Abstract
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.
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Supported by the Ministry of Health of the Czech Republic, Grant NU21-03-00539.
Conflict of interest
Alexandr Poprach has received research support from: Roche, Bristol Myers Squibb, Merck KGaA, MSD, and Novartis; consulting fees from Bristol Myers Squibb, Astellas, Janssen, and Sanofi/Aventis; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Bristol Myers Squibb, Roche, Novartis, Pfizer, MSD, and Pfizer. Igor Kiss has received research support from Roche, Bristol Myers Squibb, Merck KGaA, MSD, and Servier; consulting fees from Bristol Myers Squibb, Astellas, Janssen, and Sanofi/Aventis; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Bristol-Myers Squibb, Roche, Novartis, Pfizer, MSD, and Pfizer. Ondrej Fiala has received payment or honoraria for lectures, presentations, speakers’ bureaus, or educational events from Roche, Janssen, GSK, MSD, Pierre Fabre, BMS and Pfizer. Jindřich Kopecký has received consulting fees from Bristol Myers Squibb, Novartis, Pfizer, Merck, MSD, Ipsen; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Bristol Myers Squibb, MSD, Merck, Novartis and Pfizer. Igor Richter has received consulting fees from Bristol Myer Squibb, Pfizer, and Ipsen; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Ipsen, Bristol-Myers Squibb, Janssen, Merck KGaA, and Bayer. Bohuslav Melichar has received consulting fees from Roche, Pfizer, BMS, Novartis, MSD, Merck Serono, Servier, AstraZeneca, Amgen, E. Lilly. Hana Studentova has received research support: Roche, and Novartis; consulting fees from Bristol Myer Squibb, Astellas, Janssen, and MSD; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Ipsen, Bristol Myers Squibb, Janssen, and MSD. Radek Lakomy has received consulting fees from Bristol Myers Squibb, MSD, Novartis; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Bristol-Myers Squibb, MSD, Novartis, Sanofi/Aventis and Medison. Milos Holanek has received research support from Gilead, AstraZeneca, Novartis, Roche; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Roche, Novartis, Gilead, Pfizer, AstraZeneca, Amgen. Anezka Zemankova has received consulting fees from Bristol Myer Squibb, Ipsen, Merck; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Bristol Myers Squibb, Ipsen, Merck, Pfizer and Servier. Tomas Buchler has received research support: AstraZeneca, Roche, Bristol Myers Squibb, Exelixis, Merck KGaA, MSD, and Novartis; consulting fees from Bristol Myers Squibb, Astellas, Janssen, and Sanofi/Aventis; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Bristol Myers Squibb, AstraZeneca, Roche, Servier, Accord, MSD, and Pfizer. All unrelated to the present paper. All of the above are unrelated to the present paper. Marek Svoboda, Michal Stanik, Tamara Barusova, Lenka Pospisilova, and Aneta Rozsypalova declare no conflicts of interest.
Ethics approval
The RENIS registry has been approved by the Ethical Committee of the Brno University Hospital.
Availability of data
The datasets generated during and analysed during the current study are not publicly available due to GDPR requirements but are available in fully anonymous version from the corresponding author on reasonable request.
Author contributions
Conceptualization: AP, TB, IK. Methodology: AP, TB, TB, LP. Data Acquisition: AP, IK, MS, OF, JK, IR, BM, HS, RL, MH, AR, AZ. Statistical analysis: TB, LP. Writing—Original Draft: AP, TB. Writing—Review and Editing: all authors. Supervision: IK, TB, MS.
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Informed consent was acquired from participants prior to their inclusion in the database in accordance with the Ethical Committee approval and national regulations.
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Poprach, A., Kiss, I., Stanik, M. et al. Impact of Immunotherapy on Real-World Survival Outcomes in Metastatic Renal Cell Carcinoma. Targ Oncol 18, 893–903 (2023). https://doi.org/10.1007/s11523-023-01013-0
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DOI: https://doi.org/10.1007/s11523-023-01013-0