect that causes sores in the mouth and throat.

But there were also "downsides," Cutler said -- an increased incidence of veno-occlusive disease (blood clots in the liver) and a slight increase in the rate of late-onset GVHD. "We were a little disappointed in the results, but excited to offer an alternative to the standard of care for the past 25 years," said Cutler, who, along with Joseph Antin, MD, of Dana-Farber, senior author of the report, had led clinical studies of sirolimus beginning in 2000 in hopes that it would promote better survival from GVHD than the standard treatment.

The phase 3 randomized controlled trial was carried out by the Bone and Marrow Clinical Trials Network (BMT CTN) at 26 centers. It enrolled over 300 patients, the majority of whom had acute leukemia in remission. The patients had received stem cell transplants from a matched sibling donor.

The primary endpoint of 114-day acute GVHD-free survival was 67 percent in the tacrolimus/sirolimus group and 62 percent in the tacrolimus/methotrexate group -- a difference that was not statistically significant. At two years after transplantation, there was no difference in disease-free survival and overall survival.

"This study establishes this regimen as an alternative to the standard of care -- it could be preferable in certain scenarios," Cutler said. "It will continue to be the standard of care at Dana-Farber."


Story Source:

The above story is based on materials provided by Dana-Farber Cancer Institute. Note: Materials may be edited for content and length.


Cite This Page:

Dana-Farber Cancer Institute. "Experimental graft-versus-host disease treatment equivalent to standard care in phase 3 trial." ScienceDaily. ScienceDaily, 10 December 2012. <www.sciencedaily.com/releases/2012/12/121210174121.htm>.
Dana-Farber Cancer Institute. (2012, December 10). Experimental graft-versus-host disease treatment equivalent to standard care in phase 3 trial. ScienceDaily. Retrieved September 17, 2014 from www.sciencedaily.com/releases/2012/12/121210174121.htm
Dana-Farber Cancer Institute. "Experimental graft-versus-host disease treatment equivalent to standard care in phase 3 trial." ScienceDaily. www.sciencedaily.com/releases/2012/12/121210174121.htm (accessed September 17, 2014).

Share This



More Health & Medicine News

Wednesday, September 17, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

President To Send 3,000 Military Personnel To Fight Ebola

President To Send 3,000 Military Personnel To Fight Ebola

Newsy (Sep. 16, 2014) President Obama is expected to send 3,000 troops to West Africa as part of the effort to contain Ebola's spread. Video provided by Newsy
Powered by NewsLook.com
Obama Orders Military Response to Ebola

Obama Orders Military Response to Ebola

AP (Sep. 16, 2014) Calling the Ebola outbreak in West Africa a potential threat to global security, President Barack Obama is ordering 3,000 U.S. military personnel to the stricken region amid worries that the outbreak is spiraling out of control. (Sept. 16) Video provided by AP
Powered by NewsLook.com
UN: 20,000 Could Be Infected With Ebola by Year End

UN: 20,000 Could Be Infected With Ebola by Year End

AFP (Sep. 16, 2014) Nearly $1.0 billion dollars is needed to fight the Ebola outbreak raging in west Africa, the United Nations say, warning that 20,000 could be infected by year end. Duration: 00:40 Video provided by AFP
Powered by NewsLook.com
Obama: Ebola Outbreak Threat to Global Security

Obama: Ebola Outbreak Threat to Global Security

AP (Sep. 16, 2014) President Obama is ordering U.S. military personnel to West Africa to deal with the Ebola outbreak, which is he calls a potential threat to global security. (Sept. 16) Video provided by AP
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:
from the past week

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