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

Pere Gascón, Matti Aapro, Heinz Ludwig, Nadia Rosencher, Matthew Turner, Min Kyoung Song, Karen MacDonald, Christopher Lee, Michael Muenzberg, Ivo Abraham

Research output: Contribution to journalReview article

21 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)184-197
Number of pages14
JournalCritical Reviews in Oncology/Hematology
Volume77
Issue number3
DOIs
StatePublished - Mar 1 2011

Keywords

  • Biosimilars
  • Chemotherapy-induced neutropenia
  • Febrile neutropenia
  • Granulocyte-colony stimulating factor
  • Pharmacoepidemiology
  • Prophylaxis

ASJC Scopus subject areas

  • Hematology
  • Oncology

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