• Breast Care · Feb 2021

    Protroca: A Noninterventional Study on Prophylactic Lipegfilgrastim against Chemotherapy-Induced Neutropenia in Nonselected Breast Cancer Patients.

    • Rachel Wuerstlein, Nadia Harbeck, Eva-Maria Grischke, Dirk Forstmeyer, Raquel von Schumann, Petra Krabisch, Kerstin Lüdtke-Heckenkamp, Andrea Stefek, Oliver Stoetzer, Andrea Grafe, Gabriele Kaltenecker, Helmut Forstbauer, Doris Augustin, Iris Schrader, Joke Tio, Ulrike Nitz, Oleg Gluz, Ronald E Kates, and Monika Karla Graeser.
    • Breast Center and CCC Munich, Department of Obstetrics and Gynecology, University of Munich (LMU), Munich, Germany.
    • Breast Care. 2021 Feb 1; 16 (1): 50-58.

    BackgroundProtroca 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 MethodsOf 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.ResultsNine 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.ConclusionsApplication of lipegfilgrastim was effective as primary and secondary prophylaxis in the prevention of CT-induced neutropenia in breast cancer.Copyright © 2020 by S. Karger AG, Basel.

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