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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.
- Source :
-
Oncology research [Oncol Res] 2020 Feb 07; Vol. 28 (1), pp. 75-94. Date of Electronic Publication: 2019 Sep 26. - Publication Year :
- 2020
-
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.
- Subjects :
- Aged
Bilirubin blood
Carcinoma, Hepatocellular mortality
Chemoembolization, Therapeutic adverse effects
China
Creatinine blood
Drug Delivery Systems
Epirubicin administration & dosage
Female
Humans
Liver Neoplasms mortality
Male
Microspheres
Middle Aged
Portal Vein pathology
Progression-Free Survival
Prospective Studies
Serum Albumin, Human analysis
Survival Rate
Treatment Outcome
Antineoplastic Agents administration & dosage
Carcinoma, Hepatocellular therapy
Chemoembolization, Therapeutic methods
Doxorubicin administration & dosage
Liver Neoplasms therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1555-3906
- Volume :
- 28
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Oncology research
- Publication Type :
- Academic Journal
- Accession number :
- 31558180
- Full Text :
- https://doi.org/10.3727/096504019X15662966719585