Drug-eluting Bead Transarterial Chemoembolization Research Articles

Prophylactic Use of Antibiotics for Postsurgical Infection in c-TACE and DEB-TACE High-Risk Patients: A Case-Control Study.

Objectives According to recent reports, prophylactic use of antibiotics is not always required in conventional transarterial chemoembolization (c-TACE). However, clinical evidence of prophylactic antibiotics in drug-eluting beads transarterial chemoembolization (DEB-TACE) to prevent postsurgical infection is limited. This study is aimed to evaluate the correlation between the preoperative prophylactic application of antibiotics and postoperative infection in c-TACE or DEB-TACE, especially in a population with a high risk for postsurgical infection. Methods In this retrospective study, TACE patients diagnosed with hepatic carcinoma (between January 2019 and May 2021) were examined. The case group was given 1.5 g cefuroxime sodium 0.5–1 hour before TACE, while there was no intervention in the control group. The outcomes analyzed were leukocyte count >9.5 × 109/L on the second day after the operation and the diagnosis of infection within one month after the operation. We applied univariate, multivariate logistic regression, trend analysis, and subgroup analysis to find potential risk factors and the necessity of prophylactic antibiotics. Results Among 142 eligible cases, 72 received antibiotics while 70 were kept as control, 113 cases were treated with c-TACE, and 29 were treated with DEB-TACE. Multivariate analysis showed that the increase in white blood cell count after the operation was related to diabetes (OR 5.112, 95% CI 1.229–21.264, p = 0.025). The occurrence of postoperative infection was negatively correlated with preoperative albumin value (＜25 g/L) (OR 153.118, 95% CI 1.631–14372.331, p = 0.030). Trend analysis showed that the risk of postoperative infection increased with a decrease in serum albumin level (P < 0.05). Subgroup analysis showed that there were no significant differences in the incidence of increased leukocyte count and postoperative infection between the prophylactic and nonprophylactic treatment groups, in the case of diabetes, preoperative albumin levels, and operation mode (P > 0.1). Conclusions Prophylactic antibiotic treatment before the c-TACE or DEB-TACE had no significant correlation with postoperative leukocyte increase and postoperative infection. Diabetes history and serum albumin levels were the prominent risk factors associated with an increase in postoperative leukocyte count and postoperative infection. Future large-scale studies and randomized-controlled trials are required to confirm and validate this association.

The efficacy of drug-eluting bead or conventional transarterial chemoembolization plus apatinib for hepatocellular carcinoma with portal vein tumor thrombus

Transarterial chemoembolization (TACE) combined with apatinib has been used for advanced hepatocellular carcinoma (HCC), and the efficacy is good. The study was conducted to compare the efficacy and safety of drug-eluting bead TACE plus apatinib (D-TACE-A) with conventional TACE plus apatinib (C-TACE-A) in the treatment of HCC with portal vein tumor thrombus (PVTT). A total of 130 continuous patients who received D-TACE-A or C-TACE-A were included in the study from January 2017 to June 2020. Propensity score matching (PSM) was used to reduce potential selection bias. Before PSM, the median overall survival (mOS) (14 months) and median progression-free survival (mPFS) (7 months) in the C-TACE-A group were longer than the mOS (9 months; P = 0.001) and mPFS (4 months; P = 0.001) in the D-TACE-A group. After PSM, the mOS (14 months vs 9 months; P = 0.039) and mPFS (7 months vs 5 months; P = 0.009) in the C-TACE-A group were longer than those in the D-TACE-A group. In the multivariate regression analysis, C-TACE-A reduced the mortality rate and tumor progression rate compared with D-TACE-A. For the subgroup analysis, patients with VP1–2, without extrahepatic metastases, and with multiple TACE sessions who received C-TACE-A had a lower death risk and tumor progression risk than patients who received D-TACE-A. Before PSM, there was no statistically significant difference in any grade or grade III/IV adverse events (all P > 0.05). C-TACE-A could prolong mOS and mPFS in patients with PVTT, especially for patients with VP1–2 stage PVTT, no extrahepatic tumor metastases, and multiple TACE sessions.

The Role of Conventional TACE (cTACE) and DEBIRI-TACE in Colorectal Cancer Liver Metastases.

Simple SummaryLiver metastases of colorectal cancer have an enormous clinical impact and prevalence. As colorectal cancer is one of the most common cancers, such patients are routinely encountered in day-to-day practice. Still, surgery and systemic chemotherapy constitute the first-line therapies depending on clinical setting. However, if patients present with non-resectable liver-only or liver-dominant metastases and/or do not respond to systemic chemotherapy, local therapies based on a vascular approach can be offered by interventional radiologists to achieve local tumor control or to downstage tumor burden. These therapies are generally called transarterial chemoembolization (TACE). Such treatments can also be combined with systemic or other local therapies. Depending on local practice and expertise, TACE can be offered with a combination of chemotherapeutic agents and embolizing agents or drug-eluting beads which embolize the metastases and its feeding vascular supply and release a chemotherapeutic agent over time. In the following review we compare these different approaches in the local therapy of liver metastases of colorectal cancer by presenting representative study results.Colorectal cancer (CRC) is one of the most common tumor entities worldwide and a common cause of cancer-associated death. Colorectal cancer liver metastases (CRLM) thereby constitute a severe life-limiting factor. The therapy of CRLM presents a major challenge and surgical resection as well as systemic chemotherapy remain the first-line treatment options. Over the years several locoregional, vascular- and image-based treatments offered by interventional radiologists have emerged when conventional therapies fail, or metastases recurrence occurs. Among such options is the conventional/traditional transarterial chemoembolization (cTACE) by local injection of a combination of chemotherapeutic- and embolic-agents. A similar treatment is the more recent irinotecan-loaded drug-eluting beads TACE (DEBIRI-TACE), which are administered using the same approach. Numerous studies have shown that these different types of chemoembolization can be applied in different clinical settings safely. Furthermore, such treatments can also be combined with other local or systemic therapies. Unfortunately, due to the incoherent patient populations of studies investigating TACE in CRLM, critics state that the definite evidence supporting positive patient outcomes is still lacking. In the following article we review studies on conventional and DEBIRI-TACE. Although highly dependent on the clinical setting, prior therapies and generally the study population, cTACE and DEBIRI-TACE show comparable results. We present the most representative studies on the different chemoembolization procedures and compare the results. Although there is compelling evidence for both approaches, further studies are necessary to determine which patients profit most from these therapies. In conclusion, we determine TACE to be a viable option in CRLM in different clinical settings. Nevertheless, a multidisciplinary approach is desired to offer patients the best possible care.

Comparison of DEB-TACE and cTACE for the initial treatment of unresectable hepatocellular carcinoma beyond up-to-seven criteria: A single-center propensity score matching analysis

PurposeTo evaluate clinical outcomes of drug-eluting beads transarterial chemoembolization (DEB-TACE) with CalliSpheres microspheres and conventional TACE (cTACE) as the initial treatment in patients with unresectable hepatocellular carcinoma (HCC) beyond up-to-seven criteria. MethodsThe study retrospectively assessed the medical records of HCC patients beyond up-to-seven criteria who received the initial treatment of DEB-TACE or cTACE from June 2016 to December 2019 in our institution. To reduce the patient selection bias, propensity score matching (PSM) analysis was used. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were compared between the two groups. In addition, prognostic factors affecting PFS and OS were analyzed by univariate and multivariate methods. ResultsA total of 312 eligible HCC patients were included in the study, including 140 patients in the DEB-TACE group and 172 patients in the cTACE group. 110 patients were chosen in each group after PSM analysis and there were no significant differences in baseline characteristics (P > 0.05). Before PSM analysis, DEB-TACE had better ORR and DCR compared to cTACE group (P < 0.05). After PSM analysis, the ORR for DEB-TACE group was still higher than that for cTACE group, while no significant difference in the DCR between the two groups. In addition, DEB-TACE group had better survival benefits than cTACE group before PSM analysis (mPFS: 11.5 months vs 9.0 months, P < 0.001; mOS: 24.0 months vs 19.2 months, P = 0.045). Similarly, after PSM analysis, the median PFS and OS in the DEB-TACE group were still higher than that in the cTACE group (mPFS: 11.1 months vs 9.0 months, P = 0.015; mOS: 25.0 months vs 19.0 months, P = 0.030). Further, the univariate and multivariate analysis indicated that DEB-TACE treatment was a positive prognostic factor for PFS and OS. ConclusionDEB-TACE with CalliSpheres microspheres might be an effective and safe treatment for patients with unresectable HCC beyond up-to-seven criteria.

Treatment efficacy and safety of drug-eluting beads transarterial chemoembolization versus conventional transarterial chemoembolization in hepatocellular carcinoma patients with arterioportal fistula

ABSTRACT This study aimed to compare the treatment efficacy and tolerance between drug-eluting beads transarterial chemoembolization (DEB-TACE) and conventional transarterial chemoembolization (cTACE) in hepatocellular carcinoma (HCC) patients with arterioportal fistula (APF). A total of 44 HCC patients with APF scheduled for DEB-TACE (N = 24, as DEB-TACE group) or cTACE (N = 20, as cTACE group) were recruited. Treatment response, hepatic function, and adverse events were assessed or recorded. Besides, progression-free survival (PFS) and overall survival (OS) were calculated. Total treatment response was better in the DEB-TACE group compared with the cTACE group (P = .012). Meanwhile, the objective response rate (87.5% versus 60.0%) was higher (P = .013), while the disease control rate (95.8% versus 85.0%) was similar in the DEB-TACE group compared to the cTACE group (P = .213). Besides, PFS (mean value: 12.2 (95%CI: 9.9–14.6) months versus 7.8 (95%CI: 5.6–10.0) months) (P = .037), but not OS (mean value: 20.0 (95%CI: 18.1–21.9) months versus. 18.6 (95%CI: 15.4–21.8) months) (P = .341) was prolonged in DEB-TACE group compared with cTACE group. Regarding the safety, Child-Pugh stage, albumin level, and bilirubin level after treatment were all similar between the DEB-TACE group and cTACE group (all P > .05); moreover, no difference was found in the occurrence of adverse events during or after treatment between the two groups (all P > .05). Moreover, subsequent analyses found that embolic materials for APF (microspheres) in the DEB-TACE group did not affect the treatment efficacy (all P > .05). DEB-TACE promotes treatment response and PFS compared with cTACE and shows good safety in HCC patients with APF.

