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
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...
| Autores principales: | , , , , , , , , , , , |
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| Formato: | Artículo |
| Lenguaje: | inglés |
| Publicado: |
2017
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| Materias: | |
| Acceso en línea: | http://eprints.uanl.mx/18094/1/418.pdf |
| _version_ | 1824415129327894528 |
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| author | Aapro, Matti Karthaus, Meinolf Schwartzberg, Lee Bondarenko, Igor Sarosiek, Tomasz Oprean, Cristina Cardona Huerta, Servando Hansen, Vincent Rossi, Giorgia Rizzi, Giada Borroni, Maria Elisa Rugo, Hope |
| author_facet | Aapro, Matti Karthaus, Meinolf Schwartzberg, Lee Bondarenko, Igor Sarosiek, Tomasz Oprean, Cristina Cardona Huerta, Servando Hansen, Vincent Rossi, Giorgia Rizzi, Giada Borroni, Maria Elisa Rugo, Hope |
| author_sort | Aapro, Matti |
| collection | Repositorio Institucional |
| description | 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 |
| format | Article |
| id | eprints-18094 |
| institution | UANL |
| language | English |
| publishDate | 2017 |
| record_format | eprints |
| spelling | eprints-180942020-03-20T17:50:57Z http://eprints.uanl.mx/18094/ 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 Karthaus, Meinolf Schwartzberg, Lee Bondarenko, Igor Sarosiek, Tomasz Oprean, Cristina Cardona Huerta, Servando Hansen, Vincent Rossi, Giorgia Rizzi, Giada Borroni, Maria Elisa Rugo, Hope RC Medicina Interna, Psiquiatría, Neurología 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 2017 Article PeerReviewed text en cc_by_nc_nd http://eprints.uanl.mx/18094/1/418.pdf http://eprints.uanl.mx/18094/1.haspreviewThumbnailVersion/418.pdf 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 http://doi.org/10.1007/s00520-016-3502-x doi:10.1007/s00520-016-3502-x |
| spellingShingle | RC Medicina Interna, Psiquiatría, Neurología Aapro, Matti Karthaus, Meinolf Schwartzberg, Lee Bondarenko, Igor Sarosiek, Tomasz Oprean, Cristina Cardona Huerta, Servando Hansen, Vincent Rossi, Giorgia Rizzi, Giada Borroni, Maria Elisa Rugo, Hope 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 |
| thumbnail | https://rediab.uanl.mx/themes/sandal5/images/online.png |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | RC Medicina Interna, Psiquiatría, Neurología |
| url | http://eprints.uanl.mx/18094/1/418.pdf |
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