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ISSN (Print): 1568-0096
ISSN (Online): 1873-5576

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Review Article

Netupitant-palonosetron (NEPA) for Preventing Chemotherapy-induced Nausea and Vomiting: From Clinical Trials to Daily Practice

Author(s): Matti Aapro*, Karin Jordan, Florian Scotté, Luigi Celio, Meinolf Karthaus and Eric Roeland

Volume 22, Issue 10, 2022

Published on: 18 July, 2022

Page: [806 - 824] Pages: 19

DOI: 10.2174/1568009622666220513094352

open access plus

Abstract

Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event associated with many anticancer therapies and can negatively impact patients' quality of life and potentially limit the effectiveness of chemotherapy. Currently, CINV can be prevented in most patients with guideline-recommended antiemetic regimens. However, clinicians do not always follow guidelines, and patients often face difficulties adhering to their prescribed treatments. Therefore, approaches to increase guideline adherence need to be implemented. NEPA is the first and only fixed combination antiemetic, composed of netupitant (oral)/fosnetupitant (intravenous) and palonosetron, which, together with dexamethasone, constitute a triple antiemetic combination recommended for the prevention of CINV for patients receiving highly emetogenic chemotherapy and for certain patients receiving moderately emetogenic chemotherapy. Thus, NEPA offers a convenient and straightforward antiemetic treatment that could improve adherence to guidelines. This review provides an overview of CINV, evaluates the accumulated evidence of NEPA's antiemetic activity and safety from clinical trials and real-world practice, and examines the preliminary evidence of antiemetic control with NEPA in daily clinical settings beyond those described in pivotal trials. Moreover, we review the utility of NEPA in controlling nausea and preserving patients’ quality of life during chemotherapy, two major concerns in managing patients with cancer.

Keywords: Netupitant-palonosetron (NEPA), chemotherapy-induced nausea and vomiting (CINV), NK1 receptor antagonist, 5-HT3 receptor antagonist, quality of life, antiemetic regimens.

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[1]
Navari, R.M.; Aapro, M. Antiemetic prophylaxis for chemotherapy-induced nausea and vomiting. N. Engl. J. Med., 2016, 374(14), 1356-1367.
[http://dx.doi.org/10.1056/NEJMra1515442] [PMID: 27050207]
[2]
Jordan, K.; Jahn, F.; Aapro, M. Recent developments in the prevention of chemotherapy-induced nausea and vomiting (CINV): A comprehensive review. Ann. Oncol., 2015, 26(6), 1081-1090.
[http://dx.doi.org/10.1093/annonc/mdv138] [PMID: 25755107]
[3]
Kuchuk, I.; Bouganim, N.; Beusterien, K.; Grinspan, J.; Vandermeer, L.; Gertler, S.; Dent, S.F.; Song, X.; Segal, R.; Mazzarello, S.; Crawley, F.; Dranitsaris, G.; Clemons, M. Preference weights for chemotherapy side effects from the perspective of women with breast cancer. Breast Cancer Res. Treat., 2013, 142(1), 101-107.
[http://dx.doi.org/10.1007/s10549-013-2727-3] [PMID: 24129976]
[4]
Sun, C.C.; Bodurka, D.C.; Weaver, C.B.; Rasu, R.; Wolf, J.K.; Bevers, M.W.; Smith, J.A.; Wharton, J.T.; Rubenstein, E.B. Rankings and symptom assessments of side effects from chemotherapy: Insights from experienced patients with ovarian cancer. Support. Care Cancer, 2005, 13(4), 219-227.
[http://dx.doi.org/10.1007/s00520-004-0710-6] [PMID: 15538640]
[5]
Fernández-Ortega, P.; Caloto, M.T.; Chirveches, E.; Marquilles, R.; Francisco, J.S.; Quesada, A.; Suárez, C.; Zorrilla, I.; Gómez, J.; Zabaleta, P.; Nocea, G.; Llombart-Cussac, A. Chemotherapy-induced nausea and vomiting in clinical practice: Impact on patients’ quality of life. Support. Care Cancer, 2012, 20(12), 3141-3148.
[http://dx.doi.org/10.1007/s00520-012-1448-1] [PMID: 22460057]
[6]
Van Laar, E.S.; Desai, J.M.; Jatoi, A. Professional educational needs for chemotherapy-induced nausea and vomiting (CINV): Multinational survey results from 2388 health care providers. Support. Care Cancer, 2015, 23(1), 151-157.
