Use of Erythropoiesis Stimulating Agents (ESA) in Patients With Non-myeloid Malignancies Receiving Myelosuppressive Chemotherapy 2014 – 2021 (20170210)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  To assess the utilization of Aranesp or Epogen/Procrit for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ARANESP
• Name of medicine, other:
  Epogen/Procrit
• Study drug International non-proprietary name (INN) or common name:
  DARBEPOETIN ALFA
• Anatomical Therapeutic Chemical (ATC) code:
  (B03XA02) darbepoetin alfa

  darbepoetin alfa
• Medical condition to be studied:
  Microcytic anaemia

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1100000

Study design details

• Main study objective:
  To assess the utilization of Aranesp or Epogen/Procrit for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy stratified by calendar year and selected tumor types
• Outcomes:
  Estimate the proportion of patients with non-myeloid malignancies receiving an ESA over a 180 day follow-up period after initiation of myelosuppressive chemotherapy by calendar year, overall and stratified by specific tumor types including patients with breast cancer, adjuvant breast cancer, metastatic breast cancer, CRC, lung cancer, NSCLC, and lymphoma. Describe the demographic and clinical characteristics of patients with non-myeloid malignancies after initiation of myelosuppressive chemotherapy by calendar year, overall and stratified by specific tumor types including patients with breast cancer, adjuvant breast cancer, metastatic breast cancer, CRC, lung cancer, NSCLC, and lymphoma.
• Data analysis plan:
  The incidence proportion (%) and 95% CIs for ESA use during the 180-day follow-up period and the proportion of patients with Hb values > 10 g/dL at the time of ESA initiation were estimated for the population overall and by specific tumor type. The 95% CI surrounding the incidence estimate was based on the binomial distribution. The incidence proportion for ESA use was defined as the number of patients who received at least 1 ESA administration during follow-up divided by the number of patients at risk in the cohort at the beginning of follow-up. The incidence proportion for patients with Hb values > 10 g/dL was defined as the number of patients with Hb values > 10 g/dL divided by the number of patients with observed Hb values at the time ESA initiation. All analyses were conducted by calendar year cohort.

Documents

Study report

ORSR Abstract 20170210.pdf