Efficacy and Treatment-Related Adverse Events of Romidepsin in PTCL Clinical Studies: A Systematic Review and Meta-Analysis

Jun Du; Xinle Han; Suwen Lin; Chen Qiu; Lijun Zhu; Zoufang Huang; Jian Hou

doi:10.3389/fmed.2021.732727

Efficacy and Treatment-Related Adverse Events of Romidepsin in PTCL Clinical Studies: A Systematic Review and Meta-Analysis

Front Med (Lausanne). 2021 Nov 5:8:732727. doi: 10.3389/fmed.2021.732727. eCollection 2021.

Authors

Jun Du¹, Xinle Han², Suwen Lin², Chen Qiu³, Lijun Zhu⁴, Zoufang Huang⁵, Jian Hou¹

Affiliations

¹ Department of Hematology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
² Biomedical Research Institute, Shenzhen Peking University-The Hong Kong University of Science and Technology Medical Center, Shenzhen, China.
³ 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.
⁴ Binjiang College of Nanjing University of Information Engineering Information Management and System, Wuxi, China.
⁵ The First Affliated Hospital of Gannan Medical University, Ganzhou, China.

Abstract

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.

Keywords: PTCL; adverse events; efficiency; meta-analysis; romidepsin; systematic review.

Publication types

Systematic Review