PMID- 36568250
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230103
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 12
DP  - 2022
TI  - High efficacy of azacitidine combined with homoharringtonine, idarubicin, and 
      cytarabine in newly diagnosed patients with AML: A single arm, phase 2 trial.
PG  - 1069246
LID - 10.3389/fonc.2022.1069246 [doi]
LID - 1069246
AB  - INTRODUCTION: This study aims to evaluate the efficacy and safety of the novel 
      combination of Aza and HIA as the frontline induction therapy in newly diagnosed 
      AML patients eligible for intensive chemotherapy (IC) (registered on 
      ClinicalTrials.gov, number NCT04248595). METHODS: Aza (75mg/m2/d on days1-5 
      subcutaneous) is administered in combination with HIA [HHT 2mg/m2/d on days 4-8 
      intravenous over 3 hours, idarubicin 6mg/m2/d on days 4-6 intravenous, and 
      cytarabine 100mg/m2/d on days 4-10 intravenous]. The primary endpoint was 
      complete remission (CR) or CR with incomplete blood count recovery (CRi). 
      Secondary endpoints were overall survival (OS), relapse-free survival (RFS), and 
      adverse events (AEs). RESULTS: A total of 20 AML patients (aged 18-70 years) were 
      enrolled between Jan 2020 and Sep 2022. 95% (19/20) of patients achieved CR/CRi, 
      and 89.5% (17/19) had undetectable MRD, in which 94.7% (18/19) reached CR/CRi, 
      and 88.9% (16/18) obtained MRD negative after the 1st cycle of induction therapy. 
      Median OS and RFS were both not reached during the follow-up. The estimated 
      2-year OS and RFS were 87.5% (95%CI, 58.6% to 96.7%) and 87.1% (95%CI, 57.3% to 
      96.6%), respectively. No patient discontinued the treatment for AEs. DISCUSSION: 
      This study provides preliminary evidence for this novel combination therapy as 
      the first-line induction therapy for young or older AML patients fit for IC.
CI  - Copyright (c) 2022 Li, Huang, Hou, Gu, Song and Ge.
FAU - Li, Jun
AU  - Li J
AD  - Department of Hematology, Zhongda Hospital, School of Medicine, Southeast 
      University, Institute of Hematology Southeast University, Nanjing, China.
FAU - Huang, Yanqing
AU  - Huang Y
AD  - Department of Hematology, Zhongda Hospital, School of Medicine, Southeast 
      University, Institute of Hematology Southeast University, Nanjing, China.
FAU - Hou, Yue
AU  - Hou Y
AD  - Department of Hematology, Zhongda Hospital, School of Medicine, Southeast 
      University, Institute of Hematology Southeast University, Nanjing, China.
FAU - Gu, Yan
AU  - Gu Y
AD  - Department of Hematology, Zhongda Hospital, School of Medicine, Southeast 
      University, Institute of Hematology Southeast University, Nanjing, China.
FAU - Song, Chunhua
AU  - Song C
AD  - Hershey Medical Center, Pennsylvania State University Medical College, Hershey, 
      PA, United States.
AD  - Division of Hematology, The Ohio State University Wexner Medical Center, the 
      James Cancer Hospital, Columbus, OH, United States.
FAU - Ge, Zheng
AU  - Ge Z
AD  - Department of Hematology, Zhongda Hospital, School of Medicine, Southeast 
      University, Institute of Hematology Southeast University, Nanjing, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT04248595
PT  - Journal Article
DEP - 20221208
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC9773133
OTO - NOTNLM
OT  - AML
OT  - azacitidine
OT  - homoharringtonine
OT  - newly diagnosed
OT  - phase 2 trial
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/12/27 06:00
MHDA- 2022/12/27 06:01
PMCR- 2022/01/01
CRDT- 2022/12/26 03:48
PHST- 2022/10/13 00:00 [received]
PHST- 2022/11/25 00:00 [accepted]
PHST- 2022/12/26 03:48 [entrez]
PHST- 2022/12/27 06:00 [pubmed]
PHST- 2022/12/27 06:01 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2022.1069246 [doi]
PST - epublish
SO  - Front Oncol. 2022 Dec 8;12:1069246. doi: 10.3389/fonc.2022.1069246. eCollection 
      2022.