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01.12.2018 | Research article | Ausgabe 1/2018 Open Access

BMC Hematology 1/2018

Systematic review of azacitidine regimens in myelodysplastic syndrome and acute myeloid leukemia

BMC Hematology > Ausgabe 1/2018
Roman M. Shapiro, Alejandro Lazo-Langner
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s12878-017-0094-8) contains supplementary material, which is available to authorized users.



5-Azacitidine administered as a 7-day dosing regimen (7–0-0) is approved in high risk IPSS myelodysplastic syndrome (MDS) patients. Alternative regimens such as a 5-day (5–0-0) or 7-day with a weekend break (5–2-2) are commonly used. No randomized controlled trial has been done directly comparing all three dosing regimens. The objective of this study was to compare the efficacies of the 5–0-0, 5–2-2, and 7–0-0 regimens in MDS and AML.


A systematic review was conducted using MEDLINE, EMBASE and CENTRAL. Eligible studies were randomized controlled trials (RCTs), observational prospective and retrospective studies. The primary clinical outcomes were Objective Response Rate (ORR) defined as the sum of complete response (CR), partial response (PR), and hematological improvement (HI) as defined by the IWG 2006 criteria. A meta-analysis of simple proportions was conducted using a random effects model with weights defined according to Laird and Mosteller. Comparisons between groups were not attempted due to the heterogeneity of study designs.


The only RCT directly comparing alternative azacitidine regimens showed no difference in ORR between the 5–0-0 and 5–2-2 regimens. All other RCTs compared a dosing regimen to conventional care. The pooled proportion of ORR was 44.8% with 95% CI (42.8%, 45.5%) for 7–0-0, 41.2% with 95% CI (39.2%, 41.9%) for 5–0-0, and 45.8% with 95% CI (42.6%, 46.4%) for 5–2-2.


Indirect comparison of alternative azacitidine dosing regimens in MDS and AML shows a benefit for the 7-day regimen in attaining ORR. Additional RCTs are required to definitively address this comparison.
Additional file 1: This file includes the Medline search strategy used. (DOCX 13 kb)
Additional file 2: This file includes Tables S1, S2, and S3. The former describes the available characteristics of all patients included in this study that were reported in literature articles (abstracts did not provide sufficient information regarding baseline patient characteristics). Table S2. describes available objective response rate and survival data from literature articles retrieved for this systematic review. Table S3. is a comparison of the IWG 2000 and IWG 2006 objective response criteria. (DOCX 31 kb)
Additional file 3: This file includes the supplementary reference list for the systematic review. These references include articles and abstracts retrieved for this systematic review that were not cited in the main manuscript, but that are included in the data analysis. (DOCX 20 kb)
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