吉西他滨联合奥沙利铂治疗中晚期原发性肝癌的临床疗效和安全性观察

A CLINICAL STUDY OF GEMCITABINE PLUS OXALIPLATIN IN THE TREATMENT OF ADVANCED PRIMARY LIVER CANCER

目的：观察吉西他滨联合奥沙利铂治疗中晚期原发性肝癌（PLC）的疗效和安全性.方法：入组本研究的36例中晚期PLC患者接受了吉西他滨联合奥沙利铂方案治疗：吉西他滨1 000 mg/m^2,第1,8天,奥沙利铂130 mg/m^2,第1天,每3周重复.使用RECIST 1.0标准评价近期疗效和NCI-CTC 3.0版评价不良反应.结果：所有病例均可评价疗效和不良反应,36例患者共计接受化疗161个周期（4.5周期/例）,获得部分缓解6例（16.7％）,稳定16例（44.4％）,疾病控制率为61.1％,进展14例（38.9％）,无病例获得完全缓解;全组病例中位生存时间（mOS）为10.8个月,其中疾病获得控制的病例组的mOS为12.8个月,明显优于疾病进展病例组的4.6个月（P＜0.01）.Ⅲ～Ⅳ度血液学毒性方面,白细胞减少发生率为18.6％,血小板减少发生率为11.1％.非血液学毒性反应轻微.结论：吉西他滨联合奥沙利铂治疗中晚期PLC具有良好的疗效,病人耐受性较好.

Objective：To evaluate the efficacy and safety of gemcitabine combined with oxaliplatin （GEMOX） in treatment of patients with advanced primary liver cancer （PLC）.Methods：Thirty-six patients with advanced PLC were enrolled in the study and received the GEMOX regimen with gemcitabine 1000 mg/m2 on days 1 and 8,and oxaliplatin 130 mg/m2 on day 1.The treatment was repeated every 3 weeks.The RECIST 1.0 and NCI-CTC 3.0 was used to evaluate the effects and the toxicity,respectively.Results：All patients were assessable for efficacy and toxicity.A total of 161 treatment cycles were administered.Six patients （16.7%） had partial response,16 patients （44.4%） had stable disease,and the disease control rates （DCR） was 61.1%,14 patients （38.9%） achieved disease progression,no complete remission cases.The median overall survival times （mOS） was 10.8 months of all patients,meanwhile,the mOS of disease control group was better than that of disease progression group （12.8 months vs.4.6 months,P 〈0.01）.Grade 3-4 hematological toxicity included leucopenia （18.6%） and thrombocytopenia （11.1%）.Nonhematologic toxicity was mild.Conclusion：The combination of gemcitabine and oxaliplatin in treatment of advanced primary liver carcinoma was effective and well tolerated.