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.