[http://dx.doi.org/10.1007/s00520-014-2325-x] [PMID: 25015057]
[7]
Jordan, K.; Aapro, M.; Kaasa, S.; Ripamonti, C.I.; Scotté, F.; Strasser, F.; Young, A.; Bruera, E.; Herrstedt, J.; Keefe, D.; Laird, B.; Walsh, D.; Douillard, J.Y.; Cervantes, A. European Society for Medical Oncology (ESMO) position paper on supportive and palliative care. Ann. Oncol., 2018, 29(1), 36-43.
[http://dx.doi.org/10.1093/annonc/mdx757] [PMID: 29253069]
[8]
Basch, E.; Deal, A.M.; Dueck, A.C.; Scher, H.I.; Kris, M.G.; Hudis, C.; Schrag, D. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA, 2017, 318(2), 197-198.
[http://dx.doi.org/10.1001/jama.2017.7156] [PMID: 28586821]
[9]
Grunberg, S.M.; Osoba, D.; Hesketh, P.J.; Gralla, R.J.; Borjeson, S.; Rapoport, B.L.; du Bois, A.; Tonato, M. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--an update. Support. Care Cancer, 2005, 13(2), 80-84.
[http://dx.doi.org/10.1007/s00520-004-0718-y] [PMID: 15599601]
[10]
National Comprehensive Cancer Network. NCCN Clinical practice guidelines in oncology (NCCN Guidelines®). 2021. Available from:. https://www.nccn.org/professionals/physician_gls/pdf/antie-mesis.pdf (Accessed September 30, 2021).
[11]
Morrow, G.R.; Hickok, J.T.; Burish, T.G.; Rosenthal, S.N. Frequency and clinical implications of delayed nausea and delayed emesis. Am. J. Clin. Oncol., 1996, 19(2), 199-203.
[http://dx.doi.org/10.1097/00000421-199604000-00023] [PMID: 8610650]
[12]
Navari, R.M. Treatment of breakthrough and refractory chemotherapy-induced nausea and vomiting. BioMed Res. Int., 2015, 2015595894
[http://dx.doi.org/10.1155/2015/595894] [PMID: 26421294]
[13]
Morrow, G.R.; Roscoe, J.A.; Hynes, H.E.; Flynn, P.J.; Pierce, H.I.; Burish, T. Progress in reducing anticipatory nausea and vomiting: A study of community practice. Support. Care Cancer, 1998, 6(1), 46-50.
[http://dx.doi.org/10.1007/s005200050131] [PMID: 9458536]
[14]
Grunberg, S.M.; Warr, D.; Gralla, R.J.; Rapoport, B.L.; Hesketh, P.J.; Jordan, K.; Espersen, B.T. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--state of the art. Support. Care Cancer, 2011, 19(S1)(Suppl. 1), S43-S47.
[http://dx.doi.org/10.1007/s00520-010-1003-x] [PMID: 20972805]
[15]
Navari, R.M.; Pywell, C.M.; Le-Rademacher, J.G.; White, P.; Dodge, A.B.; Albany, C.; Loprinzi, C.L. Olanzapine for the treatment of advanced cancer-related chronic nausea and/or vomiting: A randomized pilot trial. JAMA Oncol., 2020, 6(6), 895-899.
[http://dx.doi.org/10.1001/jamaoncol.2020.1052] [PMID: 32379269]
[16]
Slusher, B.S. Mechanisms of chemotherapy-induced nausea and vomiting and antiemetic agents. Clin. Adv. Hematol. Oncol., 2013, 11(2), 3-8.
[17]
Singh, P.; Yoon, S.S.; Kuo, B. Nausea: A review of pathophysiology and therapeutics. Therap. Adv. Gastroenterol., 2016, 9(1), 98-112.
[http://dx.doi.org/10.1177/1756283X15618131] [PMID: 26770271]
[18]
Napadow, V.; Sheehan, J.D.; Kim, J.; Lacount, L.T.; Park, K.; Kaptchuk, T.J.; Rosen, B.R.; Kuo, B. The brain circuitry underlying the temporal evolution of nausea in humans. Cereb. Cortex, 2013, 23(4), 806-813.
[http://dx.doi.org/10.1093/cercor/bhs073] [PMID: 22473843]
[19]
Bošnjak, S.M.; Gralla, R.J.; Schwartzberg, L. Prevention of chemotherapy-induced nausea: The role of neurokinin-1 (NK1) receptor antagonists. Support. Care Cancer, 2017, 25(5), 1661-1671.
