Protroca: A Noninterventional Study on Prophylactic Lipegfilgrastim against Chemotherapy-Induced Neutropenia in Nonselected Breast Cancer Patients.
Breast cancer
Chemotherapy
Febrile neutropenia prophylaxis
Lipegfilgrastim
Journal
Breast care (Basel, Switzerland)
ISSN: 1661-3791
Titre abrégé: Breast Care (Basel)
Pays: Switzerland
ID NLM: 101254060
Informations de publication
Date de publication:
Feb 2021
Feb 2021
Historique:
received:
20
09
2019
accepted:
18
02
2020
entrez:
15
3
2021
pubmed:
16
3
2021
medline:
16
3
2021
Statut:
ppublish
Résumé
Protroca evaluated the efficacy and safety of primary and secondary prophylaxis of neutropenia with lipegfilgrastim (Lonquex®) in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy (CT). Of the 255 patients enrolled, 248 patients were evaluable for the intent-to-treat (ITT) and 194 patients for the per-protocol set. Primary and secondary end points after lipegfilgrastim treatment were assessed. Nine patients of the ITT set receiving lipegfilgrastim as primary prophylaxis ( Application of lipegfilgrastim was effective as primary and secondary prophylaxis in the prevention of CT-induced neutropenia in breast cancer.
Sections du résumé
BACKGROUND
BACKGROUND
Protroca evaluated the efficacy and safety of primary and secondary prophylaxis of neutropenia with lipegfilgrastim (Lonquex®) in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy (CT).
PATIENTS AND METHODS
METHODS
Of the 255 patients enrolled, 248 patients were evaluable for the intent-to-treat (ITT) and 194 patients for the per-protocol set. Primary and secondary end points after lipegfilgrastim treatment were assessed.
RESULTS
RESULTS
Nine patients of the ITT set receiving lipegfilgrastim as primary prophylaxis (
CONCLUSIONS
CONCLUSIONS
Application of lipegfilgrastim was effective as primary and secondary prophylaxis in the prevention of CT-induced neutropenia in breast cancer.
Identifiants
pubmed: 33716632
doi: 10.1159/000506622
pii: brc-0016-0050
pmc: PMC7923841
doi:
Types de publication
Journal Article
Langues
eng
Pagination
50-58Informations de copyright
Copyright © 2020 by S. Karger AG, Basel.
Déclaration de conflit d'intérêts
Rachel Wuerstlein received personal fees/travel support from Agendia, Amgen, Astra Zeneca, Boehringer Ingelheim, Carl Zeiss, Celgene, Daiichi-Sankyo, Esai, Genomic Health, Glaxo Smith Kline, Hexal, Lilly, MSD, Mundipharma, NanoString Technologies, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, PumaBiotechnology, Riemser, Roche, Sandoz/Hexal, Seattle Genetics, Tesaro Bio, and Teva. Nadia Harbeck received personal fees (lectures and/or consulting) and research funding from Amgen, Celgene, Genomic Health, NanoString Technologies, Novartis, Pfizer, Roche, AstraZeneca, Hexal, Roche/Genentech, Sandoz, and Boehringer Ingelheim (Inst). Ulrike Nitz received personal fees from Genomic Health and Roche. Oleg Gluz received personal fees/travel support from Genomic Health, NanoString Technologies, Roche, Celgene, and Teva. Eva-Maria Grischke received personal fees from Roche. Dirk Forstmeyer received personal fees (speaker's bureau and consulting) from Pfizer, Novartis, Roche, and MSD.
Références
J Clin Oncol. 2013 Sep 10;31(26):3197-204
pubmed: 23940225
J Natl Compr Canc Netw. 2008 Feb;6(2):109-18
pubmed: 18319047
Oncologist. 2007 Apr;12(4):484-94
pubmed: 17470691
Biologics. 2016 Jan 22;10:1-8
pubmed: 26858523
Cancer. 2003 Dec 1;98(11):2402-9
pubmed: 14635075
Breast Cancer Res Treat. 2014 Nov;148(1):107-16
pubmed: 25261291
Oncol Res Treat. 2015;38(5):221-9
pubmed: 25966769
Support Care Cancer. 2015 Feb;23(2):525-45
pubmed: 25284721
J Support Oncol. 2005 Nov-Dec;3(6 Suppl 4):24-5
pubmed: 16355556
Springerplus. 2015 Jul 03;4:316
pubmed: 26155455
BMC Cancer. 2013 Aug 14;13:386
pubmed: 23945072
Cancer. 2006 May 15;106(10):2258-66
pubmed: 16575919
J Oncol Pharm Pract. 2018 Sep;24(6):412-423
pubmed: 28614980
Support Cancer Ther. 2003 Oct 1;1(1):23-35
pubmed: 18628128
J Natl Compr Canc Netw. 2009 Jan;7(1):99-108
pubmed: 19176210