Purpose <p>This study aimed to evaluate the treatment outcomes and safety of cabozantinib plus nivolumab (C + N) and lenvatinib plus pembrolizumab (L + P) for patients with metastatic renal cell carcinoma (mRCC).</p> Methods <p>This multicenter retrospective analysis included 92 patients with mRCC treated with either C + N or L + P as first-line therapy between April 2018 and August 2024. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (TRAEs) were compared. Multivariable analysis was performed to identify independent prognostic factors for PFS.</p> Results <p>Fifty-three patients received C + N and 39 received L + P. PFS (24.1&#xa0;months vs. not reached, <i>P</i> = 0.725) and OS (46.7&#xa0;months vs. not reached, <i>P</i> = 0.912) were not significantly different between the C + N and L + P groups. Over a median follow-up duration of 13.9&#xa0;months, 31 patients experienced disease progression and 12 died. ORR was higher in the C + N group than in the L + P group (79% vs. 49%, <i>P</i> = 0.002), whereas DCR (100% vs. 95%, <i>P</i> = 0.096) and grade ≥ 3 TRAEs (47% vs. 36%, <i>P</i> = 0.280) were comparable. In the multivariable analysis, the treatment regimen (C + N as a reference) was not significantly associated with PFS (hazard ratio: 0.76, <i>P</i> = 0.476). Favorable/intermediate International mRCC Database Consortium risk was identified as an independent prognostic factor for PFS.</p> Conclusion <p>Treatment with C + N and L + P resulted in comparable PFS, OS, and safety profiles in patients with mRCC. Both regimens can be used to treat mRCC based on individual characteristics.</p>

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Comparison of clinical outcomes of cabozantinib plus nivolumab and lenvatinib plus pembrolizumab in patients with metastatic renal cell carcinoma

  • Kazutaka Nakamura,
  • Kazuhiko Yoshida,
  • Yuki Kobari,
  • Yuki Nemoto,
  • Hiroki Ishihara,
  • Hironori Fukuda,
  • Junpei Iizuka,
  • Hiroaki Shimmura,
  • Hiroshi Kobayashi,
  • Yasunobu Hashimoto,
  • Tsunenori Kondo,
  • Toshio Takagi

摘要

Purpose

This study aimed to evaluate the treatment outcomes and safety of cabozantinib plus nivolumab (C + N) and lenvatinib plus pembrolizumab (L + P) for patients with metastatic renal cell carcinoma (mRCC).

Methods

This multicenter retrospective analysis included 92 patients with mRCC treated with either C + N or L + P as first-line therapy between April 2018 and August 2024. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (TRAEs) were compared. Multivariable analysis was performed to identify independent prognostic factors for PFS.

Results

Fifty-three patients received C + N and 39 received L + P. PFS (24.1 months vs. not reached, P = 0.725) and OS (46.7 months vs. not reached, P = 0.912) were not significantly different between the C + N and L + P groups. Over a median follow-up duration of 13.9 months, 31 patients experienced disease progression and 12 died. ORR was higher in the C + N group than in the L + P group (79% vs. 49%, P = 0.002), whereas DCR (100% vs. 95%, P = 0.096) and grade ≥ 3 TRAEs (47% vs. 36%, P = 0.280) were comparable. In the multivariable analysis, the treatment regimen (C + N as a reference) was not significantly associated with PFS (hazard ratio: 0.76, P = 0.476). Favorable/intermediate International mRCC Database Consortium risk was identified as an independent prognostic factor for PFS.

Conclusion

Treatment with C + N and L + P resulted in comparable PFS, OS, and safety profiles in patients with mRCC. Both regimens can be used to treat mRCC based on individual characteristics.