Kim Ellen J, Kim Youn H, Rook Alain H, Lerner Adam, Duvic Madeleine, Reddy Sunil, Robak Tadeusz, Becker Jürgen C, Samtsov Alexey, McCulloch William, Waksman Joel, Whittaker Sean
a University of Pennsylvania , PA , USA.
b Stanford Cancer Center , Stanford , CA , USA.
Leuk Lymphoma. 2015;56(10):2847-54. doi: 10.3109/10428194.2015.1014360. Epub 2015 May 20.
Cutaneous T-cell lymphoma (CTCL) is a rare heterogeneous group of non-Hodgkin lymphomas that arises in the skin but can progress to systemic disease (lymph nodes, blood, viscera). Historically, in clinical trials of CTCL there has been little consistency in how responses were defined in each disease "compartment"; some studies only assessed responses in the skin. The histone deacetylase inhibitor romidepsin is approved by the US Food and Drug Administration for the treatment of CTCL in patients who have received at least one prior systemic therapy. Phase II studies that led to approval used rigorous composite end points that incorporated disease assessments in all compartments. The objective of this analysis was to thoroughly examine the activity of romidepsin within each disease compartment in patients with CTCL. Romidepsin was shown to have clinical activity across disease compartments and is suitable for use in patients with CTCL having skin involvement only, erythroderma, lymphadenopathy and/or blood involvement.
皮肤T细胞淋巴瘤（CTCL）是一组罕见的异质性非霍奇金淋巴瘤，起源于皮肤，但可进展为系统性疾病（淋巴结、血液、内脏）。从历史上看，在CTCL的临床试验中，每种疾病“分区”中反应的定义几乎没有一致性；一些研究仅评估皮肤的反应。组蛋白去乙酰化酶抑制剂罗米地辛已被美国食品药品监督管理局批准用于治疗至少接受过一种先前全身治疗的CTCL患者。导致该药物获批的II期研究使用了严格的复合终点，其中纳入了所有分区的疾病评估。该分析的目的是全面检查罗米地辛在CTCL患者各疾病分区中的活性。结果表明，罗米地辛在各个疾病分区均具有临床活性，适用于仅皮肤受累、红皮病、淋巴结病和/或血液受累的CTCL患者。
