Real-world comparison of the effectiveness and safety of immune-based combinations in elderly patients with advanced renal cell carcinoma (ARON-1 study)

BACKGROUND: Nowadays, systemic treatment with immune-based combinations for metastatic renal cell carcinoma (mRCC) is the gold standard. However, the benefit of these treatments in patients aged ≥70 years is uncertain. Thus, we evaluate the effectiveness and safety of first-line immune-based combinations in elderly patients with mRCC. METHODS: We retrospectively collected data from mRCC patients who were treated with immune-based combinations in first-line setting at 75 hospitals from 23 countries. Patients were assessed for overall survival (OS), overall response rate (ORR) and severe adverse events (SAEs). The statistical analysis encompassed the Fisher's Exact Test, the Kaplan-Meier methodology, the log-rank test, as well as univariate and multivariate Cox proportional hazards regression models. RESULTS: Of the 1990 mRCC patients included in this analysis, 739 patients were aged ≥70 years. Median OS was 41 months for patients aged <70 years and 30.1 months in patients aged ≥71 years (P<0.001). The age was a prognostic factor in both univariate and multivariate analysis. There was no difference in ORR (52% versus 44%, P=0.262). There was no statistical difference in incidence SAEs as well as dose reductions or treatment discontinuation between elderly and young patients. CONCLUSIONS: This large real-world study with mRCC patients substantiates the effectiveness and safety of first-line immune-based combination treatments in elderly patients. Nonetheless, this population has a lower survival in comparison to younger patients.