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Intravenous Fixed Combination NEPA in the Prevention of Chemotherapy-Induced Vomiting

15. 2. 2021

Summary data from several studies were used by the authors of the following analysis to evaluate the efficacy of the intravenous and oral forms of the fixed combination NEPA (netupitant/fosnetupitant + palonosetron) administered with dexamethasone in preventing chemotherapy-induced vomiting based on cisplatin or anthracycline and cyclophosphamide (AC).

Fixed i.v. Combination of NK1RA and 5-HT3RA

According to current guidelines, the standard for preventing chemotherapy-induced nausea and vomiting (CINV) in regimens with cisplatin or AC is the administration of a combination of receptor antagonists (RA) NK1, 5-HT3 and dexamethasone. NEPA is a fixed combination of NK1RA fosnetupitant/netupitant and 5-HT3RA palonosetron. Intravenous fosnetupitant has demonstrated bioequivalence with oral netupitant, and in phase III studies with patients under cisplatin or AC chemotherapy regimens, comparable safety of i.v. and p.o. NEPA was documented.

Efficacy Comparison

The efficacy of i.v. NEPA in preventing CINV was compared with that of p.o. NEPA based on data from 5 clinical studies involving 2077 adult patients with solid tumors who were receiving a cisplatin or AC chemotherapy regimen for the first time: i.v. NEPA was administered in a single 30-minute infusion and p.o. NEPA in a single tablet 60 minutes before the first dose of chemotherapy. All patients also received dexamethasone. The efficacy of NEPA was also compared with regimens including other NK1RAs (aprepitant, fosaprepitant, rolapitant) based on data from 9 phase III studies with the same chemotherapy regimen. The parameter monitored was the proportion of patients without emesis during the overall risk phase (0–120 hours) after administration of the first cycle of chemotherapy.

Results

The proportion of patients without emesis in individual studies with i.v. NEPA ranged from 82.5% to 84.2%, comparable to the results for p.o. NEPA (75.0%–91.1%). With older antiemetic regimens including other NK1RAs, the proportion of patients without emesis in the overall phase was lower, ranging from 66.0% to 76.5%.

Conclusion

The authors concluded this pooled analysis by stating that both the i.v. and p.o. forms of NEPA, together with dexamethasone, represent highly effective antiemetic treatments administered in a single dose, in line with the current recommended standard of care.

(zza)

Source: Schwartzberg L., Aapro M. S. Efficacy of intravenous (IV) NEPA, a fixed NK1/5-HT3 receptor antagonist (RA) combination, for prevention of CINV following cisplatin- and anthracycline cyclophosphamide (AC)-based chemotherapy (CT). Abstract 1765P. Ann Oncol 2019; 30 (Suppl. 5): v722.



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