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贝利司他治疗复发患者时血液学毒性罕见:贝利司他在外周T细胞淋巴瘤中毒性和安全性的系统评价

Hematologic toxicity is rare in relapsed patients treated with belinostat: a systematic review of belinostat toxicity and safety in peripheral T-cell lymphomas.

作者信息

Allen Pamela B, Lechowicz Mary Jo

机构信息

Department of Hematology and Oncology, Winship Cancer Institute of Emory University, Atlanta, GA, USA,

出版信息

Cancer Manag Res. 2018 Dec 6;10:6731-6742. doi: 10.2147/CMAR.S149241. eCollection 2018.

Abstract

Peripheral T-cell lymphomas (PTCLs) are an aggressive and diverse group of lymphomas with a T-cell origin. Most patients progress following initial treatment and require salvage therapy. The burden of symptoms is high due to its extra-nodal presentation, high rate of advanced disease, and associated cytopenias combined with its predilection for an elderly population. The disease is generally incurable at relapse in the absence of transplantation and treatment is aimed at prolonging life and reducing disease-related symptoms. Belinostat is a histone deacetylate inhibitor that was granted accelerated approval by the US Food and Drug Administration on July 3, 2014, for the treatment of relapsed PTCL. Here, a systemic review was conducted to assess the safety and efficacy of belinostat. A safety analysis involved 512 patients with relapsed malignancies, and an efficacy analysis focused on patients with relapsed PTCL and included a total of 144 patients. Common adverse events were noted including fatigue (35%), nausea (42.8%), and vomiting (28.5%), but comparatively low rates of grade 3/4 hematologic toxicity overall (6.4%). Efficacy analysis demonstrated an overall response rate of 25.7% and complete responses of 10.4% with the majority of discontinuations occurring for lack of efficacy. Ultimately, these results demonstrate that belinostat has comparable efficacy to other agents used in this setting and is well tolerated in regard to hematologic events, but there is limited data on patient-reported outcomes, reduction in disease-related symptoms, or quality of life.

摘要

外周T细胞淋巴瘤(PTCL)是一组具有T细胞起源的侵袭性且异质性的淋巴瘤。大多数患者在初始治疗后病情进展,需要挽救性治疗。由于其结外表现、晚期疾病高发生率、相关血细胞减少以及对老年人群的偏好,症状负担较重。在没有移植的情况下,该疾病复发时通常无法治愈,治疗旨在延长生命并减轻与疾病相关的症状。贝利司他是一种组蛋白脱乙酰酶抑制剂,于2014年7月3日获得美国食品药品监督管理局的加速批准,用于治疗复发的PTCL。在此,进行了一项系统评价以评估贝利司他的安全性和疗效。安全性分析纳入了512例复发恶性肿瘤患者,疗效分析聚焦于复发PTCL患者,共纳入144例患者。观察到常见的不良事件包括疲劳(35%)、恶心(42.8%)和呕吐(28.5%),但总体3/4级血液学毒性发生率相对较低(6.4%)。疗效分析显示总缓解率为25.7%,完全缓解率为10.4%,大多数停药是由于缺乏疗效。最终,这些结果表明贝利司他与该情况下使用的其他药物具有相当的疗效,并且在血液学事件方面耐受性良好,但关于患者报告的结局、疾病相关症状减轻或生活质量的数据有限。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/16ad/6289206/fb5d262e2bba/cmar-10-6731Fig1.jpg

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