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.
Journal
Bone marrow transplantation
ISSN: 1476-5365
Titre abrégé: Bone Marrow Transplant
Pays: England
ID NLM: 8702459
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
25
02
2020
accepted:
08
04
2020
revised:
02
04
2020
pubmed:
30
4
2020
medline:
22
6
2021
entrez:
30
4
2020
Statut:
ppublish
Résumé
Despite the availability of several antiemetics, clinical findings show that control of chemotherapy-induced nausea and vomiting (CINV) continues to be a serious concern for hematological patients, mainly for those receiving multiple-day (MD) and high-dose (HD) chemotherapy (CT). For CINV prophylaxis, 5-hydroxytryptamine type-3 receptor antagonists (5HT
Identifiants
pubmed: 32346078
doi: 10.1038/s41409-020-0909-2
pii: 10.1038/s41409-020-0909-2
pmc: PMC7588339
doi:
Substances chimiques
Drug Combinations
0
Isoquinolines
0
Pyridines
0
Quinuclidines
0
Dexamethasone
7S5I7G3JQL
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2114-2120Références
Trigg ME, Higa GM. Chemotherapy-induced nausea and vomiting: antiemetic trials that impacted clinical practice. J Oncol Pharm Pr. 2010;16:233–44.
doi: 10.1177/1078155209354655
Walton SM. Advances in use of the 5-HT3 receptor antagonists. Expert Opin Pharmacother. 2000;1:207–23.
doi: 10.1517/14656566.1.2.207
Miguel R. Controlling chemotherapy-induced and postoperative nausea and vomiting. Cancer Control. 1999;6:393–7.
doi: 10.1177/107327489900600416
Morrow GR, Roscoe JA, Kirshner JJ, Hynes HE, Rosenbluth RJ. Anticipatory nausea and vomiting in the era of 5-HT3 antiemetics. Support Care Cancer. 1998;6:244–7.
doi: 10.1007/s005200050161
Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA, et al. Antiemetics: American Society of Clinical Oncology Clinical Practice guideline update. J Clin Oncol. 2017;35:3240–61.
doi: 10.1200/JCO.2017.74.4789
Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E, et al. 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:v119–33.
doi: 10.1093/annonc/mdw270
Lorusso V. Management of chemotherapy-induced nausea and vomiting by risk profile: role of netupitant/palonosetron. Ther Clin Risk Manag. 2016;12:917–25.
doi: 10.2147/TCRM.S89215
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Antiemesis Version 1.2019. 2019. https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf .
Miller RC, Galvan M, Gittos MW, van Giersbergen PL, Moser PC, Fozard JR. Pharmacological properties of dolasetron, a potent and selective antagonist at 5HT3 receptors. Drug Dev Res. 1993;28:87–93.
doi: 10.1002/ddr.430280111
Hutt AJ, Tan SC. Drug chirality and its clinical significance. Drug. 1996;52:1–12.
doi: 10.2165/00003495-199600525-00003
Gregory RE, Ettinger DS. 5HT3 receptors antagonists for the prevention of chemotherapy-induced nausea and vomiting. A comparison of their pharmacology and clinical efficacy. Drugs. 1998;55:173–89.
doi: 10.2165/00003495-199855020-00002
Navari RM. Palonosetron for the treatment of chemotherapy-induced nausea and vomiting. Expert Opin Pharmacother. 2014;15:2599–608.
doi: 10.1517/14656566.2014.972366
Reddy GK, Gralla RJ, Hesketh PJ. Novel neurokinin-1 antagonists as antiemetics for the treatment of chemotherapy-induced emesis. Support Cancer Ther. 2006;3:140–2.
doi: 10.3816/SCT.2006.n.011
Rizzi A, Campi B, Camarda V, Molinari S, Cantoreggi S, Regoli D, et al. In vitro and in vivo pharmacological characterization of the novel NK
doi: 10.1016/j.peptides.2012.06.010
Aapro M, Rugo H, Rossi G, Rizzi G, Borroni ME, Bondarenko I, et al. 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;25:1328–33.
doi: 10.1093/annonc/mdu101
Hesketh PJ, Rossi G, Rizzi G, Palmas M, Alyasova A, Bondarenko I, et al. 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;25:1340–6.
doi: 10.1093/annonc/mdu110
Gralla RJ, Bosnjak SM, Hontsa A, Balser C, Rizzi G, Rossi G, et al. 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;25:1333–9.
