Exploratory analysis of the effect of a dexamethasone-sparing regimen for prophylaxis of cisplatin-induced emesis on food intake (LUNG-NEPA study).
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
23 01 2023
23 01 2023
Historique:
received:
10
10
2022
accepted:
18
01
2023
entrez:
23
1
2023
pubmed:
24
1
2023
medline:
26
1
2023
Statut:
epublish
Résumé
We demonstrated the non-inferiority of a dexamethasone (DEX)-sparing (single-dose) regimen with NEPA, a netupitant/palonosetron fixed combination, for preventing chemotherapy-induced nausea and vomiting (CINV) caused by cisplatin. This pre-planned exploratory analysis assessed the effect of the DEX-sparing regimen on a patient's food intake. Chemotherapy-naïve patients undergoing cisplatin (≥ 70 mg/m
Identifiants
pubmed: 36690734
doi: 10.1038/s41598-023-28464-9
pii: 10.1038/s41598-023-28464-9
pmc: PMC9870907
doi:
Substances chimiques
Cisplatin
Q20Q21Q62J
Palonosetron
5D06587D6R
Antiemetics
0
Dexamethasone
7S5I7G3JQL
Antineoplastic Agents
0
Banques de données
ClinicalTrials.gov
['NCT04201769']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1257Informations de copyright
© 2023. The Author(s).
Références
Roila, F. 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. 27(suppl 5), v119-133 (2016).
doi: 10.1093/annonc/mdw270
Hesketh, P. J. et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J. Clin. Oncol. 35, 3240–3261 (2017).
doi: 10.1200/JCO.2017.74.4789
Farrell, C., Brearley, S. G., Pilling, M. & Molassiotis, A. The impact of chemotherapy-related nausea on patients’ nutritional status, psychological distress and quality of life. Support. Care Cancer 21, 59–66 (2013).
doi: 10.1007/s00520-012-1493-9
Marx, W., Kiss, N., McCarthy, A. L., McKavanagh, D. & Insering, L. Chemotherapy-induced nausea and vomiting: A narrative review to inform dietetics practice. J. Acad. Nutr. Diet 116, 819–827 (2016).
doi: 10.1016/j.jand.2015.10.020
Aapro, M. et al. The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): The Pan European Emesis Registry (PEER). Ann. Oncol. 23, 1986–1992 (2012).
doi: 10.1093/annonc/mds021
Gilmore, J. W. et al. Antiemetic guideline consistency and incidence of chemotherapy-induced nausea and vomiting in US community oncology practice: INSPIRE study. J. Oncol. Pract. 10, 68–74 (2014).
doi: 10.1200/JOP.2012.000816
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 94, 1011–1015 (2006).
doi: 10.1038/sj.bjc.6603048
Han, H. S. et al. A prospective multicenter study evaluating secondary adrenal suppression after antiemetic dexamethasone therapy in cancer patients receiving chemotherapy: A Korean South West Oncology Group study. Oncologist 20, 1432–1439 (2015).
doi: 10.1634/theoncologist.2015-0211
Nakamura, M. et al. A prospective observational study on effect of short-term periodic steroid premedication on bone metabolism in gastrointestinal cancer (ESPRESSO-01). Oncologist 22, 592–600 (2017).
doi: 10.1634/theoncologist.2016-0308
Jeong, Y. et al. A pilot study evaluating steroid-induced diabetes after antiemetic dexamethasone therapy in chemotherapy-treated cancer patients. Cancer Res. Treat. 48, 1429–1437 (2016).
doi: 10.4143/crt.2015.464
Jordan, K., Jahn, F. & Aapro, M. Recent developments in the prevention of chemotherapy-induced nausea and vomiting (CINV): A comprehensive review. Ann. Oncol. 26, 1081–1090 (2015).
doi: 10.1093/annonc/mdv138
Aapro, M. et al. Double-blind, randomised, controlled study of the efficacy and tolerability of palonosetron plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy. Ann. Oncol. 21, 1083–1088 (2010).
