Clinical outcome differences based on gender in patients with advanced renal cell carcinoma (aRCC) treated with immune checkpoint inhibitors (ICIs).

e16542 Background: Current first-line therapy for aRCC involves ICIs, often administered with another ICI or tyrosine-kinase inhibitors (TKIs). While there has been some literature on the association between gender and clinical outcomes in patients with aRCC, some results are contradictory and thus the true association remains unknown. We explored the role of gender in the difference in clinical outcomes of patients undergoing therapies involving ICIs. Methods: We conducted a retrospective analysis on adult patients with advanced RCC treated with ICIs at Emory Winship Cancer Institute between 1/1/2018 and 8/31/23. Overall survival (OS) and progression-free survival (PFS) was calculated from the date of treatment initiation to death and progression, respectively. Progression was determined by RECIST v1.1 or clinical progression. Clinical benefit (CB), including stable disease, partial response, and complete response, was determined by RECIST v.1.1. CB, OS, and PFS were used to identify the association between gender and clinical outcome through univariate (UVA) and multivariate (MVA) analyses. Results: Analysis was conducted on a total of 401 patients, consisting of 283 (70.6%) males and 118 (29.4%) females. Their median age was 66 (range = 18-95). Treatment plan involved 139 (34.6%) patients for single ICI therapy, 131 (32.6%) patients for ICI/ICI therapy, 108 (26.9%) patients for ICI/TKI therapy, 6 (1.5%) patients for ICI/ICI/TKI therapy, and 17 (4.23%) patients for therapy with ICI plus an experimental drug. CB, OS, and PFS all confirmed no difference in clinical outcomes of the patients based on gender in UVA and MVA. Female patients had hazard ratios (HR) close to 1 for both OS and PFS and odds ratios (OR) close to 1 for CB. Results from Kaplan-Meier (KM) plots also support the lack of difference in clinical outcomes between genders. The KM plot indicated similar OS and PFS for female and male patients, with the median OS for female and male patients being 36 and 28.2 months and the median PFS for female and male patients being 7.4 and 7.1 months, respectively. Conclusions: Patients treated with ICIs had similar clinical outcomes based on gender as indicated by insignificant differences in CB, OS, and PFS. However, prospective studies are still needed to validate such findings. Table: see text