PMID- 31558180 OWN - NLM STAT- MEDLINE DCOM- 20200916 LR - 20210217 IS - 1555-3906 (Electronic) IS - 0965-0407 (Print) IS - 0965-0407 (Linking) VI - 28 IP - 1 DP - 2020 Feb 7 TI - Efficacy and Safety of Drug-Eluting Beads Transarterial Chemoembolization by CalliSpheres((R)) in 275 Hepatocellular Carcinoma Patients: Results From the Chinese CalliSpheres((R)) Transarterial Chemoembolization in Liver Cancer (CTILC) Study. PG - 75-94 LID - 10.3727/096504019X15662966719585 [doi] AB - 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. FAU - Sun, Junhui AU - Sun J AD - Hepatobiliary and Pancreatic Interventional Treatment Center, Division of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhouP.R. China. FAU - Zhou, Guanhui AU - Zhou G AD - Hepatobiliary and Pancreatic Interventional Treatment Center, Division of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhouP.R. China. FAU - Xie, Xiaoxi AU - Xie X AD - Interventional Center, Xinchang People's HospitalShaoxingP.R. China. FAU - Gu, Wenjiang AU - Gu W AD - Department of Intervention, Jiaxing Second HospitalJiaxingP.R. China. FAU - Huang, Jing AU - Huang J AD - Department of Hepatobiliary Surgery, Ningbo Medical Center, Lihuili Eastern HospitalNingboP.R. China. FAU - Zhu, Dedong AU - Zhu D AD - Department of Liver Oncology, Ningbo No. 2 HospitalNingboP.R. China. FAU - Hu, Wenhao AU - Hu W AD - Department of Intervention, The First Affiliated Hospital of Wenzhou Medical UniversityWenzhouP.R. China. FAU - Hou, Qinming AU - Hou Q AD - Department of Radiology, Xixi Hospital of Hangzhou, Hangzhou 6th People's HospitalHangzhouP.R. China. FAU - Shi, Changsheng AU - Shi C AD - Department of Intervention, The Third Affiliated Hospital of Wenzhou Medical UniversityRuianP.R. China. FAU - Li, Tiefeng AU - Li T AD - Department of Radiology, Beilun District People's Hospital of NingboNingboP.R. China. FAU - Zhang, Xin AU - Zhang X AD - Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhouP.R. China. FAU - Ji, Wenbin AU - Ji W AD - Department of Radiology, Taizhou Hospital of Zhejiang ProvinceLinhaiP.R. China. FAU - Ying, Shihong AU - Ying S AD - Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhouP.R. China. FAU - Peng, Zhiyi AU - Peng Z AD - Department of Radiology, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhouP.R. China. FAU - Zhou, Jian AU - Zhou J AD - Department of Radiology, Hangzhou Cancer HospitalHangzhouP.R. China. FAU - Yu, Zhihai AU - Yu Z AD - Department of Vascular and Interventional Radiology, The Affiliated Hospital of Medical College of Ningbo UniversityNingboP.R. China. FAU - Ji, Jiansong AU - Ji J AD - Department of Radiology, Lishui Central Hospital, Lishui Hospital of Zhejiang University, The Fifth Affiliated Hospital of Wenzhou Medical UniversityLishuiP.R. China. FAU - Du, Haijun AU - Du H AD - Department of Intervention, Dong Yang People's HospitalDongyangP.R. China. FAU - Guo, Xiaohua AU - Guo X AD - Department of Intervention, Jinhua Central HospitalJinhuaP.R. China. FAU - Fang, Jian AU - Fang J AD - Department of Hepatobiliary Surgery, Quzhou People's HospitalQuzhouP.R. China. FAU - Han, Jun AU - Han J AD - Department of Intervention, Jiaxing First HospitalJiaxingP.R. China. FAU - Xu, Huanhai AU - Xu H AD - Division of Digestive Endoscopy, YueQing City People's HospitalYueqingP.R. China. FAU - Sun, Zhichao AU - Sun Z AD - Department of Radiology, The First Affiliated Hospital of Zhejiang Chinese Medical UniversityHangzhouP.R. China. FAU - Yu, Wenqiang AU - Yu W AD - Department of Intervention, Zhejiang Provincial People's HospitalHangzhouP.R. China. FAU - Shao, Guoliang AU - Shao G AD - Department of Intervention, Zhejiang Cancer HospitalHangzhouP.R. China. FAU - Wu, Xia AU - Wu X AD - Department of Radiology, Sir Run Run Shaw Hospital, Zhejiang University College of MedicineHangzhouP.R. China. FAU - Hu, Hongjie AU - Hu H AD - Department of Radiology, Sir Run Run Shaw Hospital, Zhejiang University College of MedicineHangzhouP.R. China. FAU - Li, Ling AU - Li L AD - Department of Intervention, The First Affiliated Hospital of Wenzhou Medical UniversityWenzhouP.R. China. FAU - Zheng, Jiaping AU - Zheng J AD - Department of Intervention, Zhejiang Cancer HospitalHangzhouP.R. China. FAU - Luo, Jun AU - Luo J AD - Department of Intervention, Zhejiang Cancer HospitalHangzhouP.R. China. FAU - Chen, Yutang AU - Chen Y AD - Department of Intervention, Zhejiang Cancer HospitalHangzhouP.R. China. FAU - Cao, Guohong AU - Cao G AD - Department of Radiology, Shulan (Hangzhou) Hospital, Zhejiang University International HospitalHangzhouP.R. China. FAU - Hu, Tingyang AU - Hu T AD - Department of Intervention, Zhejiang Provincial People's HospitalHangzhouP.R. China. LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study DEP - 20190926 PL - United States TA - Oncol Res JT - Oncology research JID - 9208097 RN - 0 (Antineoplastic Agents) RN - 3Z8479ZZ5X (Epirubicin) RN - 80168379AG (Doxorubicin) RN - AYI8EX34EU (Creatinine) RN - RFM9X3LJ49 (Bilirubin) RN - ZIF514RVZR (Serum Albumin, Human) SB - IM MH - Aged MH - Antineoplastic Agents/*administration & dosage MH - Bilirubin/blood MH - Carcinoma, Hepatocellular/mortality/*therapy MH - Chemoembolization, Therapeutic/adverse effects/*methods MH - China MH - Creatinine/blood MH - Doxorubicin/*administration & dosage MH - Drug Delivery Systems MH - Epirubicin/administration & dosage MH - Female MH - Humans MH - Liver Neoplasms/mortality/*therapy MH - Male MH - Microspheres MH - Middle Aged MH - Portal Vein/pathology MH - Progression-Free Survival MH - Prospective Studies MH - Serum Albumin, Human/analysis MH - Survival Rate MH - Treatment Outcome PMC - PMC7851504 COIS- The authors declare no conflicts of interest. EDAT- 2019/09/29 06:00 MHDA- 2020/09/17 06:00 PMCR- 2020/02/07 CRDT- 2019/09/28 06:00 PHST- 2019/09/29 06:00 [pubmed] PHST- 2020/09/17 06:00 [medline] PHST- 2019/09/28 06:00 [entrez] PHST- 2020/02/07 00:00 [pmc-release] AID - OR1394 [pii] AID - 10.3727/096504019X15662966719585 [doi] PST - ppublish SO - Oncol Res. 2020 Feb 7;28(1):75-94. doi: 10.3727/096504019X15662966719585. Epub 2019 Sep 26.