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Poster lunch

1556 - Treatment patterns and outcomes in patients with non-small cell lung cancer (NSCLC) receiving biosimilar filgrastim for prophylaxis of chemotherapy-induced/febrile neutropenia: results from the MONITOR-GCSF study (524P)

Date

18 Nov 2017

Session

Poster lunch

Presenters

Matti Aapro

Citation

Annals of Oncology (2017) 28 (suppl_10): x155-x165. 10.1093/annonc/mdx676

Authors

M. Aapro1, A. Krendyukov2, N. Höbel2, P. Gascón3

Author affiliations

  • 1 Multidisciplinary Oncology Institute, Clinique de Genolier, 1272 - Genolier/CH
  • 2 Hexal Ag, Hexal AG, Holzkirchen/DE
  • 3 Medical Oncology, Hospital Clínic de Barcelona, Barcelona/ES
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Resources

Abstract 1556

Background

Biosimilars offer the potential to increase patient access to biological therapies and improve financial sustainability in oncology treatment.1 The filgrastim biosimilar Zarzio®/Zarxio®/EP2006 (Hexal AG) has been approved in Europe since 2009, and is prescribed according to label and guidelines for the prevention of chemotherapy-induced (CIN) and febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy. However, there is a paucity of data on the real-world use of filgrastim in non-small cell lung cancer (NSCLC). MONITOR-GCSF is an international, multicenter, prospective, observational study performed in 12 European countries. The study was designed to describe patient characteristics, treatment patterns and clinical outcomes in patients receiving biosimilar filgrastim in the prophylaxis of CIN/FN. This analysis evaluates the NSCLC cohort of the MONITOR-GCSF study.

Methods

MONITOR-GCSF enrolled 345 evaluable patients with NSCLC receiving up to 6 chemotherapy cycles. Patients were treated with biosimilar filgrastim as per their treating physician’s best judgement.

Results

At study start patient characteristics were as follows: mean (± SD) age 62.9 (± 8.56) years; mean body weight 72.3 (±14.85) kg; 69.6% of patients were male; 29.3% of patients had stage 3 disease; and 69.9% of patients had stage 4 disease. CIN (any grade) occurred in 13.6% (n = 47) of patients in Cycle 1 and in 36.5% (n = 126) of patients in all cycles. FN occurred in 1.4% (n = 5) of patients in Cycle 1 and in 5.2% (n = 18) of patients in all cycles. Grade 3—4 FN occurred in 1.2% of patients (n = 4) in Cycle 1 and in 3.8% of patients (n = 13) in all cycles.

Conclusions

In real-world practice in patients with NSCLC, biosimilar filgrastim has similar efficacy and safety compared with published data on reference filgrastim. This adds to the evidence base for biosimilar filgrastim and supports its use in the NSCLC population. Reference: 1Tabernero J, et al. ESMO Open 2016;1:e000142.

Clinical trial identification

N/A

Legal entity responsible for the study

Sandoz Biopharmaceuticals

Funding

Sandoz Biopharmaceuticals

Disclosure

M. Aapro: Amgen (honoraria, speakers bureau, expert testimony), Helsinn Healthcare (advisory role, speakers bureau, research funding), Hospira (advisory role, speakers bureau, research funding), Teva (advisory role, speakers bureau), Merck KGaA (advisory role), Merck (advisory role), Sandoz (advisory role, speakers bureau, research funding), Pierre Fabre Medicament (advisory role, speakers bureau, research funding), Vifor Pharma (advisory role, speakers bureau), Tesaro (advisory role, speakers bureau), Novartis (speakers bureau, research funding), Roche (speakers bureau), Johnson & Johnson (speakers bureau). A. Krendyukov, N. Höbel: Hexal AG (employment). P. Gascón: Sandoz (speakers bureau).

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