Safety of infusing ipilimumab over 30 minutes Journal Article

Authors: Momtaz, P.; Park, V.; Panageas, K. S.; Postow, M. A.; Callahan, M.; Wolchok, J. D.; Chapman, P. B.
Article Title: Safety of infusing ipilimumab over 30 minutes
Abstract: Purpose: The approved dose of ipilimumab is 3 mg/kg infused over 90 minutes; however, in clinical trials, 10 mg/kg has also been infused over 90 minutes. At this higher dose, patients receive 3 mg/kg within the first 27 minutes of treatment. We sought to determine whether the standard dose of 3 mg/kg could be safely infused over 30 minutes. Methods: We reviewed retrospectively the incidence of infusion-related reactions (IRRs) to ipilimumab at our institution in patients receiving doses of either 3 or 10 mg/kg infused over 90 minutes. Our findings led to a change in institutional guidelines for ipilimumab infusion time from 90 minutes to 30 minutes. We reviewed the first 14 months of our prospective experience using a 30-minute infusion of ipilimumab. Results: Between April 1, 2008, and June 30, 2013, 595 patients received 2,507 doses of ipilimumab infused at either 3 mg/kg (n = 457) or 10 mg/kg (n = 138) over 90 minutes. Although the 10 mg/kg group had a higher incidence of IRRs (4.3%) than the 3 mg/kg group (2.2%), this difference was not statistically significant (P = .22). In 120 patients treated prospectively with ipilimumab 3 mg/kg infused over 30 minutes, seven patients (5.8%) had an IRR (P = .06 compared with 90-minute infusions). All IRRs occurred at dose 2; six were grade 2, and one was grade 3. All seven patients received subsequent doses of ipilimumab safely, the majority with premedication. Conclusion: Ipilimumab at 3 mg/kg can be infused safely over 30 minutes with an acceptably low incidence of IRRs. After an IRR, patients can safely receive additional doses of ipilimumab with premedication. Copyright © 2015 American Society of Clinical Oncology. All rights reserved.
Keywords: adult; middle aged; major clinical study; clinical trial; drug safety; drug withdrawal; treatment duration; ipilimumab; neuropathy; maintenance therapy; dexamethasone; retrospective study; abdominal pain; backache; chill; coughing; dyspnea; pneumonia; pruritus; maculopapular rash; pethidine; rigor; thorax pain; acetylsalicylic acid; drug infusion; colitis; hot flush; hydrocortisone; electrocardiogram; oxygen saturation; diphenhydramine; premedication; hypophysitis; infusion rate; bloody diarrhea; t wave inversion; famotidine; infusion related reaction; human; male; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 33
Issue: 30
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2015-10-20
Start Page: 3454
End Page: 3458
Language: English
DOI: 10.1200/jco.2015.61.0030
PROVIDER: scopus
PUBMED: 26124475
PMCID: PMC5087314
Notes: Export Date: 2 December 2015 -- Source: Scopus
Altmetric Score
MSK Authors
  1. Jedd D Wolchok
    607 Wolchok
  2. Michael Andrew Postow
    175 Postow
  3. Vivian Park
    8 Park
  4. Paul Chapman
    240 Chapman
  5. Katherine S Panageas
    312 Panageas
  6. Parisa   Momtaz
    15 Momtaz