Researchers involved in an international multicenter trial have reported that romidepsin is effective for the treatment of patients with cutaneous T-cell lymphoma (CTCL). The results of this study were presented at the 50th annual meeting of the American Society of Hematology in San Francisco on December 8, 2008.[1]
Mycosis fungoides and Sezary syndrome are the most common forms of CTCL. Sezary syndrome has a leukemic form involving circulating Sezary cells. Mycosis fungoides can also evolve to a tumor stage with involvement of lymph nodes. Survival is determined by stage of the disease; some patients with localized disease can survive for decades, while patients with systemic disease have an average survival of three to four years. Treatment consists of both topical and systemic therapies. Treatment modalities include psoralen and ultraviolet A radiation (PUVA), interferon alfa, local radiation therapy, electron beam therapy, bexarotene, topical chemotherapy, extracorporeal photochemotherapy, bexarotene, dinileukin diftitox, alemtuzumab, and the usual chemotherapy given for non-Hodgkin’s lymphoma including doxorubicin. However, none of these therapies are curative. The only potentially curative approach to the treatment of patients with CTCL is stem cell transplantation.
Romidepsin inhibits histone deacetylase (HDAC), resulting in alterations in gene expression and the induction of cell differentiation, cell cycle arrest, and apoptosis. This agent also inhibits hypoxia-induced angiogenesis and depletes several heat shock protein 90 (Hsp90)-dependent oncoproteins.
This study included 96 patients with CTCL who had failed at least one prior treatment. Seventy-two patients who received two or more cycles of therapy were evaluated for response. The overall response rate was 42% with 8% achieving a complete response. Stable disease occurred in 26% for an overall disease control rate of 78%. The median time to response was two months, and the median time to disease progression was nine months. Half the patients had relief of pruritis including severe pruritis. Toxicities were deemed tolerable and manageable.
Comments: Romidepsin can be added to the rather long list of palliative therapies for CTCL.
Reference:
[1] Whittaker S, Demierre MF, Rook AH, et al. Clinically significant responses achieved with romidepsin in treatment-refractory cutaneous T-cell lymphoma: Final results from a phase 2B, multicenter, registration study. Blood. 2008;112:103, abstract 263.
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