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J Clin Oncol:CHOP方案加用罗米地辛治疗复发/难治性外周T细胞淋巴瘤的疗效和安全性

2021-12-02 Nebula MedSci原创

罗米地辛(Romidepsin)是一种组蛋白去乙酰化酶抑制剂,已被证明作为单一药物对复发性或难治性外周 T 细胞淋巴瘤 (PTCL) 具有活性。

罗米地辛(Romidepsin)是一种组蛋白去乙酰化酶抑制剂,已被证明作为单一药物对复发性或难治性外周 T 细胞淋巴瘤 (PTCL) 具有活性。环磷酰胺、多柔比星、长春新碱和泼尼松 (CHOP) 联合疗法被广泛用作 PTCL 的一线治疗;但是,该方案的疗效有限。Ib期和II期研究结果显示,罗米地辛与CHOP(Ro-CHOP)联合应用具有一定的可行性。

本研究是一项随机化的III期研究,对比了Ro-CHOP与CHOP方案用于既往未治疗过的PTCL的疗效与安全性。所有患者都接受6个疗程的CHOP(3周/疗程);Ro-CHOP组患者每个疗程的第1天和第8天额外接受罗米地辛(12 mg/m2,3周/疗程)。主要终点是无进展生存期(PFS)。

无进展生存期

2013年1月至2017年12月期间,共招募了421位患者(Ro-CHOP组 211位,CHOP组 210位)。Ro-CHOP组和CHOP组的中位无进展生存期分别是12.0个月和10.2个月(风险比[HR] 0.81;p=0.096)。此外,Ro-CHOP组和CHOP组的中位总生存期分别是51.8个月和42.0个月,客观缓解率分别是63%和60%,完全缓解率+未证实的完全缓解率分别是41%和37%(p>0.1)。

总生存期

Ro-CHOP组有30%及以上的患者报告了3/4级的需紧急治疗的副反应,包括血小板减少症(Ro-CHOP组 vs CHOP组:50% vs 10%)、中性粒细胞减少(49% vs 33%)、贫血(47% vs 17%)和白细胞减少症(32% vs 20%)。

综上,在CHOP方案的基础上,加用罗米地辛并没有改善既往未治疗过的外周 T 细胞淋巴瘤患者的无进展生存期、缓解率以及总生存期,而且还增加了≥3级的需紧急治疗的不良事件的发生率

原始出处:

Emmanuel Bachy, et al. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). Journal of Clinical Oncology. November 29, 2021. https://ascopubs.org/doi/full/10.1200/JCO.21.01815

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    2021-12-14 minlingfeng
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    2021-12-04 freve
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    2021-12-03 查查佳佳

    春新碱和泼尼松 (CHOP) 联合疗法被广泛用作 PTCL 的一线治疗;但是,该方案的疗

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