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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 efficacy and safety of nimotuzumab combined with nedaplatin and 5-fluorouracil (5-Fu) as a neoadjuvant chemotherapy for the treatment of patients with squamous carcinoma. Methods Ninety-one patients with hypopharyngeal squamous cell carcinoma were treated with nimotuzumab (300 mg on the first day) combined with nedaplatin (90 mg / m2 on the first day) and 5-Fu (750 mg / m2 on the first day) 5 days) 3 weeks program as neoadjuvant chemotherapy, surgery and postoperative radiotherapy after two cycles. The primary endpoint was tumor response rate, and secondary end points were pathologic complete response rate, burglary rate, and chemotherapy-related toxicity. Results The overall tumor remission rate was 86.8% (79/91) in all subjects and 52 (57.1%) in the imaging period, of which 47 cases (51.6%) had T down and 20 cases (22.0% Up to N down. A total of 88 patients undergoing neoadjuvant chemotherapy (1 or 2 cycles) underwent surgery, of which 68 were radical surgery for preserving laryngeal function, with a safety rate of 77.3%. Eight cases of complete remission of the primary pathological lesions, the total number of patients into the group of 8.8% (8/91). Neutropenia occurred in 29 cases (31.9%) and nausea and vomit in 26 cases (28.6%). Conclusion Nimotuzumab combined with nedaplatin and 5-Fu regimen as neoadjuvant chemotherapy can improve the tumor remission rate of patients with hypopharyngeal squamous cell carcinoma and its toxicity is well tolerated. Most patients retain laryngeal function through neoadjuvant chemotherapy.