title: 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.
abstract: 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.
authors.affiliation: Division of Medical Oncology, Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Spain.
authors.forename: Pere
authors.initials: P
authors.lastname: Gascón
authors.forename: Matti
authors.initials: M
authors.lastname: Aapro
authors.forename: Heinz
authors.initials: H
authors.lastname: Ludwig
authors.forename: Nadia
authors.initials: N
authors.lastname: Rosencher
authors.forename: Matthew
authors.initials: M
authors.lastname: Turner
authors.forename: MinKyoung
authors.initials: M
authors.lastname: Song
authors.forename: Karen
authors.initials: K
authors.lastname: MacDonald
authors.forename: Christopher
authors.initials: C
authors.lastname: Lee
authors.forename: Michael
authors.initials: M
authors.lastname: Muenzberg
authors.forename: Ivo
authors.initials: I
authors.lastname: Abraham
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D016568:Drugs, Generic / Q000009:adverse effects / Q000627:therapeutic use; D016021:Epidemiologic Studies; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D009503:Neutropenia / Q000139:chemically induced / Q000150:complications / Q000517:prevention & control* / Q000628:therapy; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D016568:Drugs, Generic; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim