TACE联合阿帕替尼与单纯TACE治疗中晚期肝癌的疗效对比：单中心随机对照临床研究
发布时间：2018-08-22 14:59
【摘要】：[目的]比较经皮肝动脉灌注化疗栓塞术(transcatheter arterial chemoembolization,TACE)联合阿帕替尼(apatinib)与单纯TACE治疗中晚期肝细胞肝癌(hepatocellular carcinoma,HCC)患者的临床疗效和安全性差异。[方法]1、选取海军总医院2015年3月至2015年8月收治的44例中晚期肝细胞肝癌患者(男性33例,女性11例;年龄34-79岁,中位年龄58.5岁),随机分为A、B两组。A组行单纯TACE治疗,B组行TACE联合阿帕替尼治疗。2、共随访12-18个月。比较治疗后3个月时两组甲胎蛋白(alpha fetoprotein,AFP)指标变化情况,及3、6、9、12个月时客观缓解率(objective response rate,ORR)。同时比较两组患者疾病无进展生存期(progression-free survival,PFS)和不良反应的发生情况。3、统计学处理:计量资料以x±s表示,两组内比较使用配对t检验,组间比较采用独立样本t检验;记数资料以频数/百分率表示,采用χ2检验;非正态分布数据用中位数(范围)表示,采用Wilcoxon秩和检验。中位PFS采用Kaplan-Meier法进行统计分析,同时绘制生存率曲线,两组组间生存差异分析采用Log-rank检验。p0.05为差异有统计学意义。[结果]1、两组患者一般资料包括年龄、性别、Child-pugh分级、KPS评分、病因学、主瘤直径等差异均无统计学意义(p0.05),具有良好的可比性。其中,AFP升高A组19例、B组16例。2、两组患者临床疗效的比较:治疗后三个月,A、B两组AFP水平均显著下降,分别较治疗前差异有统计学意义(Z=-2.289、-2.953,p均0.05),治疗后两组间比较差异无统计学意义(Z-0.126,p=0.90)。A组5例患者AFP降至正常,B组6例降至正常。3、治疗后3、6、9、12个月 A组ORR分别为36.36%、27.27%、13.64%、9.09%;而B组分别为60%、50%、45%、35%。其中治疗3、6个月时两组差异均无统计学意义(χ2=2.346;χ2=2.295,均0.05),治疗后9、12个月时两组差异均有统计学意义(χ2=5.050;χ2=4.177,均0.05)。4、A组中位无进展生存期为6.0个月;B组中位无进展生存期为12.5个月,差异有统计学意义(χ2=6.576,p=0.01)。5、两组栓塞后综合症包括发热、腹痛、恶心呕吐等不良反应发生率差异均无统计学意义(p均0.05)。B组阿帕替尼相关不良反应高血压、手足综合症、蛋白尿发生率高于A组,差异有统计学意义(p均0.05)。两组均未发生严重不良反应,且经对症处理后均可缓解。[结论]1、对于中晚期肝癌患者,TACE联合阿帕替尼与单纯TACE治疗均可有效降低患者AFP水平。联合组治疗的中远期疗效较单纯组更具优势,且更显著延长患者疾病无进展生存期。2、两组的大多数不良反应较轻微,经对症处理后不会导致治疗中断,阿帕替尼联合使用的安全性得以证实。
[Abstract]:[objective] to compare the clinical efficacy and safety of percutaneous transcatheter arterial chemoembolization (transcatheter arterial chemoembolization TACE) combined with apatinib (apatinib) and TACE alone in the treatment of middle and advanced hepatocellular carcinoma (hepatocellular carcinoma). [methods] A total of 44 patients with advanced hepatocellular carcinoma (33 males, 11 females, aged 34 to 79 years) were selected from the Naval General Hospital from March 2015 to August 2015. The median age was 58.5 years old. Group A was randomly divided into two groups: group A and group A were treated with TACE alone and group B were treated with TACE combined with apatinib for 12 to 18 months. The changes of alpha fetoprotein (alpha) in the two groups were compared 3 months after treatment, and the objective remission rate (objective response rrr) at 12 months after treatment was compared. At the same time, the incidence of progression-free survival and adverse reactions were compared between the two groups. Statistical processing: the metrological data were expressed as x 卤s, the matched t test was used in the two groups, and the independent sample t test was used in the comparison between the two groups. The data were expressed as frequency / percentage, 蠂 ~ 2 test was used, and non-normal distribution data was expressed as median (range), and Wilcoxon rank sum test was used. The median PFS was statistically analyzed by Kaplan-Meier method and the survival rate curve was drawn. The survival difference between the two groups was analyzed by Log-rank test. P0.05 was statistically significant. [results] 1. There were no significant differences between the two groups in general data including age, sex, Child-pugh grade, KPS score, etiology and diameter of the main tumor (p0.05). There were 19 patients with elevated AFP in group A and 16 patients in group B. The comparison of clinical efficacy between the two groups: the level of AFP in group A and group B were significantly decreased three months after treatment. There was no significant difference between the two groups after the treatment (Z-0.126 p0.90). The AFP in group A decreased to normal group (6 cases, normal group, 6 cases), and the ORR of group A was 36.3627.2727.277.277.27 (13.64), 9.09, respectively, and that of group A was 60,504545, 359.09, respectively, compared with that before treatment (P < 0.05), and the ORR of group A was 36.3627.277.2713.64 / 9.09, respectively, and the ORR of group A was 36.3627.277.277.2713.64 / 9.09, and the ORR of group A was 36.3627.277.27 and 13.649.09 respectively after treatment. There was no significant difference between the two groups at 3 and 6 months after treatment (蠂 2 + 2.346; 蠂 2 + 2.295, all 0.05). There were significant differences between the two groups at 9 and 12 months after treatment (蠂 25.050; 蠂 2 4.177, both 0.05). The median progression-free survival time of group A was 6.0 months and that of group B was 12.5 months. There was no significant difference in the incidence of adverse reactions such as fever, abdominal pain, nausea and vomiting between the two groups (p 0.05). The incidence of proteinuria was significantly higher than that in group A (p 0.05). There was no serious adverse reaction in both groups, and it was alleviated after symptomatic treatment. [conclusion] 1. TACE combined with apatinib and TACE can effectively reduce the level of AFP in patients with advanced liver cancer. The medium and long term curative effect of the combined treatment group was superior to that of the simple group, and the survival time of the patients without progression was significantly prolonged. Most of the adverse reactions in the two groups were mild, and the treatment would not be interrupted after symptomatic treatment. The safety of combined use of apatinib was confirmed.