Comparison of Clinical Efficacy and Safety between 70-150 µm and 100-300 µm Doxorubicin Drug-Eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma.

Background: This study aimed to compare the efficacy and safety of 70–150 μm doxorubicin drug-eluting bead (DEB) transarterial chemoembolization (TACE) with those of 100–300 μm DEB-TACE as first-line treatment in patients with hepatocellular carcinoma (HCC). Methods: We retrospectively investigated 72 patients who underwent TACE with 70–150 μm DEBs (n = 40) or 100–300 μm DEBs (n = 32) for HCC in a tertiary center between March 2013 and May 2019. Initial treatment response and adverse events were assessed using the modified Response Evaluation Criteria in Solid Tumors and the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, respectively. Results: At the 2-month post-treatment assessment, the complete and objective response rates were 47.5% and 85.0%, respectively, for the 70–150 μm group and 34.4% and 81.3%, respectively, for the 100–300 μm group; however, the difference was not statistically significant (p > 0.05). In total, 65% patients in the 70–150 μm group and 59.4 % patients in the 100-300 μm group experienced at least one symptom of post-embolization syndrome after TACE; all symptoms were classified as grade 1 or 2. There was no significant difference between the two groups in terms of post-procedural laboratory changes such as changes in liver enzymes and bilirubin levels (p > 0.05). Laboratory toxicity of grade 3 occurred in three patients, all of which were transient elevation of liver enzyme levels. Hepatobiliary adverse events, such as bile duct injury, biloma, liver abscess, and hepatic infarction, were not observed in either treatment group. Conclusion: This study found no significant difference in tumor response between 70–150 μm and 100–300 μm DEB-TACE. Both groups showed favorable safety profiles, and the difference was not significant.

The Efficacy of Drug-eluting Bead Transarterial Chemoembolization Loaded With Oxaliplatin for the Treatment of Stage III-IV Non-small-cell Lung Cancer

To explore the safety and efficacy of drug-eluting bead transarterial chemoembolization (DEB-TACE) loaded with oxaliplatin for stage III-IV non-small-cell lung cancer (NSCLC). From October 2018 to May 2021, a total of 31 patients with stage III-IV NSCLC received DEB-TACE loaded with oxaliplatin. Demographic characteristics, adverse events (AEs), and treatment responses were collected. Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. All 31 patients successfully received DEB-TACE loaded with oxaliplatin. No procedure-related severe adverse events occurred. Hemoptysis symptoms presented in 8 patients but disappeared within 1-3 days. After DEB-TACE for 1, 2, and 6 months, the objective response rate (ORR) was 42%, 35%, and 26%, while the disease control rate (DCR) was 90%, 84% and 61%, respectively. The median PFS was 7 months (range 1-31 months), and the PFS rates at 3, 6, and 12 months were 87%, 71% and 29%, respectively. The median OS was 11 months (range 1-31 months), with OS rates of 87%, 77%, and 39% at 3, 6, and 12 months, respectively. Oxaliplatin-loaded DEB-TACE is a feasible, safe, and effective treatment for patients with advanced refractory non-small-cell lung cancer.

Combination therapy of sorafenib and drug-eluting bead transarterial chemoembolization for advanced hepatocellular carcinoma with and without hepatic arteriovenous shunt.

To compare the efficacy and safety of combination therapy with sorafenib and drug-eluting bead transarterial chemoembolization (DEB-TACE) in advanced hepatocellular carcinoma (HCC) with or without hepatic arteriovenous shunt (HAVS). This retrospective, single-center study enrolled 59 advanced HCC patients treated with combination therapy, of whom 33 (55.9%) patients had HAVS. Tumor response according to the mRECIST criteria was evaluated based on the CT images 1 month after TACE, and changes in the arterial enhancement ratio (AER) of tumors and portal vein tumor thrombosis were also documented. Time-to-progression (TTP), overall survival (OS), and prognostic factors were analyzed. Safety was evaluated with the incidence of TACE-related complications within 6 weeks after TACE. The tumor response between the two groups showed no significant difference in the objective response rate (69.2% in the group without HAVS vs 60.6% in the group with HAVS, p = 0.492) or disease control rate (92.3% vs 87.9%, p = 0.685). The two groups showed comparable TTP (4.23 vs 2.33 months, p = 0.235) and OS (12.77 vs 12.97 months, p = 0.910). A drop in the AER of tumors of more than 20% on post-TACE CT independently predicted better OS. With regard to safety, there was no significant difference between the two groups. For advanced HCC, combination therapy had equal efficacy and safety in patients with HAVS compared to those without HAVS, indicating that DEB-TACE is an optional and effective treatment in these patients.