[http://dx.doi.org/10.1007/s00520-017-3585-z] [PMID: 28108820]
[20]
Jordan, K.; Chan, A.; Gralla, R.J.; Jahn, F.; Rapoport, B.; Warr, D.; Hesketh, P.J. 2016 Updated MASCC/ESMO consensus recommendations: Emetic risk classification and evaluation of the emetogenicity of antineoplastic agents. Support. Care Cancer, 2017, 25(1), 271-275.
[http://dx.doi.org/10.1007/s00520-016-3332-x] [PMID: 27501965]
[21]
Hesketh, P.J.; Kris, M.G.; Basch, E.; Bohlke, K.; Barbour, S.Y.; Clark-Snow, R.A.; Danso, M.A.; Dennis, K.; Dupuis, L.L.; Dusetzina, S.B.; Eng, C.; Feyer, P.C.; Jordan, K.; Noonan, K.; Sparacio, D.; Lyman, G.H. Antiemetics: ASCO Guideline update. J. Clin. Oncol., 2020, 38(24), 2782-2797.
[http://dx.doi.org/10.1200/JCO.20.01296] [PMID: 32658626]
[22]
Roila, F.; Molassiotis, A.; Herrstedt, J.; Aapro, M.; Gralla, R.J.; Bruera, E.; Clark-Snow, R.A.; Dupuis, L.L.; Einhorn, L.H.; Feyer, P.; Hesketh, P.J.; Jordan, K.; Olver, I.; Rapoport, B.L.; Roscoe, J.; Ruhlmann, C.H.; Walsh, D.; Warr, D.; van der Wetering, M. participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann. Oncol., 2016, 27(Suppl. 5), v119-v133.
[http://dx.doi.org/10.1093/annonc/mdw270] [PMID: 27664248]
[23]
Multinational Association of Supportive Care in Cancer. MASCC/ESMO antiemetic guidelines. 2019. 2019. Available from:. https://mascc.memberclicks.net/assets/Guidelines-Tools/Antiemetics/mascc_antiemetic_guidelines_english_v.1.5SEPT29.2019.pdf (Accessed October 5, 2021).
[24]
Aapro, M.; Molassiotis, A.; Dicato, M.; Peláez, I.; Rodríguez-Lescure, Á.; Pastorelli, D.; Ma, L.; Burke, T.; Gu, A.; Gascon, P.; Roila, F. PEER investigators. The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): The Pan European Emesis Registry (PEER). Ann. Oncol., 2012, 23(8), 1986-1992.
[http://dx.doi.org/10.1093/annonc/mds021] [PMID: 22396444]
[25]
Burmeister, H.; Aebi, S.; Studer, C.; Fey, M.F.; Gautschi, O. Adherence to ESMO clinical recommendations for prophylaxis of chemotherapy-induced nausea and vomiting. Support. Care Cancer, 2012, 20(1), 141-147.
[http://dx.doi.org/10.1007/s00520-010-1079-3] [PMID: 21234609]
[26]
Gilmore, J.W.; Peacock, N.W.; Gu, A.; Szabo, S.; Rammage, M.; Sharpe, J.; Haislip, S.T.; Perry, T.; Boozan, T.L.; Meador, K.; Cao, X.; Burke, T.A. Antiemetic guideline consistency and incidence of chemotherapy-induced nausea and vomiting in US community oncology practice: INSPIRE Study. J. Oncol. Pract., 2014, 10(1), 68-74.
[http://dx.doi.org/10.1200/JOP.2012.000816] [PMID: 24065402]
[27]
Dranitsaris, G.; Molassiotis, A.; Clemons, M.; Roeland, E.; Schwartzberg, L.; Dielenseger, P.; Jordan, K.; Young, A.; Aapro, M. The development of a prediction tool to identify cancer patients at high risk for chemotherapy-induced nausea and vomiting. Ann. Oncol., 2017, 28(6), 1260-1267.
[http://dx.doi.org/10.1093/annonc/mdx100] [PMID: 28398530]
[28]
Aapro, M.; Ruffo, P.; Panteri, R.; Costa, S.; Piovesana, V. Oncologist perspectives on chemotherapy-induced nausea and vomiting (CINV) management and outcomes: A quantitative market research-based survey. Cancer Rep., 2018, 1(4)e1127
[http://dx.doi.org/10.1002/cnr2.1127] [PMID: 32729252]
[29]
Aapro, M.; Scotté, F.; Escobar, Y.; Celio, L.; Berman, R.; Franceschetti, A.; Bell, D.; Jordan, K. Practice patterns for prevention of chemotherapy-induced nausea and vomiting and antiemetic guideline adherence based on real-world prescribing data. Oncologist, 2021, 26(6), e1073-e1082.
