Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health/DHHS, 6130 Executive Blvd., Rockville, MD 20852, USA.
Blood. 2011 Jun 2;117(22):5827-34. doi: 10.1182/blood-2010-10-312603. Epub 2011 Feb 25.
Romidepsin (depsipeptide or FK228) is a histone deacetylase inhibitor, one of a new class of agents active in T-cell lymphoma. A phase 2 trial was conducted in cutaneous (CTCL) and peripheral (PTCL) T-cell lymphoma. Major and durable responses in CTCL supported the approval of romidepsin for CTCL. Forty-seven patients with PTCL of various subtypes including PTCL NOS, angioimmunoblastic, ALK-negative anaplastic large cell lymphoma, and enteropathy-associated T-cell lymphoma were enrolled. All patients had received prior therapy with a median of 3 previous treatments (range 1-11); 18 (38%) had undergone stem-cell transplant. All patients were evaluated for toxicity; 2 patients discovered to be ineligible were excluded from response assessment. Common toxicities were nausea, fatigue, and transient thrombocytopenia and granulocytopenia. Complete responses were observed in 8 and partial responses in 9 of 45 patients, for an overall response rate of 38% (95% confidence interval 24%-53%). The median duration of overall response was 8.9 months (range 2-74). Responses were observed in various subtypes, with 6 responses among the 18 patients with prior stem-cell transplant. The histone deacetylase inhibitor romidepsin has single agent clinical activity associated with durable responses in patients with relapsed PTCL.
罗米地辛（去乙酰化酶抑制剂或 FK228）是一种组蛋白去乙酰化酶抑制剂，属于在 T 细胞淋巴瘤中具有活性的新型药物之一。一项针对皮肤（CTCL）和外周（PTCL）T 细胞淋巴瘤的 2 期试验已经进行。在 CTCL 中观察到主要和持久的反应，这支持了罗米地辛在 CTCL 中的批准。47 名患有各种亚型的 PTCL 患者（包括 PTCLNOS、血管免疫母细胞性、ALK 阴性间变性大细胞淋巴瘤和肠病相关 T 细胞淋巴瘤）入组。所有患者均接受过先前的治疗，中位数为 3 次先前治疗（范围 1-11）；18 名（38%）接受过干细胞移植。所有患者均进行了毒性评估；2 名发现不符合条件的患者被排除在反应评估之外。常见的毒性包括恶心、疲劳、短暂的血小板减少和粒细胞减少。45 名患者中有 8 名完全缓解，9 名部分缓解，总缓解率为 38%（95%置信区间 24%-53%）。总缓解的中位持续时间为 8.9 个月（范围 2-74）。在各种亚型中均观察到缓解，18 名有干细胞移植史的患者中有 6 名出现缓解。组蛋白去乙酰化酶抑制剂罗米地辛在复发性 PTCL 患者中具有单药临床活性，并与持久缓解相关。
