Liang Bin, Xiang Hua, Ma Cong, Xiong Bin, Ma Yilong, Zhao Chang, Yao Yuanhui, Zhang Zishu, Chen Changyong, Li Haiping, Long Qingyun, Zhou Jun, Luo Chao, Qiu Huaiming, Hu Hongyao, Zhao Hui, Zhou Guofeng, Zheng Chuansheng
Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.
Department of Interventional Radiology, Hunan Provincial People's Hospital, Changsha, People's Republic of China.
Cancer Manag Res. 2020 Feb 10;12:941-956. doi: 10.2147/CMAR.S187203. eCollection 2020.
This study aimed to compare the efficacy and safety between transarterial chemoembolization (TACE) with CalliSpheres microspheres (CSM-TACE) and conventional TACE (cTACE) in patients with hepatocellular carcinoma (HCC).
Three hundred and thirty-five HCC patients receiving CSM-TACE or cTACE were consecutively enrolled in this multi-center, retrospective cohort study, and then divided into CSM-TACE group and cTACE group accordingly. Complete response (CR), objective response (ORR) and disease control response (DCR) was assessed according to mRECIST criteria at 1 month (M1), 3 months(M3) and 6 months(M6) after treatment. Progression-free survival (PFS) and overall survival (OS) were assessed. Liver function indexes and adverse events (AEs) were also evaluated.
CR at M3 (=0.020) and ORR at M1 (<0.001), M3 (<0.001) and M6 (=0.017) after treatment were significantly higher in the CSM-TACE compared with cTACE group. DCRs, PFS (25.3 months vs 24.2 months, =0.503) and OS (27.8 months vs 25.3 months, =0.203) were similar between the two groups. CSM-TACE was independently correlated with higher ORR at M1 (=0.002) and longer OS (=0.023). Abnormal alkaline phosphatase (ALP) (=0.049) was independently associated with lower ORR at M3, and history of alcohol intake (=0.019) and largest nodule size ≥7 cm (=0.015) independently correlated with lower ORR at M6 (=0.015). Largest nodule size ≥7 cm (=0.029) and abnormal albumin (ALB) (=0.046) were independently associated with shorter PFS. Child-Pugh stage B/C (=0.023), abnormal ALB (=0.001), ALP (=0.008) and alpha-fetoprotein (AFP) (=0.005) were independently associated with shorter OS. Most liver function indexes and AEs were similar between the two groups (>0.05), except that ALP (=0.005), total bilirubin (=0.031), pain during procedure (=0.034) and occurrence of fever post(treatment (=0.017) were significantly elevated in the CSM-TACE compared with cTACE group.
CSM-TACE presents with a better treatment response and similar survival profile compared with cTACE in HCC patients.
本研究旨在比较使用载药微球的经动脉化疗栓塞术（CSM-TACE）与传统经动脉化疗栓塞术（cTACE）治疗肝细胞癌（HCC）患者的疗效和安全性。
本多中心回顾性队列研究连续纳入335例接受CSM-TACE或cTACE治疗的HCC患者，并据此分为CSM-TACE组和cTACE组。根据mRECIST标准在治疗后1个月（M1）、3个月（M3）和6个月（M6）评估完全缓解（CR）、客观缓解率（ORR）和疾病控制率（DCR）。评估无进展生存期（PFS）和总生存期（OS）。还评估了肝功能指标和不良事件（AE）。
与cTACE组相比，CSM-TACE组治疗后M3时的CR（=0.020）以及M1（<0.001）、M3（<0.001）和M6（=0.017）时的ORR显著更高。两组之间的DCR、PFS（25.3个月对24.2个月，=0.503）和OS（27.8个月对25.3个月，=0.203）相似。CSM-TACE与M1时更高的ORR（=0.002）和更长的OS（=0.023）独立相关。碱性磷酸酶（ALP）异常（=0.049）与M3时较低的ORR独立相关，饮酒史（=0.019）和最大结节大小≥7 cm（=0.015）与M6时较低的ORR独立相关（=0.015）。最大结节大小≥7 cm（=0.029）和白蛋白（ALB）异常（=0.046）与较短的PFS独立相关。Child-Pugh B/C期（=0.023）、ALB异常（=0.001）、ALP（=0.008）和甲胎蛋白（AFP）（=0.005）与较短的OS独立相关。两组之间大多数肝功能指标和AE相似（>0.05），但与cTACE组相比，CSM-TACE组的ALP（=0.005）、总胆红素（=0.031）、术中疼痛（=0.034）和治疗后发热发生率（=0.017）显著升高。
与cTACE相比，CSM-TACE在HCC患者中表现出更好的治疗反应和相似的生存情况。
