尼妥珠单抗联合DCF方案治疗晚期胃癌的临床观察

目的 观察尼妥珠单抗联合DCF方案治疗晚期胃癌的近期疗效及不良反应。方法 36 例晚期胃癌患者分为治疗组和对照组。治疗组（n =17）采用尼妥珠单抗联合DCF方案治疗：尼妥珠单抗200mg，每周1 次，连用6 个周期，之后同剂量每2 周1 次进行巩固治疗，至病情进展停用；多西他赛60mg/m2，静脉滴注，dl；顺铂60mg/m2，静脉滴注，dl；氟尿嘧啶600mg/m2，持续静脉输注120h。对照组（n=19）仅用DCF 方案治疗，同治疗组。结果 36 例患者均可进行评价。治疗组有效率（RR）为64.8 %，疾病控制率（DCR）为82.4%；对照组RR为31.6%，DCR为47.4％。两组间RR、DCR 比较差异均有统计学意义（P＜0.05）。治疗组与对照组主要的毒副反应有疲乏、白细胞减少、恶心呕吐、脱发等，两组间比较差异无统计学意义（P＞0.05）。结论 尼妥珠单抗联合DCF 方案治疗晚期胃癌安全有效，值得进一步扩大样本研究。

Clinical study on nimotuzumab combined with DCF regimen in the treatment of advanced gastric cancer

Objective To evaluate the efficacy and toxicity of DCF regimen combined with a humanized murine monoclonal antibody that inhibit EGFR＇s extracellular domain—nimotuzumab on advanced gastric carcinoma.Methods Thirty-six patients with advanced gastric cancer were enrolled in this study and divided into two groups： the research group and the control group with 17 and 19 patients respectively.Patients were given nimotuzumab 200mg i.v.weekly for 6 weeks and then every two weeks in the research group followed until disease progression.Both groups were given docetaxel 60mg/m 2 on day 1 plus cisplatin 60mg/m 2 on day 1 and 5-fluorouracil 600mg/m 2 infused continually for 120 hours.Results All thirty-six patients were evaluable for objective response.The response rate（RR） was 64.8% in the research group and 31.6% in the control group,showing significant difference（P=0.049）.There was also significant difference in the disease control rate（DCR） between the two groups（82.4% vs.47.4%,P=0.032）.The major side effects include asthenia,bone marrow suppression,nausea,vomiting and alopecia.However,the difference was not significant in the frequency of adverse reaction between the two groups（P〉0.05）.Conclusion Nimotuzumab combined with DCF regimen is effective in the treatment of advanced gastric cancer,with mild to moderate side effects.It deserves enlargement of samples and further research.