Universität zu Köln

Wuerstlein, Rachel, Harbeck, Nadia, Grischke, Eva-Maria, Forstmeyer, Dirk, von Schumann, Raquel, Krabisch, Petra, Ludtke-Heckenkamp, Kerstin, Stefek, Andrea, Stoetzer, Oliver, Grafe, Andrea, Kaltenecker, Gabriele, Forstbauer, Helmut, Augustin, Doris, Schrader, Iris, Tio, Joke, Nitz, Ulrike, Gluz, Oleg, Kates, Ronald E. and Graeser, Monika Karla (2021). Protroca: A Noninterventional Study on Prophylactic Lipegfilgrastim against Chemotherapy-Induced Neutropenia in Nonselected Breast Cancer Patients. Breast Care, 16 (1). S. 50 - 59. BASEL: KARGER. ISSN 1661-3805

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Abstract

Background: Protroca evaluated the efficacy and safety of primary and secondary prophylaxis of neutropenia with lipegfilgrastim (Lonquex (R)) in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy (CT). Patients and 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: Nine patients of the ITT set receiving lipegfilgrastim as primary prophylaxis (n = 222) had febrile neutropenia of grade 3-4 (5 patients) or infection of grade 3-4 (4 patients); 1/26 of those receiving secondary prophylaxis had an event. Dose reductions were performed in 9.5% of the patients. Postponement of cancer CT cycles for >3 days occurred in <15% of patients; 10.8% (92/851 AEs) and 8% (2/25 SAEs) of documented adverse events and serious adverse events, respectively, were related to lipegfilgrastim. Conclusions: Application of lipegfilgrastim was effective as primary and secondary prophylaxis in the prevention of CT-induced neutropenia in breast cancer.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Wuerstlein, Rachel UNSPECIFIED UNSPECIFIED UNSPECIFIED Harbeck, Nadia UNSPECIFIED UNSPECIFIED UNSPECIFIED Grischke, Eva-Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED Forstmeyer, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED von Schumann, Raquel UNSPECIFIED UNSPECIFIED UNSPECIFIED Krabisch, Petra UNSPECIFIED UNSPECIFIED UNSPECIFIED Ludtke-Heckenkamp, Kerstin UNSPECIFIED UNSPECIFIED UNSPECIFIED Stefek, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Stoetzer, Oliver UNSPECIFIED UNSPECIFIED UNSPECIFIED Grafe, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaltenecker, Gabriele UNSPECIFIED UNSPECIFIED UNSPECIFIED Forstbauer, Helmut UNSPECIFIED UNSPECIFIED UNSPECIFIED Augustin, Doris UNSPECIFIED UNSPECIFIED UNSPECIFIED Schrader, Iris UNSPECIFIED UNSPECIFIED UNSPECIFIED Tio, Joke UNSPECIFIED UNSPECIFIED UNSPECIFIED Nitz, Ulrike UNSPECIFIED UNSPECIFIED UNSPECIFIED Gluz, Oleg UNSPECIFIED UNSPECIFIED UNSPECIFIED Kates, Ronald E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Graeser, Monika Karla UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-601258
DOI:	10.1159/000506622
Journal or Publication Title:	Breast Care
Volume:	16
Number:	1
Page Range:	S. 50 - 59
Date:	2021
Publisher:	KARGER
Place of Publication:	BASEL
ISSN:	1661-3805
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Oncology; Obstetrics & Gynecology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60125