Efficacy Of Transarterial Chemoembolization Research Articles

Safety and Efficacy of Transarterial Chemoembolization and Immune Checkpoint Inhibition with Camrelizumab for Treatment of Unresectable Hepatocellular Carcinoma.

BackgroundThe clinical outcomes of hepatocellular carcinoma (HCC) patients who receive transarterial chemoembolization (TACE) and immunotherapy are not well characterized. The present study evaluates the safety and efficacy of TACE in combination with immune checkpoint inhibitor treatment for unresectable HCC.MethodsA retrospective analysis of 34 HCC patients who received TACE and treatment with the immune checkpoint inhibitor (ICI), Camrelizumab, between July 2019 and May 2021, was performed. This included 21 patients who developed progressive disease and eight who remained stable after several sessions of TACE, along with five patients who were initially diagnosed with advanced HCC. Adverse events (AEs), objective response rate (ORR) according to modified response evaluation criteria in solid tumors, progression-free survival (PFS), and overall survival (OS) were evaluated.ResultsThe median follow-up from ICI initiation was 10.6 months (range: 2.4–25.0 months). Grade I/II and grade III/IV AEs from ICI treatment occurred in 20 (58.8%) and 2 patients (5.9%), respectively. Two to three months after ICI therapy, the ORR was 35.3% (12/34) and the median PFS and OS was 6.1 months (range: 1.1–19.3 months) and 13.3 months (range: 2.4–25.0 months), respectively.ConclusionTACE in combination with ICI could be a promising treatment approach for unresectable HCC patients.

The efficacy of TACE; how can automated feeder software help?

BackgroundThis is a prospective study of 44 patients having 57 hepatocellular carcinoma (HCC) lesions indicated for transarterial chemoembolization (TACE) and a control group of 41 patients having 55 HCC lesions. TACE in the study group was performed on an angiography machine with an installed automated feeder detection (AFD) software (EmboGuide; Philips Healthcare, Best, The Netherlands) and in the control group was performed on a similar angiography machine (ALLURA XPER FD 20, Philips, Holland), but lacking the AFD software. The aim is to evaluate the clinical utilization of cone-beam CT (CBCT) and (AFD) software in accurate detection of (HCC) arterial feeders, the effect of (AFD) software utilization on the outcome of (TACE) and its utilization effect on fluoroscopy time and radiation dose to the patient during the (TACE) procedure.ResultsThe highest percentage of agreement was between the number of arterial feeders detected by EmboGuide and the actual number of feeders detect during embolization reaching 91.2% with p value < 0.001. The residual non-intended non-embolized areas among the study group at 1-month follow-up were found in 2 out of 57 lesions compared to 9 out of 55 lesions in the control group. The average dose-area product (DAP) among the study group was less than that of the control group.ConclusionCBCT using AFD software provides more information about tumor feeders with consequent more efficient targeted embolization, higher success rate of TACE and less patient exposure to radiation.

The safety and efficacy of transarterial chemoembolization (TACE) + lenvatinib + programmed cell death protein 1 (PD-1) antibody of advanced unresectable hepatocellular carcinoma.

