PDF(Pubmed)
Abstract：
Diffuse large B-cell lymphoma (DLBCL) accounts for approximately 24% of new cases of B-cell non-Hodgkin lymphoma in the US each year. Up to 50% of patients relapse or are refractory (R/R) to the standard first-line treatment option, R-CHOP. The anti-CD19 monoclonal antibody tafasitamab, in combination with lenalidomide (LEN), is an NCCN preferred regimen for transplant-ineligible patients with R/R DLBCL and received accelerated approval in the US (July 2020) and conditional marketing authorization in Europe (August 2021) and other countries, based on data from the L-MIND study. The recommended dose of tafasitamab is 12 mg/kg by intravenous infusion, administered in combination with LEN 25 mg for 12 cycles, followed by tafasitamab monotherapy until disease progression or unacceptable toxicity. Tafasitamab + LEN is associated with durable responses in patients with R/R DLBCL. The majority of clinically significant treatment-associated adverse events are attributable to LEN and can be managed with dose modification and supportive therapy. We provide guidelines for the management of patients with R/R DLBCL treated with tafasitamab and LEN in routine clinical practice, including elderly patients and those with renal and hepatic impairment, and advice regarding patient education as part of a comprehensive patient engagement plan. Our recommendations include LEN administration at a reduced dose if required in patients unable to tolerate the recommended dose. No dose modification is required for tafasitamab in special patient populations.
摘要：
弥漫性大B细胞淋巴瘤（DLBCL）约占美国每年B细胞非霍奇金淋巴瘤新病例的24％。高达50％的患者复发或难以接受标准一线治疗（R/R）。R-CHOP.抗CD19单克隆抗体他法西他单抗，联合来那度胺（LEN），是针对R/RDLBCL移植不合格患者的NCCN首选方案，并在美国（2020年7月）获得了加速批准，并在欧洲（2021年8月）和其他国家获得了有条件的营销授权，基于L-MIND研究的数据。他他他单抗的推荐剂量为12mg/kg，通过静脉输注，与LEN25mg联合给药12个周期，然后是他法他他单抗单药治疗，直到疾病进展或不可接受的毒性。Tafasitamab+LEN与R/RDLBCL患者的持续反应相关。大多数临床上显着的治疗相关不良事件可归因于LEN，可以通过剂量调整和支持疗法进行管理。我们为常规临床实践中使用他法他单抗和LEN治疗的R/RDLBCL患者提供管理指南。包括老年患者和肾和肝损害患者，以及关于患者教育的建议，作为全面患者参与计划的一部分。我们的建议包括如果不能耐受推荐剂量的患者需要以减少的剂量给予LEN。在特殊患者人群中，塔法他单抗不需要剂量修改。
