Dataset Information

Efficacy and safety of raltitrexed-eluting CalliSpheres^® bead transarterial chemoembolization in patients with intermediate-stage hepatocellular carcinoma: a single-arm, prospective study.

ABSTRACT:

Background

The most common loadable chemotherapeutic drugs in drug-eluting bead transarterial chemoembolization (DEB-TACE) include doxorubicin, epirubicin, etc. CalliSpheres^® beads have exhibited efficient loadability and eluting characteristics for raltitrexed as well as in vitro and animal experiments. However, the efficacy and safety of raltitrexed-loaded DEB-TACE in patients with intermediate-stage hepatocellular carcinoma (HCC) remain unclear.

Objectives

To assess the efficacy and safety of raltitrexed-loaded DEB-TACE in patients with intermediate-stage HCC.

Design

The study was conducted as a single-arm prospective study.

Methods

This study was a prospective, single-arm trial conducted between June 2019 and June 2022. CalliSpheres^® beads loaded with raltitrexed were used in the DEB-TACE procedure. The follow-up lasted for at least 1 year or until death. The primary endpoint was overall survival (OS), and the secondary endpoints were time to progression (TTP), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs).

Results

The 6-month ORR and disease control rates were 90.1% and 93.8%, respectively. The median OS was 33.0 months. The 1-, 2-, and 3-year survival rates were 95.1%, 82.1%, and 43.6%, respectively. Child-Pugh class and bilobar disease occurrence were identified as independent OS predictors. The median TTP and PFS were 22.7 and 19.8 months, respectively. Eleven (11.5%) patients experienced at least one grade 3 AE, and serious AEs were reported in five participants (5.2%). No patient experienced grade 4 or 5 AEs.

Conclusion

Raltitrexed-loaded DEB-TACE is feasible, safe, and effective in patients with intermediate-stage HCC.

Trial registration

This trial was registered at www.chictr.org.cn under the identifier: 1900024097 on 25 June 2019.

SUBMITTER: Sun Z

PROVIDER: S-EPMC10868504 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and safety of raltitrexed-eluting CalliSpheres<sup>®</sup> bead transarterial chemoembolization in patients with intermediate-stage hepatocellular carcinoma: a single-arm, prospective study.

Sun Zhanguo Z Jiao Dechao D Fang Yi Y Liu Yiming Y Xu Kaihao K Zhang Chengzhi C Huang Yuanhao Y Han Xinwei X

Therapeutic advances in medical oncology 20240214

<h4>Background</h4>The most common loadable chemotherapeutic drugs in drug-eluting bead transarterial chemoembolization (DEB-TACE) include doxorubicin, epirubicin, etc. CalliSpheres<sup>®</sup> beads have exhibited efficient loadability and eluting characteristics for raltitrexed as well as <i>in vitro</i> and animal experiments. However, the efficacy and safety of raltitrexed-loaded DEB-TACE in patients with intermediate-stage hepatocellular carcinoma (HCC) remain unclear.<h4>Objectives</h4>To ...[more]

PMID: 38362379

Similar Datasets

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.

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.

Dataset Information

Efficacy and safety of raltitrexed-eluting CalliSpheres^® bead transarterial chemoembolization in patients with intermediate-stage hepatocellular carcinoma: a single-arm, prospective study.

Background

Objectives

Design

Methods

Results

Conclusion

Trial registration

Publications

Efficacy and safety of raltitrexed-eluting CalliSpheres<sup>®</sup> bead transarterial chemoembolization in patients with intermediate-stage hepatocellular carcinoma: a single-arm, prospective study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Efficacy and safety of raltitrexed-eluting CalliSpheres® bead transarterial chemoembolization in patients with intermediate-stage hepatocellular carcinoma: a single-arm, prospective study.

Background

Objectives

Design

Methods

Results

Conclusion

Trial registration

Publications

Efficacy and safety of raltitrexed-eluting CalliSpheres<sup>®</sup> bead transarterial chemoembolization in patients with intermediate-stage hepatocellular carcinoma: a single-arm, prospective study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Efficacy and safety of raltitrexed-eluting CalliSpheres^® bead transarterial chemoembolization in patients with intermediate-stage hepatocellular carcinoma: a single-arm, prospective study.