Rocky Mountain Cancer Centers/US Oncology, Denver, CO, USA.
Janssen Scientific Affairs, LLC, Horsham, PA, USA.
Clin Ther. 2019 May;41(5):866-881.e7. doi: 10.1016/j.clinthera.2019.03.013. Epub 2019 Apr 25.
Daratumumab was initially approved by the US Food and Drug Administration to be given intravenously over the course of several hours during each administration. Because the duration of the first dose can exceed 7 h, the US Oncology Network developed a split first dose schedule to administer the first administration (dose) over 2 consecutive days.
This trial was a retrospective cohort study of adult multiple myeloma (MM) patients who initiated daratumumab within the US Oncology Network between November 1, 2015, and June 30, 2017. Descriptive analyses were conducted to compare split dose versus single-dose groups, and a multivariable linear regression model was developed to identify factors associated with total administration time.
In total, 622 patients were included in the analysis (364 split first dose patients and 258 single-dose patients). Infusion reactions to the first administration were documented for 47.8% of split first dose patients and 48.3% of single-dose patients. Among the total study population, the most common reactions were lower respiratory tract-related reactions (26.1%), upper respiratory tract-related reactions (17.2%), and gastrointestinal adverse events (12.5%), with no statistically significant differences between groups. The median infusion duration was 4.5 h for day 1 of the split first dose and 6.5 h for the single dose (P < 0.0001); the total median infusion time was 8.7 h for the split first dose. In multivariable regression, the only factor associated with infusion time was dosing schedule.
These results provide real-world evidence regarding the safety and infusion time of the first infusion of daratumumab. Although the total administration time was longer among patients receiving a split first dose, the shorter day 1 infusion for this dosing schedule without increased infusion reactions may be an option for community oncology clinics.
达雷妥尤单抗最初经美国食品和药物管理局批准，在每次给药过程中静脉输注数小时。由于第一剂的持续时间可能超过 7 小时，美国肿瘤学网络制定了一个分剂量的首剂量方案，将首剂（剂量）在连续两天内给药。
这是一项回顾性队列研究，纳入了 2015 年 11 月 1 日至 2017 年 6 月 30 日期间在美国肿瘤学网络内接受达雷妥尤单抗治疗的成年多发性骨髓瘤（MM）患者。进行描述性分析以比较分剂量组与单剂量组，建立多变量线性回归模型以确定与总给药时间相关的因素。
共有 622 例患者纳入分析（364 例分剂量首剂量患者和 258 例单剂量患者）。47.8%的分剂量首剂量患者和 48.3%的单剂量患者出现首剂输注反应。在总研究人群中，最常见的反应是下呼吸道相关反应（26.1%）、上呼吸道相关反应（17.2%）和胃肠道不良事件（12.5%），组间无统计学差异。分剂量首剂量第 1 天的中位输注时间为 4.5 小时，单剂量的中位输注时间为 6.5 小时（P<0.0001）；分剂量的总中位输注时间为 8.7 小时。多变量回归分析显示，唯一与输注时间相关的因素是剂量方案。
这些结果提供了达雷妥尤单抗首剂输注的安全性和输注时间的真实世界证据。尽管接受分剂量首剂量的患者总给药时间更长，但这种剂量方案第 1 天的输注时间较短且无增加的输注反应，可能是社区肿瘤学诊所的一种选择。
