Critical Reviews in Oncology / Hematology
Volume 77, Issue 3 , Pages 184-197 , March 2011

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

      Affiliations

    • Division of Medical Oncology, Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Calle Villarroel 170, 08036 Barcelona, Spain
  • ,
  • Matti Aapro

      Affiliations

    • Institut Multidisciplinaire d’Oncologie, Clinique de Genolier, 1, route du Muids, 1272 Genolier, Switzerland
  • ,
  • Heinz Ludwig

      Affiliations

    • Medizinische Abteilung I – Onkologie und Haematologie, Wilhelminenspital, Montleartstrasse 37, 1160 Wien, Austria
  • ,
  • Nadia Rosencher

      Affiliations

    • Département d’Anesthésiologie et Soins Intensifs, Hôpital Cochin and Université Paris 5 Descartes, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France
  • ,
  • Matthew Turner

      Affiliations

    • Sandoz Biopharmaceuticals, Holzkirchen, Germany
  • ,
  • MinKyoung Song

      Affiliations

    • Matrix45, Earlysville, VA, USA
    • School of Nursing, University of Pennsylvania, 418 Curie Blvd., Philadelphia, PA 19104, USA
  • ,
  • Karen MacDonald

      Affiliations

    • Matrix45, Earlysville, VA, USA
  • ,
  • Christopher Lee

      Affiliations

    • Matrix45, Earlysville, VA, USA
    • Center for Health Outcomes and Pharmacoeconomic Research, The University of Arizona, Tucson, AZ, USA
  • ,
  • Michael Muenzberg

      Affiliations

    • Sandoz Biopharmaceuticals, Holzkirchen, Germany
  • ,
  • Ivo Abraham

      Affiliations

    • Matrix45, Earlysville, VA, USA
    • Center for Health Outcomes and Pharmacoeconomic Research, The University of Arizona, Tucson, AZ, USA
    • Corresponding Author InformationCorresponding author at: Matrix45, 620 Frays Ridge Road, Earlysville, VA 22936, USA. Tel.: +1 434 978 1045; fax: +1 978 945 8374.

,Accepted 27 January 2010.

