Open AccessEfficacy and Safety of Drug-Eluting Beads Transarterial Chemoembolization by CalliSpheres® in 275 Hepatocellular Carcinoma Patients: Results From the Chinese CalliSpheres® Transarterial Chemoembolization in Liver Cancer (CTILC) Study
Author(s) -
JunHui Sun,
Gengui Zhou,
Xi Shan Xie,
Wenjiang Gu,
Jing Huang,
Dedong Zhu,
Wenhao Hu,
Qinming Hou,
Changsheng Shi,
Tiefeng Li,
Xin Zhang,
Wenbin Ji,
ShengHua Ying,
Zhangli Peng,
Jian Zhou,
Zhihai Yu,
Jiansong Ji,
Haijun Du,
Xiang-Zhao Guo,
Jian Fang,
Jun Han,
Haiyun Xu,
Zhichao Sun,
Wenqiang Yu,
Guoliang Shao,
Xia Wu,
Hongjie Hu,
Ling Li,
Jianbao Zheng,
Jun Luo,
Yu-Tang Chen,
Guohong Cao,
Tie Hu
Publication year - 2020
Publication title -
oncology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.267
H-Index - 57
eISSN - 1555-3906
pISSN - 0965-0407
DOI - 10.3727/096504019x15662966719585
Subject(s) - medicine , hepatocellular carcinoma , gastroenterology , liver function , response evaluation criteria in solid tumors , renal function , liver cancer , creatinine , adverse effect , survival rate , prospective cohort study , albumin , chemotherapy , phases of clinical research
The purpose of this study was to investigate the efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) treatment in Chinese hepatocellular carcinoma (HCC) patients and the prognostic factors for treatment response as well as survival. A total of 275 HCC patients were included in this prospective study. Treatment response was assessed by modified Response Evaluation Criteria in Solid Tumors (mRECIST), and progression-free survival (PFS) as well as overall survival (OS) were determined. Liver function and adverse events (AEs) were assessed before and after DEB-TACE operation. Complete response (CR), partial response (PR), and objective response rate (ORR) were 22.9%, 60.7%, and 83.6%, respectively. The mean PFS was 362 (95% CI: 34.9‐375) days, the 6-month PFS rate was 89.4 ± 2.1%, while the mean OS was 380 (95% CI: 370‐389) days, and the 6-month OS rate was 94.4 ± 1.7%. Multivariate logistic regression revealed that portal vein invasion ( p = 0.011) was an independent predictor of worse clinical response. Portal vein invasion ( p = 0.040), previous cTACE treatment ( p = 0.030), as well as abnormal serum creatinine level (BCr) ( p = 0.017) were independent factors that predicted worse ORR. In terms of survival, higher Barcelona Clinic Liver Cancer (BCLC) stage ( p = 0.029) predicted for worse PFS, and abnormal albumin (ALB) ( p = 0.011) and total serum bilirubin (TBIL) ( p = 0.009) predicted for worse OS. The number of patients with abnormal albumin, total protein (TP), TBIL, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were augmented at 1 week posttreatment and were similar at 1‐3 months compared with baseline. The most common AEs were pain, fever, nausea, and vomiting, and no severe AEs were observed in this study. DEB-TACE was effective and tolerable in treating Chinese HCC patients, and portal vein invasion, previous cTACE treatment, abnormal BCr, ALB, and TBIL appear to be important factors that predict worse clinical outcome.