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

Author:

Sun Junhui1,Zhou Guanhui1,Xie Xiaoxi2,Gu Wenjiang3,Huang Jing4,Zhu Dedong5,Hu Wenhao6,Hou Qinming7,Shi Changsheng8,Li Tiefeng9,Zhang Xin10,Ji Wenbin11,Ying Shihong10,Peng Zhiyi10,Zhou Jian12,Yu Zhihai13,Ji Jiansong14,Du Haijun15,Guo Xiaohua16,Fang Jian17,Han Jun18,Xu Huanhai19,Sun Zhichao20,Yu Wenqiang21,Shao Guoliang22,Wu Xia23,Hu Hongjie23,Li Ling6,Zheng Jiaping22,Luo Jun22,Chen Yutang22,Cao Guohong24,Hu Tingyang21

Affiliation:

1. Hepatobiliary and Pancreatic Interventional Treatment Center, Division of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhouP.R. China

2. Interventional Center, Xinchang People’s HospitalShaoxingP.R. China

3. Department of Intervention, Jiaxing Second HospitalJiaxingP.R. China

4. Department of Hepatobiliary Surgery, Ningbo Medical Center, Lihuili Eastern HospitalNingboP.R. China

5. Department of Liver Oncology, Ningbo No. 2 HospitalNingboP.R. China

6. Department of Intervention, The First Affiliated Hospital of Wenzhou Medical UniversityWenzhouP.R. China

7. Department of Radiology, Xixi Hospital of Hangzhou, Hangzhou 6th People’s HospitalHangzhouP.R. China

8. Department of Intervention, The Third Affiliated Hospital of Wenzhou Medical UniversityRuianP.R. China

9. Department of Radiology, Beilun District People’s Hospital of NingboNingboP.R. China

10. Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhouP.R. China

11. Department of Radiology, Taizhou Hospital of Zhejiang ProvinceLinhaiP.R. China

12. Department of Radiology, Hangzhou Cancer HospitalHangzhouP.R. China

13. Department of Vascular and Interventional Radiology, The Affiliated Hospital of Medical College of Ningbo UniversityNingboP.R. China

14. Department of Radiology, Lishui Central Hospital, Lishui Hospital of Zhejiang University, The Fifth Affiliated Hospital of Wenzhou Medical UniversityLishuiP.R. China

15. Department of Intervention, Dong Yang People’s HospitalDongyangP.R. China

16. Department of Intervention, Jinhua Central HospitalJinhuaP.R. China

17. Department of Hepatobiliary Surgery, Quzhou People’s HospitalQuzhouP.R. China

18. Department of Intervention, Jiaxing First HospitalJiaxingP.R. China

19. Division of Digestive Endoscopy, YueQing City People’s HospitalYueqingP.R. China

20. Department of Radiology, The First Affiliated Hospital of Zhejiang Chinese Medical UniversityHangzhouP.R. China

21. Department of Intervention, Zhejiang Provincial People’s HospitalHangzhouP.R. China

22. Department of Intervention, Zhejiang Cancer HospitalHangzhouP.R. China

23. Department of Radiology, Sir Run Run Shaw Hospital, Zhejiang University College of MedicineHangzhouP.R. China

24. Department of Radiology, Shulan (Hangzhou) Hospital, Zhejiang University International HospitalHangzhouP.R. China

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.

Publisher

Cognizant, LLC

Subject

Cancer Research,Oncology,General Medicine

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