The International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score is the most important prognostic score to stratify patients with metastatic renal cell carcinoma (mRCC), helping to guide treatment choice in first line. We hypothesized that IMDC change may also exert a prognostic role in subsequent lines of mRCC therapy.
Meet-URO 15 is a multicenter Italian study of patients with mRCC receiving nivolumab as a second or subsequent line of therapy. This posthoc analysis aimed to evaluate the overall survival (OS) and progression-free survival (PFS) from nivolumab start as primary endpoints, overall response rate (ORR) and disease-control rate (DCR) as secondary endpoints, according to the change in the IMDC category from the first-line setting (baseline) to nivolumab start. Patients with available prognostic IMDC category information at baseline and before nivolumab were included.
492 patients were included in the analysis. At baseline, 165 (33.5%), 287 (58.3%), and 40 patients (8.2%) had favorable, intermediate, and poor IMDC categories, respectively. Before nivolumab, 364 patients (73.9%) remained in the same prognostic category as at baseline, 27 (5.5%) improved, and 101 (20.5%) deteriorated. Significantly longer mPFS (P = .01) and mOS (P < .01) were reached by patients with a stable favorable group compared to those worsening to intermediate/poor. A longer mOS was also achieved from intermediate/poor patients who improved their IMDC category before nivolumab compared to those remaining stable/worsening (P < .01 and P = .04, respectively). Maintaining IMDC category stability from baseline to nivolumab determined a more consistent DCR in favorable patients (P = .03). Overall, patients who improved their IMDC risk score reached better survival outcomes than those who remained stable/deteriorated.
In our sub-analysis, the shift in the IMDC risk category appears to be a helpful prognostic tool for assessing the outcomes of patients with mRCC treated with ≥2nd line nivolumab.
Clinical genitourinary cancer. 2024 Nov 10 [Epub ahead of print]
Brigida Anna Maiorano, Martina Catalano, Chiara Mercinelli, Giandomenico Roviello, Marco Maruzzo, Ugo De Giorgi, Silvia Chiellino, Andrea Sbrana, Luca Galli, Paolo Andrea Zucali, Cristina Masini, Emanuele Naglieri, Giuseppe Procopio, Sara Merler, Lucia Fratino, Cinzia Baldessari, Riccardo Ricotta, Veronica Mollica, Mariella Sorarù, Marianna Tudini, Veronica Prati, Andrea Malgeri, Francesco Atzori, Marilena Di Napoli, Orazio Caffo, Massimiliano Spada, Franco Morelli, Giuseppe Prati, Franco Nolè, Francesca Vignani, Alessia Cavo, Helga Lipari, Silvia Puglisi, Alessio Signori, Andrea Necchi, Giuseppe Luigi Banna, Giuseppe Fornarini, Sebastiano Buti, Sara Elena Rebuzzi
Department of Medical Oncology, IRCCS San Raffaele Hospital, Milan, Italy. Electronic address: ., Department of Health Sciences, University of Florence, Florence, Italy., Department of Medical Oncology, IRCCS San Raffaele Hospital, Milan, Italy; Unit of Medical Oncology 2, Azienda Ospedaliero-Universitana Pisana, Pisa, Italy., Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto (IOV) - Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy., Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy., Medical Oncology Unit, IRCCS Policlinico San Matteo, Pavia, Italy., Oncology Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy., Unit of Medical Oncology 2, Azienda Ospedaliero-Universitana Pisana, Pisa, Italy., Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Department of Oncology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy., Medical Oncology Unit, AUSL-IRCCS of Reggio Emilia, Reggio Emilia, Italy., Division of Medical Oncology, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy., Prostate Program, Genito-urinari Medical Oncology, IRCCS Foundation Istituto Nazionale Tumori, Milan, Italy., Section of Innovation Biomedicine-Oncology Area, Department of Engineering for Innovation Medicine, University of Verona & Verona University & Hospital Trust, Verona, Italy., Medical Oncology, Centro di Riferimento Oncologico di Aviano, National Cancer Institute, Aviano, Italy., Division of Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy., Medical Oncology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) MultiMedica, Milan, Italy., Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., UOC Oncologia, AULSS 6 Euganea, Ospedale di Camposampiero, Padova, Italy., Medical Oncology, St. Salvatore Hospital, L'Aquila, Italy., Oncology Unit, Michele e Pietro Ferrero Hospital, Azienda Sanitaria Locale (ASL) CN 2, Verduno, Italy., Department of Medical Oncology, Fondazione Policlinico Campus Bio-Medico, Roma, Italy., SSD Oncologia Medica, Azienda Sanitaria Locale (ASL) Sulcis, Cagliari, Italy., Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy., Department of Medical Oncology, Santa Chiara Hospital, Trento, Italy., UOC Oncologia Medica, Istituto Fondazione G. Giglio, Cefalù, Italy., Medical Oncology Department, Casa Sollievo Della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy., Department of Oncology, Advanced Technologies AUSL - IRCCS Reggio Emilia, Reggio Emilia, Italy., Medical OncologyDivision of Urogenital & Head & Neck Tumors, IEO, European Institute of Oncology IRCCS, Milano, Italy., Division of Medical Oncology, Ordine Mauriziano Hospital, Torino, Italy., Oncology Unit, Villa Scassi Hospital, Genova, Italy., Division of Medical Oncology, Cannizzaro Hospital, Catania, Italy., Medical Oncology 2 Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy., Department of Health Sciences, University of Genoa, Genoa, Italy., Department of Medical Oncology, IRCCS San Raffaele Hospital, Milan, Italy; Vita e Salute San Raffaele University, Milan, Italy., Portsmouth Hospitals University NHS Trust, Portsmouth, UK; Faculty of Science and Health, School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK., Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino of Genova, Genova, Italy., Oncology Unit, University Hospital of Parma, Parma, Italy; Department of Medicine and Surgery, University of Parma, Parma, Italy., Medical Oncology Unit, Ospedale San Paolo, Savona, Italy.