Abstract 3993
Background
Only limited data are available on the impact of primary prophylactic use of G-CSF in high risk breast cancer (BC) patients (pts) treated with dose dense (dd) chemotherapy (CTx) protocols in standard clinical practice. Lipegfilgrastim (LF) is a glyco-pegylated long-acting G-CSF indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia (FN).
Methods
NADENS was a multi-center, prospective, non-interventional study (NIS) in Germany on the primary prophylactic LF administration for BC pts treated with dd two-weekly CTx. 328 pts were enrolled at 68 sites (27 hospitals with 143 pts, 41 private practices with 185 pts, Safety Set (SAF)). Due to protocol violations 46 pts were excluded from analysis set (282 pts).
Results
Severe neutropenia (SN, grade 3/4) occurred in 131 pts (46.5%) at least once during max. 4 observed cycles. Incidences in cycles 1/2/3/4 were 33.3%/22.1%/22.9%/19.8%, respectively. 6 pts (2.1%) experienced a FN, (incidence per cycle 1.1%/0.4%/1.4%/0.4%). Altogether 275 SN and 9 FN events were documented for the 1,121 observed CTx cycles. CTx had to be modified in 74 pts (26.2%). 96 pts (34.0%) received anti-infectives. 35 pts were hospitalized (12.4%) with 51 single hospitalizations. Reasons included FN (4 events), other neutropenic complications (5) and infections (7). No stay on ICU was reported. AEs were observed for 119 pts (36.3% of SAF, 342 events) and SAEs for 23 pts (7.0%, 30 events). No AE was fatal, 12 AEs (3.6%) were rated as grade 4. 89 AEs (in 61 pts) were classified as probable or possible drug related. For 280 pts (99.3%) treatment with LF was rated as ‘beneficial’ by the treating physician. Tolerability of LF treatment was assessed mostly as ’very good’ (152 pts, 53.9%) or ’good’ (120 pts, 42.6%), ’moderate’ was documented for 8 pts (2.8%), ’bad’ for 2 pts (0.7%).
Conclusions
NADENS provides a realistic picture about the use and efficacy of LF for this defined patient group in daily clinical care in Germany. LF was found to be effective and safe and results fall in the range of those observed in RCTs. No new safety signal was detected. The known limitations of non-interventional studies have to be considered.
Clinical trial identification
XM22-ONC-40115 (BfArM NIS No 7038).
Editorial acknowledgement
Legal entity responsible for the study
Teva GmbH, Ulm, Germany.
Funding
Teva GmbH, Ulm, Germany.
Disclosure
M. Kiechle: Advisory / Consultancy: Teva GmbH. C. Schem: Advisory / Consultancy, Speaker Bureau / Expert testimony: Teva GmbH. D. Lüftner: Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Teva GmbH; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Amgen; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: AstraZeneca; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Celgene; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Lilly; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Loreal; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: MSD; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Mundipharma; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Mylan; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Novartis; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Pfizer; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Roche; Non-remunerated activity/ies, Honoraria for Advisory Board activities and/or oral presentations: Tesaro. X. Hamann: Full / Part-time employment: Teva GmbH. R. Jünemann: Full / Part-time employment: Teva GmbH. M. Tölg: Honoraria (institution), CRO for reported study: Teva GmbH. U. Köhler: Advisory / Consultancy: Teva GmbH.
Resources from the same session
4925 - Prognostic role of CD73 in metastatic Non Small Cell Lung Cancer according to the presence of driver alterations
Presenter: Giulia Galli
Session: Poster Display session 1
Resources:
Abstract
785 - JAK-STAT inhibitor overcomes interferon γ-reduced, NK cell-mediated cytotoxicity in non-small-cell lung cancer cells
Presenter: Riki Okita
Session: Poster Display session 1
Resources:
Abstract
2326 - Low LATS2 expression is associated with poor prognosis in non small cell lung cancer
Presenter: Si-hyong Jang
Session: Poster Display session 1
Resources:
Abstract
5960 - Application of ESCAT and OncoKB scales in Liquid biopsy (LB) in Advanced NSCLC patients (pts): Is it feasible and reliable?
Presenter: Michael McCusker
Session: Poster Display session 1
Resources:
Abstract
4855 - IDH1R132H mutation induces a less aggressive phenotype of glioma cells and affects the radiosensitivity by interacting with Wnt/β-catenin signaling
Presenter: Xuetao Han
Session: Poster Display session 1
Resources:
Abstract
2641 - Impact of Angiopoietin-2 on glioblastoma response to combined chemo-radiotherapy
Presenter: Charly Helaine
Session: Poster Display session 1
Resources:
Abstract
5743 - The Discovery of RNA-aptamers That Selectively Bind and Inhibit Glioblastoma Stem Cells by targeting EphA2
Presenter: Alessandra Affinito
Session: Poster Display session 1
Resources:
Abstract
4160 - Impact of tumor reoxygenation by nanoparticles on Tumor Associated Macrophages (TAMs)
Presenter: Aurélie Ferré
Session: Poster Display session 1
Resources:
Abstract
2474 - Prognostic significance of c-Rel/p50 heterodimer in the tumor microenvironment of uveal melanoma
Presenter: Seema Kashyap
Session: Poster Display session 1
Resources:
Abstract
1769 - Synergistic role of BAP1 and DNA damage response pathway in uveal melanoma and its prognostic significance.
Presenter: JAYANTI JHA
Session: Poster Display session 1
Resources:
Abstract