Phase IIIb safety and efficacy of intravenous NEPA for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer receiving initial and repeat cycles of anthracycline and cyclophosphamide (AC) chemotherapy
The Oncologist Dec 13, 2019
Schwartzberg L, Navari R, Clark-Snow R, et al. - Given no infusion-site or anaphylactic reactions associated with intravenous (IV) NEPA [a combination antiemetic of a neurokinin-1 (NK1) receptor antagonist (RA) (netupitant [oral]/fosnetupitant [intravenous; IV]) and 5-HT3RA, palonosetron] that provides 5-day CINV prevention with a single dose] were identified in a phase III study of patients receiving cisplatin, however, patients receiving anthracycline-cyclophosphamide (AC)-based chemotherapy exhibited hypersensitivity reactions and anaphylaxis with other IV NK1RAs, especially fosaprepitant, therefore, researchers assessed the safety as well as the effectiveness of IV NEPA in the AC setting. Including females with breast cancer naive to highly or moderately emetogenic chemotherapy, a phase IIIb, multinational, randomized, double-blind study was performed. A single 30-minute infusion of IV NEPA or single oral NEPA capsule on day 1 before AC, in repeated (up to 4) cycles, was administered to patients by using randomization. All patients received oral dexamethasone on day 1 only. Findings revealed high efficacy as well as safety of IV NEPA, with no related hypersensitivity and injection-site reactions in patients taking AC.
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