Varghese Joy, Kedarisetty Chandan, Venkataraman Jayanthi, Srinivasan Vijaya, Deepashree Thiruchunapalli, Uthappa Mangerira, Ilankumaran Kaliamurthy, Govil Sanjay, Reddy Mettu, Rela Mohamed
Institute of Liver Diseases and Transplantation, Global Health city, Chennai, India.
Ann Hepatol. 2017 March-April;16(2):247-254. doi: 10.5604/16652681.1231583.
Transarterial chemoembolization (TACE) or sorafenib is recommended for hepatocellular carcinoma BCLC stages B and C respectively. We studied the role of combination of TACE and sorafenib in BCLC stages B/C.
We undertook an observational study on a cohort of cirrhotics with HCC from August 2010 through October 2014. Patients in BCLC stages B/C who had received TACE and/or sorafenib were included. mRECIST criteria were used to assess tumor response. The primary end point was overall survival.
Out of 124 patients, 47.6% were in BCLC-B and 52.4% in BCLCC. Baseline characteristics were comparable. The predominant etiology was cryptogenic (37.2% and 38.5%, p = NS). 49.1% in BCLC-B and 56.9% in BCLC-C had received TACE+sorafenib. In BCLC-B, the overall survival improved from 9 months (95% CI 6.3-11.7) using TACE only to 16 months (95% CI 12.9-19.1) using TACE+sorafenib (p < 0.05). In BCLC-C, addition of TACE to sorafenib improved the overall survival from 4 months (95%CI 3-5) to 9 months (95%CI 6.8-11.2) (p < 0.0001). As per mRECIST criteria, patients on TACE+sorafenib had reduced progressive disease (37.8% vs. 83.3%), improved partial response (43.2% vs. 3.3%) and one had complete response compared to those on sorafenib alone (p < 0.0001) in BCLC-C but not in BCLC-B group. Hand foot syndrome was noted in 27.7% patients on sorafenib and post TACE syndrome in 80.2% patients, but both were reversible. No major adverse events were noted.
TACE+sorafenib was more effective than TACE or sorafenib alone in HCC BCLC stages B or C with a significant survival benefit and improved tumour regression especially in BCLC-C patients.
经动脉化疗栓塞术(TACE)或索拉非尼分别被推荐用于巴塞罗那临床肝癌(BCLC)分期为B期和C期的肝细胞癌患者。我们研究了TACE与索拉非尼联合应用于BCLC分期B/C期患者的作用。
我们对2010年8月至2014年10月期间一组患有肝癌的肝硬化患者进行了一项观察性研究。纳入了接受过TACE和/或索拉非尼治疗的BCLC分期B/C期患者。采用改良实体瘤疗效评价标准(mRECIST)评估肿瘤反应。主要终点是总生存期。
124例患者中,47.6%为BCLC-B期,52.4%为BCLC-C期。基线特征具有可比性。主要病因是隐源性(分别为37.2%和38.5%,p=无统计学差异)。BCLC-B期患者中49.1%和BCLC-C期患者中56.9%接受了TACE+索拉非尼治疗。在BCLC-B期,仅使用TACE时总生存期为9个月(95%CI 6.3-11.7),使用TACE+索拉非尼时提高到16个月(95%CI 12.9-19.1)(p<0.05)。在BCLC-C期,索拉非尼联合TACE可使总生存期从4个月(95%CI 3-5)提高到9个月(95%CI 6.8-11.2)(p<0.0001)。根据mRECIST标准,与单独使用索拉非尼的患者相比,BCLC-C期接受TACE+索拉非尼治疗的患者疾病进展减少(37.8%对83.3%),部分缓解改善(43.2%对3.3%),且有1例完全缓解(p<0.0001),而BCLC-B期患者未出现这种情况。27.7%接受索拉非尼治疗的患者出现手足综合征,80.2%接受TACE治疗的患者出现TACE后综合征,但两者均为可逆性。未观察到重大不良事件。
对于BCLC分期B期或C期的肝癌患者,TACE+索拉非尼比单独使用TACE或索拉非尼更有效,具有显著的生存获益,尤其在BCLC-C期患者中可改善肿瘤退缩。