Papillary Renal Cell Carcinoma: Outcomes for Patients Receiving First-line Immune-based Combinations or Tyrosine Kinase Inhibitors from the ARON-1 Study.

Papillary renal cell carcinoma (pRCC) is the most frequent histological subtype of non-clear cell RCC (nccRCC). Owing to the heterogeneity of nccRCC, patients are often excluded from large phase 3 trials focused on clear cell RCC, so treatment options for nccRCC remain limited. Our aim was to investigate the efficacy of first-line treatment with tyrosine kinase inhibitors (TKIs) or immuno-oncology (IO)-based combinations in patients with pRCC.

We performed a multicenter retrospective analysis of real-world data collected for patients with advanced pRCC treated in 40 centers in 12 countries as part of the ARON-1 project (NCT05287464). The primary endpoints were overall survival (OS), progression-free survival (PFS), the overall response rate (ORR), and time to second progression (PFS2). OS, PFS, and PFS2 were estimated using the Kaplan-Meier method and results were compared between the treatment groups using a log-rank test. Univariate and multivariable analyses were carried out using Cox proportional-hazard models.

We included 200 patients with metastatic pRCC, of whom 73 were treated with IO-based combinations and 127 with TKIs. Median OS was 22.5 mo in the TKI group 28.8 mo in the IO group (p = 0.081). Median PFS was 6.4 mo in the TKI group and 17.4 mo in the IO group (p < 0.001). The ORR was higher in the IO group than in the TKI group (41% vs 27%; p = 0.037).

Our results show that IO-based combinations have superior efficacy outcomes to TKIs for first-line treatment of metastatic pRCC.

The ARON-1 project collects clinical data for patients with kidney cancer treated in multiple centers worldwide to assess outcomes in the real-world setting. We analyzed data for patients with metastatic kidney cancer of a specific subtype to evaluate the efficacy of different first-line treatments. Patients treated with immune-based combinations had better outcomes than patients treated with tyrosine kinase inhibitors.

European urology oncology. 2024 Apr 03 [Epub ahead of print]

Francesco Massari, Veronica Mollica, Ondrej Fiala, Ugo De Giorgi, Jakub Kucharz, Maria Giuseppa Vitale, Javier Molina-Cerrillo, Gaetano Facchini, Emmanuel Seront, Edoardo Lenci, Maria T Bourlon, Francesco Carrozza, Renate Pichler, Cristian Lolli, Zin W Myint, Ravindran Kanesvaran, Mariangela Torniai, Pasquale Rescigno, Alfonso Gomez de Liaño, Roubini Zakopoulou, Sebastiano Buti, Camillo Porta, Enrique Grande, Matteo Santoni

Department of Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Department of Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy. Electronic address: ., Department of Oncology and Radiotherapeutics, Faculty of Medicine and University Hospital Pilsen, Charles University, Pilsen, Czechia; Biomedical Center, Faculty of Medicine, Charles University, Pilsen, Czechia., Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy., Department of Uro-oncology, Maria Sklodowska-Curie National Research Institute of Oncology Warsaw, Poland., Division of Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy., Department of Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain., Medical Oncology Unit, SM delle Grazie Hospital, Pozzuoli, Italy., Department of Medical Oncology, Centre Hospitalier de Jolimont, Haine Saint Paul, Belgium., UOC Oncologia, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy., Hematology and Oncology Department, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico., Oncology Unit, Santa Maria delle Croci Hospital, Department of Oncology and Hematology, AUSL Romagna, Ravenna, Italy., Department of Urology, Medical University of Innsbruck, Innsbruck, Austria., Markey Cancer Center, University of Kentucky, Lexington, KY, USA., Division of Medical Oncology, National Cancer Centre Singapore, Singapore., UOC Oncologia Medica, Ospedale A. Murri, Fermo, Italy., Translational and Clinical Research Institute, Centre for Cancer, Newcastle University, Newcastle upon Tyne, UK., Medical Oncology Department, CHU Insular-Materno Infantil, Las Palmas, Spain., 2nd Department of Propedeutic Internal Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece., Medical Oncology Unit, University Hospital Parma, Parma, Italy., Interdisciplinary Department of Medicine, Aldo Moro University of Bari, Bari, Italy; Division of Medical Oncology, A.O.U. Consorziale Policlinico di Bari, Bari, Italy., Department of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain., Oncology Unit, Macerata Hospital, Macerata, Italy.