Granulocyte Colony-Stimulating Factor (“G-CSF”): Patient profiles, Scheduling Patterns and Clinical Outcomes

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Neulasta Onpro
• Study drug International non-proprietary name (INN) or common name:
  PEGFILGRASTIM
• Anatomical Therapeutic Chemical (ATC) code:
  (L03AA13) pegfilgrastim

  pegfilgrastim
• Medical condition to be studied:
  Breast cancer

  Colorectal cancer

  Ovarian cancer

  Non-Hodgkin's lymphoma

  Non-small cell lung cancer

Population studied

• Short description of the study population:
  Adult patients with a diagnosis of breast cancer, colorectal cancer, NHL, NSCLC, or ovarian cancer, treated with pegfilgrastim within US Oncology Network (USON) clinics during January 1, 2018 and October 31, 2019, with follow-up until December 31, 2019.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Breast cancer, colorectal cancer, non-Hodgkin’s lymphoma, non-small cell lung cancer, or ovarian cancer patients
• Estimated number of subjects:
  15443

Study design details

• Main study objective:
  The aim of this study is to understand the patient profiles, scheduling patterns and clinical outcomes among patients with breast cancer, colorectal cancer, ovarian cancer, NHL or NSCLC treated with pegfilgrastim in the US community setting.
• Outcomes:
  Phase 1: • Patient demographics and clinical disease characteristics • Scheduling patterns with pegfilgrastim Phase 2 • Scheduling patterns with pegfilgrastim • Clinical outcomes among patients initiating pegfilgrastim • Recourse utilization (hospitalization and ER visits) among patients initiating pegfilgrastim
• Data analysis plan:
  Descriptive analyses will be conducted to evaluate the demographic, clinical and treatment characteristics of the overall study population. Descriptive statistics will be used to summarize clinical outcomes and resource utilization among patients selected for chart review in Phase 2. No multivariable statistical analyses will be conducted (e.g. multivariable logistic regression). Results will be reported in aggregate using SAS® 9.4 (SAS Institute Inc. Cary, NC, US). All results will be reported at patient-level (stratified by optimal, sub-optimal or missed appointments for pegfilgrastim) and cycle-level (stratified by chemotherapy cycle 1-6). Data from all sources and any derived variables will be merged into one master dataset for analysis. Data will be handled in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health (HITECH).