NADIR: A Non-Interventional Study on the Prophylaxis of Chemotherapy-Induced Neutropenia Using Lipegfilgrastim - First Interim Analysis.
Oncol Res Treat
; 38(5): 221-9, 2015.
Article
in En
| MEDLINE
| ID: mdl-25966769
ABSTRACT
BACKGROUND:
The non-interventional study (NIS) NADIR was designed to assess the effectiveness and safety of lipegfilgrastim, a novel glycopegylated granulocyte-colony stimulating factor, in reducing the risk of both febrile and severe neutropenia.METHODS:
Here, the interim analysis of NIS Nadir performed under real-world conditions at 80 oncology practices across Germany is reported. For a patient to be included, lipegfilgrastim at a subcutaneous single dose of 6 mg had to be administered during at least 1 cycle of the chemotherapy under consideration.RESULTS:
The interim analysis included 224 patients. Median patient age was 61.1 years (interquartile range 51.2-70.2 years). Main tumor type was breast cancer followed by lung cancer, and non-Hodgkin's lymphoma (46.0, 13.4, and 10.7%, respectively). When lipegfilgrastim was given as primary prophylaxis, no patient developed febrile neutropenia (FN). 1.3% of patients developed FN when primary prophylaxis was withheld. Only 68.6% of patients undergoing chemotherapy and at high risk (> 20%) of developing FN were treated with lipegfilgrastim during the first cycle, exposing disparity between real-world practices and current treatment guidelines. Lipegfilgrastim was well tolerated. The only grade 3/4 treatment-related adverse event was anemia in 1 patient.CONCLUSION:
Lipegfilgrastim was effective and safe when administered for the prevention of chemotherapy-induced neutropenia under real-world conditions.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Granulocyte Colony-Stimulating Factor
/
Chemotherapy-Induced Febrile Neutropenia
Type of study:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Observational_studies
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Oncol Res Treat
Year:
2015
Document type:
Article
Affiliation country:
Germany
Publication country:
CH
/
SUIZA
/
SUÍÇA
/
SWITZERLAND