Romidepsin Plus Liposomal Doxorubicin Is Safe and Effective in Patients with Relapsed or Refractory T-Cell Lymphoma: Results of a Phase I Dose-Escalation Study.
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Apoptosis
Cell Line, Tumor
Depsipeptides
/ administration & dosage
Dose-Response Relationship, Drug
Doxorubicin
/ administration & dosage
Female
Humans
Lymphoma, T-Cell
/ drug therapy
Lymphoma, T-Cell, Cutaneous
/ drug therapy
Lymphoma, T-Cell, Peripheral
/ drug therapy
Male
Middle Aged
Nausea
/ chemically induced
Neoplasm Recurrence, Local
/ drug therapy
Neutropenia
/ chemically induced
Patient Safety
Polyethylene Glycols
/ administration & dosage
Prospective Studies
Skin Neoplasms
/ drug therapy
Thrombocytopenia
/ chemically induced
Treatment Outcome
Vomiting
/ chemically induced
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500
Informations de publication
Date de publication:
01 03 2020
01 03 2020
Historique:
received:
04
07
2019
revised:
08
10
2019
accepted:
20
11
2019
pubmed:
28
11
2019
medline:
5
1
2021
entrez:
28
11
2019
Statut:
ppublish
Résumé
The histone deacetylase (HDAC) inhibitor romidepsin and the anthracycline liposomal doxorubicin (LD) have modest single-agent activity in cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). We investigated the safety and efficacy of the combination of these two agents in CTCL and PTCL. Using CTCL cell lines and primary CTCL tumor cells, we demonstrated synergistic antitumor activity with romidepsin plus doxorubicin. We then conducted a phase I dose-escalation study of the romidepsin/LD combination in relapsed/refractory CTCL and PTCL. The primary objective was to determine the MTD of romidepsin in combination with LD at 20 mg/m Eleven patients with CTCL and 12 patients with PTCL were treated. The MTD of romidepsin was determined to be 12 mg/m Romidepsin plus LD demonstrated an acceptable safety profile and promising clinical efficacy with deep skin responses in relapsed/refractory CTCL. Thus, this combination could be considered as a bridge to skin-directed treatment or allogeneic hematopoietic cell transplantation in patients with aggressive CTCL.
Identifiants
pubmed: 31772119
pii: 1078-0432.CCR-19-2152
doi: 10.1158/1078-0432.CCR-19-2152
doi:
Substances chimiques
Depsipeptides
0
liposomal doxorubicin
0
Polyethylene Glycols
3WJQ0SDW1A
Doxorubicin
80168379AG
romidepsin
CX3T89XQBK
Types de publication
Clinical Trial, Phase I
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1000-1008Informations de copyright
©2019 American Association for Cancer Research.