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Dacogen Is Safe And Effective In Older Myelodysplastic Syndromes Patients (ASH 2009)

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Published: Jan 15, 2010 12:28 pm
Dacogen Is Safe And Effective In Older Myelodysplastic Syndromes Patients (ASH 2009)

Dacogen (decitabine) is an effective and well-tolerated treatment for older myelodysplastic syndromes (MDS) patients, according to findings presented at the 51st Annual American Society of Hematology (ASH) meeting on December 6.

The risk of developing MDS increases with age, and older patients make up a large share of all MDS patients.  Older cancer patients, however, often find it particularly challenging to deal with the side effects of many cancer drugs.

For these reasons, physicians who treat MDS are particularly interested in knowing whether a potential MDS treatment is both effective and safe for older patients.

Dacogen is one of several drugs the U.S. Food and Drug Administration has approved in recent years for the treatment of MDS.

Dr. George F. Geils, the author of the findings presented at the ASH meeting, analyzed data from two recent clinical trials of Dacogen.  The goal of this analysis was to assess the efficacy and safety of Dacogen in two subgroups of older patients: patients aged 65 to 75 years, and patients aged 75 years and older.

The data from the two clinical trials were examined for overall response rate, duration of response, time to response, transfusion independence, and tolerability.

In one trial, patients were given Dacogen intravenously at 20 mg/m2 for five consecutive days every four weeks.

In the other trial, patients received Dacogen intravenously at 15 mg/m2 over three hours every eight hours for three consecutive days every six weeks.

In both trials, the overall response rate was higher for the 65 to 75 age group (38 percent and 16 percent) than for the 75 and older age group (23 percent and 9 percent).

More patients in the 65 to 75 age group achieved transfusion independence in both studies (39 percent and 43 percent, respectively) than patients in the 75 and older age group (15 percent and 21 percent, respectively).

However, patients aged 75 years and older responded more rapidly in both trials (72 days and 93 days, respectively) than patients aged 65 to 75 years (84 days and 101 days, respectively). In addition, the older patients showed a more durable response in both studies (554 days and 295, respectively) than their slightly younger counterparts (343 days and 226 days, respectively).

The most common side effects were moderate to severe anemia (low red blood cell levels), leukopenia (number of white blood cells outside of normal range), neutropenia (low white blood cell levels), and thrombocytopenia (low platelet levels). There were no reported cases of neutropenia in patients aged 75 years and above.

Dr. Geils, the author of the ASH study, concluded that Dacogen was effective and generally well-tolerated by both subgroups of older MDS patients. He further concluded that, based on his data analysis, physicians need not place undue weight on a patient’s age when considering whether or not Dacogen is an appropriate treatment.

Likewise, Dr. Geils believes the results of his study support further research into the efficacy and safety of Dacogen in elderly and other high-risk MDS patients.

For more information, please see abstract 2792 at the ASH Meeting Web site.

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19 Comments »

  • Mauro Souza said:

    Hello, my father in law, who was diagnosed as Myelodysplastic patient 8 years ago, recently received 20 mg/m2 of DACOGEN for five consecutive days, then he was relised by the doctor. He was supposed to return to the hospital 4 weeks later, however he started feeling very weak, so he had to go back to the hospital. It was a month and a half ago, and since then he became weaker and weaker. He’s missed the second part of the DACOGEN treatment due to his body incapability. I’d like to know if it’s normal of happening and if there is any other method to try to overcome this? Thank you very much.

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    Julie Shilane said:

    Dear Mauro,

    Dr. Amelia Langston from Emory Winship Cancer Institute said, “It is always hard to know a patient’s exact situation without medical details, so my comments will be general.

    “It is normal that people become a bit weaker in the week or two after Dacogen. This is due to the effects of the chemo on the bone marrow as well as more general effects on the body. I usually see patients on Dacogen in the office at least once per week in between cycles in order to check the blood work, give transfusions if needed, and provide any other supportive care that might be necessary.

    “It sounds as if your father-in-law might need to have more regular visits with the hematologist in order to preempt problems like infection, anemia (needing transfusion), dehydration, and other things. If more intensive monitoring and supportive care as an outpatient does not result in a smoother course, this may not be a good treatment for his MDS.”

  • nancy said:

    ny ideas, my md doesn’t seem to know and i searched the net. HELP.

  • MARIA e. MORA said:

    My mom was just diagnosed with MDS and her counts are refractory anemia 10/30 and plts 40, but mostly 70-90. No symptoms at all. No fatigue, bleeding, or petechia. Her MD wants to start EPO next month and blood draws monthly. Does this sound right?

