7028 Background: A recent phase III trial showed AZA is the first treatment to significantly extend overall survival (OS) in higher- risk MDS pts (Fenaux, Blood 2007;110:817). This subsequent analysis explored improvements in patient outcomes during prolonged survival, as reflected by transfusion requirements, cytopenias, levels of anemia, infections requiring antimicrobial agents, and hospitalization days. Methods: 358 pts with higher-risk MDS, defined as FAB RAEB, RAEB-T, or CMML and IPSS Int-2 or High, were enrolled. Pts were randomized to AZA (75 mg/m2/d SC x 7d q 28d) + best supportive care (BSC) or conventional care regimens (CCR). CCR + BSC included low-dose ara-C (20 mg/m2/d x 14d q 28d), or standard chemotherapy (7+3 regimen), or BSC only. Prophylactic G-CSF and erythropoietin were not allowed. Results: Significantly more RBC transfusion-dependent pts at baseline (BL) achieved transfusion independence (TI) with AZA vs CCR and significantly more pts who were RBC TI at BL remained TI with AZA vs CCR (Table). Similarly, significantly more pts treated with AZA vs CCR had any IWG 2000 hematologic improvement (49% vs 29%, p<0.0001). The hazard ratio for anemia with AZA vs CCR was 0.89 (95%CI: 0.82, 0.97; p=0.009). Rate of infection requiring IV antimicrobial treatment was reduced by one- third with AZA vs CCR (relative risk [RR] = 0.67; 95%CI: 0.35, 1.20; p=0.133). Risk of additional days in the hospital was significantly reduced with AZA vs CCR (RR = 0.82; 95%CI: 0.81, 0.88; p<0.0001). On average, AZA pts had approximately 7 fewer days per pt-year in the hospital. Conclusions: In addition to prolonging OS, AZA was associated with improved patient outcome measures demonstrated by clinically meaningful reductions in transfusion requirements, cytopenias, anemia, infections requiring antimicrobial agents, and hospitalization days. Further research is needed to measure the impact of these improvements on overall quality of life and health economic measures for these pts. RBC Transfusion Independence After Therapy RBC AZA n/N, % [95%CI] CCR n/N, % [95%CI] Difference AZA vs CCR P value BL-Dependent 50/111, 45% [36, 55] 13/144, 11% [6, 19] 34% <0.0001 BL-Independent 58/68, 85% [75, 93] 37/65, 57% [44, 69] 28% 0.0005 Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Pharmion Amgen, Celgene, EMB Statistical Solutions, LLC, Pharmion Pharmion Amgen, Celgene, Cephalon, Johnson & Johnson, Novartis, Pharmion, Roche Pharmion