Romidepsin treatment for relapsed or refractory peripheral and cutaneous T-cell lymphoma: Real-life data from a national multicenter observational study.
Adult
Aged
Aged, 80 and over
Antibiotics, Antineoplastic
/ administration & dosage
Depsipeptides
/ administration & dosage
Drug Resistance, Neoplasm
Female
Humans
Kaplan-Meier Estimate
Lymphoma, T-Cell, Cutaneous
/ drug therapy
Lymphoma, T-Cell, Peripheral
/ drug therapy
Male
Middle Aged
Prognosis
Recurrence
Retreatment
Treatment Outcome
histone deacetylase inhibitor
lymphoma T-cell
treatment outcome
Journal
Hematological oncology
ISSN: 1099-1069
Titre abrégé: Hematol Oncol
Pays: England
ID NLM: 8307268
Informations de publication
Date de publication:
Dec 2019
Dec 2019
Historique:
received:
12
09
2019
accepted:
21
10
2019
pubmed:
2
11
2019
medline:
14
1
2020
entrez:
2
11
2019
Statut:
ppublish
Résumé
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.
Substances chimiques
Antibiotics, Antineoplastic
0
Depsipeptides
0
romidepsin
CX3T89XQBK
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
569-577Informations de copyright
©2019 John Wiley & Sons, Ltd.
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