Abstract 722P
Background
Cabozantinib (Cabo) is approved in Europe for the treatment of patients (pts) with metastatic renal cell carcinoma (mRCC) in treatment-naïve adults with intermediate or poor risk or following prior VEGFR-targeted therapy CABOREAL describes the use of Cabo in a real-life setting in the largest unselected population to date of Pts with mRCC who have received at least one dose of Cabo. We report here, the use and the activity of Cabo in real-life conditions according to age (<65, 65-75 and >75 years).
Methods
Data were retrospectively collected from 26 centers (NTC03744585). Pts were treated with Cabo via the French Early Access Program from Sep 12, 2016 to Feb 19, 2018. Descriptive analyses were conducted.
Results
Among the 410 pts included, 221 were <65 years, 157 65-75 years, and 32 >75 years. In these subgroups, 42.5%/35.3%, 40.1%/24.8% and 34.4%/40.6% had intermediate/poor IMDC risk, respectively; number of lines of treatment prior to cabo were ≥3 in 41.6%, 38.9% and 50.0% of pts, respectively. For the <65, 65-75 and >75 years subgroups, the starting dose was: 60mg in 79.1%, 65.6% and 40.6%; 40 mg in 19.5%, 31.8% and 50.0%, and 20mg in 1.4%, 1.3% and 9.4%, respectively. The median [95%CI] overall survival (OS) since Cabo initiation was 13.6 months [10.2-15.4], 16.2 months [14.1-19.5] and 13.3 months [6.5-18.3] for <65, 65-75 and >75 years, respectively. Exposure and patterns of use of Cabo are summarized in the table.
Conclusions
Results from this subanalysis of CABOREAL show that in a real-life situation, dose adaptations allowed similar duration of treatment and clinical outcome regardless the age, despite pts >75 years having had a more frequent low starting dose. Table: 722P
Exposure and patterns of use of Cabo
| Age Subgroup, Y | N | Cabo treatment duration Median months [Range] | Average daily dose Median MG [Range] | Dose modification % [95%CI] | Alternative dosing schedule % [95%CI] |
| <65 | 221 | 7.1 [0.1-29.1] | 42.2 [14.9-60.0] | 55.0 [48.4-61.6] | 14.5 [9.9-19.2] |
| 65-75 | 157 | 8.6 [0.1-27.8] | 38.2 [13.9-60.0] | 66.2 [58.8-73.6] | 16.6 [10.7-22.4] |
| >75 | 32 | 7.1 [0.2-17.7] | 33.7 [14.7-60.0] | 46.9 [29.6-64.2] | 18.8 [5.2-32.3] |
Clinical trial identification
NTC03744585.
Editorial acknowledgement
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
M. Gross-Goupil: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca. A. Fléchon: Honoraria (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Travel/Accommodation/Expenses: Bayer; Honoraria (self), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Travel/Accommodation/Expenses: Ipsen. L. Mourey: Honoraria (self), Advisory/Consultancy, Shareholder/Stockholder/Stock options: Sanofi; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: MSD. D. Topart: Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Ipsen; Honoraria (self): Janssen; Honoraria (self): Sanofi; Honoraria (self): BMS. G. Gravis: Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (institution), Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self): Astellas; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen. S. Oudard: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bayer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi. J.M. Tourani: Honoraria (self), Travel/Accommodation/Expenses: Ipsen. L. Geoffrois: Honoraria (self), Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Travel/Accommodation/Expenses: MSD; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self): AstraZeneca. A. Thiery-Vuillemin: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche/Genentech; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy: Astellas. P. Barthélémy: Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Janssen Cilag; Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy: EusaPharma; Advisory/Consultancy: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas. S. Ladoire: Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche. B. Laguerre: Travel/Accommodation/Expenses: Pfizer; Honoraria (self): BMS; Honoraria (self): Roche; Honoraria (self): Ipsen; Honoraria (self): MSD. R. Bourouina: Full/Part-time employment: Ipsen. V. Perrot: Full/Part-time employment: Ipsen. B. Escudier: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Ipsen/Exelixis; Advisory/Consultancy: Roche; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Merck; Advisory/Consultancy: AstraZeneca. L. Albiges: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Amgen; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Roche; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Merck; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Exelixis; Advisory/Consultancy: Peloton Therapeutics; Advisory/Consultancy: Corvus Pharmaceuticals. All other authors have declared no conflicts of interest.