Safety and efficacy of immune checkpoint inhibitors in advanced urological cancers with pre-existing autoimmune disorders: a retrospective international multicenter study

• DOI: 10.1136/jitc-2020-000538
• Publication Date: 2020-03-26T12:55:15Z
• Authors: Nieves Martinez C...; Wanling Xie; Majd Issa; Hannah Dzimitrowicz; Abhishek Tripathi; Benoit Beuselinck; Elaine Lam; Yousef Zakharia; Rana Mckay; Sumit Shah; Amir Mortazavi; Michael R. Harrison; Spyridon Sideris; Marina D Kaymakcalan; Sarah Abou Alaiwi; Amin H Nassar; Pier Vitale Nuzzo; Anis Hamid; Toni K Choueiri; Lauren C Harshman
• Keywords: Cumulative incidence

Background There is limited experience regarding the safety and efficacy of checkpoint inhibitors (CPI) in patients with autoimmune disorders (AD) advanced urological cancers as they are generally excluded from clinical trials due to risk exacerbations. Methods This multicenter retrospective cohort analysis renal cell cancer (RCC) urothelial (UC) pre-existing AD treated CPI catalogued incidence exacerbations, new immune-related adverse events (irAEs) outcomes. Competing models estimated cumulative incidences exacerbations irAEs at 3 6 months. Results Of 106 (58 RCC, 48 UC) 10 centers, 35 (33%) had grade 1/2 clinically active whom (9%) required corticosteroids or immunomodulators baseline. Exacerbations occurred 38 (36%) 17 (45%) requiring (16%) discontinuing CPI. New onset 40 (38%) 22 (55%) 8 (20%) Grade 3/4 13 irAEs. No treatment-related deaths occurred. Median follow-up was 15 For objective response rate (ORR) 31% (95% CI 20% 45%), median time treatment failure (TTF) 7 months 4 10) 12-month overall survival (OS) 78% 63% 87%). UC, ORR 40% 26% 55%), TTF 5.0 2.3 9.0) OS 47% 76%). Conclusions Patients RCC UC well-controlled can benefit manageable toxicities that consistent what expected a non-AD population. Prospective study warranted comprehensively evaluate benefits AD.