title: Safety of Infusing Ipilimumab Over 30 Minutes.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Parisa Momtaz, Vivian Park, Katherine S. Panageas, Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Memorial Sloan-Kettering Cancer Center; Jedd D. Wolchok, Ludwig Institute for Cancer Research; and Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Weill Cornell Medical College, New York, NY.
authors.forename: Parisa
authors.initials: P
authors.lastname: Momtaz
authors.affiliation: Parisa Momtaz, Vivian Park, Katherine S. Panageas, Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Memorial Sloan-Kettering Cancer Center; Jedd D. Wolchok, Ludwig Institute for Cancer Research; and Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Weill Cornell Medical College, New York, NY.
authors.forename: Vivian
authors.initials: V
authors.lastname: Park
authors.affiliation: Parisa Momtaz, Vivian Park, Katherine S. Panageas, Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Memorial Sloan-Kettering Cancer Center; Jedd D. Wolchok, Ludwig Institute for Cancer Research; and Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Weill Cornell Medical College, New York, NY.
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Panageas
authors.affiliation: Parisa Momtaz, Vivian Park, Katherine S. Panageas, Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Memorial Sloan-Kettering Cancer Center; Jedd D. Wolchok, Ludwig Institute for Cancer Research; and Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Weill Cornell Medical College, New York, NY.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Postow
authors.affiliation: Parisa Momtaz, Vivian Park, Katherine S. Panageas, Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Memorial Sloan-Kettering Cancer Center; Jedd D. Wolchok, Ludwig Institute for Cancer Research; and Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Weill Cornell Medical College, New York, NY.
authors.forename: Margaret
authors.initials: M
authors.lastname: Callahan
authors.affiliation: Parisa Momtaz, Vivian Park, Katherine S. Panageas, Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Memorial Sloan-Kettering Cancer Center; Jedd D. Wolchok, Ludwig Institute for Cancer Research; and Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Weill Cornell Medical College, New York, NY.
authors.forename: Jedd D
authors.initials: JD
authors.lastname: Wolchok
authors.affiliation: Parisa Momtaz, Vivian Park, Katherine S. Panageas, Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Memorial Sloan-Kettering Cancer Center; Jedd D. Wolchok, Ludwig Institute for Cancer Research; and Michael A. Postow, Margaret Callahan, Jedd D. Wolchok, and Paul B. Chapman, Weill Cornell Medical College, New York, NY. chapmanp@mskcc.org.
authors.forename: Paul B
authors.initials: PB
authors.lastname: Chapman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000074324:Ipilimumab; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D012189:Retrospective Studies
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000074324:Ipilimumab