453 Background: More than 70% of hepatocellular carcinoma (HCC) patients are in the intermediate or advanced stages at the time of diagnosis. TACE, TKI and PD-1 antibody are all recommended for patients with unresectable HCC (uHCC) according to Chinese HCC guidelines. There are few scientific trials to back up the safety and effecacy of TACE+TKI+PD-1 antibody for the treatment of uHCC and conversion resection. In this study, we explored the safety and efficacy of the TACE+TKI+PD-1 antibody in uHCC. Methods: This is a prospective, multicenter, cohort study (NCT04997850). Key Eligibility Criteria:18 years old ≤ age ≤ 70 years old; HCC confirmed by histopathology or cytology; No systemic treatment history. ECOG PS score 0-1; Child-Pugh A/B; BCLC stage B/C.Experience group: TACE + Lenvatinib (12mg when≥ 60kg/8mg when &lt; 60kg QD) + Camrelizumab/ Sintilimab (200 mg ivgtt Q3W);Control group: TACE. Results: From Sep 2020 to May 2021, 38 patients were enrolled in experimental group (Table). At the cutoff date (Sep 10 2021), the median follow-up was of 33.34 weeks (Table). The conversion resection rate was 50% (19/38), and the conversion success rate was 52.6% (20/38). Among the 19 patients, 5 cases achieved complete pathological response and 1 case achieved major pathological response. The 48 weeks’ OS rate and PFS were 96.4% (95%CI 92.9% to 99.9%) and 91.7%(95%CI 85.8% to 97.4%).22 patients had level 3 treatment related adverse events (TRAE), there were no level 4 and 5 TRAEs. At the last follow-up, the ORR rate based on mRECIST was 84.2%, and the DCR rate was 94.7% (Table). Conclusions: TACE + Lenvatinib + PD-1 antibody is safe and effective, and conversion resection after the triple-treatment is feasible for uHCC. Clinical trial information: 04997850.[Table: see text]

TALENTACE: A phase III, open-label, randomized study of on-demand transarterial chemoembolization combined with atezolizumab + bevacizumab or on-demand transarterial chemoembolization alone in patients with untreated hepatocellular carcinoma.

TPS487 Background: In 2020, there were ̃905,000 new cases and ̃830,000 deaths from liver cancer globally, and a respective 410,038 and 391,152 in China (5-year overall survival [OS]: 14.1%).1,2,3 Hepatocellular carcinoma (HCC) accounts for 75%–85% of liver cancers.1 Transarterial chemoembolization (TACE) is the preferred treatment for patients with intermediate-stage unresectable HCC (uHCC); however, there are issues with the need for repeated dosing and the heterogenous target population (median OS: 13–43 mo). Treatment with TACE + systemic therapy may improve this. Although several trials reported negative results for TACE + sorafenib (sor) vs TACE alone in patients with uHCC, the TACTICS trial showed improved untreatable (unTACEable) progression-free survival (PFS) (25.2 vs 13.5 mo; P= 0.006).4 While promising, the unmet need for combination therapies remains. The recent IMbrave150 trial showed significantly improved OS with atezolizumab (atezo) + bevacizumab (bev) vs sor (19.2 vs 13.4 mo; P= 0.0009) in patients with uHCC5, making it an attractive option for combination with TACE. Methods: TALENTACE (NCT047126430) is a phase III, open-label, randomized study to evaluate the efficacy and safety of TACE + atezo + bev or TACE alone in patients with uHCC. Key inclusion criteria are ≥18 years old, HCC diagnosis, no prior systemic treatment, no prior locoregional treatment of target lesions, eligible for TACE treatment, tumor max diameter + tumor number ≥6, and not a candidate for curative therapy. Patients with tumors that have macrovascular invasion (MVI) or extrahepatic spread (EHS) are excluded. Patients will be randomized (1:1) to receive TACE + atezo + bev or TACE alone. TACE will be performed by clinical demand; atezo (1200 mg) and bev (15 mg/kg) will be administered by intravenous infusion on Day 1 of each 21-day cycle. Co-primary endpoints are independent review committee-determined TACE-PFS (randomization to unTACEable progression, TACE failure/refractoriness, or death) and OS. Secondary endpoints include investigator-determined TACE-PFS; time to unTACEable progression, progression, MVI, EHS, and MVI/EHS; objective response rate, duration of response, patient reported outcomes, and incidence of adverse events.

Atezolizumab and bevacizumab with transarterial chemoembolization in hepatocellular carcinoma: The DEMAND randomized phase II clinical trial.

