尼妥珠单抗（TheraCim-hR3）联合顺铂/放疗治疗局部晚期头颈部鳞状细胞癌的 II 期研究。
Phase II study of nimotuzumab (TheraCim-hR3) concurrent with cisplatin/radiotherapy in patients with locally advanced head and neck squamous cell carcinoma.
机构信息
Division of Medical Oncology, National Cancer Centre Singapore, Singapore.
Cancer Coordinating Center, The Medical City Clark, Mabalacat, Philippines.
出版信息
Head Neck. 2021 May;43(5):1641-1651. doi: 10.1002/hed.26635. Epub 2021 Feb 5.
BACKGROUND
The efficacy of a combination of nimotuzumab, a humanized monoclonal antibody to the epidermal growth factor receptor, with chemoradiation in locally advanced head and neck squamous cell carcinoma (HNSCC) was evaluated in a phase II study.
METHODS
Patients with stage III/IV HNSCC received 3-weekly cisplatin 100 mg/m for three cycles and weekly nimotuzumab 200 mg for 8 weeks concurrently with radiotherapy. Primary endpoint was best overall response (BOR) and secondary endpoint was progression-free survival (PFS).
RESULTS
Thirty-seven patients were included; the majority were Chinese (76%), male (89%), and had stage IVA/IVB HNSCC (92%). BOR of complete and partial response was seen in 22/37 (59%) and 10/37 (27%) patients, respectively. Median PFS was 17.5 months (95% CI: 11.1-54.5) and 3-year PFS was 40.4% (95% CI: 24.3-55.9). The frequency and type of adverse events observed were similar to standard chemoradiation.
CONCLUSION
The combination of nimotuzumab with cisplatin and radiotherapy was safe and achieved high response rates in HNSCC.
背景
在一项 II 期研究中评估了尼妥珠单抗（一种针对表皮生长因子受体的人源化单克隆抗体）联合放化疗治疗局部晚期头颈部鳞状细胞癌（HNSCC）的疗效。
方法
III/IV 期 HNSCC 患者接受 3 周一次的顺铂 100mg/m2 治疗 3 个周期，每周一次尼妥珠单抗 200mg 治疗 8 周，同时进行放疗。主要终点是最佳总体缓解（BOR），次要终点是无进展生存期（PFS）。
结果
共纳入 37 例患者，其中大多数为中国人（76%），男性（89%），且为 IVA/IVB 期 HNSCC（92%）。22/37（59%）和 10/37（27%）例患者分别出现完全缓解和部分缓解。中位 PFS 为 17.5 个月（95%CI：11.1-54.5），3 年 PFS 为 40.4%（95%CI：24.3-55.9）。观察到的不良事件的频率和类型与标准放化疗相似。
结论
尼妥珠单抗联合顺铂和放疗在 HNSCC 中安全且可获得较高的缓解率。
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