Treatment patterns and outcomes in patients with non-small cell lung cancer receiving biosimilar filgrastim for prophylaxis of chemotherapy-induced/febrile neutropaenia: Results from the MONITOR-GCSF study

Eur J Cancer Care (Engl). 2019 Jul;28(4):e13034. doi: 10.1111/ecc.13034. Epub 2019 Apr 10.

Abstract

Objective: Real-world evidence data on the use of granulocyte colony-stimulating factor (G-CSF) in patients with non-small cell lung cancer (NSCLC) are limited. MONITOR-GCSF is a pan-European, multicentre, prospective, non-interventional study designed to describe patient characteristics, treatment patterns and clinical outcomes in patients receiving biosimilar filgrastim in the prophylaxis of chemotherapy-induced neutropaenia (CIN) and febrile neutropaenia (FN).

Methods: In this subanalysis, patient characteristics, treatment patterns, and outcomes are described for 345 patients with stage 3 or 4 NSCLC, receiving up to six chemotherapy cycles. Patients were treated with biosimilar filgrastim as per their treating physician's best judgement.

Results: CIN (any grade) occurred in 13.6% of patients in Cycle 1 and in 36.5% of patients in all cycles. FN occurred in 1.4% of patients in Cycle 1 and in 5.2% of patients in all cycles. Grade 3-4 FN occurred in 1.2% of patients in Cycle 1 and in 3.8% of patients in all cycles.

Conclusion: Results show that in real-life practice in patients with NSCLC, biosimilar filgrastim has similar effectiveness and safety to the known effectiveness and safety profile of reference filgrastim, supporting the use of biosimilar filgrastim for the real-world treatment of neutropaenia in patients with NSCLC.

Keywords: biosimilar; filgrastim; granulocyte colony-stimulating factor; non-small cell lung cancer; real world.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Arthralgia / chemically induced
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Chemotherapy-Induced Febrile Neutropenia / prevention & control*
  • Cough / chemically induced
  • Drug Substitution
  • Female
  • Filgrastim / therapeutic use*
  • Gastroenteritis / chemically induced
  • Hematologic Agents / therapeutic use*
  • Humans
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology
  • Male
  • Middle Aged
  • Myalgia / chemically induced
  • Pain / chemically induced
  • Treatment Outcome

Substances

  • Hematologic Agents
  • Filgrastim

Grant support