希罗达草酸铂方案联合艾迪治疗进展期胃癌的临床研究

目的 探讨希罗达草酸铂方案联合艾迪治疗进展期胃癌的疗效,生存率及毒副反应.方法 64例经胃镜活检病理学确诊的不能手术或术后复发转移未接受过任何化疗的晚期胃癌,男44例,女性20例,年龄32～74 岁,中位年龄48岁;均为Ⅲ～Ⅳ期,Karnofsky评分≥70分.随机分为2组治疗组和对照组,采用希罗达草酸铂方案联合艾迪注射液,希罗达1250 mg/m2 Bid d1～14 P.O,草酸铂120 mg/m2 5%葡萄糖注射液500 ml,静脉滴注4h,艾迪60 ml 生理盐水400 ml,d1～14,静脉滴注,3周为1疗程,32例进展期胃癌用希罗达草酸铂方案治疗,不加艾迪作为对照组,剂量同上,6个疗程后评估.结果 治疗组32例,CR 1例,PR 22例,PR 70.2%,中位无病生存期7.3个月,中位生存期11.9个月,1年生存率75.2%(24/32),2年生存率22.5%(7/32),卡氏评分比治疗前提高10分,主要副反应为中性粒细胞减少9.3%(3/32),末梢神经木麻15.2%(5/32),手足综合征9.3%(3/32),未出现3级以上的药物相关副反应.对照组RR56.8%,中位无病生存期6.5个月,中位生存期10.1个月,1年生存率为59.2%,2年生存率15.4%,卡氏平分较治疗前无明显变化,中性粒细胞减少15.1%,末梢神经木麻20.8%,手足综合征18.2%.两组生存率、有效率、毒副反应比较有统计学意义(P＜0.05).结论 希罗达草酸铂方案联合艾迪治疗进展期胃癌中位无病生存期,中位生存期及1、2年生存率高,症状得到明显改善,生活质量提高,毒副反应轻,体现中西医结合治疗的优势,在治疗晚期胃癌中安全、可靠,值得推广应用.

Capecitabine and Oxaliplatin Combined with AiDi Injection in the Treatment of Advanced Gastrie Cancer

Objective To determine the efficacy and toxicities of capecitabine and oxaliplatin combined with AiDi injection as first-line treatment in advanced gastric cancer.Methods Sixty-four patients with pathologically approved unresectable or recurrent,metastatic gastric cancer were included in this study.Their age ranged from 32 to 74 years with a median of 48.There were 44 male and 20 female.The patients were randomized into two groups.32 cases were treated with capecitabin and oxaliplation combined AiDi injection,with capecitabine 1250 mg/m2.d from d1 to d14,oxaliplation 120 mg/m2.d intravenously in d1 in continuous injection for 3 hours,and AiDi injuction 60ml/d by intravenous injection from d1 to d14.The treatment was repeated every 3 weeks.Results were reviewed afer 3 cycles.Patients in control group were treated with capecitabine and oxaliplation.Results: Complete response was noted in 1 patients,and partial response was noted in 22 patients in the treatment group,with an overall response rate of 70.2%.The median time to tumor progression was 7.3 months,and median overall survival time was 11.9 months.One and two year survival rate was 75.2%(24/32)and 22.5% (7/32).The karnofsky performance status was improved 10 after treatment.Toxicities included hand-foot syndrome (HFS) in 9.3% (3/32).Leukopenia in 9.3% (3/32),neuro-sensory adnormity in 15.2% (5/32).No treatment related death was noted.The overall response rate in the control group was 56.8%.The median time to tumor progression was 6.5 months,and the median overall survival time was 10.1months.The one and two year survival was 59.2% and 15.4%.Toxicities in the control group included leukopenia in 15.1%,hand-foot syndrome in 18.2% and mild neuro-sensory adnormity in 20.8%.There were significant differences between the two groups in the survival,response rate,toxicities(P< 0.05).Conclusion capecitabine and oxaliplatin combined AiDi injection chemotherapy regimen was an effective and well-tolerated alternative treatment in advanced gastric cancer.