PMID- 34805202
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211123
IS  - 2296-858X (Print)
IS  - 2296-858X (Electronic)
IS  - 2296-858X (Linking)
VI  - 8
DP  - 2021
TI  - Efficacy and Treatment-Related Adverse Events of Romidepsin in PTCL Clinical 
      Studies: A Systematic Review and Meta-Analysis.
PG  - 732727
LID - 10.3389/fmed.2021.732727 [doi]
LID - 732727
AB  - Background: Peripheral T-cell lymphoma (PTCL) is an extensive class of 
      biologically and clinically heterogeneous diseases with dismal outcomes. The 
      histone deacetylase inhibitor (HDACi) romidepsin was approved for relapsed and 
      refractory (R/R-PTCL) in 2011. This meta-analysis was performed to assess the 
      efficacy and safety of romidepsin in PTCL. Methods: We searched for articles on 
      the HDAC inhibitor romidepsin in the treatment of PTCL in Embase, Web of Science, 
      and PubMed. The methodology is further detailed in PROSPERO (CRD42020213651, 
      CRD42020213553). The 2-year overall survival (OS), 2-year progression-free 
      survival (PFS), and their corresponding to 95% confidence intervals (CIs) were 
      measured. Besides, corresponding 95% CIs were pooled for the complete response 
      (CR), partial response (PR), duration of response (DoR), and risk of adverse 
      events (AEs). Results: Eleven studies containing 388 patients were incorporated 
      into the quantitative synthesis, of which R/R-PTCL patients were the dominant 
      portion, accounting for 94.3% (366/388). For all studies, the CR rate was 20% 
      (95% CI, 13-27%, random effects model), and the PR rate was 18% (95% CI, 12-25%, 
      random effects model). The 2-year OS was 48% (95% CI, 38-59%, fixed effects 
      model), and the 2-year PFS was 17% (95% CI, 13-21%, fixed effects model). There 
      were no significant differences between romidepsin monotherapy and romidepsin 
      plus additional drugs. Hematological toxicities, such as lymphopenia and 
      granulocytopenia, remained the most continually happening grade 3 or higher AEs, 
      accounting for 46 and 28%, respectively. None of the studies reported any 
      drug-related mortality. Conclusions: Considering that most of the included 
      patients had R/R-PTCL, the addition of romidepsin significantly enhance the 
      efficacy. And AEs were tolerable as the grade 3/4 AEs in romidepsin monotherapy 
      was 7% (95% CI, 6-8%). It is imperative to further expand the first-line 
      application of romidepsin and carry out personalized therapy based on 
      epigenomics, which will improve the survival of PTCL patients. Systematic Review 
      Registration: 
      https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020213651 and 
      https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020213553.
CI  - Copyright (c) 2021 Du, Han, Lin, Qiu, Zhu, Huang and Hou.
FAU - Du, Jun
AU  - Du J
AD  - Department of Hematology, Renji Hospital, School of Medicine, Shanghai Jiao Tong 
      University, Shanghai, China.
FAU - Han, Xinle
AU  - Han X
AD  - Biomedical Research Institute, Shenzhen Peking University-The Hong Kong 
      University of Science and Technology Medical Center, Shenzhen, China.
FAU - Lin, Suwen
AU  - Lin S
AD  - Biomedical Research Institute, Shenzhen Peking University-The Hong Kong 
      University of Science and Technology Medical Center, Shenzhen, China.
FAU - Qiu, Chen
AU  - Qiu C
AD  - State Key Laboratory of Experimental Hematology, Institute of Hematology and 
      Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union 
      Medical College, Tianjin, China.
FAU - Zhu, Lijun
AU  - Zhu L
AD  - Binjiang College of Nanjing University of Information Engineering Information 
      Management and System, Wuxi, China.
FAU - Huang, Zoufang
AU  - Huang Z
AD  - The First Affliated Hospital of Gannan Medical University, Ganzhou, China.
FAU - Hou, Jian
AU  - Hou J
AD  - Department of Hematology, Renji Hospital, School of Medicine, Shanghai Jiao Tong 
      University, Shanghai, China.
LA  - eng
PT  - Systematic Review
DEP - 20211105
PL  - Switzerland
TA  - Front Med (Lausanne)
JT  - Frontiers in medicine
JID - 101648047
PMC - PMC8602095
OTO - NOTNLM
OT  - PTCL
OT  - adverse events
OT  - efficiency
OT  - meta-analysis
OT  - romidepsin
OT  - systematic review
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- 2021/11/23 06:00
MHDA- 2021/11/23 06:01
PMCR- 2021/11/05
CRDT- 2021/11/22 06:53
PHST- 2021/06/29 00:00 [received]
PHST- 2021/10/04 00:00 [accepted]
PHST- 2021/11/22 06:53 [entrez]
PHST- 2021/11/23 06:00 [pubmed]
PHST- 2021/11/23 06:01 [medline]
PHST- 2021/11/05 00:00 [pmc-release]
AID - 10.3389/fmed.2021.732727 [doi]
PST - epublish
SO  - Front Med (Lausanne). 2021 Nov 5;8:732727. doi: 10.3389/fmed.2021.732727. 
      eCollection 2021.