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

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.

Evaluating clinical impact of a shortened infusion duration for ramucirumab: a model-based approach

“…Retrospective and prospective studies of various therapeutic antibodies (e.g., ramucirumab, bevacizumab, rituximab, daratumumab, and infliximab), with IRR incidence as an endpoint, have found that a more rapid rate of infusion/shortened infusion time does not appear to increase IRR incidence. For example, a recent small prospective study found no immediate IRRs in patients receiving ramucirumab infused over 20 min following at least one initial 60-min infusion without evidence of immediate IRRs [18]. Hence, the commonly held perception that immediate IRR incidence is related to infusion rate warrants further investigation.…”