Grövdal M et al. Blood 2008;112:Abstract 223.

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Grövdal M et al. Blood 2008;112:Abstract 223. Maintenance Treatment with 5-Azacitidine for Patients with High Risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia Following MDS (MDS-AML) in Complete Remission (CR) after Induction Chemotherapy Grövdal M et al. Blood 2008;112:Abstract 223.

Introduction Approximately 50% of patients with high-risk MDS or MDS-AML achieve CR after administration of induction chemotherapy. However, the duration of CR and of overall survival (OS) is frequently short. Study objectives: Assess the clinical feasibility and utility of long-term maintenance treatment with 5-azacitidine in patients with high risk MDS or MDS-AML who achieve CR after induction chemotherapy. Source: Grövdal M et al. Blood 2008;112:Abstract 223.

Phase II Multicenter Study of Long-Term Maintenance with 5-Azacitidine in Patients with MDS or MDS-AML Eligibility (n=60) High-risk MDS (IPSS intermediate-2 or high-risk, n=23) MDS-AML (n=37) Not eligible for stem cell transplantation Induction Chemotherapy with Daunorubicin and Cytarabine CR (n=24) 5-Azacitidine Maintenance (n=23) Subcutaneous, 5/28 days Mean dose 54.3 mg/m2 Promoter methylation status of the P15ink4b (P15), E-cadherin (CDH) and hypermethylated in cancer 1 (HIC) genes was assessed at study start, at CR, and for some patients during follow-up. Source: Grövdal M et al. Blood 2008;112:Abstract 223.

Results Summary The median CR duration in patients receiving 5-azacitidine maintenance therapy (n=23) was 13.5 months. Four of 23 patients (17%) had a CR exceeding 24 months. Two patients with CDH hypermethylation at baseline had CR durations of two and five months, respectively. The probability of reaching CR was negatively correlated to hypermethylation of the CDH promoter (p=0.008). The median survival was 20 months in patients receiving 5-azacitidine maintenance therapy. In the whole group, survival was shorter in patients with hypermethylation of the CDH gene (3 months vs 9 months, p=0.005). Baseline methylation status of p15 did not affect CR duration or overall survival. No side effects were reported in 52% of the patients receiving 5-azacitidine maintenance therapy. Source: Grövdal M et al. Blood 2008;112:Abstract 223.

Summary and Conclusions 5-azacitidine maintenance therapy after induction chemotherapy is feasible in patients with high-risk MDS or MDS-AML. Median duration of CR was 13.5 mos. Mild adverse events were reported. 5-azacitidine maintenance therapy, however, does not appear to prevent relapse in the majority of patients. Hypermethylation of multiple genes is a strong negative factor for probability of CR, duration of CR and survival. The probability of achieving CR was negatively correlated to CDH promoter hypermethylation (p=0.008), and none of the six patients with all three genes hypermethylated achieved CR (p=0.03). Two patients with baseline hypermethylation of the CDH gene had CR durations of only 2 and 5 months, respectively. Survival was shorter in patients with hypermethylation of the CDH gene than in patients lacking it (9 mos vs 3 mos, p=0.005). Source: Grövdal M et al. Blood 2008;112:Abstract 223.