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Romidepsin treatment for relapsed or refractory peripheral and cutaneous T‐cell lymphoma: Real‐life data from a national multicenter observational study
Author(s) -
Shimony Shai,
Horowitz Netanel,
Ribakovsky Elena,
Rozovski Uri,
Avigdor Abraham,
Zloto Keren,
Berger Tamar,
Avivi Irit,
Perry Chava,
Abadi Uri,
Raanani Pia,
GafterGvili Anat,
Gurion Ronit
Publication year - 2019
Publication title -
hematological oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 44
eISSN - 1099-1069
pISSN - 0278-0232
DOI - 10.1002/hon.2691
Subject(s) - romidepsin , medicine , lymphoma , peripheral t cell lymphoma , adverse effect , refractory (planetary science) , oncology , univariate analysis , gastroenterology , immunology , t cell , multivariate analysis , histone deacetylase , immune system , biochemistry , chemistry , physics , astrobiology , gene , histone
Romidepsin is a class I selective histone deacetylase (HDAC) inhibitor approved by the Food and Drug Administration (FDA) for relapsed/refractory (R/R) cutaneous T‐cell lymphoma (CTCL) and peripheral T‐cell lymphoma (PTCL), treated with at least one prior systemic therapy. Currently, there is paucity of real‐life data on the efficacy and safety of romidepsin in R/R T‐cell lymphoma. This national, multicenter study presents real‐life data on the efficacy and safety of romidepsin in R/R T‐cell lymphoma. Patients diagnosed and treated with romidepsin for R/R CTCL or PTCL between 2013 and 2018 were retrospectively reviewed. Outcomes included overall survival (OS), event‐free survival (EFS), overall response rate (ORR), complete response (CR), and adverse events. Fifty‐three patients with R/R PTCL (n = 42) or CTCL (n = 11) were included. Among CTCL patients, median OS was not reached, ORR was 25%, and none achieved CR. Among PTCL patients, median OS was 7.1 months, EFS was 1.9 months, ORR rate was 33%, and 12.5% achieved CR. In a univariate analysis, predictors for longer EFS include any response to therapy, number of previous lines, and PTCL subclass (with better results for angioimmunobalstic T‐cell lymphoma). In a univariate and multivariate analysis for OS, treatment response was the only factor predicting OS (OR 4.48; CI 95%, 1.57‐12.79; P = .005). Most grade 3 and 4 adverse events were hematological (35%). Infections were reported in 34% of patients. This real‐life experience with romidepsin confirms the results of the pivotal phase II trials. PTCL subtype and the number of previous lines of therapy have an impact on EFS. In addition, patients who had good response to romidepsin benefited most in terms of both EFS and OS. Efforts should be done to identify those patients.