  • Freida Wright said:

    My husband was diagnosed in 2008 with MDS. He was on another drug for 6 months and had terrible side effects. He has had no side effects with Dacogen which he started in 2009. Now and again he had platelet transfusions. This Jan. he was diagnosed with AML. In Feb he had 2 bags of packed red cells and one in March. Then in early March he had to have 3 separate transfusions of platelets on 3 separate days but he was given platelets that were expiring that evening. This Weds. he was given platelets that were donated the previous day. Now 4 days later he has no symptoms of low platelets as of today.( usually blood blisters in the mouth).
    Monday he is supposed to start Dacogen (his choice). Oncologist said she doesn’t know whether this will help him and was against it. Will it help him now he has AML? He is a very active and animated 85 yrs old.

  • MDS Beacon Staff said:

    Maria — Dr. Amelia Langston from Emory Winship Cancer Institute said, “That seems an appropriate plan for the moment. If the platelets fall further, other therapies such as Vidaza may be considered.”

    Freida — Dr. Amelia Langston from Emory Winship Cancer Institute said, “From your description of his history, it sounds like the AML developed on Dacogen. If this is the case, it will probably not help at this point. If, on the other hand, the AML developed after Dacogen had been stopped for some time, resuming it might be of benefit. If you are in a major city, I suggest a consultation at a large center to see if there may be a clinical trial he might be eligible for.”

    In both cases, Dr. Langston cautioned, “Since I have not seen and fully evaluated this patient, I can only make general comments, and these should not be considered a substitute for medical advice.”

  • Reni said:

    I have been diagnosed with MDS since 2002.
    each year my hemoglobin dropped 1 poin, even though I received Procrit shots. other tratments Thalomide, Revlemid (tried twice) gave me severe side effects.(Rash and fever)
    My hemoglobin now is 6.9, and my doctor wants to try DACOGEN.
    Are there ingrediants similar to Revlemid, since there is a warning for pregnancy.(Iam past menopause.)
    Lately I have had blood transfusions, but now have iron overload.
    Since the bloodcount drops with Dacogen, would it be save tostart the treatment?

  • Reni said:

    I have had several treatments for my MDS, but every year my hemoglobin dropped 1 point, that now it is 6.9
    we tried Procrit, no success, Thalomide, severe reactions, Revlimid,rash and fever, and now my doctor wants to try Dacogen.
    Since there is also a warning for pregnancy, does Dacogen have the same ingrdients than Revlemid?
    Lately I have had blood tranfusions, but now face the danger of iron overload.
    Since the blood count goes down farther with Dacogen, it is advisable for me to try it?

  • MDS Beacon Staff said:

    Dear Reni,

    Dr. David Steensma from the Dana-Farber Cancer Institute in Boston said the following:

    “Dacogen is not the same as Revlimid, but there is pregnancy risk from many different types of compounds. Since Dacogen turns on and off genes that are important for fetal development that is why the product information says this.

    Usually the blood count goes down with Dacogen but after a few treatments if it is working the blood counts go up so if your doctor has recommended it, it is reasonable to try, although I can’t make a specific recommendation/give direct medical advice without knowning the full details.”

  • Reni said:

    Thank you for responding.

  • hovsepian said:

    Hello my father is 63 years old and is diagnosed AML since one months ego .his first chemothraphy wasnt succesful and his doctor priscribed dacogen ;but we live in iran and unfotunetly dident find this drug .please guide me in whitch way we can buy it ? help me please, help.

  • Martha said:

    My husband was diagnosed with MDS two years ago (9/2009). He is 86 years old and had no prior significant medical history. He was treated with Vidaza, until March 2011. Vidaza was stopped when his oncologist determined it was no longer working. One dose of Revlimid was attempted and discontinued because of the severe side effects.
    Two months ago we were told that the disease had progressed to acute myeloid leukemia. He has been receiving tranfusions, RBC and platelets approximately every two weeks. The oncologist recommended Dacogen and my husband received his first treatment 3 weeks ago. Last week he required 3 units RBC and one unit of platelets. He feels very weak, somewhat short of breath (he uses O2)and has developed lower ext edema.
    Has Dacogen been effective in the treatment of AML?

  • MDS Beacon Staff said:

    Hello Martha,

    We’re very sorry to hear about your husband’s situation. We hope that you and your doctors are able to find an effective approach to his health needs.

