this study aimed to compare the efficacy and safety between transarterial chemoembolization (tace) with callispheres® microspheres (csm-tace) and conven- tional tace (ctace) in patients with hepatocellular carcinoma (hcc).
patients and methods
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 (p=0.020) and orr at m1 (p<0.001), m3 (p<0.001) and m6 (p=0.017) after treatment were significantly higher in the csm-tace compared with ctace group. dcrs, pfs (25.3 months vs 24.2 months, p=0.503) and os (27.8 months vs 25.3 months, p=0.203) were similar between the two groups. csm-tace was independently correlated with higher orr at m1 (p=0.002) and longer os (p=0.023). abnormal alkaline phosphatase (alp) (p=0.049) was independently associated with lower orr at m3, and history of alcohol intake (p=0.019) and largest nodule size≥7 cm (p=0.015) independently correlated with lower orr at m6 (p=0.015). largest nodule size≥7 cm (p=0.029) and abnormal albumin (alb) (p=0.046) were independently associated with shorter pfs. child-pugh stage b/c (p=0.023), abnormal alb (p=0.001), alp (p=0.008) and alpha-fetoprotein (afp) (p=0.005) were independently associated with shorter os. most liver function indexes and aes were similar between the two groups (p>0.05), except that alp (p=0.005), total bilirubin (p=0.031), pain during procedure (p=0.034) and occurrence of fever post(treatment (p=0.017) were significantly elevated in the csm-tace compared with ctace group.
csm-tace治疗组crr（m3，p = 0.020）、orr（m1，p <0.001；m3，p <0.001；m6，p = 0.017）显著性高于ctace组。两组间dcr，pfs（25.3个月vs.24.2个月，p = 0.503）和os（27.8个月vs 25.3个月，p = 0.203）无显著性差异。多因素分析显示csm-tace与更高的orr（m1，p = 0.002）和更长的os（p = 0.023）独立相关。然而，碱性磷酸酶（alp）与更低的orr独立相关（m3，p = 0.049）；酒精摄入史（p = 0.019）和最大结节≥7cm（p = 0.015）与m6更低的orr独立相关；最大结节≥7cm（p = 0.029）和白蛋白异常（alb）（p = 0.046）与更短的pfs独立相关；child-pugh b/c期（p = 0.023），alb（p = 0.001），alp（p = 0.008）和甲胎蛋白（afp）（p = 0.005）与更短的os独立相关。安全性方面，csm-tace组术中疼痛（p = 0.034）、术后发热（p = 0.017）、alp（p = 0.005）和总胆红素（p = 0.031）显著性高于ctace组，两组间其他肝功能指标和ae相似。
csm-tace presents with a better treatment response and similar survival profile compared with ctace in hcc patients.