肝癌方加减联合细胞免疫治疗晚期原发性肝细胞癌的临床观察

Clinical Observation on Advanced Primary Hepatocellular Carcinoma by Ganai Formula(肝癌方) Combined with Cells Immunotherapy

目的:评估肝癌方联合细胞免疫治疗晚期原发性肝细胞癌(HCC)的疗效和安全性。方法:回顾性分析2010年1月至2015年12月以肝癌方加减联合细胞免疫治疗以及单纯细胞免疫治疗的晚期HCC患者60例,分别为32例、28例。按照RECIST 1.1版标准评估疗效,按照《抗癌药急性及亚急性毒性反应分度标准(WHO标准)》评估不良反应。结果:58例可评价疗效,客观有效率(ORR)及疾病控制率(DCR)分别为25.9%和77.6%;中位生存期为34个月,累积1年生存率为77.6%,2年生存率为62.1%,3年生存率为50.0%。单纯细胞免疫治疗与肝癌方加减联合细胞免疫治疗的ORR、DCR及中位生存期分别为22.2%、66.7%;29.0%、90.3%;18个月、46个月,DCR及中位生存期差异均有统计学意义(P<0.05)。两组不良反应发生率比较,发热、恶心呕吐及腹泻方面差异有统计学意义(P<0.05)。结论:细胞免疫治疗晚期HCC有较好的临床疗效,不良反应可耐受;肝癌方加减联合细胞免疫治疗HCC临床疗效优于单纯细胞免疫治疗。

Objective： To evaluate the efficacy and safety of Ganai Formula combined with cells immunotherapy for the treatment of advanced primary hepatocellular carcinoma. Methods： The 60 cases of advanced primary hepatocellular carcinoma patients during January 2010 to December 2015 were reviewed, including 32 cases treated with Ganai Formula combined with cells immunotherapy and 28 cases treated with cells immunotherapy .The efficacy was assessed based on RECIST 1.1, and the adverse events were evaluated according to Cancer drugs in acute and subacute toxicity reaction dividing standard （the WHO standard）. Results： There were 58 patients assessable for efficacy. The objective response rate （ORR） and disease control rate （DCR） were 25.9% and 77.6% respectively; The median survival was 34 months; The cumulative 1-year, 2-year and 3-year survival rates were 77.6%, 62.1% and 50.0%, respectively. The DCR and median survival showed significant difference between cells immunotherapy group and cells immunotherapy plus Ganai formula group （66.7% vs. 90.3%38 months vs. 34 months） showed significant difference （P〈0.05） while the ORR showed no significant difference （22.2% vs. 29.0%, P〉0.05） .The adverse reactions showed significant difference between two groups on fever, nausea, vomiting and diarrhea （P〈0.05）. Conclusion： The therapy based on cells immunotherapy shows good clinical efficacy for the treatment of advanced primary hepatocellular carcinoma, and the adverse reactions could be tolerated. Besides, the efficiency of Ganai Formula combined with cells immunotherapy regimen is better than cells immunotherapy alone regimen.