TY - JOUR
T1 - Clinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides
AU - Foss, Francine
AU - Duvic, Madeleine
AU - Lerner, Adam
AU - Waksman, Joel
AU - Whittaker, Sean
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Patients with cutaneous T-cell lymphoma (CTCL) who have cutaneous tumors or folliculotropic disease involvement typically have a poor prognosis. Analysis of the pivotal phase II trial of romidepsin for relapsed or refractory CTCL showed that single-agent romidepsin induced a clinical response or stable disease in most patients with cutaneous tumors and/or folliculotropic disease involvement, supporting its use in these patient populations. 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.
AB - Patients with cutaneous T-cell lymphoma (CTCL) who have cutaneous tumors or folliculotropic disease involvement typically have a poor prognosis. Analysis of the pivotal phase II trial of romidepsin for relapsed or refractory CTCL showed that single-agent romidepsin induced a clinical response or stable disease in most patients with cutaneous tumors and/or folliculotropic disease involvement, supporting its use in these patient populations. 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.
KW - CTCL
KW - Cutaneous T-cell lymphoma
KW - Cutaneous tumors
KW - Histone deacetylase inhibitor
KW - Pruritus
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U2 - 10.1016/j.clml.2016.08.009
DO - 10.1016/j.clml.2016.08.009
M3 - Article
C2 - 27637428
AN - SCOPUS:84994491976
SN - 2152-2650
VL - 16
SP - 637
EP - 643
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 11
ER -