[http://dx.doi.org/10.1002/onco.13716] [PMID: 33555084]
[30]
Clark-Snow, R.; Affronti, M.L.; Rittenberg, C.N. Chemotherapy-induced nausea and vomiting (CINV) and adherence to antiemetic guidelines: Results of a survey of oncology nurses. Support. Care Cancer, 2018, 26(2), 557-564.
[http://dx.doi.org/10.1007/s00520-017-3866-6] [PMID: 28871358]
[31]
Dielenseger, P.; Börjeson, S.; Vidall, C.; Young, A.; Jahn, P. Evaluation of antiemetic practices for prevention of chemotherapy-induced nausea and vomiting (CINV): Results of a European oncology nurse survey. Support. Care Cancer, 2019, 27(11), 4099-4106.
[http://dx.doi.org/10.1007/s00520-019-04697-1] [PMID: 30783815]
[32]
Aapro, M.S.; Chrápavá, M.; Curca, R.O.D.; Gales, L.; Grigorescu, A.C.; Karlínová, B.; Kellnerová, R.; Petru, E.; Pluzanski, A.; Rubach, M.; Steger, G.G.; Tesarova, P.; Yordanov, N.; Walaszkowska-Czyz, A. Assessing the impact of antiemetic guideline compliance on prevention of chemotherapy-induced nausea and vomiting (CINV): Results of the Nausea/Emesis Registry in Oncology (NERO). Proceedings of the 56th American Society of Clinical Oncology Annual Meeting, Chicago, IL, USAMay 29-June 2, 2020
[http://dx.doi.org/10.1200/JCO.2020.38.15_suppl.12083]
[33]
Roeland, E.J.; Ruddy, K.J.; LeBlanc, T.W.; Nipp, R.D.; Binder, G.; Sebastiani, S.; Potluri, R.; Schmerold, L.; Papademetriou, E.; Schwartzberg, L.; Navari, R.M. What the HEC? Clinician adherence to evidence-based antiemetic prophylaxis for highly emetogenic chemotherapy. J. Natl. Compr. Canc. Netw., 2020, 18(6), 676-681.
[http://dx.doi.org/10.6004/jnccn.2019.7526] [PMID: 32502985]
[34]
Vidall, C.; Fernández-Ortega, P.; Cortinovis, D.; Jahn, P.; Amlani, B.; Scotté, F. Impact and management of chemotherapy/radiotherapy-induced nausea and vomiting and the perceptual gap between oncologists/oncology nurses and patients: A cross-sectional multinational survey. Support. Care Cancer, 2015, 23(11), 3297-3305.
[http://dx.doi.org/10.1007/s00520-015-2750-5] [PMID: 25953380]
[35]
De Laurentiis, M.; Bonfadini, C.; Lorusso, V.; Cilenti, G.; Di Rella, F.; Altavilla, G.; Otero, M.; Ardizzoia, A.; Marchetti, P.; Peverelli, G.; Amoroso, D.; Vecchio, S.; Fiorio, E.; Orecchia, S. Incidence of nausea and vomiting in breast cancer patients treated with anthracycline plus cyclophosphamide-based chemotherapy regimens in Italy: NAVY observational study. Support. Care Cancer, 2018, 26(12), 4021-4029.
[http://dx.doi.org/10.1007/s00520-018-4259-1] [PMID: 29943152]
[36]
European Medicines Agency. Guideline on clinical development of fixed combination medicinal products. Available from:. https://www.ema.europa.eu/en/documents/scientific-guideline/gui-deline-clinical-development-fixed-combination-medicinal-products -revision-2_en.pdf (Accessed September 30, 2021).
[37]
Zelek, L.; Debourdeau, P.; Bourgeois, H.; Wagner, J.P.; Brocard, F.; Lefeuvre-Plesse, C.; Chauffert, B.; Leheurteur, M.; Bachet, J.B.; Simon, H.; Mayeur, D.; Scotté, F. A pragmatic study evaluating NEPA versus aprepitant for prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy. Oncologist, 2021, 26(10), e1870-e1879.
[http://dx.doi.org/10.1002/onco.13888] [PMID: 34216177]
[38]
Akynzeo® (netupitant and palonosetron); Helsinn Therapeutics, Inc.: Lugano, Switzerland, 2020.
