Open Access

ARTICLE

Efficacy 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

Junhui Sun^*1, Guanhui Zhou^*1, Xiaoxi Xie^†, Wenjiang Gu^‡, Jing Huang^§, Dedong Zhu^¶, Wenhao Hu^#, Qinming Hou^**, Changsheng Shi^††, Tiefeng Li^‡‡ , Xin Zhang^§§, Wenbin Ji^¶¶, Shihong Ying^§§, Zhiyi Peng^§§, Jian Zhou^##, Zhihai Yu^***, Jiansong Ji^†††, Haijun Du^‡‡‡, Xiaohua Guo^§§§, Jian Fang^¶¶¶, Jun Han^###, Huanhai Xu^****, Zhichao Sun^††††, Wenqiang Yu^‡‡‡‡, Guoliang Shao^§§§§, Xia Wu^¶¶¶¶ ,Hongjie Hu^¶¶¶¶ , Ling Li^#, Jiaping Zheng^§§§§, Jun Luo^§§§§, Yutang Chen^§§§§, Guohong Cao^####, Tingyang Hu^‡‡‡‡

* Hepatobiliary and Pancreatic Interventional Treatment Center, Division of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, P.R. China
† Interventional Center, Xinchang People’s Hospital, Shaoxing, P.R. China
‡ Department of Intervention, Jiaxing Second Hospital, Jiaxing, P.R. China
§ Department of Hepatobiliary Surgery, Ningbo Medical Center, Lihuili Eastern Hospital, Ningbo, P.R. China
¶ Department of Liver Oncology, Ningbo No. 2 Hospital, Ningbo, P.R. China
# Department of Intervention,The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, P.R. China
** Department of Radiology, Xixi Hospital of Hangzhou, Hangzhou 6th People’s Hospital, Hangzhou, P.R. China
†† Department of Intervention, The Third Affiliated Hospital of Wenzhou Medical University, Ruian, P.R. China
‡‡ Department of Radiology, Beilun District People’s Hospital of Ningbo, Ningbo, P.R. China
§§ Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, P.R. China
¶¶ Department of Radiology, Taizhou Hospital of Zhejiang Province, Linhai, P.R. China
## Department of Radiology, Hangzhou Cancer Hospital, Hangzhou, P.R. China
*** Department of Vascular and Interventional Radiology, The Affiliated Hospital of Medical College of Ningbo University, Ningbo, P.R. China
††† Department of Radiology, Lishui Central Hospital, Lishui Hospital of Zhejiang University, The Fifth Affiliated Hospital of Wenzhou Medical University, Lishui, P.R. China
‡‡‡ Department of Intervention, Dong Yang People’s Hospital, Dongyang, P.R. China
§§§ Department of Intervention, Jinhua Central Hospital, Jinhua, P.R. China
¶¶¶ Department of Hepatobiliary Surgery, Quzhou People’s Hospital, Quzhou, P.R. China
### Department of Intervention, Jiaxing First Hospital, Jiaxing, P.R. China
**** Division of Digestive Endoscopy, YueQing City People’s Hospital, Yueqing, P.R. China
†††† Department of Radiology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, P.R. China
‡‡‡‡ Department of Intervention, Zhejiang Provincial People’s Hospital, Hangzhou, P.R. China
§§§§ Department of Intervention, Zhejiang Cancer Hospital, Hangzhou, P.R. China
¶¶¶¶ Department of Radiology, Sir Run Run Shaw Hospital, Zhejiang University College of Medicine, Hangzhou, P.R. China
#### Department of Radiology, Shulan (Hangzhou) Hospital, Zhejiang University International Hospital, Hangzhou, P.R. China

Oncology Research 2020, 28(1), 75-94. https://doi.org/10.3727/096504019X15662966719585

Abstract

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.

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