Abstract 782P
Background
Patients with pre-existing autoimmune disease (AD) have historically been excluded from most immune checkpoint inhibitor (ICI) clinical trials due to concerns including potential toxicity or decreased efficacy. Real-world data support the use of ICIs for patients with ADs across multiple tumor types, however data are limited. We examined the association between pre-existing AD and ICI treatment outcomes among patients with metastatic urothelial cancer (mUC) in the real-world setting.
Methods
This was a retrospective analysis of Truven Health MarketScan® Commercial, Medicare Supplemental, and Coordination of Benefits (Medicare) databases. Patients with a primary diagnosis of mUC, ≥18 years old, received ICI for any line of treatment between 1/1/2016 - 6/30/2019, and continuously enrolled in the database from 6 months prior to 1 month following the metastatic date were analyzed. AD was identified at any time prior to ICI therapy initiation. Time to treatment discontinuation was used as a proxy to quantify ICI treatment outcomes.
Results
Of the 455 eligible patients, 71 (16%) had a prior AD. Among those with AD, the most common was type 1 diabetes (25%), followed by rheumatoid arthritis (10%) and pernicious anemia (10%), while 28% had a history of two or more ADs. Patients with vs. without prior AD were older (mean age 70.4 vs. 66.5; p<0.001) and had a higher co-morbidity burden. There was a shorter median unadjusted time to ICI treatment discontinuation among patients with a prior AD (6.82 months; 95% CI=3.93-29.02) vs. without (8.13 months; 95% CI=6.49-12.50), but findings were not statistically significant (p=0.27). Adjusting for age, sex, comorbidity, and line of therapy, there was no significant difference in time to ICI treatment discontinuation between patients with vs. without prior AD (HR=1.29; 95%CI=0.87-1.90).
Conclusions
There was a shorter time to treatment discontinuation in patients with vs. without prior AD, but findings were not statistically significant. Broader inclusion of patients with mUC reflective of real-world populations in ICI clinical studies will better define tolerance and efficacy of novel therapies for urothelial cancer.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Genentech.
Funding
Genentech.
Disclosure
J. Hoffman-Censits: Advisory/Consultancy: Genentech. S. Abou Alaiwi: Advisory/Consultancy: Genentech. C.S. Meyer: Shareholder/Stockholder/Stock options, Full/Part-time employment: Genentech. J. Linsenmeier: Shareholder/Stockholder/Stock options, Full/Part-time employment: Genentech. M. Metcalf: Advisory/Consultancy: Genentech. S. Satram: Research grant/Funding (self): Genentech, Inc.