[39]
Akynzeo 300 mg/0.50 mg hard capsules; Akynzeo 235 mg/0.25 mg powder for concentrate for solution for infusion [summary of product characteristics]. 2020. Available from: https://www.ema. europa.eu/en/documents/product-information/akynzeo-epar-prod-uct-information_en.pdf (Accessed September 30, 2020).
[40]
Aapro, M.; Rugo, H.; Rossi, G.; Rizzi, G.; Borroni, M.E.; Bondarenko, I.; Sarosiek, T.; Oprean, C.; Cardona-Huerta, S.; Lorusso, V.; Karthaus, M.; Schwartzberg, L.; Grunberg, S. A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy. Ann. Oncol., 2014, 25(7), 1328-1333.
[http://dx.doi.org/10.1093/annonc/mdu101] [PMID: 24603643]
[41]
Gralla, R.J.; Bosnjak, S.M.; Hontsa, A.; Balser, C.; Rizzi, G.; Rossi, G.; Borroni, M.E.; Jordan, K. A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy. Ann. Oncol., 2014, 25(7), 1333-1339.
[http://dx.doi.org/10.1093/annonc/mdu096] [PMID: 24631949]
[42]
Hesketh, P.J.; Rossi, G.; Rizzi, G.; Palmas, M.; Alyasova, A.; Bondarenko, I.; Lisyanskaya, A.; Gralla, R.J. Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: A randomized dose-ranging pivotal study. Ann. Oncol., 2014, 25(7), 1340-1346.
[http://dx.doi.org/10.1093/annonc/mdu110] [PMID: 24608196]
[43]
Jordan, K. New formulation, new drug? The importance of assessing the safety of new supportive care formulations in oncology. Ann. Oncol., 2018, 29(7), 1494-1496.
[http://dx.doi.org/10.1093/annonc/mdy187] [PMID: 29790903]
[44]
Zhang, L.; Lu, S.; Feng, J.; Dechaphunkul, A.; Chang, J.; Wang, D.; Chessari, S.; Lanzarotti, C.; Jordan, K.; Aapro, M. A randomized phase III study evaluating the efficacy of single-dose NEPA, a fixed antiemetic combination of netupitant and palonosetron, versus an aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC). Ann. Oncol., 2018, 29(2), 452-458.
[http://dx.doi.org/10.1093/annonc/mdx698] [PMID: 29092012]
[45]
Schwartzberg, L.; Roeland, E.; Andric, Z.; Kowalski, D.; Radic, J.; Voisin, D.; Rizzi, G.; Navari, R.; Gralla, R.J.; Karthaus, M. Phase III safety study of intravenous NEPA: A novel fixed antiemetic combination of fosnetupitant and palonosetron in patients receiving highly emetogenic chemotherapy. Ann. Oncol., 2018, 29(7), 1535-1540.
[http://dx.doi.org/10.1093/annonc/mdy169] [PMID: 29722791]
[46]
Conter, H.; Mithoowani, H.; Prady, C.; Gupta, R.; Khodadad, K. A phase IV, real world observational study on the use of netupitant/palonosetron (NEPA®) for the prevention of CINV in patients receiving highly emetogenic chemotherapy (HEC) over multiple cycles. J. Oncol. Pharm. Pract., 2020, 26(4)(Suppl.), 18-19.
[47]
Schwartzberg, L.; Navari, R.; Clark-Snow, R.; Arkania, E.; Radyukova, I.; Patel, K.; Voisin, D.; Rizzi, G.; Wickham, R.; Gralla, R.J.; Aapro, M.; Roeland, E. 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, 2020, 25(3), e589-e597.
[http://dx.doi.org/10.1634/theoncologist.2019-0527] [PMID: 32162813]
[48]
Caputo, R.; Cazzaniga, M.E.; Sbrana, A.; Torrisi, R.; Paris, I.; Giordano, M.; Montesarchio, V.; Guarneri, V.; Amaducci, L.; Bilancia, D.; Cilenti, G.; Fabi, A.; Collovà, E.; Schirone, A.; Bonizzoni, E.; Celio, L.; De Placido, S.; De Laurentiis, M. Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: A multi-cycle, phase II study. BMC Cancer, 2020, 20(1), 232.
