Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study)

Abstract

Purpose The purpose of this study is to examine the realworld treatment patterns and outcomes of chemotherapyinduced (febrile) neutropenia (chemotherapy-induced (CIN)/ febrile neutropenia (FN)) prophylaxis with biosimilar filgrastim (Zarzio®). Methods MONITOR-GCSF is an international (12 countries), multi-center (140), prospective (max. six cycles), observational, open-label, pharmaco-epidemiologic study of cancer patients (n=1447) treated with myelosuppressive chemotherapy across a total of 6,213 cycles and receiving prophylaxis with Zarzio®. Data were analyzed using both the patient and cycle as unit of analysis. Results Most (72.3 %) received primary prophylaxis; dosed mainly (53.2 %) at 30 MIU but differentiated by weight, chemotoxicity, and tumor type; and mainly (53.2 %) initiated in the 24-72h post-chemotherapy window but differentiated by prophylaxis type, tumor type, and chemotoxicity and for modal/median duration of 5 days. Relative to European Organisation for Research and Treatment of Cancer (EORTC) guidelines, 56.6 % were correctly prophylacted, 17.4 % under-prophylacted, and 26.0 % over-prophylacted. The following incidence rates were recorded: CIN grade 4 13.2 % of patients and 3.9 % of cycles, FN 5.9 % of patients and 1.4 % of cycles, CIN/FN-related hospitalizations 6.1 % of patients and 1.5 % of cycles, CIN/FN-related chemotherapy disturbances 9.5 % of patients and 2.8 % of cycles, and composite outcomes index 22.3 % of patients and 6.7 % of cycles. Rates varied by type of prophylaxis and tumor, chemotoxicity, initiation day, and prophylaxis duration. There were 1834

Predictive modeling of the outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (MONITOR-GCSF study)

“…The MONITOR-GCSF study evaluated the ‘real-world’ treatment patterns, outcomes, and associated determinants of Zarzio ® prophylaxis in patients with stage 3 or 4 solid or hematological malignancies receiving myelosuppressive chemotherapy and at risk for CIN/FN [13–15] using the 2010 updated European Organisation for Research and Treatment of Cancer (EORTC) guidelines for the use of GCSF in the prophylaxis of CIN/FN as framework [2]. …”

Revisão sistemática e análise de custo-minimização de lipegfilgrastim na profilaxia da neutropenia e da neutropenia febril relacionadas à quimioterapia citotóxica

“…No entanto, essa 50 J Número de ciclos (Cooper et al, 2011) -2.449,00 -4.898,00 -38.268,94 -76.537,87 Taxa de sala* -3.673,50 -3.673,50 -38.383,40 -57.403,40 Tempo de tratamento com Filgrastim (dias) (Cooper et al, 2011, Gascon et al, 2016 Desconto (Lipegfilgrastim)** -3.673,50 -6.119,06 -57.403,40 -59.848,97 Desconto ( Tabela 8. Variação de parâmetros na análise de sensibilidade determinística…”

“…Os parâmetros variados foram a estimativa de taxa de sala para administração da droga, o número de ciclos (Cooper et al, 2011), a estimativa de desconto do preço dos comparadores e o tempo de tratamento com filgrastim (Cooper et al, 2011, Gascon et al, 2016.…”

“…Em outro estudo observacional, Gáscon et al, 2016, avaliaram prospectivamente o padrão de tempo e desfechos de profilaxia de neutropenia (febril) em 12 países europeus, em pacientes sob quimioterapia mielosupressiva (n = 1447). Este estudo relata uma média de 5,11 ± 2,32 dias de tratamento e mediana de 5 dias, porém avalia apenas filgrastim biossimilar (Gascon et al, 2016). Uma vez que o tempo de tratamento com filgrastim está relacionado com os custos totais com aquisição de droga, honorários mé-dicos e taxa de sala, a incerteza nesse parâmetro afeta consideravelmente o resultado econômico final de uma análise econômica completa.…”

Hematopoietic growth factors in lung cancer

“…To date, the available data regarding specific biosimilar epoetin in solid tumors and filgrastim in NSCLC, although limited, seem encouraging [80]. In fact, the most recent updates involving biosimilar filgrastim come from preclinical data [81] and comparisons with its originator in solid tumors, with particular focus on breast cancer [82][83][84][85]; globally, such comparative studies did not show substantial differences between the products. Similarly, although most comparative data on biosimilar epoetin come from nephrology [86], a recent, large observational study in the clinical setting of solid and hematologic malignancies [87] favored its use.…”