Evidence map›Paper›PMID 26111956›Full record

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

Comparison of effectiveness of biosimilar filgrastim (Nivestim™), reference Amgen filgrastim and pegfilgrastim in febrile neutropenia primary prevention in breast cancer patients treated with neo(adjuvant) TAC: a non-interventional cohort study.

M Brito, S Esteves, R André, M Isidoro, A Moreira

Abstract readComparative Study
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. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 19% 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019
    Review
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

M BritoMedical Oncology Department, Instituto Português de Oncologia Francisco Gentil, Rua Prof. Lima Basto, 1099-023, Lisbon, Portugal. margarida.brito@gmail.com.ORCID http://orcid.org/0000-0002-6104-5902
S EstevesClinical Research Unit, Instituto Português de Oncologia Francisco Gentil, Lisbon, Portugal.
R AndréMedical Oncology Department, Instituto Português de Oncologia Francisco Gentil, Rua Prof. Lima Basto, 1099-023, Lisbon, Portugal.
M IsidoroPharmacy Department, Instituto Português de Oncologia Francisco Gentil, Lisbon, Portugal.
A MoreiraMedical Oncology Department, Instituto Português de Oncologia Francisco Gentil, Rua Prof. Lima Basto, 1099-023, Lisbon, Portugal.
Instituto Português de Oncologia de Coimbra Francisco Gentil · PTInstituto Português de Oncologia Francisco Gentil · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeBiosimilars are supported by limited clinical data at the time of approval. Recently, Nivestim™, a biosimilar of reference of filgrastim, was approved for prevention of chemotherapy-related febrile neutropenia (FN). To add clinical experience to this new biosimilar, we performed a study to compare the effectiveness of Nivestim™ with reference filgrastim and pegfilgrastim in FN prevention in patients receiving high-risk FN chemotherapy.

methodsThis is a comparative cohort study, with retrospective data collection. Three cohorts were identified according to the type of primary prophylaxis employed over different time periods: reference filgrastim (2004-2006), pegfilgrastim (2007-2008) and biosimilar filgrastim (2011-2012). The study included female patients with early breast cancer that received FN primary prophylaxis during (neo)adjuvant docetaxel/doxorubicin/cyclophosphamide (TAC).

resultsReference filgrastim cohort included 147 patients and pegfilgrastim and biosimilar filgrastim cohorts 139 and 134 patients, respectively. FN rates per patient/cycle were 16 % (95 % confidence interval (CI) 10.2-22.5 %)/3 % (95 % CI 2.1-4.7 %) in the reference filgrastim group, 9 % (95 % CI 4.5-14.6 %)/2 % (95 % CI 1.3-3.6 %) in the pegfilgrastim group and 16 % (95 % CI 10.0-22.9 %)/4 % (95 % CI 2.5-5.3 %) in the biosimilar filgrastim cohort. The median absolute neutrophil count (ANC) at FN presentation was lower in the biosimilar group in comparison with reference filgrastim. FN episodes with ANC < 100 cells/μL were more frequent in the biosimilar group (50 %) when compared with reference filgrastim (4 %) and pegfilgrastim (6 %). No differences concerning FN complications were seen, with the exception of more chemotherapy delays in the biosimilar group when compared with pegfilgrastim.

conclusionNo differences in biosimilar effectiveness were detected. The clinical relevance of the profound neutropenia found in the biosimilar cohort needs further attention.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsBiosimilar PharmaceuticalsBreast NeoplasmsCohort StudiesCyclophosphamideDocetaxelDoxorubicinFebrile NeutropeniaFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansMiddle AgedNeoadjuvant TherapyPolyethylene GlycolsBiosimilar PharmaceuticalsCyclophosphamideDocetaxelDoxorubicinFilgrastimGranulocyte Colony-Stimulating FactorpegfilgrastimPolyethylene GlycolsRecombinant ProteinsTaxoidsBreast cancerFebrile neutropeniaFilgrastimG-CSF biosimilar

Identifiers

PMID26111956
OpenAlexW857367169

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.