尼妥珠单抗联合PF方案治疗晚期食管鳞癌的探索性研究

目的观察尼妥珠单抗联合PF方案治疗晚期食管鳞癌的近期疗效及不良反应。方法人选的46例患者随机分为两组，每组23例。PF方案组给予顺铂80mg／m2，静脉滴注，4周为1疗程；5-FU750mg／m2，持续24小时泵入X5天，4周为1疗程；联合组在PF组的基础上，给予尼妥珠单抗，第1周400mg/（次-周），第2-8周200mg/（次·周），静脉滴注。结果联合组治疗后的有效率为34．8％，疾病控制率为73．9％，均优于单纯PF方案组（21．7％和47．8％）（P〈0．05）；发生Ⅲ～Ⅳ级骨髓抑制的患者数少于PF组（P〈0．05）；疾病进展时间、中位生存时间和1年无进展生存率均长于PF组，差异均有统计学意义（均P〈0．05）。结论尼妥珠单抗联合化疗治疗晚期食管鳞痹安伞有效．值得讲一彤扩大样本研究．

Nimotuzumab combined with cisplatin and 5-FU in treatment of patients with advanced esophageal squamous cell carcinoma

Objective To assess the short-term effect and adverse reaction of nimotuzumab in combination with chemotherapy for advanced esophageal squamous cell carcinoma （ESCC）. Methods Forty-six patients with advanced ESCC were randomly divided into two groups with 23 cases in each group. Patients in PF group were given cisplatin 80 mg/m2 ,IVD and 5-FU 750 mg/m2 , continuous 24-h pump-in 5 days, with 4 weeks as a cycle. Patients in combination group were given nimotuzumab 400 mg IVD in the 1 st week ,200 rag/week from the 2nd to 8th week, on the base of PF regime. Results The response rate and disease control rate of combined group after treatment were 34.8% and 73.9% ,significantly better than those of PF regimen group （21.7% and 47.8% ） （P 〈0.05）. The occurrence rate of m - Iv myelosuppression of combination group was significantly lower than that of PF group （ P 〈 0.05 ）. Time to progression （TTP） , the median survival time （MST） and one-year survival of combination group were significantly longer than those of PF group （ P 〈 0.05 ）. Conclusion Nimotuzumab in combination with cisplatin/5-FU regimen is safe and effective in the treatment of patients with advanced ESCC.