TPS492 Background: Atezolizumab and bevacizumab is the first approved immunotherapeutic regimen for first-line treatment of patients with advanced hepatocellular carcinoma (HCC). The efficacy and tolerability of this regimen suggests that its use could be extended to the treatment of patients with intermediate-stage HCC in combination with transarterial chemoembolization (TACE). The effect of TACE combined with atezolizumab and bevacizumab could improve response and tumor control as well as prevent disease progression in non-responders to TACE. Response to the early use of immunotherapy could also reduce the number and extent of TACE cycles needed to achieve tumor control, thereby contributing to the prevention of collateral damage to the liver parenchyma and preservation of liver function. Initiating immunotherapy first may also promote the access of circulating lymphocytes into tumor lesions. The DEMAND study investigates the efficacy and ideal sequence of TACE and immunotherapy in intermediate stage HCC. Methods: This investigator-initiated, multi-center, randomized, open-label phase 2 trial is the first study to evaluate the safety and efficacy of atezolizumab and bevacizumab prior to, or in combination with TACE in patients with unresectable HCC. 106 patients (Barcelona Clinic Liver Cancer Stage A not amenable to curative therapy or B, Child-Pugh A or B7, Eastern Cooperative Oncology Group performance status 0 or 1, no prior TACE) will be randomized in a 1:1 ratio to receive either up-front atezolizumab and bevacizumab followed by TACE selectively directed against progressive lesions (Arm A, 53 patients), or TACE and synchronous treatment with atezolizumab and bevacizumab (Arm B, 53 patients). Patients receive study treatment until loss of clinical benefit or unacceptable toxicity for up to 24 months. The use of local ablation is allowed for the treatment of lesions which cannot be targeted sufficiently selectively by TACE, or of de-novo lesions. The primary endpoint is the 24-month survival rate; secondary endpoints include objective response rate, progression-free survival, safety and quality of life. Translational analyses aim at identifying predictive biomarkers and focus on immune cell phenotyping in tumor and peripheral blood, circulating tumor DNA and changes in the diversity of the gut microbiome. Recruitment is ongoing in 15 German centers with 21 of 106 patients randomized. Clinical trial information: NCT04224636.

Transarterial chemoembolization (TACE) plus apatinib-combined therapy versus TACE alone in the treatment of intermediate to advanced hepatocellular carcinoma patients: A real-world study

Apatinib exhibits the synergistic effect with transarterial chemoembolization (TACE) though inhibiting the neoangiogenetic reaction caused by TACE. In this real-world study, we aimed to evaluate the efficacy and safety of TACE plus apatinib-combined therapy (ACT) in intermediate to advanced hepatocellular carcinoma (HCC) patients. Data from 168 intermediate to advanced HCC patients who received TACE alone (N = 49) or TACE plus ACT (N = 119) were extracted. Besides, ACT was defined as apatinib with or without other therapy, such as arsenic trioxide, microwave ablation and radioactive seed implantation. In TACE plus ACT group, the median overall survival (OS) was 30 months (95% confidence interval (CI): 24-40 months) with 1-year, 3-year and 5-year OS rate of 84.0%, 41.2% and 21.5%, respectively. While in TACE group, the median OS was only 14 months (95%CI: 11-17 months) with 1-year, 3-year and 5-year OS rate of 55.1%, 18.4% and 16.1%, separately. By comparation, the OS was prolonged in TACE plus ACT group compared with TACE group (P<0.001). After adjusted by multivariate Cox's regression analysis, TACE plus ACT (vs. TACE) independently related to the longer OS (hazard ratio: 0.504, P = 0.001). In TACE plus ACT group, the most frequent adverse events included hand-foot syndrome (95.8%), hypertension (95.8%), fatigue (90.8%), albuminuria (85.7%), anorexia (79.0%), diarrhea (66.4%), myelosuppression (58.8%), nausea/vomiting (49.6%) and abdominal pain (39.5%), besides, no grade 4 adverse events and treatment-related death occurred. TACE plus ACT is a promising treatment choice for the intermediate to advanced HCC patients.

Association of CK19 expression with efficacy of adjuvant TACE after hepatic resection in hepatocellular carcinoma patients at high risk of recurrence

This study retrospectively explored the potential association between CK19 expression and efficacy of adjuvant conventional transarterial chemoembolization (TACE) after hepatic resection in patients with hepatocellular carcinoma (HCC) at high risk of recurrence. Read more at JCTRes.com

Hepatocellular Carcinoma With Portal Vein Tumor Thrombus Treated With Transarterial Chemoembolization and Sorafenib vs. 125Iodine Implantation.

