Abstract 670P
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 VEGF-targeted therapy. CABOREAL describes the use of Cabo in a real-world setting (RWS) in the largest unselected population to date of pts with mRCC who received at least one dose of Cabo. We report here, the use and the activity of Cabo in subgroup of pts who received concomitant radiotherapy (cRT) or concomitant bone targeted agents (cBTA).
Methods
Data were retrospectively collected from 26 centers (NCT03744585). Pts were treated with Cabo via the French Early Access Program from Sep 12, 2016 to Feb 19, 2018. Descriptive analyses were conducted. Median overall survival since Cabo initiation (mOS) was assessed but safety was not.
Results
Overall, 410 pts were included. 85 pts received cRT, 24.7% of them received Cabo as 2nd line therapy. 35 pts received cBTA (denosumab or bisphosphonates). Cabo patterns of use are summarized in the table. In the subgroup of pts treated with Cabo and cRT vs no cRT, the median duration of treatment (mDOT) (range) was 10.9 months (m) (0.6;29.1) vs 6.5 m (0.1;28.0) (p<0.001), the mOS was 16.6 m vs 14.2 m and the overall survival rate at 24 m (OS24) was 31.7% vs 29.5%. In the subgroup of pts with bone metastasis (met) treated by Cabo and cBTA vs no cBTA the mDOT (range) was 8.2 m (1.1;22.7) vs 6.9 m (0.1;29.0) (not significant), the mOS 14.8 m vs 12.4 m and the OS24 was 25.3% vs 26.2%. Table: 670P
| Pts subgroup | N | Initiation dose at 60 mg % | Average daily dose median mg | Dose modification % |
| Overall population | ||||
| - Cabo and cRT - Cabo and no cRT | 85 325 | 75.3 69.8 | 37.9 40.0 | 61.2 58.0 |
| Population with bone met | ||||
| - Cabo and cRT for bone met - Cabo and no cRT for bone met | 62 171 | 75.8 69.0 | 40.2 40.1 | 56.5 53.8 |
| - Cabo and cBTA - Cabo and no cBTA | 35 194 | 68.6 71.0 | 36.7 40.5 | 68.6 51.8 |
Conclusions
In a RWS of Cabo use in 2nd/3rd line or beyond for mRCC, the use of cRT was associated with longer DOT suggestive of increase benefit of therapy management strategy. A similar trend was noted in pts treated with cBTA in pts with bone met. A multimodal approach with cRT and cBTA was associated with longer time on treatment with Cabo.
Clinical trial identification
NCT03744585.
Editorial acknowledgement
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
M. Gross-Goupil: Financial Interests, Advisory Board: Ipsen, Roche, BMS, MSD, Pfizer, Novartis, AstraZeneca; Financial Interests, Other, Honoraria (self): Ipsen, Roche, BMS, MSD, Pfizer, Novartis, AstraZeneca; Financial Interests, Other, Travel/accommodations/expenses: Ipsen, Roche, BMS, MSD, Pfizer, Novartis, AstraZeneca. A. Fléchon: Financial Interests, Personal, Other, Honoraria (self): Merck, BMS, Ipsen, Pfizer; Financial Interests, Other, Travel expenses, including accommodations: Merck, BMS, Ipsen, Pfizer. L. Mourey: Financial Interests, Other, Honoraria (self): Sanofi, Astellas, Janssen, Ipsen, BMS, AstraZeneca, Pfizer, MSD; Financial Interests, Advisory Role, Advisory/consultancy: Astellas, Sanofi, BMS, Janssen; Financial Interests, Other, Travel/accommodations/expenses: Sanofi, Astellas, Janssen, Ipsen, BMS, AstraZeneca, Pfizer, MSD. D. Topart: Financial Interests, Institutional, Invited Speaker: Sanofi; Financial Interests, Personal and Institutional, Advisory Board: Janssen; Financial Interests, Personal and Institutional, Expert Testimony: Astellas; Financial Interests, Personal and Institutional, Invited Speaker: