【摘要】 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。方法入选的46例患者随机分为两组,每组23例。PF方案组给予顺铂80 mg/m2,静脉滴注,4周为1疗程;5-FU 750 mg/m2,持续24小时泵入×5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400 mg/(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癌安全有效,值得进一步扩大样本研究。更多还原

【Abstract】 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 1st week,200 mg / 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 Ⅲ ~ 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.更多还原