doi: 10.1093/annonc/mdu096
Stiff PJ, Fox-Geiman MP, Kiley K, Rychlik K, Parthasarathy M, Fletcher-Gonzalez D, et al. Prevention of nausea and vomiting associated with stem cell transplant: results of a prospective, randomized trial of aprepitant used with highly emetogenic preparative regimens. Biol Blood Marrow Transpl. 2013;19:49–55.
doi: 10.1016/j.bbmt.2012.07.019
Schmitt T, Goldschmidt H, Neben K, Freiberger A, Hüsing J, Gronkowski M, et al. 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;32:3413–20.
doi: 10.1200/JCO.2013.55.0095
Svanberg A, Birgegård G. Addition of aprepitant (Emend®) to standard antiemetic regimen continued for 7 days after chemotherapy for stem cell transplantation provides significant reduction of vomiting. Oncology. 2015;89:31–6.
doi: 10.1159/000371523
Pielichowski W, Barzal J, Gawronski K, Mlot B, Oborska S, Wasko-Grabowska A, et al. A triple-drug combination to prevent nausea and vomiting following BEAM chemotherapy before autologous hematopoietic stem cell transplantation. Transpl Proc. 2011;43:3107–10.
doi: 10.1016/j.transproceed.2011.08.010
Chu CC, Hsing CH, Shieh JP, Chien CC, Ho CM, Wang JJ. The cellular mechanisms of the antiemetic action of dexamethasone and related glucocorticoids against vomiting. Eur J Pharm. 2014;722:48–54.
doi: 10.1016/j.ejphar.2013.10.008
Mounier N, Gisselbrecht C. Conditioning regimens before transplantation in patients with aggressive non-Hodgkin’s lymphoma. Ann Oncol. 1998;9 Suppl 1:S15–21.
doi: 10.1093/annonc/9.suppl_1.S15
Shimoni A, Zwas ST. Radioimmunotherapy and autologous stem-cell transplantation in the treatment of B-cell non-Hodgkin lymphoma. Semin Nucl Med. 2016;46:119–25.
doi: 10.1053/j.semnuclmed.2015.10.009
Trigg ME, Inverso DM. Nausea and vomiting with high-dose chemotherapy and stem cell rescue therapy: a review of antiemetic regimens. Bone Marrow Transpl. 2008;42:501–6.
doi: 10.1038/bmt.2008.257
Navari RM. Prevention of emesis from multiple-day and high-dose chemotherapy regimens. J Natl Compr Cancer Netw. 2007;5:51–9.
doi: 10.6004/jnccn.2007.0007
Musso M, Scalone R, Bonanno V. Palonosetron (Aloxi) and dexamethasone for the prevention of acute and delayed nausea and vomiting in patients receiving multiple-day chemotherapy. Support Care Cancer. 2009;17:205–9.
doi: 10.1007/s00520-008-0510-5
Mirabile A, Celio L, Magni M, Bonizzoni E, Gianni AM, Di Nicola M. Evaluation of an every-other-day palonosetron schedule to control emesis in multiple-day high-dose chemotherapy. Future Oncol. 2014;10:2569–78.
doi: 10.2217/fon.14.132
Grunberg SM. Antiemetic activity of corticosteroids in patients receiving cancer chemotherapy: dosing, efficacy, and tolerability analysis. Ann Oncol. 2007;18:233–40.
doi: 10.1093/annonc/mdl347
Vardy J, Pond G, Dodd A, Warr D, Seruga B, Clemons M, et al. A randomized double-blind placebo-controlled cross-over trial of the impact on quality of life of continuing dexamethasone beyond 24 h following adjuvant chemotherapy for breast cancer. Breast Cancer Res Treat. 2012;136:143–51.
doi: 10.1007/s10549-012-2205-3
Di Renzo N, Montanini A, Mannina D, Dondi A, Muci S, Mancuso S, et al. Single-dose palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with aggressive non-Hodgkin’s lymphoma receiving moderately emetogenic chemotherapy containing steroids: results of a phase II study from the Gruppo Italiano per lo Studio dei Linfomi (GISL). Support Care Cancer. 2011;19:1505–10.
doi: 10.1007/s00520-010-0974-y
Choi BS, Borsaru GP, Ballinari G, Voisin D, Di Renzo N. Multicenter phase IV study of palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with non-Hodgkin lymphomas undergoing repeated cycles of moderately emetogenic chemotherapy. Leuk Lymphoma. 2014;55:544–50.
doi: 10.3109/10428194.2013.813498
Eisai Inc. Akynzeo® (netupitant and palonosetron) [prescribing information]. Woodcliff Lake, NJ: Eisai Inc; 2014.