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Vidaza and Dacogen Improve Overall Survival Of MDS Patients (EHA 2009)

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Published: Jun 12, 2009 9:50 am

Israeli researchers presented the effectiveness of hypomethylating agents Vidaza (azacitidine) and Dacogen (decitabine) on improving overall survival of myelodysplastic syndromes (MDS) patients. This information was presented at the European Hematology Association (EHA) 14th Congress in Berlin.

Methyl groups that are bound to DNA sequences cause problems by preventing the regulation of cellular growth and causing uncontrollable cell division. Hypomethylating or demethylating agents, like Vidaza or Dacogen, allow the DNA sequences to function normally by removing these problematic methyl groups.

Researchers found four relevant randomized controlled trials, but only evaluated three, which compared 952 patients who received either hypomethylating agents or supportive care. Supportive care, such as blood transfusions and antibiotics, does not cure MDS or prevent acute myeloid leukemia (AML) transformation, but treats symptoms caused by low blood cell counts known as cytopenias. Stem cell transplantation is currently the only therapy able to generate complete recovery from MDS. This study evaluated Vidaza and Dacogen with respect to non-curative treatments.

The study evaluated overall survival, length of time to AML or death, complete or partial response, and severity of side effects. A complete response, as measured by the 2000 International Working Group (IWG) criteria, is defined by having a blood count of more than 1,000 neutrophil per µL and more than 100,000 platelets per µL. Evaluation of two of the four studies consisting of 549 patients showed treatment with Vidaza resulted in longer overall survival time than treatment with supportive care. However, one of the trials with 233 patients taking Dacogen did not show this same overall survival advantage.

An overview of all three evaluated studies and a fourth study abstract concluded that hypomethylating agents significantly lengthened the progression time to AML or death, improved the number of complete or partial responses, and resulted in few side effects.

For more information, see abstract 0261 from the “Myelodysplastic syndromes I” session of the 14th Congress of the EHA.

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7 Comments »

  • Janice Dunn said:

    My sister has MDS with cmml and might be considering a bone marrow transplant, I had hepititus back in 1978. It is type A. Would it be a possibility to be a donor for her if needed?

  • Albert w said:

    Is Dacogen still being manufactured if so how available is the drug worldwide? I am a South African citizen and was treated with this drug in 2008 and 2009 and my situation remained stable and has not transformed into AML as yet.

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    Julie Shilane said:

    Janice, According to http://www.marrow.org, if you have fully recovered from your hepatitis A, you would be eligible to register as a bone marrow donor. However, your sister should check with her MDS specialist to see whether as an MDS and CMML patient she would be eligible to receive a transplant from someone who had hepatitis A. You will both also need to be tested to make sure you are a match.

    Albert, Dacogen is available in South Africa on a compassionate use basis, meaning that it is not yet approved in South Africa but is given on a case-by-case basis to patients who don’t have many or any other treatment options. Each individual case is reviewed by the local medicines control council. I have emailed you contact information for a medical advisor at Janssen-Cilag, the company that markets Dacogen outside of the U.S. Your physician should contact him for assistance with your case.

  • ranichintam said:

    I have MDS with RARS Intermediate risk 1. I am responding well to Vidaza. I completed X4 cycles. Is this life long treatment? I read median survival 31/2 years. Can you explain this?

  • MDS Beacon Staff said:

    Hi Ranichintam,

    The National Comprehensive Cancer Network guidelines recommend that Vidaza be given for 4-6 cycles but that the number of cycles may need to be extended.

    A number of recent studies have shown that prolonged Vidaza therapy can improve response and sometimes even survival in higher-risk patients, patients who achieve stable disease, and transfusion-dependent patients. Vidaza can also be used prior to stem cell transplantation.

  • Becky Jean said:

    Hi Ranichintam: I haven’t started Vidaza but wondered what kind of side effects you had.

  • Connie Johnson said:

    My sister had her second bone marrow biopsy done and has been on Revilamid for app. 15 months and her blood levels continue to drop , she has only had two transfusions in that time length. Her results on the last biopsy results were persistent clone with add (5q), with new clonal evolution to include del (20q), suggesting an aggressive myeloid disorder. The plan is to change her medication to something new. Could anyone give us an understanding of what is going on?