TY - JOUR
T1 - Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim
AU - Gascón, Pere
AU - Aapro, Matti
AU - Ludwig, Heinz
AU - Rosencher, Nadia
AU - Turner, Matthew
AU - Song, Min Kyoung
AU - MacDonald, Karen
AU - Lee, Christopher
AU - Muenzberg, Michael
AU - Abraham, Ivo
PY - 2011/3
Y1 - 2011/3
N2 - The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the use of Zarzio® in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. Driven by a novel, integrated, multi-focal framework for post-approval observational studies, it examines determinants of response at both the patient and the physician level; integrates statistical methodologies from the social and behavioral sciences; assesses factors predictive of poor treatment response; and evaluates the congruence of treatment with EORTC guidelines and the approved label. This pan-European study will recruit at least 1000 patients from a minimum of 75 centers and follow them for maximum 6 cycles of chemotherapy. Apart from descriptive and associative procedures, statistical analysis will include variance attribution methods; hierarchical linear, logistic, and Poisson modeling; Kaplan-Meier time-to-event analysis, Mantel-Cox log-rank or generalized Wilcoxon-Breslow tests, and Cox proportional hazards modeling; and clustering and related data mining techniques.
AB - The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the use of Zarzio® in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. Driven by a novel, integrated, multi-focal framework for post-approval observational studies, it examines determinants of response at both the patient and the physician level; integrates statistical methodologies from the social and behavioral sciences; assesses factors predictive of poor treatment response; and evaluates the congruence of treatment with EORTC guidelines and the approved label. This pan-European study will recruit at least 1000 patients from a minimum of 75 centers and follow them for maximum 6 cycles of chemotherapy. Apart from descriptive and associative procedures, statistical analysis will include variance attribution methods; hierarchical linear, logistic, and Poisson modeling; Kaplan-Meier time-to-event analysis, Mantel-Cox log-rank or generalized Wilcoxon-Breslow tests, and Cox proportional hazards modeling; and clustering and related data mining techniques.
KW - Biosimilars
KW - Chemotherapy-induced neutropenia
KW - Febrile neutropenia
KW - Granulocyte-colony stimulating factor
KW - Pharmacoepidemiology
KW - Prophylaxis
UR - http://www.scopus.com/inward/record.url?scp=79952172080&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79952172080&partnerID=8YFLogxK
U2 - 10.1016/j.critrevonc.2010.01.014
DO - 10.1016/j.critrevonc.2010.01.014
M3 - Review article
C2 - 20189821
AN - SCOPUS:79952172080
SN - 1040-8428
VL - 77
SP - 184
EP - 197
JO - Critical Reviews in Oncology/Hematology
JF - Critical Reviews in Oncology/Hematology
IS - 3
ER -