Nivolumab (NIVO) and drug eluting bead transarterial chemoembolization (deb-TACE): Updated results from an ongoing phase 1 study of patients (pts) with liver limited hepatocellular carcinoma (HCC).

437 Background: TACE is a standard of care for liver limited HCC and impacts the immune microenvironment, potentially augmenting the effects of immune checkpoint inhibitors. Methods: This is a multicenter phase 1 study of NIVO and deb-TACE in unresectable HCC pts and Child Pugh A cirrhosis (NCT03143270). The primary objective is to assess safety. Secondary objectives include response rate by RECIST v1.1, progression-free and overall survival by Kaplan-Meier methodology, and blood/tumor immune correlates. A 3 + 3 design with expansion cohort sequentially evaluates 3 cohorts of differing schedules of NIVO relative to deb-TACE. Deb-TACE (75mg of doxorubicin) is administered on Day 0. NIVO is dosed at 240mg IV every 14 days for 1 year (Cohort 1: NIVO begins day +14 after deb-TACE; Cohort 2, interrupted NIVO dosing begins at Day -28 but is held on the Day 0 then restarted on Day +14; Cohort 3, continuous NIVO dosing begins on Day -28 without interruption). Results: As of September 2021, 19 pts were treated [median 67 years (range: 54-78), male (80%), ECOG PS 0 (47%), Child Pugh A (100%), 3 pts in each cohort 1 and 2, 13 pts in cohort 3]. No cases of treatment related liver failure or Grade 5 adverse events (AEs) were observed. 1 DLT of Grade 3 transaminitis was observed in cohort 3 and resolved without intervention and did not recur with drug rechallenge. Median ALT at baseline, day 28, day 56, and end of treatment (EOT) were 27, 43.5, 36.5, and 29 U/L. Median bilirubin at baseline, day 28, day 56, and EOT were 0.6, 0.6, 0.5, and 0.6 mg/dL. Mean ALBI score at baseline (N=19) and EOT (N=14) were -2.75 ± 0.48 vs. -2.55 ± 0.50. The most common treatment-related AEs of any grade were fatigue (53%), ALT/AST increase (42%), fever (37%), and pruritis (32%). The objective response rate by RECIST v 1.1 was 21% (Table). 5/19 pts remained on study with SD or better for ≥12 (range 12-43) months. Updated survival analysis will be presented at the meeting; correlatives at a separate venue. Conclusions: Nivolumab administered with deb-TACE is safe with antitumor activity. This study provides a needed benchmark for the safety of embolization along with anti-PD1 therapy in liver limited HCC. The clinical question of combining immunotherapy with embolization to improve outcome over embolization alone remains investigational and several, pivotal, phase 3 studies are ongoing. Clinical trial information: NCT03143270. [Table: see text]

Efficacy and safety of drug-eluting bead transarterial chemoembolization (DEB-TACE) plus apatinib versus DEB-TACE alone in treating huge hepatocellular carcinoma patients

BackgroundApatinib, a tyrosine kinase inhibitor, inhibits angiogenesis under the tumor hypoxic environment induced by drug-eluting bead transarterial chemoembolization (DEB-TACE), which is hypothesized to have synergic effect with DEB-TACE in treating hepatocellular carcinoma (HCC) patients. This study aimed to evaluate the efficacy and safety of DEB-TACE plus apatinib in treating huge HCC patients.MethodsTotally, 73 huge HCC patients (tumor size > 10 cm) were screened and divided into DEB-TACE plus apatinib group (N = 34) or DEB-TACE group (N = 39) based on the treatment they received. Their clinical response and adverse events were retrieved. The progression-free survival (PFS) and overall survival (OS) were calculated.ResultsDEB-TACE plus apatinib achieved a trend of higher objective response rate (64.7% vs. 43.6%, P = 0.071), but similar disease control rate (88.2% vs. 79.5%, P = 0.314) than DEB-TACE alone. Moreover, DEB-TACE plus apatinib reached an improved PFS (median (95%CI): 19.0 months (15.5–22.5) vs. 10.9 months (8.0–13.8), P = 0.025) and OS (median (95%CI): 25.1 months (20.3–29.9) vs. 13.7 months (9.8–17.6), P = 0.042) than DEB-TACE alone. After adjustment by multivariate Cox’s regression analyses, DEB-TACE plus apatinib (vs. DEB-TACE alone) was independently correlated with better PFS (HR: 0.420, P = 0.004) and OS (HR: 0.477, P = 0.022). Regarding safety, adverse events were mostly mild and manageable; also, they were of no difference between DEB-TACE plus apatinib and DEB-TACE alone (all P > 0.05).ConclusionDEB-TACE plus apatinib achieves prolonged PFS and OS, while similar adverse events occurrence compared to DEB-TACE alone in huge HCC treatment.

