1. A Prospective Trial Evaluating the Safety of a Shortened Infusion of Ramucirumab in Patients with Gastrointestinal Cancer.
- Author
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Hashimoto N, Mitani S, Taniguchi H, Narita Y, Kato K, Masuishi T, Kadowaki S, Onishi S, Tajika M, Takahashi S, Shimomura K, Takahata C, Hotta E, Kobara M, and Muro K
- Subjects
- Aged, Antibodies, Monoclonal, Humanized pharmacology, Antineoplastic Agents pharmacology, Clinical Trials as Topic, Female, Humans, Male, Middle Aged, Prospective Studies, Ramucirumab, Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Agents therapeutic use, Gastrointestinal Neoplasms drug therapy
- Abstract
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., (© AlphaMed Press; the data published online to support this summary are the property of the authors.)
- Published
- 2019
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