摘要
目的探讨索拉非尼治疗中晚期肝细胞癌（HCC）的疗效,并考察应用索拉菲尼后血清甲胎蛋白（AFP）水平变化以及AFP应答对于HCC患者预后影响,为索拉非尼治疗HCC效果评价提供临床依据。方法 经病理证实或临床确诊的中晚期HCC患者61例,连续口服索拉非尼,根据实体肿瘤的疗效评价标准（RECIST）进行疗效评价,并在第6周检测患者血清AFP水平,并进行影像学检查,应用Cox比例风险模型检测HCC患者风险比。结果 61例患者中位无进展生存期（PFS）为7个月（95%CI 2.1～14.3个月）,中位总生存时间（OS）为11个月（95%CI 7.2～23.6个月）。RECIST评定,CR 2例（3.3%）,PR 6例（9.8%）,SD 37例（60.7%）,PD 16例（26.2%）,疾病控制率为73.8%。AFP应答组与非应答组PFS与OS差异有统计学意义（P〈0.05）;而影像学肿瘤控制组与影像学肿瘤进展组PFS与OS差异均无统计学意义（P〉0.05）。AFP应答组PFS与OS的风险比分别为0.58（95%CI 0.26～0.97）和0.68（95%CI 0.31～0.89）,而影像学肿瘤控制组PFS与OS的风险比分别为0.96（95%CI 0.35～1.57）和0.98（95%CI 0.71～2.46）。在多因素Cox回归分析中,CLIP评分和AFP应答这两个因素均具有显著性。服用索拉非尼主要不良反应为手足皮肤反应和白细胞、血小板减少,经对症处理或减小剂量后均可明显缓解。结论 索拉非尼治疗中晚期肝细胞癌疗效显著,AFP应答可以作为监测索拉非尼治疗中晚期肝细胞癌疗效的检测标志物。
Objective To investigate therapeutic effect of sorafenib for advanced hepatocelluar carcinoma（HCC）,including progression free survival（PFS）,overall survival（OS） and alpha fetoprotein（AFP） variation to identify the prognostic usefulness of AFP response in clinic application.Methods Pathologically confirmed or clinically diagnosed patients with advanced HCC in 61 cases,continuous oral sorafenib efficacy evaluation based on Response Evaluation Criteria in Solid Tumors（RECIST）,and in the first six weeks,detected serum AFP level and did imaging examination,using the Cox proportional hazards model to detect patients with HCC risk ratio.Results 61 patients with median PFS was 7 months（93%CI2.1-14.3 months）,and median OS was 11 months（95%CI 7.2-23.6 months）.RECIST assessment,CR in 2 cases（3.3%）,PR in 6 cases（9.8%）,SD in 37 cases（60.7%）,PD in 16 cases（26.2%）;disease control rate was 73.8%.AFP responders and non-responders PFS with OS difference was statistically significant（P〈0.05）;while the control group and radiographic imaging of tumor progression and OS,PFS group differences were not statistically significant（P〈0.05）AFP response group risk ratio of PFS and OS was 0.58（95%CI 0.26-0.97） and 0.68（95%CI 0.31-0.89）,while the risk of radiological controls PFS with OS ratios were 0.96（95%CI 0.35-1.57） and 0.98（95%CI 0.71-2.46）.In multivariate Cox regression analysis,CLIP score and AFP responses of these two factors was significant.Taking sorafenib main adverse reactions were hand-foot skin reaction and white blood cells,thrombocytopenia,after symptomatic treatment or reduce the dose can be significantly alleviated.Conclusion The sorafenib was efficient in the treatment of advanced HCC.AFP response may be considered as a novel method to capture sorafenib activity in advanced HCC.
出处
《疑难病杂志》
CAS
2014年第5期451-455,共5页
Chinese Journal of Difficult and Complicated Cases
关键词
索拉非尼
肝细胞癌
中晚期
甲胎蛋白
疾病无进展时间
总生存时间
Sorafenib
Hepatocellular carcinoma
advanced
Alpha fetoprotein
Progression free survival
Overall survival