Efficacy, safety, and prognostic factors of drug-eluting beads transarterial chemoembolization using CalliSpheres in treating huge hepatocellular carcinoma patients.

The treatment of huge hepatocellular carcinoma (HCC) is still challengeable due to its deteriorative heterogeneity, for which conventional transarterial chemoembolization (TACE) is proposed as an efficient therapy; however, drug-eluting beads TACE (DEB-TACE) is rarely reported in these patients. Thus, the current study aimed to explore the efficacy, prognostic factors, and safety of DEB-TACE using CalliSpheres in huge HCC patients. Ninety-nine huge HCC patients treated by DEB-TACE using CalliSpheres were retrospectively reviewed. Treatment response, change of tumor markers, liver function indexes, progression-free survival (PFS), and adverse events were retrieved. Objective response rate (ORR) was 66.1%, 48.6%, and 23.8%, then disease control rate (DCR) was 85.5%, 67.6%, and 33.3% at month (M) 1, M3, and M6, respectively; furthermore, carcinoembryonic antigen (CEA) (p = 0.037), alpha fetoprotein (AFP) (p < 0.001), and protein induced by vitamin K absence or antagonist-II (PIVKA-II) (p < 0.001) were all declined at 1month after DEB-TACE. The median PFS was 8.3 (95% confidence interval: 6.0-10.6) months with 1-year and 2-year PFS rates of 38.5% and 15.5%, accordingly. Moreover, elevated China liver cancer (CNLC) stage (p = 0.036, hazard ratio (HR): 1.937) and abnormal cancer antigen 199 (p = 0.019, HR: 2.465) were correlated with unfavorable PFS. Besides, liver function indexes were not deteriorated after DEB-TACE. Lastly, main adverse events included pain (20.2%), fever (17.2%), nausea (14.1%), and vomit (9.1%), which were mild and manageable. DEB-TACE using CalliSpheres presents satisfying efficacy and tolerable safety in huge HCC patients, suggesting that it might be a good treatment option for these patients.

Comparison of Treatment Response, Survival Profiles, as Well as Safety Profiles Between CalliSpheres® Microsphere Transarterial Chemoembolization and Conventional Transarterial Chemoembolization in Huge Hepatocellular Carcinoma.

PurposeCalliSpheres® microspheres (CSM) are the first drug-eluting beads (DEB) developed in China. This study aimed to compare treatment response, survival, and safety profiles between DEB transarterial chemoembolization (DEB-TACE) with CSM and conventional TACE (cTACE) in huge hepatocellular carcinoma (HCC) patients.MethodsA total of 71 patients with huge HCC who underwent DEB-TACE or cTACE were consecutively enrolled in this retrospective cohort study. Treatment response was assessed at first month (M1), third month (M3), and sixth month (M6) after TACE therapy; progression-free survival (PFS) and overall survival (OS) were evaluated; liver function indexes were recorded before TACE operation (M0), at first week (W1), M1 and M6 after TACE therapy; adverse events which occurred after TACE operation were recorded.ResultsDEB-TACE presented with higher objective response rate (60.0% vs. 29.7%, p < 0.05) and disease control rate (86.7% vs. 59.4%, p < 0.05) compared with cTACE at M3. Regarding survival profiles, PFS [median: 3.3 months (95% CI: 2.8–3.7) vs. 2.1 months (95% CI: 1.7–2.5)] as well as OS [median: 7.8 months (95% CI: 4.6–11.0) vs. 5.7 months (95% CI: 5.0–6.3)] were longer in DEB-TACE group compared with cTACE group (both p < 0.01). Multivariate Cox’s regression further illustrated that DEB-TACE vs. cTACE was an independent protective factor for PFS and OS (both p < 0.01). As for safety profiles, patients’ liver function injury was reduced in the DEB-TACE group compared with the cTACE group. The incidence of fever was lower, and CINV was less severe in the DEB-TACE group compared with the cTACE group (both p < 0.05), while no difference in occurrence of liver abscess, increase of ascites, or moderate pain between two groups was observed.ConclusionDEB-TACE with CSM presents with better treatment response, survival profiles, as well as safety profiles compared with cTACE in treatment for huge HCC patients.

