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. 2025 Jul 14.
doi: 10.1007/s10147-025-02829-8. Online ahead of print.

Trends in real-world outcomes of patients with metastatic renal cell cancer in the recent treatment era: a single-institution analysis

Yasutomo Nakai  1 , Shunki Nakagawa  1 , Yutaka Kurahashi  1 , Shu Okamoto  1 , Yuichiro Nakamura  1 , Yujiro Hayashi  1 , Norihiko Kawamura  1 , Akira Nagahara  1 , Kazuo Nishimura  1 , Masashi Nakayama  2
Affiliations

Trends in real-world outcomes of patients with metastatic renal cell cancer in the recent treatment era: a single-institution analysis

Yasutomo Nakai et al. Int J Clin Oncol. .

Abstract

Background: Systemic therapy for metastatic renal cell cancer (mRCC) has changed significantly due to randomized controlled trial results. We investigated whether these changes affect real-world outcomes and clarified factors associated with treatment outcomes in patients from a single institution outside of clinical trials.

Methods: We retrospectively reviewed records of mRCC patients treated at Osaka International Cancer Institute between January 2005 and May 2024. Between-group analysis of progression-free survival (PFS) and overall survival (OS) by Kaplan-Meier comparison and identification of survival-associated factors by univariate and multivariate analyses were performed. Patients assumed ineligible for clinical trials were analyzed in subgroups according to any of Eastern Cooperative Oncology Group performance status > 1, hemoglobin level < 9.0 g/dL, estimated glomerular filtration rate < 40 mL/min/1.73 m2, platelet count < 100,000/μL, neutrophil count < 1500/μL, non-clear cell histology, or brain metastasis.

Results: In total, 320 patients were evaluated: 2005-2009, n = 58; 2010-2014, n = 77; 2015‒2019, n = 86; and 2020‒2024, n = 99. Significant between-group differences were observed for median PFS (7 vs. 8 vs. 12 vs. 20 months; p = 0.0048) and (35 vs. 38 vs. 67 vs. 52 months; p = 0.0206). Multivariate analysis revealed that first-line or subsequent-line immune checkpoint inhibitor (ICI) use was an independent factor for OS (HR: 0.28, p < 0.0001). Even among 112 (35%) trial-ineligible patients, multivariate analysis demonstrated that the use of first-line or subsequent-line ICI was an independent factor for OS (HR: 0.26, p < 0.0001).

Conclusion: Over time, treatment outcomes appeared to have improved with real-world treatment for mRCC, with use of ICIs being related to improvements in treatment outcomes.

Keywords: Immune checkpoint inhibitor; Real world; Trial-ineligible cases; mRCC.

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Conflict of interest statement

Declarations. Conflict of interest: None. Ethical approval: Ethics approval was obtained from the Research Ethics Committees of Osaka International Cancer Institute (Approval No. 1712229289-5, date of registration 22/Dec/2017, retrospectively registered). Consent to participate/publication: Informed consent was obtained in the form of opt-out on this web site ( https://oici.jp/file/houkatu/ken-hinyouki-06.pdf ).

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