PMID- 30557099
OWN - NLM
STAT- MEDLINE
DCOM- 20200511
LR  - 20200511
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 35
IP  - 7
DP  - 2019 Jul
TI  - Prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia with 
      lipegfilgrastim in 2489 cancer patients: final results from the 
      non-interventional study NADIR.
PG  - 1127-1138
LID - 10.1080/03007995.2018.1560200 [doi]
AB  - Objectives: The non-interventional study (NIS) NADIR (DRKS00005711) evaluated the 
      effectiveness and safety of prophylaxis with lipegfilgrastim, a glycopegylated 
      granulocyte-colony stimulating factor, in 2500 patients undergoing chemotherapy 
      in routine clinical practice. Primary objective was the incidence of 
      chemotherapy-induced severe neutropenia, febrile neutropenia (FN), and 
      neutropenia-associated complications. Methods: NADIR was a prospective NIS 
      conducted in 201 study centers in Germany. Results: The analysis included 2489 
      patients. Main tumor types were breast cancer (n = 1198, 48.1%), lung cancer 
      (n = 303, 12.2%), non-Hodgkin lymphoma (NHL; n = 337, 13.5%), and prostate cancer 
      (n = 111, 4.5%). Nine hundred and ten (36.6%) patients were aged >/=65 years 
      (regarded as "elderly" patients). Severe neutropenia (CTCAE grade 3/4) was 
      reported in 26.8% (n = 666) and 25.2% (n = 229) of the total population and 
      elderly patients, respectively. FN was documented in 2.7% (n = 68) of the total 
      population vs 3.0% (n = 27) of elderly patients. Primary prophylaxis with 
      lipegfilgrastim among patients with high risk of FN (>20%) was documented in 
      83.5% of the total population and 75.1% of elderly patients. Infections (CTCAE 
      grade 3/4) were documented in 99 patients (4.0%) in the total population vs 47 
      (5.1%) elderly patients. Fatal infections were reported in 14 (0.6%) patients in 
      the total population vs 11 (1.2%) elderly patients. Overall, most frequent 
      lipegfilgrastim-related adverse events (AEs) included bone pain (8.0%), anemia 
      (3.2%), leucocytosis (2.7%), and thrombocytopenia (2.5%). Of the patients, 18.0% 
      had >/=1 documented serious AE; none of the fatal events (2.7%) was 
      lipegfilgrastim-related. Conclusions: Lipegfilgrastim administered to patients 
      with solid tumor/NHL undergoing chemotherapy in routine clinical practice showed 
      similar effectiveness and safety compared to the pivotal trials.
FAU - Fietz, Thomas
AU  - Fietz T
AD  - a Outpatient Center for Hematology, Oncology and Gastroenterology , Singen , 
      Germany.
FAU - Luck, Andreas
AU  - Luck A
AD  - b Outpatient Center for Oncology and Urology , Rostock , Germany.
FAU - Schulz, Holger
AU  - Schulz H
AD  - c Outpatient Center for Internal Oncology and Hematology , Frechen , Germany.
FAU - Harde, Johanna
AU  - Harde J
AD  - d iOMEDICO AG, Departments of Statistics and Clinical Operations, and Medical 
      Department , Freiburg i.Br. , Germany.
FAU - Losem, Christoph
AU  - Losem C
AD  - e Outpatient Center for Hematology and Oncology , Neuss , Germany.
FAU - Grebhardt, Sina
AU  - Grebhardt S
AD  - d iOMEDICO AG, Departments of Statistics and Clinical Operations, and Medical 
      Department , Freiburg i.Br. , Germany.
FAU - Wolff, Thomas
AU  - Wolff T
AD  - f Outpatient Center for Oncology Lerchenfeld , Hamburg , Germany.
FAU - Potthoff, Karin
AU  - Potthoff K
AD  - d iOMEDICO AG, Departments of Statistics and Clinical Operations, and Medical 
      Department , Freiburg i.Br. , Germany.
FAU - Muller, Udo
AU  - Muller U
AD  - g Department of Medical Oncology, TEVA GmbH , Ulm , Germany.
FAU - Zaiss, Matthias
AU  - Zaiss M
AD  - h Outpatient Center for Interdisciplinary Hematology and Oncology , Freiburg 
      i.Br. , Germany.
FAU - Kurbacher, Christian Martin
AU  - Kurbacher CM
AD  - i Gynecology I (gynecological oncology), Gynecological Center Bonn-Friedensplatz 
      , Bonn , Germany.
LA  - eng
SI  - DRKS/DRKS00005711
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190121
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Antineoplastic Agents)
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 Agents/administration & dosage/*adverse effects
MH  - Febrile Neutropenia/*prevention & control
MH  - Female
MH  - Filgrastim/*administration & dosage
MH  - Germany
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Neoplasms/*drug therapy
MH  - Polyethylene Glycols/*administration & dosage
MH  - Primary Prevention
MH  - Prospective Studies
MH  - Young Adult
OTO - NOTNLM
OT  - Lipegfilgrastim
OT  - chemotherapy-induced febrile neutropenia
OT  - granulocyte-colony stimulating factor
OT  - prophylaxis
OT  - routine clinical practice
EDAT- 2018/12/18 06:00
MHDA- 2020/05/12 06:00
CRDT- 2018/12/18 06:00
PHST- 2018/12/18 06:00 [pubmed]
PHST- 2020/05/12 06:00 [medline]
PHST- 2018/12/18 06:00 [entrez]
AID - 10.1080/03007995.2018.1560200 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2019 Jul;35(7):1127-1138. doi: 10.1080/03007995.2018.1560200. 
      Epub 2019 Jan 21.