Drug-eluting bead transarterial chemoembolization followed by apatinib is effective and safe in treating hepatocellular carcinoma patients with BCLC stage C

BackgroundThe present study aimed to evaluate the efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) followed by apatinib in treating hepatocellular carcinoma (HCC) patients with Barcelona Clinic Liver Cancer (BCLC) stage C. MethodsTotally, 110 HCC patients with BCLC stage C treated with DEB-TACE followed by apatinib were consecutively enrolled. Treatment response (including complete response rate (CR), objective response rate (ORR) and disease control rate (DCR)), survival data (progression-free survival (PFS), overall survival (OS)), and adverse events were documented during the follow-up. ResultsCR, ORR and DCR were 25.5%, 77.2% and 79.1% at 3 months, then were 29.1%, 59.1% and 71.0% at 6 months, respectively. Regarding survival, median PFS (95%CI) was 6.3 (5.0-7.7) months, meanwhile 1-year and 2-year PFS were 19.8% and 3.3%, respectively; median OS (95%CI) was 16.9 (10.2-23.7) months, then 1-year, 2-year and 3-year OS were 66.5%, 34.7% and 14.2%, respectively. Further subgroup analysis indicated that nodule size, Child-Pugh stage, Eastern Cooperative Oncology Group performance status score and level of portal vein invasion were negatively correlated with PFS or OS, which were further validated by univariate and multivariate Cox's regression analysis. Most adverse events by DEB-TACE and apatinib treatment were mild and well-tolerable. ConclusionDEB-TACE followed by apatinib is effective and safe in treating BCLC stage C HCC patients, indicating its role as an acceptable option in HCC management.

A comparative study of efficacy and safety of transarterial chemoembolization with CalliSpheres and conventional transarterial chemoembolization in treating unresectable intrahepatic cholangiocarcinoma patients.

Objective: Previous studies reported that drug-eluting beads transarterial chemoembolization (DEB-TACE) with CalliSpheres is effective and safe to treat hepatocellular carcinoma patients and metastatic liver cancer patients, however few studies reported its clinical application in intrahepatic cholangiocarcinoma (ICC) patients. Therefore, this study aimed to compare the efficacy between DEB-TACE versus conventional transarterial chemoembolization (cTACE) in unresectable ICC patients.Methods: Between January 2016 and June 2020, 89 patients with unresectable ICC were retrospectively analyzed, and enrolled into DEB-TACE group (N=40) and cTACE group (N=49) based on the transarterial treatment. Treatment response was assessed according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Time to progression (TTP) and overall survival (OS) were analyzed by using the Kaplan-Meier curve. Factors affecting OS and TTP were determined by Cox's proportional hazards regression model.Results: DEB-TACE group showed higher DCR (87.5% vs. 65.3%, P=0.011), while similar ORR (67.5% vs. 57.1%, P=0.317) compared to cTACE group. Furthermore, DEB-TACE group had longer OS (median 10 months vs 6 months, P=0.006), while similar TTP compared to cTACE group (median 4 months vs 2 months, P=0.098). After adjustment by multivariant Cox's regression, DEB-TACE (versus cTACE) independently correlated with longer OS (P=0.031). Further subgroup analyses displayed that OS was prolonged in DEB-TACE group compared to cTACE group in patients with multiple tumors (P=0.032) and patients with no lymph node metastasis (P=0.023). Apart from abdominal pain, no difference of adverse events between the two groups was observed. There was no difference in liver function (Bilirubin, Albumin, Prothrombin time) before and after treatment (4 weeks) in both groups.Conclusion: In patients with unresectable ICC, DEB-TACE significantly improved the OS when compared with cTACE and was well tolerated.

Lenvatinib with or without Concurrent Drug-Eluting Beads Transarterial Chemoembolization in Patients with Unresectable, Advanced Hepatocellular Carcinoma: A Real-World, Multicenter, Retrospective Study

Introduction: Lenvatinib is the first-line treatment for advanced hepatocellular carcinoma (HCC). We aimed to compare the clinical outcomes of lenvatinib plus drug-eluting beads transarterial chemoembolization (DEB-TACE) versus lenvatinib alone in real-world practice. Methods: This retrospective analysis included 142 consecutive patients who received lenvatinib plus DEB-TACE and 69 patients who received lenvatinib alone as first-line treatment from 15 Chinese academic centers from November 2018 to November 2019. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) were evaluated by modified Response Evaluation Criteria in Solid Tumors criteria, and safety profiles were compared between the two groups. Results: The median OS and PFS were significantly longer in the combined therapy group than in the monotherapy group in whole cohort (median OS, 15.9 vs. 8.6 months, p = 0.0022; median PFS, 8.6 vs. 4.4 months, p < 0.001) and after propensity score matching analysis (median OS, 13.8 vs. 7.8 months, p = 0.03; median PFS, 7.8 vs. 4.5 months, p = 0.009). Moreover, the treatment option was an independent prognostic factor for OS and PFS with adjustment based upon baseline characteristics (adjusted hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.36–0.78, p = 0.001, and adjusted HR: 0.42, 95% CI: 0.30–0.60, p < 0.001, respectively) and propensity score (adjusted HR: 0.52, 95% CI: 0.36–0.76, p = 0.001, and adjusted HR: 0.46, 95% CI: 0.33–0.64, p < 0.001, respectively). Moreover, a greater ORR was observed in the combined group (ORR: 46.48% vs. 13.05%, p < 0.001). Furthermore, the most common adverse events (AEs) were elevated aspartate aminotransferase (54.9%) and fatigue (46.4%) in the lenvatinib plus DEB-TACE group and lenvatinib group, respectively. Most AEs were mild-to-moderate and manageable. Conclusions: With well-tolerated safety, lenvatinib plus DEB-TACE was more effective than lenvatinib monotherapy in improving OS, PFS, and ORR. Thus, it may be a promising treatment for advanced HCC. Future prospective studies confirming these findings are warranted.

