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Background <p>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.</p> Methods <p>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 &gt; 1, hemoglobin level &lt; 9.0&#xa0;g/dL, estimated glomerular filtration rate &lt; 40&#xa0;mL/min/1.73&#xa0;m<sup>2</sup>, platelet count &lt; 100,000/μL, neutrophil count &lt; 1500/μL, non-clear cell histology, or brain metastasis.</p> Results <p>In total, 320 patients were evaluated: 2005–2009, <i>n</i> = 58; 2010–2014, <i>n</i> = 77; 2015‒2019, <i>n</i> = 86; and 2020‒2024, <i>n</i> = 99. Significant between-group differences were observed for median PFS (7 vs. 8 vs. 12 vs. 20&#xa0;months; <i>p</i> = 0.0048) and (35 vs. 38 vs. 67 vs. 52&#xa0;months; <i>p</i> = 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, <i>p</i> &lt; 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, <i>p</i> &lt; 0.0001).</p> Conclusion <p>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.</p>

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

  • 期刊论文

  • 发表日期：

    2025年7月14日

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

摘要

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.