Cabozantinib in the Routine Management of Renal Cell Carcinoma: A Systematic Literature Review of Real-World Evidence.

Real-world cabozantinib use has increased since its approval to treat patients with advanced renal cell carcinoma (RCC) in 2016. We reviewed cabozantinib use in real-world clinical practice and compared outcomes with pivotal cabozantinib randomized control trials (RCTs). This PRISMA-standard systematic literature review evaluated real-world effectiveness and tolerability of cabozantinib in patients with RCC (PROSPERO registration: CRD42021245854). Systematic MEDLINE, Embase, and Cochrane database searches were conducted on November 2, 2022. Eligible publications included ≥ 20 patients with RCC receiving cabozantinib. After double-screening for eligibility, standardized data were abstracted, qualitatively summarized, and assessed for risk of bias using the Newcastle-Ottawa Scale. Of 353 screened publications, 41 were included, representing approximately 11,000 real-world patients. Most publications reported cabozantinib monotherapy cohort studies (40/41) of retrospective (39/41) and multicenter (32/41) design; most included patients from North America and/or Europe (30/41). Baseline characteristics were demographically similar between real-world and pivotal RCT populations, but real-world populations showed greater variation in prevalence of prior nephrectomy, multiple-site/brain metastasis, and nonclear-cell RCC histology. Cabozantinib activity was reported across real-world treatment lines and tumor types. Overall survival, progression-free survival, and objective response rate values from pivotal RCTs were within the ranges reported for equivalent outcomes across real-world studies. Common real-world grade ≥ 3 adverse events were consistent with those in pivotal RCTs (fatigue, palmar-plantar erythrodysesthesia syndrome, diarrhea, hypertension), but less frequent. No new tolerability concerns were identified. Real-world RCC survival outcomes for cabozantinib monotherapy were broadly consistent with pivotal RCTs, despite greater heterogeneity in real-world populations.

Clinical genitourinary cancer. 2023 Nov 08 [Epub ahead of print]

Marine Gross-Goupil, Lubomir Bodnar, Matthew T Campbell, Agnieszka Michael, Balaji Venugopal, Jakub Żołnierek, Pascale Dutailly, Giuseppe Procopio, Laurence Albiges

Centre Hospitalier Universitaire de Bordeaux Saint André, Bordeaux, France. Electronic address: ., University of Natural Sciences and Humanities in Siedlce, Institute of Health Sciences, Siedlce, Poland., The University of Texas MD Anderson Cancer Center, Houston, TX., University of Surrey, School of Biosciences and Medicine, Guildford, UK., Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow, UK., LuxMed Onkologia, Warsaw, Poland., Ipsen, Boulogne-Billancourt, France., Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy., Institut Gustave Roussy, Paris, France.