对于复发性或转移性鼻咽癌 (RM-NPC)，一线治疗之外的治疗选择是有限的。多靶点酪氨酸激酶抑制剂安罗替尼在 RM-NPC 中的作用尚不清楚。在这项前瞻性单臂 2 期试验中，组织学证实为 RM-NPC 且之前至少接受过两线全身治疗失败的患者符合资格。每 3 周在第 1-14 天给予安罗替尼 12 毫克，每天一次，直至疾病进展或出现无法耐受的毒性。主要终点是疾病控制率，定义为根据 RECIST 标准达到完全缓解、部分缓解或疾病稳定的患者百分比。从 2019 年 4 月至 2021 年 3 月，入组了 39 名患者，并接受了中位数 4 个周期（范围、 0.5-20)的安罗替尼治疗。分别在 8 名和 20 名患者中观察到部分缓解和疾病稳定。疾病控制率为71.8%，客观缓解率为20.5%。中位随访时间为 17.2 个月，中位无进展生存期为 5.7 个月。 12个月总生存率为58.3%，未达到中位总生存率。最常见的3/4级治疗相关不良事件是手足综合征（23.7%）、口腔粘膜炎（21.0%）、高血压（7.9%）和甘油三酯升高（7.9%）。 34.2% 的患者发生了全部 1 级或 2 级出血。安罗替尼单药疗法对于经过大量预处理的 RM-NPC 患者表现出有希望的抗肿瘤活性和疾病控制，并且具有可耐受的毒性特征。ClinicalTrials.gov：NCT03906058.© 2023。作者。

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.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.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.Anlotinib monotherapy exhibited promising anti-tumor activities and disease control for heavily pretreated RM-NPC patients with a tolerable toxicity profile.ClinicalTrials.gov: NCT03906058.© 2023. The Author(s).