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
2421 - Lenvatinib plus PD-1 blockade in advanced bile tract carcinoma.
Presenter: Jianzhen Lin
Session: Poster Display session 3
Resources:
Abstract
5368 - Durvalumab and Paclitaxel Combination for treatment of metastatic triple negative breast cancer is safe with very promising efficacy
Presenter: Hazem Ghebeh
Session: Poster Display session 3
Resources:
Abstract
1520 - A prospective cohort study on the pharmacokinetics of nivolumab in metastatic non-small cell lung cancer, melanoma, and renal cell cancer patients
Presenter: Daan Hurkmans
Session: Poster Display session 3
Resources:
Abstract
1603 - Safety and clinical activity of subcutaneously (SC) administered anti-PD-1 antibody PF-06801591 in phase I dose-expansion cohorts of locally advanced or metastatic non-small-cell lung cancer (NSCLC) and urothelial carcinoma (UC)
Presenter: Byoung Cho
Session: Poster Display session 3
Resources:
Abstract
3922 - Development of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM): A scale to measure quality of life in cancer patients treated with ICMs
Presenter: Aaron Hansen
Session: Poster Display session 3
Resources:
Abstract
2408 - Immune checkpoint inhibitors (ICIs) as “chemotherapy (Ctx) sensitization” strategy in advanced solid tumors
Presenter: Francisco Javier Ros Montana
Session: Poster Display session 3
Resources:
Abstract
3612 - Validation of progression-free survival (PFS) as surrogate endpoint in randomised trials of immune checkpoint inhibitors in advanced solid cancers
Presenter: Peey Sei Kok
Session: Poster Display session 3
Resources:
Abstract
3827 - Pharmacokinetic (PK) analysis of weight-based and fixed dose cemiplimab in patients (pts) with advanced malignancies
Presenter: Michael Migden
Session: Poster Display session 3
Resources:
Abstract
2120 - A burst of highly differentiated CD4 TL identifies a subset of fast progressors, and correlates with hyperprogressive disease in NSCLC patients treated with ICI
Presenter: Hugo Arasanz
Session: Poster Display session 3
Resources:
Abstract
4254 - Nivolumab treatment in advanced non-small cell lung cancer (aNSCLC): a French nationwide retrospective cohort (UNIVOC Study)
Presenter: Christos Chouaid
Session: Poster Display session 3
Resources:
Abstract