Background The Meet-URO score allowed a more accurate prognostication than the International Metastatic RCC Database Consortium (IMDC) for patients with pre-treated metastatic renal cell carcinoma (mRCC) by adding the pre-treatment neutrophil-to-lymphocyte ratio and presence of bone metastases. Materials and methods A post hoc analysis was carried out to validate the Meet-URO score on the overall survival (OS) of patients with IMDC intermediate-poor-risk mRCC treated with first-line nivolumab plus ipilimumab within the prospective Italian Expanded Access Programme (EAP). We additionally considered progression-free survival (PFS) and disease response rates. Harrell’s c-index was calculated to compare the accuracy of survival prediction. Results Overall the EAP included 306 patients, with a median follow-up of 12.2 months, median OS was not reached, 1-year OS was 66.8% and median PFS was 7.9 months. By univariable analysis, both the IMDC score and the two additional variables of the Meet-URO score were associated with either OS or PFS (P < 0.001 for all comparisons). The four Meet-URO risk groups (G) had 1-year OS of 92%, 72%, 50% and 21% for G2 (29.1% of patients), G3 (28.8%), G4 (33.0%) and G5 (9.1%), respectively. OS was significantly shorter in each consecutive G (P = 0.001 for G3, P < 0.001 for both G4 and G5 compared to G2). Similarly, Meet-URO Gs 2-5 showed decreasing median PFS and response rates. The Meet-URO score showed the highest c-index for both OS (0.73) and PFS (0.67). Limitations include the post hoc nature of this analysis and the lack of a comparative arm to assess predictive value. Conclusion The Meet-URO score appeared to show better prognostic classification than the IMDC alone in patients with mRCC at IMDC intermediate-poor risk treated with first-line nivolumab and ipilimumab.

Validation of the Meet-URO score in patients with metastatic renal cell carcinoma receiving first-line nivolumab and ipilimumab in the Italian Expanded Access Program / Rebuzzi, S. E.; Signori, A.; Buti, S.; Banna, G. L.; Murianni, V.; Damassi, A.; Maruzzo, M.; Giannarelli, D.; Tortora, G.; Galli, L.; Rizzo, M.; De Giorgi, U.; Antonuzzo, L.; Bracarda, S.; Cartenì, G.; Atzori, F.; Tamberi, S.; Procopio, G.; Fratino, L.; Lo Re, G.; Santoni, M.; Baldessari, C.; Astone, A.; Calabrò, F.; Brunelli, M.; Porta, C.; Rescigno, P.; Basso, U.; Fornarini, G.. - In: ESMO OPEN. - ISSN 2059-7029. - 7:6(2022), p. 100634. [10.1016/j.esmoop.2022.100634]

Validation of the Meet-URO score in patients with metastatic renal cell carcinoma receiving first-line nivolumab and ipilimumab in the Italian Expanded Access Program

Buti, S.;
2022-01-01

Abstract

Background The Meet-URO score allowed a more accurate prognostication than the International Metastatic RCC Database Consortium (IMDC) for patients with pre-treated metastatic renal cell carcinoma (mRCC) by adding the pre-treatment neutrophil-to-lymphocyte ratio and presence of bone metastases. Materials and methods A post hoc analysis was carried out to validate the Meet-URO score on the overall survival (OS) of patients with IMDC intermediate-poor-risk mRCC treated with first-line nivolumab plus ipilimumab within the prospective Italian Expanded Access Programme (EAP). We additionally considered progression-free survival (PFS) and disease response rates. Harrell’s c-index was calculated to compare the accuracy of survival prediction. Results Overall the EAP included 306 patients, with a median follow-up of 12.2 months, median OS was not reached, 1-year OS was 66.8% and median PFS was 7.9 months. By univariable analysis, both the IMDC score and the two additional variables of the Meet-URO score were associated with either OS or PFS (P < 0.001 for all comparisons). The four Meet-URO risk groups (G) had 1-year OS of 92%, 72%, 50% and 21% for G2 (29.1% of patients), G3 (28.8%), G4 (33.0%) and G5 (9.1%), respectively. OS was significantly shorter in each consecutive G (P = 0.001 for G3, P < 0.001 for both G4 and G5 compared to G2). Similarly, Meet-URO Gs 2-5 showed decreasing median PFS and response rates. The Meet-URO score showed the highest c-index for both OS (0.73) and PFS (0.67). Limitations include the post hoc nature of this analysis and the lack of a comparative arm to assess predictive value. Conclusion The Meet-URO score appeared to show better prognostic classification than the IMDC alone in patients with mRCC at IMDC intermediate-poor risk treated with first-line nivolumab and ipilimumab.
Validation of the Meet-URO score in patients with metastatic renal cell carcinoma receiving first-line nivolumab and ipilimumab in the Italian Expanded Access Program / Rebuzzi, S. E.; Signori, A.; Buti, S.; Banna, G. L.; Murianni, V.; Damassi, A.; Maruzzo, M.; Giannarelli, D.; Tortora, G.; Galli, L.; Rizzo, M.; De Giorgi, U.; Antonuzzo, L.; Bracarda, S.; Cartenì, G.; Atzori, F.; Tamberi, S.; Procopio, G.; Fratino, L.; Lo Re, G.; Santoni, M.; Baldessari, C.; Astone, A.; Calabrò, F.; Brunelli, M.; Porta, C.; Rescigno, P.; Basso, U.; Fornarini, G.. - In: ESMO OPEN. - ISSN 2059-7029. - 7:6(2022), p. 100634. [10.1016/j.esmoop.2022.100634]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2935411
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