奥沙利铂单药治疗Child-Pugh B 级中晚期肝癌的临床研究

目的 观察奥沙利铂单药治疗Child-Pugh B 级中晚期原发性肝癌（primary liver cancer,PLC）的疗效及不良反应。方法 将7个肿瘤中心2014年11月—2016年11月接诊的共67例Child-Pugh B 级中晚期PLC,按患者的意愿分为两组：奥沙利铂单药组（治疗组,32例）和对症支持治疗组（观察组,35例）。评价两组客观缓解率（objective remission rate,ORR）、疾病控制率(disease control rate ,DCR)、中位生存时间(median overall survival ,mOS)、中位无进展生存期（median progression free survival,mPFS）、1年存活率（ survival rate,SR）以及不良反应。结果 治疗组32例中,部分缓解（partial remission,PR） 3例,稳定（steady state,SD） 12例,进展（progressive disease,PD） 17例,ORR为9.4％,DCR为46.9％,mOS为6.2个月,mPFS为2.9个月,1年SR为12.5%（4例）;观察组35例中PR 0例,SD 7例,PD 28例,ORR为0.0%,DCR为20.0％,mOS为5.2个月,mPFS为2.1个月,1年SR为5.7%（2例）。两组均无获得完全缓解（complete remission, CR）的患者。两组PR、ORR、DCR、mOS和mPFS比较,差异有统计学意义（P<0.05）。两组1年SR比较,差异无统计学意义（χ²=0.944,P=0.331）,但治疗组有更好的趋势。治疗组32例发生常见的副反应分别为消化道反应15例（46.9%）、肾毒性7例（21.9%）、肝毒性14例（43.8%）、骨髓抑制15例（46.9%）、心脏毒性5例（15.6%）、周围神经毒性9例（28.1%）,大多数为Ⅰ度~Ⅱ度副反应。结论 奥沙利铂单药治疗Child-Pugh B 级中晚期PLC安全有效,多数不良反应较轻,对患者有良好的病情控制和生存获益。

Clinical study of oxaliplatin in treating the patients with Child-Pugh B advanced primary liver cancer

Objective To evaluate the therapeutic efficacy and toxicity of oxaliplatin in patients with Child-Pugh B advanced primary liver cancer (PLC). Methods Sixty seven patients with Child-Pugh B advanced PLC admitted to 7 cancer centers from November 2014 to November 2016 were divided into 2 groups according to the patient's wishes, treatment group(32 patients, treatment with oxaliplatin) and observation group (35 patients,did not treatment with oxaliplatin). The therapeutic efficacy as Objective remission rate (ORR), disease control rate (DCR), median overall survival(mOS), median progression free survival (mPFS), one year survival rate (SR), and toxicity in these patients were evaluated. Results All the 32 patients in treatment group, three patients obtained partial response (PR), 12 stable disease (SD) and 17 progressive disease(PD). ORR was 9.4％,DCR was 46.9％,mOS was 6.2 months,mPFS was 2.9 months,1 year SR was 12.5%（4 cases）;Thirty five patients in observation group, there was no patients obtained PR, seven patients SD and 28 patients of PD. ORR was 0.0%,DCR was 20.0％,mOS was 5.2 months,mPFS was 2.1 months,1 year SR was 5.7%（2 cases）. No CR patients were found in either group. There was statistically significant difference in the two group about ORR, DCR, mOS and mPFS（P<0.05）. There was no statistically significant difference in the two group about one year SR（χ²=0.944,P=0.331）,but the treatment group had a better trend. The adverse events of oxaliplatin occurred in the treatment group (32 patients), such as gastrointestinal reaction, renal toxicity, hepatotoxicity, cardiotoxicity, myelosuppression and peripheral nerve toxicity were respectively cases of 15(46.9%), 7(21.9%), 14(43.8%), 15(46.9%), 5(15.6%) and 9(28.1%). Most of these adverse events wereⅠ-Ⅱ grade. Conclusion Oxaliplatin is safe and effective to the patients with Child-Pugh B advanced PLC. The patient has good condition control and survival benefit,and the adverse reaction is mild and tolerable.