Cutaneous T-cell lymphomas (CTCL) are a heterogeneous group of neoplasm of skin-homing T
cells that includes Mycosis Fungoid (MF), which is the most common, Sézary syndrome (SS), the
leukemia variant of MF, and other variants of CTCL which are less prevalent. Clinical
manifestations and prognosis are highly variable. Improving the management of this incurable
disease with limited toxicity is the main point of the current research. Romidepsin is a
well-tolerated histone deacetylase inhibitor which has demonstrated activity against advanced
stages of CTCL. In November 2009, it was approved by the US Food and Drug Administration
(FDA) for the treatment of CTCL in patients who have received at least one prior systemic
therapy. FDA-dose approved is 14 mg/m2 days 1, 8, 15 of a 21 day-cycle. It is said that it
should be continued as long as the patient receives benefit and tolerates the drug. We
experienced in our clinic that a long-term (>6 months) use of Romidepsin, even with spared
doses allows patients to maintain disease in complete remission or under control without
severe side effects. We aim to demonstrate how many patients have benefited of this
maintenance therapy, and detect the side effects related to the long-term use of Romidepsin,
as well as characterize those patients that can get benefit of this therapy.