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Data Support Azacytidine as First-Line Therapy for Patients With High-Risk MDS: Presented at EHA By Emma Hitt, PhD COPENHAGEN, Denmark -- June 15, 2008 -- The survival advantage seen with azacytidine (AZA) versus low-dose Ara-C (LDAC) is accompanied by a lower risk of myelosuppression and reduced transfusion dependence in patients with high-risk myelodysplastic syndrome (MDS), according to new research. "This study adds to findings showing that AZA is clearly superior to LDAC, and this agent should be considered first-line therapy in this setting," Pierre Fenaux, MD, said in an interview. Dr. Fenaux and colleagues presented the findings here on June 13 at the 13th Congress of the European Hematology Association (EHA). The AZA-001 phase 3 randomised trial previously demonstrated that AZA was the first MDS treatment to significantly prolong overall survival (OS) in patients with high-risk MDS compared with 3 conventional-care regimens, including LDAC. The original overall survival findings were 24.4 months in the AZA compared with 15 months in patients treated with conventional care regimen. The current study was a subgroup analysis of patients (n = 94) preselected to receive LDAC in the original AZA-001 trial. These patients were randomised to AZA 75 mg/mē QD, given subcutaneously for 7 days every 28 days for at least 6 cycles (n = 45) or to LDAC 20 mg/mē QD for 14 days, given every 28 days for at least 4 cycles (n = 49). The findings of this subgroup analysis suggest that treatment-emergent grade 3-4 haematologic events occurred less frequently with AZA than with LDAC. A total of 67% of patients in the LDAC group experienced early discontinuations compared with only 39% of the patients receiving AZA. The median OS was 24.4 months (95% confidence interval [CI], 12.0-34.7) with AZA versus 15.3 months (95% CI, 13.9-18.8) with LDAC (P = .001). In addition, the combined complete and partial response rates also were significantly higher with AZA (31% vs 12%, P = 0.042). Major and minor haematologic improvement rates were observed in 53% of patients in the AZA group versus 25% of those in the LDAC group (P = .006). Transfusion independence was also more common with AZA than with LDAC (45% vs 13%, P = .011). Rates of thrombocytopenia were similar between groups but higher rates of grade 3-4 anaemia were observed in the LDAC group (14%) versus the AZA group (7%), and more deaths during the study were observed with the LDAC (59% vs 45%) group. "Low-dose Ara-C is currently widely used in Europe, and so the findings of this study have clear implications for clinical practice," Dr. Fenaux said in an interview. According to Dr. Fenaux, AZA should be approved for high-risk MDS patients by the European Medicines Agency by the end of the year. [Presentation title: Fenaux P, Gattermann N, Seymour J, et al. Effect of Azacitidine (AZA) Versus Low-Dose Ara-C (LDAC) on Overall Survival (OS), Hematologic Response, Transfusion Independence, and Safety in Patients (pts) With Higher-Risk Myelodysplastic Syndromes (MDS)] E-mail this page to a friend or colleague! To print, use this version