Study type

Study topic

Human medicinal product
DiseaseĀ /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
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