PMID- 36428152
OWN - NLM
STAT- MEDLINE
DCOM- 20230130
LR  - 20230214
IS  - 2152-2669 (Electronic)
IS  - 2152-2669 (Linking)
VI  - 23
IP  - 2
DP  - 2023 Feb
TI  - Azacitidine Monotherapy in Patients With Treatment-Naive Higher-risk 
      Myelodysplastic Syndrome: A Systematic Literature Review and Meta-analysis.
PG  - 127-137
LID - S2152-2650(22)01719-0 [pii]
LID - 10.1016/j.clml.2022.11.002 [doi]
AB  - BACKGROUND: The global incidence of myelodysplastic syndromes (MDS) has been 
      estimated as 0.06 to 0.26/100,000. Since their introduction, hypomethylating 
      agents have played a central role in the treatment of MDS, with heterogeneous 
      real-world outcomes. MATERIALS AND METHODS: We assessed and synthesized clinical 
      outcomes of azacitidine (AZA) monotherapy in treatment-naive patients with 
      higher-risk MDS. A systematic literature review was conducted by searching 
      MEDLINE, Embase, and CENTRAL to identify randomized clinical trials (RCTs) and 
      observational studies, both prospective and retrospective, reporting complete 
      remission (CR), partial remission (PR), overall survival (OS), duration of 
      response (DOR), time-to-response (TTR), and myelosuppressive adverse events (AEs) 
      for patients treated with AZA monotherapy. Noncomparative meta-analyses were used 
      to summarize effects. RESULTS: The search identified 3250 abstracts, of which 34 
      publications describing 16 studies (5 RCTs, 3 prospective, and 8 retrospective 
      observational) were included. Across all studies, pooled CR was 16%; PR was 6%; 
      Median OS was 16.4 months; median DOR was 10.1 months; median TTR was 4.6 months. 
      Proportions of grade 3/4 anemia and thrombocytopenia AEs were 10% and 30%. 
      CONCLUSIONS: The effectiveness and efficacy of AZA monotherapy-as measured by CR 
      and median OS-was limited. These findings highlight a significant unmet medical 
      need for effective treatments for patients with higher-risk MDS.
CI  - Copyright (c) 2022 The Author(s). Published by Elsevier Inc. All rights reserved.
FAU - Hasegawa, Ken
AU  - Hasegawa K
AD  - Gilead Sciences, Inc., Foster City, CA. Electronic address: 
      ken.hasegawa1@gilead.com.
FAU - Wei, Andrew H
AU  - Wei AH
AD  - Peter MacCallum Cancer Centre, Royal Melbourne Hospital and Walter and Eliza Hall 
      Institute of Medical Research, Melbourne, VIC.
FAU - Garcia-Manero, Guillermo
AU  - Garcia-Manero G
AD  - University of Texas MD Anderson Cancer Center, Houston, TX.
FAU - Daver, Naval G
AU  - Daver NG
AD  - University of Texas MD Anderson Cancer Center, Houston, TX.
FAU - Rajakumaraswamy, Nishanthan
AU  - Rajakumaraswamy N
AD  - Gilead Sciences, Inc., Foster City, CA.
FAU - Iqbal, Shahed
AU  - Iqbal S
AD  - Gilead Sciences, Inc., Foster City, CA.
FAU - Chan, Rebecca J
AU  - Chan RJ
AD  - Gilead Sciences, Inc., Foster City, CA.
FAU - Hu, Hao
AU  - Hu H
AD  - Gilead Sciences, Inc., Foster City, CA.
FAU - Tse, Preston
AU  - Tse P
AD  - McMaster University, Hamilton, ON, Canada.
FAU - Yan, Jiajun
AU  - Yan J
AD  - McMaster University, Hamilton, ON, Canada.
FAU - Zoratti, Michael J
AU  - Zoratti MJ
AD  - McMaster University, Hamilton, ON, Canada.
FAU - Xie, Feng
AU  - Xie F
AD  - McMaster University, Hamilton, ON, Canada.
FAU - Sallman, David A
AU  - Sallman DA
AD  - H. Lee Moffitt Cancer Center, Tampa, FL.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PT  - Systematic Review
DEP - 20221106
PL  - United States
TA  - Clin Lymphoma Myeloma Leuk
JT  - Clinical lymphoma, myeloma & leukemia
JID - 101525386
RN  - M801H13NRU (Azacitidine)
RN  - 0 (Antimetabolites, Antineoplastic)
SB  - IM
MH  - Humans
MH  - *Azacitidine/adverse effects
MH  - Antimetabolites, Antineoplastic/adverse effects
MH  - *Myelodysplastic Syndromes/drug therapy
MH  - Treatment Outcome
MH  - Remission Induction
OTO - NOTNLM
OT  - Hypomethylating agents
OT  - Mds
OT  - Remission
OT  - Survival
OT  - Treatment outcomes
EDAT- 2022/11/26 06:00
MHDA- 2023/01/31 06:00
CRDT- 2022/11/25 22:05
PHST- 2022/08/31 00:00 [received]
PHST- 2022/10/26 00:00 [revised]
PHST- 2022/11/03 00:00 [accepted]
PHST- 2022/11/26 06:00 [pubmed]
PHST- 2023/01/31 06:00 [medline]
PHST- 2022/11/25 22:05 [entrez]
AID - S2152-2650(22)01719-0 [pii]
AID - 10.1016/j.clml.2022.11.002 [doi]
PST - ppublish
SO  - Clin Lymphoma Myeloma Leuk. 2023 Feb;23(2):127-137. doi: 
      10.1016/j.clml.2022.11.002. Epub 2022 Nov 6.