Abstract 741P
Background
Before July 2017, cabozantinib was available in the UK via a MAP, thereby generating early clinical experience with this treatment. Here we describe baseline characteristics and clinical outcomes of patients with aRCC who received cabozantinib in the UK MAP.
Methods
CERES (NCT03696407), a retrospective chart review conducted at six specialist centres, included adults with treatment-refractory aRCC who received cabozantinib in the UK MAP. Data were collected from the date of RCC diagnosis until 24 months post-cabozantinib initiation or the patient’s death (whichever occurred earlier). We report patient characteristics and, in post hoc analyses, overall survival (OS) and progression free survival (PFS) stratified by CCI score. CCI predicts 1-year mortality based on patients’ comorbidities. Each prespecified comorbidity is weighted according to associated mortality risk (score 1–6); higher CCI total scores indicate a higher risk of mortality.
Results
In total, 100 patients received second- or later-line cabozantinib. Median (range) follow-up was 10.84 (0.4–33.5) months. Patient characteristics are reported in the Table. Most patients had an ECOG performance status of 0 (25.8%) or 1 (55.1%). Excluding metastatic solid tumour, the most common comorbidities were moderate to severe chronic kidney disease (52.0%) and uncomplicated diabetes mellitus (11.0%). Median (95% CI) OS and PFS were significantly longer in patients with CCI total scores ≤ 6 versus those with CCI total scores > 6 (OS, 23.52 [16.26–not reached] months versus 7.26 [5.75–9.17] months [p < 0.0001]; PFS, 10.25 [6.80–13.54] months versus 4.73 (2.92–5.85) months [p = 0.0052]).
Conclusions
In this real-world, UK study, most patients with aRCC had additional comorbidities contributing to 1-year mortality risk. Lower CCI total scores were associated with longer OS and PFS. Table: 741P
| Patient characteristicsa | Full analysis set (N = 100) |
| Sex, male, n (%) | 68 (68.0) |
| Age, years, median (Q1, Q3) | 64 (58, 69) |
| IMDC risk group, n (%)b | |
| Favourable | 19 (19.0) |
| Intermediate | 48 (48.0) |
| Poor | 23 (23.0) |
| Unknown | 10 (10.0) |
| Charlson Comorbidity Index | |
| Total score, median (Q1, Q3) | 8.0 (6.0, 8.0) |
| Total score >6, n (%)c | 63 (63.0) |
| Total score ≤6, n (%)c | 37 (37.0) |
aAt cabozantinib initiation unless otherwise stated. bData reflects the assessment that was performed closest to the date of cabozantinib initiation. cAnalyses performed post hoc. IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; Q, quartile
Clinical trial identification
NCT03696407.
Editorial acknowledgement
Dr David Gothard of Oxford PharmaGenesis, Oxford, UK, provided medical writing and editorial support, which was sponsored by Ipsen, in accordance with Good Publication Practice guidelines.
Legal entity responsible for the study
Ipsen.
Funding
Ipsen.
Disclosure
K. Fife: Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony, Research grant/Funding (institution): BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy: Eisai; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Exelixis; Advisory/Consultancy: Eusa. B.E. Szabados: Honoraria (self): Merck; Honoraria (self): Pfizer; Honoraria (self): Ipsen; Travel/Accommodation/Expenses: Roche/GNE. B. Klair: Shareholder/Stockholder/Stock options, Full/Part-time employment: Ipsen. V. Perrot: Full/Part-time employment: Ipsen. A. Michael: Advisory/Consultancy: Clovis; Advisory/Consultancy: Esai; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Tesaro. B. Venugopal: Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: EUSA Pharma; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Ipsen.