Efficacy and safety of netupitant/palonosetron combination (NEPA) in preventing nausea and vomiting in non-Hodgkin's lymphoma patients undergoing to chemomobilization before autologous stem cell transplantation.

Antiemetics / adverse effects Antineoplastic Agents / adverse effects Drug Therapy, Combination / adverse effects Hematopoietic Stem Cell Transplantation Humans Lymphoma, Non-Hodgkin / drug therapy Nausea / chemically induced Palonosetron / adverse effects Transplantation, Autologous Treatment Outcome Vomiting / chemically induced

ASCT CINV Multiday chemotherapy NEPA Netupitant Palonosetron

Journal

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

ISSN: 1433-7339

Titre abrégé: Support Care Cancer

Pays: Germany

ID NLM: 9302957

Informations de publication

Date de publication:
Feb 2022

Historique:

received: 26 02 2021

accepted: 09 08 2021

pubmed: 18 9 2021

medline: 7 1 2022

entrez: 17 9 2021

Statut: ppublish

Résumé

Prevention of chemotherapy-induced nausea and vomiting (CINV) is particularly challenging for patients receiving highly emetogenic preparative regimens before autologous stem cell transplantation (ASCT) due to the daily and continuous emetogenic stimulus of the multiple day chemotherapy. While studies have shown effective prevention of CINV during the conditioning phase with NK This multicenter, open-label, phase IIa study evaluated the efficacy of every-other-day dosing of NEPA administered during chemomobilization in patients with relapsed-refractory aggressive non-Hodgkin's lymphoma. Eighty-one patients participated. Response rates were 77.8% for complete response (no emesis and no rescue use), 72.8% for complete control (complete response and no more than mild nausea), 86.4% for no emesis, and 82.7% for no rescue use during the overall phase (duration of chemomobilization through 48 h after). NEPA was well tolerated with no treatment-related adverse events reported. NEPA, administered with a simplified every-other-day schedule, show to be very effective in preventing CINV in patients at high risk of CINV undergoing to chemomobilization of hematopoietic stem cells prior to ASCT.

Identifiants

DOI: 10.1007/s00520-021-06495-0 PMID: 34533630 PMC: PMC8727426

pubmed: 34533630

doi: 10.1007/s00520-021-06495-0

pii: 10.1007/s00520-021-06495-0

pmc: PMC8727426

doi:

Substances chimiques

Antiemetics 0

Antineoplastic Agents 0

Palonosetron 5D06587D6R

netupitant 7732P08TIR

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

Pagination

1521-1527

Informations de copyright

Références

Giralt S, Costa L, Schriber J, Dipersio J, Maziarz R, McCarty J et al (2014) Optimizing autologous stem cell mobilization strategies to improve patient outcomes: consensus guidelines and recommendations. Biol Bone Marrow Transplant 20:295–308

doi: 10.1016/j.bbmt.2013.10.013

Tendas A, Niscola P, Perrotti A, Dentamaro T, de Fabritiis P, Arcese W (2015) Chemotherapy induced nausea and vomiting in bone marrow transplant: the unmet need. Support Care Cancer 23(8):2211

doi: 10.1007/s00520-015-2711-z

Tendas A, Sollazzo F, Bruno A, Cupelli L, Niscola P, Pignatelli AC et al (2012) Obstacles to managing chemotherapy-induced nausea and vomiting in high-dose chemotherapy with stem cell transplant. Support Care Cancer 20(5):891–892

doi: 10.1007/s00520-012-1411-1

Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA et al (2020) Antiemetics: ASCO Guideline Update. J Clin Oncol 38(24):2782–2797

doi: 10.1200/JCO.20.01296

Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E et al (2016) 2019 Updates 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 27:v119–v133

doi: 10.1093/annonc/mdw270

Stiff PJ, Fox-Geiman MP, Kiley K, Rychlik K, Parthasarathy M, Fletcher-Gonzalez D et al (2013) 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 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 (2014) 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 32:3413–3420

doi: 10.1200/JCO.2013.55.0095

Svanberg A, Birgegård G (2015) Addition of aprepitant (Emend®) to standard antiemetic regimen continued for 7 days after chemotherapy for stem cell transplantation provides significant reduction of vomiting. Oncology 89:31–36

doi: 10.1159/000371523

Spinelli T, Calcagnile S, Giuliano C, Rossi G, Lanzarotti C, Mair S, Stevens L, Nisbet I (2014) Netupitant PET imaging and ADME studies in humans. J Clin Pharmacol 54(1):97–108. https://doi.org/10.1002/jcph.198

doi: 10.1002/jcph.198 pubmed: 24122871

Rojas C, Slusher BS (2012) Pharmacological mechanism of 5-HT3 and tachykinin NK-1 receptor antagonism to prevent chemotherapy-induced nausea and vomiting. Eur J Pharmacol 684:1–7

doi: 10.1016/j.ejphar.2012.01.046

Stathis M, Pietra C, Rojas C et al (2012) Inhibition of substance P-mediated responses in NG108-15 cells by netupitant and palonosetron exhibit synergistic effects. Eur J Pharmacol 689(1–3):25–30

doi: 10.1016/j.ejphar.2012.05.037

Hesketh PJ, Rossi G, Rizzi G, Palmas M, Alyasova A, Bondarenko I et al (2014) Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapyinduced nausea and vomiting following highly emetogenic chemotherapy: a randomized dose-ranging pivotal study. Ann Oncol 25:1340–1346

doi: 10.1093/annonc/mdu110

Aapro M, Rugo H, Rossi G, Rizzi G, Borroni ME, Bondarenko I et al (2014) 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 25:1328–1333

doi: 10.1093/annonc/mdu101

Di Renzo N, Musso M, Scimè R, Cupri A, Perrone T, De Risi C et al (2020) 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. https://doi.org/10.1038/s41409-020-0909-2

doi: 10.1038/s41409-020-0909-2 pubmed: 32346078 pmcid: 7588339

Di Renzo N, Montanini A, Mannina D, Dondi A, Muci S, Mancuso S et al (2011) 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 19(10):1505–1510. https://doi.org/10.1007/s00520-010-0974-y

doi: 10.1007/s00520-010-0974-y pubmed: 20694798

Choi BS, Borsaru GP, Ballinari G, Voisin D, Di Renzo N (2014) 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 55(3):544–550. https://doi.org/10.3109/10428194.2013.813498

doi: 10.3109/10428194.2013.813498 pubmed: 23772665

Tendas A, Marchesi F, Mengarelli A, Annibali O, Tomarchio V, Saltarelli D et al (2019) Prevention of chemotherapy-induced nausea and vomiting after high-dose melphalan and stem cell transplantation: review of the evidence and suggestions. Support Care Cancer 27(3):793–803. https://doi.org/10.1007/s00520-018-4594-2

doi: 10.1007/s00520-018-4594-2 pubmed: 30564934

Clemmons AB, Orr J, Andrick B, Gandhi A, Sportes C, DeRemer D (2018) 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 24(10):2065–2071. https://doi.org/10.1016/j.bbmt.2018.06.005

Trigg ME, Inverso DM (2008) Nausea and vomiting with high-dose chemotherapy and stem cell rescue therapy: a review of antiemetic regimens. Bone Marrow Transpl 42:501–506

doi: 10.1038/bmt.2008.257

Navari RM (2007) Prevention of emesis from multiple-day and high-dose chemotherapy regimens. J Natl Compr Cancer Netw 5:51–59

doi: 10.6004/jnccn.2007.0007