Abstract 3249
Background
Cabozantinib (cabo) is a potent VEGFR-TKI currently approved in mRCC as a standard of care in second line or beyond. However, the incidence of grade 3-4 weight loss (WL) reported in pivotal trial seems underestimated. The aim was to evaluate the weight loss in real life under cabo.
Methods
All consecutive mRCC patients treated with cabo at a single institution from January 2014 to August 2018 were included. Patients with ascite/oedema were excluded. Weight was evaluated every month under cabo. Toxicities that may influence weight loss as diarrhea, nausea, anorexia, stomatite were collected. Individual profile, weigh change from baseline and time to first grade 2 WL(> 10%) and grade 3 WL(>20%) were described; disease control rate (CR+PR+SD) and objective response rate (CR+PR) according to RECIST 1.1. We analysed Grade 1, 2, 3 WL at 1, 3 and 6 months in patients without progression disease beyond 6 months of cabo.
Results
From 102 patients receiving cabo, 91 patients with a median follow-up of a 15.9 months [range: 1.2-58.7] were included: 69.2% male, median age: 62.0 [28.0-78.0] years and median baseline BMI: 24.8 [16.6-49.3] kg/m2. IMDC score was good, intermediate and poor in 12 (13.5%), 58 (65.2%) and 19 (21.4%), respectively. Median cabo treatment duration was 10.4 months [1-26.9]. At study cut off, n = 37 (40.7%) patients are still on treatment, 39 (42.9%) stopped cabo for disease progression and 15 (16.5%) for toxicity. Overall, 32 patients (35.1%) had more than 10% WL (grade 2) from baseline including 10 patients (11%) with more than 20% WL (grade ≥ 3). DCR was 96.4 [95%CI 89.8-99.3] and ORR was 34.9% [95%CI 24.8-46.2]. Median overall survival was 20.3 months. In responders to cabo more than 6 months (n = 59), cumulative incidence of grade 2 and grade 3 WL were respectively: 44.1% (n = 26) and 13.6% (n = 8). Median time to first grade 2 WL was 11.9 months. In this group, 11.3%, 42.9%, 47.6% of patients lost weigh more than 5% at 1, 3, 6 month compared to baseline under cabo.
Conclusions
Significant weight loss with cabozantinib is undereported in clinical trials compared to real world setting. It requires investigations and early management to anticipate sarcopenia in patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
E. Colomba: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (institution), Advisory / Consultancy: SANOFI. B. Raynard: Advisory / Consultancy, Research grant / Funding (self): Fresenius Kabi. B. Escudier: Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: EXELIXIS; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: NOVARTIS; Honoraria (self), Advisory / Consultancy: Pfizer. L. Albiges: Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Astellas; Honoraria (self), Advisory / Consultancy: Pfizer. All other authors have declared no conflicts of interest.
Resources from the same session
5763 - cfDNA is an acceptable but insufficient means of characterizing FGFR3 mutation in patients with metastatic urothelial cancer (mUC)
Presenter: Sumanta Pal
Session: Poster Display session 3
Resources:
Abstract
5877 - Efficacy of anti-PD(L)1 treatment in patients with metastatic urothelial cancer based on mRNA- and protein- based PD-L1 determination: Results from the multicentric, retrospective FOsMIC trial
Presenter: Jonas Jarczyk
Session: Poster Display session 3
Resources:
Abstract
5204 - A differential bladder microbiota composition is associated with tumor grade in bladder cancer.
Presenter: Monica Parra-Grande
Session: Poster Display session 3
Resources:
Abstract
4904 - Molecular characterization of metastatic urothelial carcinoma (mUC) in prior or current smokers (PCS) vs non-smokers (NS)
Presenter: Victor Sacristan Santos
Session: Poster Display session 3
Resources:
Abstract
5370 - Evaluation of different diagnostic methods for identification of FGFR alteration in advanced urothelial carcinomas: Proficiency Results based on multiple RNA extraction kits and mutation detection methods
Presenter: Veronika Weyerer
Session: Poster Display session 3
Resources:
Abstract
2579 - Title: Genomic characterization of non-schistosomiasis-related squamous cell carcinoma (NSR-SCC) of the urinary bladder: a retrospective study of potential prognostic and predictive biomarkers
Presenter: Esmail Al-ezzi
Session: Poster Display session 3
Resources:
Abstract
2203 - TiNivo: Tivozanib combined with nivolumab results in prolonged progression free survival in patients with metastatic renal cell carcinoma (mRCC). Final Results.
Presenter: Philippe Barthelemy
Session: Poster Display session 3
Resources:
Abstract
4712 - First-Line Pembrolizumab (pembro) Monotherapy for Advanced Non‒Clear Cell Renal Cell Carcinoma (nccRCC): Updated Follow-Up for KEYNOTE-427 Cohort B
Presenter: Cristina Suárez
Session: Poster Display session 3
Resources:
Abstract
2091 - First-Line Pembrolizumab (pembro) Monotherapy in Advanced Clear Cell Renal Cell Carcinoma (ccRCC): Updated Follow-Up For KEYNOTE-427 Cohort A
Presenter: James Larkin
Session: Poster Display session 3
Resources:
Abstract
2368 - Association Between Depth of Response and Overall Survival: Exploratory Analysis in Patients With Previously Untreated Advanced Renal Cell Carcinoma (aRCC) in CheckMate 214
Presenter: Viktor Grünwald
Session: Poster Display session 3
Resources:
Abstract