Incidence of new Primary Malignancies Among Patients With Bone Metastases From Breast, Prostate, or Lung Cancer Treated With XGEVA or Intravenous Zoledronic Acid: a Retrospective Cohort Study (20170728)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  XGEVA
• Medical condition to be studied:
  Breast cancer stage IV

  Prostate cancer stage IV

  Non-small cell lung cancer stage IV

Population studied

• Short description of the study population:
  Patients aged 18 years or older who were diagnosed with a first primary, microscopically confirmed breast, prostate, or lung cancer in SEER between 2000 and 2014. Patients must have received their first record for XGEVA or ZA between 2011 and 2014, and had a record of bone metastases within 30 days before or after this date in the Medicare claims data (ICD-9-CM code 198.5 or ICD-10-CM code C79.5) or had a record of bone metastases in the SEER data at diagnosis.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Breast, prostate, or lung cancer patients
• Estimated number of subjects:
  15000

Study design details

• Main study objective:
  To estimate, overall and by primary malignancy site, incidence (rate, cumulative incidence proportion) of any subsequent new primary malignancy (any haematologic or non-haematologic tumours, excluding non-melanoma skin cancer after the first primary malignancy) among patients with breast, prostate, or lung cancer and bone metastases who were newly treated with either XGEVA or IV zoledronic acid
• Outcomes:
  New primary malignancy (any haematologic or non-haematologic tumours, excluding non-melanoma skin cancer subsequent to the first primary malignancy)
• Data analysis plan:
  This is a descriptive study and will focus on exposure cohort-specific analyses (XGEVA, intravenous zoledronic acid). No formal statistical comparisons or significance testing are planned. The primary analyses estimate the incidence rate and cumulative incidence proportion of new primary malignancy in each exposure cohort using 95% confidence interval as a measure of the uncertainty of the estimates. Cumulative incidence proportions will account for the competing risk of death. Analyses will be conducted both for index malignancy types combined and individually (breast, prostate, lung).

Documents

Study results

01.09.01 Clinical Study Report ORSR Abstract 2020-01-29 20170728 Final Analysis