BMS. G. Gravis: Financial Interests, Institutional, Advisory Board: BMS, Janssen, Pfizer, Alliance Merck-Pfizer, AAA; Financial Interests, Institutional, Invited Speaker: Astellas, MSD, Janssen, Amgen, BMS, Sanofi; Financial Interests, Institutional, Funding: Janssen; Financial Interests, Institutional, Principal Investigator, Coordinating PI: BMS; Financial Interests, Other, Travel/Accommodations/Expenses: BMS, Janssen, Sanofi. S.M. Oudard: Financial Interests, Advisory Board: AstraZeneca, Merck, Sanofi, Novartis, BMS, Ipsen, Astellas, Janssen, Pfizer, Bayer; Financial Interests, Personal, Other, Honoraria (self): AstraZeneca, Merck, Sanofi, Novartis, BMS, Ipsen, Astellas, Janssen, Pfizer, Bayer; Financial Interests, Other, Travel expenses, including accommodations: AstraZeneca, Merck, Sanofi, Novartis, BMS, Ipsen, Astellas, Janssen, Pfizer, Bayer; Financial Interests, Institutional, Research Grant: AstraZeneca, Sanofi, BMS, Ipsen, Janssen, Pfizer, Bayer; Financial Interests, Institutional, Funding: AstraZeneca, Sanofi, BMS, Ipsen, Janssen, Pfizer, Bayer; Financial Interests, Other, Travel/Accommodations/Expenses: AstraZeneca, Merck, Sanofi, Novartis, BMS, Ipsen, Astellas, Janssen, Pfizer, Bayer. L. Geoffrois: Financial Interests, Personal, Advisory Board: Ipsen, BMS, Pfizer, MSD, Merck; Financial Interests, Personal, Invited Speaker: Ipsen. A. Thiery-Vuillemin: Financial Interests, Other, Honoraria: Pfizer, AstraZeneca, Sanofi, Janssen, Novartis, Ipsen, Roche/Genentech, BMS, MSD, Astellas; Financial Interests, Advisory Role, Consulting or Advisory Role: Pfizer, AstraZeneca, Sanofi, Janssen, Novartis, Ipsen, Roche/Genentech, BMS, MSD, Astellas; Financial Interests, Institutional, Funding, Research funding: Pfizer; Financial Interests, Other, Travel, Accommodations, Expenses: Pfizer, AstraZeneca, Janssen, Ipsen, Roche/Genentech, MSD, Astellas. P. Barthelemy: Financial Interests, Advisory Role, Advisory/consultancy fees: Amgen, Astellas, BMS, Janssen Cilag, EUSA Pharma, Ipsen, MSD, Novartis, Pfizer, Roche, Sanofi; Financial Interests, Other, Travel expenses, including accommodations: Astellas, BMS, Ipsen, Janssen, MSD, Pfizer, Roche, Sanofi; Financial Interests, Other, Travel/accommodations/expenses: BMS, Ipsen, Janssen, MSD, Pfizer, Roche; Financial Interests, Other, Honoraria: Seagen. S. Ladoire: Financial Interests, Institutional, Funding, Research funding: Novartis; Financial Interests, Personal, Expert Testimony: Lilly, Pfizer, Novartis, BMS, Astellas, Roche, Ipsen, Janssen, Sanofi; Financial Interests, Personal, Other, Travel/accommodations/expenses: Pfizer, Novartis, AstraZeneca, Sanofi, Astellas, Janssen, Ipsen, BMS. B. Laguerre: Financial Interests, Other, Honoraria (self): Pfizer, AstraZeneca, Janssen, Astellas, Ipsen, MSD, Roche; Financial Interests, Other, Travel expenses, including accommodations: Pfizer, Novartis, BMS. L. Zara: Financial Interests, Personal, Full or part-time Employment: Ipsen. V. Perrot: Financial Interests, Personal, Full or part-time Employment: Ipsen. B. Escudier: Financial Interests, Personal, Advisory Board: Pfizer, BMS, Ipsen, Aveo, Eisai. L. Albiges: Financial Interests, Institutional, Other, Honoraria Advisory/Consultancy: Astellas, AstraZeneca, Bellerophon, BMS, Corvus Pharmaceuticals, Ipsen, Janssen, Merck & Co, MSD, Novartis, Pfizer, Springer Healthcare; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Funding: BMS. All other authors have declared no conflicts of interest.