Abstract
BACKGROUND: Anlotinib has shown encouraging therapeutic effect on various solid tumors. This study assessed the efficacy and safety of anlotinib monotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma (rmNPC). PATIENTS AND METHODS: This study retrospectively included 30 patients with rmNPC, most following at least one previous line of systemic therapy. Patients underwent anlotinib monotherapy (12 or 10 mg/day). The primary endpoint was objective response rate (ORR). The secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity. RESULTS: Thirteen patients (43.3%) had metastatic NPC, 10 (33.3%) had recurrent NPC, and 7 (23.3%) had both meta-static and recurrent NPC. Twenty-two patients (73.3%) were platinum-refractory, and 23 (76.7%) received at least three cycles of anlotinib therapy. The best overall response was partial response observed in four patients, stable disease in 18, and progressive disease in eight. The ORR was 13.3% (95% CI, 0.4-26.2%) and disease control rate was 73.3% (95% CI, 56.5-90.1%). The median OS and PFS were 11.5 months (95% CI, 7.5-15.5) and 5.7 months (95% CI, 4.7-6.7), respectively. The relatively common grade 3 or higher adverse events were hand-foot syndrome (13.3%) and oral mucositis (13.3%). CONCLUSIONS: Anlotinib monotherapy demonstrated positive efficacy in patients with rmNPC. It was well tolerated by these patients and had acceptable toxicity.