Open Access

ARTICLE

The Comprehensive Analysis of Efficacy and Safety of CalliSpheres^® Drug-Eluting Beads Transarterial Chemoembolization in 367 Liver Cancer Patients: A Multiple-Center, Cohort Study

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

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

Oncology Research 2020, 28(3), 249-271. https://doi.org/10.3727/096504019X15766663541105

Abstract

This study aimed to investigate the efficacy, safety, and prognostic factors of drug-eluting beads transarterial chemoembolization (DEB-TACE) in treating Chinese patients with liver cancer. A total of 367 liver cancer patients from 24 medical centers were consecutively enrolled in this multiple-center, prospective cohort study, including 275 hepatocellular carcinoma (HCC) cases, 37 intrahepatic cholangiocarcinoma (ICC) cases, and 55 secondary liver cancer cases. All the patients received CalliSpheres^® DEB-TACE treatment. Treatment response, overall survival (OS), change of liver function, and adverse events (AEs) were assessed. DEB-TACE treatment achieved 19.9% complete response (CR) and 79.6% objective response rate (ORR), with mean OS of 384 days [95% confidence interval (CI): 375–393 days]. CR and ORR were both higher in HCC patients compared with primary ICC patients and secondary liver cancer patients, while no difference was discovered in OS. Portal vein invasion was an independent risk factor for CR, while portal vein invasion, previous conventional TACE (cTACE) treatment, and abnormal blood creatinine (BCr) were independent risk factors for ORR. In addition, largest nodule size 5.0 cm, abnormal albumin (ALB), and abnormal total bilirubin (TBIL) independently correlated with unfavorable OS. Most liver function indexes were recovered to baseline levels at 1–3 months after DEB-TACE. Common AEs were pain, fever, vomiting, and nausea; most of them were at mild grade. CalliSpheres^® DEB-TACE is efficient and well tolerated in Chinese liver cancer patients. Portal vein invasion, previous cTACE treatment, largest nodule size, abnormal BCr, ALB, and TBIL correlate with worse prognosis independently.

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