TACE联合索拉菲尼与TACE治疗巴塞罗那B期肝癌的临床对比研究

A Comparative Study on TACE Combined with Sorafenib versus TACE in the Treatment of BCLC Hepatocellular Carcinoma

目的评价经皮肝动脉灌注化疗栓塞术（TACE）联合索拉非尼（sorafenib）与单纯TACE治疗巴塞罗那（BCLC）B期肝细胞癌的临床疗效和安全性。方法回顾性分析2010年8月~2014年10月收治的52例BCLC B期肝细胞癌患者的临床资料。其中,TACE联合索拉菲尼组24例,单纯TACE组28例。治疗3个月后,观察和比较两组患者的疾病控制率和总体中位生存期及并发症、不良反应的发生情况。结果治疗3个月后,TACE联合索拉菲尼组患者完全缓解0例,部分缓解12例,病情稳定8例,病情持续进展4例,总体疾病控制率为83.3%,中位生存期为18.6（7.3~28.7）月;单纯TACE组患者完全缓解0例,部分缓解13例,病情稳定8例,病情持续进展7例,总体疾病控制率为75.0%,中位生存期为17.8（5.9~32.9）月,与TACE联合索拉菲尼组比较,差异均无统计学意义（P〉0.05）。TACE联合索拉菲尼组的索拉菲尼相关不良反应包括手足皮肤反应11例（45.8%）、高血压3例（12.5%）、胃肠道反应5例（20.0%）、脱发1例（4.1%）、粒细胞减少3例（12.5%）、皮疹3例（12.5%）,其中1例为3级不良反应;单纯TACE组患者的主要不良反应为发热、胃肠道反应、疼痛,发生率分别为96.4%、18.5%、100.0%,结论对BCLC B期肝癌而言,TACE联合索拉菲尼治疗并未显示出优于单纯TACE治疗的优势,尚需要更大样本的研究进一步证实。

Objective To evaluate the efficacy and safety of transarterial chemoembolization（TACE） combined with sorafenib versus TACE in treating hepatocellular carcinoma in Barcelona clinic liver cancer B stage（BCLC B）, so as to provide evidence for clinical practice. Methods A total of 52 patients with HCC who were admitted in our hospital between August 2010 and October 2014 were included this study. Patients were classified into TACE combined with sorafenib group（24 cases） and simple TACE group（28 cases）. After three months of treatment, the disease control rate, including complete remission（CR）, partial remission（PR）, and stable disease（SD）, and early complication rate were compared with the Pearson X2 test. The overall survival was assessed using a Kaplan-Meier analysis, and comparisons were performed using the log-rank test. A P value of less than 0.05 was considered statistically significant. Results After treatment, no patients got CR in both groups. But in the combined group, 12 cases got PR, 8 had SD, and 4 had progressive disease（PD）, with a disease control rate of 83.3% and a median survival of 18.6 months（17.3 ~ 28.7 months）. While in TACE group, there were 13 cases of PR, 8 cases of SD, 7 cases of PD, with a disease control rate of 75.0% and a median survival of 17.8 months（5.9 ~ 32.9 months）. There was no significant difference in three-month disease control rate and median survival between the two groups（P〉0.05）. Further, the sorafenib-related adverse events were observed, including hand-foot skin reaction（11 cases, 45.0%）, hypertension（3 cases, 12.5%）, gastrointestinal events（5 cases, 20.0%）, alopecia（1 case, 4.1%）, granulopenia（3 cases, 12.5%）, rash（3 cases, 12.5%）. In the TACE group, the main adverse reaction included fever, gastrointestinal reaction, pain, with the incidence of 96.4%, 18.5%, 100.0%, respectively. Conclusion TACE combined with sorafenib did not bring out more benefits than TACE for the patient with BCLC B hepatocellular carcinoma.