地塞米松与抗组胺药联合地塞米松预处理预防胃癌中 ramucirumab 联合 nab-紫杉醇输注相关反应的非劣效性：一项多中心回顾性研究。
Dexamethasone is non-inferior to antihistamine plus dexamethasone premedication in preventing ramucirumab plus nab-paclitaxel infusion-related reactions in gastric cancer: a multicenter retrospective study.
机构信息
Department of Pharmacy, University of Fukui Hospital, Yoshida-Gun, 23-3 Matsuoka-Shimoaizuki, Eiheiji-Cho, Fukui, Japan.
Department of Pharmacy, Japanese Red Cross Fukui Hospital, Fukui, Japan.
出版信息
Support Care Cancer. 2024 Oct 7;32(10):704. doi: 10.1007/s00520-024-08910-8.
PURPOSE
Ramucirumab (RAM) is recommended as premedication with H-receptor antagonists (HRA) to prevent infusion-related reactions (IRRs). However, RAM is a human antibody with a low incidence of IRRs. We evaluated the noninferiority of non-HRA (dexamethasone [DEX] alone) premedication to HRA (plus DEX) premedication in terms of IRRs in patients with gastric cancer receiving RAM plus nanoparticle albumin-bound paclitaxel (nab-PTX).
METHODS
This was a noninferiority, multicenter, retrospective trial conducted in three Japanese centers to assess the incidence of IRRs in patients receiving RAM plus nab-PTX for gastric cancer between 2018 and 2023. Patients with gastric cancer receiving RAM plus nab-PTX were divided into groups with and without HRA premedication. The incidence of IRRs was compared between the two groups.
RESULTS
Ninety patients were evaluated, with non-HRA and HRA premedications in 43 and 47 cases, respectively. After the first dose of RAM, IRRs were not observed in either group. IRRs during the overall doses were 0% for non-HRA premedication and 2.1% for HRA premedication (90% confidence interval (CI): -5.6%-1.3% for each comparison). The upper limit of the 90% CI (1.3%) did not exceed the noninferiority margin (Δ) of + 10% and therefore met the noninferiority criteria.
CONCLUSION
RAM plus nab-PTX for gastric cancer with DEX premedication may be possible without HRA premedication.
目的
雷莫芦单抗（RAM）被推荐与 H 受体拮抗剂（HRA）联用作为预处理，以预防输注相关反应（IRR）。然而，RAM 是一种人源抗体，IRR 发生率较低。我们评估了在接受 RAM 联合白蛋白结合型紫杉醇纳米粒（nab-PTX）治疗的胃癌患者中，非 HRA（单独地塞米松[DEX]）预处理与 HRA（加 DEX）预处理在 IRR 方面的非劣效性。
方法
这是一项在三个日本中心进行的非劣效性、多中心、回顾性研究，旨在评估 2018 年至 2023 年间接受 RAM 联合 nab-PTX 治疗的胃癌患者发生 IRR 的情况。将接受 RAM 联合 nab-PTX 治疗的胃癌患者分为接受和不接受 HRA 预处理的两组。比较两组的 IRR 发生率。
结果
共有 90 例患者接受了评估，其中 43 例和 47 例分别接受了非 HRA 和 HRA 预处理。在接受 RAM 首次剂量后，两组均未观察到 IRR。在总剂量期间，IRR 发生率分别为非 HRA 预处理组为 0%，HRA 预处理组为 2.1%（每例比较的 90%置信区间（CI）为-5.6%至 1.3%）。90%CI 的上限（1.3%）未超过非劣效性边界（Δ）+10%，因此符合非劣效性标准。
结论
对于接受 RAM 联合 nab-PTX 治疗的胃癌患者，DEX 预处理可能可以不联合 HRA 预处理。
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