摘要
目的探讨尼妥珠单抗(NTZ)联合TP方案诱导化疗对表皮生长因子受体(EGFR)阳性局部晚期鼻咽癌的近期疗效及其安全性。方法前瞻性选取贵州省人民医院2020年1月-2022年12月收治的Ⅲ-ⅣA期鼻咽癌患者48例,采用随机数表法分为NTZ+多西他赛/白蛋白紫杉醇+顺铂(NTP)组(n=24)与多西他赛/白蛋白紫杉醇+顺铂(TP)组(n=24)。NTP组2或3个周期诱导治疗后序贯NTZ配合顺铂同步放化疗,采用免疫组化检测肿瘤组织EGFR表达水平,探究NTP组患者EGFR表达强度和尼妥珠单抗的治疗效果;比较两组诱导治疗结束后的近期疗效、肿瘤退缩率及不良反应发生情况。结果NTP组EGFR阳性表达率为100%,EGFR表达强度与联合NTZ的诱导治疗疗效相关(P<0.05);诱导治疗结束后的两组疗效比较,NTP组颈部淋巴结的客观缓解率(ORR)明显高于TP组(75.0%vs.45.8%,P=0.039),两组肿瘤原发病灶及总体(肿瘤原发病灶和颈部淋巴结)ORR比较差异无统计学意义(P>0.05);不良反应方面,NTP组白细胞减少、胃肠道反应发生率低于TP组(P<0.05),皮疹发生率高于TP组(P<0.05),两组肝功能异常、血红蛋白及血小板减少比较差异无统计学意义(P>0.05)。结论鼻咽癌组织中存在不同强度的EGFR表达,EGFR表达强度较高时,联合NTZ诱导治疗临床获益更明显;NTZ联合TP诱导方案治疗对于局部晚期鼻咽癌颈部淋巴结的近期疗效和安全性较好。
Objective To investigate the short-term efficacy and safety of chemotherapy induced by nimotuzumab(NTZ)combined with TP regimen and sequential concurrent chemoradiotherapy in patients with epidermal growth factor receptor positive(EGFR-positive)locally advanced nasopharyngeal carcinoma.Methods A total of 48 patients with stageⅢto IV A nasopharyngeal carcinoma in Guizhou Provincial People's Hospital from January 2020 to December 2022 were prospectively enrolled,and were randomized into two groups:NTP(NTZ+docetaxel/albumin-paclitaxel+cisplatin)group and TP(Docetaxel/albumin-paclitaxel+cisplatin)group(24 cases per group)by random number table method.After 2 or 3 cycles of induction chemotherapy in NTP group,NTZ was sequentially used in combination with cisplatin for concurrent chemoradiotherapy.Immunohistochemistry was used to detect the EGFR expression level,exploring EGFR expression intensity and the therapeutic effect of NTZ in NTP group patients.Meanwhile,short-term efficacy,withdrawal rate and toxic side effects were compared between the two groups after induction chemotherapy.Results In NTP group,the positive expression rate of EGFR was 100%,and EGFR expression intensity significantly correlated with the efficacy of NTZ-combined induction therapy(P<0.05).After induction chemotherapy,the objective response rate(ORR)of cervical lymph nodes in NTP group was significantly higher than that in TP group(75%vs.45.8%,P=0.039).The primary lesion ORR and overall(primary lesion and cervical lymph node)ORR showed no significant difference between the two groups(P>0.05).Comparison of adverse reactions between the two groups during induction therapy:leukopenia and gastrointestinal reaction in NTP group were lower than those in TP group(P<0.05),but rash was higher than those in TP group(P<0.05).There was no significant difference in liver function,hemoglobin and thrombocytopenia between two groups(P>0.05).Conclusions EGFR expression intensity varies in nasopharyngeal carcinoma tissues,with higher levels indicating greater clinical benefit of combined induction therapy with NTZ.NTZ combined with TP induction regimen demonstrates good short-term efficacy and safety for cervical lymph nodes in patients with locally advanced nasopharyngeal carcinoma.
作者
宋娟
孙轶
廖加群
何馨云
黄立敏
雷竹
李源丽
朱海振
Song Juan;Sun Yi;Liao Jia-Qun;He Xin-Yun;Huang Li-Min;Lei Zhu;Li Yuan-Li;Zhu Hai-Zhen(The Second Clinical Medical College,Guizhou University of Traditional Chinese Medicine,Guiyang,Guizhou 550000,China;Department of Oncology,Guizhou Provincial People's Hospital,Guiyang,Guizhou 550000,China)
出处
《解放军医学杂志》
CAS
CSCD
北大核心
2024年第6期623-628,共6页
Medical Journal of Chinese People's Liberation Army
基金
国家自然科学基金(82260357)
贵州省科技计划项目(黔科合基础[2020]1Y428,黔科合支撑[2021]一般093)。
