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利妥昔单抗联合来那度胺治疗滤泡性和低级别非霍奇金淋巴瘤患者的不良反应管理。

Management of Adverse Events From the Combination of Rituximab and Lenalidomide in the Treatment of Patients With Follicular and Low-Grade Non-Hodgkin Lymphoma.

机构信息

Lymphoma Research Foundation, New York, NY.

University of Lille, CHU Lille, Lille, France.

出版信息

Clin Lymphoma Myeloma Leuk. 2020 Sep;20(9):563-571. doi: 10.1016/j.clml.2020.03.009. Epub 2020 Mar 20.

Abstract

Frontline treatment for patients with indolent non-Hodgkin lymphoma often includes immunochemotherapy. Although the disease of most patients responds to initial treatment, relapse is common. Recent results from the phase 3 Augment trial showed that combining rituximab with the immunomodulatory drug lenalidomide (R) significantly improved efficacy over rituximab monotherapy in patients with recurrent non-Hodgkin lymphoma. As a result of these data, R was approved in the US (Food and Drug Administration) and Japan (Pharmaceuticals and Medical Devices Agency) for previously treated adult patients with follicular and marginal zone lymphoma; and by the European Medicine Agency and the Swiss Agency for Therapeutic Products (Swissmedic) for previously treated adult patients with follicular lymphoma. R has also been studied as initial treatment, where results have been comparable, but not superior, to chemoimmunotherapy. The resulting expanded use of R reinforces the need for a detailed review of its safety profile and management, as presented here. Tolerability of R has been consistent among trials, with most adverse events (AEs) being predictable and manageable. Hematologic AEs, particularly grade 3/4 neutropenia; low-grade cutaneous reactions, such as rash; and gastrointestinal AEs represent the most common AEs associated with R. The general R safety profile and optimal strategies for AE management are discussed.

摘要

惰性非霍奇金淋巴瘤患者的一线治疗通常包括免疫化疗。虽然大多数患者的疾病对初始治疗有反应,但复发很常见。最近的 3 期 Augment 试验结果表明,与利妥昔单抗单药治疗相比,利妥昔单抗联合免疫调节药物来那度胺(R)显著提高了复发性非霍奇金淋巴瘤患者的疗效。由于这些数据,R 在 美国(食品和药物管理局)和日本(药品和医疗器械局)获得批准,用于先前接受治疗的滤泡性和边缘区淋巴瘤成人患者;并在 欧洲药品管理局和瑞士治疗产品管理局(Swissmedic)获得批准,用于先前接受治疗的滤泡性淋巴瘤成人患者。R 也被研究用于初始治疗,结果与化疗免疫治疗相当,但并不优于后者。R 的广泛应用进一步强调了需要详细审查其安全性概况和管理,正如这里所介绍的。R 的耐受性在试验中是一致的,大多数不良反应(AE)是可预测和可管理的。血液学 AE,特别是 3/4 级中性粒细胞减少症;低度皮肤反应,如皮疹;和胃肠道 AE 是与 R 相关的最常见 AE。讨论了 R 的总体安全性概况和 AE 管理的最佳策略。

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