全量或半量索拉非尼联合卡培他滨治疗肝细胞肝癌的临床观察

摘要

目的:比较全量或半量索拉非尼(Sor)联合卡培他滨(CAP)治疗肝细胞肝癌的疗效和不良反应.方法:收集2012年2月至2016年6月肝细胞肝癌患者38例,随机分为A组(全量Sor联合CAP,n=19)和B组(半量Sor联合CAP,n=19).A组:Sor 400 mg/次,B组:Sor 200 mg/次,每天2次口服,连续服用,直到疾病进展或不能耐受不良反应为止.A、B组均联用CAP 850 mg/m2每次,每天2次口服,连用14天,休息1周,每21天重复.结果:A组部分缓解(PR)3例,稳定(SD)11例,进展(PD)5例,总有效率(ORR)为15.8%,疾病控制率(DCR)为73.7%,中位肿瘤进展时间(mTTP)为(4.5 ± 0.3)个月,中位总生存期(mOS)为7.2个月[95%可信区间(95%CI):7.1~7.3].B组PR 2例,SD 11例,PD 6例,ORR为10.5%,DCR为68.4%,mTTP为(4.4 ± 0.4)个月,mOS为7.3个月(95%CI:7.2 ~7.4).两组的 ORR比较,P =1.000;DCR比较,P=0.721;TTP比较,P=0.549;OS比较,P=0.265,差异均无统计学意义(P>0.05).不良反应:A组除手足综合征和高血压发生率明显高于B组外,其它不良反应发生率无统计学差异.结论:半量Sor联合CAP治疗晚期肝细胞肝癌疗效与全量Sor联合CAP无显著差异,半量Sor联合CAP组的手足综合征和高血压的发生率显著低于全量Sor联合CAP组.%Objective:To observe the efficacy and side effect of treatment with full or half dose of sorafenib com-bined with capecitabine(CAP)in hepatocellular carcinoma(HCC).Methods:From February,2012 to June,2016, thirty-eight patients with HCC were divided randomly into group A(full dose of sorafenib plus CAP)(n=19)and group B(half dose of sorafenib plus CAP)(n=19).Sorafenib 400 mg,po,bid,in group A and 200 mg,po,bid,in group B,continuously until progression or intolerable side effect.In group A and group B,CAP 800 mg/m2,po,bid, d1~14,and take a week rest,repeated every 21 days.Results:There were 3 cases partial response(PR),11 cases stable disease(SD),5 cases progression disease(PD),and the overall response rate(ORR)was 15.8% and the disease control rate(DCR)was 73.7%,and the median time to progression(mTTP)was(4.5 ± 0.3)months and the medi-an overall survival(mOS)was 7.2(95%CI:7.1~7.3)months in group A.There were 2 cases PR,11 cases SD,6 cases PD,the ORR was 10.5% and the DCR was 68.4%,and the mTTP was(4.4 ± 0.4)months and the mOS was 7.3(95%CI:7.2~7.4)months in group B.There was no statistical difference between group A and group B in ORR (P=1.000),DCR(P=0.721),TTP(P=0.549)and OS(P=0.265).There was no statistical difference between group A and group B in adverse reactions except hand-food syndrome and hypertension in group A significantly more than group B.Conclusion:There was no statistical difference between half dose and full dose of sorafenib combined with capecitabine in patients with HCC and there was a significant lower incidence of hand-food syndrome and hy-pertension in group of half dose of sorafenib combined with capecitabine than in group of full dose of sorafenib com-bined with capecitabine.