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
2673 - Clinical activity of vofatamab (V), an FGFR3 selective antibody in combination with pembrolizumab (P) in metastatic urothelial carcinoma (mUC), updated interim analysis of FIERCE-22
Presenter: Arlene Siefker-Radtke
Session: Poster Display session 3
Resources:
Abstract
2600 - Atezolizumab (atezo) vs chemotherapy (chemo) in patients (pts) with platinum-treated locally advanced or metastatic urothelial carcinoma (mUC): a long-term overall survival (OS) and safety update from the Phase III IMvigor211 study
Presenter: Michiel Van der Heijden
Session: Poster Display session 3
Resources:
Abstract
3598 - Three-Year Follow-Up From the Phase 3 KEYNOTE-045 Trial: Pembrolizumab (Pembro) Versus Investigator’s Choice (Paclitaxel, Docetaxel, or Vinflunine) in Recurrent, Advanced Urothelial Cancer (UC)
Presenter: Andrea Necchi
Session: Poster Display session 3
Resources:
Abstract
2382 - First Report of Efficacy and Safety From a Phase 2 Trial of Tislelizumab, an Anti-PD-1 Antibody, for the Treatment of PD-L1+ Locally Advanced or Metastatic Urothelial Carcinoma (UC) in Asian Patients
Presenter: Dingwei Ye
Session: Poster Display session 3
Resources:
Abstract
2388 - Quality of Life of Metastatic Urothelial Cancer (mUC) Patients Treated with Enfortumab Vedotin (EV) Following Platinum-Containing Chemotherapy and a Checkpoint Inhibitor (CPI): Data from EV-201 Cohort 1
Presenter: Bradley McGregor
Session: Poster Display session 3
Resources:
Abstract
3748 - Safety and efficacy of atezolizumab (atezo) in patients (pts) with autoimmune disease (AID): subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma
Presenter: Yohann Loriot
Session: Poster Display session 3
Resources:
Abstract
1126 - Validation of the VIO prognostic index in patients with metastatic urothelial carcinoma treated with immune-checkpoint inhibitors
Presenter: Rafael Morales Barrera
Session: Poster Display session 3
Resources:
Abstract
3693 - Pathologic outcomes after neoadjuvant chemotherapy for high-risk muscle invasive bladder cancer
Presenter: Justin Matulay
Session: Poster Display session 3
Resources:
Abstract
4840 - Analysis of response to prior therapies and therapies after treatment with erdafitinib in fibroblast growth factor receptor (FGFR)-positive patients (pts) with metastatic urothelial carcinoma (mUC)
Presenter: Arlene Siefker-Radtke
Session: Poster Display session 3
Resources:
Abstract
1221 - Clinical outcomes by sex with atezolizumab (atezo) monotherapy in patients (pts) with locally advanced/metastatic urothelial carcinoma (mUC)
Presenter: Jean Hoffman-censits
Session: Poster Display session 3
Resources:
Abstract