[http://dx.doi.org/10.1186/s12885-020-6707-9] [PMID: 32188417]
[49]
Yeo, W.; Lau, T.K.; Kwok, C.C.; Lai, K.T.; Chan, V.T.; Li, L.; Chan, V.; Wong, A.; Soo, W.M.; Yeung, E.W.; Wong, K.H.; Tang, N.L.; Suen, J.J.; Mo, F.K. NEPA efficacy and tolerability during (neo)adjuvant breast cancer chemotherapy with cyclophosphamide and doxorubicin. BMJ Support. Palliat. Care, 2020. bmjspcare- 2019-002037. 2020.
[50]
Schilling, J.; Kurbacher, C.M.; Hanusch, C.; Busch, S.; Holländer, M.; Kreiss-Sender, J.; Rezek, D.; Flahaut, E.; Karthaus, M. Quality of life effects of an oral fixed combination of netupitant and palonosetron in chemotherapy-induced nausea and vomiting prevention: Real-world evidence in patients with breast cancer receiving anthracycline-cyclophosphamide-based chemotherapy. Breast Care (Basel), 2021, 1-7.
[http://dx.doi.org/10.1159/000514891]
[51]
Karthaus, M.; Oskay-Özcelik, G.; Wülfing, P.; Hielscher, C.; Guth, D.; Zahn, M.O.; Flahaut, E.; Schilling, J. Real-world evidence of NEPA, netupitant-palonosetron, in chemotherapy-induced nausea and vomiting prevention: Effects on quality of life. Future Oncol., 2020, 16(14), 939-953.
[http://dx.doi.org/10.2217/fon-2020-0187] [PMID: 32298187]
[52]
Roeland, E.J.; Binder, G.; Ma, J.; Lanzarotti, C.; Zhang, L. Evaluation of daily breakthrough chemotherapy-induced nausea and vomiting (CINV) rates in a phase III study of NEPA versus an aprepitant (APR)/granisetron (GRAN) regimen. Proceedings of the 53rd American Society of Clinical Oncology Annual Meeting, Chicago, IL, USAJune 2-6, 2017
[http://dx.doi.org/10.1200/JCO.2017.35.31_suppl.120]
[53]
Hesketh, P.J.; Kris, M.G.; Basch, E.; Bohlke, K.; Barbour, S.Y.; Clark-Snow, R.A.; Danso, M.A.; Dennis, K.; Dupuis, L.L.; Dusetzina, S.B.; Eng, C.; Feyer, P.C.; Jordan, K.; Noonan, K.; Sparacio, D.; Somerfield, M.R.; Lyman, G.H. Antiemetics: American society of clinical oncology clinical practice guideline update. J. Clin. Oncol., 2017, 35(28), 3240-3261.
[http://dx.doi.org/10.1200/JCO.2017.74.4789] [PMID: 28759346]
[54]
Schwartzberg, L.S.; Marks, S.M.; Gabrail, N.Y.; Geller, R.B.; Kish, J. Real-world effectiveness of palonosetron-based antiemetic regimens: Preventing chemotherapy-induced nausea and vomiting. J. Comp. Eff. Res., 2019, 8(9), 657-670. [b]
[http://dx.doi.org/10.2217/cer-2018-0104] [PMID: 31070042]
[55]
Valerio, M.R.; Gebbia, V.; Borsellino, N.; Vecchia, M.; Serretta, V.; Pardo, S.; Cipolla, C.; Galanti, D. NEPA as antiemetic prophylaxis after failure of 5HT3-RA plus dexamethasone in patients receiving carboplatin and gemcitabine chemotherapy: A monocentric real-life experience. J. Oncol. Pharm. Pract., 2021, 27(3), 609-613.
[http://dx.doi.org/10.1177/1078155220929409] [PMID: 32507099]
[56]
Zilioli, V.R.; Muzi, C.; Minga, P.; Codega, P.; Crucitti, L.; Meli, E.; Esposito, A.; Panico, C.; Rusconi, C.; Cairoli, R. Safety and efficacy of netupitant/palonosetron and dexamethasone in classical Hodgkin’s lymphoma patients with inadequate chemotherapy-induced nausea and vomiting prophylaxis with palonosetron and dexamethasone: A single-center real-life experience. Int. J. Hematol. Oncol., 2020, 9(1), IJH23.
[http://dx.doi.org/10.2217/ijh-2020-0001] [PMID: 32382409]
[57]
Schmitt, T.; Goldschmidt, H.; Neben, K.; Freiberger, A.; Hüsing, J.; Gronkowski, M.; Thalheimer, M.; Pelzl, H.; Mikus, G.; Burhenne, J.; Ho, A.D.; Egerer, G. Aprepitant, granisetron, and dexamethasone for prevention of chemotherapy-induced nausea and vomiting after high-dose melphalan in autologous transplantation for multiple myeloma: Results of a randomized, placebo-controlled phase III trial. J. Clin. Oncol., 2014, 32(30), 3413-3420.
