MDS-112: A SEER-Medicare Analysis of Treatment Patterns and Outcomes in Patients with Myelodysplastic Syndromes Treated with Hypomethylating Agent

Abstract

Context: The hypomethylating agents (HMAs) azacitidine (AZA) and decitabine (DEC) are standard-of-care in patients with higher-risk MDS. However, real-world outcomes of patients with MDS treated with HMAs have not been comprehensively assessed. Objective: To describe real-world treatment patterns and outcomes among patients with MDS treated with HMAs. Design: Adult patients with a confirmed MDS diagnosis between 01/2009-12/2015 treated with HMAs were identified in the SEER-Medicare database (01/2006-12/2016). The index date was the date of HMA initiation. Patients were required to have Medicare Parts A and B coverage for ≥12 months pre-index and ≥1 month post-index. Patients with evidence of stem cell transplant or acute myeloid leukemia (AML) pre-index, or enrollment in a clinical trial at any time were excluded. Results: A total of 3,046 patients with MDS treated with HMAs were included. Average age was 77.4 years and 36.8% were female. Most patients (70.9%) were classified in the higher-risk MDS group; 8.0% and 21.1% were classified in the intermediate-1-risk and unknown-risk MDS groups. Median OS was 11.6, 18.4, and 19.1 months in the higher-risk, intermediate-1-risk, and unknown risk MDS groups, respectively; median time to AML transformation was 19.3 months, 50.4 months, and not reached, respectively. Patients received an average of 5.1 HMA cycles (median, 4.0 cycles); most were complete cycles (90.9%; per label or, for AZA, also including the commonly used alternative regimens of 5-day 5-0-0 or 7-day with a weekend break 5-2-2). Mean duration of HMA cycles was 32.6 days (median, 28.0 days). Overall, 45.3% of patients received Conclusions: In this US real-world observational study, >70% of patients with MDS treated with HMAs were at higher-risk of AML transformation or death. Patients in the higher-risk MDS group had poor prognosis, with a median OS