Abstract:the study aimed to compare the tumor response to and complications of doxorubicin-eluting calliSphere bead-transarterial chemoembolization (DeB-tAce) using small-and medium-sized beads in patients with hepatocellular carcinoma (Hcc) who underwent multiple rounds of oncology therapies. Sixty patients with intermediate stage HCC who had previously received multiple oncology therapies underwent DEB-TACE with CalliSpheres of 100-300 μm (small bead group, n = 34) or 300-500 μm (medium bead group, n = 26) in diamete… Show more
“…Many pieces of research have proved that it can load more kinds of chemotherapy drugs and has a higher drug-loading efficiency compared with other DEBs [7][8][9]. According to several recent studies, unresectable HCC patients who receive DEB-TACE treatment using CSM have better treatment response, prolonged overall survival (OS) and reduced adverse events (AEs) compared with cTACE [10][11]. Therefore, the purpose of this study was to investigate the treatment efficacy and safety of DEB-TACE using CSM and to identify important prognostic factors related to the survival of HCC patients with PVTT.…”
Objective
: To prospectively evaluate the safety and therapeutic effectiveness of drug-eluting beads transcatheter arterial chemoembolization (DEB-TACE) with CalliSpheres® microsphere (CSM) for the treatment of hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT), and to analyze the prognostic factors.
Method
: Between November 2015 and November 2017, consecutive 58 HCC patients with PVTT who received DEB-TACE with CSM treatment were prospectively enrolled in this study. The demographic characteristics, adverse events (AEs) and treatment response were collected. Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. Univariate and multivariate Cox regression analyses were performed to determine the independent factors correlated with OS.
Results
: The objective response rate (ORR) was 79.3% in terms of tumors and 44.8% in thrombi. The median PFS and OS of patients were 5.0 months and 9.0 months respectively. The cumulative survival rate at 3-, 6-, 9-, 12-, 18- and 24-month were 94.8%, 72.4%, 53.4%, 41.4%, 22.4% and 19.0%, respectively. In a stepwise multivariate Cox proportional hazards model, the higher Child-Pugh classification (HR=2.279; 95%CI, 1.042-4.985, p = 0.039) and tumor burden (p = 0.008) were the significant predictors of poorer OS after adjustment for known risk factors. The most common clinical AEs were postembolization syndrome (PES) and the most prevalent laboratory toxicity was transient liver function damage.
Conclusion
: DEB-TACE with CSM is safe and well-tolerated in HCC patients with PVTT, and reveals a favorable preliminary clinical outcome. The higher Child-Pugh classification and liver tumor burden are independent prognostic factors associated with poor survival for HCC patients with PVTT treated by DEB-TACE with CSM.
“…Many pieces of research have proved that it can load more kinds of chemotherapy drugs and has a higher drug-loading efficiency compared with other DEBs [7][8][9]. According to several recent studies, unresectable HCC patients who receive DEB-TACE treatment using CSM have better treatment response, prolonged overall survival (OS) and reduced adverse events (AEs) compared with cTACE [10][11]. Therefore, the purpose of this study was to investigate the treatment efficacy and safety of DEB-TACE using CSM and to identify important prognostic factors related to the survival of HCC patients with PVTT.…”
Objective
: To prospectively evaluate the safety and therapeutic effectiveness of drug-eluting beads transcatheter arterial chemoembolization (DEB-TACE) with CalliSpheres® microsphere (CSM) for the treatment of hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT), and to analyze the prognostic factors.
Method
: Between November 2015 and November 2017, consecutive 58 HCC patients with PVTT who received DEB-TACE with CSM treatment were prospectively enrolled in this study. The demographic characteristics, adverse events (AEs) and treatment response were collected. Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. Univariate and multivariate Cox regression analyses were performed to determine the independent factors correlated with OS.
Results
: The objective response rate (ORR) was 79.3% in terms of tumors and 44.8% in thrombi. The median PFS and OS of patients were 5.0 months and 9.0 months respectively. The cumulative survival rate at 3-, 6-, 9-, 12-, 18- and 24-month were 94.8%, 72.4%, 53.4%, 41.4%, 22.4% and 19.0%, respectively. In a stepwise multivariate Cox proportional hazards model, the higher Child-Pugh classification (HR=2.279; 95%CI, 1.042-4.985, p = 0.039) and tumor burden (p = 0.008) were the significant predictors of poorer OS after adjustment for known risk factors. The most common clinical AEs were postembolization syndrome (PES) and the most prevalent laboratory toxicity was transient liver function damage.
Conclusion
: DEB-TACE with CSM is safe and well-tolerated in HCC patients with PVTT, and reveals a favorable preliminary clinical outcome. The higher Child-Pugh classification and liver tumor burden are independent prognostic factors associated with poor survival for HCC patients with PVTT treated by DEB-TACE with CSM.
“…Besides, the pharmacokinetic profile revealed the speed of drug‐eluting, which is critical to the treatment efficacy of TACE. Many studies compare the embolic particles with different sizes, such as 100–300 versus 700–900 μm, 100–300 versus 300–500 and 500–700 μm, 100–300 versus 300–500 μm, and 70–150 versus 100–300 μm (Namur et al, 2010; Padia et al, 2013; Prajapati et al, 2014; Wang et al, 2020). A preliminary study found that the DOX‐loaded LC/DC Beads with 100–300 μm size employed a higher necrosis rate than 700–900 μm beads.…”
Transarterial chemoembolization (TACE) is a recommended treatment for patients suffering from intermediate and advanced hepatocellular carcinoma (HCC). As compared to the conventional TACE, drug‐eluting bead TACE demonstrates several advantages in terms of survival, treatment response, and adverse effects. The selection of embolic agents is critical to the success of TACE. Many studies have been performed on the modification of the structure, size, homogeneity, biocompatibility, and biodegradability of embolic agents. Continuing efforts are focused on efficient loading of versatile chemotherapeutics, controlled sizes for sufficient occlusion, real‐time detection intra‐ and post‐procedure, and multimodality imaging‐guided precise treatment. Here, we summarize recent advances and applications of microspheres and nanoparticles in TACE for HCC.
This article is categorized under:
Therapeutic Approaches and Drug Discovery > Nanomedicine for Oncologic Disease
“…Therefore, it is essential that the embolic microsphere has a suitable diameter for TACE, which is based on blood vessel size. The size of microspheres used for TACE in clinical trials has ranged from 50 to 500 µm [33]. To evaluate the size variation in the GG and GG/AFGO-Dox microspheres, their diameter was measured using a laser diffraction particle size analyzer.…”
Section: Synthesis and Characterization Of Gg And Gg/afgo-dox Microspheresmentioning
The purpose of this study was to develop a four-step cascade drug-release system for transcatheter arterial chemoembolization (TACE) therapeutic applications according to disease-driven and patient-focused design theories. The four steps underlying these strategies involve the blockage of nutrient supply, nanoparticles, codelivery and the cell cytotoxic effect. Calibrated spherical gellan gum (GG) and nanoparticle-containing gellan gum microspheres were prepared using a water-in-oil emulsification method. Self-assembled nanoparticles featuring amine-functionalized graphene oxide (AFGO) as the doxorubicin (Dox) carrier were prepared. The results confirm that, as a drug carrier, AFGO–Dox nanoparticles can facilitate the transport of doxorubicin into HepG2 liver cancer cells. Subsequently, AFGO–Dox was introduced into gellan gum (GG) microspheres, thus forming GG/AFGO–Dox microspheres with a mean size of 200–700 μm. After a drug release experiment lasting 28 days, the amount of doxorubicin released from 674 and 226 μm GG/AFGO–Dox microspheres was 2.31 and 1.18 μg/mg, respectively. GG/AFGO–Dox microspheres were applied in a rabbit ear embolization model, where ischemic necrosis was visible on the ear after 12 days. Our aim for the future is to provide better embolization agents for transcatheter arterial chemoembolization (TACE) using this device.
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