新辅助化疗方案尼妥珠单抗联合奈达铂和5-氟尿嘧啶治疗下咽鳞癌初步临床分析  

Preliminary clinical analysis of neo-adjuvant chemotherapy with nimotuzumab plus nedaplatin and fluorouracil in hypopharyngeal squamous cell carcinoma

作　　者：董频[1] 英信江[1] 陈歆维[1] 邓志宏 张少强[3] 於子卫[1] 金斌[1] 孙臻峰[1] 谢晋[1] 祝江才[1] 

机构地区：[1]上海交通大学附属第一人民医院耳鼻咽喉头颈外科,上海200080 [2]第四军医大学第一附属医院西京医院耳鼻咽喉头颈外科,陕西西安710032 [3]西安交通大学第一附属医院耳鼻咽喉头颈外科,陕西西安710061

出　　处：《山东大学耳鼻喉眼学报》2016年第3期10-14,共5页Journal of Otolaryngology and Ophthalmology of Shandong University

摘　　要：目的探讨尼妥珠单抗联合奈达铂和5-氟尿嘧啶（fluorouracil,5-Fu）新方案,作为新辅助化疗来治疗下咽鳞癌患者术前的疗效和安全性。方法对初治的91例下咽鳞癌患者以尼妥珠单抗（300 mg第1天）联合奈达铂（90 mg/m2第1天）和5-Fu（750 mg/m2第1~5天）3周方案作为新辅助化疗,两个周期后予以手术和术后放射治疗。主要研究终点为肿瘤缓解率,次要研究终点为病理完全缓解率、保喉率和化疗相关毒性。结果所有入组对象的总体肿瘤缓解率为86.8%（79/91）,52例（57.1%）影像学降期,其中47例次（51.6%）达T降期,20例次（22.0%）达N降期。新辅助化疗（1或2个周期）后共88例行手术治疗,其中68例为保留喉功能的下咽癌根治性手术,保喉率为77.3%。8例术后原发灶病理完全缓解,占总入组患者数的8.8%（8/91）。29例（31.9%）出现中性粒细胞减少,26例（28.6%）出现恶心呕吐等胃肠道反应。结论尼妥珠单抗联合奈达铂和5-Fu方案作为新辅助化疗可提高下咽鳞癌患者的肿瘤缓解率,且对其毒性耐受良好,多数患者通过新辅助化疗保留喉功能。Objective To investigate the safety and efficacy of nimotuzumab combined with nedaplatinand and fluorouracil（ 5-FU） as neo-adjuvant chemotherapy in the treatment of hypopharyngeal squamous cell carcinoma. Methods Betw een July 2012 and December 2014,w e performed initial treatment on 91 cases of hypopharyngeal squamous cell carcinoma w ith the nimotuzumab（ 300 mg / m2 day 1） combined w ith nedaplatin（ 90 mg / m2 day 1） and 5-FU（ 750 mg / m2day1-5） as neo-adjuvant chemotherapy,w ith one cycle for 3 w eeks. Tw o cycles w ere follow ed by surgery and radiation therapy. The primary endpoint w as tumor response rate,pathological complete response rate,the rate of laryngeal preservation and chemotherapy related toxicity. Results The response rate of tumor w as 86. 8%（ 79 /91） after tw o cycles of neo-adjuvant chemotherapy. Fifty-tw o patients（ 57. 1%） got dow nstage,w ith T dow nstage in 47（ 51. 6%） cases and N dow nstage in 20（ 22. 0%） cases. Eighty-eight patients got surgery after the neo-adjuvant chemotherapy,of w hich68 patients（ 77. 3%） preserved laryngeal function. The pathological complete response w as 8. 8%（ 8 /91） of the total.The toxicity w as mild and manageable. There w ere 29 cases of neutropenia（ 31. 9%）,26 cases of nausea / vomiting（ 28. 6%）. Conclusion Nimotuzumab plus nedaplatin and 5-FU regimen as neo-adjuvant chemotherapy was highly effective for improving the hypopharyngeal carcinoma patients＇ tumor response rate and preserving their organ function,w hile the toxicities w ere w ell tolerable.

关 键 词：下咽癌 鳞状细胞癌 受体 表皮生长因子 新辅助化疗 靶向 

分 类 号：R739.63[医药卫生—肿瘤]