Chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim in elderly versus non-elderly cancer patients: Patterns, outcomes, and determinants (MONITOR-GCSF study).
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.



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.



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.



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.
Institut Multidisciplinaire d'Oncologie, Clinique de Genolier, Genolier, Switzerland. Electronic address: maapro@genolier.net.
Matti
M
Aapro
Universitaetsklinikum Hamburg Eppendorf, Hamburg, Germany.
Carsten
C
Bokemeyer
Wilhelminen Cancer Research Institute, Wilhelminenspital, Wien, Austria.
Heinz
H
Ludwig
Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.
Pere
P
Gascón
Dipartimento di Oncologia e Ematologia, Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino, Torino, Italy.
Mario
M
Boccadoro
Matrix45, Tucson, AZ, USA; Universitaet Basel, Basel, Switzerland.
Kris
K
Denhaerynck
Hexal AG, Holzkirchen, Germany.
Michael
M
Gorray
Hexal AG, Holzkirchen, Germany.
Andriy
A
Krendyukov
Matrix45, Tucson, AZ, USA.
Karen
K
MacDonald
Matrix45, Tucson, AZ, USA; Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA.
Ivo
I
Abraham
D000328:Adult; D000367:Age Factors; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage*; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000145:classification / Q000517:prevention & control*; D005260:Female; D000069585:Filgrastim / Q000008:administration & dosage*; D006401:Hematologic Agents / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D065129:Pre-Exposure Prophylaxis; D011446:Prospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors
D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D006401:Hematologic Agents; D000069585:Filgrastim
Biosimilar; Elderly; Filgrastim; Geriatric; Granulocyte colony-stimulating factor; Neutropenia