Low Incidence of Infusion-Related Reactions Reported With 30-Minute Ipilimumab Infusion
In a single-institution study reported in the Journal of Clinical Oncology, Momtaz et al found that the rate of infusion-related reactions remained acceptably low when ipilimumab (Yervoy) 3 mg/kg was infused over 30 minutes in patients with advanced melanoma. The currently approved dose of ipilimumab is 3 mg/kg infused over 90 minutes. In clinical trials, the drug has been given at 10 mg/kg over 90 minutes, equivalent to receiving 3 mg/kg in the first 27 minutes of infusion.
Change in Institutional Guidelines
Retrospective review of the incidence of infusion-related reactions in 595 patients with metastatic solid tumors receiving 2,507 ipilimumab doses at 3 mg/kg (n = 457) or 10 mg/kg (n = 138) over 90 minutes between April 2008 and June 2013 at Memorial Sloan Kettering Cancer Center showed no significant difference between dose groups (4.3% vs 2.2%, P = .22). These findings led to a change in institutional guidelines for ipilimumab infusion time from 90 minutes to 30 minutes.
Prospective Findings
Over the first 14 months of using 3 mg/kg over 30 minutes in patients with melanoma, 7 (5.8%) of 120 had infusion-related reactions (P = .06 vs 3 mg/kg over 90 minutes). All infusion-related reactions occurred at the second dose of ipilimumab, with six being grade 2 and one being grade 3. All seven patients received subsequent doses of ipilimumab over 30 to 90 minutes.
Five patients received diphenhydramine premedication and tolerated dose 3 without a reaction. Of the two patients who did not receive premedication, one had an infusion-related reaction at dose 3; this patient received dose 4 with premedication without an infusion-related reaction.
The investigators concluded: “Ipilimumab at 3 mg/kg can be infused safely over 30 minutes with an acceptably low incidence of infusion-related reactions. After an infusion-related reaction, patients can safely receive additional doses of ipilimumab with premedication.”
Paul B. Chapman, MD, of Memorial Sloan Kettering Cancer Center, is the corresponding author of the Journal of Clinical Oncology article.
The study was supported in part by the John K. Figge Fund. For full disclosures of the study authors, visit jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
