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. 2021 Feb;16(1):50-58.
doi: 10.1159/000506622. Epub 2020 Apr 6.

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

Rachel Wuerstlein  1   2 , Nadia Harbeck  1   2 , Eva-Maria Grischke  3 , Dirk Forstmeyer  4 , Raquel von Schumann  5 , Petra Krabisch  6 , Kerstin Lüdtke-Heckenkamp  7 , Andrea Stefek  8 , Oliver Stoetzer  9 , Andrea Grafe  10 , Gabriele Kaltenecker  11 , Helmut Forstbauer  12 , Doris Augustin  13 , Iris Schrader  14 , Joke Tio  15 , Ulrike Nitz  2   5 , Oleg Gluz  2   5   16 , Ronald E Kates  2 , Monika Karla Graeser  2   5
Affiliations

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

Rachel Wuerstlein et al. Breast Care (Basel). 2021 Feb.

Abstract

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.

Keywords: Breast cancer; Chemotherapy; Febrile neutropenia prophylaxis; Lipegfilgrastim.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Consort diagram. The ITT and PP sets consisted of 248 and 194 patients, respectively; 222 patients and 26 patients received primary and secondary prophylaxis, respectively, in the ITT set, and 171 patients and 23 patients received primary and secondary prophylaxis, respectively, in the PP set.
See this image and copyright information in PMC

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