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 (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组治疗后m3 (p=0.020) cr、m1 (p<0.001)、m3 (p<0.001)、m6 (p=0.017)的 orr明显高于ctace组。两组间dcrs、pfs(25.3个月vs 24.2个月，p=0.503)、os(27.8个月vs 25.3个月，p=0.203)比较接近。csm-tace与m1的orr (p=0.002) 独立相关，而且具有更长的os (p=0.023)。异常碱性磷酸酶(alp) (p=0.049)与m3时较低的orr，酒精摄入史(p=0.019)，最大结节≥7cm (p=0.015)以及m6时较低的orr独立相关(p=0.015)。最大结节≥7cm (p=0.029)和异常白蛋白(alb) (p=0.046)与较短的pfs独立相关。child-pugh期b/c (p=0.023)、alb异常(p=0.001)、alp (p=0.008)和甲胎蛋白(afp) (p=0.005)分别与较短os相关。除了csm-tace组患者alp (p=0.005)、总胆红素(p=0.031)、术中疼痛(p=0.034)、治疗后发热(p=0.017)明显高于ctace组(p=0.017)外，两组患者肝功能指标及aes基本相似(p>0.05)。
csm-tace presents with a better treatment response and similar survival profile compared with ctace in hcc patients.