Kawasaki Yumena, Steele Aaron Paul, Rosenberg Aaron, Guglielmo Julie
Department of Pharmacy, University of California Davis Medical Center, Sacramento, CA, USA.
Comprehensive Cancer Center, Division of Malignant Hematology, Cellular Therapy & Transplantation, University of California Davis Medical Center, Sacramento, CA, USA.
J Oncol Pharm Pract. 2024 Aug 1:10781552241268429. doi: 10.1177/10781552241268429.
Teclistamab, a bispecific T-cell engaging antibody targeting B-cell maturation antigen (BCMA), is indicated for the treatment of relapsed or refractory multiple myeloma after at least four lines of therapy. It has boxed warnings for life threatening cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). To mitigate these risks, teclistamab is initiated using step-up doses. This article examines safety event rates following the implementation of a 2-day separation between step-up doses at one institution to streamline patient care.
This was a retrospective, single-center study encompassing all patients who received teclistamab within a 1-year period. The primary endpoint was the overall incidence of CRS and ICANS. Secondary endpoints included hospital length of stay, hematological toxicities, infection rates, among other adverse events.
A total of 27 patients were included in the analysis and stratified into accelerated (days 1,3,5) or standard (days 1,4,7) dosing groups. CRS occurred in 48% (11) of patients for the accelerated dosing and 50% (2) for the standard dosing group. ICANS was seen in 17% (4) of patients in the accelerated dosing group and none in the standard dosing group. Average length of stay in the accelerated dose was 7.6 days versus 9.2 days in the standard dose group.
Accelerated dose escalation of teclistamab yielded safety event rates comparable to those in the literature. These findings may support outpatient administration for teclistamab. Accelerated dose escalation strategy allowed for the optimization of hospitalization and resources.
替雷利珠单抗是一种靶向B细胞成熟抗原(BCMA)的双特异性T细胞衔接抗体,适用于至少经过四线治疗后的复发或难治性多发性骨髓瘤的治疗。它有关于危及生命的细胞因子释放综合征(CRS)和免疫效应细胞相关神经毒性综合征(ICANS)的黑框警告。为降低这些风险,替雷利珠单抗采用逐步递增剂量给药。本文研究了在一家机构实施逐步递增剂量之间间隔2天以优化患者护理后安全事件的发生率。
这是一项回顾性单中心研究,纳入了在1年内接受替雷利珠单抗治疗的所有患者。主要终点是CRS和ICANS的总体发生率。次要终点包括住院时间、血液学毒性、感染率以及其他不良事件。
共有27例患者纳入分析,并分为加速给药组(第1、3、5天)或标准给药组(第1、4、7天)。加速给药组48%(11例)的患者发生CRS,标准给药组为50%(2例)。加速给药组17%(4例)的患者出现ICANS,标准给药组未出现。加速给药组的平均住院时间为7.6天,标准给药组为9.2天。
替雷利珠单抗加速剂量递增产生的安全事件发生率与文献报道相当。这些发现可能支持替雷利珠单抗的门诊给药。加速剂量递增策略有助于优化住院安排和资源利用。