Combinations of immune-checkpoint inhibitors (ICIs) are the standard of care (SOC) for treatment-naive metastatic renal cell carcinoma (mRCC) patients. In this multicenter study, we evaluated the RW safety and efficacy of cabozantinib plus nivolumab in mRCC patients.
Data were retrospectively collected from twelve cancer centers in Germany, Switzerland, and Austria. Patients with advanced or mRCC were eligible. The investigator-based objective response rate (ORR) and progression free survival (PFS) were calculated from the start of the treatment to progression or death. Descriptive statistics and Kaplan-Meier (KM) plots were utilized where appropriate.
In total, 96 eligible patients (66.6% male) with a median age of 66.0 years were included. The most common histology was clear-cell RCC (ccRCC) in 63.4% (n = 61). A prior nephrectomy was performed in 60.4% (n = 58). ECOG 0-1 was 68.8% (n = 66). A partial response was documented in 43.8% of patients (n = 42), a stable disease in 32.3% (n = 31), and a progressive disease in 8.3% (n = 8) as the best overall response. Response data were not evaluable in 13.5% (n = 13). The median follow-up time was 12.7 months (95% CI, 10.0-15.3). The PFS rate at 6 months was 89.8% in the overall population (86.8% for ccRCC; 90.0% for non-ccRCC). Adverse events (AEs) were reported in 82.3% (n = 79) for all grades and 41.7% (n = 40) for grades 3-5. Elevated liver enzymes (34.4%), diarrhea (31.3%), and hand-foot syndrome (29.2%) were the three most frequent AEs of any grade and causality.
In this real-world cohort of mRCC patients, the application of cabozantinib plus nivolumab was shown to be safe and feasible. Our data support the use of cabozantinib plus nivolumab as a first-line standard therapy in mRCC patients. Major limitations were the retrospective data capture and short follow-up time of our study.
Cancers. 2024 Aug 28*** epublish ***
Thomas Hilser, Christopher Darr, Günter Niegisch, Marco Julius Schnabel, Susan Foller, Lorine Häuser, Stefanie Zschäbitz, Jonas Lewerich, Philipp Ivanyi, Katrin Schlack, Pia Paffenholz, Eveline Daetwyler, Dora Niedersüß-Beke, Viktor Grünwald
West German Tumor Center Essen, Department of Internal Medicine, University Hospital Essen, 45147 Essen, Germany., Department of Urology, University Hospital Essen, 45147 Essen, Germany., Department of Urology, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, 40225 Düsseldorf, Germany., Department of Urology, University Regensburg, Caritas-Hospital St. Josef, 93053 Regensburg, Germany., Department of Urology, University Hospital Jena, 07747 Jena, Germany., Department of Urology and Neuro-Urology, Marien Hospital Herne, Ruhr-University Bochum, 44625 Herne, Germany., National Center for Tumor Diseases, Department of Medical Oncology, University Hospital Heidelberg, 69120 Heidelberg, Germany., Department of Urology, Klinikum Rechts der Isar, Technical University Munich, 81675 Munich, Germany., Department of Hemostaesiology, Oncology and Stem Cell Transplantation, Medical University Hannover, 30625 Hannover, Germany., Department of Urology, University Hospital Muenster, 48149 Muenster, Germany., Centre for Integrated Oncology (CIO) Düsseldorf, CIO Aachen-Bonn-Cologne-Düsseldorf, 50937 Köln, Germany., Division of Medical Oncology and Hematology, Cantonal Hospital St. Gallen, 9000 St. Gallen, Switzerland., 1st Department of Medical Oncology and Haematology, Klinik Ottakring, 1160 Vienna, Austria.