Update on the MONITOR-GCSF study of biosimilar filgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia in cancer patients: Protocol amendments

Pere Gascón, Matti Aapro, Heinz Ludwig, Nadia Rosencher, M. Boccadoro, Matthew Turner, Karen MacDonald, Michael Muenzberg, Ivo Abraham

Research output: Contribution to journalComment/debatepeer-review

13 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 biosimilar filgrastim in the prophylaxis of febrile neutropenia in chemotherapy-treated cancer patients. The background and methodology of this study are described in an article published concurrently in this journal. As important amendments have been made to the protocol, and the purpose of the prior article was to serve as a resource for future referencing, we detail these amendments in this present article: explicit statement about the use of biosimilar filgrastim for both primary and secondary prophylaxis of chemotherapy-induced febrile neutropenia in the objectives and methodology of the study; length of observation; the addition of stage III and stage IV ovarian cancer and multiple myeloma to the tumor types studied; and the deletion of dose dense chemotherapy regimens as an exclusion criterion.

Original languageEnglish (US)
Pages (from-to)198-200
Number of pages3
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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