ATROPOS: Survival Analysis of ICI-associated Myocarditis

Summary

ATROPOS is an international, registry-based observational study of cancer patients with immune checkpoint inhibitor-associated myocarditis (ICI-M). The study evaluates whether immunosuppressive treatment strategies, including first-line glucocorticoids and subsequent second-line immunosuppressants, are associated with overall mortality, and whether these associations vary according to myocarditis severity. The target number of cases to be included is 1500 spanning from at least 160 centers, located in at least 18 countries. Analyses will adjust for clinically relevant confounders and may use time-dependent survival models where appropriate.

Eligibility

Inclusion Criteria:

* cancer patients exposed to at least one immune checkpoint inhibitor
* possible, probable or definite immune checkpoint inhibitor-associated myocarditis recorded in the international registry according to registry/adjudication definitions
* available index-date/presentation information
* available mortality follow-up.

Exclusion Criteria:

* duplicate records
* not enough data to classify as myocarditis
* record/patient withdrawn from research use unresolved data-quality issues preventing inclusion in the final SAP-defined analysis set.

Conditions2

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