Background and AimsThis study investigated the feasibility, safety, and efficacy of transarterial chemoembolization (TACE) combined with CT-guided 125iodine seed implantation for treatment of hepatocellular carcinoma (HCC) with first-branch portal vein tumor thrombosis (PVTT).MethodsThis prospective, controlled, multicenter study included HCC patients with Barcelona Clinic Liver Cancer stage C disease and PVTT in the right and/or left portal veins. Patients were treated with either TACE and sorafenib or TACE and CT-guided 125iodine seed implantation and regularly evaluated for clinical response and adverse events, with treatment termination resulting from declining clinical status, loss to follow-up, or death.ResultsThis study demonstrated a significant between-group difference in median overall survival (OS); therefore, it was terminated early. A total of 123 patients were included in this study, with 52 patients in the TACE-sorafenib group and 71 patients in the TACE-125iodine group, without significant differences in baseline characteristics between groups. The median OS was 8.3 months (95% CI: 6.105–10.495) in the TACE-sorafenib group and 13.8 months (95% CI: 9.519–18.081) in the TACE-125iodine group. In a subgroup analysis of type IIa versus type IIb PVTT, the median OS was 17.5 months for type IIa and 7.1 months for IIb in the TACE-125iodine group. The median OS was 9.3 months for IIa and 4.0 months for IIb in the TACE-sorafenib group. Univariate and multivariate analyses confirmed that the PVTT type and treatment strategy were significant independent factors affecting OS. The objective response rates (ORR) for intrahepatic lesions and PVTT showed significant differences between groups. Most patients in both groups experienced minor adverse events related to TACE. The overall incidence of sorafenib-related adverse events or toxic effects was 90.4% in TACE-sorafenib group. In the TACE-125iodine group, the incidence of pneumothorax and minor hepatic subcapsular hemorrhage were 7.04% and 9.86%, respectively.ConclusionsThis study showed that TACE-125iodine treatment significantly enhanced survival of patients with HCC and type II PVTT, especially subtype IIa, with minimal adverse events.Clinical Trial RegistrationChinese Clinical Trials Database, identifier ChiCTR-ONN-16007929.

Transarterial Chemoembolization Combined With Endoscopic Therapy Is Beneficial for Unresectable Hepatocellular Carcinoma With Esophagogastric Varices.

BackgroundThe efficacy of transarterial chemoembolization (TACE) combined with endoscopic therapy for unresectable hepatocellular carcinoma with esophagogastric varices remains unclear.MethodsThe study has been registered on ClinicalTrials.gov with the number NCT05017922 (https://register.clinicaltrials.gov). Eligible patients were divided into combined group (received TACE plus endoscopic therapy) and control group (only received TACE). The occurrence of death and bleeding episodes during the follow-up was recorded. Kaplan–Meier analysis was used to compare outcomes between the two groups. Cox proportional hazard model was used to determine independent predictors for the survival.ResultsEighty-nine patients were included, 42 in the combined group, others in the control group. During the follow-up, 51 patients died, the 1-year, 2-year, and 3-year survival rates were 64.9%, 45.5%, and 34.5%. The cumulative survival was significantly higher in the combined group than in the control group (p = 0.027); the 1-year, 2-year, and 3-year survival rates were 75.5%, 55.9%, 43.8% and 55.0%, 35.9%, 26.6%, respectively. Forty-four patients experienced bleeding, the bleeding rate was significantly higher in the control group than in the combined group (77.4% vs. 56.8%, p = 0.016). Multivariate analysis showed that treatment, hemoglobin, portal vein tumor thrombosis, and aspartate aminotransferase were independent predictors for overall survival; the first three factors were also independent predictors for bleeding-free survival. Patients who received primary prophylaxis had longer overall survival (p = 0.042) and bleeding-free survival (p = 0.029) than those who received secondary prophylaxis.ConclusionsTACE combined with endoscopic therapy significantly improved survival and reduced bleeding rates in unresectable hepatocellular carcinoma with esophagogastric varices patients. Portal vein tumor thrombosis was a strong negative prognostic factor for both overall survival and bleeding-free survival. Primary prophylaxis improved survival benefits compared with secondary prophylaxis.

