Awareness And Management Of Vidaza Side Effects May Contribute To Treatment Success In Myelodysplastic Syndromes Patients
Side effects of Vidaza (azacitidine) treatment in myelodysplastic syndromes (MDS) patients may be temporary and can be managed with dose delays, dose reductions, and supportive care according to an analysis published in the European Journal of Hematology.
The authors of the analysis suggest that treating physicians should be aware of potential treatment-associated side effects and measures how to manage them to ensure long-term Vidaza treatment and maximize treatment benefits.
Vidaza is a DNA demethylating agent approved for the treatment of MDS. Two recent clinical trials have shown that Vidaza prolongs the time to acute myeloid leukemia progression, decreases red blood cell transfusion-dependence and improves blood cell development. One of the trials also showed that Vidaza extended overall survival in higher-risk MDS compared to conventional care.
The results of the two trials also showed that it took some time before patients began to show improvements from Vidaza treatments. In one study, patients experienced the most positive survival results after a median of nine Vidaza treatment cycles.
The authors of the report were concerned that patients may end Vidaza treatment prematurely before reaching the complete benefit due to treatment-related side effects.
The researchers therefore analyzed previously unpublished side effect data from the two clinical trials to provide more details on treatment-related side effects.
Patients in both trials received 75 mg/m2 Vidaza daily for seven consecutive days every 28 days.
Researchers found the most common side effects associated with Vidaza therapy to be low blood counts, fatigue, fever, injection site reactions, nausea, and constipation.
Researchers also found that side effects of Vidaza tended to be temporary and that the drug did not cause a long-term toxic response.
Most of the side effects occurred during the first two cycles, decreasing in frequency with subsequent cycles. Nausea, vomiting, constipation, and injection-site reactions were most commonly seen during the first week of treatment for each cycle.
Researchers found strategies such as delaying the next dosing cycle, dose reduction, and administering blood transfusions worked best to minimize side effects. Patients in the study were also prescribed medications for their digestive problems.
Researchers concluded that raising awareness among treating physicians about treatment-related side effects and how to manage them can ensure patients do not prematurely discontinue therapy before experiencing its full effects. They added that it may also make patients more willing to continue treatment for the required length of time, improving overall survival.
For more information, see the analysis in the European Journal of Haematology (abstract).
Related Articles:
- Elderly MDS Patients With Other Diseases Respond Well To Vidaza Treatment And Do Not Experience Additional Side Effects (EHA 2010)
- Vidaza and Thalidomide Combination Therapy Shows No Unexpected Side Effects In Myelodysplastic Syndromes Patients (ASH 2009)
- Vidaza Improves Survival in Elderly Myelodysplastic Syndromes Patients
- Oral Vidaza Shows Activity In Myelodysplastic Syndromes Patients
- Vidaza May Be Safe And Effective In MDS Patients Of All Ages (ASH 2009)
My face had swelled up, sores on my gums, difficulty swallowing, and exhaustion now leaves me with shortness of breath when I walk a mild distance. I have called my doctor and he called in a fungal medication but I am calling back to ask about the other problems. (shortness of breath and unable to do normal exertion) I wanted to ask you if you think these things could be a side effect of the Dacogen? Thank you.
Dear Susan,
Dr. David Steensma from the Dana Farber Cancer Center said, “There have been a few reports of inflammatory lung infiltrates in patients receiving Dacogen. But dyspnea (difficulty in breathing) is a non-specific symptom and can be from infection (pneumonia) due to a low white cell count, anemia from the MDS itself, deconditioning (loss of physical strength and stamina), pulmonary embolism (blockage of the main artery of the lung, can still happen even in patients with low platelet count), or some combination of the above, and is not necessarily a direct effect of the Dacogen.”
My 81-yr old mother has MDS (RAEB-2), diagnosed 5 months ago, and has had 4 cycles of Vidaza. She also developed Sweet’s syndrome around the time of diagnosis and was hospitalized. She is doing well on Vidaza (blast count went from 13% to 0.5% in peripheral blood). She has been on prednisone for the Sweet’s, but when tapered from 60 to 5 mg, she began having Sweet’s symptoms. She has been in and out of the hospital because of lung infiltrates and Sweet’s and is now doing well on 50 mg prednisone, which will be tapered more slowly (every 2 weeks instead of every week).
The current problem is that she has fevers 5-7 days after a cycle of Vidaza (101.8 and below). It happens like clockwork. No infections present. We have been giving her 650 mg Tylenol, which has reduced the fevers. Her doctor wants to take her off Tylenol and put her on Celebrex 200 mg bid to control inflammation, which they believe is caused by the MDS or the Vidaza. I am worried about the side effects of Celebrex, however. Any suggestions? Her doctor has never treated a patient with Sweet’s and MDS. Any experts who have treated patients with both conditions out there?
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