Nimotuzumab combined with docetaxel and cisplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma: a multicenter, phase 2 trial

作者：Qihua Zou, Yi Cao, Yulin Lai, Fang Yu, Yuchen Zhang, Panpan Liu, Lixia Lu, Hao Wu, Tianying Huang, Ning Su, Zhihua Li, Xicheng Wang, Xiaopeng Tian, Lirong Li, Yingxian Liu, Qingqing Cai, Yi Xia · 发表于：BMC Medicine · 年份：2025 · DOI：10.1186/s12916-025-04103-0 · 被引用次数：6 · 研究领域：Head and Neck Cancer Studies、Head and Neck Surgical Oncology、Oral health in cancer treatment

BACKGROUND: To evaluate the efficacy and safety of nimotuzumab combined with docetaxel and cisplatin (TPN) as the first-line therapy in patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). METHODS: on day 1) every 3 weeks for 6 cycles. The primary endpoint was the objective response rate (ORR), and the secondary endpoints included the disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Between October 15, 2018, and July 20, 2022, 52 patients were enrolled. The ORR and DCR in the intention-to-treat population were 65.4% and 90.4%, respectively. With a median follow-up of 38.1 months, the median PFS and OS were 7.4 and 40.4 months, respectively. The majority of adverse events were grades 1-2. Grade 3/4 adverse events were neutropenia (42.3%), leukopenia (32.7%), febrile neutropenia (11.5%), nausea (7.7%), fatigue (5.8%), infection (5.8%), thrombocytopenia (1.9%), and anorexia (1.9%). There was no treatment-related death. Low baseline plasma Epstein-Barr virus (EBV) DNA level and the clearance of plasma EBV DNA after 2 cycles of treatment were associated with longer PFS. Additionally, patients who received ≥ 2400 mg of nimotuzumab and ≥ 4 cycles of docetaxel plus cisplatin had superior ORR and survival. CONCLUSIONS: First-line therapy with the TPN regimen showed promising efficacy with a well-tolerated safety profile in RM-NPC patients. TRIAL REGISTRATION:...