Open AccessProtroca: A Noninterventional Study on Prophylactic Lipegfilgrastim against Chemotherapy-Induced Neutropenia in Nonselected Breast Cancer Patients
Author(s) -
Rachel Wuerstlein,
Nadia Harbeck,
EvaMaria Grischke,
Dirk Forstmeyer,
Raquel von Schumann,
Petra Krabisch,
Kerstin Lüdtke-Heckenkamp,
Andrea Stefek,
Oliver J. Stoetzer,
A Gräfe,
Gabriele Kaltenecker,
Helmut Forstbauer,
D Augustin,
Iris Schrader,
Joke Tio,
Ulrike Nitz,
Oleg Gluz,
Ronald Kates,
Monika Graeser
Publication year - 2020
Publication title -
breast care
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.767
H-Index - 30
eISSN - 1661-3805
pISSN - 1661-3791
DOI - 10.1159/000506622
Subject(s) - medicine , neutropenia , adverse effect , febrile neutropenia , breast cancer , chemotherapy , surgery , adjuvant , cancer
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: 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.