Abstract 2634
Background
Pre-clinical and clinical evidence suggests a rationale for the use of anti-angiogenic agents in recurrent and/or metastatic salivary gland carcinomas (RMSGCs). This study evaluates the activity the efficacy and safety of anlotinib, a novel vascular endothelial growth factor receptor (VEGFR) inhibitor in patients with RMSGCs.
Methods
In this single-arm phase II study, patients with RMSGCs were treated with anlotinib 12mg QD p.o. until disease progression, intolerable toxicity or withdrawal of consent. The primary endpoint was the objective response rate (ORR). Progression-free survival (PFS), overall survival (OS), and adverse events were also assessed. This study had been registered with ClinicalTrails. gov: NCT 03591666.
Results
Between June 2018 and February 2019, 24 patients with RMSGCs were screened and 21 patients were enrolled in this study. 10 patients (47.6%) were male, and the median age was 54 years (range 29-75). The most common histologic type was adenoid cystic carcinoma (52.4%), which was followed by adenocarcinoma (19.0%). 16 patients (76.2%) were treated as third-line or further treatment. The objective response rate was 19.1% (95%CI 5.4%-41.9%). The disease control rate was 81.0% (95%CI 58.1%-94.6%). One patient died due to the progress of the disease. At the time of the data cutoff, with a median follow-up of was 4.8 months (range 0.9-9.3), the median PFS had not been reached, and the PFS rate at 6 months was 78.9% (95% CI, 58.1%-94.6%). No drug-related mortality occurred. The most common clinically significant grade 3 or higher adverse events were hypertension (28.6%) and hand-foot syndrome (9.5%).
Conclusions
Anlotinib showed a high disease control rate in patients with RMSGCs. The toxicity was tolerable and manageable.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5655 - Bioactivation of napabucasin triggers reactive oxygen species–mediated cancer cell death
Presenter: Fieke Froeling
Session: Poster Display session 3
Resources:
Abstract
4097 - Targeting NRG1-fusions in multiple tumour types: Afatinib as a novel potential treatment option
Presenter: Stephen V Liu
Session: Poster Display session 3
Resources:
Abstract
1129 - Aspirin and Ticagrelor for the prevention of tumour cell induced platelet aggregation
Presenter: Meera Chauhan
Session: Poster Display session 3
Resources:
Abstract
4514 - Pharmacokinetic/ pharmacodynamic (PK/PD) exposure-response characterization of GSK3359609 (GSK609) from INDUCE-1, a phase I open-label study
Presenter: Michele Maio
Session: Poster Display session 3
Resources:
Abstract
5169 - In vitro functional interrogation of viable Circulating Tumor Associated Cells (C-TACs) for evaluating Platin resistance.
Presenter: Stefan Schuster
Session: Poster Display session 3
Resources:
Abstract
5827 - Targeting ARG2 as a novel therapeutic approach for cancer
Presenter: Marcin Grzybowski
Session: Poster Display session 3
Resources:
Abstract
3129 - MPS1 and PLK1 as new therapy targets in TP53 mutated solid tumors
Presenter: Balazs Gyorffy
Session: Poster Display session 3
Resources:
Abstract
2129 - The Tumor Static Exposure (TSE) concept & utility: application to combination treatment of radiation and radiosensitizing agent in tumor xenograft experiments
Presenter: Samer El Bawab
Session: Poster Display session 3
Resources:
Abstract
1814 - General Methodology to Optimize Tumor Treating Fields Delivery Utilizing Numerical Simulations
Presenter: Noa Urman
Session: Poster Display session 3
Resources:
Abstract
3010 - The Australian Exceptional Responders Program: a National collaboration
Presenter: Megan Barnet
Session: Poster Display session 3
Resources:
Abstract