PMID- 38054008
OWN - NLM
STAT- MEDLINE
DCOM- 20231207
LR  - 20240322
IS  - 1664-3224 (Electronic)
IS  - 1664-3224 (Linking)
VI  - 14
DP  - 2023
TI  - Venetoclax combined with hypomethylating agents and the CAG regimen in 
      relapsed/refractory AML: a single-center clinical trial.
PG  - 1269163
LID - 10.3389/fimmu.2023.1269163 [doi]
LID - 1269163
AB  - OBJECTIVE: This study aimed to evaluate the efficacy and safety of venetoclax in 
      combination with hypomethylating agents and CAG (VEN-DCAG) regimens in patients 
      with relapsed/refractory acute myeloid leukemia (R/R AML). METHODS: The treatment 
      response was analyzed by retrospective methods in R/R AML patients treated with 
      the VEN-DCAG regimen at our institution. This included, but was not limited to, 
      CR/CRi (complete remission/complete remission with incomplete hematologic 
      recovery) rate, measurable residual disease (MRD) negative rate, and overall 
      survival (OS). RESULTS: 20 patients with R/R AML were recruited, with a median 
      age of 40 years (10-70), 11 of whom were male (55%), and a median follow-up of 
      10.4 months (0.7-21.8). The overall response rate (ORR) after receiving 1 course 
      of VEN-DCAG was 90% (18/20), with 17 (85%) CR/CRi (10 MRD-CR), 1 (5%) PR, and 2 
      (10%) NR. Subsequently, 12 patients (7 MRD-CR, 4 MRD+CR, 1 NR) were treated with 
      the VEN-DCAG regimen, and 3 MRD+CR patients turned negative, and 13 patients 
      finally achieved MRD-CR. Among them, 7 patients were in the relapse group, all 
      achieving CR/CRi (6 MRD-CR), and 13 patients in the refractory group, with 10 
      CR/CRi (7 MRD-CR). The ORR for patients in the relapse and refractory groups was 
      100% (7/7) and 84.6% (11/13), respectively. Further, all patients experienced 
      adverse events (AEs) of varying degrees of severity, with hematologic AEs 
      primarily consisting of myelosuppression, while non-hematologic AEs were more 
      common in the form of fever, gastrointestinal distress, and infections. 11 
      patients were followed up with bridging allogeneic hematopoietic stem cell 
      transplantation (allo-HSCT) therapy. At the last follow-up, 11 patients (7 
      MRD-CR, 4 MRD+CR) who received allo-HSCT, 1 (MRD+CR) died, and 9 patients (6 
      MRD-CR, 1 PR, 2 NR) who did not receive allo-HSCT, 5 (2 MRD-CR, 1 PR, 2 NR) died 
      as well. CONCLUSION: The VEN-DCAG regimen may be an effective treatment option 
      for R/R AML patients, with high ORR and MRD negative remission rates in both the 
      relapsed and refractory groups. It is recommend that patients should be bridged 
      to allo-HSCT as soon as possible after induction to CR by the VEN-DCAG regimen, 
      which can lead to a significant long-term survival benefit. CLINICAL TRIAL 
      REGISTRATION: https://www.chictr.org.cn/, identifier ChiCTR2300075985.
CI  - Copyright (c) 2023 Liu, Li, Zhang, Yu and Jing.
FAU - Liu, Yifan
AU  - Liu Y
AD  - Medical School of Chinese PLA, Department of Hematology in the Fifth Medical 
      Center of PLA General Hospital, Beijing, China.
FAU - Li, Yanfen
AU  - Li Y
AD  - Medical School of Chinese PLA, Department of Hematology in the Fifth Medical 
      Center of PLA General Hospital, Beijing, China.
FAU - Zhang, Ran
AU  - Zhang R
AD  - Medical School of Chinese PLA, Department of Hematology in the Fifth Medical 
      Center of PLA General Hospital, Beijing, China.
FAU - Yu, Zhangyu
AU  - Yu Z
AD  - Medical School of Chinese PLA, Department of Hematology in the Fifth Medical 
      Center of PLA General Hospital, Beijing, China.
FAU - Jing, Yu
AU  - Jing Y
AD  - Medical School of Chinese PLA, Department of Hematology in the Fifth Medical 
      Center of PLA General Hospital, Beijing, China.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20231120
PL  - Switzerland
TA  - Front Immunol
JT  - Frontiers in immunology
JID - 101560960
RN  - N54AIC43PW (venetoclax)
RN  - CAG protocol
SB  - IM
MH  - Humans
MH  - Male
MH  - Child
MH  - Adolescent
MH  - Young Adult
MH  - Adult
MH  - Middle Aged
MH  - Aged
MH  - Female
MH  - Retrospective Studies
MH  - *Leukemia, Myeloid, Acute/therapy
MH  - Recurrence
PMC - PMC10694223
OTO - NOTNLM
OT  - CAG regimen
OT  - acute myeloid leukemia
OT  - hypomethylating agents
OT  - relapsed/refractory
OT  - venetoclax
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- 2023/12/06 06:41
MHDA- 2023/12/07 12:42
PMCR- 2023/01/01
CRDT- 2023/12/06 04:16
PHST- 2023/07/29 00:00 [received]
PHST- 2023/10/25 00:00 [accepted]
PHST- 2023/12/07 12:42 [medline]
PHST- 2023/12/06 06:41 [pubmed]
PHST- 2023/12/06 04:16 [entrez]
PHST- 2023/01/01 00:00 [pmc-release]
AID - 10.3389/fimmu.2023.1269163 [doi]
PST - epublish
SO  - Front Immunol. 2023 Nov 20;14:1269163. doi: 10.3389/fimmu.2023.1269163. 
      eCollection 2023.