Romidepsin: a histone deacetylase inhibitor for refractory cutaneous T-cell lymphoma.

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of romidepsin in refractory cutaneous T-cell lymphoma (CTCL).

DATA SOURCES:

An English-language literature search of PubMed and MEDLINE (Nov 2011-April 2012) was performed using the terms romidepsin, CTCL, and depsipeptide (FK228). The National Comprehensive Cancer Network guidelines, American Society of Clinical Oncology abstracts, American Society of Hematology abstracts, clinical trial registry, and prescribing information from the manufacturer were reviewed for additional information.

STUDY SELECTION AND DATA EXTRACTION:

Phase 1 and 2 trials evaluating the efficacy and safety of romidepsin were reviewed with a specific focus on its use in cutaneous T-cell lymphoma. All peer-reviewed articles with clinically relevant information were evaluated for inclusion.

DATA SYNTHESIS:

In advanced stage CTCL, single or combination chemotherapy regimen responses are variable and lack durability. Romidepsin is a histone deacetylase inhibitor approved for refractory cutaneous T-cell lymphoma. Romidepsin has shown an improvement in duration of response and pruritus over traditional therapy. In 2 independent Phase 2 trials, romidepsin showed an overall response rate of 34% and durable response of 13-15 months in patients with refractory CTCL. The most frequent toxicities of romidepsin include nausea, vomiting, fatigue, or myelosuppression. Clinically insignificant QT interval changes have been observed but did not correlate with a decrease in left ventricular ejection fraction, or elevated laboratory markers of myocardial damage.

CONCLUSIONS:

Romidepsin is an effective, durable, and well-tolerated single-agent therapy in patients with refractory CTCL and should be considered for formulary addition in this population.

• Authors: Miryoung Kim, Lisa A Thompson, Sarah D Wenger, Cindy L O'Bryant
• Journal: The Annals of pharmacotherapy (Ann Pharmacother) Vol. 46 Issue 10 Pg. 1340-8 (Oct 2012) ISSN: 1542-6270 [Electronic] United States
• PMID: 22968522 (Publication Type: Journal Article, Review)

Chemical References

• Depsipeptides
• Histone Deacetylase Inhibitors
• romidepsin

Topics

• Depsipeptides (pharmacology, therapeutic use)
• Drug Interactions
• Histone Deacetylase Inhibitors (pharmacology, therapeutic use)
• Humans
• Lymphoma, T-Cell, Cutaneous (drug therapy)
• Treatment Outcome