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Comparison of treatment efficacy and safety between drug-eluting bead transarterial chemoembolization with CalliSpheres® microspheres and conventional transarterial chemoembolization as first-line treatment in hepatocellular carcinoma patients.

ABSTRACT: We aimed to compare the treatment response, survivals and safety of drug-eluting bead (DEB) transarterial chemoembolization (TACE) with CalliSpheres® microspheres (CSM) and conventional TACE (cTACE) as first-line treatment in Chinese HCC patients. 192 HCC patients from multiple centers received DEB-TACE with CSM or cTACE treatment as first-line treatment were included and assigned to DEB-TACE group (N=94) or cTACE group (N=98) accordingly. Treatment response was assessed at 1 month (M1), M3 and M6 after treatment. Progression-free survival (PFS) and overall survival (OS) was evaluated. Liver function indexes and adverse events were recorded. Complete response (CR) and objective response rate (ORR) were higher, while disease control rate (DCR) rate was similar in DEB-TACE group compared with cTACE group, and further multivariate logistic regression analysis validated that DEB-TACE vs cTACE independently predicted higher ORR. For survivals, no difference in PFS or OS was observed between DEB-TACE and cTACE groups, and multivariate Cox's proportional hazards regression revealed that DEB-TACE vs cTACE was not correlated with PFS or OS either. Additionally, no difference in liver function indexes at M1 or changes of liver function indexes from M0 to M1 between DEB-TACE and cTACE groups after treatment was observed, whereas DEB-TACE resulted in higher incidence of pain and fever during treatment or hospitalization. DEB-TACE with CSM discloses better treatment response, similar survival profiles and equal liver function injury but increased incidence of short-term adverse events than cTACE as the first-line therapy in treating HCC patients.

SUBMITTER: Ma Y

PROVIDER: S-EPMC6943446 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Comparison of treatment efficacy and safety between drug-eluting bead transarterial chemoembolization with CalliSpheres<sup>®</sup> microspheres and conventional transarterial chemoembolization as first-line treatment in hepatocellular carcinoma patients.

Ma Yilong Y Zhao Chang C Zhao Hui H Li Haiping H Chen Changyong C Xiang Hua H Zheng Chuansheng C Ma Cong C Luo Chao C Qiu Huaiming H Yao Yuanhui Y Hu Hongyao H Xiong Bin B Zhou Jun J Zhu Hui H Long Qingyun Q

American journal of translational research 20191215 12

We aimed to compare the treatment response, survivals and safety of drug-eluting bead (DEB) transarterial chemoembolization (TACE) with CalliSpheres<sup>®</sup> microspheres (CSM) and conventional TACE (cTACE) as first-line treatment in Chinese HCC patients. 192 HCC patients from multiple centers received DEB-TACE with CSM or cTACE treatment as first-line treatment were included and assigned to DEB-TACE group (N=94) or cTACE group (N=98) accordingly. Treatment response was assessed at 1 month (M ...[more]

PMID: 31934293

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Project description:BackgroundDrug-eluting embolic transarterial chemoembolization (DEE-TACE) is an advance in TACE technique. However, at present there is insufficient evidence to support that DEE-TACE is superior to conventional TACE (cTACE) for hepatocellular carcinoma (HCC). The aim of this meta-analysis is to evaluate the efficacy and safety of TACE with CalliSpheres® microspheres (CSM-TACE) compared with cTACE in patients with HCC.Data sourcesPubMed, Embase, Web of Science, CNKI and Wanfang Databases were searched to identify relevant articles published before March 26, 2020. The data regarding treatment response, survival profile, adverse events and liver function indexes were retrieved.ResultsA total of 16 studies with 1454 HCC patients (722 treated with CSM-TACE and 732 with cTACE) were included. Patients receiving CSM-TACE had higher 1-month complete response (CR), objective response rate (ORR), disease control rate (DCR) (odds ratio (OR): 2.00, 95% confidence interval (95% CI): 1.29-3.09; OR: 2.87, 95% CI: 2.15-3.83; OR: 2.01, 95% CI: 1.37-2.95, respectively), 3-month CR, ORR, DCR (OR: 4.04, 95%CI: 2.46-6.64; OR: 3.39, 95%CI: 2.45-4.70; OR: 1.71, 95%CI: 1.14-2.55 respectively), and 6-month CR, ORR, DCR (OR: 4.02, 95%CI: 2.26-7.16; OR: 3.00, 95%CI: 2.05-4.38; OR: 2.66, 95%CI: 1.70-4.16 respectively) than those treated with cTACE. Furthermore, CSM-TACE exhibited a trend toward improved progression free survival (hazard ratio (HR): 0.86, 95%CI: 0.67-1.11) and overall survival (HR: 0.79, 95%CI: 0.59-1.07) over cTACE although these differences did not reach statistical significance. In terms of safety, the two TACE treatments showed similar post-treatment pain (OR: 0.84, 95%CI: 0.55-1.28), fever (OR: 0.99, 95%CI: 0.60-1.63), nausea/vomiting (OR: 0.84, 95% CI: 0.60-1.17), as well as 1-month follow-up alanine aminotransferase (Mean difference (MD): -3.66, 95%CI: -10.38-3.07), aspartate aminotransferase (MD: -2.30, 95%CI: -8.91-4.31) and total bilirubin (MD: -0.15, 95%CI: -2.26-1.96).ConclusionCSM-TACE displays superior treatment response, non-inferior survival profile and safety over cTACE in HCC patients.

Project description: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.

Dataset Information

Comparison of treatment efficacy and safety between drug-eluting bead transarterial chemoembolization with CalliSpheres® microspheres and conventional transarterial chemoembolization as first-line treatment in hepatocellular carcinoma patients.

Publications

Comparison of treatment efficacy and safety between drug-eluting bead transarterial chemoembolization with CalliSpheres<sup>®</sup> microspheres and conventional transarterial chemoembolization as first-line treatment in hepatocellular carcinoma patients.

Similar Datasets

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