BACKGROUND AND OBJECTIVE: 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. METHODS: 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. KEY FINDINGS AND LIMITATIONS: 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). CONCLUSIONS AND CLINICAL IMPLICATIONS: Our results show that IO-based combinations have superior efficacy outcomes to TKIs for first-line treatment of metastatic pRCC. PATIENT SUMMARY: 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.

2nd Department of Propedeutic Internal Medicine Attikon University Hospital National and Kapodistrian University of Athens Athens Greece

Department of Medical Oncology Centre Hospitalier de Jolimont Haine Saint Paul Belgium

Department of Medical Oncology Hospital Ramón y Cajal Madrid Spain

Department of Medical Oncology IRCCS Azienda Ospedaliero Universitaria di Bologna Bologna Italy

Department of Medical Oncology IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola Italy

Department of Medical Oncology MD Anderson Cancer Center Madrid Madrid Spain

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 Uro oncology Maria Sklodowska Curie National Research Institute of Oncology Warsaw Poland

Department of Urology Medical University of Innsbruck Innsbruck Austria

Division of Medical Oncology National Cancer Centre Singapore Singapore

Division of Oncology Department of Oncology and Hematology University Hospital of Modena Modena Italy

Hematology and Oncology Department Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico City Mexico

Interdisciplinary Department of Medicine Aldo Moro University of Bari Bari Italy; Division of Medical Oncology A O U Consorziale Policlinico di Bari Bari Italy

Markey Cancer Center University of Kentucky Lexington KY USA

Medical Oncology Department CHU Insular Materno Infantil Las Palmas Spain

Medical Oncology Unit SM delle Grazie Hospital Pozzuoli Italy

Medical Oncology Unit University Hospital Parma Parma Italy

Oncology Unit Macerata Hospital Macerata Italy

Oncology Unit Santa Maria delle Croci Hospital Department of Oncology and Hematology AUSL Romagna Ravenna Italy

Translational and Clinical Research Institute Centre for Cancer Newcastle University Newcastle upon Tyne UK

UOC Oncologia Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro Italy

UOC Oncologia Medica Ospedale A Murri Fermo Italy

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