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Background <p>Immune checkpoint inhibitor doublet (ICI-ICI) and ICI plus tyrosine kinase inhibitor (ICI-TKI) regimens are the cornerstone of treatment for metastatic renal cell carcinoma (mRCC), although no head-to-head comparisons are currently available. This study aimed to compare the real-world effectiveness of ICI-ICI versus ICI-TKI combinations in patients with intermediate- and poor-risk mRCC according to International Metastatic RCC Database Consortium (IMDC).</p> Methods <p>The Meet-URO 33 study is a multicentre retrospective-prospective registry collecting real-world data on patients with mRCC. Multivariable logistic and Cox models were built for objective response rate (ORR), PFS and OS, with a propensity score (PS) adjustment for baseline imbalances.</p> Results <p>Among 1497 patients, 755 were intermediate-risk (199 ICI-ICI, 556 ICI-TKI) and 312 poor-risk (77 ICI-ICI, 212 ICI-TKI). Median follow-up was 14.2&#xa0;months (8.0&#xa0;months and 14.5&#xa0;months in poor- and intermediate-risk subgroups, respectively). In poor-risk patients, median OS was 20.3 versus 12.9&#xa0;months (HR 0.87, 95% CI 0.59–1.28, <i>p</i> = 0.49), and median PFS was 6.7 versus 8.7&#xa0;months (HR 1.10, 95% CI 0.79–1.54, <i>p</i> = 0.53), for ICI-ICI versus ICI–TKI, respectively. In the intermediate-risk patients treated with ICI-ICI versus ICI-TKI, median OS was 37.8 versus 35.5&#xa0;months (HR 1.08; 95% CI 0.77–1.50; <i>p</i> = 0.65), and median PFS was 17.8 versus 18.6&#xa0;months (HR 1.29, 95% CI 1.00–1.66, <i>p</i> = 0.050). ORR was 42.9% versus 45.8% in poor-risk patients (OR 0.72, 95% CI 0.39–1.34, <i>p</i> = 0.303) and 48.1% versus 54.3% in intermediate-risk patients (OR 0.71, 95% CI 0.48–1.04, <i>p</i> = 0.075).</p> Conclusions <p>No statistically significant differences in survival or response were observed between ICI-ICI and ICI-TKI combinations in patients with IMDC intermediate- and poor-risk mRCC.</p>

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Effectiveness of ICI-ICI versus ICI-TKI combinations in patients with IMDC intermediate- and poor-risk metastatic renal cell carcinoma: a sub-analysis of the MEET-URO 33 study

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  • 发表日期：

    2026年2月3日

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  • Michele Maffezzoli,
  • Alessio Signori,
  • Alessandro Acunzo,
  • Sebastiano Buti,
  • Michela Bosoni,
  • Elena Verzoni,
  • Andrea Di Marco,
  • Cristian Lolli,
  • Marilena Di Napoli,
  • Martina Fanelli,
  • Alberto Dalla Volta,
  • Cristina Masini,
  • Giandomenico Roviello,
  • Roberto Iacovelli,
  • Alessia Mennitto,
  • Roberto Filippi,
  • Mariella Sorarù,
  • Luigi Formisano,
  • Annalisa Guida,
  • Emanuela Fantinel,
  • Carlo Messina,
  • Lucia Bonomi,
  • Sarah Scagliarini,
  • Cecilia Nasso,
  • Silvia Chiellino,
  • Brigida Anna Maiorano,
  • Filippo Deppieri,
  • Alessia Cavo,
  • Vincenza Conteduca,
  • Silvia Zai,
  • Paolo Andrea Zucali,
  • Marcello Tucci,
  • Francesca Vignani,
  • Francesca La Russa,
  • Laura Lombardo,
  • Claudia Caserta,
  • Federico Paolieri,
  • Francesca Bertolotti,
  • Pasquale Rescigno,
  • Giuseppe Luigi Banna,
  • Giuseppe Fornarini,
  • Davide Bimbatti,
  • Sara Elena Rebuzzi

摘要

Background

Immune checkpoint inhibitor doublet (ICI-ICI) and ICI plus tyrosine kinase inhibitor (ICI-TKI) regimens are the cornerstone of treatment for metastatic renal cell carcinoma (mRCC), although no head-to-head comparisons are currently available. This study aimed to compare the real-world effectiveness of ICI-ICI versus ICI-TKI combinations in patients with intermediate- and poor-risk mRCC according to International Metastatic RCC Database Consortium (IMDC).

Methods

The Meet-URO 33 study is a multicentre retrospective-prospective registry collecting real-world data on patients with mRCC. Multivariable logistic and Cox models were built for objective response rate (ORR), PFS and OS, with a propensity score (PS) adjustment for baseline imbalances.

Results

Among 1497 patients, 755 were intermediate-risk (199 ICI-ICI, 556 ICI-TKI) and 312 poor-risk (77 ICI-ICI, 212 ICI-TKI). Median follow-up was 14.2 months (8.0 months and 14.5 months in poor- and intermediate-risk subgroups, respectively). In poor-risk patients, median OS was 20.3 versus 12.9 months (HR 0.87, 95% CI 0.59–1.28, p = 0.49), and median PFS was 6.7 versus 8.7 months (HR 1.10, 95% CI 0.79–1.54, p = 0.53), for ICI-ICI versus ICI–TKI, respectively. In the intermediate-risk patients treated with ICI-ICI versus ICI-TKI, median OS was 37.8 versus 35.5 months (HR 1.08; 95% CI 0.77–1.50; p = 0.65), and median PFS was 17.8 versus 18.6 months (HR 1.29, 95% CI 1.00–1.66, p = 0.050). ORR was 42.9% versus 45.8% in poor-risk patients (OR 0.72, 95% CI 0.39–1.34, p = 0.303) and 48.1% versus 54.3% in intermediate-risk patients (OR 0.71, 95% CI 0.48–1.04, p = 0.075).

Conclusions

No statistically significant differences in survival or response were observed between ICI-ICI and ICI-TKI combinations in patients with IMDC intermediate- and poor-risk mRCC.