Pere Gascón1, Matti Aapro2, Heinz Ludwig3, Carsten Bokemeyer4, Mario Boccadoro5, Matthew Turner6, Kris Denhaerynck7, Karen MacDonald7, Ivo Abraham8,9. 1. Division of Medical Oncology, Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain. 2. Institut Multidisciplinaire d'Oncologie, Clinique de Genolier, Genolier, Switzerland. 3. Medizinische Abteilung I-Onkologie und Haematologie, Wilhelminenspital, Wien, Austria. 4. Universitaetsklinikum Hamburg Eppendorf, Hamburg, Germany. 5. Dipartimento di Oncologia e Ematologia, Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino, Torino, Italy. 6. Sandoz Biopharmaceuticals, Holzkirchen, Germany. 7. Matrix45, Tucson, AZ, USA. 8. Matrix45, Tucson, AZ, USA. abraham@pharmacy.arizona.edu. 9. Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Drachman Hall B306H, 1295 N Martin, Tucson, AZ, 85721, USA. abraham@pharmacy.arizona.edu.
Abstract
PURPOSE: The purpose of this study is to examine the real-world treatment patterns and outcomes of chemotherapy-induced (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 musculoskeletal events with 24.7 % of patients reporting bone pain of any grade (mostly mild to moderate), and 148 adverse drug reactions, including 4 serious, were recorded in 76 patients. CONCLUSIONS: The clinical and safety outcomes are well within the range of historically reported data for originator filgrastim underscoring the clinical effectiveness and safety of biosimilar filgrastim in daily clinical practice.
PURPOSE: The purpose of this study is to examine the real-world treatment patterns and outcomes of chemotherapy-induced (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 cancerpatients (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 musculoskeletal events with 24.7 % of patients reporting bone pain of any grade (mostly mild to moderate), and 148 adverse drug reactions, including 4 serious, were recorded in 76 patients. CONCLUSIONS: The clinical and safety outcomes are well within the range of historically reported data for originator filgrastim underscoring the clinical effectiveness and safety of biosimilar filgrastim in daily clinical practice.
Authors: Pere Gascón; Matti Aapro; Heinz Ludwig; Nadia Rosencher; M Boccadoro; Matthew Turner; Karen MacDonald; Michael Muenzberg; Ivo Abraham Journal: Crit Rev Oncol Hematol Date: 2011-03 Impact factor: 6.312
Authors: G H Lyman; D C Dale; E Culakova; M S Poniewierski; D A Wolff; N M Kuderer; M Huang; J Crawford Journal: Ann Oncol Date: 2013-06-20 Impact factor: 32.976
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Authors: Heinz Ludwig; Pere Gascón; Carsten Bokemeyer; Matti Aapro; Mario Boccadoro; Kris Denhaerynck; Andriy Krendyukov; Karen MacDonald; Ivo Abraham Journal: Support Care Cancer Date: 2018-10-20 Impact factor: 3.603
Authors: Matti Aapro; Ralph Boccia; Robert Leonard; Carlos Camps; Mario Campone; Sylvain Choquet; Marco Danova; John Glaspy; Iwona Hus; Hartmut Link; Thamer Sliwa; Hans Tesch; Vicente Valero Journal: Support Care Cancer Date: 2017-08-25 Impact factor: 3.603
Authors: Carsten Bokemeyer; Pere Gascón; Matti Aapro; Heinz Ludwig; Mario Boccadoro; Kris Denhaerynck; Michael Gorray; Andriy Krendyukov; Ivo Abraham; Karen MacDonald Journal: Support Care Cancer Date: 2017-01-22 Impact factor: 3.603