PMID- 30347466
OWN - NLM
STAT- MEDLINE
DCOM- 20190425
LR  - 20190425
IS  - 1600-0609 (Electronic)
IS  - 0902-4441 (Linking)
VI  - 102
IP  - 2
DP  - 2019 Feb
TI  - Prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia with 
      lipegfilgrastim in patients with non-Hodgkin lymphoma (NADIR study).
PG  - 174-181
LID - 10.1111/ejh.13189 [doi]
AB  - OBJECTIVE: The prospective non-interventional study (NIS) NADIR was designed to 
      evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim 
      (Lonquex((R)) ), a glycopegylated granulocyte colony-stimulating factor, in cancer 
      patients with different tumor entities undergoing chemotherapy in routine 
      clinical practice. The primary objective was incidence of severe neutropenia, 
      febrile neutropenia (FN), and neutropenia-associated complications. METHOD: NADIR 
      was a national, multicenter, prospective NIS. RESULTS: Here, we present the data 
      on patients with non-Hodgkin lymphoma (NHL). Final analysis comprised 337 NHL 
      patients having received >/=1 administration of lipegfilgrastim. Primary 
      prophylaxis with lipegfilgrastim was documented in 78.7% of patients with high 
      risk to develop FN. In total, >/=1 severe neutropenia (grade 3/4) was reported in 
      115 (34.1%) patients and >/=1 event of FN documented in 15 (4.5%) patients. Grade 
      3/4 infections were reported in 22 (6.5%) patients overall. Most frequently 
      reported adverse events (AEs) related to lipegfilgrastim in total were bone pain 
      (5.4%), leukocytosis (2.1%), back pain (1.8%), platelet count decreased (1.2%), 
      and myalgia (1.2%). Fatal serious AEs were documented in 9 (2.7%) patients; none 
      were attributable to lipegfilgrastim. CONCLUSION: Prophylaxis or therapeutic 
      intention with lipegfilgrastim in NHL patients in routine clinical practice 
      showed similar effectiveness and safety as demonstrated in the pivotal trials.
CI  - (c) 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
FAU - Wolff, Thomas
AU  - Wolff T
AD  - Outpatient Center for Oncology Lerchenfeld, Hamburg, Germany.
FAU - Schulz, Holger
AU  - Schulz H
AD  - Outpatient Center for Internal Oncology and Hematology, Frechen, Germany.
FAU - Losem, Christoph
AU  - Losem C
AD  - Outpatient Center for Hematology and Oncology, Neuss, Germany.
FAU - Reichert, Dietmar
AU  - Reichert D
AD  - Outpatient Center for Oncology, Westerstede, Germany.
FAU - Hurtz, Hans-Jurgen
AU  - Hurtz HJ
AD  - Outpatient Center for Internal Medicine, Hematology, Oncology and 
      Gastroenterology, Halle, Germany.
FAU - Sandner, Reiner
AU  - Sandner R
AD  - Outpatient Center for Internal Medicine, Oncology and Internal Hematology, 
      Passau, Germany.
FAU - Harde, Johanna
AU  - Harde J
AD  - iOMEDICO AG, Freiburg, Germany.
FAU - Grebhardt, Sina
AU  - Grebhardt S
AD  - iOMEDICO AG, Freiburg, Germany.
FAU - Potthoff, Karin
AU  - Potthoff K
AUID- ORCID: 0000-0003-1015-9624
AD  - iOMEDICO AG, Freiburg, Germany.
FAU - Mueller, Udo
AU  - Mueller U
AD  - TEVA GmbH, Ulm, Germany.
FAU - Fietz, Thomas
AU  - Fietz T
AD  - Outpatient Center for Hematology, Oncology and Gastroenterology, Singen, Germany.
LA  - eng
GR  - TEVA GmbH, Germany/
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20181123
PL  - England
TA  - Eur J Haematol
JT  - European journal of haematology
JID - 8703985
RN  - 3A58010674 (pegfilgrastim)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - PVI5M0M1GW (Filgrastim)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse effects/therapeutic use
MH  - Chemotherapy-Induced Febrile Neutropenia/diagnosis/*prevention & control
MH  - Comorbidity
MH  - Febrile Neutropenia/diagnosis/*etiology/*prevention & control
MH  - Female
MH  - Filgrastim/administration & dosage/*therapeutic use
MH  - Humans
MH  - Incidence
MH  - Lymphoma, Non-Hodgkin/*complications/diagnosis/drug therapy
MH  - Male
MH  - Middle Aged
MH  - Polyethylene Glycols/administration & dosage/*therapeutic use
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - chemotherapy-induced febrile neutropenia
OT  - granulocyte colony-stimulating factor
OT  - lipegfilgrastim
OT  - non-Hodgkin lymphoma
OT  - primary prophylaxis
OT  - routine clinical practice
EDAT- 2018/10/23 06:00
MHDA- 2019/04/26 06:00
CRDT- 2018/10/23 06:00
PHST- 2018/04/03 00:00 [received]
PHST- 2018/05/29 00:00 [revised]
PHST- 2018/05/30 00:00 [accepted]
PHST- 2018/10/23 06:00 [pubmed]
PHST- 2019/04/26 06:00 [medline]
PHST- 2018/10/23 06:00 [entrez]
AID - 10.1111/ejh.13189 [doi]
PST - ppublish
SO  - Eur J Haematol. 2019 Feb;102(2):174-181. doi: 10.1111/ejh.13189. Epub 2018 Nov 
      23.