Navigation Links
Experimental graft-vs.-host disease treatment equivalent to standard care in Phase 3 trial
Date:12/10/2012

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"


'/>"/>

Contact: Teresa Herbert
teresa_herbert@dfci.harvard.edu
617-632-4090
Dana-Farber Cancer Institute
Source:Eurekalert

Related medicine news :

1. Experimental Chemo Combo for Colon Cancer Disappoints
2. Experimental Pill for Multiple Sclerosis Shows Promise
3. Experimental Gel May Help Those With Advanced Parkinsons
4. Experimental Drug Eases Autistic Behaviors in Mice
5. Experimental Drug Helps Fight Some Childhood Cancers, Study Finds
6. Experimental drug improves muscle strength among male cancer patients
7. Experimental Vaccine Seems to Stop Nicotine Addiction in Mice
8. Content Writing King Announces Cancellation Of Experimental Video Creation Process For Their Article Marketing Website
9. Fertility preservation with cryopreservation of ovarian tissue: from experimental to mainstream
10. Experimental drug may extend therapeutic window for stroke
11. Experimental Chemical Helps Blind Mice See
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize each ... Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into hand ... select a ProHand generator and drag it above media or text in the Final ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016 Any dentist who has made an implant ... process. Many of them do not even offer this as ... high laboratory costs involved. And those who ARE able to ... a high cost that the majority of today,s patients would ... Parsa Zadeh , founder of Dental Evolutions Inc. and inventor ...
(Date:6/23/2016)... 23, 2016  In a startling report released today, National ... by lacking a comprehensive, proven plan to eliminate prescription opioid overdoses. ... of how states are tackling the worst drug crisis in recorded ... – Kentucky , New Mexico ... . Of the 28 failing states, three – Michigan ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... to 2022" report to their offering. ... financial data derived from varied research sources to present unique ... on the market during the next five years, including a ... markets, regional and country level analysis. The report provides a ...
Breaking Medicine Technology: