Abstract 941P
Background
Nasopharyngeal carcinoma is a relatively uncommon disease but shows distinct geographical distribution. There is no consensus regarding treatment following failure of first-line platinum-based chemotherapy regimens for recurrent or metastatic nasopharyngeal carcinoma patients. This study aimed to assess the anti-tumour activity and safety of apatinib combined with capecitabine in patients with advanced nasopharyngeal carcinoma.
Methods
This is an open label, single-arm group, phase II trial. Eligible patients were aged 18 to 70 years old, failed at least one prior chemotherapy regimen, Eastern Cooperative Oncology Group (ECOG) performance score of 0-2, life expectancy ≥3 months. All patients received apatinib at an initial dose of 500mg once daily and capecitabine 1000mg/m2 day1-14 of a 21-day cycle until evaluation of disease progression, unaccepted toxicity, patient withdrawal or death. The primary endpoints were objective response rate (ORR) and disease control rate (DCR). Progression free survival (PFS), overall survival (OS), quality of life, and safety profile were also analysed in all treated patients.
Results
Between Sep 27, 2018, and Apr 6, 2020, 108 patients were screened for eligibility, of whom 54 patients were enrolled in the study. The median age was 46 years-old (22 to 68). At the cut-off date (Apr 6,2020),41 patients were evaluable for ORR and DCR as per RECIST1.1. The ORR was 41.5% (17/41) and DCR was 95.1% (39/41). The median PFS was 6.88 months (95%Cl,4.36 to 13.62) and OS was not matured. The most common grade 3/4 adverse events (AEs) were sore throat (7/41, 17.1%), oral mucositis (5/41,12.2%), hypertension (4/41, 9.7%), fatigue (3/41, 7.3%), and bleeding (2/41, 4.9%). Two cases of treatment-related severe AEs occurred with clinical significance: one patient developed grade 4 proteinuria; another developed grade 4 increased alanine aminotransferase. There were no treatment-related deaths.
Conclusions
Apatinib combined with capecitabine demonstrates favourable clinical benefit and a manageable safety profile in patients with advanced nasopharyngeal carcinoma. This treatment might represent a promising option for these patients.
Clinical trial identification
CTR1800017229.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Chinese Society of Clinical Oncology (CSCO)-Hengrui Clinical Oncology Research Fund.
Disclosure
All authors have declared no conflicts of interest.