Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma.

Abstract

PURPOSE:

The primary objective of this study was to confirm the efficacy of romidepsin in patients with treatment refractory cutaneous T-cell lymphoma (CTCL).

PATIENTS AND METHODS:

This international, pivotal, single-arm, open-label, phase II study was conducted in patients with stage IB to IVA CTCL who had received one or more prior systemic therapies. Patients received romidepsin as an intravenous infusion at a dose of 14 mg/m(2) on days 1, 8, and 15 every 28 days. Response was determined by a composite assessment of total tumor burden including cutaneous disease, lymph node involvement, and blood (Sézary cells).

RESULTS:

Ninety-six patients were enrolled and received one or more doses of romidepsin. Most patients (71%) had advanced stage disease (≥ IIB). The response rate was 34% (primary end point), including six patients with complete response (CR). Twenty-six of 68 patients (38%) with advanced disease achieved a response, including five CRs. The median time to response was 2 months, and the median duration of response was 15 months. A clinically meaningful improvement in pruritus was observed in 28 (43%) of 65 patients, including patients who did not achieve an objective response. Median duration of reduction in pruritus was 6 months. Drug-related adverse events were generally mild and consisted mainly of GI disturbances and asthenic conditions. Nonspecific, reversible ECG changes were noted in some patients.

CONCLUSION:

Romidepsin has significant and sustainable single-agent activity (including improvement in pruritus) and an acceptable safety profile, making it an important therapeutic option for treatment refractory CTCL.

• Authors: Sean J Whittaker, Marie-France Demierre, Ellen J Kim, Alain H Rook, Adam Lerner, Madeleine Duvic, Julia Scarisbrick, Sunil Reddy, Tadeusz Robak, Jürgen C Becker, Alexey Samtsov, William McCulloch, Youn H Kim
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 28 Issue 29 Pg. 4485-91 (Oct 10 2010) ISSN: 1527-7755 [Electronic] United States
• PMID: 20697094 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibiotics, Antineoplastic
• Depsipeptides
• romidepsin

Topics

• Aged
• Antibiotics, Antineoplastic (administration & dosage, adverse effects, therapeutic use)
• Asthenia (chemically induced)
• Depsipeptides (administration & dosage, adverse effects, therapeutic use)
• Drug Administration Schedule
• Drug Resistance, Neoplasm
• Female
• Humans
• Infusions, Intravenous
• Lymphoma, T-Cell, Cutaneous (drug therapy)
• Male
• Middle Aged
• Nausea (chemically induced)
• Neoplasm Staging
• Prospective Studies
• Skin (drug effects, pathology)
• Skin Neoplasms (drug therapy)
• Treatment Outcome
• Vomiting (chemically induced)