Background

An infusion-related reaction (IRR) is a well-known adverse event related to monoclonal antibodies, and antihistamine premedication is recommended to prevent IRRs. Ramucirumab plus FOLFIRI therapy is the standard second-line treatment for metastatic colorectal cancer (CRC). Ramucirumab is a fully human antibody, suggesting that the incidence of IRRs is lower, however, the current recommendation for the proper use of ramucirumab is antihistamine premedication, but the incidence and severity of ramucirumab-induced IRR without antihistamine premedication have not been elucidated.

Methods

A retrospective study to evaluate the incidence of ramucirumab-induced IRRs in unresectable CRC patients treated by ramucirumab plus FOLFIRI therapy. If the incidence of IRR without antihistamine premedication was not higher than that of cetuximab in a previous report (5.7%), planning a prospective study was considered.

Results

A total of 147 patients with unresectable CRC who had been treated by ramucirumab plus FOLFIRI therapy were identified. Of them, 106 (72%) patients received intravenous antihistamine premedication. An IRR occurred in 2 patients (1.4%), 1 grade 2 and 1 grade 3. They received antihistamine and steroid premedication. On the other hand, IRRs were not observed in 41 patients without antihistamine premedication, and the incidence of IRRs was significantly lower compared with the previous report of cetuximab (p < 0.001).

Conclusion

The incidence of ramucirumab-induced IRRs without antihistamine premedication is low. Not using antihistamine premedication can decrease medical costs. These findings warrant further investigation in large-scale cohorts to clarify the incidence and severity of ramucirumab-induced IRRs and further clarify the proper use of ramucirumab.

中文翻译：

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晚期结直肠癌患者雷莫芦单抗联合 FOLFIRI 的输注相关反应

 背景

输注相关反应 (IRR) 是与单克隆抗体相关的众所周知的不良事件，建议术前服用抗组胺药来预防 IRR。 Ramucirumab 联合 FOLFIRI 疗法是转移性结直肠癌 (CRC) 的标准二线治疗。雷莫芦单抗是完全人源抗体，提示 IRR 发生率较低，然而，目前正确使用雷莫芦单抗的推荐是抗组胺术前用药，但未经抗组胺药术前用药时雷莫芦单抗诱发 IRR 的发生率和严重程度尚未阐明。

 方法

一项回顾性研究，旨在评估接受雷莫芦单抗联合 FOLFIRI 治疗的不可切除的 CRC 患者中雷莫芦单抗诱导的 IRR 发生率。如果未预先服用抗组胺药的 IRR 发生率不高于先前报告中西妥昔单抗的发生率 (5.7%)，则考虑计划一项前瞻性研究。

 结果

共有 147 名接受雷莫芦单抗联合 FOLFIRI 治疗的不可切除 CRC 患者被确定。其中，106 名（72%）患者接受了静脉抗组胺术前用药。 2 名患者 (1.4%) 发生 IRR，其中 1 名 2 级和 1 名 3 级。他们接受了抗组胺药和类固醇术前用药。另一方面，41名未预先服用抗组胺药的患者未观察到IRR，且IRR的发生率较之前报道的西妥昔单抗显着降低（ p < 0.001）。

 结论

无需预先服用抗组胺药，雷莫芦单抗诱导的 IRR 发生率较低。不使用抗组胺药术前用药可以降低医疗费用。这些发现值得在大规模队列中进行进一步研究，以阐明雷莫芦单抗诱导的 IRR 的发生率和严重程度，并进一步阐明雷莫芦单抗的正确使用。