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
2507 - KEYLYNK-010: Phase 3 Study of Pembrolizumab (pembro) Plus Olaparib (OLA) vs Enzalutamide (ENZA) or Abiraterone (ABI) in ENZA- or ABI-Pretreated Patients (pts) With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Had Progression on Chemotherapy (CTx)
Presenter: Evan Yu
Session: Poster Display session 3
Resources:
Abstract
2944 - PROSTRATEGY: A Spanish Genitourinary Oncology Group (SOGUG) multi-arm multistage (MAMS) phase III trial of immunotherapy strategies in high-volume metastasic hormone-sensitive prostate cancer.
Presenter: Jose Arranz Arija
Session: Poster Display session 3
Resources:
Abstract
3535 - A phase 1 study of AMG 160, a half-life extended bispecific T cell engager (HLE BiTE) immuno-oncology therapy targeting PSMA, in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
Presenter: Ben Tran
Session: Poster Display session 3
Resources:
Abstract
4951 - ProBio: An outcome-adaptive, multi-arm, open-label, multiple assignment randomised controlled biomarker-driven trial in patients with metastatic castration-resistant prostate cancer (EudraCT: 2018-002350-78, NCT03903835)
Presenter: Johan Lindberg
Session: Poster Display session 3
Resources:
Abstract
2892 - A phase 3 randomized, placebo-controlled, double-blind study of niraparib plus abiraterone acetate and prednisone versus abiraterone acetate and prednisone in patients with metastatic prostate cancer (NCT03748641)
Presenter: Kim Chi
Session: Poster Display session 3
Resources:
Abstract
2427 - The Extended/Phase II Study of Safety And Tolerability Of Proxalutamide (GT0918) In Subjects With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Who Failed Either Abiraterone (Abi) Or Enzalutamide (Enza)
Presenter: Nicholas Vogelzang
Session: Poster Display session 3
Resources:
Abstract
3224 - Addition of an oral docetaxel treatment (ModraDoc006/r) to androgen deprivation therapy (ADT) and intensity-modulated radiation therapy (IMRT) in patients with high risk N+M0 prostate cancer
Presenter: Marit Vermunt
Session: Poster Display session 3
Resources:
Abstract
3312 - A phase II randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy with LHRH agonist or antagonist versus anti-androgen therapy with apalutamide in patients with biochemical progression after radical prostatectomy.
Presenter: Piet Dirix
Session: Poster Display session 3
Resources:
Abstract
2829 - Health-Related Quality of Life (HRQoL) and Updated Follow-Up From KEYNOTE-057: Phase 2 Study of Pembrolizumab (pembro) for Patients (pts) With High-Risk (HR) Non–Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guérin (BCG)
Presenter: Ronald de Wit
Session: Poster Display session 3
Resources:
Abstract
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