PMID- 35680626
OWN - NLM
STAT- MEDLINE
DCOM- 20220613
LR  - 20220716
IS  - 0253-2727 (Print)
IS  - 2707-9740 (Electronic)
IS  - 0253-2727 (Linking)
VI  - 43
IP  - 4
DP  - 2022 Apr 14
TI  - [Efficacy and safety of IAC regimen for relapse/refractory acute myeloid 
      leukemia: a prospective randomized controlled study].
PG  - 287-292
LID - 10.3760/cma.j.issn.0253-2727.2022.04.004 [doi]
AB  - Objective: To evaluate the efficacy and toxicity profiles of idarubicin, 
      cytarabine, and cyclophosphamide (IAC) in relapse/refractory acute myeloid 
      leukemia (AML) . Methods: This study was a prospective, randomized controlled 
      clinical trial with the registration number NCT02937662. The patients were 
      randomly divided into two groups. The experimental group was treated with an IAC 
      regimen, and the regimen of the control group was selected by doctors according 
      to medication experience. After salvage chemotherapy, allogeneic hematopoietic 
      stem cell transplantation (allo-HSCT) was conducted as far as possible according 
      to the situation of the patients. We aimed to observe the efficacy, safety, and 
      toxicity of the IAC regimen in relapse/refractory AML and to explore which is the 
      better regimen. Results: Forty-two patients were enrolled in the clinical trial, 
      with a median age of 36 years (IAC group, 22 cases and control groups, 20 cases) 
      . 1 in circleThe objective response rate was 71.4% in the IAC group and 40.0% in the 
      control group (P=0.062) ; the complete remission (CR) rate was 66.7% in the IAC 
      group and 40.0% in the control group (P=0.121) . The median follow-up time of 
      surviving patients was 10.5 (range:1.7-32.8) months; the median overall survival 
      (OS) was 14.1 (range: 0.6-49.1) months in the IAC group and 9.9 (range: 2.0-53.8) 
      months in the control group (P=0.305) . The 1-year OS was 54.5% (95%CI 
      33.7%-75.3%) in the IAC group and 48.2% (95%CI 25.9%-70.5%) in the control group 
      (P=0.305) , with no significant difference between these two regimens. 2 in circleThe main 
      hematologic adverse events (AEs) were anemia, thrombocytopenia, and neutropenia. 
      The incidence of grade 3-4 hematologic AEs in the two groups was 100% (22/22) in 
      the IAC group and 95% (19/20) in the control group. The median time of 
      neutropenia after chemotherapy in the IAC group and control group was 20 (IQR: 
      8-30) and 14 (IQR: 5-50) days, respectively (P=0.023) . 3 in circleThe CR rate of the early 
      relapse (relapse within 12 months) group was 46.7% and that of the late relapse 
      (relapse after 12 months) group was 72.7% (P=0.17) . The median OS time of early 
      recurrence was 9.9 (range:1.7-53.8) months, and that of late recurrence patients 
      was 19.3 (range: 0.6-40.8) months (P=0.420) , with no significant differences 
      between the two groups. The 1-year OS rates were 45.3% (95%CI 27.2%-63.3%) and 
      66.7% (95%CI 40.0%-93.4%) , respectively (P=0.420) . Survival analysis showed 
      that the 1-year OS rates of the hematopoietic stem cell transplantation group and 
      non-hematopoietic stem cell transplantation group were 87.5% (95%CI 71.2%-100%) 
      and 6.3% (95%CI 5.7%-18.3%) , respectively. The OS rate of the hematopoietic stem 
      cell transplantation group was significantly higher than that of the 
      non-hematopoietic stem cell transplantation group (P<0.001) . Conclusion: The IAC 
      regimen is a well-tolerated and effective regimen in relapsed/refractory AML; 
      this regimen had similar efficacy and safety with the regimen selected according 
      to the doctor's experience for treating relapsed/refractory AML. For 
      relapsed/refractory patients with AML, allogeneic hematopoietic stem cell 
      transplantation should be attempted as soon as possible to achieve long-term 
      survival.
FAU - Li, C H
AU  - Li CH
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Wei, S N
AU  - Wei SN
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Qiu, S W
AU  - Qiu SW
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Gong, B F
AU  - Gong BF
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Gong, X Y
AU  - Gong XY
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Li, Y
AU  - Li Y
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Liu, Y T
AU  - Liu YT
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Fang, Q Y
AU  - Fang QY
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Zhang, G J
AU  - Zhang GJ
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Liu, K Q
AU  - Liu KQ
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Zhou, C L
AU  - Zhou CL
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Lin, D
AU  - Lin D
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Liu, B C
AU  - Liu BC
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Wang, Y
AU  - Wang Y
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Mi, Y C
AU  - Mi YC
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Wei, H
AU  - Wei H
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
FAU - Wang, J X
AU  - Wang JX
AD  - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical 
      Sciences & Peking Union Medical College, State Key Laboratory of Experimental 
      Hematology, Haihe Laboratory of Cell Ecosystem, National Clinical Research Center 
      for Blood Diseases, Tianjin 300020, China.
LA  - chi
GR  - 2021YFC2500300/National Key Research and Development Program of China/
GR  - 82141122/National Natural Science Foundation of China/
GR  - HH22KYZX0039/Haihe Laboratory of Cell Ecosystem/
GR  - 2020-I2M-C&T-A-019/CAMS Innovation Fund for Medical Sciences/
GR  - 21ZXGWSY00030/Tianjin Municipal Science and Technology Commission Grant/
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - China
TA  - Zhonghua Xue Ye Xue Za Zhi
JT  - Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi
JID - 8212398
RN  - 04079A1RDZ (Cytarabine)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - ZRP63D75JW (Idarubicin)
SB  - IM
MH  - Adult
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - Cyclophosphamide/therapeutic use
MH  - Cytarabine/therapeutic use
MH  - *Hematopoietic Stem Cell Transplantation
MH  - Humans
MH  - Idarubicin/therapeutic use
MH  - *Leukemia, Myeloid, Acute/drug therapy
MH  - *Neutropenia
MH  - Prospective Studies
MH  - Recurrence
MH  - Retrospective Studies
PMC - PMC9189487
OTO - NOTNLM
OT  - Antineoplastic combined chemotherapy protocols
OT  - Leukemia, myeloid, acute
OT  - Refractory
OT  - Relapsed
COIS- 利益冲突 所有作者声明不存在利益冲突
EDAT- 2022/06/10 06:00
MHDA- 2022/06/14 06:00
PMCR- 2022/04/01
CRDT- 2022/06/09 23:17
PHST- 2022/06/09 23:17 [entrez]
PHST- 2022/06/10 06:00 [pubmed]
PHST- 2022/06/14 06:00 [medline]
PHST- 2022/04/01 00:00 [pmc-release]
AID - cjh-43-04-287 [pii]
AID - 10.3760/cma.j.issn.0253-2727.2022.04.004 [doi]
PST - ppublish
SO  - Zhonghua Xue Ye Xue Za Zhi. 2022 Apr 14;43(4):287-292. doi: 
      10.3760/cma.j.issn.0253-2727.2022.04.004.