ESMO Virtual Congress 2020: Real-World Evidence of the Impact of Prior Autoimmune Disease on Immune Checkpoint Inhibitor Outcomes in Patients with Metastatic Urothelial Cancer

( Clinical trials of immune checkpoint blockade (ICB) historically exclude patients with pre-existing autoimmune diseases because of concerns around decreased efficacy due to immunosuppression as well as toxicity. Real-world evidence suggests that immune-related adverse events associated with immune checkpoint blockade are manageable in patients with pre-existing autoimmune disease. In this presentation, Dr. Hoffman-Censits and colleagues present data from the US administrative claims database concerning pre-existing autoimmune disease and immune checkpoint blockade in patients with metastatic urothelial cancer (mUC).

Of the 455 patients with mUC receiving ICB as any line therapy in the database, 71 had pre-existing autoimmune disease. These patients were older, had a higher Charlson Comorbidity Index without cancer, and more often had Medicare insurance. Most patients receive nivolumab as ICB (37.8%), followed by pembrolizumab (31%). Type 1 diabetes was the most common type of autoimmune disease (25.4%), followed by pernicious anemia (9.9%) and rheumatoid arthritis (9.9%). These data are summarized below.


In this cohort, the median unadjusted time to treatment discontinuation was numerically shorter than for patients with pre-existing autoimmune disease relative to patients without autoimmune disease (8.1 versus 6.8 months, p = 0.27). The authors used sensitivity analyses to assess outcomes in patients receiving ICB as first line therapy only, and the results were consistent with the main model of patients receiving ICB for any line therapy.


This study limited by the possibility of diagnosis miscoding and the possibility that a medical code was utilized as part of a rule-out workup. Studies utilizing larger cohorts of patients with pre-existing autoimmune conditions and ICB treatment are warranted to understand the safety and efficacy of this important treatment modality for these patients.

Presented by: Jean Hoffman-Censits, MD, Medical Oncologist, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, Maryland, US

Written by: Alok Tewari, MD, PhD, Medical Oncologist at the Dana-Farber Cancer Institute, at the 2020 European Society for Medical Oncology Virtual Congress (#ESMO20), September 19th-September 21st, 2020.
email news signup