SHORTER INFUSION TIME FEASIBLE FOR IPILIMUMAB

NEW YORK (Reuters Health) - The standard dose of ipilimumab can be safely infused over 30 minutes with an acceptable rate of infusion-related reactions, according to new findings.

In 2011, when the U.S. Food and Drug Administration approved ipilimumab for treating metastatic melanoma, a 90-minute infusion period was specified for the standard 3 milligrams per kilogram dose, Dr. Paul Chapman, of Memorial Sloan-Kettering Cancer Center in New York City and colleagues note. "The basis for the 90-minute infusion requirement is unclear, but it presumably was intended to minimize the incidence of infusion-related reactions," they add.

However, the investigators add, clinical trials of ipilimumab also tested a 10 mg/kg dose infused over 90 minutes, meaning that patients received 3 mg/kg within the first 30 minutes of treatment, the researchers report in an article online June 29 in the Journal of Clinical Oncology.

To investigate whether the shorter infusion period was safe, Dr. Chapman and colleagues conducted a retrospective study comparing the risk of infusion-related reactions (IRRs) between patients who received 3 mg/kg and those given 10 mg/kg, all over a 90-minute period. Their analysis included 595 patients who received 2507 doses of the drug, with 457 patients receiving 3 mg/kg and 138 receiving 10 mg/kg.

In the higher-dose group, 4.3% of patients had IRRs, versus 2.2% of the lower-dose group, but the difference was not statistically significant.

The investigators then looked at 120 patients treated prospectively with 3 mg/kg over 30 minutes, 5.8% of whom had IRRs. All of the IRRs occurred when patients were given their second dose of medication, and included six grade 2 reactions and one grade 3 reaction. All of the seven patients who had IRRs went on to safely receive subsequent doses of ipilimumab, most of whom received premedication.

"Ipilimumab can be infused safely over 30 minutes instead of the standard 90 minutes," Dr. Chapman told Reuters Health in a telephone interview. "It saves patients a lot of time. In a cancer center, it also lets you treat more patients in a day."

The findings show, he added, that when drugs get FDA approved, "there's still a lot of optimization that can be done in terms of how best to give them."

Six authors reported relationships with pharmaceutical companies, including Bristol-Myers Squibb, marketer of ipilimumab (Yervoy).

SOURCE: http://bit.ly/1HsLOq3

J Clin Oncol 2015.