Long Term Efficacy and Assessment of Tumor Response of Transarterial Chemoembolization in Neuroendocrine Liver Metastases: A 15-Year Monocentric Experience.

Simple SummaryNeuroendocrine tumors (NET) are rare tumors, with long-term survival even for patients with liver metastases. Transarterial chemoembolization (TACE) is one of the most widely used treatments in this setting. The aim of the study was to assess the long-term efficacy of TACE in a large cohort of patients with NET liver metastases and to correlate imaging findings with survival. In our study including 202 patients with NET liver metastases and a mean follow-up of 8.2 years, TACE was effective to provide disease control for 26 months and a 5.3-year median overall survival (OS). Imaging responses using RECIST and mRECIST criteria were significantly correlated to OS: the median-OS was twice as long among mRECIST responders versus non-responders, with 80.5 months and 39.6 months respectively. These findings are of major importance for everyday practice as they confirm TACE’s effectiveness and usefulness of imaging evaluation to better tailor patient treatment and repeat TACE sessions whenever necessary.Background: transarterial chemoembolization (TACE) is an established treatment for neuroendocrine tumor (NET) liver metastases. The aim was to evaluate the long-term treatment efficacy of TACE for NET liver metastases, and correlate imaging response with survival. Methods: this IRB-approved, single-center, retrospective study evaluated all TACE procedures performed for NET liver metastases from 2003–2017 for imaging tumor response (RECIST and mRECIST), time to liver progression (TTLP), time to untreatable progression with TACE (TTUP), and overall survival (OS). Patient, tumor, and treatment characteristics were analyzed as prognostic factors. Survival curves according to the Kaplan–Meier method were compared by Log-rank test. Tumor responses according to RECIST and mRECIST were correlated with OS. Results: 555 TACE procedures were performed in 202 NET patients (38% grade 1, 60% grade 2) with primary tumors originating from pancreas, small bowel, and lung (39, 26, and 22% respectively). Median follow-up was 8.2 years (90–139 months). Median TTLP and TTUP were 19.3 months (95%CI 16.3–22.3) and 26.2 months (95%CI 22.3–33.1), respectively. Median OS was 5.3 years (95%CI 4.2–6.7), and was higher among mRECIST responders (80.5 months; 95%CI 64.6–89.8) than in non-responders (39.6 months; 95%CI = 32.8–60.2; p < 0.001). In multivariable analysis, age, tumor grade and liver involvement predicted worse OS, whereas administration of somatostatin analogs correlated with improved OS. Conclusion: TACE for NET liver metastases provides objective response and sustained local disease control rates. RECIST and mRECIST responses correlate with OS.

Peritumoral portal enhancement during transarterial chemoembolization: a potential prognostic factor for patients with hepatocellular carcinoma.

BackgroundTumor response and survival varies in patients treated with transarterial chemoembolization (TACE) for intermediate stage hepatocellular carcinoma (HCC) and may be associated with several factors.PurposeTo evaluate safety and efficacy of TACE in patients with intermediate stage HCC and to identify factors related to tumor response and survival.Material and MethodsConsecutive patients with HCC treated with TACE between September 2008 and September 2018 were retrospectively reviewed.ResultsIn 87 patients (71 men; mean age = 68 ± 9 years), 327 TACE treatments were performed (mean = 3/patient; range = 1–12). Mean and median overall survival were 32 and 19 months, respectively. Survival rates at 30 days, one, three, and five years were 99%, 71%, 19%, and 8%, respectively. Objective response (OR) was seen in 84% and disease control (DC) was seen in 92% of the patients. Patients in whom peritumoral portal lipiodol enhancement (PPLE) was seen during TACE had better OR (97 vs. 73%; P = 0.007) and DC (100 vs. 85%; P = 0.024), and a reduced risk of death (hazard ratio [HR] = 0.52; 95% confidence interval = 0.32–0.86) compared to those without PPLE. Severe adverse events were rare (15%) and occurred more often in patients with a larger tumor size.ConclusionsTACE was effective and safe in patients with intermediate stage HCC. Patients with PPLE during TACE had better tumor response and longer survival than those without PPLE. Severe adverse events occurred more often in patients with larger tumors.