Efficacy of Drug-Eluting Beads Transarterial Chemoembolization Plus Camrelizumab Compared With Conventional Transarterial Chemoembolization Plus Camrelizumab for Unresectable Hepatocellular Carcinoma.

ObjectivesThe purpose of this study was to compare the efficacy and safety of drug-eluting beads transarterial chemoembolization plus camrelizumab (D-TACE-C) with conventional transarterial chemoembolization plus camrelizumab (C-TACE-C) in the treatment of patients with unresectable hepatocellular carcinoma (HCC).Materials and MethodsThis was a retrospective study that evaluated the consecutive medical records of patients with unresectable HCC who had undergone D-TACE-C or C-TACE-C from April 2020 to August 2021. Efficacy of treatment was evaluated using tumor response, progression-free survival (PFS) and survival rates. The adverse events were recorded.ResultsA total of 54 patients were included in this study, including 27 patients who had received D-TACE-C treatment, and 27 patients who had received C-TACE-C treatment. The median PFS and DCR in the D-TACE-C group were significantly longer than those for the C-TACE-C group (PFS: 10 vs. 3 months, P=.017; DCR: 70.4% vs. 40.7%, P = .028). Cox regression analysis showed that D-TACE-C was the only protective factor for PFS. The 6-month and 12-month survival rates in D-TACE-C group and C-TACE-C group were 85.2% versus 79.4% (P = .646) and 65.2% versus 65.1% (P = .903), respectively. Reactive cutaneous capillary endothelial proliferation was the most common adverse event associated with the treatment. There was no significant difference in the adverse events related to TACE and camrelizumab between the two groups. No treatment-related deaths occurred in this study.ConclusionsD-TACE-C is a safe and well-tolerated treatment, and may produce better PFS and tumor response in patients with unresectable HCC than C-TACE-C.

Comparison of tumor response following conventional versus drug-eluting bead transarterial chemoembolization in early- and very early-stage hepatocellular carcinoma

ObjectiveTo compare the safety of conventional transarterial chemoembolization (cTACE) vs drug-eluting bead TACE (DEB-TACE) in very early- and early-stage hepatocellular carcinoma (HCC). MethodsData of patients with early- and very early-stage HCC treated with cTACE or DEB-TACE were evaluated retrospectively in this study. A total of 40 patients were included, 20 treated with cTACE and 20 with DEB-TACE. The cTACE and DEB-TACE groups were comprised of 80% and 75% males, while there were 20% females in cTACE group and 25% in Deb-TACE group respectively. The mean age of patients in cTACE group was 57.43 ​+ ​5.6 years, while it was 56.4 ​+ ​5.5 years in DEB-TACE group. All patients had liver status of Child–Pugh Class A and a score ≤ 7 in Child-Pugh class type B in very early- (stage 0) or early-phase (stage A) stages according to the Barcelona Clinic Liver Cancer (BCLC) system. ResultsThe Child-Pugh class degradation in the cTACE group was slightly higher than that in the DEB-TACE group. Serious complications like peritumoral parenchymal ischemia were observed in 4 patients in the cTACE group and 5 in the DEB-TACE group. Localized bile duct dilation was seen in 2 patients in the cTACE group and 6 in the DEB-TACE group.No significant variation in serious complications between the two groups was established in localized bile duct dilatation. Other minor complications noted were liver failure, liver abscess, liver infarction, acute cholecystitis, biliary tree necrosis, and mortality. Further, no substantial variation in tumor response between the groups was reported immediately and 1-year post-procedural assessment. Conversion rate to other treatment modalities such as surgical resection, radiofrequency ablation (RFA), or swap between cTACE and DEB-TACE was substantially higher in the DEB-TACE group (40%) than in the cTACE group (10%) at the 1-year completion period of the study. ConclusionIn terms of tumor response, the DEB-TACE group showed a better response, to some extent, as an initial therapy for HCC in the early stages as compared to the cTACE group, and DEB-TACE also exhibited better clinical efficacy in patients with HCC.

Conventional Transarterial Chemoembolization Versus Drug-Eluting Beads in Patients with Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis.

