A Prospective Trial Evaluating the Safety of a Shortened Infusion of Ramucirumab in Patients with Gastrointestinal Cancer

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 i...

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Published in:The oncologist (Dayton, Ohio) Ohio), 2019-02, Vol.24 (2), p.159-e66
Main Authors: Hashimoto, Naoya, Mitani, Seiichiro, Taniguchi, Hiroya, Narita, Yukiya, Kato, Kyoko, Masuishi, Toshiki, Kadowaki, Shigenori, Onishi, Sachiyo, Tajika, Masahiro, Takahashi, Shinji, Shimomura, Kazuhiro, Takahata, Chihoko, Hotta, Eri, Kobara, Makiko, Muro, Kei
Format: Article
Language:English
Subjects:
Aged
Antibodies, Monoclonal, Humanized - pharmacology
Antibodies, Monoclonal, Humanized - therapeutic use
Antineoplastic Agents - pharmacology
Antineoplastic Agents - therapeutic use
Clinical Trial Results
Clinical Trials as Topic
Female
Gastrointestinal Neoplasms - drug therapy
Humans
Male
Middle Aged
Prospective Studies
Ramucirumab
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Summary: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。
ISSN:1083-7159
1549-490X
DOI:10.1634/theoncologist.2018-0580