Anlotinib as a third-line or further treatment for recurrent or metastatic nasopharyngeal carcinoma: a single-arm, phase 2 clinical trial

Background Treatment options beyond the first-line setting for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) are limited. The role of the multitarget tyrosine kinase inhibitor anlotinib in RM-NPC is unclear. Methods In this prospective, single-arm, phase 2 trial, patients with histologic...

Full description

Saved in:
Bibliographic Details
Published in:BMC medicine 2023-11, Vol.21 (1), p.1-423, Article 423
Main Authors: Fang, Yu, Su, Ning, Zou, Qihua, Cao, Yi, Xia, Yi, Tang, Linquan, Tian, Xiaopeng, Liu, Panpan, Cai, Qingqing
Format: Article
Language:English
Subjects:
Analysis
Angiogenesis inhibitors
Anlotinib
Antiangiogenic therapy
Anticancer properties
Antimitotic agents
Antineoplastic agents
Antitumor agents
Cancer
Cancer therapies
Carcinoma
Care and treatment
Clinical trials
Development and progression
Disease control
Dosage and administration
Health services
Hemorrhage
Hypertension
Immunotherapy
Kinases
Medical prognosis
Metastases
Metastasis
Metastatic
Mucositis
Nasopharyngeal cancer
Nasopharyngeal carcinoma
Patients
Prevention
Product development
Protein-tyrosine kinase
Recurrent
Relapse
Risk factors
Survival
Throat cancer
Toxicity
Triglycerides
Tyrosine
Vascular endothelial growth factor
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Background Treatment options beyond the first-line setting for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) are limited. The role of the multitarget tyrosine kinase inhibitor anlotinib in RM-NPC is unclear. Methods In this prospective, single-arm, phase 2 trial, patients with histologically confirmed RM-NPC and failure of at least two lines of prior systemic treatments were eligible. Anlotinib was given at 12 mg once daily on days 1-14 every 3 weeks until disease progression or intolerable toxicities. The primary end point was disease control rate, defined as the percentage of patients achieving complete response, partial response, or stable disease by RECIST criteria. Results From April 2019 to March 2021, 39 patients were enrolled and received a median of 4 cycles (range, 0.5-20) of anlotinib treatment. Partial response and stable disease were observed in 8 and 20 patients, respectively. The disease control rate was 71.8%, and objective response rate was 20.5%. With a median follow-up of 17.2 months, the median progression-free survival was 5.7 months. The 12-month overall survival was 58.3%, and the median overall survival was not reached. The most frequent grade 3/4 treatment-related adverse events were hand-foot syndrome (23.7%), oral mucositis (21.0%), hypertension (7.9%), and triglyceride elevation (7.9%). Hemorrhage, all grade 1 or 2, occurred in 34.2% of the patients. Conclusions Anlotinib monotherapy exhibited promising anti-tumor activities and disease control for heavily pretreated RM-NPC patients with a tolerable toxicity profile. Trial registration ClinicalTrials.gov: NCT03906058. Keywords: Anlotinib, Nasopharyngeal carcinoma, Recurrent, Metastatic, Antiangiogenic therapy
ISSN:1741-7015
1741-7015
DOI:10.1186/s12916-023-03140-x