Matti Aapro1, Carsten Bokemeyer2, Heinz Ludwig3, Pere Gascón4, Mario Boccadoro5, Kris Denhaerynck6, Michael Gorray7, Andriy Krendyukov7, Karen MacDonald8, Ivo Abraham9. 1. Institut Multidisciplinaire d'Oncologie, Clinique de Genolier, Genolier, Switzerland. Electronic address: maapro@genolier.net. 2. Universitaetsklinikum Hamburg Eppendorf, Hamburg, Germany. 3. Wilhelminen Cancer Research Institute, Wilhelminenspital, Wien, Austria. 4. Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain. 5. Dipartimento di Oncologia e Ematologia, Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino, Torino, Italy. 6. Matrix45, Tucson, AZ, USA; Universitaet Basel, Basel, Switzerland. 7. Hexal AG, Holzkirchen, Germany. 8. Matrix45, Tucson, AZ, USA. 9. Matrix45, Tucson, AZ, USA; Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA.
Abstract
BACKGROUND: Myelotoxic chemotherapy is associated with chemotherapy-induced (febrile) neutropenia (CIN/FN). The MONITOR-GCSF study evaluated biosimilar filgrastim (Zarzio®) prophylaxis patterns, associated outcomes, and determinants. We performed stratified analyses comparing elderly and non-elderly patients. METHODS: Comparative (elderly/non-elderly) analysis of demographics and clinical status, prophylaxis, associated CIN/FN outcomes (CIN grade 4 [CIN4], FN, CIN/FN-related hospitalizations and chemodisturbances, composite), and, per hierarchical modeling, determinants thereof evaluated at the patient- and cycle-level. RESULTS: There were no significant differences between both cohorts in prophylaxis initiation/duration and associated outcomes, but proportionately more elderly patients were correctly-prophylacted and fewer over-prophylacted. Common determinants of poor CIN/FN outcomes included concomitant antibiotic prophylaxis, impaired performance status, and any grade CIN in a previous cycle, whereas common determinants of good outcomes included over-prophylaxis and prophylaxis initiation within 24-72h. In the elderly, female gender, liver/renal/cardiovascular disease, secondary prophylaxis, and under-prophylaxis were associated with poorer outcomes. In the non-elderly, CIN4 at baseline or in a prior cycle was associated with poorer CIN/FN outcomes, and higher biosimilar filgrastim dose and, perhaps counter-intuitively, under-prophylaxis with better outcomes. CONCLUSION: Adequate GCSF support is essential for all patients, but especially for elderly patients with serious chronic disease, certainly, if concomitant antibiotic prophylaxis is indicated and if a CIN4 episode occurred in a prior cycle. The potential impact of impaired performance status, especially ECOG≥2 at chemotherapy start or a worsening to such during chemotherapy; under-prophylaxis, including inadequate secondary prophylaxis, should be considered in elderly patients. Timely GCSF initiation and over-prophylaxis is associated with lower rates of adverse CIN/FN events in elderly and non-elderly patients, and should be further evaluated in prospective randomized trials.
BACKGROUND: Myelotoxic chemotherapy is associated with chemotherapy-induced (febrile) neutropenia (CIN/FN). The MONITOR-GCSF study evaluated biosimilar filgrastim (Zarzio®) prophylaxis patterns, associated outcomes, and determinants. We performed stratified analyses comparing elderly and non-elderly patients. METHODS: Comparative (elderly/non-elderly) analysis of demographics and clinical status, prophylaxis, associated CIN/FN outcomes (CIN grade 4 [CIN4], FN, CIN/FN-related hospitalizations and chemodisturbances, composite), and, per hierarchical modeling, determinants thereof evaluated at the patient- and cycle-level. RESULTS: There were no significant differences between both cohorts in prophylaxis initiation/duration and associated outcomes, but proportionately more elderly patients were correctly-prophylacted and fewer over-prophylacted. Common determinants of poor CIN/FN outcomes included concomitant antibiotic prophylaxis, impaired performance status, and any grade CIN in a previous cycle, whereas common determinants of good outcomes included over-prophylaxis and prophylaxis initiation within 24-72h. In the elderly, female gender, liver/renal/cardiovascular disease, secondary prophylaxis, and under-prophylaxis were associated with poorer outcomes. In the non-elderly, CIN4 at baseline or in a prior cycle was associated with poorer CIN/FN outcomes, and higher biosimilar filgrastim dose and, perhaps counter-intuitively, under-prophylaxis with better outcomes. CONCLUSION: Adequate GCSF support is essential for all patients, but especially for elderly patients with serious chronic disease, certainly, if concomitant antibiotic prophylaxis is indicated and if a CIN4 episode occurred in a prior cycle. The potential impact of impaired performance status, especially ECOG≥2 at chemotherapy start or a worsening to such during chemotherapy; under-prophylaxis, including inadequate secondary prophylaxis, should be considered in elderly patients. Timely GCSF initiation and over-prophylaxis is associated with lower rates of adverse CIN/FN events in elderly and non-elderly patients, and should be further evaluated in prospective randomized trials.
Authors: J Feliu; V Heredia-Soto; R Gironés; B Jiménez-Munarriz; J Saldaña; C Guillén-Ponce; M J Molina-Garrido Journal: Clin Transl Oncol Date: 2019-06-25 Impact factor: 3.405
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
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Authors: Bernardo Leon Rapoport; Matti Aapro; Marianne Paesmans; Ronwyn van Eeden; Teresa Smit; Andriy Krendyukov; Jean Klastersky Journal: BMC Cancer Date: 2018-09-24 Impact factor: 4.430