Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma
Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma
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DOI：
10.1182/blood-2010-10-312603
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发表时间：
2011-06-02
期刊：
影响因子：
20.3
通讯作者：
Bates, Susan E.
中科院分区：
文献类型：
--
作者：
Piekarz, Richard L.;Frye, Robin;Bates, Susan E.
罗米地辛（缩酚酸肽或FK 228）是一种组蛋白脱乙酰酶抑制剂，是T细胞淋巴瘤中活性的一类新药物。在皮肤（CTCL）和外周（PTCL）T细胞淋巴瘤中进行了2期试验。CTCL的主要和持久的反应支持批准罗米地辛用于CTCL。入组了47例不同亚型的PTCL患者，包括PTCL NOS、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。所有患者均接受过既往治疗，中位既往治疗次数为3次（范围1-11次）; 18例（38%）接受过干细胞移植。对所有患者进行了毒性评价; 2例发现不合格的患者被排除在缓解评估之外。常见的毒性反应为恶心、疲乏、一过性血小板减少和粒细胞减少。在45例患者中观察到8例完全缓解和9例部分缓解，总缓解率为38%（95%置信区间24%-53%）。总体缓解的中位持续时间为8.9个月（范围2-74）。在各种亚型中观察到缓解，在18名既往接受过干细胞移植的患者中有6名缓解。组蛋白去乙酰化酶抑制剂罗米地辛具有与复发性PTCL患者的持久应答相关的单药临床活性。该研究已在临床试验中注册。gov as NCT 00007345.（血。2011; 117（22）：5827-5834）
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 stemcell transplant. The histone deacetylase inhibitor romidepsin has single agent clinical activity associated with durable responses in patients with relapsed PTCL. This study has been registered at clinical-trials. gov as NCT00007345. (Blood. 2011; 117(22): 5827-5834)