Sekeres MA et al. Proc ASH 2015;Abstract 908.

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Presentation transcript:

Sekeres MA et al. Proc ASH 2015;Abstract 908. Additional Analyses of a Randomized Phase II Study of Azacitidine Combined with Lenalidomide or with Vorinostat vs Azacitidine Monotherapy in Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML): North American Intergroup Study SWOG S1117 Sekeres MA et al. Proc ASH 2015;Abstract 908.

SWOG-S1117 Trial: Azacitidine (AZA) versus AZA/Lenalidomide (LEN) versus AZA/Vorinostat (VOR) in Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) Randomized Phase II trial of AZA versus AZA/LEN versus AZA/VOR N = 277 patients with higher-risk MDS or CMML and no previous exposure to AZA, LEN or VOR Primary endpoint: Updated overall response rate (ORR) Data sets from both ASH 2014 and ASH 2015 show no significant difference in ORR between AZA and the combination regimens: Trend for longer response duration with the combinations (p = 0.083) No significant differences in median overall survival (OS): AZA versus AZA/LEN p = 0.38 AZA versus AZA/VOR p = 0.17 AZA versus combinations p = 0.19 Sekeres M et al. Proc ASH 2015;Abstract 908.

SWOG-S1117: Conclusions Subgroup analyses: Higher-risk MDS: Similar ORR and OS CMML: ORR significantly higher with AZA/LEN compared to AZA (63% vs 29%; p = 0.04) Cytogenetic risk category: OS worse across study arms for chromosome 5 abnormality, -7 and del(17p) categories OS possibly improved with combination regimens for chromosome 5 abnormality Treatment at high-volume sites or MDS Centers of Excellence did not alter these effects or outcomes. Sekeres M et al. Proc ASH 2015;Abstract 908.