尼妥珠单抗治疗头颈部鳞状细胞癌的临床观察

Clinical analysis of Nituzumab in the treatment of head and neck squamous cell carcinoma

目的探讨尼妥珠单抗在局部晚期头颈部鳞状细胞癌(HNSCC)治疗中的疗效及安全性。方法2021年3月至2022年1月共31例在哈尔滨医科大学附属肿瘤医院治疗的HNSCC患者。其中,男性30例,女性1例,年龄43~84岁,平均年龄63.2岁。所有患者经影像学和组织免疫学检查为HNSCC,EGFR均为阳性(+),肝、肾功能正常,31例患者均给予尼妥珠单抗靶向治疗,单次剂量200 mg~400 mg,3~7周期,其中17例患者联合放化疗,13例患者联合放疗,1例患者联合化疗及免疫治疗。放疗单次剂量1.8~2.12 Gy,总剂量50~70 Gy。采用R语言(版本4.2.2)分析肿瘤缓解率、总生存期(OS)和无进展生存期(PFS)。结果31名患者完成治疗和随访,随访时间2~23个月,中位随访时间11个月。CR 5例,PR 13例,SD 8例,5例无法评价,ORR为58.1%。患者1年OS为64%,1年PFS为56%。在治疗过程中出现5例3~4级血液毒性反应,1例3级恶心,1例3级呕吐,均由化疗所致;2例3级口腔黏膜炎,未见其他严重不良反应。结论在头颈部鳞状细胞癌的治疗中加入尼妥珠单抗具有良好的耐受性,并且取得了良好的临床获益。

Objective To investigate the efficacy and safety of nituzumab in the treatment of locally advanced head and neck squamous cell carcinoma(HNSCC).Methods A total of 31 HNSCC patients were treated in the Affiliated Cancer Hospital of Harbin Medical University from March 2021 to January 2022.Among them,there were 30 males and 1 female,aged 43-84 years with an average age of 63.2 years.Imaging and tissue immunological tests showed HNSCC in all patients,EGFR was positive(+),and liver and kidney function were normal.31 patients were given targeted therapy with nituzumab at a single dose of 200-400 mg for 2-7 cycles,including 17 patients combined with chemoradiotherapy,13 patients combined with radiotherapy,and 1 patient combined with chemotherapy and immunotherapy.The single dose of radiotherapy was 1.8-2.12 Gy,and the total dose was 50-70 Gy.R language(version 4.2.2)was used to analyze tumor response rate,overall survival,and progression-free survival.Results 31 patients completed the treatment and follow-up,the follow-up time was 2-23 months,the median follow-up time was 11 months.CR(5 cases),PR(13 cases),SD(8 cases),and SD(5 cases)could not be evaluated.ORR was 58.1%.1-year OS was 64%and 1-year PFS was 56%.In the course of treatment,there were 5 cases of grade III-IV hematotoxicity,1 case of grade III nausea and 1 case of grade III vomiting,all caused by chemotherapy.There were 2 cases of grade III oral mucositis and no other serious adverse reactions.Conclusion The addition of nituzumab in the treatment of head and neck squamous cell carcinoma is well tolerated and can improve the sensitivity of chemoradiotherapy and achieve good clinical benefits.