FROM JOURNAL OF CLINICAL ONCOLOGY

Thirty-minute infusions of ipilimumab appear to be as safe as standard 90-minute infusions for patients with metastatic melanoma and other solid tumors, with “an acceptably low incidence of infusion-related reactions,” investigators reported online in the Journal of Clinical Oncology.

The approved dose for ipilimumab is 3 mg/kg infused over 90 minutes – a time period intentionally selected to be conservative when use of this monoclonal antibody began, “but not based on any specific data of which we are aware,” said Dr. Parisa Momtaz of Memorial Sloan-Kettering Cancer Center, New York, and her associates.

“Now, with extensive experience with the drug, we are in a position to reassess this guideline,” they noted.

Recent clinical trials have assessed a 10-mg/kg dose infused over 90 minutes. “We reasoned that in these patients, the standard dose of 3 mg/kg had been administered in the first 27 minutes. This suggested that a standard 3-mg/kg dose of ipilimumab might be safely administered over 30 minutes, potentially leading to improved efficiency and convenience” for patients and treatment centers alike, the investigators said.

Dr. Momtaz and her associates retrospectively assessed the incidence of infusion-related reactions among 595 patients treated at their center with either dose of the agent during a 5-year period, focusing on grade 2 and 3 symptoms of flushing, chills, pruritus, rash, nausea, dyspnea, cough, bronchospasm, fever, malaise, headache, hypotension, diaphoresis, tachycardia, and pain. The proportions of patients who had such reactions were not significantly different between the 138 who received the 10-mg/kg dose (4.3%) and the 457 who received the 3-mg/kg dose (2.2%). The standard approach at Sloan-Kettering was then changed to 30-minute rather than 90-minute infusion times for ipilimumab (J. Clin. Oncol. 2015 June 29; [doi:10.1200/JCO.2015.61.0030]).

The investigators then prospectively assessed infusion-related reactions among the next 120 patients who received 30-minute infusions of 3 mg/kg ipilimumab during the ensuing 14 months. The rate of reactions was 5.8% in this cohort, which was comparable to the previously observed rates and deemed to be “acceptably low.” These reactions typically were mild to moderate, responded to immediately with the administration of diphenhydramine and/or corticosteroids, and were never dose limiting, they noted.

tor@frontlinemedcom.com

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