[http://dx.doi.org/10.1200/JCO.2013.55.0095] [PMID: 25225424]
[58]
Clemmons, A.B.; Orr, J.; Andrick, B.; Gandhi, A.; Sportes, C.; DeRemer, D. Randomized, placebo-controlled, phase III trial of fosaprepitant, ondansetron, dexamethasone (FOND) versus FOND plus olanzapine (FOND-O) for the prevention of chemotherapy-induced nausea and vomiting in patients with hematologic malignancies receiving highly emetogenic chemotherapy and hematopoietic cell transplantation regimens: The FOND-O trial. Biol. Blood Marrow Transplant., 2018, 24(10), 2065-2071.
[http://dx.doi.org/10.1016/j.bbmt.2018.06.005] [PMID: 29906570]
[59]
Schwartzberg, L.; Parisi, S.; Bernareggi, A. Model-predicted netupitant pharmacokinetic (PK) profiles on repeated-dose schedules: Accumulation and safety considerations for chemotherapy-induced nausea and vomiting (CINV) prophylaxis in multiday emetogenic chemotherapy. Proceedings of the American Society of Health-System Pharmacists Midyear Clinical Meeting Exhibition, Las Vegas, NV, USA; December 4-6, 2016
[60]
Badalamenti, G.; Incorvaia, L.; Messina, C.; Musso, E.; Casarin, A.; Ricciardi, M.R.; De Luca, I.; Bazan, V.; Russo, A. Correction to: One shot NEPA plus dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) in sarcoma patients receiving multiple-day chemotherapy. Support. Care Cancer, 2019, 27(9), 3593-3597.
[http://dx.doi.org/10.1007/s00520-019-4645-3] [PMID: 30762142]
[61]
Di Renzo, N.; Musso, M.; Scimè, R.; Cupri, A.; Perrone, T.; De Risi, C.; Pastore, D.; Guarini, A.; Mengarelli, A.; Benedetti, F.; Mazza, P.; Capria, V.; Chiusolo, P.; Cupelli, L.; Federico, V.; Bozzoli, V.; Messa, A.R.; Codega, P.; Bonizzoni, E.; Specchia, G. Efficacy and safety of multiple doses of NEPA without dexamethasone in preventing nausea and vomiting induced by multiple-day and high-dose chemotherapy in patients with non-Hodgkin’s lymphoma undergoing autologous hematopoietic stem cell transplantation: A phase IIa, multicenter study. Bone Marrow Transplant., 2020, 55(11), 2114-2120.
[http://dx.doi.org/10.1038/s41409-020-0909-2] [PMID: 32346078]
[62]
Bubalo, J.; Chen, A.I.; Leong, K.; Gille, B.; Nagle, S.; Bensch, K.; Macey, T.; Ellison, K.; Booth, G.; Misra, S.; Maziarz, R.T. Phase II clinical trial of NEPA (netupitant/palonosetron) for prevention of chemotherapy induced nausea and vomiting (CINV) in patient receiving the BEAM conditioning regimen. Biol. Blood Marrow Transplant., 2019, 25(3)(Suppl.), S284.
[http://dx.doi.org/10.1016/j.bbmt.2018.12.357]
[63]
Bubalo, J.; Radke, J.; Bensch, K.; Chen, A.; Misra, S.; Nagle, S.; Maziarz, R. A phase II clinical trial of NEPA (netupitant/palonosetron) for prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in patients receiving the BEAM conditioning regimen prior to Hematopoietic Cell Transplantation (HSCT); Cell. Ther, 2021. [Epub ahead of print
[64]
Vardy, J.; Chiew, K.S.; Galica, J.; Pond, G.R.; Tannock, I.F. Side effects associated with the use of dexamethasone for prophylaxis of delayed emesis after moderately emetogenic chemotherapy. Br. J. Cancer, 2006, 94(7), 1011-1015.
[http://dx.doi.org/10.1038/sj.bjc.6603048] [PMID: 16552437]
[65]
Chow, R.; Warr, D.G.; Navari, R.M.; Tsao, M.; Milakovic, M.; Popovic, M.; Chiu, L.; Chiu, N.; Lam, H.; DeAngelis, C. Efficacy and safety of 1-day versus 3-day dexamethasone for the prophylaxis of chemotherapy-induced nausea and vomiting: A systematic review and meta-analysis of randomized controlled trials. J. Hosp. Manag. Health Policy, 2018, 2(5), 25.
