Real-world evidence of cabozantinib in patients with metastatic renal cell carcinoma: Results from the CABOREAL Early Access Program.

BACKGROUND

Real-world data on cabozantinib in metastatic renal cell carcinoma (mRCC) is limited. This study (CABOREAL) reports treatment patterns and outcomes for patients treated with cabozantinib through the French Early Access Program.

PATIENTS AND METHODS

This multicentre (n = 26), observational, retrospective study enrolled patients with mRCC who had received ≥1 dose of cabozantinib. Overall survival (OS) was estimated using the Kaplan-Meier method; subgroups were compared using the log-rank test. A multiple Cox regression model assessed predictive factors of OS after cabozantinib initiation.

RESULTS

Four hundred and ten recruited patients started treatment between September 2016 and February 2018: the Eastern Cooperative Oncology Group Performance Status ≥2, 39.3%; poor International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk, 31.7%; 0-1, 2 and ≥3 previous treatment lines, 25.3%, 33.4% and 41.2%, respectively; bone metastases, 55.9%; brain metastases, 16.8%. Median (min-max) follow-up was 14.4 (0-30) months. Overall, 57.0% of patients had a dose reduction, 15.6% an alternative dose schedule. The median average daily dose was 40.0 mg. Median (quartile [Q]1-Q3) treatment duration was 7.6 (0.1-29.1) months, median OS was 14.4 months, and the 12-month OS rate was 56.5% (95% confidence interval: 51.5-61.2). Most patients (54.4%) received subsequent treatment. Predictive factors associated with longer OS were body mass index ≥25 kg/m

CONCLUSIONS

In the largest real-world study to date, cabozantinib was effective in unselected, heavily pretreated patients with mRCC. Initiation at 60 mg/day was associated with improved outcomes. CLINICALTRIALS.

GOV IDENTIFIER

NCT03744585.

Informations de copyright

Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest statement Laurence Albiges reports receiving funding from Amgen, Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Exelixis, Ipsen, Merck KGaA, MSD, Novartis, Pfizer and Roche. Aude Fléchon reports receiving honoraria and travel expenses from Bristol Myers Squibb, Ipsen, MSD, Novartis, Pfizer and Roche. Christine Chevreau reports receiving honoraria from AstraZeneca, Bristol Myers Squibb, Ipsen, MSD and Pfizer. Delphine Topart reports receiving honoraria from Amgen, Astellas, Bristol Myers Squibb, Ipsen, Janssen and Pfizer. Gwenaëlle Gravis reports receiving travel expenses from Astellas, Bristol Myers Squibb, Ipsen, Janssen, Pfizer and Sanofi. Stéphane Oudard reports receiving honoraria from Bayer, Bristol Myers Squibb, Ipsen, Merck KGaA, MSD, Novartis and Pfizer. Lionnel Geoffrois reports receiving honoraria from Bristol Myers Squibb, Ipsen, Janssen, Merck KGaA and MSD. Antoine Thiery-Vuillemin's institution reports receiving funding from Pfizer. Antoine Thiery-Vuillemin reports receiving consulting fees and honoraria from Bristol Myers Squibb, Ipsen, MSD, Novartis, Pfizer and Roche. Philippe Barthélémy reports being on the advisory boards of Bristol Myers Squibb, Ipsen, Janssen, MSD, Novartis, Pfizer and Roche, and receiving honoraria from Astellas, EUSA Pharma and Sanofi. Sylvain Ladoire reports receiving travel, accommodation and consulting fees from Ipsen. Brigitte Laguerre reports receiving honoraria from Sanofi. Bernard Escudier reports receiving funding from Aveo, Bristol Myers Squibb, Ipsen, Novartis, Pfizer and Roche. Marine Gross-Goupil reports receiving honoraria from Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Janssen, Merck KGaA, MSD, Novartis, Pfizer, Roche and Sanofi. Valérie Perrot and Anaïs Billard report being employees of Ipsen. Other authors declare no conflict of interest relating to the submitted work.