Adis, a Wolters Kluwer Business, Auckland, New Zealand.
Drugs. 2011 Jul 30;71(11):1469-80. doi: 10.2165/11207170-000000000-00000.
Romidepsin is a histone deacetylase inhibitor with high inhibitory activity for class I histone deacetylases. Intravenous romidepsin is indicated in the US for the treatment of adult patients with cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) who have received at least one prior systemic therapy. The clinical efficacy of romidepsin has been demonstrated in two noncomparative, multicentre, phase II trials in patients with relapsed, refractory or advanced CTCL. In both trials, therapy with intravenous romidepsin was associated with an overall response (i.e. both complete response and partial response) rate of 34% and a complete response rate of 6%. The efficacy of romidepsin was also evaluated in patients with relapsed or refractory PTCL in two noncomparative, multicentre, phase II trials. Intravenous romidepsin therapy was associated with overall response rates of 38% and 26% and a complete response rate of 18% and 13% in these trials. Romidepsin had an acceptable tolerability profile in clinical trials in patients with CTCL or PTCL. The most common adverse events of grade 3 or 4 severity considered at least possibly related to romidepsin were haematological or asthenic in nature, and included leukopenia, lymphopenia, granulocytopenia, thrombocytopenia, fatigue and anaemia.
罗米地辛是一种组蛋白去乙酰化酶抑制剂，对 I 类组蛋白去乙酰化酶具有高抑制活性。罗米地辛静脉注射在美国被批准用于治疗接受过至少一次系统治疗的成人皮肤 T 细胞淋巴瘤（CTCL）或外周 T 细胞淋巴瘤（PTCL）患者。罗米地辛在两项非比较、多中心、二期临床试验中已证明对复发、难治或晚期 CTCL 患者具有临床疗效。在这两项试验中，静脉注射罗米地辛治疗与总缓解率（即完全缓解和部分缓解）为 34%和完全缓解率为 6%相关。罗米地辛在两项非比较、多中心、二期临床试验中也评估了复发或难治性 PTCL 患者中的疗效。静脉注射罗米地辛治疗与总缓解率为 38%和 26%和完全缓解率为 18%和 13%相关。罗米地辛在 CTCL 或 PTCL 患者的临床试验中具有可接受的耐受性。最常见的 3 级或 4 级严重程度的不良事件被认为至少可能与罗米地辛有关，主要为血液学或虚弱，包括白细胞减少症、淋巴细胞减少症、粒细胞减少症、血小板减少症、疲劳和贫血。
