目的 探讨曲妥珠单抗联合卡培他滨和顺铂治疗HER2阳性晚期胃癌的临床疗效及安全性.方法 经病理组织学确诊为晚期胃癌或胃食管连接部腺癌,经免疫组化(IHC)和/或荧光原位杂交法(FISH)检测HER2阳性共30例,其中观察组14例,对照组(单用顺铂+卡培他滨方案)16例.观察组卡培他滨1000 mg/m2,bid,d1～14,q3w;顺铂40 mg/m2,d1 ～2,q3w,6周期,曲妥珠单抗首8 mg/kg,q3w,此后每周6mg/kg,q3w维持进展后停药;对照组单纯化疗6周期,观察其临床疗效与不良反应.结果 观察组总有效率为50.0％,中位存活期为12.8个月,中位TTP8.2月;对照组总有效率为37.5％,中位存活期为9.2个月,中位TTP5.6月,观察组总有效率及中位生存时间明显优于对照组(P＜0.05);两组患者毒副反应轻重程度及发生率比较差异无显著性(P＞0.05).结论 曲妥珠单抗联合化疗可提高HER-2阳性晚期胃癌治疗的临床疗效,安全可靠,可考虑做为选择方案之一.%Objective To investigate the clinical efficacy and safety of trastuzumab combined with capecitabine and cisplatin on the treatment of HER-2 positive advanced gastric cancer.Methods 30 cases were diagnosed as advanced gastric cancer or EGJ adenocarcinoma in histopathology or with HER2 positive gastric cancer by IHC and/or FISH.They were divided into the observation group(14 cases)and the control group(16 cases)(treated solely with cisplatin and capecitabine).The observation group was treated with capecitabine in 1000 mg/m2,bid,dl-14,q3w;cisplatin in 40 mg/m2,dl-2,q3w for six cycles.Furthermore,they were treated with trastuzumab in 8 mg/kg,q3w,and then in 6 mg/kg,q3w each week until continual improvement.The control group was treated solely with chemotherapy for six cycles.The clinical efficacy and toxic and adverse effects of both groups were observed.Results The ORR of the observation group was 50.0％,the median survival time was 12.8 months,and the median was TFP8.2 months.The ORR of the control group was 37.5％,the median survival time was 9.2 months,and the median was TTP5.6 months.The ORR and median survival time of the observation group were both significantly better than those of the control group(P＜ 0.05).There was no significant difference between both groups in toxic and adverse effects and the incidence(P ＞ 0.05).Conclusions Together with chemotherapy,trastuzumab combination can improve the clinical efficacy of HER-2 positive advanced gastric cancer with safety and reliability.So now it serves as one of the alternative treatment options.
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