Incidence of febrile neutropenia and myelotoxicity of chemotherapy: a meta-analysis of biosimilar G-CSF studies in breast cancer, lung cancer, and non-Hodgkin's lymphoma.
BACKGROUND
The aim of this meta-analysis of 3 clinical studies, conducted with breast cancer, lung cancer, and non-Hodgkin's lymphoma patients, was to compare a new granulocyte colony-stimulating factor (G-CSF) biosimilar, XM02, with filgrastim in terms of its prophylactic effect on the development of febrile neutropenia (FN) during the first chemotherapy cycle in relation to the myelotoxic potency of the applied chemotherapy regimen.


METHODS
Overall, 608 patients (363 under XM02 and 245 under filgrastim) were included in the meta-analysis. The majority of patients were allocated to the chemotherapy categories docetaxel-doxorubicin (45.4%) and cyclophosphamide-hydroxy daunomycin (adriamycin)-oncovin (vincristine)-prednisolone (CHOP)/platinum(Pt)-vinorelbine or Pt-vinblastine/ Pt-etoposide (43.1%); another 11.5% were allocated to the category Pt-gemcitabine/Pt-docetaxel or Pt-paclitaxel.


RESULTS
FN in the XM02 and filgrastim groups was reported for 12.1 and 12.5% of patients, respectively, under docetaxeldoxorubicin, for 13.5 and 11.9% under CHOP/Pt-vinorelbine or Pt-vinblastine/Pt-etoposide, and for 15.6 and 12.0% under Pt-gemcitabine/Pt-docetaxel or Pt-paclitaxel.


CONCLUSIONS
The incidence of FN in the first cycle of chemotherapy under primary G-CSF prophylaxis is low (in the range of 12-16%) and not directly correlated with the myelotoxic potency of the applied chemotherapy regimen. XM02 demonstrated to be non-inferior to filgrastim regarding the incidence of FN, irrespective of the myelotoxicity of the chemotherapy regimen.
Engert
Andreas
A
Klinik I für Innere Medizin, Klinikum der Universität zu Köln, Cologne, Germany. a.engert@uni-koeln.de
del Giglio
Auro
A
Bias
Peter
P
Lubenau
Heinz
H
Gatzemeier
Ulrich
U
Heigener
David
D
D015897:Comorbidity; D005334:Fever / Q000453:epidemiology*; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D009369:Neoplasms / Q000188:drug therapy* / Q000453:epidemiology*; D009503:Neutropenia / Q000453:epidemiology*; D018570:Risk Assessment; D012307:Risk Factors; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
D016179:Granulocyte Colony-Stimulating Factor