斑蝥酸钠维生素B6注射液同步低剂量放疗序贯FOLFOX4方案治疗晚期肝细胞癌的临床研究  

Clinical observation of disodium cantharidinate and vitamin B6 injection combined with low-dose radiotherapy sequenced by FOLFOX4 regimen for advanced hepatocellular carcinoma

作　　者：许耀灿 陈科权 梁维朝 高伟伟 冯坚 陈柏裕 朱伟强 黎宗琼 徐海欢 梁永 XU Yaocan;CHEN Kequan;LIANG Weichao;GAO Weiwei;FENG Jian;CHEN Boyu;ZHU Weiqiang;LI Zongqiong;XU Haihuan;LIANG Yong(Department of Oncology,Guiping People s Hospital,Guiping 537200,China)

机构地区：[1]桂平市人民医院肿瘤科

出　　处：《临床肿瘤学杂志》2020年第1期33-39,共7页Chinese Clinical Oncology

基　　金：广西壮族自治区卫生与计划生育委员会计划课题资助项目(Z2015701)

摘　　要：目的探讨斑蝥酸钠维生素B6注射液同步低剂量放疗序贯FOLFOX4方案治疗晚期肝细胞癌(HCC)的疗效和不良反应。方法收集2015年3月至2016年12月晚期HCC患者41例,接受斑蝥酸钠维生素B6注射液(40ml静滴,每天1次)同步三维适形放疗(20~40Gy/10f,2周完成),放疗结束后2~4周行FOLFOX4方案化疗(奥沙利铂85mg/m^2静滴,d1;亚叶酸钙200 mg/m^2静滴,d1、d2;氟尿嘧啶400 mg/m^2静推d1、d2,600 mg/m^2持续静滴22 h,d1、d2,14天为1个周期)化疗12个周期。观察近期疗效、总生存时间(OS)、无进展生存时间(PFS)和不良反应。结果 41例入组患者中37例可评价近期疗效,获CR 1例、PR 8例、SD 19例,PD 9例,有效率为24.3%,疾病控制率为75.7%。放疗野内局部控制率为81.1%(30/37)。随访截止于2018年9月18日,中位随访10.5个月,死亡34例。41例患者的中位OS为9.7个月(95%CI:5.5~14.1个月),37例患者的中位PFS为5.9个月(95%CI:5.1~9.1个月)。亚组分析显示,放疗靶区内病灶的中位PFS为9.1个月(95%CI:4.1~32.0个月),靶区外病灶的中位PFS为5.0个月(95%CI:3.7~7.8个月),差异有统计学意义(P=0.02);巨块型单发病灶患者的中位OS为16.6个月(95%CI:3.0~33.3个月),而肝内多发病灶者为6.8个月(95%CI:5.0~10.5个月),差异有统计学意义(P=0.04)。主要不良反应包括骨髓抑制、消化道反应、周围神经毒性和过敏反应等。仅1例发生3级不良反应,其余均为1~2级,无1例出现治疗相关性死亡。结论斑蝥酸钠维生素B6注射液同步低剂量放疗序贯FOLFOX4方案治疗晚期HCC可延长患者的OS,不良反应可耐受,值得进一步开展随机对照临床研究。Objective To investigate the efficacy and safety of disodium cantharidinate and vitamin B6 injection combined with low dose radiotherapy sequenced by FOLFOX4 regimen for advanced hepatocellular carcinoma(HCC).Methods From March 2015 to December 2016,41 patients with advanced HCC were enrolled in this study.All patients received disodium cantharidinate and vitamin B6 injection(40ml iv once daily)combined with low dose three-dimensional conformal radiotherapy(20-40Gy/10f/2 weeks)followed by FOLFOX4 regimen(oxaliplatin 85mg/m^2 iv,d 1;leucovorin 200 mg/m^2 iv 2 h,d 1,d 2;fluorouracil 400 mg/m^2 iv bolus,d 1,d 2;fluorouracil 600 mg/m^2civ 22 h,d 1,d 2.Two weeks was a cycle.)for 12 cycles.Short-term efficacy,overall survival(OS),progress-free survival(PFS)and adverse events were observed.Results Among the 41 patients,37 were evaluatable for short-term efficacy.There were 1 patient with CR,8 patients with PR,19 patients with SD and 9 patients with PD.The response rate was 24.3%and disease control rate was 75.7%.The local control rate of radiotherapy field was 81.1%(30/37).Till 18 september 2018,the median follow-up period was 10.5 months,and deaths were observed in 34 patients.The median OS of 41 patients was 9.7 months(95%CI:5.5-14.1months),and the median PFS of 37 patients was 5.9 months(95%CI:5.1-9.1months)respectively.Subgroup analysis indicated that the median PFS of focus in the target area of radiotherapy was 9.1 months(95%CI:4.1-32.0 months),longer than 5.0 months(95%CI:3.7-7.8 months)of focus outside the target area(P=0.02).The median OS of patients with massive single focus was 16.6 months(95%CI:3.0-33.3 months),longer than 6.8 months(95%CI:5.0-10.5 months)of those with multiple intrahepatic lesions(P=0.04).The major adverse events included gastrointestinal reaction,myelosuppression,peripheral neurotoxicity and anaphylaxis,mainly in grade 1-2.Grade 3 adverse event was only found in one patient and no treatment related death was observed.Conclusion Disodium cantharidinate and vitamin B6 injection combined with

关 键 词：肝细胞癌(HCC) 斑蝥酸钠维生素B6注射液 放射治疗 化学治疗 

分 类 号：R735.7[医药卫生—肿瘤]