1555P - Biosimilar filgrastim initiation in patients enrolled in the monitor G-CSF observational study relative to EORTC guidelines

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Supportive Care
Presenter Matti Aapro
Authors M.S. Aapro1, P. Gascon2, H. Ludwig3, C. Bokemeyer4, M. Boccadoro5, M. Turner6, M. Muenzberg6, K. Denhaerynck7, I. Abraham7, K. Macdonald7
  • 1Institut Multidisciplinaire D’oncologie, Clinique de Genolier, 1272 - Genolier/CH
  • 2Medical Oncology, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 31st Department Of Medicine, Wilhelminenspital, 1171 - Wien/AT
  • 4Dept. Hemato/oncology, UKE II. Medizinische Klinik und PoliklinikMedizinische Klinik II., 20246 - Hamburg-Eppendorf/DE
  • 5Section Of Hematology, Università degli studi di Torino, Torino/IT
  • 6Sandoz International Gmbh, Sandoz Biopharmaceuticals, Holzkirchen/DE
  • 7Matrix 45, Matrix 45, Tucson/US

Abstract

Introduction

MONITOR G-CSF is a prospective observational study of practice patterns and outcomes for prophylaxis of chemotherapy-induced febrile neutropenia (FN) with biosimilar filgrastim (Zarzio®, Sandoz Biopharmaceuticals).

Methods

This analysis describes treatment initiation with biosimilar filgrastim in the 788 patients enrolled to date (target 1500) in the MONITOR G-CSF study relative to the 2010 EORTC G-CSF guidelines. Patients were enrolled at 134 centres (199 open) across 12 European countries.

Results

In this mainly female (62%) and older (61.6 ± 11.9 years) cohort with predominately solid tumours (79%), FN risk based on chemotherapy (CT) regimen was <10% in 18%, 10-20% in 43% and >20% in 39% of patients. All patients with <10% FN risk had ≥1, 95% had ≥2 and 74% had ≥3 other risk factors. Biosimilar filgrastim was initiated as primary prophylaxis in 70% of patients, at 24-72 hours (51%) or days 5-8 (30%) after CT and typically (45%) for 5 days. Table 1 summarizes biosimilar filgrastim therapy by tumour type and CT toxicity. Table 2 presents other risk factors on CT regimens with 10-20% FN risk. Table 1.

All patients

Prophylaxis (%) Initiation (%) Duration (%)
Primary Secondary 24-72 h Days 5-8 3 days 5 days
Tumour type:OncologyHaematology 7070 3030 5624 3056 1611 4247
CT toxicity: > 20%10-20% < 10% 767456 242644 534954 293225 131315 443941
Table 2.

FN risk 10-20%

Prophylaxis (%)
Patient-related risk factors Primary Secondary
Age >65 years 79 21
Advanced disease (Stage IV) 74 26
History of prior FN 29 71
No antibiotic prophylaxis 73 24
Poor performance (ECOG >2) 83 17
Female 76 24
Hb <12 g/dl 70 30
Liver, renal or CV disease 72 28
One or more risks 74 26

Conclusions

Variability exists in biosimilar filgrastim initiation by tumour type (day of initiation), CT toxicity and patient-related risk. About a quarter of patients with FN risk >20% or 10-20% in combination with other risk factors did not receive primary prophylaxis as recommended. The trend to initiate filgrastim in regimens with <10% risk maybe indicative of changing practice trends to optimise patient well-being and minimise FN risk but needs to be further evaluated. The relationship between EORTC guideline congruence and clinical outcomes will be evaluated in future analyses.

Disclosure

M.S. Aapro: Member of the steering committee for Sandoz Biopharmaceuticals supported study.

P. Gascon: Member of the steering committee for Sandoz Biopharmaceuticals supported study.

H. Ludwig: Member of the steering committee for Sandoz Biopharmaceuticals supported study. On Speakers Bureau and advisory board for Amgen.

C. Bokemeyer: Member of the steering committee for Sandoz Biopharmaceuticals supported study.

M. Boccadoro: Member of the steering committee for Sandoz Biopharmaceuticals supported study.

M. Turner: Employee of Sandoz Biopharmaceuticals.

M. Muenzberg: Employee of Sandoz Biopharmaceuticals.

K. Denhaerynck: Employee of Matrix 45.

I. Abraham: Employee of Matrix 45.

K. Macdonald: Employee of Matrix 45.