Researchers affiliated with the AZA-001 study have reported that Vidaza® (azacitadine) prolongs survival of patients with higher-risk myelodysplastic syndromes (MDS). The final analysis of this randomized study was published in the March 2009 issue of Lancet Oncology, and[1] preliminary results were presented at the 2007 meeting of the American Society of Hematology.
Previous studies have shown that Vidaza is effective for the treatment of patients with MDS; this has lead to approval by the U.S. Food and Drug Administration.
The AZA-001 study involved 358 patients who were deemed higher risk based on an International Prognostic Scoring System classification of Intermediate-2 or Higher, or those with French-American-British [FAB] classifications of refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia with 10-29% blasts. Patients in this study were randomly allocated to receive Vidaza or conventional treatment, which could involve AML-style remission induction therapy. However, 105 patients received best supportive care only. The median age of patients in this study was 69 years.
The main results of this randomized trial with a median of 21-months’ follow-up are shown in the following table:
Table 1: Vidaza Versus Conventional Care in MDS
| Vidaza | Conventional Care |
Number of Patients | 179 | 179 |
Median Overall Survival | 24.5 months | 15.0 months |
Number deceased | 82 | 113 |
2-year survival | 51% | 26% |
Median time to transformation or death | 13 months | 7.6 months |
Complete and partial response rate | 29% | 12% |
Comments: Vidaza appears to be a useful drug for the treatment of patients with MDS who are not candidates for stem cell transplantation.
Reference:
[1] Fenauz P, Mufti GJ, Hellstrom-Lindberg e, et al. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randmised, open-label, phase III study. Lancet Oncology. 2009;10:223-232.
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