Abstract
BackgroundThe ZOHé study was a prospective, non-interventional, multicentre study in France to assess the use of biosimilar filgrastim Zarzio® (Sandoz filgrastim) in routine clinical practice in patients at risk of neutropenia-inducing chemotherapy (CT).MethodsPatients ≥ 18 years undergoing CT for a malignant disease and with a first prescription for Zarzio® were enrolled in two cohorts according to tumour type: solid tumour or haematological malignancy; results from the solid tumour cohort are reported here. Analyses primarily described the prescription and use of Zarzio® in current practice, and also included identification of factors linked to prescription for primary prophylaxis and comparison of Zarzio® use in relation to European Organisation for Research and Treatment of Cancer (EORTC) guidelines.ResultsResponses were obtained from 125 physicians and 1179 patients with solid tumours, allowing robust statistical analysis of the data. Use of Zarzio® in clinical practice was relatively standardised and followed label indication. The patient profile was in line with EORTC guidelines for granulocyte colony-stimulating factor (G-CSF) febrile neutropenia (FN) prophylaxis, and the majority of patients had ≥ 1 EORTC factor(s) for increased risk of febrile neutropenia. Some patients (10.8%) received Zarzio® despite receiving CT regimens categorised in guidelines as low (< 10%) FN risk (‘over prophylaxis’). Nearly half of patients’ CT regimens did not have a recommended FN risk category. Zarzio® was commonly initiated as primary prophylaxis; initiation in Cycle ≥ 2 of the current line of CT was associated more with a history of neutropenia. The safety profile of Zarzio® was confirmed.ConclusionsUse of Zarzio® in routine clinical practice is generally in line with EORTC guidelines for prophylaxis of CT-induced neutropenia. Patient-related risk factors appear to be a stronger driver of clinicians’ decision to initiate Zarzio® than CT risk category for FN. The intrinsic risk of FN associated with a specific CT protocol is often miscategorised by physicians. In contrast to earlier reports of underuse of G-CSF prophylaxis, over prophylaxis is observed in a small subgroup of patients with FN risk of < 10%.
Highlights
The ZOHé study was a prospective, non-interventional, multicentre study in France to assess the use of biosimilar filgrastim Zarzio® (Sandoz filgrastim) in routine clinical practice in patients at risk of neutropeniainducing chemotherapy (CT)
Given that biosimilar granulocyte colony-stimulating factor (G-CSF) for treating CT-induced neutropenia are well established in Europe, the ZOHé study aimed to investigate how the biosimilar filgrastim Zarzio® is currently used in routine clinical practice by haematologists and oncologists in France
This study provides an insight into the treatment patterns with filgrastim, it does not address whether these changing patterns of use of G-CSF relate to the biosimilar per se or changing patterns of G-CSF use in general
Summary
The ZOHé study was a prospective, non-interventional, multicentre study in France to assess the use of biosimilar filgrastim Zarzio® (Sandoz filgrastim) in routine clinical practice in patients at risk of neutropeniainducing chemotherapy (CT). Regulatory approval is based on the totality of evidence for quality, safety and efficacy data demonstrating that there are no clinically meaningful differences between the reference molecule and the biosimilar (European Medicines Agency Guideline on similar biological medical products [14]). Benefits of G-CSF biosimilars over the original molecule are mainly cost reductions, as equivalent clinical safety and efficacy, as part of the totality of evidence, was demonstrated in pharmacodynamic studies and confirmed by observational data [15, 16]. Having confirmed bioequivalence in phase I and phase III studies [17, 18], the biosimilar Sandoz filgrastim was approved in February 2009 for the same indications as the reference product (Neupogen®) [19, 20], including myelosuppressive CT-induced neutropenia [17], and marketed under the name Zarzio® in Europe. Zarzio® was the first biosimilar to receive marketing approval in the USA, in March 2015, under the name Zarxio® [24]
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