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

J Geriatr Oncol. 2017 Mar;8(2):86-95. doi: 10.1016/j.jgo.2016.09.006. Epub 2016 Nov 6.

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.

Keywords: Biosimilar; Elderly; Filgrastim; Geriatric; Granulocyte colony-stimulating factor; Neutropenia.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors*
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects*
  • Biosimilar Pharmaceuticals / administration & dosage*
  • Chemotherapy-Induced Febrile Neutropenia / classification
  • Chemotherapy-Induced Febrile Neutropenia / prevention & control*
  • Female
  • Filgrastim / administration & dosage*
  • Hematologic Agents / administration & dosage*
  • Humans
  • Male
  • Middle Aged
  • Neoplasms / drug therapy*
  • Pre-Exposure Prophylaxis
  • Prospective Studies
  • Risk Factors
  • Severity of Illness Index
  • Sex Factors

Substances

  • Antineoplastic Agents
  • Biosimilar Pharmaceuticals
  • Hematologic Agents
  • Filgrastim