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 fluoroura-cil (5-FU)as neo-adjuvant chemotherapy in the treatment of hypopharyngeal squamous cell carcinoma.Methods Be-tween July 2012 and December 2014,we performed initial treatment on 91 cases of hypopharyngeal squamous cell carcino-ma with the nimotuzumab (300 mg/m2 day 1)combined with nedaplatin (90 mg /m2 day 1 )and 5-FU (750 mg /m2 day1-5)as neo-adjuvant chemotherapy,with one cycle for 3 weeks.Two cycles were followed by surgery and radiation therapy.The primary endpoint was tumor response rate,pathological complete response rate,the rate of laryngeal pres-ervation and chemotherapy related toxicity.Results The response rate of tumor was 86.8% (79 /91)after two cycles of neo-adjuvant chemotherapy.Fifty-two patients (57.1%)got downstage,with T downstage in 47(51.6%)cases and N downstage in 20(22.0%)cases.Eighty-eight patients got surgery after the neo-adjuvant chemotherapy,of which 68 patients (77.3%)preserved laryngeal function.The pathological complete response was 8.8% (8 /91)of the total. The toxicity was mild and manageable.There were 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 ef-fective for improving the hypopharyngeal carcinoma patients’tumor response rate and preserving their organ function, while the toxicities were well tolerable.