WSG (West German Study Group)-Protroca evaluated the efficacy and safety of primary and secondary prophylaxis (ppx) of neutropenia with lipegfilgrastim (Lonquex®) in breast cancer (BC) patients (pts) receiving neo-adjuvant or adjuvant treatment in routine praxis.
Eligibility: histologically confirmed BC pts, age ≥18 years, prior or concurrent neo-adjuvant or adjuvant treatment with dose-dense chemotherapy (CT), or with moderate risk CT with risk factors (age >65 years, severe co-morbidities). Primary endpoint: occurrence rate of febrile neutropenia (FN) and/or severe infection (SI) (grade 3–4). Secondary endpoints: dose reductions of further CT or cycle postponement of CT after start of Lonquex® treatment, adverse events (AEs) and serious adverse events (SAEs) related to Lonquex® according to NCI-CTCAE Version 4.0. 47.3% (15.4%) and 38.7% (69.2%) of pts with primary (secondary) ppx received anthracycline (A)-containing dose-dense and A-containing conventionally dense regimen, respectively.
Of the 255 enrolled pts (2015–2017), 248 pts were evaluable for the intent to treat (ITT) set (222 and 26 pts with primary and secondary ppx, respectively). 5 pts of the ITT set receiving Lonquex® as primary ppx had FN grade 3–4 (2.3%). Regarding SI, 5 pts of the ITT population (2.0%) had an infection of grade 3–4; 4 pts got primary ppx (1.8%) and one received secondary ppx (3.9%). Dose reductions were only performed in 9.5% of pts (all of them receiving primary ppx). Postponement of CT cycles for >3 days was observed in 14.4% and 11.5% of pts with Lonquex® as primary and secondary ppx, respectively. 67.6% (84.6%) and 6.3% (11.5%) of ITT pts with primary (secondary) ppx exhibited AEs and SAEs, respectively. 10.8% (92/851 AEs) and 8% (2/25 SAEs of 851 AEs) of documented AEs and SAEs, respectively, were related to Lonquex®.
In WSG-Protroca, the application of Lonquex® was effective as primary and secondary ppx in the prevention of CT-induced neutropenia. Observed adverse drug reactions and AEs were in line with the Lonquex® summary of product characteristics and CT, respectively; no new toxicities were identified.
West German Study Group (WSG).
Teva Biotech GmbH.
R. Wuerstlein: Agendia, Amgen, AZ, BI, Carl Zeiss, Celgene, Daiichi-Sankyo, Esai, GE, GSK, Hexal, Lilly, MSD, Mundipharma, NanoString, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, Puma Biotechnology, Riemser, Roche, Sandoz, Seattle Genetics, Tesaro Bio, Teva. N. Harbeck: Honoraria for consulting: Amgen, Hexal. U. Nitz: Honoraria: Genomic Health, Roche. O. Gluz: Honoraria: Genomic Health, NanoString Technologies, Roche; Travel, accommodations, expenses: Celgene; Teva. All other authors have declared no conflicts of interest.