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Abstract: SA-PO1259

Overall Survival with Sequential Systemic Anticancer Therapy and First-Line Response in Patients with Metastatic Renal Cell Carcinoma and ESKD: A Real-World Analysis

Session Information

Category: Onconephrology

  • 1600 Onconephrology

Authors

  • Milanez, Tomaz, Univerzitetni klinicni center Ljubljana, Ljubljana, Slovenia
  • Srinivasan, Vinay, Rowan University Cooper Medical School, Camden, New Jersey, United States
  • Seruga, Bostjan, Onkoloski Institut Ljubljana, Ljubljana, Slovenia
  • Arnol, Miha, Univerzitetni klinicni center Ljubljana, Ljubljana, Slovenia
  • Ocvirk, Janja, Onkoloski Institut Ljubljana, Ljubljana, Slovenia
  • Jaimes, Edgar A., Weill Cornell Medicine, New York, New York, United States
Background

Sequential systemic anticancer therapy (SACT) improves overall survival (OS) in metastatic renal cell carcinoma (mRCC), with more treatment lines associated with longer OS. Real-world data (RWD) across histologies support immune checkpoint inhibitor benefit across treatment lines, although eGFR <30 ml/min is associated with shorter OS. ORR per RECIST in 1st-line SACT is associated with improved OS in mRCC patients, including those receiving IO-based combinations, across IMDC risk groups.

Methods

We retrospectively identified patients with mRCC and ESKD who received SACT with VEGFR-TKIs, ICI, or mTOR inhibitors, alone or in combinations, at the Institute of Oncology Ljubljana in Slovenia between January 2009 and December 2025. OS was defined as time from cohort entry to death from any cause, with censoring at last known vital status or administratively on 31 December 2025. Median OS was calculated across IMDC risk groups. CR, PR, SD, and PD were assessed by physician evaluation of best response per RECIST v1.1.

Results

A total of 41 patients with mRCC and ESKD received SACT. Median age at initiation was 70 years; 80.5% were male and 92.7% had clear cell histology. By IMDC criteria, 34% patients had favorable-risk disease. Among 28 patients receiving 1st-line VEGFR-TKI SACT, PR was 46.4% and SD 25 % as best response. In 10 patients treated with 1st-line ICI-based therapy, PR was 50% and SD 30%. Three patients receiving VEGFR-TKI plus ICI, 2 treated with lenvatinib+pembrolizumab achieved ORR, including 1 CR. The ORR was 54% in patients treated with ICIs or ICI plus VEGFR-TKI. The median OS for entire histology across all IMDC prognostic risk groups was 28 months (95% CI, 18–38). Among patients who received at least one cycle of ICI, the median OS was 47 months (95% CI, 28–66). In patients who received VEGFR-TKIs, mTOR inhibitors, or a combination during the SACT sequence (n = 20) the median OS was 12 months (95% CI, 4–19).

Conclusion

ORR in mRCC patients with ESKD receiving first-line ICI- or ICI+VEGFR-TKI–based SACT was ~8% higher across IMDC groups, with ~34% favorable risk; CR was observed in the ICI+VEGFR-TKI group. Longer median OS was found in patients who received at least one cycle of ICI during sequential SACT. Further observational studies are needed to evaluate the effectiveness of SACT in this cohort.

Funding

  • Other NIH Support