Simple SummaryHepatocellular carcinoma (HCC) is the most common type of liver cancer and accounts for approximately 6% of all human cancers. In this study, we performed a systematic review and pooled analysis of the conventional transcatheter arterial chemoembolization (C-TACE) compared to drug-eluting beads TACE (DEB-TACE) as two treatment options for patients with unresectable HCC. Treatment with DEB-TACE appears to be non-inferior compared to conventional C-TACE and associated with a better objective response and disease control with fewer severe complications and all-cause mortality. In light of these findings, research efforts should attempt to further characterize the efficacy and safety profile of DEB-TACE as a potential component of unresectable HCC management.Hepatocellular carcinoma (HCC) occurs in nearly three-quarters of all primary liver cancers, with the majority not amenable to curative therapies. We therefore aimed to re-evaluate the safety, efficacy, and survival benefits of treating patients with drug-eluting beads transcatheter arterial chemoembolization (DEB-TACE) compared to the conventional transcatheter arterial chemoembolization (C-TACE). Several databases were searched with a strict eligibility criterion for studies reporting on adult patients with unresectable or recurrent HCC. The pooled analysis included 34 studies involving 4841 HCC patients with a median follow-up of 1.5 to 18 months. There were no significant differences between DEB-TACE and C-TACE with regard to complete response, partial response and disease stability. However, disease control (OR: 1.42 (95% CI (1.03,1.96) and objective response (OR: 1.33 (95% CI (0.99, 1.79) were significantly more effective for DEB-TACE treatment with fewer severe complications and all-cause mortality. The pooled-analysis did not find superiority of DEB-TACE in complete or partial response, disease stability, controlling disease progression, and 30 day or end-mortality. However, results showed that DEB-TACE is associated with a better objective response, disease control, and lower all-cause mortality with severe complications compared to C-TACE treatment. Given that the safety outcomes are based on limited studies with a potential for bias, there was no clear improvement of DEB-TACE over C-TACE treatment.

Effect of drug-eluting bead transarterial chemoembolization loaded with cisplatin on normal dogs.

Transcatheter arterial embolization (TAE) and transcatheter arterial chemoembolization (TACE) are standard treatments for advanced hepatocellular carcinoma (HCC) and particularly for unresectable tumors or liver metastases in humans. However, reports on TACE used in veterinary medicine are few. This study aimed to evaluate the feasibility and safety of drug-eluting bead transarterial chemoembolization (DEB-TACE). We performed DEB-TACE in four clinically normal dogs and pharmacokinetically compared the results against hepatic arterial infusion (HAI) of cisplatin in two dogs. Drug-eluting beads (DEB) loaded with cisplatin were injected through a microcatheter for selective embolization of the left hepatic artery. After embolization, computed tomography (CT) images and histological examination findings were obtained during a 4-week observation period. Serum platinum concentrations were measured to evaluate cisplatin after each procedure. Biochemical analysis was performed during a 12-week observation period. Embolization was successful in all dogs, and there were no clinically apparent abnormalities. Embolization was confirmed up to 4 weeks after DEB-TACE in two of the four dogs and up to 1 week in the other two dogs using postoperative CT images. Cisplatin was not detected in peripheral veins in all dogs after DEB-TACE, but it was detected in trace amounts after HAI. DEB-TACE using cisplatin was safe and well tolerated by normal dogs. DEB-TACE may be useful in terms of determining systemic toxicity and drug concentration within tumors.

Liver MRI and clinical findings to predict response after drug eluting bead transarterial chemoembolization in hepatocellular carcinoma

To identify the gadoxetic acid (GA)-enhanced magnetic resonance imaging (MRI) and laboratory findings that enable prediction of treatment response and disease-free survival (DFS) after the first session of drug eluting bead transarterial chemoembolization (DEB-TACE) in patients with hepatocellular carcinoma (HCC). A total of 55 patients who underwent GA-enhanced MRI and DEB-TACE from January 2014 to December 2018 were included. All MRI features were reviewed by two radiologists. Treatment response was evaluated according to the modified Response Evaluation Criteria in Solid Tumors. Univariate and multivariate logistic regression analyses were used to determine predictive factors of treatment response and DFS, respectively. A total of 27 patients (49.1%) achieved complete response (CR) after one session of treatment. There were no significant differences between the two groups in terms of clinical and laboratory characteristics. Heterogeneous signal intensity in the hepatobiliary phase (HBP) was the only independent predictor of non-CR (odds ratio, 4.807; p = 0.048). Recurrent HCC was detected in 19 patients (70.4%) after CR. In the multivariate analysis, elevated serum alpha-fetoprotein (AFP) level (≥ 30 ng/mL) was the only significant parameter associated with DFS (hazard ratio, 2.916; p = 0.040). This preliminary study demonstrated that heterogeneous signal intensity in the HBP and high serum AFP were useful predictive factors for poor treatment response and short DFS after DEB-TACE, respectively.