References 

  1. Lalami Y, Paesmans M, Aoun M, et al. A prospective randomized evaluation of G-CSF or G-CSF plus oral antibiotics in chemotherapy-treated patients at high risk of developing febrile neutropenia. Supportive Care in Cancer. 2004;12:725–730
  2. Lyman GH, Lyman CH, Agboola O. Risk models for predicting chemotherapy-induced neutropenia. The Oncologist. 2005;10:427–437
  3. Kuderer N, Dale D, Crawford J, Cosler L, Lyman G. Impact of primary prophylaxis with granulocyte colony-stimulating factor or febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review. Journal of Clinical Oncology. 2007;25:3158–3167
  4. Calhoun E, Chang CH, Welshman E, Cella D. The impact of chemotherapy delays on quality of life in patients with cancer. Journal of Supportive Oncology. 2004;2:64–65
  5. Wingard JR, Elmongy M. Strategies for minimizing complications of neutropenia: prophylactic myeloid growth factors or antibiotics. Critical Reviews in Oncology and Hematology. 2009;
  6. National Cancer Institute . Cancer therapy evaluation program, common toxicity criteria, version 2.0. 2009;Last accessed 30 November, 2009. Available from URL: http://ctep.info.nih.gov/protocolDevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf
  7. Lalami Y, Paesmans M, Muanza F, et al. Can we predict the duration of chemotherapy-induced neutropenia in febrile neutropenic patients, focusing on regimen-specific risk factors? A retrospective analysis. Annals of Oncology. 2006;17:507–514
  8. Crawford J, Dale D, Lyman GH. Chemotherapy-induced neutropenia. Cancer. 2003;100:228–237
  9. Komorokji R, Lyman G. The colony-stimulating factors: use to prevent and treat neutropenia and its complications. Expert Opinion on Biological Therapies. 2004;4:1897–1910
  10. Aapro M, Cameron D, Pettengell R, et al. EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. European Journal of Cancer. 2006;42:2433–2453
  11. Gridelli C, Aapro M, Barni S, et al. Role of colony stimulating factors (CSFs) in solid tumours: results of an expert panel. Critical Reviews in Oncology and Hematology. 2007;63:53–64
  12. Zielinski C, Awada A, Cameron D, Cufer T, Martin M, Aapro M. The impact of new European Organisation for Research and Treatment of Cancer guidelines on the use of granulocyte colony-stimulating factor on the management of breast cancer patients. European Journal of Cancer. 2008;44:353–365
  13. Raposo CG, Marin AP, Barón MG. Colony-stimulating factors: clinical evidence for treatment and prophylaxis of chemotherapy-induced febrile neutropenia. Clinical Translational Oncology. 2006;8:729–734
  14. Crawford J, Ozer H, Stoller R, et al. Reduction in granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. New England Journal of Medicine. 1991;325:164–170
  15. Trillet-Lenoir V, Green J, Manegold C, et al. Recombinant granulocyte colony-stimulating factor reduces the infectious complications of cytotoxic chemotherapy. European Journal of Cancer. 2006;29A:319–324
  16. Mangi MH, Newland AC. Febrile neutropenia: prophylactic and therapeutic use of GM-CSF. European Journal of Cancer. 2000;35:4–7
  17. Morrison V, Wong M, Hershman D, Campos L, Ding B, Malin J. Observational study of the prevalence of febrile neutropenia in patients who received filgrastim or pegfilgrastim associated with 3–4 week chemotherapy regimens in community oncology practices. Journal of Managed Care Pharmacy. 2007;13:337–348
  18. Smith T, Khatcheressian J, Lyman G, et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. Journal of Clinical Oncology. 2006;24:3187–3205
  19. Lyman GH. Guidelines of the National Comprehensive Cancer Network on the use of myeloid growth factors with cancer chemotherapy: a review of evidence. Journal of the National Comprehensive Cancer Network. 2005;3:557–571
  20. Greil R, Jost LM. ESMO recommendations for the application of hematopoietic growth factors. Annals of Oncology. 2005;16(Suppl. 1):80–82
  21. Klastersky J, Awada A, Aoun M, Paesmans M. Should the indications for the use of myeloid growth factors for the prevention of febrile neutropenia in cancer patients be extended?. Current Opinion in Oncology. 2009;21:297–302
  22. Aapro M, MacDonald K, Van Erps J, et al. Managing cancer-related anemia in congruence with the EORTC guidelines is an independent predictor of haemoglobin outcome: initial evidence from the RESPOND study. European Journal of Cancer. 2009;45:8–11
  23. Last accessed, 30 November, 2009. http://www.emea.europa.eu/humandocs/Humans/EPAR/zarzio/zarzio.htm.
  24. Gascón P, Fuhr U, Sörgel F, et al. Development of a new G-CSF product based on biosimilarity assessment. Annals of Oncology. 2009;
  25. Pettengell R, Bosly A, Szucs T, et al. Multivariate analysis of febrile neutropenia occurrence in patients with non-Hodgkins lymphoma: data from the INC-EU prospective observational European neutropenia study. British Journal of Haematology. 2008;144:677–685
  26. Hsieh FY, Lavori PW. Sample-size calculations for the Cox proportional hazards regression model with nonbinary covariates. Controlled Clinical Trials. 2000;21:552–560
  27. Machin D, Campbell M, Fayers P, Pinol A. Sample size tables for clinical studies. 2nd ed.. Malden, MA: Blackwell Science; 1997;
  28. Nesselroade JR, Salthouse TA. Methodological and theoretical implications of intra-individual variability in perceptual-motor performance. Journal of Gerontology: Psychological Science. 2004;59B:49–55
  29. Geller NL, Pocock SJ. Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners. Biometrics. 1987;43:213–223
  30. Schulz KF, Grimes DA. Multiplicity in randomised trials II: subgroup and interim analyses. The Lancet. 2005;365:1657–1661

PII: S1040-8428(10)00029-6

doi: 10.1016/j.critrevonc.2010.01.014

Critical Reviews in Oncology / Hematology
Volume 77, Issue 3 , Pages 184-197 , March 2011