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.

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Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.

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Disclosure MG-G: Consultancy or advisory role: Amgen, Astellas Medivation, AstraZeneca, Bayer/Onyx, Bristol Myers Squibb, Eisai, Ipsen, Janssen-Cilag, MSD Oncology, Pfizer, Roche, and Sanofi; Research funding (to institution): AstraZeneca, Ipsen, Janssen-Cilag, Merck, MSD Oncology, Pfizer, and Roche; Travel, accommodations, and expenses: Astellas Pharma, AstraZeneca, Ipsen, Janssen-Cilag, Pfizer, and Roche. LB: Consultancy or advisory role: AstraZeneca, Ipsen, MSD, Novartis, Pfizer, and Roche. MTC: Consultancy or advisory role: Astellas, AstraZeneca, AXDev, Eisai, EMD Serono, Exelixis, Genentech, Pfizer, and SeaGen; Research funding: ApricityHealth, Aravive, AstraZeneca, Exelixis, Janssen, and Pfizer/EMD Serono; Nonbranded educational programs: Bristol Myers Squibb, Merck, Pfizer/EMD Serono, and Roche. AM: Consultancy or advisory role: Bristol Myers Squibb, Clovis Oncology, Eisai, GSK, Ipsen, Pfizer, and Tesaro. BV: Consultancy or advisory role: Bristol Myers Squibb, EUSA Pharma, and Merck Sharp & Dohme; travel/accommodation/expenses: Bristol Myers Squibb, EUSA Pharma, and Ipsen; Research funding (institution): Bristol Myers Squibb, Exelixis, Ipsen, Merck Sharp & Dohme, and Pfizer; Honoraria (self): Bristol Myers Squibb, Ipsen, and Pfizer; Speaker bureau/expert testimony: Bristol Myers Squibb, Eisai, EUSA Pharma, Merck Serono, Merck Sharp & Dohme, and Pfizer. JZ: Research funding: Ipsen. PD: Employment: Ipsen; Stock and other ownership interests: Biogen and Ipsen. GP: Consulting or advisory role: Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Janssen, Ipsen, Lilly, Merck, MSD, Novartis, Pfizer, and Roche. LA: Consulting or advisory role: Astellas Pharma, Bristol Myers Squibb, Ipsen, Janssen, Merck, MSD, Pfizer, and Roche; Travel, accommodation, expenses: Bristol Myers Squibb, Ipsen, and MSD.