Patel Ashka, Clark Stefanie, Espiritu Jennifer, Dechen Tenzin, Tran Qua
Pharmacy Department, 1859Beth Israel Deaconess Medical Center, Boston, MA, USA.
J Oncol Pharm Pract. 2022 Jun;28(4):816-821. doi: 10.1177/10781552211009967. Epub 2021 Apr 17.
Daratumumab is an anti-CD38 monoclonal antibody approved for multiple myeloma. The initial infusion is administered over a median of 7.5 hours with subsequent infusions given over 3 to 4 hours. Studies show high incidence of infusion related reactions (IRRs) with the initial dose which decreases with subsequent infusions. Accelerated 90 minute daratumumab infusions following the second dose of standard administration are widely accepted in practice including at Beth Israel Deaconess Medical Center (BIDMC) despite limited data from small safety studies. The objective of this study is to evaluate the safety of accelerated daratumumab administration compared to standard administration. The primary outcome is the incidence of common terminology criteria for adverse events (CTCAE) version 5.0 grade 1 or higher for IRRs in accelerated and standard infusions. Secondary outcomes include non-IRR adverse events and amount of supportive care medications used pre- and post- and during accelerated and standard infusions. A total of seventy five patients received a daratumumab infusion between November 2015 and August 2019. There were a total of 420 daratumumab infusions evaluated, 317 (75.5%) were standard infusions of which 152 infusions were standard infusions that preceded an accelerated infusion. There were a total of 103 (24.5%) accelerated infusions. IRRs occurred in a total of 38 (9%) of the infusions with CTCAE grade 2 reactions occurring in total of 21 (5%) infusions and grade 1 occurring in 15 (3.6%) infusions. Overall accelerated daratumumab administration is safe and well tolerated when given following at least two standard infusions.
达雷妥尤单抗是一种被批准用于治疗多发性骨髓瘤的抗CD38单克隆抗体。初始输注时间中位数为7.5小时,后续输注时间为3至4小时。研究表明,初始剂量的输注相关反应(IRR)发生率较高,后续输注时发生率会降低。尽管小型安全性研究的数据有限,但在包括贝斯以色列女执事医疗中心(BIDMC)在内的实际应用中,第二剂标准给药后加速90分钟输注达雷妥尤单抗已被广泛接受。本研究的目的是评估与标准给药相比,加速输注达雷妥尤单抗的安全性。主要结局是加速输注和标准输注中不良事件通用术语标准(CTCAE)5.0版1级或更高等级IRR的发生率。次要结局包括非IRR不良事件以及加速输注和标准输注前后及期间使用的支持性护理药物数量。2015年11月至2019年8月期间,共有75名患者接受了达雷妥尤单抗输注。共评估了420次达雷妥尤单抗输注,其中317次(75.5%)为标准输注,其中152次标准输注先于一次加速输注。共有103次(24.5%)加速输注。总共38次(9%)输注发生了IRR,其中CTCAE 2级反应共发生在21次(5%)输注中,1级反应发生在15次(3.6%)输注中。总体而言,在至少两次标准输注后给予加速达雷妥尤单抗给药是安全的且耐受性良好。