尼妥珠单抗负一周用药后鼻咽癌症状变化的观察性研究  

An observational study of symptomatic changes in patients with nasopharyngeal carcinoma following nimotuzumab administration one week before radiotherapy

作　　者：王泽坤 张江鹄 陈雪松 王静波 吴润叶 张烨 曲媛 王凯 黄晓东 易俊林 罗京伟 Wang Zekun;Zhang Jianghu;Chen Xuesong;Wang Jingbo;Wu Runye;Zhang Ye;Qu Yuan;Wang Kai;Huang Xiaodong;Yi Junlin;Luo Jingwei(Department of Radiation Oncology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing100021,China;Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Department of Radiation Oncology,Peking University Cancer Hospital&Institute,Beijing100142,China)

机构地区：[1]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院放疗科,北京100021 [2]北京大学肿瘤医院暨北京市肿瘤防治研究所放射治疗科,恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142

出　　处：《中华放射肿瘤学杂志》2024年第12期1125-1130,共6页Chinese Journal of Radiation Oncology

基　　金：中央高水平医院临床科研业务费(2022-CICAMS-80102022203);中国癌症基金会北京希望马拉松专项基金(LC2021L06);北京大学肿瘤医院科学研究基金(ZY202409)。

摘　　要：目的前瞻性观察鼻咽癌患者放疗开始前一周应用尼妥珠单抗后肿瘤相关症状的变化情况。方法前瞻性收集中国医学科学院肿瘤医院收治的表皮生长因子受体(EGFR)表达阳性的非远处转移性鼻咽癌患者,患者同时存在由原发灶和/或颈部转移淋巴结导致的症状。在尼妥珠单抗首次用药前1日(D0)记录入组患者的肿瘤相关症状,用药后第2~7日(D2~D7)连续对患者进行访视并记录症状变化情况。入组患者分别在D0、D7采用视觉模拟评分法(VAS)对鼻咽癌相关症状进行评分,采用配对样本t检验对评分进行分析。结果自2020年6月至2023年4月,共计21例患者符合入组标准。全组中位年龄为49岁(范围:27~69岁),男女比例为1.3∶1。全组患者中,17例(81%)、3例(14%)、1例(5%)患者分别完成了8、7、6个周期的尼妥珠单抗同步治疗。全组患者均按研究要求进行症状评估。尼妥珠单抗首次用药后症状总体缓解率为62%,其中耳鸣、头痛、耳闷、颈部包块继发疼痛、回吸涕带血、鼻塞的缓解情况依次为4/6、5/8、4/10、4/10、4/11、3/11例。尼妥珠单抗负一周用药后鼻咽癌症状总体VAS评分显著降低(P<0.001),其中以耳鸣、耳闷及头痛VAS评分降低最为显著。结论放疗前一周应用尼妥珠单抗显著减轻鼻咽癌患者肿瘤相关症状,其中以耳鸣、耳闷及头痛减轻最为明显。Objective To prospectively observe the changes of tumor-related symptoms in patients with nasopharyngeal carcinoma following the administration of nimotuzumab one week before radiotherapy.Methods Non-metastatic nasopharyngeal carcinoma patients with positive epidermal growth factor receptor(EGFR)expression and symptoms caused by the primary lesion or metastatic cervical lymph nodes admitted to Cancer Hospital of Chinese Academy of Medical Sciences were prospectively recruited.Investigators recorded tumor-related symptoms in recruited patients one day before the first administration of nimotuzumab(D0)and conducted follow-up visits from day 2 to day 7 after the first administration(D2-D7)to document symptom changes.All recruited patients were asked to assess tumor-related symptoms on D0 and D7 by visual analogue scale(VAS)scores.VAS scores were analyzed by paired t-test.Results From June 2020 to April 2023,a total of 21 patients met the inclusion criteria.The median age was 49 years(range:27-69 years),with a male-to-female ratio of 1.3:1.Among the patients,17 patients(81%)received concurrent nimotuzumab for 8 cycles,7 cycles for 3 cases(14%),and 6 cycles for 1 case(5%),respectively.All patients completed symptom assessments as required.The overall response rate of symptoms after the first administration of nimotuzumab was 62%,with response rates of 4/6、5/8、4/10、4/10、4/11、3/11 for tinnitus,headache,aural fullness,secondary pain caused by neck mass,nasal bleeding,and nasal obstruction,respectively.The VAS scores for overall symptoms were significantly decreased after the administration of nimotuzumab one week before radiotherapy(P<0.001),with the most significant decrease in VAS scores for tinnitus,aural fullness,and headache.Conclusion The administration of nimotuzumab one week before radiotherapy significantly alleviates tumor-related symptoms in patients with nasopharyngeal carcinoma,particularly in alleviating tinnitus,aural fullness,and headache.

关 键 词：鼻咽肿瘤 放射疗法 症状 尼妥珠单抗 

分 类 号：R739.63[医药卫生—肿瘤]