%0 Journal Article %T A Pragmatic Study Evaluating NEPA Versus Aprepitant for Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy %+ Equipe 3: EREN- Equipe de Recherche en Epidémiologie Nutritionnelle (CRESS - U1153) %+ Hôpital Avicenne [AP-HP] %+ Institut Sainte Catherine [Avignon] %+ Clinique Victor Hugo [Le Mans] %+ Centre Eugène Marquis (CRLCC) %+ CHU Amiens-Picardie %+ CHirurgie, IMagerie et REgénération tissulaire de l’extrémité céphalique - Caractérisation morphologique et fonctionnelle - UR UPJV 7516 (CHIMERE) %+ Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel) %+ Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)) %+ Institut mediterranéen des sciences de l'information et de la communication (IMSIC) %+ Département interdisciplinaire d’organisation des parcours patients (DIOPP) %A Zelek, Laurent %A Debourdeau, Philippe %A Bourgeois, Hugues %A Wagner, Jean Philippe %A Brocard, Fabien %A Lefeuvre-Plesse, Claudia %A Chauffert, Bruno %A Leheurteur, Marianne %A Bachet, Jean-Baptiste %A Simon, Helene %A Mayeur, Didier %A Scotte, Florian %< avec comité de lecture %@ 1083-7159 %J Oncologist %I Oxford University Press %V 26 %N 10 %P E1870-E1879 %8 2021 %D 2021 %R 10.1002/onco.13888 %Z Life Sciences [q-bio]Journal articles %X Background Neurokinin (NK) 1 receptor antagonists (RAs), administered in combination with a 5-hydroxytryptamine-3 (5-HT3) RA and dexamethasone (DEX), have demonstrated clear improvements in chemotherapy-induced nausea and vomiting (CINV) prevention over a 5-HT(3)RA plus DEX. However, studies comparing the NK1RAs in the class are lacking. A fixed combination of a highly selective NK(1)RA, netupitant, and the 5-HT(3)RA, palonosetron (NEPA), simultaneously targets two critical antiemetic pathways, thereby offering a simple convenient antiemetic with long-lasting protection from CINV. This study is the first head-to-head NK(1)RA comparative study in patients receiving anthracycline cyclophosphamide (AC) and non-AC moderately emetogenic chemotherapy (MEC). Materials and Methods This was a pragmatic, multicenter, randomized, single-cycle, open-label, prospective study designed to demonstrate noninferiority of single-dose NEPA to a 3-day aprepitant regimen in preventing CINV in chemotherapy-naive patients receiving AC/non-AC MEC in a real-life setting. The primary efficacy endpoint was complete response (no emesis/no rescue) during the overall (0-120 hour) phase. Noninferiority was achieved if the lower limit of the 95% confidence interval (CI) of the difference between NEPA and the aprepitant group was greater than the noninferiority margin set at -10%. Results Noninferiority of NEPA versus aprepitant was demonstrated (risk difference 9.2%; 95% CI, -2.3% to 20.7%); the overall complete response rate was numerically higher for NEPA (64.9%) than aprepitant (54.1%). Secondary endpoints also revealed numerically higher rates for NEPA than aprepitant. Conclusion This pragmatic study in patients with cancer receiving AC and non-AC MEC revealed that a single dose of oral NEPA plus DEX was at least as effective as a 3-day aprepitant regimen, with indication of a potential efficacy benefit for NEPA. Implications for Practice In the absence of comparative neurokinin 1 (NK1) receptor antagonist (RA) studies, guideline committees and clinicians consider NK(1)RA agents to be interchangeable and equivalent. This is the first head-to-head study comparing one NK(1)RA (oral netupitant/palonosetron [NEPA]) versus another (aprepitant) in patients receiving anthracycline cyclophosphamide (AC) and non-AC moderately emetogenic chemotherapy. Noninferiority of NEPA versus the aprepitant regimen was demonstrated; the overall complete response (no emesis and no rescue use) rate was numerically higher for NEPA (65%) than aprepitant (54%). As a single-dose combination antiemetic, NEPA not only simplifies dosing but may offer a potential efficacy benefit over the current standard-of-care. %G English %L hal-03598654 %U https://u-picardie.hal.science/hal-03598654 %~ UNIV-PARIS13 %~ EPHE %~ UNIV-TLN %~ UNIV-AMU %~ UNIV-PICARDIE %~ CNAM %~ APHP %~ FNCLCC %~ IGR %~ BECQUEREL %~ CORDELIERS %~ PSL %~ SORBONNE-UNIVERSITE %~ SORBONNE-UNIV %~ IMSIC %~ SU-SCIENCES %~ TEST-DEV %~ INRAE %~ SORBONNE-PARIS-NORD %~ UNIV-PARIS %~ UNIVERSITE-PARIS %~ UP-SANTE %~ EPHE-PSL %~ SU-TI %~ U-PICARDIE %~ CHIMERE %~ ALLIANCE-SU %~ CRESS %~ INCIAM %~ TEST3-HALCNRS %~ HESAM-CNAM %~ HESAM