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Poster display session

2403 - G-CSF and G-CSF biosimilars: a meta-analysis of randomized clinical trials in breast cancer patients


10 Sep 2017


Poster display session


Edoardo Botteri


Annals of Oncology (2017) 28 (suppl_5): v543-v567. 10.1093/annonc/mdx388


E. Botteri1, A. Krendyukov2, G. Curigliano3

Author affiliations

  • 1 Norwegian National Advisory Unit On Women's Health, Oslo University Hosp., 0424 - Oslo/NO
  • 2 Industriestr 25, Hexal AG, Holzkirchen/DE
  • 3 Division Of Experimental Therapeutics, European Institute of Oncology, Milan/IT


Abstract 2403


The granulocyte colony-stimulating factors (G-CSFs) filgrastim and pegfilgrastim are widely used to prevent neutropenia in cancer patients undergoing myelosuppressive chemotherapy. Several G-CSF biosimilars are available, their development involving a step-wise approach including analytical comparison with the reference and iterative process development. Randomized clinical trials (RCTs) have confirmed that the reference product and its biosimilar provide the same clinical efficacy and safety and play pivotal role in the totality of evidence concept. However some heterogeneity exists among the studies. For G-CSF biosimilars, patients with breast cancer (BC) are the most sensitive population in which to confirm similarity. The aim of this meta-analysis was to compare the clinical efficacy of approved or proposed G-CSF biosimilars (filgrastim or pegfilgrastim) with reference G-CSF in patients with BC.


A Medline literature search up to March 2017 identified randomized clinical trials (RCTs) comparing biosimilar G-CSF to reference in BC patients. Primary efficacy endpoint was mean difference in duration of severe neutropenia (DSN). Secondary efficacy measures were differences in depth of absolute neutrophil count (ANC) nadir and time to ANC recovery. Random effect models were fitted to obtain pooled estimates of the mean difference and their corresponding 95% confidence intervals (CIs).


Eight eligible RCTs were included. Overall difference in DSN between reference and biosimilar medicines was not statistically significant (0.06 days [95% CI -0.05, 0.17]) (Table). The secondary efficacy endpoints also showed no significant differences between reference and biosimilars.rnTable:

1572P Mean and mean difference on duration of severe neutropenia* during chemotherapy Cycle 1

rnBiosimilarsReference productsMean difference
Study and year of publicationReference G-CSFBiosimilar G-CSFMeanNo. of patientsMeanNo. of patientsWeightIV, Random, 95% CI
Blackwell 2015FilgrastimFilgrastim1.171071.210714.2%−0.03 [-0.32, 0.26]
Blackwell 2016PegfilgrastimPegfilgrastim1.361551.1915320.2%0.17 [-0.07, 0.41]
Del Giglio 2008FilgrastimFilgrastim1.11401.11366.4%0.00 [-0.43, 0.43]
Harbeck 2016PegfilgrastimPegfilgrastim0.751550.8315528.1%−0.08 [-0.28, 0.12]
Park 2016FilgrastimPegfilgrastim2.28362.08385.6%0.20 [-0.26, 0.66]
Waller 2010FilgrastimFilgrastim1.61651.38513.4%0.30 [0.01, 0.59]
Waller 2016PegfilgrastimPegfilgrastim1.21271.26712.2%0.00 [-0.31, 0.31]
Pooled estimate (95% CI)rnrnrnrn885rn741100%0.06 [-0.05, 0.17]

Heterogeneity:Chi2 = 6.27 (P = 0.39); I2 = 4% *Days with absolute neutrophil count less than 0.5 × 109/L (


This meta-analysis showed no differences in clinical efficacy between biosimilar and reference G-CSF in breast cancer patients.

Clinical trial identification

Legal entity responsible for the study





A. Krendyukov: Employee of Hexal AG G. Curigliano: Honoraria from Pfizer, Roche, Sandoz. All other authors have declared no conflicts of interest.

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