载药微球栓塞联合索拉非尼治疗中晚期巨块型肝细胞肝癌的临床疗效及安全性

Clinical study of drug-eluting bead transcatheter arterial chemoembolization combined with sorafenib in treatment of local and advanced massive hepatocellular carcinoma

目的探索载药微球栓塞(DEB-TACE)联合索拉非尼治疗中晚期巨块型肝细胞肝癌的临床疗效及安全性。方法纳入2017年1月至2018年10月在浙江省肿瘤医院介入科接受DEB-TACE联合索拉非尼治疗的中晚期巨块型肝细胞肝癌患者42例。分析DEB-TACE联合索拉非尼治疗后1、3、6、12个月疾病控制率(DCR)、局部有效率(ORR)、无进展生存期(PFS)、总生存期(OS)、DEB-TACE术后不良反应及药物不良反应发生情况。采用癌症治疗功能评价系统量表体系中的共性模块评估患者治疗前后生活质量变化。结果42例患者治疗后1、3、6和12个月的ORR分别为73.8%、83.3%、58.5%和21.1%,DCR分别为97.6%、90.5%、80.5%和47.4%,中位PFS为9.0(95%CI:7.3~10.6)个月,中位OS为20.0(95%CI:18.7~21.3)个月。患者耐受性良好,索拉非尼相关的药物不良反应主要包括手足皮肤反应17例、高血压11例、腹痛8例和腹泻7例等,其中3~4级毒性反应发生率为26.2%。患者治疗后1周生活质量评估各项指标得分及总得分较治疗前有所下降,但在治疗后1、3个月逐步升高,尤其是生理状况、情感状况及功能状况3项指标得分明显升高,差异均有统计学意义(均P<0.05)。结论DEB-TACE联合索拉非尼治疗中晚期巨块型肝细胞肝癌近期临床疗效明显,患者对不良反应可以耐受。

Objective To explore the clinical efficacy and safety of drug-eluting bead transcatheter arterial chemoembolization(DEB-TACE)combined with sorafenib in the treatment of advanced massive hepatocellular carcinoma.Methods The clinical data of 42 patients with advanced massive hepatocellular carcinoma treated in our department from January 2017 to October 2018 were analyzed retrospectively.The data of the tumor disease control rate(DCR),objective respo-se rate(ORR),progression-free survival(PFS),overall survival(OS),postoperative complications and adverse drug reactions were analyzed at 1,3,6 and 12 months after DEB-TAC combined with sorafenib treatment.The patients'quality of life was evaluated before and after treatment with the general module in the functional assessment of cancer therapy.Results The ORRs of the patients were 73.8%,83.3%,58.5%and 21.1%at 1,3,6 and 12 months after treatment respectively.The DCRs were 97.6%,90.5%,80.5%and 47.4%at 1,3,6 and 12 months after treatment respectively.The median PFS was 9.0 months(95%CI:7.3-10.6)and the median OS was 20.0 months(95%CI:18.7-21.3).Sorafenib-related adverse drug reactions mainly included hand and foot skin reactions,hypertension,abdominal pain and diarrhea,etc.,and the incidence of grade 3/4 toxicities were 26.2%.The scores of life quality of the patients decreased after treatment in 1 week,and gradually increased after treatment in 1 month and 3 months,among which the scores of physiological state,emotional state and functional state showed marked improvement(all P<0.05).Conclusion The short-term clinical efficacy and safety of DEB-TACE combined with sorafenib in the treatment of advanced massive hepatocellular carcinoma are obvious,and the side effects are tolerable.