【学位授予单位】：南方医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R735.7
本文编号：2197454
[Abstract]:[objective] to compare the clinical efficacy and safety of percutaneous transcatheter arterial chemoembolization (transcatheter arterial chemoembolization TACE) combined with apatinib (apatinib) and TACE alone in the treatment of middle and advanced hepatocellular carcinoma (hepatocellular carcinoma). [methods] A total of 44 patients with advanced hepatocellular carcinoma (33 males, 11 females, aged 34 to 79 years) were selected from the Naval General Hospital from March 2015 to August 2015. The median age was 58.5 years old. Group A was randomly divided into two groups: group A and group A were treated with TACE alone and group B were treated with TACE combined with apatinib for 12 to 18 months. The changes of alpha fetoprotein (alpha) in the two groups were compared 3 months after treatment, and the objective remission rate (objective response rrr) at 12 months after treatment was compared. At the same time, the incidence of progression-free survival and adverse reactions were compared between the two groups. Statistical processing: the metrological data were expressed as x 卤s, the matched t test was used in the two groups, and the independent sample t test was used in the comparison between the two groups. The data were expressed as frequency / percentage, 蠂 ~ 2 test was used, and non-normal distribution data was expressed as median (range), and Wilcoxon rank sum test was used. The median PFS was statistically analyzed by Kaplan-Meier method and the survival rate curve was drawn. The survival difference between the two groups was analyzed by Log-rank test. P0.05 was statistically significant. [results] 1. There were no significant differences between the two groups in general data including age, sex, Child-pugh grade, KPS score, etiology and diameter of the main tumor (p0.05). There were 19 patients with elevated AFP in group A and 16 patients in group B. The comparison of clinical efficacy between the two groups: the level of AFP in group A and group B were significantly decreased three months after treatment. There was no significant difference between the two groups after the treatment (Z-0.126 p0.90). The AFP in group A decreased to normal group (6 cases, normal group, 6 cases), and the ORR of group A was 36.3627.2727.277.277.27 (13.64), 9.09, respectively, and that of group A was 60,504545, 359.09, respectively, compared with that before treatment (P < 0.05), and the ORR of group A was 36.3627.277.2713.64 / 9.09, respectively, and the ORR of group A was 36.3627.277.277.2713.64 / 9.09, and the ORR of group A was 36.3627.277.27 and 13.649.09 respectively after treatment. There was no significant difference between the two groups at 3 and 6 months after treatment (蠂 2 + 2.346; 蠂 2 + 2.295, all 0.05). There were significant differences between the two groups at 9 and 12 months after treatment (蠂 25.050; 蠂 2 4.177, both 0.05). The median progression-free survival time of group A was 6.0 months and that of group B was 12.5 months. There was no significant difference in the incidence of adverse reactions such as fever, abdominal pain, nausea and vomiting between the two groups (p 0.05). The incidence of proteinuria was significantly higher than that in group A (p 0.05). There was no serious adverse reaction in both groups, and it was alleviated after symptomatic treatment. [conclusion] 1. TACE combined with apatinib and TACE can effectively reduce the level of AFP in patients with advanced liver cancer. The medium and long term curative effect of the combined treatment group was superior to that of the simple group, and the survival time of the patients without progression was significantly prolonged. Most of the adverse reactions in the two groups were mild, and the treatment would not be interrupted after symptomatic treatment. The safety of combined use of apatinib was confirmed.
【学位授予单位】：南方医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R735.7
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