Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses.
Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses.
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罗米地辛治疗复发/难治性外周 T 细胞淋巴瘤：关键研究更新表明持久反应。
DOI：
10.1186/1756-8722-7-11
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发表时间：
2014-01-23
影响因子：
28.5
通讯作者：
Horwitz S
中科院分区：
文献类型：
--
作者：
Coiffier B;Pro B;Prince HM;Foss F;Sokol L;Greenwood M;Caballero D;Morschhauser F;Wilhelm M;Pinter-Brown L;Padmanabhan Iyer S;Shustov A;Nielsen T;Nichols J;Wolfson J;Balser B;Horwitz S
罗米地辛是一种结构独特、有效的双环1类选择性组蛋白去乙酰化酶抑制剂，已被美国食品和药物管理局批准用于治疗既往接受≥1次全身治疗的皮肤t细胞淋巴瘤患者和既往接受≥1次全身治疗的周围t细胞淋巴瘤（PTCL）患者。PTCL的批准是基于罗米地辛治疗复发/难治性PTCL的关键研究结果（n = 130，中位随访，13.4个月）。目的是提供最新的数据（中位随访22.3个月），并描述对罗米地辛达到长期反应（≥12个月）的患者的特征。既往接受≥1次全身治疗后复发或难治性PTCL患者接受罗米地辛14mg /m2，每28天在第1、8和15天静脉输注4小时，最多6个周期；有反应或病情稳定的患者可继续使用罗咪地辛超过6个周期。主要终点是由独立审查委员会确定的确诊/未确诊完全缓解率（CR/CRu）。次要终点包括客观缓解率（ORR）和缓解持续时间（DOR）。对于达到CR/CRu的患者，检查DOR的基线特征（≥12个月vs < 12个月）。对roidepsin的ORR为25%，其中CR/CRu为15%。所有应答者的DOR中位数为28个月（范围< 1-48+），达到CR/CRu的患者没有达到DOR中位数。对先前治疗缺乏反应或短暂反应的患者使用罗米地辛可获得持久的反应。在19例达到CR/CRu的患者中，10例有长期（≥12个月）缓解；研究的基线特征——包括重度预处理、对既往治疗的反应或晚期疾病——均不排除对罗米地辛的长期反应。中位无进展生存期为29个月，达到CR/CRu≥12个月的患者的生存期明显长于CR/CRu < 12个月或< CR/CRu的患者。延长治疗和更长的随访不影响罗米地辛报道的安全性。在一部分复发/难治性PTCL患者中，罗米地辛治疗可产生高度持久的缓解，缓解持续时间长达48个月。NCT00426764
Romidepsin is a structurally unique, potent, bicyclic class 1 selective histone deacetylase inhibitor approved by the US Food and Drug Administration for the treatment of patients with cutaneous T-cell lymphoma who have received ≥ 1 prior systemic therapy and patients with peripheral T-cell lymphoma (PTCL) who have received ≥ 1 prior therapy. Approval for PTCL was based on results (n = 130; median follow-up, 13.4 months) from the pivotal study of romidepsin for the treatment of relapsed/refractory PTCL. The objective is to present updated data (median follow-up, 22.3 months) and to characterize patients who achieved long-term responses (≥ 12 months) to romidepsin. Patients with PTCL who relapsed from or were refractory to ≥ 1 prior systemic therapy received romidepsin 14 mg/m2 as a 4-hour intravenous infusion on days 1, 8, and 15 every 28 days for up to 6 cycles; patients with response or stable disease could continue romidepsin beyond 6 cycles. The primary endpoint was rate of confirmed/unconfirmed complete response (CR/CRu) determined by an Independent Review Committee. Secondary endpoints included objective response rate (ORR) and duration of response (DOR). For patients who achieved CR/CRu, baseline characteristics by DOR (≥ 12 vs < 12 months) were examined. The ORR to romidepsin was 25%, including 15% with CR/CRu. The median DOR for all responders was 28 months (range, < 1-48+) and was not reached for those who achieved CR/CRu. Patients with lack of response or transient response to prior therapy achieved durable responses with romidepsin. Of the 19 patients who achieved CR/CRu, 10 had long-term (≥ 12 months) responses; none of the baseline characteristics examined—including heavy pretreatment, response to prior therapy, or advanced disease—precluded long-term responses to romidepsin. With a median progression-free survival of 29 months, patients who achieved CR/CRu for ≥ 12 months had significantly longer survival vs those with CR/CRu for < 12 months or < CR/CRu. Extended treatment and longer follow-up did not affect the reported safety profile of romidepsin. Treatment with romidepsin leads to highly durable responses in a subset of patients with relapsed/refractory PTCL, with responses ongoing as long as 48 months. NCT00426764
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影响因子：
14.8
作者：
Bradner, James E.;West, Nathan;Grachan, Melissa L.;Greenberg, Edward F.;Haggarty, Stephen J.;Warnow, Tandy;Mazitschek, Ralph
通讯作者：
Mazitschek, Ralph
影响因子：
50.5
作者：
Ascani, S;Zinzani, PL;Pileri, SA
通讯作者：
Pileri, SA
影响因子：
254.7
作者：
Flowers, Christopher R.;Sinha, Rajni;Vose, Julie M.
通讯作者：
Vose, Julie M.
影响因子：
45.3
作者：
Pro, Barbara;Advani, Ranjana;Shustov, Andrei
通讯作者：
Shustov, Andrei
影响因子：
50.5
作者：
Anderson, JR;Armitage, JO;Weisenburger, DD
通讯作者：
Weisenburger, DD