[http://dx.doi.org/10.21037/jhmhp.2018.04.05]
[66]
Celio, L.; Bonizzoni, E.; Zattarin, E.; Codega, P.; de Braud, F.; Aapro, M. Impact of dexamethasone-sparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: A meta-analysis of randomised evidence. BMC Cancer, 2019, 19(1), 1268.
[http://dx.doi.org/10.1186/s12885-019-6454-y] [PMID: 31888544]
[67]
European Society for Medical Oncology. Cancer patient management during the COVID-19 pandemic. Supportive care strategies during the COVID-19 pandemic. Available from:. https://www.esmo.org/guidelines/cancer-patient-management-duri-ng-the-covid-19-pandemic/supportive-care-in-the-covid-19-era (Accessed September 30, 2020).
[68]
Celio, L.; Cortinovis, D.; Cogoni, A.A.; Cavanna, L.; Martelli, O.; Carnio, S.; Collovà, E.; Bertolini, F.; Petrelli, F.; Cassano, A.; Chiari, R.; Zanelli, F.; Pisconti, S.; Vittimberga, I.; Letizia, A.; Misino, A.; Gernone, A.; Bonizzoni, E.; Pilotto, S.; De Placido, S.; Bria, E. Dexamethasone-sparing regimens with oral netupitant and palonosetron for the prevention of emesis caused by high-dose cisplatin: A randomized noninferiority study. Oncologist, 2021, 26(10), e1854-e1861.
[http://dx.doi.org/10.1002/onco.13851] [PMID: 34101934]
[69]
Ito, Y.; Tsuda, T.; Minatogawa, H.; Kano, S.; Sakamaki, K.; Ando, M.; Tsugawa, K.; Kojima, Y.; Furuya, N.; Matsuzaki, K.; Fukuda, M.; Sugae, S.; Ohta, I.; Arioka, H.; Tokuda, Y.; Narui, K.; Tsuboya, A.; Suda, T.; Morita, S.; Boku, N.; Yamanaka, T.; Nakajima, T.E. Placebo-controlled, double-blinded phase III study comparing dexamethasone on day 1 with dexamethasone on days 1 to 3 with combined neurokinin-1 receptor antagonist and palonosetron in high-emetogenic chemotherapy. J. Clin. Oncol., 2018, 36(10), 1000-1006.
[http://dx.doi.org/10.1200/JCO.2017.74.4375] [PMID: 29443652]
[70]
Navari, R.M.; Bonizzoni, E.; Wickham, R.; Clark-Snow, R. Pooled analysis of phase 3 studies comparing a single-dose fixed combination of Netupitant/Palonosetron (NEPA) vs. a 3-day Aprepitant-based Regimen (APR) for prevention of Chemotherapy- Induced Nausea and Vomiting (CINV) in patients receiving Highly Emetogenic Chemotherapy (HEC). J. Natl. Compr. Cancer Netw., 2020, 18(3.5), BPI20-2019.
[http://dx.doi.org/10.6004/jnccn.2019.7430]
[71]
Clark-Snow, R.; Wickham, R.; Bonizzoni, E.; Roeland, E. Pooled phase 3 studies evaluating NEPA, a single-dose fixed combination of Netupitant/Palonosetron (NEPA) vs. a 3-day Aprepitant-based Regimen (APR) for prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in patients receiving high-dose cisplatin. Oncol. Nurs. Forum, 2020, 47(2), 97.
[72]
Schwartzberg, L.; Karthaus, M.; Rossi, G.; Rizzi, G.; Borroni, M.E.; Rugo, H.S.; Jordan, K.; Hansen, V. Fixed combination of oral NEPA (netupitant-palonosetron) for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients receiving multiple cycles of chemotherapy: Efficacy data from 2 randomized, double-blind phase III studies. Cancer Med., 2019, 8(5), 2064-2073.
[http://dx.doi.org/10.1002/cam4.2091] [PMID: 30968588]
[73]
Gilmore, J.; Bernareggi, A. Complementary pharmacokinetic profiles of netupitant and palonosetron support the rationale for their oral fixed combination for the prevention of chemotherapy-induced nausea and vomiting. J. Clin. Pharmacol., 2019, 59(4), 472-487.
[http://dx.doi.org/10.1002/jcph.1338] [PMID: 30412271]

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