Safety profile of nivolumab administered as 30-min infusion: analysis of data from CheckMate 153.

Autor: Waterhouse D; Oncology Hematology Care, Cincinnati, OH, USA. David.waterhouse@usoncology.com.; US Oncology Research, Houston, TX, USA. David.waterhouse@usoncology.com., Horn L; Vanderbilt University Medical Center, Nashville, TN, USA., Reynolds C; Ocala Oncology Center, Ocala, FL, USA.; US Oncology Research, Houston, TX, USA., Spigel D; Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN, USA., Chandler J; West Cancer Center, PC, Memphis, TN, USA., Mekhail T; Florida Hospital Cancer Institute, Orlando, FL, USA., Mohamed M; Cone Health Cancer Center at Wesley Long, Greensboro, NC, USA., Creelan B; H. Lee Moffitt Cancer Center, Tampa, FL, USA., Blankstein KB; Hunterdon Hematology Oncology, Flemington, NJ, USA., Nikolinakos P; University Cancer and Blood Center, LLC, Athens, GA, USA., McCleod MJ; Florida Cancer Specialists, Cape Coral, FL, USA., Li A; Bristol-Myers Squibb, Princeton, NJ, USA., Oukessou A; Bristol-Myers Squibb, Princeton, NJ, USA., Agrawal S; Bristol-Myers Squibb, Princeton, NJ, USA., Aanur N; Bristol-Myers Squibb, Princeton, NJ, USA.
Jazyk: angličtina
Zdroj: Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2018 Apr; Vol. 81 (4), pp. 679-686. Date of Electronic Publication: 2018 Feb 13.
DOI: 10.1007/s00280-018-3527-6
Abstrakt: Purpose: Nivolumab has been administered using a 60-min infusion time. Reducing this time to 30 min would benefit both patients and infusion facilities. This analysis compared the safety of 30- and 60-min infusions of nivolumab in patients with previously treated advanced non-small cell lung cancer.
Methods: CheckMate 153 is an open-label, phase 3b/4, predominantly community-based study ongoing in the United States and Canada. Patients with stage IIIB/IV disease with progression/recurrence after at least one prior systemic therapy received nivolumab 3 mg/kg every 2 weeks over 30 or 60 min for 1 year or until disease progression. The primary outcome overall was to estimate the incidence of grade 3-5 treatment-related select adverse events; a retrospective objective was to estimate the incidence of hypersensitivity/infusion-related reactions (IRRs) with the 30-min infusion. Exploratory pharmacokinetic analyses were performed using a population pharmacokinetics model.
Results: Of 1420 patients enrolled, 369 received only 30-min infusions and 368 received only 60-min infusions. Similar frequencies of hypersensitivity/IRRs were noted in patients receiving 30-min [2% (n = 8)] and 60-min [2% (n = 7)] infusions. Grade 3-4 treatment-related hypersensitivity/IRRs led to treatment discontinuation in < 1% of patients in each group; < 1% of patients in each group received systemic corticosteroids. Hypersensitivity/IRRs were managed by dosing interruptions, with minimal impact on total dose received. Nivolumab pharmacokinetics were predicted to be similar in the two groups.
Conclusions: Nivolumab infused over 30 min had a comparable safety profile to the 60-min infusion, including a low incidence of IRRs.
Databáze: MEDLINE
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