doi: 10.1093/annonc/mdp584
Aapro, M. 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. 25, 1328–1333 (2014).
doi: 10.1093/annonc/mdu101
Celio, L. et al. Impact of dexamethasone-sparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: A meta-analysis of randomised evidence. BMC Cancer 19, 1268 (2019).
doi: 10.1186/s12885-019-6454-y
Ito, Y. et al. Placebo-controlled, double-blind 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. 36, 1000–1006 (2018).
doi: 10.1200/JCO.2017.74.4375
Celio, L., Bonizzoni, E. & Aapro, M. Is the dexamethasone-sparing strategy ready for cisplatin? Too early for an answer. J. Clin. Oncol. 36, 2741–2742 (2018).
doi: 10.1200/JCO.2018.78.8109
Celio, L. et al. Dexamethasone-sparing regimens with oral netupitant and palonosetron for the prevention of emesis caused by high-dose cisplatin: A randomized noninferiority study. Oncologist 26, e1854–e1861 (2021).
doi: 10.1002/onco.13851
Chang, V. T. & Ingham, J. Symptom control. Cancer Invest. 21, 564–578 (2003).
doi: 10.1081/CNV-120022376
Martin, L. et al. Diagnostic criteria for the classification of cancer-associated weight loss. J. Clin. Oncol. 33, 90–99 (2015).
doi: 10.1200/JCO.2014.56.1894
Bauer, J., Capra, S. & Ferguson, M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur. J. Clin. Nutr. 56, 779–785 (2002).
doi: 10.1038/sj.ejcn.1601412
Watanabe, S. M. et al. A multicentre comparison of two numerical versions of the Edmonton Symptom Assessment System in palliative care patients. J. Pain Symptom Manag. 41, 456–468 (2011).
doi: 10.1016/j.jpainsymman.2010.04.020
Moro, C. et al. Edmonton symptom assessment scale: Italian version in two palliative care settings. Support. Care Cancer 14, 30–37 (2006).
doi: 10.1007/s00520-005-0834-3
Caputo, R. et al. 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 20, 232 (2020).
doi: 10.1186/s12885-020-6707-9
Vagnildhaug, O. M. et al. The applicability of a weight loss grading system in cancer cachexia: A longitudinal analysis. J. Cachexia Sarcopenia Muscle 8, 789–797 (2017).
doi: 10.1002/jcsm.12220
Liu, J. et al. Symptom trajectories during chemotherapy in patients with non-small cell lung cancer (NSCLC) and the function of prolonging low dose dexamethasone in promoting enhanced recovery after chemotherapy. Thorac. Cancer 12, 783–795 (2021).
doi: 10.1111/1759-7714.13830
Kris, M. G. et al. Incidence, course, and severity of delayed nausea and vomiting following the administration of high-dose cisplatin. J. Clin. Oncol. 10, 1379–1384 (1985).
doi: 10.1200/JCO.1985.3.10.1379
Molassiotis, A., Farrell, C., Bourne, K., Brearley, S. G. & Pilling, M. An exploratory study to clarify the cluster of symptoms predictive of chemotherapy-related nausea using random forest modeling. J. Pain Symptom Manag. 44, 692–703 (2012).
doi: 10.1016/j.jpainsymman.2011.11.003
Boltong, A. et al. A prospective cohort study of the effects of adjuvant breast cancer chemotherapy on taste function, food liking, appetite and associated nutritional outcomes. PLoS ONE 31, e103512 (2014).
doi: 10.1371/journal.pone.0103512
Celio, L. et al. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: Results from a randomized phase 3 study. BMC Cancer 22, 915 (2022).
doi: 10.1186/s12885-022-10018-3
Hashimoto, H. et al. Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 21, 242–249 (2020).
doi: 10.1016/S1470-2045(19)30678-3
Italian Group for Antiemetic Research. Cisplatin-induced delayed emesis: Pattern and prognostic factors during three subsequent cycles. Ann. Oncol. 5, 585–589 (1994).
doi: 10.1093/oxfordjournals.annonc.a058928