    Regarding your question … there are indeed data suggesting that Dacogen can be a useful treatment for AML. The company that markets Dacogen, Eisai, issued the following press release about the latest clinical trial that examined the efficacy and safety of Dacogen when used as a treatment for AML.

    http://us.eisai.com/view_press_release.asp?ID=210&press=324

    Based on the results of this trial and other studies, Eisai has asked the FDA to officially approve Dacogen as a treatment for AML. Here is a press release on that topic:

    http://us.eisai.com/view_press_release.asp?ID=210&press=328

    Even without an official FDA approval, your husband’s doctors are still permitted to prescribe Dacogen as a treatment for AML if they believe there is sufficient evidence supporting use of the drug in that way.

    All the best,

    The MDS Beacon Staff

  • Robyn Mack said:

    My husband has a history (12 years) of Waldenstrom macroglobulinemia and recently presents with a new onset of pancytopenia. After a bone marrow biopsy, the pathology report diagnosed him with MDS Leukemia. His oncologist is treating him with Dacogen, and supporting treatments (transfusions, RBC and platelets). I’m told he would not be a candidate for bone marrow transplant because he has 2 cancers (waldenstrom and leukemia). In your opinion, could MDS be the transformation of WM and therefore not considered to be a different cancer and therefore unable to receive a bone marrow transplant.

    Thank you.

  • MDS Beacon Staff said:

    Hello Robyn,

    Thank you for your question. We are sorry to hear of your husband’s diagnosis.

    We forwarded your question to Dr. Bart Lee Scott at the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance.

    In his opinion, the Waldenström macroglobulinemia and MDS are two different cancers, but the fact that your husband has these two cancers should not exclude him from receiving a stem cell transplant.

    Please let us know if you have any further questions in regard to this matter.

    All the best,

    The MDS Beacon Team

  • salil chandra said:

    what are the possibilities of recovery in 16% MDS if dacogen is given? does the disease re-occur after treatment? if so after how many years?

  • Virendra Kumar said:

    I am 57 years old. I have been diagnosed MDS patient accelerating to AML. I have been given 2 rounds of 4 days DACOGEN 50 mg. My liver & kidney are functioning well. I am not having major side effects except anemia, thrombocytopenia, high RDW. I am being PRC transfusion every month and POCS transfusion at an interval of 2 to 5 days. Bone Marrow report is as follows:In view of BCR-ABL negativity – picture is that of atypical CML/ Chronic Myelomonocytic Leukemia in accelerated phase.BM Biopsy: Hypercellular marrow, showing infilteration by myeloid cells in varying stages of maturation, along with mature myeloid cells present. Focal areas showing infiltrarion by blasts. Impression: Accelerated – Bordering in to Acute Leukemic Phase in background of Chronic Myeloproliferation Disorder.Chromosomal analysis revealed a normal male karyotype, unremarkable for numerical and structural Chromosomal abnormality, detectable at the level of resolution (ISCN) 400. Blasts 18-20%, Myelocyte 25%, Metamyelocyte 20%,Megakaryocytes Diminished, Segmented cells 14%, Eisonophil & Precursors 5%, Basphilla 6%, Monocyte 9%. Do with this report can I be treated with DACOGEN and platelet cells can come to normal stage. I shall be obliged if I could be suggested on or before III rd round of DACOGEN expected since 15th January, 2012. Thank you.

  • jack seltzer said:

    I have a collection of presumed non-mds-contaminated stem cells collected in 2001the for MM(multiple myeloma) treatment. I am in
    complete remission wrt MM with indications of the return of MM being very remote. However I now have MDS and am being treated with Dacogen with significant side effects, primarily low Hg with significant exhaustion lasting many weeks after the Dacogen. An alternative procedure could be some level of chemo followed by the previosly mentioned stored platelets. Are there MDS patients out there who have had this kind of procedure? I’m 76up andwas in pretty good shape, but not since the Dacogen (have had 2 treatments 6I months apart.

  • Neoma Shimer said:

    My husband age 79 was treated for progressive prostrate cancer, Oct. 2011-Mar. 30, 2012 He had 2 treatments with internal radiation.
    He then had low blood counts, vitamin B/12. Then 2 units of blood or platlets Anyway they did bone marroow test. Not making enough blood. Labs 2 week intervals then one each followed with a shot (procrit).

    We had a visit with cancer speacaist and he seemed to be very uncomfortable with us. Kept saying it was not from the prostrate. My conclusion after about it. It was most likely from the treatment.

    We go back to oour local oncolgist next week, what may we expect? Is this a treatable thing that will likly keep him somewhat active?