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, MinKyoung Song, Karen MacDonald, Christopher Lee, Michael Muenzberg, Ivo Abraham

Research output: Contribution to journalArticle

21 Citations (Scopus)

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 2011
Externally publishedYes

Fingerprint

Biosimilar Pharmaceuticals
Febrile Neutropenia
Granulocyte Colony-Stimulating Factor
Epidemiologic Studies
Behavioral Sciences
Drug Therapy
Data Mining
Social Sciences
Observational Studies
Cluster Analysis
Guidelines
Physicians
Therapeutics
Filgrastim
Neoplasms

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Hematology
  • Geriatrics and Gerontology

Cite this

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. / Gascón, Pere; Aapro, Matti; Ludwig, Heinz; Rosencher, Nadia; Turner, Matthew; Song, MinKyoung; MacDonald, Karen; Lee, Christopher; Muenzberg, Michael; Abraham, Ivo.

In: Critical Reviews in Oncology/Hematology, Vol. 77, No. 3, 03.2011, p. 184-197.

Research output: Contribution to journalArticle

Gascón, Pere ; Aapro, Matti ; Ludwig, Heinz ; Rosencher, Nadia ; Turner, Matthew ; Song, MinKyoung ; MacDonald, Karen ; Lee, Christopher ; Muenzberg, Michael ; Abraham, Ivo. / 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. In: Critical Reviews in Oncology/Hematology. 2011 ; Vol. 77, No. 3. pp. 184-197.
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