title: Over- and under-prophylaxis for chemotherapy-induced (febrile) neutropenia relative to evidence-based guidelines is associated with differences in outcomes: findings from the MONITOR-GCSF study.
abstract: In the MONITOR-GCSF study of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim, 56.6% of patients were prophylacted according to amended EORTC guidelines, but 17.4% were prophylacted below and 26.0% above guideline recommendations.
  
  
  
  MONITOR-GCSF is a prospective, observational study of 1447 evaluable patients from 140 cancers centers in 12 European countries treated with myelosuppressive chemotherapy for up to 6 cycles receiving biosimilar GCSF prophylaxis. Patients were classified as under-, correctly-, or over-prophylacted with GCSF relative to guideline recommendations based on their chemotherapy risk, individual risk factors, and type of GCSF prophylaxis (primary versus secondary).
  
  
  
  Differences between under- (17.4%), correctly- (56.6%), or over-prophylacted (26.0%) groups were found in terms of patient risk factors (age, performance status, history of FN, comorbid conditions) as well as prophylaxis patterns (type of prophylaxis, day of GCSF initiation, and GCSF duration). Rates of chemotherapy-induced neutropenia (CIN) (all grades), FN, and CIN-related hospitalizations were consistently lower in over-prophylacted patients relative to under- and correctly-prophylacted patients. No differences were observed between under- and correctly-prophylacted patients except for CIN/FN-related chemotherapy disturbances. No GCSF safety differences were found between groups (except for headaches).
  
  
  
  The real-world evidence provided by the MONITOR-GCSF study indicates that providing GCSF support may yield better CIN, FN, and CIN/FN-related hospitalization outcomes if patients are prophylacted at levels above guideline recommendations. Patients who are under-prophylacted are at higher risk for disturbances to their chemotherapy regimens. Our findings support the guideline recommendation that CIN/FN risk be assessed at the beginning of each chemotherapy cycle.
authors.affiliation: Universitaetsklinikum Hamburg Eppendorf, Hamburg, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Bokemeyer
authors.affiliation: Division of Medical Oncology, Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Pere
authors.initials: P
authors.lastname: Gascón
authors.affiliation: Institut Multidisciplinaire d'Oncologie, Clinique de Genolier, Genolier, Switzerland.
authors.forename: Matti
authors.initials: M
authors.lastname: Aapro
authors.affiliation: Medizinische Abteilung I - Onkologie und Haematologie, Wilhelminenspital, Wien, Austria.
authors.forename: Heinz
authors.initials: H
authors.lastname: Ludwig
authors.affiliation: Dipartimento di Oncologia e Ematologia, Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino, Torino, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Boccadoro
authors.affiliation: Matrix45, 6159 W Sunset Rd, Tucson, AZ, 85743, USA.|Universitaet Basel, Basel, Switzerland.
authors.forename: Kris
authors.initials: K
authors.lastname: Denhaerynck
authors.affiliation: Hexal AG, Holzkirchen, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Gorray
authors.affiliation: Hexal AG, Holzkirchen, Germany.
authors.forename: Andriy
authors.initials: A
authors.lastname: Krendyukov
authors.affiliation: Matrix45, 6159 W Sunset Rd, Tucson, AZ, 85743, USA. iabraham@matrix45.com.|Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA. iabraham@matrix45.com.
authors.forename: Ivo
authors.identifier: 0000-0002-5224-4977
authors.initials: I
authors.lastname: Abraham
authors.affiliation: Matrix45, 6159 W Sunset Rd, Tucson, AZ, 85743, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: MacDonald
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D005260:Female; D005334:Fever / Q000139:chemically induced*; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects*; D008297:Male; D009503:Neutropenia / Q000139:chemically induced*; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor
keywords: Biosimilar; Chemotherapy-induced neutropenia; EP2006; Febrile neutropenia; Filgrastim; Granulocyte colony stimulating factor; Prophylaxis