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阿维鲁单抗、度伐鲁单抗和阿替利珠单抗给药后的输液相关反应:一项回顾性观察研究。

Infusion-Related Reactions Subsequent to Avelumab, Durvalumab, and Atezolizumab Administration: A Retrospective Observational Study.

作者信息

Hata Keiko, Nakamura Keina, Maeda Shinichiro, Maeda Makiko, Fujio Yasushi, Hirobe Sachiko

机构信息

Laboratory of Clinical Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Osaka University, Suita 565-0871, Japan.

Department of Pharmacy, Osaka University Hospital, Suita 565-0871, Japan.

出版信息

Clin Pract. 2024 Feb 23;14(2):377-387. doi: 10.3390/clinpract14020029.

Abstract

BACKGROUND

Avelumab, durvalumab, and atezolizumab are anti-programmed death-ligand 1 (PD-L1) antibodies approved for clinical application in Japan. Despite targeting the same molecule, avelumab elicits a different frequency of infusion-related reactions (IRRs) compared with durvalumab and atezolizumab, leading to differences in premedication recommendations. This study aimed to collect information to verify the relationship during IRRs and the characteristics of antibody molecules, by investigating the frequency of IRRs caused by three types of antibodies and the actual status of prophylactic measures.

METHODS

This single-center, retrospective observational study collected the medical records of 73 patients who received avelumab, durvalumab, or atezolizumab at Osaka University Hospital.

RESULTS

The frequency of IRRs was 50.0% (12/24) for avelumab, 31.0% (8/27) for durvalumab, and 18.2% (4/22) for atezolizumab. The IRRs were grade 2 in seven patients and grade 1 in five patients treated with avelumab, grade 2 in six patients and grade 1 in two patients treated with durvalumab, and grade 1 in all patients treated with atezolizumab. Among patients in whom symptoms were observed during the first administration, measures were taken to prevent IRRs for the second administration, but cases were confirmed in which symptoms reappeared, especially in patients who received durvalumab.

CONCLUSION

Our findings indicate that the frequency of IRRs due to anti-PD-L1 antibodies is higher than that previously reported in clinical trials and different modifications in antibody molecules may affect the difference in IRR frequency.

摘要

背景

阿维鲁单抗、度伐鲁单抗和阿替利珠单抗是在日本获批用于临床的抗程序性死亡配体1(PD-L1)抗体。尽管它们靶向同一分子,但与度伐鲁单抗和阿替利珠单抗相比,阿维鲁单抗引发的输液相关反应(IRR)频率不同,导致预处理建议存在差异。本研究旨在通过调查三种抗体引起的IRR频率及预防措施的实际情况,收集信息以验证IRR与抗体分子特征之间的关系。

方法

这项单中心回顾性观察研究收集了大阪大学医院73例接受阿维鲁单抗、度伐鲁单抗或阿替利珠单抗治疗患者的病历。

结果

阿维鲁单抗的IRR频率为50.0%(12/24),度伐鲁单抗为31.0%(8/27),阿替利珠单抗为18.2%(4/22)。接受阿维鲁单抗治疗的患者中,7例IRR为2级,5例为1级;接受度伐鲁单抗治疗的患者中,6例为2级,2例为1级;接受阿替利珠单抗治疗的所有患者IRR均为1级。在首次给药期间出现症状的患者中,采取了预防措施以防止第二次给药时出现IRR,但仍有症状再次出现的病例得到证实,尤其是接受度伐鲁单抗治疗的患者。

结论

我们的研究结果表明抗PD-L1抗体引起的IRR频率高于先前临床试验报告的数据,抗体分子结构上的差异可能影响IRR频率的不同。

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