Outcomes of patients (pts) with advanced urothelial carcinoma (aUC) treated with immune checkpoint inhibitors (ICIs): Associations with age, race, sex and smoking history.

person Dimitrios Makrakis The University of Washington School of Medicine, Seattle, WA info_outline Dimitrios Makrakis, Rafee Talukder, Lucia Carril, Ivan de Kouchkovsky, Joseph J Park, Mehmet Asim Bilen, Rana R. McKay, Neeraj Agarwal, Yousef Zakharia, Michael E. Devitt, David James Pinato, Christopher J. Hoimes, Benjamin Adam Gartrell, Abhishek Tripathi, Aristotelis Bamias, Alexandra Drakaki, Jure Murgic, Giuseppe Di Lorenzo, Petros Grivas, Ali Raza Khaki

Authors person Dimitrios Makrakis The University of Washington School of Medicine, Seattle, WA info_outline Dimitrios Makrakis, Rafee Talukder, Lucia Carril, Ivan de Kouchkovsky, Joseph J Park, Mehmet Asim Bilen, Rana R. McKay, Neeraj Agarwal, Yousef Zakharia, Michael E. Devitt, David James Pinato, Christopher J. Hoimes, Benjamin Adam Gartrell, Abhishek Tripathi, Aristotelis Bamias, Alexandra Drakaki, Jure Murgic, Giuseppe Di Lorenzo, Petros Grivas, Ali Raza Khaki Organizations The University of Washington School of Medicine, Seattle, WA, University of Washington, Seattle , WA, Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain, University of California San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, Division of Oncology, Department of Medicine, University of Michigan, Ann Arbor, MI, Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA, University of California San Diego, Moores Cancer Center, La Jolla, CA, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, University of Iowa, Iowa City, IA, University of Virginia, Charlottesville, VA, Department of Surgery and Cancer, Imperial College, London, United Kingdom, Duke Cancer Center, Durham, NC, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, National and Kapodistrian University of Athens, Athens, Greece, University of California Los Angeles, Los Angeles, CA, Princess Margaret Cancer Center, Toronto, ON, Canada, Oncology Unit, Andrea Tortora Hospital, ASL Salerno, Pagani, Italy, University of Washington, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, Seattle, WA, University of Washington, Seattle, WA Abstract Disclosures Research Funding No funding received None Background: ICIs have altered the therapeutic landscape in pts with aUC and new biomarkers are needed to better predict response and outcomes with ICIs. It is unclear whether demographics, such as race, age, sex and history of smoking, are associated with outcomes with ICIs. We hypothesized that specific demographic groups (sex, age, race, smoking history) would be associated with outcomes with ICIs in aUC. Methods: We performed a retrospective cohort study across 25 institutions. Data collected included demographic and clinicopathologic factors, response and outcomes. We calculated observed response rate (ORR), Progression-Free Survival (PFS) and overall survival (OS) for specific demographic groups. We built multivariable models (logistic regression for ORR; Cox regression for PFS and OS) with all demographic groups to assess outcomes. Analysis was done for the overall population and stratified by treatment line (first line [1L]; salvage [2+L]). The stratified analysis was also adjusted for known prognostic risk scores (internally developed for 1L; Bellmunt for 2+L); p-value < 0.05 was significant. Results: We identified 1026 pts; 754, 744 and 780 were included in OS, ORR and PFS analysis. Overall, median age at ICI initiation was 70; 26% female; 75% White, 11% Hispanic, 5% Black, 8% other; 69% had smoking history; 28% with mixed histology; 17% with upper tract UC. In the unstratified analysis, age 65-74 (vs < 65) was significantly associated with higher ORR (32% vs 22%) and median PFS (5 vs 3 mo HR 0.8); otherwise no significant difference was noted among groups for ORR, PFS, OS in both the stratified and unstratified analyses (Table). Conclusions: We did not identify significant associations between age, sex, race or smoking history and ORR, PFS, OS with ICIs in pts with aUC. Limitations include retrospective nature, lack of randomization, possible selection and confounding factors. Further research is required to identify prognostic and predictive biomarkers for ICI therapy in aUC. Demographic groups 1 L 2+ L Odds ratio OS HR PFS HR Odds ratio OS HR PFS HR < 65 years (ref) (ref) (ref) (ref) (ref) (ref) 65-74 years 1.77 (0.95-3.31) 0.78 (0.51-1.17) 0.70 (0.49-1.00) 1.89 (0.99-3.63) 0.96 (0.69-1.34) 0.84 (0.63-1.14) 75+ years 1.63 (0.88-3.02) 1.09 (0.75-1.59) 0.75 (0.53-1.06) 1.13 (0.51-2.49) 1.12 (0.76-1.66) 0.88 (0.62-1.25) White (ref) (ref) (ref) (ref) (ref) (ref) Black 0.88 (0.29-2.68) 0.57 (0.22-1.47) 0.61 (0.28-1.33) 1.14 (0.34-3.84) 0.90 (0.39-2.07) 1.12 (0.60-2.09) Hispanic 1.43 (0.67-3.04) 0.90 (0.59-1.37) 0.70 (0.45-1.08) 0.71 (0.28-1.77) 0.87 (0.53-1.45) 1.47 (0.97-2.20) Other 0.69 (0.28-1.65) 1.10 (0.67-1.81) 0.98 (0.63-1.52) 1.12 (0.42-2.98) 0.89 (0.46-1.70) 0.89 (0.50-1.58)