1.中国人民解放军联勤保障部队第九六六医院耳鼻咽喉科;2.辽宁省大连市友谊医院耳鼻咽喉头颈外科;3.安徽医科大学头颈外科
国家自然科学基金资助项目(NO.82071055)
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目的 探讨尼妥珠单抗联合阿帕替尼对局部晚期头颈部鳞癌的疗效及安全性。方法 选取2021年7月至2023年6月医院收治的局部晚期头颈部鳞癌患者72例，按照奇偶数字法分为观察组和对照组，各36例，对照组采用阿帕替尼联合TP化疗方案，观察组在对照组基础上联合尼妥珠单抗治疗。治疗3个周期后，比较两组的客观缓解率（ORR）、疾病控制率（DCR）、鳞状细胞癌相关抗原（SCC-Ag）、胸腺激酶1（TK1）及细胞角质蛋白19片段抗原21-1（CYFRA21-1）、不良反应、1年总生存期（OS）和无进展生存期（PFS）。结果 观察组ORR、DCR高于对照组（P＜0.05）。治疗后，观察组和对照组的SCC-Ag分别为（1.12±0.16）、（1.37±0.25），TK1分别为（1.65±0.21）、（1.95±0.18），CYFRA21-1分别为（5.46±0.75）、（7.02±0.91），观察组低于对照组（P＜0.05）。两组白细胞减少、红细胞减少、血小板降低、中性粒细胞减少、转氨酶升高、肌酐升高、电解质紊乱、恶心/呕吐、便秘、低蛋白血症、皮肤黏膜过敏、外周神经障碍的发生率比较，差异无统计学意义（P＞0.05）。观察组死亡3例，1年OS为91.43%，1年PFS为71.43%。对照组死亡5例，1年OS为78.79%，1年PFS为57.58%。两组均未达到中位OS、中位PFS，观察组的PFS曲线高于对照组（P＜0.05）。结论 尼妥珠单抗联合阿帕替尼治疗局部晚期头颈部鳞癌患者，有助于提高ORR、DCR，延长PFS，疗效及安全性良好。
Objective To investigate the effectiveness and safety of combining Nimotuzumab and apatinib for the treatment of locally advanced head and neck squamous cell carcinoma. Methods A total of 72 patients with locally advanced head and neck squamous cell carcinoma, who were admitted to the hospital between July 2021 and June 2023, were selected. They were assigned to either the observation group or the control group using the odd-even number method, with 36 patients in each group. The control group received Apatinib combined with TP chemotherapy, while the observation group received treatment with Nimotuzumab in addition to the control group. After 3 cycles of treatment, compare the objective response rate (ORR), disease control rate (DCR), squamous cell carcinoma associated antigen (SCC Ag), thymic kinase 1 (TK1), and cytokeratin 19 fragment antigen 21-1 (CYFRA21-1), adverse reactions, 1-year overall survival (OS), and progression free survival (PFS) between the two groups. Results The observation group showed higher ORR and DCR compared to the control group (P<0.05). After treatment, the SCC Ag levels in the observation group and control group were (1.12 ± 0.16), (1.37 ± 0.25), TK1 levels were (1.65 ± 0.21), (1.95 ± 0.18), and CYFRA21-1 levels were (5.46 ± 0.75), (7.02 ± 0.91), respectively, and the observation group was lower than the control group (P<0.05). No statistically significant difference was observed in the incidence of leukopenia, erythropenia, thrombocytopenia, neutropenia, transaminase elevation, creatinine elevation, electrolyte imbalance, nausea/vomiting, constipation, hypoalbuminemia, skin and mucosal allergies, and peripheral nerve disorders between the two groups (P>0.05). There were 3 deaths in the observation group, with a 1-year OS of 91.43% and a 1-year PFS of 71.43%. There were 5 deaths in the control group, with a 1-year OS of 78.79% and a 1-year PFS of 57.58%. Both groups did not reach the median OS and median PFS, and the PFS curve of the observation group was superior to that of the control group (P<0.05). Conclusion The combination of Nimotuzumab and Apatinib in the treatment of locally advanced head and neck squamous cell carcinoma patients can help improve ORR DCR， Extended PFS, with good efficacy and safety.
