Clinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides
Francine Foss, Madeleine Duvic, Adam Lerner, Joel Waksman, Sean Whittaker, Francine Foss, Madeleine Duvic, Adam Lerner, Joel Waksman, Sean Whittaker
Abstract
Background: Tumor stage and folliculotropic mycosis fungoides are uncommon subtypes of cutaneous T-cell lymphoma (CTCL) with an aggressive disease course. Romidepsin is a histone deacetylase inhibitor approved by the US Food and Drug Administration for patients with CTCL who have received ≥ 1 previous systemic therapy. In the present study, we examined the efficacy and safety of romidepsin in patients from the pivotal, single-arm, open-label, phase II study of relapsed or refractory CTCL with cutaneous tumors and/or folliculotropic disease involvement.
Materials and methods: Patients with CTCL who had received ≥ 1 previous systemic therapy received romidepsin at 14 mg/m2 on days 1, 8, and 15 of 28-day cycles. Responses were determined by a composite endpoint (assessments of the skin, blood, and lymph nodes). Patients with cutaneous tumors and/or folliculotropic disease involvement were identified by review of diagnosis and histology reports.
Results: The objective response rate to romidepsin was 45% in patients with cutaneous tumors (n = 20) and 60% in patients with folliculotropic disease involvement (n = 10).
Conclusion: Romidepsin is active in subtypes of CTCL with less favorable outcomes, such as tumor stage and folliculotropic mycosis fungoides.
Trial registration: ClinicalTrials.gov NCT00106431.
Keywords: CTCL; Cutaneous T-cell lymphoma; Cutaneous tumors; Histone deacetylase inhibitor; Pruritus.
Copyright © 2016 Elsevier Inc. All rights reserved.
Source: PubMed