Efficacy and safety of Anlotinib in combination with gemcitabine and cisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A single-arm clinical trial.

Abstract

The effectiveness and safety of combining anlotinib with gemcitabine and cisplatin in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC) have not been definitively established. This research seeks to investigate the potential benefits and risks of utilizing this combination therapy in the first-line management of R/M NPC. The research involved 22 individuals diagnosed with R/M NPC and who had not undergone any previous treatment. These patients were administered a concomitant therapy of anlotinib, gemcitabine, and cisplatin in cycles occurring every 3 weeks. The primary focus of the study was to assess progression-free survival (PFS), while secondary endpoints included overall survival (OS), disease control rate (DCR), and objective response rate (ORR). The findings revealed that the median PFS duration for patients with R/M NPC receiving the GPA regimen as a first-line treatment was 12.6 months, with a 95% confidence interval (CI): 0.1 to 25.2. The median OS was reported as 37.4 months, with 95% CI: 28.0 to 46.8. The DCR in this study was 95.5%, while the ORR was 63.6%. Anlotinib has demonstrated a degree of effectiveness in the initial treatment of R/M NPC, while maintaining an acceptable level of safety.