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

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....

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Bibliographic Details
Published in:Cancer chemotherapy and pharmacology 2018-04, Vol.81 (4), p.679-686
Main Authors: Waterhouse, David, Horn, Leora, Reynolds, Craig, Spigel, David, Chandler, Jason, Mekhail, Tarek, Mohamed, Mohamed, Creelan, Ben, Blankstein, Kenneth B., Nikolinakos, Petros, McCleod, Michael J., Li, Ang, Oukessou, Abderrahim, Agrawal, Shruti, Aanur, Nivedita
Format: Article
Language:English
Subjects:
Cancer Research
Corticoids
Corticosteroids
Data processing
Hypersensitivity
Immunotherapy
Incidence
Lung cancer
Medicine
Medicine & Public Health
Monoclonal antibodies
Non-small cell lung carcinoma
Oncology
Original Article
Patients
Pharmacokinetics
Pharmacology
Pharmacology/Toxicology
Safety
Targeted cancer therapy
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Summary: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
ISSN:0344-5704
1432-0843
DOI:10.1007/s00280-018-3527-6