Adding netupitant to a chemotherapy-induced nausea and vomiting (CINV) regimen can improve outcomes without increased toxicity, according to a pooled analysis published in the journal The Oncologist.1
Standard prophylaxis for CINV in patients receiving highly emetogenic and anthracycline-cyclophosphamide–based chemotherapy includes a 5HT3 receptor antagonist, an NK1 receptor antagonist, and a corticosteroid. For this study, researchers sought to document the safety profile of the fixed combination formulation of netupitant and palonosetron in comparison with other therapies.
Researchers analyzed data from 3280 patients included in 4 randomized, double-blind, phase 2 and 3 clinical trials. Patients were classified as having received netupitant/palonosetron plus dexamethasone, palonosetron plus dexamethasone, or aprepitant plus ondansetron/palonosetron and dexamethasone.
Results showed that the frequencies of treatment-emergent and treatment-related adverse events were similar across the 4 treatment groups. Researchers observed treatment-related headache and constipation in 2% or more of patients receiving CINV prophylaxis.
Researchers found that most treatment-emergent adverse events were mild and consistent with expected chemotherapy and disease-related adverse events.
Cardiac effects, which have been observed in patients receiving ondansetron or dolasetron, were also similar across groups, with QT prolongation, tachycardia, and dyspnea occurring in 1.6%, 1.1%, and 0.9% of patients, respectively.
1. Aapro M, Hesketh PJ, Jordan K, et al. Safety of an oral fixed combination of netupitant and palonosetron (NEPA): Pooled data from the phase II/III clinical program [published online ahead of print March 21, 2016]. Oncologist. doi:10.1634/theoncologist.2015-0301.