Lessons learned: A shortened infusion of ramucirumab (from 60 to 20 minutes) was safe and feasible without infusion-related reactions.Twenty-minute infusions of ramucirumab can be an option for patients with no infusion-related reactions during the first 60-minute treatment.
Background: Ramucirumab is usually administered over 60 minutes, during which it is unlikely to cause infusion-related reactions (IRRs). This prospective study evaluated the safety of a shortened infusion of ramucirumab.
Methods: Patients who received their first dose of ramucirumab in a 60-minute infusion without developing IRRs were eligible and received their second ramucirumab dose for 20 minutes. The primary study endpoint was incidence of IRR during the first short-term infusion, and the secondary endpoints were incidence of IRR at any time and adverse events other than IRR.
Results: Of the 40 patients enrolled (median age, 68.5 years), 20 (55%) were male, 27 (67.5%) had stage IV gastric cancer, 25 (62.5%) received ramucirumab in combination with taxane-based chemotherapy, and 24 (60%) received only a single administration of ramucirumab prior to their enrollment. Notably, no IRR was observed during the first short-term infusion (IRR rate, 0%; 95% confidence interval [CI], 0%-0.72%). Among the 149 short-term infusions performed, there were no instances of IRRs or unexpected adverse events related to the treatment (Table 1).
Conclusion: For patients without development of IRRs upon the first ramucirumab administration, shortening infusion time (from 60 to 20 minutes) is safe and feasible.
经验教训
• 雷莫芦单抗的短时(60 分钟到 20 分钟)注射是安全可行的,且没有注射相关反应。
• 对于前 60 分钟治疗期间未出现注射相关反应的患者,也可选择 20 分钟的雷莫芦单抗注射。
摘要
背景。通常会在 60 分钟内注射雷莫芦单抗,在此期间不太可能引起注射相关反应 (IRRs)。此项前瞻性研究评估了雷莫芦单抗短时注射的安全性。
方法。在 60 分钟注射过程中接受第一剂雷莫芦单抗注射而未出现 IRR 的患者可以接受第二剂 20 分钟雷莫芦单抗注射。主要研究终点是第一次短时注射期间 IRR 的发生率,次要终点是任何时间的 IRR 发生率和 IRR 以外的不良反应事件。
结果。在 40 位参与研究的患者中(中值年龄为 68.5 岁),有 20 人 (55%) 是男性,27 人 (67.5%) 患有 IV 期胃癌,25 人 (62.5%) 接受了雷莫芦单抗联合基于紫杉烷的化疗治疗,24 人 (60%) 在参与研究之前仅接受了雷莫芦单抗单次给药。值得注意的是,在第一次短时注射期间,未观察到 IRR(IRR 率,0%;95% 置信区间 [CI],0%‐0.72%)。在实施的 149 次短时注射中,未发现 IRR 实例或与治疗有关的意外不良反应事件(表 1)。
结论。对于在第一次雷莫芦单抗给药后未出现 IRR 的患者,缩短注射时间(60 到 20 分钟)是安全可行的。
© AlphaMed Press; the data published online to support this summary are the property of the authors.