Cabozantinib llus nivolumab in adult patients with advanced or metastatic renal cell carcinoma

• Verfasst von: Hilser, Thomas Klaus Joseph Wilhelm [VerfasserIn]
• Verfasst von: Darr, Christopher [VerfasserIn]
• Verfasst von: Niegisch, Günter [VerfasserIn]
• Verfasst von: Schnabel, Marco Julius [VerfasserIn]
• Verfasst von: Foller, Susan [VerfasserIn]
• Verfasst von: Häuser, Lorine [VerfasserIn]
• Verfasst von: Zschäbitz, Stefanie [VerfasserIn]
• Verfasst von: Lewerich, Jonas [VerfasserIn]
• Verfasst von: Ivanyi, Philipp [VerfasserIn]
• Verfasst von: Schlack, Katrin [VerfasserIn]
• Verfasst von: Paffenholz, Pia Valerie [VerfasserIn]
• Verfasst von: Daetwyler, Eveline [VerfasserIn]
• Verfasst von: Niedersüß-Beke, Dora [VerfasserIn]
• Verfasst von: Grünwald, Viktor [VerfasserIn]
• Titel: Cabozantinib llus nivolumab in adult patients with advanced or metastatic renal cell carcinoma
• Titelzusatz: a retrospective, non-interventional study in a real-world cohort/GUARDIANS project
• Verf.angabe: 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 and Viktor Grünwald
• E-Jahr: 2024
• Jahr: 28 August 2024
• Umfang: 11 S.
• Illustrationen: Diagramme
• Fussnoten: Gesehen am 10.03.2025
• Titel Quelle: Enthalten in: Cancers
• Ort Quelle: Basel : MDPI, 2009
• Jahr Quelle: 2024
• Band/Heft Quelle: 16(2024), 17, Artikel-ID 2998, Seite 1-11
• ISSN Quelle: 2072-6694
• DOI: doi:10.3390/cancers16172998
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: cabozantinib
• Sach-SW: immunotherapy
• Sach-SW: metastatic renal cell carcinoma
• Sach-SW: real-world data
• K10plus-PPN: 1919438815

Abstract

Introduction: 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. Methods: 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. Results: 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. Discussion/Conclusions: 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.