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

Author(s):  
Zhiyi Peng ◽  
Guohong Cao ◽  
Qinming Hou ◽  
Ling Li ◽  
Shihong Ying ◽  
...  

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.

Author(s):  
Junhui Sun ◽  
Guanhui Zhou ◽  
Xiaoxi Xie ◽  
Wenjiang Gu ◽  
Jing Huang ◽  
...  

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.


Author(s):  
Yaohong Liu ◽  
Wensou Huang ◽  
Mingji He ◽  
Hui Lian ◽  
Yongjian Guo ◽  
...  

This study aimed to investigate the efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) treatment in Barcelona Clinic Liver Cancer (BCLC) stage C liver cancer patients. In 39 patients with BCLC stage C liver cancer, after the first cycle of DEB-TACE, 2 (5.1%) and 24 (61.5%) patients achieved complete response (CR) and partial response (PR) to give an overall objective response rate (ORR) of 66.7%. With respect to the second cycle of therapy, the ORR was higher in patients receiving DEB-TACE compared with those receiving cTACE (57.1% vs. 11.1%). After the first cycle of DEB-TACE treatment, the percentages of abnormal albumin (ALB), total protein (TP), total bilirubin (TBIL), and alanine aminotransferase (ALT) worsened at 1 week and recovered at 1 month. The number of patients with abnormal aspartate aminotransferase (AST) did not increase at 1 week but elevated at 1 month. After the second cycle of DEB-TACE or cTACE treatment, no difference was observed between cTACE and DEB-TACE in terms of all adverse events (AEs) at all visits, and most of the AEs did not change after the second cycle in both groups. The most common AEs after the first and second treatment cycles were pain, fever, and nausea/vomiting. These results demonstrate that DEB-TACE offers patients with BCLC stage C liver cancer a clinically active short-term treatment that is safe and relatively well tolerated.


2021 ◽  
Author(s):  
Ning Peng ◽  
Linfeng Mao ◽  
Yiwen Tao ◽  
Kaiyin Xiao ◽  
Guandou Yuan ◽  
...  

Abstract Purpose: The purpose was to explore the effect of drug-eluting beads transarterial chemoembolization (DEB-TACE) on down-staging in unresectable liver cancer patients.Methods: 15 unresectable liver cancer patients received DEB-TACE as a down-staging treatment before hepatectomy were enrolled. Data (including demographics, histories, clinical features at diagnosis and cycles of DEB-TACE before hepatectomy) were collected. Treatment response was evaluated at one month after DEB-TACE. Tumor diameter was evaluated by abdominal computed tomography scan. The residual liver volume was evaluated by IQQA liver system, Relapse-free survival (RFS) and overall survival (OS) were calculated by Kaplan-Meier curves.Results: After DEB-TACE, 3 (20.0%) patients achieved complete response (CR) and 10 (66.7%) patients achieved objective response rate (ORR), meanwhile, 5 (27.8%) tumors achieved CR and 12 (66.7%) tumors achieved ORR. Tumor diameter was decreased after DEB-TACE compared to before DEB-TACE (9.4±3.3 vs. 5.4±3.5 cm) (P<0.01). As to residual liver volume, it was increased after DEB-TACE compared to before DEB-TACE (1066.2 cm3 vs. 1172.5 cm3) (P=0.007). More importantly, 15 (100%) patients could receive resection after DEB-TACE, (including 14 (93.3%) patients with curative resection and 1 (6.7%) patient with palliative resection). For survival, the median RFS was 26.0 months, and the percentage of 5-year accumulating RFS was 20%. As to OS, the median OS was 54.5 months, and the percentage of 5-year accumulating OS was 40%. For safety profiles, 5 patients had postoperative pain, 7 patients had fever, and 1 had nausea and vomiting.Conclusion: DEB-TACE might be an efficient and safety down-staging treatment in unresectable liver cancer patients.


Author(s):  
Yashwant Patidar ◽  
Amar Mukund ◽  
Shiv K. Sarin ◽  

Abstract Background Portal vein tumor thrombosis (PVTT) is a common complication of hepatocellular carcinoma (HCC) occurring in 30 to 40% of cases. The presence of PVTT in HCC is regarded as an advanced disease that confers poor prognosis and survival. Transarterial chemoembolization (TACE) has traditionally been considered to be contraindicated in cases of PVTT, due to the risk of hepatic infarction, and further deteriorate liver function. We evaluated safety, technical efficacy, and outcomes of TACE in HCC with PVTT. Methods From search results of the hospital database, out of 652 patients who underwent TACE for HCC, 73 patients of HCC with PVTT were retrospectively evaluated. Post-TACE tumor response by computed tomography (CT)/magnetic resonance imaging (MRI) imaging as per modified response evaluation criteria in solid tumors (mRECIST) criteria, if any occurrence of acute hepatic failure was assessed. Prognostic factors influencing survival were also determined. Results In our study population, the mean age of the patients was 58 years. The 12- and 24-month survival rates were 59 and 14%, respectively, with an overall median survival of 12.3 months. A total of 58.9% patients had branch portal vein tumor thrombus and 41.1% had tumor thrombus in the main portal vein. We did not encounter any mortality or acute liver failure following TACE in a 30-day period. Both univariate and multivariate analysis revealed Child–Pugh score (p = 0.01) and the extent of tumoral thrombus (p 0.004) as a significant prognostic factor. Patients with branch PVTT, no ascites, and Child–Pugh A had better survival than those having main portal vein tumor thrombus, ascites, and Child–Pugh B. Conclusion Our study concluded that TACE can achieve good disease control and improved survival in HCC with portal vein invasion despite being considered as a relative contraindication. Technical expertise, selection of patients, such as superselective catheterization and preserved liver function, are the key factors for a safe therapeutic procedure. Child–Pugh score and extent of portal vein invasion were the significant prognostic factors determining survival.


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