1557P - Use of biosimilar G-CSF for prevention of chemotherapy-induced neutropenia: pooled analysis of clinical usage studies

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Complications of Treatment
Supportive Care
Presenter Pedro Gascon
Authors P. Gascon1, H. Tesch2, K. Verpoort3, M.S. Rosati4, N. Salesi5, H. Barker6, S. Agrawal7, M. Muenzberg8, M. Turner8
  • 1Medical Oncology, Hospital Clinic y Provincial de Barcelona, 08036 - Barcelona/ES
  • 2Bethanien Hospital, DE-60389 - Frankfurt am Main/DE
  • 3Ärzte Für Innere Medizin – Schwerpunkte Hämatologie Und Onkologie, Gemeinschaftspraxis für Hämatologie/Onkologie, Hamburg/DE
  • 4Dept. Oncology A, Policlinico Umberto I, IT-00161 - Roma/IT
  • 5Combined Department Of Medical Oncology, Ospedale di Gaeta “M. Di Liegro”, Gaeta/IT
  • 6Rotherham Hospital, Rotherham NHS Foundation Trust, Rotherham/UK
  • 7Division Of Haemato-oncology, St Bartholomew’s Hospital, London/UK
  • 8Sandoz International Gmbh, Sandoz Biopharmaceuticals, Holzkirchen/DE

Abstract

Introduction

Biosimilar versions of G-CSF have been approved for the prevention of chemotherapy-induced neutropenia since 2008, with approval being based on comparable efficacy, safety and quality with the originator G-CSF. Early clinical experience with biosimilar G-CSF is of interest, given questions initially raised over the use of biosimilars as well as their possible impact on patterns of use. Here we report an analysis of pooled data from five post-approval clinical studies of biosimilar G-CSF.

Methods

Data were pooled from five studies of biosimilar G-CSF (Zarzio®, Sandoz Biopharmaceuticals) for primary or secondary prophylaxis of chemotherapy-induced neutropenia in patients with cancer. These consisted of two large multicentre observational studies plus three small single-centre studies conducted across 12 European countries. All studies were conducted in Europe and reflected real-life clinical use of biosimilar G-CSF. Patients receiving biosimilar G-CSF for interventional treatment were excluded from this analysis.

Results

Data from 1302 patients treated with biosimilar G-CSF were available for analysis. The most frequent types of cancer were breast cancer (n = 541; 42%), lung cancer (n = 212; 16%) and lymphoma/leukaemia (n = 201; 15%). Thirty-six percent of patients had a febrile neutropenia risk of >20% while 39.6% had a risk of 10 − 20% based on chemotherapy regimen. A further 12.1% of patients received biosimilar G-CSF despite a febrile neutropenia risk of <10% (12.4% data unknown or missing). Overall, 2.2% of patients experienced an episode of febrile neutropenia (2.0% of patients with breast cancer) and 8.5% had severe (grade 4) neutropenia (ANC <500 neutrophils /µL) (9.4% with breast cancer). Any disturbances to chemotherapy regimens are currently being analysed.

Conclusions

Biosimilar G-CSF appears to be effective for the prevention of chemotherapy-induced neutropenia. Occurrence of severe or febrile neutropenia was similar to that observed in studies of the originator G-CSF in clinical practice. The increased affordability of biosimilar G-CSF may encourage physicians to more closely adhere to clinical guideline recommendations, including increased use of G-CSF use as primary prophylaxis.

Disclosure

P. Gascon: Membership on an advisory board for Sandoz Biopharmaceuticals.

H. Tesch: Participation in an advisory board for Sandoz Biopharmaceuticals. Investigator in study funded by Hexal AG.

K. Verpoort: Received funding for research study from Sandoz Biopharmaceuticals.

H. Barker: Participation in an advisory board for Sandoz Biopharmaceuticals.

S. Agrawal: Participation in an advisory board for Sandoz Biopharmaceuticals.

M. Muenzberg: Employee of Sandoz Biopharmaceuticals.

M. Turner: Employee of Sandoz Biopharmaceuticals.

All other authors have declared no conflicts of interest.