BACKGROUND: Treatment options for metastatic renal cell carcinoma (mRCC) are rapidly expanding, and immunotherapy using checkpoint inhibitors is a first- or second-line option for most patients. OBJECTIVE: The objective of the present retrospective analysis was to explore the real-world impact of checkpoint inhibitor-based immunotherapy compared with therapy using other types of targeted therapies using a large real-world database. METHODS: RenIS, a registry of patients with mRCC was used as a data source. Outcomes were compared for cohorts treated with TKIs or mTOR inhibitors only [targeted therapy (TT) cohort] versus patients who received immunotherapy (IO) using a checkpoint inhibitor in any line of treatment (IO cohort). Data from a total of 1981 patients were extracted from the registry, including 1767 patients in the TT cohort and 214 patients in the IO cohort. RESULTS: The median overall survival from the initiation of first-line treatment was 24.5 months versus not reached (p < 0.001) in the TT cohort versus the IO cohort, respectively [HR 0.23, 95% CI (0.17-0.31), p < 0.001]. The probability of 5-year survival was 24.2 versus 67.9% in the TT cohort versus the IO cohort, respectively. Immunotherapy in any line of treatment was associated with a lower risk of death. Overall survival was superior for patients receiving immunotherapy as the first or second treatment line compared with patients treated with non-immunological targeted therapy. CONCLUSION: In real-world patients with mRCC, immunotherapy is associated with significant survival benefit. The present retrospective analysis shows the real-world benefit of second-line immunotherapy in patients previously treated with tyrosine-kinase inhibitors.

Department of Comprehensive Cancer Care and Faculty of Medicine Masaryk Memorial Cancer Institute and Masaryk University Brno Czech Republic

Department of Oncology 1st Faculty of Medicine Charles University and Thomayer University Hospital Prague Czech Republic

Department of Oncology 2nd Faculty of Medicine Charles University and Motol University Hospital 5 Uvalu 84 150 06 Prague Czech Republic

Department of Oncology and Radiotherapy Faculty of Medicine and University Hospital in Pilsen Charles University Pilsen Czech Republic

Department of Oncology Liberec Regional Hospital Liberec Czech Republic

Department of Oncology Palacky University Medical School and Teaching Hospital Olomouc Czech Republic

Department of Urologic Oncology Masaryk Memorial Cancer Institute and Masaryk University Brno Czech Republic

Faculty of Medicine in Pilsen Biomedical Centre Charles University Pilsen Czech Republic

Institute of Biostatistics and Analyses Brno Brno Czech Republic

University Hospital in Hradec Králové Hradec Králové Czech Republic

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