Comparison of Safety and Efficacy of Oral and Intravenous Administration of Combination NEPA in the Prophylaxis of Chemotherapy-Induced Nausea and Vomiting
Both oral and intravenous administration of a combination of netupitant (a neurokinin 1 receptor antagonist − NK1RA) with palonosetron (a 5-HT3 receptor antagonist) offer prevention of chemotherapy-induced nausea and vomiting (CINV) for up to 5 days after its administration. Although the i.v. form of netupitant (fosnetupitant) + palonosetron (NEPA) did not lead to injection site reactions or anaphylactic reactions in a Phase III study, hypersensitivity and anaphylactic reactions have been described with other i.v. administered NK1RAs. Thus, the aim of the study recently published in the journal The Oncologist was to evaluate the safety and efficacy of i.v. NEPA in women with breast cancer treated with anthracycline and cyclophosphamide-containing chemotherapy.
Methodology and Course of the Study
This was an international randomized double-blind Phase III study involving 402 patients with breast cancer who had not previously been treated with moderately or highly emetogenic chemotherapy. Women received either a single 30-minute infusion of i.v. NEPA or 1 capsule of p.o. NEPA on Day 1 of the chemotherapy cycle containing an anthracycline cytostatic and cyclophosphamide, up to 4 cycles of chemotherapy. All patients also received p.o. dexamethasone on Day 1.
Findings
The results showed a comparable profile and incidence of adverse events in patients treated with i.v. and p.o. NEPA. Adverse events were mild or moderate in both therapeutic groups, in line with the expected low incidence. No cases of injection site reactions or anaphylactic reactions were recorded.
The efficacy of both i.v. and p.o. preparations was also comparable. In the 1st cycle of chemotherapy, 73.0% of women with i.v. NEPA and 77.3% of women with p.o. NEPA achieved no vomiting and did not need rescue medication (in the overall interval 0–120 hours). This corresponding response to treatment remained consistent in the subsequent cycles.
Conclusion
Prophylaxis of CINV with a single dose of i.v. or p.o. NEPA demonstrated similar efficacy and safety in patients treated with chemotherapy containing anthracyclines and cyclophosphamide. Intravenous NEPA does not contain any allergenic excipients and did not cause any infusion site reactions or anaphylactic reactions. Along with the administration of dexamethasone, both forms of NEPA comply with recommendations for prophylactic anti-emetic treatment in oncology patients.
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Source: Schwartzberg L., Navari R., Clark-Snow R. et al. 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. Oncologist 2019 Dec 4, pii: theoncologist.2019-0527, doi: 10.1634/theoncologist.2019-0527 [Epub ahead of print].
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