There is little available data on the safety and clinical mechanism of immune checkpoint inhibitors (CPI) due to the fact that patients with renal cell carcinoma (RCC) or urothelial carcinoma (UC) struggling with significant autoimmune disorders (AD) are typically excluded from these trials. A research team led by the Jules Bordet Institute (Belgium) collected data from nine centers on patients with RCC and UC with AD who were treated with CPI. The incidence of immune-related adverse events (AE) or AD exacerbations occurred in 36% and 37% respectively, and the investigators concluded generally manageable while only a smaller number of patients required CPI cessation due to toxicity.
Victoria Socha of Docwire news recently reported on a study titled “Retrospective analysis of the safety and efficacy of immune checkpoint inhibitors (CPI among patients with existing autoimmune disorders (AD) and renal cell carcinoma (RCC) or urothelial carcinoma). The study sponsors presented their findings at the 2019 American Society of Oncology meeting in Chicago.
A retrospective data analyses was organized and sponsored by the Jules Bordet Institute, Brussels, Belgium. Led by Nieves Martinez Chanza, MD, the team collected day from nine centers on RCC and UC patients with AD who were treated with CPI. The team utilized the Common Terminology Criteria for Adverse Events (version 5.0) (CTCAEv5) criteria were used to assess objective response rate (ORR); and Kaplan Meier models utilized for overall survival.
Docwire reported that 103 patients (57 with RCC and 46 with UC) exhibited a broad spectrum of AD, including psoriasis (22%), thyroiditis (20%), rheumatoid arthritis (13%), polymyalgia rheumatica (8%), inflammatory bowel disease (6%), multiple sclerosis (3%) and lupus (3%). Most received CPI as first-or second-line (77% of RCC patients; 93% of UC patients) and anti-PD/L1 monotherapy (65% of RCC patients; 98% of UC patients).
With the start of CPI therapy, 36 patients experienced critically active AD (all grade 1-2) and four required systemic immunosuppression. 38 patients had AD exacerbations, including arthritis (12% RCC; 24$ UC) and rash (11% RCC, 9% UC). 37 patients had new onset immune-related AEs including colitis (12% RCC, 4%), rash (11% RCC; 9%UC) and hypothyroid (7% RCC 7% UC), and nephritis (7% UC).
By time of data cutoff, 39 patients with RCC and 36 with US had discontinued CPI; 16% for toxicity. ORR was 31% for patients with RCC and 35% for patients with UC. The 1 year overall survival rate was 74% (95% confidence interval, 58%-84%) for patients with RCC and 60% (95% confidence interval 43% to 74%) for patients with UC.
The researchers concluded that “AD exacerbations or new acquired immune related AEs occurred in 37% and 36% respectively and were generally manageable. Only a minority required CPI cessation due to toxicity.”
An integrated, multidisciplinary center unique in Belgium, which enjoys an international reputation. The hospital is devoted entirely to patients affected by cancer. For more than 75 years, their teams have been offering patients leading-edge diagnostic and therapeutic strategies in the prevention, screening, and active treatment of all types of cancer. They carry on important clinical research activities including clinical trials leading to major discoveries as well as offering high-level, specialized university training.