Risk of Venous Thromboembolism and All-Cause Mortality in Cancer Patients Treated with Epoetins either with or without Transfusions versus Cancer Patients Treated with Transfusions alone

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

  Other
• Non-interventional study design, other:
  Nested case-control study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B03XA01) erythropoietin

  erythropoietin

  (B03XA02) darbepoetin alfa

  darbepoetin alfa

  (B03XA03) methoxy polyethylene glycol-epoetin beta

  methoxy polyethylene glycol-epoetin beta

  (B03XA04) peginesatide

  peginesatide
• Medical condition to be studied:
  Deep vein thrombosis

  Pulmonary embolism

  Death

Population studied

• Short description of the study population:
  Cancer patients receiving epoetin treatment either with or without additional transfusions.; Cohort members had to fulfil all of the following inclusion criteria: (i) at least 12 months of continuous insurance time before the initial outpatient epoetin dispensation or transfusion administration, (ii) no outpatient epoetin dispensation or code indicating transfusion administration within the 12 months before cohort entry, and (iii) at least one outpatient or inpatient diagnosis of cancer other than non-melanoma skin cancer or a code indicating chemotherapy within 6 months before cohort entry, but no diagnosis of cancer or code indicating chemotherapy between 6 months and 1 year before cohort entry.
• 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:
  Immunocompromised
• Estimated number of subjects:
  69888

Study design details

• Main study objective:
  The main objective of this study was to assess the risk of VTE and all-cause mortality in incident cancer patients receiving epoetin treatment either with or without additional transfusions compared to cancer patients receiving blood transfusions alone in Germany in a real world setting.
• Outcomes:
  - Venous thromboembolism (defined as deep vein thrombosis of the leg/hip or pulmonary embolism)- All-cause mortality was defined as death of any cause. Deaths were identified using core and hospital data searching for death as the reason for end of insurance or the reason for the end of hospitalization, respectively.
• Data analysis plan:
  Characteristics of patients at the time of cohort entry and treatment with epoetin and transfusions were described stratified by sex and age at cohort entry, and compared between the five treatment groups (epoetin treatment only, transfusions only, epoetin followed by transfusions, transfusions followed by epoetin, concomitant initiation of transfusions and epoetin).A nested case-control analysis using conditional logistic regression was conducted to estimate adjusted ORs with corresponding 95% CIs for VTE and recent treatment with epoetin and/or transfusion. Treatment was defined as “recent” if a VTE occurred up to 28 days after the end of the respective therapy.Multivariable Cox proportional hazard regression models were used to estimate adjusted HRs and related 95% CIs. The main objective was to compare patients receiving epoetin treatment either with or without additional transfusions compared to cancer patients receiving blood transfusions alone.