中国多发性骨髓瘤患者快速注射达雷妥尤单抗的安全性和可行性分析。
Safety and feasibility analysis of rapid daratumumab infusion in Chinese patients with multiple myeloma.
机构信息
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
出版信息
Cancer Med. 2024 Jun;13(11):e7347. doi: 10.1002/cam4.7347.
BACKGROUND
With the increasing use of daratumumab (DARA)-containing regimens for multiple myeloma (MM) patients in China, the standard infusion time of DARA is long, with the potential for infusion-related reactions (IRRs) and increased hospitalization and use of resources. Shortening the duration of DARA infusion helps to optimize the hospital stay and enhance the patient treatment experience. The current, commonly used 90-min rapid DARA infusion regimen may not be applicable to Chinese MM patients, and therefore, we explored a new 110-min rapid DARA infusion regimen aimed at reducing the treatment burden on patients to guarantee therapeutic safety.
METHODS
MM inpatients treated with the DARA regimen were divided into two groups according to the number of times the DARA regimen was used: a standard infusion regimen for patients treated with the first two doses of DARA and a 110-min rapid infusion regimen for patients treated with more than two doses of DARA. Anti-allergy medications were routinely administered prior to the start of DARA infusion, patient consent, and authorization was obtained for all treatments, and statistical evaluation of the results was conducted via descriptive analyses, one-way ANOVA and chi-square tests.
RESULTS
A total of 129 patients were included in this study: 68 in the standard infusion group, with 121 DARA infusions, and 129 in the rapid infusion group (patients who participated in the standard infusion subsequently participated in the rapid infusion), with 738 DARA infusions. The incidence of IRRs was 27.27% (36/121) in the standard infusion group and 1.35% (10/738) in the rapid infusion group, which were significantly different (p < 0.001). The incidence of IRRs after rapid infusion in other studies was <6%. The incidence of grade 1 IRRs in the rapid infusion group was 0.81% (6/738), the incidence of grade 2 IRRs was 0.54% (4/738), and there were no IRRs above grade 3; age, sex, and underlying disease had no effect on the choice of infusion method (p > 0.05). The mean infusion time after the occurrence of IRRs was also shorter in the rapid infusion group than in the standard infusion group (F = 24.781, p < 0.001).
CONCLUSION
The 110-min rapid infusion DARA regimen is feasible and safe for use in Chinese MM patients.
背景
随着达雷妥尤单抗（DARA）在中国多发性骨髓瘤（MM）患者中的应用越来越多，DARA 的标准输注时间较长，可能会发生输注相关反应（IRR），并增加住院和资源使用。缩短 DARA 输注时间有助于优化住院时间并改善患者的治疗体验。目前，常用的 90 分钟快速 DARA 输注方案可能不适用于中国 MM 患者，因此，我们探索了一种新的 110 分钟快速 DARA 输注方案，旨在减轻患者的治疗负担，保证治疗安全性。
方法
根据 DARA 方案使用次数，将接受 DARA 方案治疗的 MM 住院患者分为两组：标准输注组（前两剂 DARA 治疗患者）和 110 分钟快速输注组（多于两剂 DARA 治疗患者）。在开始 DARA 输注前常规给予抗过敏药物，所有治疗均获得患者同意和授权，并通过描述性分析、单因素方差分析和卡方检验进行结果统计评估。
结果
本研究共纳入 129 例患者：标准输注组 68 例，共输注 121 次 DARA；快速输注组 129 例（标准输注组中随后参与快速输注的患者），共输注 738 次 DARA。标准输注组的 IRR 发生率为 27.27%（36/121），快速输注组为 1.35%（10/738），差异有统计学意义（p<0.001）。其他研究中快速输注后的 IRR 发生率<6%。快速输注组 1 级 IRR 发生率为 0.81%（6/738），2 级 IRR 发生率为 0.54%（4/738），无 3 级以上 IRR；年龄、性别和基础疾病对输注方式选择无影响（p>0.05）。快速输注组发生 IRR 后的平均输注时间也短于标准输注组（F=24.781，p<0.001）。
结论
110 分钟快速输注 DARA 方案在中国 MM 患者中是可行且安全的。
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