Evidence map›Paper›PMID 26306517›Full record

ArticleSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study).

Pere Gascón, Matti Aapro, Heinz Ludwig, Carsten Bokemeyer, Mario Boccadoro, Matthew Turner, Kris Denhaerynck, Karen MacDonald, Ivo Abraham

Erratum issuedOpen access · bronzeAbstract read
PubMed Publisher
In one paragraph

Article in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
4.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 66 citations in OpenAlex.

  1. Trial
  2. Article
  3. Effectiveness and safety of pegylated filgrastim (Pelgraz®) for the prevention of febrile neutropenia during cancer chemotherapy in all-day practice in Germany.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Observational
  4. Article
  5. Review
  6. Patterns of primary prophylactic granulocyte colony-stimulating factor use in older Medicare patients with cancer receiving myelosuppressive chemotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  7. Review
  8. Article
  9. Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020
    Review
  10. Risk assessment of febrile neutropenia and evaluation of G-CSF use in patients with cancer: a real-life study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Article
  11. Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019
    Review
  12. Filgrastim prophylaxis in elderly cancer patients in the real-life setting: a French multicenter observational study, the TULIP study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Observational
  13. Article
  14. Article
  15. Article
  16. Article
  17. Observational
  18. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 6 countries.

Pere GascónDivision of Medical Oncology, Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.
Matti AaproInstitut Multidisciplinaire d'Oncologie, Clinique de Genolier, Genolier, Switzerland.
Heinz LudwigMedizinische Abteilung I-Onkologie und Haematologie, Wilhelminenspital, Wien, Austria.
Carsten BokemeyerUniversitaetsklinikum Hamburg Eppendorf, Hamburg, Germany.
Mario BoccadoroDipartimento di Oncologia e Ematologia, Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino, Torino, Italy.
Matthew TurnerSandoz Biopharmaceuticals, Holzkirchen, Germany.
Kris DenhaerynckMatrix45, Tucson, AZ, USA.
Karen MacDonaldMatrix45, Tucson, AZ, USA.
Ivo AbrahamMatrix45, Tucson, AZ, USA. abraham@pharmacy.arizona.edu.
Matrix Research (United States) · USAzienda Ospedaliero Universitaria San Giovanni Battista · ITClinique de Genolier · CHEppendorf (Germany) · DEHospital Clínic de Barcelona · ESWilhelminen Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe purpose of this study is to examine the real-world treatment patterns and outcomes of chemotherapy-induced (febrile) neutropenia (chemotherapy-induced (CIN)/febrile neutropenia (FN)) prophylaxis with biosimilar filgrastim (Zarzio®).

methodsMONITOR-GCSF is an international (12 countries), multi-center (140), prospective (max. six cycles), observational, open-label, pharmaco-epidemiologic study of cancer patients (n = 1447) treated with myelosuppressive chemotherapy across a total of 6,213 cycles and receiving prophylaxis with Zarzio®. Data were analyzed using both the patient and cycle as unit of analysis.

resultsMost (72.3 %) received primary prophylaxis; dosed mainly (53.2 %) at 30 MIU but differentiated by weight, chemotoxicity, and tumor type; and mainly (53.2 %) initiated in the 24-72h post-chemotherapy window but differentiated by prophylaxis type, tumor type, and chemotoxicity and for modal/median duration of 5 days. Relative to European Organisation for Research and Treatment of Cancer (EORTC) guidelines, 56.6 % were correctly prophylacted, 17.4 % under-prophylacted, and 26.0 % over-prophylacted. The following incidence rates were recorded: CIN grade 4 13.2 % of patients and 3.9 % of cycles, FN 5.9 % of patients and 1.4 % of cycles, CIN/FN-related hospitalizations 6.1 % of patients and 1.5 % of cycles, CIN/FN-related chemotherapy disturbances 9.5 % of patients and 2.8 % of cycles, and composite outcomes index 22.3 % of patients and 6.7 % of cycles. Rates varied by type of prophylaxis and tumor, chemotoxicity, initiation day, and prophylaxis duration. There were 1834 musculoskeletal events with 24.7 % of patients reporting bone pain of any grade (mostly mild to moderate), and 148 adverse drug reactions, including 4 serious, were recorded in 76 patients.

conclusionsThe clinical and safety outcomes are well within the range of historically reported data for originator filgrastim underscoring the clinical effectiveness and safety of biosimilar filgrastim in daily clinical practice.

Indexed as

AdultAgedBiosimilar PharmaceuticalsChemotherapy-Induced Febrile NeutropeniaFemaleFeverFilgrastimGranulocyte Colony-Stimulating FactorHumansInduction ChemotherapyMaleMiddle AgedNeoplasmsProspective StudiesTreatment OutcomeBiosimilar PharmaceuticalsFilgrastimGranulocyte Colony-Stimulating FactorBiosimilarChemotherapy-induced neutropeniaFebrile neutropeniaFilgrastimGranulocyte colony-stimulating factorProphylaxis

Identifiers

PMID26306517
OpenAlexW1751328374

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.