MDS Patients With Impaired Kidney Function Can Be Treated With Vidaza And Dacogen
Published: Jul 12, 2010 2:55 pm
Patients with myelodysplastic syndromes who also have impaired kidney function can be treated with Vidaza or Dacogen, although dose adjustments will be needed in some cases, according to a study conducted by researchers at the University of Texas M.D. Anderson Cancer Center.
Elderly patients, the population most affected by myelodysplastic syndromes (MDS), frequently experience impaired kidney function. Vidaza (azacitidine) and Dacogen (decitabine) are the two standard drugs used for patients with MDS, acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML).
In their study, the researchers investigated the effects of Vidaza and Dacogen in MDS, AML, and CMML patients with impaired kidney function. They were concerned about side effects, which can be caused by the drug dose being too high, or in this patient population, when the kidneys are unable to remove the drug from the bloodstream.
Over four years, researchers monitored 41 patients with a diagnosis of intermediate- to high-risk MDS, AML, or CMML who were receiving Vidaza or Dacogen in their treatment regimen.
All patients in the study had some form of kidney disease, characterized by a glomerular filtration rate (GFR) of less than 59 mL per minute. Those with a GFR lower than 29 mL per minute were classified as having severely impaired kidney function.
Patients received either Vidaza or Dacogen every four weeks, according to their individual dose schedules and regimens. The median number of cycles was three. Almost all patients (95 percent) received the standard dose at the start of therapy.
Researchers found that 63 percent of patients responded to the therapy, with 10 percent achieving a complete response. There was no difference in the overall response rate between the patients taking Vidaza and those receiving Dacogen.
Of the patients with severely impaired kidney function, 58 percent responded to treatment.
The median overall survival for all patients was 8.6 months, and the median overall survival for MDS patients was 9 months. It was estimated that 18 months after the start of treatment, 12 percent of patients would be alive.
Researchers did not notice a significant treatment-associated decline in kidney function in patients who received more than five cycles of treatment.
Fifty-one percent of patients experienced severe blood-related side effects. Other severe side effects included fatigue (7 percent), bone pain (5 percent), and liver dysfunction (5 percent). Sixty-eight percent of patients required hospitalization, a slightly higher rate than previous studies.
Ten patients (24 percent) required a reduction in dosage. Six of those ten patients had severely impaired kidney function.
Researchers concluded that use of Vidaza and Dacogen is a viable treatment for MDS patients with impaired kidney function. Response and side effect rates were comparable to those in previous studies of patients without impaired kidney function.
There is concern for patients with severely impaired kidney function, who in this study experienced a greater number of side effects and needed more dose reductions.
Researchers therefore recommended careful dosing of Vidaza and Dacogen in patients with severely impaired kidney function.
For more information, please see the study in the journal Clinical Lymphoma, Myeloma & Leukemia (abstract).
- Kidney Function May Not Affect Vidaza’s Safety And Efficacy In Higher-Risk MDS Patients
- Vidaza and Dacogen Effective In Myelodysplastic Syndromes Patients With Decreased Kidney Function (ASCO 2009)
- Estybon May Be Effective For MDS Patients Who Experience Vidaza And Dacogen Failure (ASH 2010)
- Vidaza and Dacogen Improve Overall Survival Of MDS Patients (EHA 2009)
- Vidaza Or Dacogen Treatment May Be Effective In MDS Patients Before Stem Cell Transplantation (EHA 2010)