NEPA, a fixed oral combination of netupitant and palonosetron, improves control of chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of chemotherapy: results of a randomized, double-blind, phase 3 trial versus oral palonosetron

Aapro, Matti y Karthaus, Meinolf y Schwartzberg, Lee y Bondarenko, Igor y Sarosiek, Tomasz y Oprean, Cristina y Cardona Huerta, Servando y Hansen, Vincent y Rossi, Giorgia y Rizzi, Giada y Borroni, Maria Elisa y Rugo, Hope (2017) NEPA, a fixed oral combination of netupitant and palonosetron, improves control of chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of chemotherapy: results of a randomized, double-blind, phase 3 trial versus oral palonosetron. Supportive Care in Cancer, 25 (4). pp. 1127-1135. ISSN 0941-4355

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Abstract Purpose Antiemetic guidelines recommend co-administration of targeted prophylacticmedicationsinhibitingmolecular pathwaysinvolvedinemesis.NEPAisafixedoralcombinationofa newNK1receptorantagonist(RA),netupitant(NETU300mg), and palonosetron (PALO 0.50 mg), a pharmacologically distinct 5-HT3 RA. NEPA showed superior prevention of chemotherapy-inducednauseaandvomiting(CINV)compared with oral PALO in a single chemotherapy cycle; maintenance of efficacy/safetyover continuingcycles is the objectiveof this study. Methods This study is a multinational, double-blind study comparing a single oral dose of NEPA vs oral PALO in chemotherapy-naïve patients receiving anthracycline/ cyclophosphamide-based chemotherapy along with dexamethasone 12 mg (NEPA) or 20 mg (PALO) on day 1. The primary efficacy endpoint was delayed (25–120 h) complete response (CR: no emesis, no rescue medication) in cycle 1. Sustained efficacy was evaluated during the multicycle extension by calculating the proportion of patients with overall (0–120 h) CR in cycles 2 –4 and by assessing the probability of sustained CR over multiple cycles. Results Of 1455 patients randomized, 1286 (88 %) participated in the multiple-cycle extension for a total of 5969 cycles; 76 % completed ≥4 cycles. The proportion of patients with an overall CR was significantly greater for NEPA than oral PALO for cycles 1–4 (74.3 vs 66.6 %, 80.3 vs 66.7 %, 83.8 vs 70.3 %, and 83.8 vs 74.6 %, respectively; p ≤ 0.001 each cycle). The cumulative percentage of patients with a sustained CR over all 4 cycles was also greater for NEPA (p < 0.0001). NEPA was well tolerated over cycles. Conclusions NEPA, a convenient, guideline-consistent, fixed antiemetic combination is effective and safe over multiple cycles of chemotherapy. Keywords Neurokinin-1receptorantagonist .NEPA . Netupitant .Palonosetron .CINV.Multiplecycles

Tipo de elemento: Article
Palabras claves no controlados: Neurokinin-1 receptor antagonist, NEPA, Netupitant, Palonosetron, CINV, Multiple cycles
Materias: R Medicina > RC Medicina Interna, Psiquiatría, Neurología
Divisiones: Medicina
Usuario depositante: Editor Repositorio
Creadores:
CreadorEmailORCID
Aapro, MattiNO ESPECIFICADONO ESPECIFICADO
Karthaus, MeinolfNO ESPECIFICADONO ESPECIFICADO
Schwartzberg, LeeNO ESPECIFICADONO ESPECIFICADO
Bondarenko, IgorNO ESPECIFICADONO ESPECIFICADO
Sarosiek, TomaszNO ESPECIFICADONO ESPECIFICADO
Oprean, CristinaNO ESPECIFICADONO ESPECIFICADO
Cardona Huerta, ServandoNO ESPECIFICADONO ESPECIFICADO
Hansen, VincentNO ESPECIFICADONO ESPECIFICADO
Rossi, GiorgiaNO ESPECIFICADONO ESPECIFICADO
Rizzi, GiadaNO ESPECIFICADONO ESPECIFICADO
Borroni, Maria ElisaNO ESPECIFICADONO ESPECIFICADO
Rugo, HopeNO ESPECIFICADONO ESPECIFICADO
Fecha del depósito: 20 Mar 2020 17:50
Última modificación: 20 Mar 2020 17:50
URI: http://eprints.uanl.mx/id/eprint/18094

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