Venugopal, B., Pillai, M., Powles, T., Savage, P., Michael, A., Fife, K., Klair, B., Perrot, V. and Szabados, B. (2022) Early clinical experience with cabozantinib for advanced renal cell carcinoma in the UK: real-world treatment pathways and clinical outcomes. Clinical Genitourinary Cancer, 20(1), 94-94.e10. (doi: 10.1016/j.clgc.2021.09.005) (PMID:34802966)
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Abstract
BACKGROUND: Cabozantinib monotherapy is approved in the UK for patients with treatment-naïve intermediate- or poor-risk advanced renal cell carcinoma (aRCC), or patients who received prior vascular endothelial growth factor-targeted therapy. Data are limited on the real-world use of cabozantinib for aRCC. PATIENTS AND METHODS: CERES (NCT03696407) was a retrospective study of patients with aRCC who received cabozantinib through the UK managed access programme (MAP; August 2016-July 2017), at which time cabozantinib had European regulatory approval for second- or later-line use only. The study objectives were to characterize aRCC treatment patterns and evaluate cabozantinib effectiveness. Outcomes were stratified by cabozantinib treatment line, MAP treatment date (months 0-7 vs. 8-12) and (post hoc) Charlson Comorbidity Index (CCI; ≥ 6 vs. < 6). RESULTS: Of 100 patients included, 99% had stage IV disease, 63% had a CCI ≥ 6 and 81% had an Eastern Cooperative Oncology Group Performance Status 0-1. Median (range) duration of follow-up was 10.8 (0.4-33.5) months. Cabozantinib was administered as second-line, third-line and fourth- or later-line in 41%, 31% and 28% of patients, respectively. Most patients (84%) initiated cabozantinib at 60 mg. Average (range) cabozantinib dose was 45.5 (19.6-59.8) mg/day; 66% of patients had ≥ 1 dose reduction. Disease progression was the most common reason for discontinuation (65.1%). Median (95% confidence interval) progression-free survival (PFS) and overall survival (OS) were 6.01 (5.16-7.85) and 10.84 (7.92-16.85) months, respectively. Overall response rate was 34.5%; disease control rate 70.1% and duration of response 6.9 (1.8-26.9) months. No significant differences in survival estimates were observed between treatment line or treatment date subgroups. Total CCI score ≤ 6 (vs. > 6) was associated with prolonged median PFS and OS. CONCLUSION: Cabozantinib demonstrated clinical activity in this UK real-world aRCC population. The results provide a benchmark for future real-world studies in aRCC.
Item Type: | Articles |
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Status: | Published |
Refereed: | Yes |
Glasgow Author(s) Enlighten ID: | Venugopal, Dr Balaji |
Authors: | Venugopal, B., Pillai, M., Powles, T., Savage, P., Michael, A., Fife, K., Klair, B., Perrot, V., and Szabados, B. |
College/School: | College of Medical Veterinary and Life Sciences > School of Cancer Sciences |
Journal Name: | Clinical Genitourinary Cancer |
Publisher: | Elsevier |
ISSN: | 1558-7673 |
ISSN (Online): | 1938-0682 |
Published Online: | 08 October 2021 |
Copyright Holders: | Copyright © 2021 The Authors |
First Published: | First published in Clinical Genitourinary Cancer 20(1):94-94.e10 |
Publisher Policy: | Reproduced under a Creative Commons licence |
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