{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T15:02:19Z","timestamp":1781103739476,"version":"3.54.1"},"reference-count":39,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2021,11,5]],"date-time":"2021-11-05T00:00:00Z","timestamp":1636070400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:p><jats:bold>Background:<\/jats:bold> 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.<\/jats:p><jats:p><jats:bold>Methods:<\/jats:bold> 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).<\/jats:p><jats:p><jats:bold>Results:<\/jats:bold> 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\u201327%, random effects model), and the PR rate was 18% (95% CI, 12\u201325%, random effects model). The 2-year OS was 48% (95% CI, 38\u201359%, fixed effects model), and the 2-year PFS was 17% (95% CI, 13\u201321%, 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.<\/jats:p><jats:p><jats:bold>Conclusions:<\/jats:bold> 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\u20138%). 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.<\/jats:p><jats:p><jats:bold>Systematic Review Registration:<\/jats:bold><jats:ext-link>https:\/\/www.crd.york.ac.uk\/prospero\/display_record.php?ID=CRD42020213651<\/jats:ext-link> and <jats:ext-link>https:\/\/www.crd.york.ac.uk\/prospero\/display_record.php?ID=CRD42020213553<\/jats:ext-link>.<\/jats:p>","DOI":"10.3389\/fmed.2021.732727","type":"journal-article","created":{"date-parts":[[2021,11,5]],"date-time":"2021-11-05T06:39:43Z","timestamp":1636094383000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":10,"title":["Efficacy and Treatment-Related Adverse Events of Romidepsin in PTCL Clinical Studies: A Systematic Review and 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