Comparative clinical effectiveness of azacitidine versus decitabine in older patients with myelodysplastic syndromes
Open Access
- 21 September 2016
- journal article
- research article
- Published by Wiley in British Journal of Haematology
- Vol. 175 (5), 829-840
- https://doi.org/10.1111/bjh.14305
Abstract
The hypomethylating agents (HMAs) azacitidine and decitabine are both approved for treatment of myelodysplastic syndromes (MDS) in the USA. In Europe, decitabine is not approved due to lack of survival advantage in randomized trials. The two drugs have not been compared in clinical trials. We identified patients diagnosed with MDS between 2004 and 2011 from the Surveillance, Epidemiology, and End Results (SEER)‐Medicare linked database in the USA who received ≥ 10 doses of either HMA. We estimated survival from HMA initiation with Kaplan–Meier methods and used multivariate Cox proportional hazards models to adjust for covariates. Analyses controlled for histological subtype and we conducted a subset analysis limited to patients with refractory anaemia with excess blasts (RAEB). In 2025 HMA‐treated patients, median survival was 15 months with no difference in survival based on the HMA received in adjusted analysis (decitabine versus azacitidine, hazard ratio = 1·06, 95% confidence interval: 0·94–1·19, P = 0·37). For RAEB patients (n = 523), median survival was 12 months, with no significant difference based on HMA received. No significant survival difference was found between azacitidine and decitabine in patients with MDS, including RAEB. Importantly, population‐based survival of azacitidine‐treated RAEB patients was substantially shorter than in the AZA‐001 clinical trial (11 versus 24·5 months).Keywords
Funding Information
- National Cancer Institute (P30 CA016359)
- American Cancer Society
- California Department of Public Health
- University of Southern California (N01‐PC‐35139)
- Public Health Institute (N02‐PC‐15105, U55/CCR921930‐02)
This publication has 24 references indexed in Scilit:
- Current therapy of myelodysplastic syndromesBlood Reviews, 2013
- Comparison of 7-day azacitidine and 5-day decitabine for treating myelodysplastic syndromeAnnals of Hematology, 2013
- Underreporting of Myeloid Malignancies by United States Cancer RegistriesCancer Epidemiology, Biomarkers & Prevention, 2012
- Platelet doubling after the first azacitidine cycle is a promising predictor for response in myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML) patients in the Dutch azacitidine compassionate named patient programmeBritish Journal of Haematology, 2011
- Low-Dose Decitabine Versus Best Supportive Care in Elderly Patients With Intermediate- or High-Risk Myelodysplastic Syndrome (MDS) Ineligible for Intensive Chemotherapy: Final Results of the Randomized Phase III Study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study GroupJournal of Clinical Oncology, 2011
- Prognostic factors for response and overall survival in 282 patients with higher-risk myelodysplastic syndromes treated with azacitidineBlood, 2011
- Myelodysplastic syndromesCancer, 2007
- Decitabine improves patient outcomes in myelodysplastic syndromesCancer, 2006
- Overview of the SEER-Medicare DataMedical Care, 2002
- Randomized Controlled Trial of Azacitidine in Patients With the Myelodysplastic Syndrome: A Study of the Cancer and Leukemia Group BJournal of Clinical Oncology, 2002