Prophylaxis with lipegfilgrastim in patients with primary breast cancer receiving dose dense chemotherapy: Results from the German NIS NADENS

Abstract

Abstract 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). 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. Luftner: 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. Junemann: Full / Part-time employment: Teva GmbH. M. Tolg: Honoraria (institution), CRO for reported study: Teva GmbH. U. Kohler: Advisory / Consultancy: Teva GmbH.