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.

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.

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.

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.

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.

ESMO open. 2022 Dec 06 [Epub ahead of print]

S E Rebuzzi, A Signori, S Buti, G L Banna, V Murianni, A Damassi, M Maruzzo, D Giannarelli, G Tortora, L Galli, M Rizzo, U De Giorgi, L Antonuzzo, S Bracarda, G Cartenì, F Atzori, S Tamberi, G Procopio, L Fratino, G Lo Re, M Santoni, C Baldessari, A Astone, F Calabrò, M Brunelli, C Porta, P Rescigno, U Basso, G Fornarini

Medical Oncology Unit, San Paolo General Hospital, Savona; Department of Internal Medicine and Medical Specialties (Di.M.I.), University of Genova, Genova., Health Sciences, Section of Biostatistics, University of Genova, Genova., Medical Oncology Unit, University Hospital of Parma, Parma; Department of Medicine and Surgery, University of Parma, Parma, Italy., Department of Oncology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK. Electronic address: ., Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino, Genova., Academic Unit of Medical Oncology, IRCCS Ospedale Policlinico San Martino, Genova., Oncology Unit 1, Istituto Oncologico Veneto IOV-IRCCS, Padova., Department of Biostatistics, IRCCS Regina Elena National Cancer Institute, Rome., Medical Oncology, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome; Medical Oncology, Università Cattolica del Sacro Cuore, Rome., Medical Oncology, Azienda Ospedaliero-Universitaria Pisana, Pisa., Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia., Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola., Clinical Oncology Unit, Careggi University Hospital, Florence; Department of Experimental and Clinical Medicine, University of Florence, Florence., Medical and Translational Oncology, Department of Oncology, Azienda Ospedaliera Santa Maria, Terni., Division of Oncology, Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli, Napoli., Medical Oncology Department, University Hospital, University of Cagliari, Cagliari., Oncology Unit, Ospedale 'degli Infermi', Faenza., SS Oncologia Medica Genitourinaria, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano., Department of Medical Oncology, Centro di Riferimento Oncologico di Aviano CRO-IRCCS, Aviano., Oncology Unit, Macerata Hospital, Macerata., Department of Oncology and Hematology, University Hospital of Modena, Modena., Division of Medical Oncology, Fatebenefratelli San Pietro Hospital, Rome., Division of Medical Oncology, San Camillo Forlanini Hospital, Rome., Department of Diagnostics and Public Health, Pathology Unit, University and Hospital Trust of Verona, Verona., Interdisciplinary Department of Medicine, University of Bari 'A. Moro', Bari; Division of Medical Oncology, A.O.U. Consorziale Policlinico di Bari, Bari, Italy., Department of Oncology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK.