Drug-eluting Bead Transarterial Chemoembolization Research Articles

The cost-effectiveness of TheraSphere in patients with hepatocellular carcinoma who are eligible for transarterial embolization

IntroductionThe aim of the study is to estimate the cost-effectiveness of TheraSphere against other embolic treatments in a population with early to intermediate stage hepatocellular carcinoma (HCC) who are unresectable at presentation and are eligible for transarterial embolization (TAE), conventional transarterial chemoembolization (cTACE) or drug-eluting bead TACE (DEB-TACE). Materials and methodsA Markov model was constructed using a UK National Health Service (NHS) perspective, a 20-year time horizon, and four-week cycles. The eight health states included ‘watch and wait’, ‘transplantation’ (pre-, post and post (No HCC)), ‘resection’, ‘no HCC other’, ‘pharmacological management’ and ‘death’. Clinical data were sourced from literature and expert opinion. Resource use and costs were reflective of the NHS, and benefits were quantified using Quality-Adjusted Life Years (QALYs), with utility weights sourced from literature.Comparators were TAE, cTACE and DEB-TACE. The primary output was the Incremental Cost-Effectiveness Ratio (ICER) expressed as cost per QALY gained. An ICER of under £20,000/QALY gained for an intervention is cost-effective and represents efficient use of healthcare resources. Extensive deterministic and probabilistic sensitivity analyses were undertaken. ResultsTheraSphere patients were predicted to gain 0.7 additional QALYs compared to all other treatments. The base case ICERs for TheraSphere were £17,300, £17,279 and £23,020 per QALY gained compared to TAE, cTACE and DEB-TACE, respectively. In the TheraSphere cohort, 87% more patients were predicted to achieve downstaging compared to all other treatment options. ConclusionsThis study indicates that treatment with TheraSphere is a potentially cost-effective option for patients with early to intermediate stage HCC.

Additional Treatment Using Transcatheter Arterial Infusion with Drug-Eluting Beads Transarterial Chemoembolization Contributes to Prolonged Survival of Patients with BCLC Stage C Hepatocellular Carcinoma after Discontinuing Lenvatinib: Preliminary Study

Objective: Lenvatinib is considered the first-line treatment for unresectable advanced hepatocellular carcinoma (HCC); however, in some clinical cases, discontinuation of lenvatinib is unavoidable. It is important to elucidate if transcatheter arterial infusion (TAI) with drug-eluting beads transarterial chemoembolization (DEB-TACE) is a feasible second-line treatment after discontinuing lenvatinib. In this study, we aimed to evaluate the efficacy, hepatic function and nutritional status associated with TAI with DEB-TACE for patients who previously discontinued lenvatinib. Materials and Methods: We included 35 patients who were prescribed lenvatinib for unresectable HCC between July 2018 and December 2019, of whom 12 discontinued lenvatinib during the study. The changes in the albumin-bilirubin (ALBI) score and the controlling nutritional status (CONUT) score before and after discontinuing lenvatinib were examined. Furthermore, the tolerability and survival of patients treated using TAI with DEB-TACE as a second-line treatment were analysed. Results: The ALBI and CONUT scores were significantly worse when lenvatinib was started and stopped (p<0.05). The CONUT score was significantly worse in the second-line group than in the follow-up group when beginning and discontinuing lenvatinib; however, this score tended to improve after DEB-TACE. The group that underwent TAI with DEB-TACE as a second-line treatment had significantly better survival than the follow-up group (log‑rank test, p=0.029; generalized Wilcoxon test, p=0.042). Conclusion: In patients who could undergo TAI with DEB-TACE as a second-line treatment after discontinuing lenvatinib, the CONUT score improved, while the ALBI score was maintained and welltolerated; these scores may have contributed to improved survival compared with follow-up patients. Future studies with larger sample sizes are necessary to confirm our findings.

Drug-eluting beads transarterial chemoembolization sequentially combined with radiofrequency ablation in the treatment of untreated and recurrent hepatocellular carcinoma.

BACKGROUNDDrug-eluting beads transarterial chemoem-bolization (DEB-TACE) has the advantages of slow and steady release, high local concentration, and low incidence of adverse drug reactions compared to the traditional TACE. DEB-TACE combined with sequentially ultrasound-guided radiofrequency ablation (RFA) therapy has strong anti-cancer effects and little side effects, but there are fewer related long-term studies until now.AIMTo explore the outcome of DEB-TACE sequentially combined with RFA for patients with primary hepatocellular carcinoma (HCC).METHODSSeventy-six patients with primary HCC who underwent DEB-TACE sequentially combined with RFA were recruited. Forty patients with untreated HCC were included in Group A, and 36 patients with recurrent HCC were included in Group B. In addition, 40 patients with untreated HCC who were treated with hepatectomy were included in Group C. The serological examination, preoperative magnetic resonance imaging examination, and post-treatment computed tomography enhanced examination were performed for all patients. The efficacy was graded as complete remission (CR), partial remission (PR), stable disease and progressive disease at the 3rd, 6th, and 9th. All patients were followed up for 3 years and their overall survival (OS), disease-free survival (DFS) were assessed.RESULTSThe efficacy of Group A and Group C was similar (P > 0.05), but the alanine aminotransferase, aspartate aminotransferase and total bilirubin of Group A were lower than those of Group C (all P < 0.05). The proportions of CR (32.5%), PR (37.5%) were slightly higher than Group A (CR: 27.5%, PR: 35%), but the difference was not statistically significant (χ2 = 0.701, P = 0.873). No operational-related deaths occurred in Group A and Group C. The OS (97.5%, 84.7%, and 66.1%) and the DFS (75.0%, 51.7%, and 35.4%) of Group A at the 1st, 2nd, and 3rd year after treatment were similar with those of Group C (OS: 90.0%, 79.7%, and 63.8%; DFS: 80.0%, 59.7%, and 48.6%; P > 0.05). The OS rates in Group A and Group B (90%, 82.3%, and 66.4%) were similar (P > 0.05). The DFS rates in Group B (50%, 31.6%, and 17.2%) were lower than that of Group A (P = 0.013).CONCLUSIONThe efficacy of DEA-TACE combined with RFA for untreated HCC is similar with hepatectomy. Patients with recurrent HCC could get a longer survival time through the combined treatment.

Trans-arterial chemoembolization (TACE) in treatment of non-resectable hepatocellular carcinoma: comparative study between conventional TACE and drug eluting bead TACE

To compare tumour response and complications of conventional TACE with lipidol versus DEB-TACE in the treatment of non-resectable HCC.Prospective non randomized comparative clinical trial was performed for patients receiving TACE at interventional radiology unit in Radiodiagnosis department in Zagazig university hospitals. Forty patients were included in this study, 16 patients were treated with drug eluting beads TACE and 24 patients were treated with conventional TACE.Follow up triphasic CT was performed 1 month after the procedure, we found that complete response was 6 cases (25 %) in c TACE group, and 4 cases (25%) in drug eluting bead TACE group, Partial response was achieved in 11 cases (45.8%) in c TACE group, and in 8 cases (50 %) in DEBs-TACE group, Cases with stable disease were 5 cases (20.8%) in c TACE group, and it was 3 cases (18.7%) in DEBs-TACE group, progressive disease is noted in two cases (8.3 %) in c TACE group, and one case (6.2 %) in drug eluting TACE group. Complications were as follow: 18 cases (75%) with abdominal pain in c TACE group, and 6 cases (37.5%) with abdominal pain in DEBs-TACE group, Nausea and vomiting were noted in 13 cases (54.17%) in c TACE group and in 3 cases (18.75%)in DEBs TACE group, Alopecia was noted in 8 cases (33.3 %) in c TACE group and in one case (6.25%) in DEBs TACE group.There were no significant differences between two groups regarding tumour response after 1 month. Almost all complications were significantly lower in DEBs-TACE group than in c TACE group, especially with abdominal pain, nausea, vomiting and alopecia. Abbreviations: c TACE: conventional trans-arterial chemoembolization, DEB TACE: drug eluting beads trans-arterial chemoembolization, HCC: hepatocellular carcinoma, CR: complete response, PR: partial response, SD: stable disease, PD: progressive disease.

A novel application of drug-eluting transarterial chemoembolization in treating non-liver cancers.

This case series aimed to preliminarily evaluate the efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) in patients with lung, renal, gastric, and other non-liver cancers.Twenty-four patients who underwent DEB-TACE or DEB-TACE combined with other therapies were reviewed in this case series. Treatment responses were assessed at 1 month after treatment according to the modified Response Evaluation Criteria in Solid Tumors. Overall survival (OS) and adverse events were recorded.In the total patients, the objective response and disease control rate were 79.2% and 87.5%, respectively. And the mean OS in total patients was 14.7 months (95% confidence interval: 9.6-19.9 months). The number of patients who had generalized aches, nausea, vomit, fever, abdominal discomfort, chest discomfort, elevated blood pressure, cough, loss of appetite, and headache in total patients were 7 (29.2%), 11 (45.8%), 6 (25.0%), 2 (8.3%), 3 (12.5%), 3 (12.5%), 1 (4.2%), 1 (4.2%), 1 (4.2%), and 1 (4.2%), respectively. The objective response rates in patients with lung, renal, gastric, and other non-liver cancer were 70.0%, 85.7%, 100.0%, and 80.0%, respectively. In patients with lung, renal, gastric, and other non-liver cancers, the mean values of the OSs were 13.4 months, 12.4 months, 7.6 months, and 20.3 months, respectively. And the most common adverse events in lung cancer patients, renal carcinoma patients, gastric cancer patients, and patients with other non-liver cancers were post-embolization syndrome.DEB-TACE may be an effective and safe therapeutic option in patients with lung, renal, gastric, and other non-liver cancers.

Drug-Eluting Beads versus Lipiodol Transarterial Chemoembolization for the Treatment of Hypovascular Hepatocellular Carcinoma: A Single-Center Retrospective Study.

PurposeTo evaluate the efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) and conventional TACE (C-TACE) in treating hypovascular hepatocellular carcinoma (HCC).Materials and MethodsThe medical records based on HCC patients who underwent TACE from January 2016 to June 2019 were reviewed in the study. The diagnosis of hypovascular HCC was conducted by two senior radiologists according to imaging. We evaluated the adverse events (AEs), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) in the study.ResultsA total of 98 patients with hypovascular HCC were included in the study. 46 patients underwent DEB-TACE treatment, and 52 patients underwent C-TACE treatment. The PFS of DEB-TACE group and C-TACE group was 12.0 months and 7.0 months (P < 0.001), and OS was 21.0 months and 14.0 months (P = 0.035), respectively. In addition, DEB-TACE group had better ORR (76.1% vs 40.4%, P < 0.001) and DCR (91.3% vs 75.0%, P = 0.033) compared to C-TACE group. The occurrence rate of AEs showed no difference between the two groups (67.3% vs 57.7%, P = 0.323). Furthermore, we found that DEB-TACE can be identified as a positive independent prognostic factor for improved PFS and OS.ConclusionDEB-TACE, as an effective treatment, can yield better objective response rate, similar safety profile and improved survival for hypovascular HCC patients compared to C-TACE.

Comprehensive predictive factors for CalliSpheres® microspheres (CSM) drug-eluting bead-transarterial chemoembolization and conventional transarterial chemoembolization on treatment response and survival in hepatocellular carcinoma patients

Transarterial chemoembolization (TACE) is widely applied in hepatocellular carcinoma (HCC) patients who are not suitable for surgical treatment. We aimed to investigate the treatment outcomes and comprehensive prognostic factors of CalliSpheres® microspheres (CSM) drug-eluting bead TACE (DEB-TACE) treatment and conventional TACE (cTACE) treatment in HCC patients. Three hundred and thirty-five HCC patients received DEB-TACE or cTACE treatment were consecutively enrolled in multi-center, retrospective cohort study. Treatment response was conducted at M1, M3 or M6 after treatment. Progression free survival (PFS) and overall survival (OS) were recorded. Thirty-seven baseline factors including demographic characteristics, clinical features, biochemical indexes and previous treatment histories were selected. In total patients, history of drink and largest nodule size≥7cm independently predicted worse ORR, DEB-TACE predicted better OS, while largest nodule size≥7cm, increased Child-Pugh stage, ALB abnormal, ALP abnormal or AFP abnormal predicted worse survival. For DEB-TACE group, previous cTACE and ANC abnormal independently predicted worse ORR, and hepatic vein invasion, increased Child-Pugh stage or AFP abnormal independently predicted poor survival. For cTACE group, largest nodule size≥7cm independently predicted poor ORR, and multifocal disease as well as ALB abnormal predicted poor OS. History of drink, largest nodule size≥7cm, DEB-TACE, increased Child-Pugh stage, abnormal ALB, ALP or AFP are potential prognostic factors in total patients, previous cTACE and ANC abnormal, hepatic vein invasion, increased Child-Pugh stage or AFP abnormal are potential prognostic factors in DEB-TA group, and largest nodule size≥7cm, multifocal disease and ALB abnormal are potential prognostic factors in cTACE group.

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

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.

Neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios as predictors of tumor response in hepatocellular carcinoma after DEB-TACE.

To investigate the predictive value of quantifiable imaging and inflammatory biomarkers in patients with hepatocellular carcinoma (HCC) for the clinical outcome after drug-eluting bead transarterial chemoembolization (DEB-TACE) measured as volumetric tumor response and progression-free survival (PFS). This retrospective study included 46 patients with treatment-naïve HCC who received DEB-TACE. Laboratory work-up prior to treatment included complete and differential blood count, liver function, and alpha-fetoprotein levels. Neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) were correlated with radiomic features extracted from pretreatment contrast-enhanced magnetic resonance imaging (MRI) and with tumor response according to quantitative European Association for the Study of the Liver (qEASL) criteria and progression-free survival (PFS) after DEB-TACE. Radiomic features included single nodular tumor growth measured as sphericity, dynamic contrast uptake behavior, arterial hyperenhancement, and homogeneity of contrast uptake. Statistics included univariate and multivariate linear regression, Cox regression, and Kaplan-Meier analysis. Accounting for laboratory and clinical parameters, high baseline NLR and PLR were predictive of poorer tumor response (p = 0.014 and p = 0.004) and shorter PFS (p = 0.002 and p < 0.001). When compared to baseline imaging, high NLR and PLR correlated with non-sphericaltumor growth (p = 0.001 and p < 0.001). This study establishes the prognostic value of quantitative inflammatory biomarkers associated with aggressive non-sphericaltumor growth and predictive of poorer tumor response and shorter PFS after DEB-TACE. • In treatment-naïve hepatocellular carcinoma (HCC), high baseline platelet-to-lymphocyte ratio (PLR) and neutrophil-to-lymphocyte ratio (NLR) are associated with non-nodular tumor growth measured as lowtumor sphericity. • High PLR and NLR are predictive of poorer volumetric enhancement-based tumor response and PFS after DEB-TACE in HCC. • This set of readily available, quantitative immunologic biomarkers can easily be implemented in clinical guidelines providing a paradigm to guide and monitor the personalized application of loco-regional therapies in HCC.

Increased Arterio-Portal Shunt Formation after Drug-Eluting Beads TACE for Hepatocellular Carcinoma

Background and Aims: Conventional transcatheter arterial chemoembolization (C-TACE) and drug-eluting bead (DEB)-based TACE are current treatments for hepatocellular carcinoma (HCC). We compared the therapeutic efficacies and adverse events of these methods in a single-center retrospective cohort study. Methods: We enrolled 174 patients treated between January 2010 and October 2016; 98 and 76 underwent C-TACE and DEB-TACE, respectively, with 76 and 22 of the former group and 49 and 27 of the latter group classified as Child-Pugh class A and B, respectively. Therapeutic outcomes, progression-free survival (PFS), and adverse events were evaluated. Results: The PFS rates in the C-TACE and DEB-TACE groups were 8.1 and 6.1 months, respectively (p = 0.79). The response and disease control rates were 64 and 71% in C-TACE patients and 69 and 78% in DEB-TACE patients, respectively (p = 0.25). Postprocedural pain, vomiting, and fever were more frequent following C-TACE than DEB-TACE (p < 0.001). In contrast, the incidences of bilomas and arterio-portal shunts were significantly higher following DEB-TACE (p < 0.001); the incident rates of arterio-portal shunt formation were 8.1 and 48.7% in patients undergoing C-TACE and DEB-TACE, respectively. Child-Pugh class A was significantly associated with arterio-portal shunt formation after DEB-TACE on multivariate analysis. Conclusions: There were no significant differences in the therapeutic efficacies of C-TACE and DEB-TACE. However, the frequency of arterio-portal shunt formation was significantly higher in HCC patients with Child-Pugh class A undergoing DEB-TACE. Our findings imply that C-TACE should be selected for HCC patients with Child-Pugh class A and DEB-TACE should be chosen for those with Child-Pugh class B.

Drug-eluting bead transarterial chemoembolization for hepatocellular carcinoma: does size really matter?

We aimed to compare the safety and effectiveness of 100-300 μm versus 300-500 μm drug-eluting bead transarterial chemoembolization (DEB-TACE) and to investigate the impact of tumor and feeding artery size on treatment outcome of different particle sizes in the treatment of hepatocellular carcinoma (HCC). This retrospective cohort study enrolled 234 consecutive patients who underwent TACE using 100-300 μm DEB (Group A, n=75) and 300-500 μm DEB (Group B, n=159) in a tertiary center between August 2012 and March 2017. Initial treatment response and adverse events were assessed using modified Response Evaluation Criteria in Solid Tumors (mRECIST) and National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, respectively. A total of 704 HCCs in 234 patients were evaluated. The average index tumor size was 3.8 cm. Multivariate analysis showed that tumor size, lobe involvement, particle size, and tumor location were significant predictive factors of complete response. The overall rate of complete response in groups A and B were 56.0% and 33.3% (P = 0.001), respectively. Group A had higher complete response rate than group B in the subgroup of BCLC B with tumor <3 cm (57.9% vs. 21.1%; P = 0.020) and subgroup of feeding artery ≥0.9 mm (55.2% vs. 30.9%; P = 0.014). There were fewer major complications in group A compared with group B (0% vs. 6.9%, P = 0.018). TACE with 100-300 μm DEB is associated with better initial treatment response and fewer major complications compared with 300-500 μm. Our study also highlights the impact of tumor characteristics on treatment outcome of different DEB size, which might help to select the optimal sphere size for TACE in the treatment of HCC.

Drug-eluting beads-transcatheter arterial chemoembolization with or without iodine-125 treatment is effective and tolerable in treating advanced non-small cell lung cancer patients: a pilot study.

BackgroundThis study aimed to explore the efficacy and safety of drug-eluting beads-transcatheter arterial chemoembolization (DEB-TACE) with or without iodine-125 (125I) seed implantation in treating advanced non-small cell lung cancer (NSCLC) patients.MethodsA total of 25 advanced NSCLC patients underwent DEB-TACE were consecutively enrolled, among which 17 cases also received 125I seed implantation post DEB-TACE treatment. Treatment response, overall survival (OS), biochemical indexes and safety profiles were recorded and analyzed.ResultsZero (0.0%), 13 (54.2%), 9 (37.5%) and 2 (8.3%) patients realized complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) respectively, and the objective response rate (ORR) and disease control rate (DCR) were 54.2% and 91.7%. The median OS was 12.6 (95% CI: 7.8–17.5) months. No difference of treatment response or OS was observed between DEB-TACE treatment alone and DEB-TACE plus 125I seed implantation. Predictive factors analysis revealed that tumor size correlated with worse OS. Besides, chest distress grade and dyspnea grade were decreased after DEB-TACE procedure, while clinical symptoms were not changed after 125I seed implantation. The common adverse events (AEs) were fever (32.0%), pain (12.0%) by DEB-TACE treatment, and common AE was pain (26.7%) by 125I seed implantation.ConclusionsDEB-TACE with or without 125I seed implantation is effective and tolerable in treating advanced NSCLC patients.

Value of Gd-EOB-DTPA-Enhanced MRI and Diffusion-Weighted Imaging in Detecting Residual Hepatocellular Carcinoma After Drug-Eluting Bead Transarterial Chemoembolization

To investigate the value of gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid (Gd-EOB-DTPA)-enhanced magnetic resonance imaging (MRI) and diffusion-weighted imaging (DWI) in diagnosing residual hepatocellular carcinoma (HCC) after drug-eluting bead transarterial chemoembolization (DEB-TACE). Sixty-two patients (50 men, 12 women; mean age, 56.8 ± 1.4 years) with 74 HCCs who underwent Gd-EOB-DTPA-enhanced MRI and DWI in 1-2-month intervals after DEB-TACE were retrospectively studied. Imaging features derived from Gd-EOB-DTPA-enhanced MRI and DWI were analyzed and compared between residual HCCs and necrotic tumors. The sensitivity and specificity of Gd-EOB-DTPA-enhanced MRI and DWI with quantitative apparent diffusion coefficient (ADC) values in diagnosing residual HCCs were calculated and compared, based on the reference standard of pathology and/or angiography. Thirty-three residual HCCs and 41 necrotic tumors were diagnosed. Residual HCCs presented characteristics of arterial hypervascularity (90.91%) and DWI hyperintensity (78.78%), which were of importance in differentiating necrotic tumors (p< 0.05). DWI showed lower sensitivity (78.79% vs. 96.97%, p< 0.001) and specificity (78.05% vs. 100%, p< 0.001) than Gd-EOB-DTPA-enhanced MRI in diagnosing residual HCCs after DEB-TACE. Residual HCCs had a significantly higher mean ADC value than necrotic tumors (1.30 ± 0.32 × 10-3 mm2/s vs. 1.55 ± 0.50 × 10-3 mm2/s, p< 0.001). Receiver operating characteristic curve analysis for identifying residual HCCs demonstrated that the threshold ADC value of 1.25 × 10-3 mm2/s had 84.85% sensitivity and 87.80% specificity. Gd-EOB-DTPA-enhanced MRI is superior to DWI in diagnosing residual HCCs after DEB-TACE, and arterial hypervascularity and DWI hyperintensity are important imaging features in distinguishing residual HCCs from necrotic tumors.

Comparative Study of Drug-eluting Beads versus Conventional Transarterial Chemoembolization for Treating Peculiar Anatomical Sites of Gastric Cancer Liver Metastasis.

BackgroundThis study aimed to assess the relative safety and short-term efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) and conventional transarterial chemoembolization (c-TACE) for treating peculiar anatomical sites of gastric cancer liver metastasis.Material/MethodsOf the 68 patients with gastric cancer liver metastases confirmed by imaging and pathology, 35 were treated with DEB-TACE and 33 with c-TACE. The DEB-TACE group comprised 26 males and 9 females aged 28–75 years (56.8±6.3), and the c-TACE group included 19 males and 14 females aged 33–77 (60.2±9.4) years. Liver functions of the 2 groups were compared between pre-TACE and 1-week and 1-month after TACE. Computed tomography and magnetic resonance imaging were reexamined at 1, 3, and 6 months after TACE, and short-term efficacy was assessed based on modified response evaluation criteria in solid tumors.ResultsOne month following DEB-TACE and c-TACE, the number of cases with objective response (OR) was 29 cases (29 out of 35 cases, 82.9%) and 20 cases (20 out of 33 cases, 60.6%) and disease control (DC) in the 2 groups was 33 cases (33 out of 35 cases, 94.3%) and 26 cases (26 out of 33 cases, 78.8%) respectively (P=0.041, P=0.031). Alanine transaminase (ALT) and Aspartate transaminase (AST) significantly increased in the DEB-TACE and c-TACE groups 1 week later (P<0.001). There were no serious complications in the 2 groups; incidences of nausea and vomiting were significantly lower, but instances of fever were markedly elevated in the DEB-TACE group (P=0.023, P=0.016, respectively).ConclusionsThe safety, feasibility, and short-term efficacy of DEB-TACE and c-TACE in the treatment of gastric cancer liver metastasis are clear. DEB-TACE leads to less incidences of nausea and vomiting but more incidences of fever than c-TACE.

Predictive performance of the mHAP-II score in a real-life western cohort with hepatocellular carcinoma following trans-arterial chemoembolisation with drug-eluting beads (DEB-TACE)

ObjectivesTo evaluate the predictive performance of the modified hepatoma arterial embolisation prognostic II (mHAP-II) score in a real-life western hepatocellular carcinoma (HCC) cohort treated with drug-eluting bead-TACE and compare the mHAP-II with other scores in this cohort.MethodsOne hundred seventy-nine HCC patients (mean age 77 (± 9) years, 87% male) with one or more drug-eluting bead (DEB)-TACE sessions using 100–300 μm microspheres were retrospectively analysed. Performance analysis of the mHAP-II score was based on Mann-Whitney U tests, the Kaplan-Meier method, log-rank tests, receiver operating characteristics, Akaike’s information criterion and Cox regression models.ResultsIn this population, HCC risk factors were mainly alcohol abuse (31%) and hepatitis C (28%). The median survival of the entire cohort was 29.4 months. mHAP-II classification of the cohort was mHAP-II B (30%), C (41%) and D (23%) respectively. Survival of all subgroups differed significantly from each other (each p < 0.05). Area under the curve for receiver operating characteristic was 0.60 and Akaike’s information criterion was 21.8 (p = 0.03), indicating a superior performance of mHAP-II score compared with HAP score and BCLC. Tumour number ≥ two (HR 1.54), alpha-fetoprotein > 400 μg/l (HR 1.14), serum albumin < 3.6 g/dl (HR 1.63) and total bilirubin > 0.9 mg/dl (HR 1.58) contributed significantly in Cox proportional hazards regression (each p < 0.05).ConclusionThe mHAP-II score can predict survival outcomes of western HCC patients undergoing DEB-TACE and further subdivide this heterogeneous group; however, certain limitations concerning the predictive power of mHAP-II score must be taken into account.Key Points• This retrospective study evaluated the predictive performance of the modified hepatoma arterial embolisation prognostic II (mHAP-II) score in a real-life western HCC cohort treated with drug-eluting bead-TACE.• Survival of all mHAP-II subgroups differed significantly, area under the curve for mHAP-II was 0.60 and Akaike’s information criterion was 21.8.• The mHAP-II score can predict survival outcomes of western HCC patients undergoing DEB-TACE and further subdivide this heterogeneous group. However, because the study is underpowered, true survival prediction may be more difficult to infer.

Drug-eluting beads transarterial chemoembolization by CalliSpheres is effective and well tolerated in treating intrahepatic cholangiocarcinoma patients: A preliminary result from CTILC study.

This study aimed to investigate the efficacy and safety of drug-eluting beads (DEB) transarterial chemoembolization (TACE) treatment in Chinese intrahepatic cholangiocarcinoma (ICC) patients.37 ICC patients underwent DEB-TACE treatment in CTILC study (registered on clinicaltrials.gov with registry No. NCT03317483) were included in this present study. Treatment response was assessed according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Overall survival (OS) was calculated from the time of DEB-TACE operation until the date of death from any causes. Liver function change and adverse events (AEs) were recorded during and after DEB-TACE operation.3 (8.1%) patients achieved complete response (CR) and 22 (59.5%) patients achieved partial response (PR), with objective response rate (ORR) of 67.6%. After DEB-TACE treatment, mean OS was 376 days (95%CI: 341–412 days). Multivariate logistic regression analysis revealed that Bilobar disease (P = .040, OR: 0.105, 95% CI: 0.012–0.898) and portal vein invasion (P = .038, OR: 0.104, 95% CI: 0.012–0.881) could independently predict less possibility of ORR. Patients with ALB abnormal, TP abnormal, ALT abnormal and AST abnormal were increased at 1-week post DEB-TACE treatment (P = .034, P = .001, P < .001, P = .006, respectively), while returned to the levels at baseline after 1 to 3 months (all P > .050). Besides, most of the AEs were mild including pain, fever, vomiting, and nausea in this study.DEB-TACE was effective and well tolerated in treating ICC patients, and bilobar disease as well as portal vein invasion were independently correlated with less probability of ORR achievement.

Initial experience of drug-eluting bead transarterial chemoembolization with CalliSpheres® microspheres in treating liver metastases patients.

BackgroundTo evaluate the treatment efficacy, survival, safety profiles and factors affecting the clinical outcomes of drug-eluting bead transarterial chemoembolization (DEB-TACE) in liver metastases patients.MethodsA total of 39 liver metastases patients underwent DEB-TACE treatment with the novel CalliSpheres® microspheres were retrospectively enrolled. Patients’ demographic information, tumor characteristics, history of treatment, laboratory indexes, and treatment procedures were recorded, meanwhile, patients’ treatment response survival and adverse events were also evaluated.ResultsThe rate of complete response, partial response, stable disease and progressive disease of total treated cycles were 1.6%, 34.4%, 54.7% and 9.4%, respectively, and 5.0%, 26.7%, 57.8% and 10.6% of total treated nodules, respectively. Regarding survival, the median progression-free survival (PFS) was 15.3 months (95% CI: 9.7–20.8 months) and the median overall survival was 28.7 months (95% CI: 20.3–37.0 months). Cox’s proportional hazard model regression analyses disclosed that previous liver resection was correlated with worse PFS, while combined targeted therapy and disease control rate after the first DEB-TACE were correlated with longer PFS. For safety profiles, biochemical indexes showed that patients’ liver function was deteriorated at 1 week after DEB-TACE, but was mainly recovered at 1 month after DEB-TACE.ConclusionsDEB-TACE is an efficient and safe treatment choice for liver metastases, moreover, strict screening of indications for resection and combined therapy with targeted therapy might improve the efficacy of DEB-TACE.

Doxorubicin-loaded polyphosphate glass microspheres for transarterial chemoembolization.

The standard of care for intermediate stage hepatocellular carcinoma is transarterial chemoembolization (TACE). Drug-eluting bead TACE (DEB-TACE) has emerged as a leading form of TACE, as it uses highly calibrated microspheres to deliver consistent embolization and controlled drug release to the tumor microenvironment. We report here on doxorubicin (DOX)-loaded polyphosphate glass microspheres (PGM) as a novel resorbable, radiopaque, preloaded DEB-TACE platform. Coacervate composed of polyphosphate chains complexed with Ba2+ , Ca2+ , and Cu2+ can be loaded with DOX prior to PGM synthesis, with PGM production achieved using a water-in-oil emulsion technique at room temperature yielding highly spherical particles in clinically relevant size fractions. In vitro, DOX release was found to be linear, pH dependent, and in accordance with Type II non-Fickian transport. PGM degradation was characterized by an initial burst release of degradation products over 7 days, followed by a plateau in mass loss at approximately 75% over a period of several weeks. in vitro studies indicate that PGM degradation products, namely Cu2+ , are cytotoxic and may interact with eluted DOX to impair its pharmacological activity. With additional compositional considerations, this approach may prove promising for DEB-TACE applications.

3:27 PM Abstract No. 301 Drug-eluting beads transcatheter arterial chemoembolization is effective and well-tolerated in hepatocellular carcinoma patients with portal vein tumor thrombus

The aim of this study was to investigate the efficacy and safety of drug-eluting beads transcatheter arterial chemoembolization (DEB-TACE) and prognostic factors in hepatocellular carcinoma (HCC) patients with portal vein tumor thrombus (PVTT). 58 HCC patients with PVTT who received DEB-TACE treatment were included in this retrospective study, and the baseline characteristics were recorded. Treatment response was assessed at 4-6 weeks post treatment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST), Overall survival (OS) was calculated using the Kaplan–Meier method, and adverse events (AEs) were also recorded. Univariate and multivariate Cox regression analyses were used to evaluate the relevant clinical variables in predicting OS. 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 stage (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. As to AEs, they were mainly transient elevated liver enzymes and postembolization syndrome, all of which were not severe. DEB-TACE is effective and well-tolerated in HCC patients with PVTT. The higher Child-Pugh stage and tumor burden are independent predictors for poorer OS.

Abstract No. 535 Drug-eluting bead transarterial chemoembolization versus conventional transarterial chemoembolization in colorectal liver metastasis: efficacy and safety and prognostic factors

To evaluate the efficacy, safety and prognostic factors of drug-eluting bead transarterial chemoembolization (DEB-TACE) and conventional transarterial chemoembolization (cTACE) in the treatment of colorectal liver metastasis (CRLM). This study retrospectively analyzed 75 patients with CRLM who received DEB-TACE treatment (36 cases) or cTACE treatment (39 cases) between January 2016 and December 2017. Local control, survival outcome and complications were compared between the two groups. Univariate and multivariate analyses of prognostic factors affecting progression-free survival (PFS) and total survival (OS) were performed. The median duration of follow-up in the two groups was 10.49 months (range, 0.5-22). The median PFS and OS in DEB-TACE group were 10.0 months and 13.0 months, respectively, and in the cTACE group were 6.0 months and 8.5 months (P = 0.009 and 0.008). The 3-, 6- and 12-month survival rates in DEB-TACE group were 100.0%, 94.4%, and 55.6%, respectively. The survival rates in the cTACE group were 92.3%, 71.8%, and 35.9%, respectively. There was no statistically significant difference in the 3-month survival rate (P = 0.083), but significant statistical difference in the 6-month and 12-month survival rates (P = 0.008 and 0.030). Univariate and multivariate survival analyses showed that different treatment methods, tumor size and tumor number were important prognostic factors for PFS and OS. DEB-TACE has advantages over cTACE in prolonging PFS and OS in CRLM patients. Different treatment methods, tumor number and tumor size are important prognostic factors affecting PFS and OS. However, further randomized, multicenter and prospective trials are still needed to confirm the results of this study.Tabled 1Local tumor control and survival of two treatment cohorts.ParameterDEB-TACE (N=36)cTACE (N=39)Z, χ2or t valuePmRECIST (%)Z = 8.8160.032 CR16.7 (6/36)12.8 (5/39) PR41.7 (15/36)15.4 (6/39) SD25.0 (9/36)30.8 (12/39) PD16.7 (6/36)41.0 (16/39)Response rate (%)83.3 (30/36)59.0 (23/39)χ2 = 5.5390.025PFS (months)χ2 = 6.8970.009 Median10.06.0 IQR6.0-14.02.0-10.0OS (months)χ2 = 7.1280.008 Median13.08.5 IQR9.0-16.05.0-12.5OS rate (%) 3 months100.0 (36/36)92.3 (36/39)t = 1.7800.083 6 months94.4 (34/36)71.8 (28/39)t = 2.7410.008 12 months55.6 (20/36)35.9 (14/39)t = 2.2140.030 Open table in a new tab