Abstract 803TiP
Background
Aged fragile patients are not usually included in clinical trials and efficacy and tolerability of the different treatments in this population are unknown. In the METEOR trial efficacy was similar in all age groups. Conversely, ageing has been associated with a decrease in the efficacy of immune checkpoint inhibitors due to immunosenescenc, thus, TKis might be a better treatment option. However, the absence of data and concerns about possible secondary effects associated, can preclude clinicians to treat aged fragile patients with cabozantinib. A pilot phase II trial would help to have data on safety and efficacy of cabozantinib in this aged fragile population.
Trial design
Pilot open-label, multicenter study to evaluate cabozantinib safety and efficacy in previously untreated aged population with metastatic renal cell carcinoma. Patients will receive cabozantinib 40 mg p.o. once daily in 28-day cycles. Dose can be escalated to 60 mg to avoid suboptimal exposure to the drug if 40 mg is considered tolerated. Geratric evaluation scales will be performed to all patients and correlation between study outcomes and functionality, comorbidity and cognitive and social status will be evaluated. 50 patients is expected to be included in 2 years in ten spanish centers of SOGUG cooperative group. Mean inclusion criteria: Histological diagnosis of renal cell cancer. Metastatic and measurable disease per RECIST 1.1. ECOG 0-2. No previous treatment for mRCC. Patients aged >70 years old with SIOG (Society of Geriatric Oncology) defined fragile population or patients >75 years with or without SIOG defined fragility. Fragile patients are defined as those with G8 scale under 14 points and with one or two reversible deficiencies in ADL (activities in daily life) or CISR-G grade 2 comorbidities (a single grade 3 comorbidity may also be reversible) or weight loss of 5-10% during the last 3 months. All patients will be evaluated for geriatric assessment, comorbidities and dependence status with the following scales: CISR-G, ADL/IADL index, Barthel index, Mini-Cog test, Gijon's social-familial evaluation scale, Hospital anxiety and Depression Scale. HAD scale, Vulnerable Elders Survey 13 and Short Physical Performance Battery.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
SOGUG cooperative group.
Funding
Ipsen.
Disclosure
M.A. Climent Duran: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Astra. R. Girones Sarrio: Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: EUSA; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: abbot; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Angellini. J.C. Villa Guzman: Advisory/Consultancy: Roche; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Merck. M.J. Juan Fita: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Janssen; Speaker Bureau/Expert testimony: Sanofi; Speaker Bureau/Expert testimony: Astellas; Speaker Bureau/Expert testimony: BMS; Speaker Bureau/Expert testimony: Bayer. N. Fernandez Nuñez: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Boehringer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Janssen; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Sanofi; Travel/Accommodation/Expenses: Lilly; Travel/Accommodation/Expenses: Pfizer. All other authors have declared no conflicts of interest.