European Multicenter Study on Degradable Starch Microsphere TACE: The Digestible Way to Conquer HCC in Patients with High Tumor Burden.

Simple SummaryIn this European multicenter study, we investigated the treatment efficacy and safety of degradable starch microsphere transarterial chemoembolization (DSM-TACE) for HCC treatment in 121 patients in whom other standard therapies failed or patients were not eligible. Patients survived a median of 15.5 months with a median time to tumor progression of 9.5 months and a disease control rate of 83.2%. The patients who survived longer had HCC lesions ≤10 cm, the involvement of one liver lobe only, lower Child–Pugh class and Barcelona Clinic Liver Cancer (BCLC) tumor stage, absence of vascular invasion, and the absence of extrahepatic metastases. Of these factors, a lesion of ≤10 cm and unilobar disease were identified as independent survival factors. Safety analysis revealed low rates of adverse events and maintained liver function after several treatments regardless of the treated liver volume. Thus, DSM-TACE is a veritable treatment alternative for unresectable HCC, where other treatments fail or cannot be offered due to contraindications.To evaluate the safety and efficacy of transarterial chemoembolization with degradable starch microspheres (DSM-TACE) for the treatment of hepatocellular carcinoma (HCC) with a high tumor burden ineligible for or failing other palliative therapies, 121 patients from three European centers were included. Kaplan–Meier analysis was used for median overall survival (OS) and time to progression (TTP, mRECIST criteria) in months with a 95% confidence interval (95% CI). Uni- (UVA) and multivariate (MVA) analyses were performed using the Cox Proportional Hazard Model. The median OS of the study cohort was 15.5 (13.3–18.7) months. The UVA identified HCC lesions ≤10 cm, unilobar involvement, lower Child–Pugh class and Barcelona Clinic Liver Cancer (BCLC) stage, absence of vascular invasion, and extrahepatic metastases as factors for prolonged survival. MVA confirmed lesions of ≤10 cm and unilobar disease as independent OS factors. Median TTP was 9.5 (7.6–10.3) months. The best response was achieved after a median of 3 (range: 1–6) treatments with CR/PR/SD/PD in 13.5%/44.5%/25.2%/16.8%, respectively. DSM-TACE was well tolerated with no major clinical adverse events and only limited major laboratory events. Preserved liver function was observed after repetitive DSM-TACE treatments. Repetitive DSM-TACE is a safe, well-tolerated and effective treatment option for HCC patients with high tumor burden ineligible or failing other palliative therapies.

Optimal timing of combining sorafenib with trans-arterial chemoembolization in patients with hepatocellular carcinoma: A meta-analysis

BackgroundThe combination therapy of trans-arterial chemoembolization (TACE) and sorafenib were proved to be one of the effective methods for intermediate and advanced hepatocellular carcinoma (HCC). Although it has been confirmed that the combination therapy can prolong survival for advanced HCC effectively, the therapeutic efficacy and safety are still controversial and the clinical value has not been determined. This meta-analysis aims to evaluate the efficacy and safety of combination therapy and discuss the optimal timing of combination for better clinical benefits. Data sourcesPubMed, EMBASE, the Cochrane Library, MEDLINE, and Web of Science were systematically reviewed to search for relevant studies published before May 15, 2021. Studies comparing the efficacy and safety of TACE + sorafenib with TACE + placebo / alone were adopted. Two reviewers independently extracted study outcomes. The data were analyzed through fixed/random-effect meta-analysis models with Review Manager (Version 5. 3) software. Results7 randomized controlled trials (RCTs) were included with 1464 patients with unresectable HCC (734 in TACE + sorafenib group and 730 in TACE + placebo or alone group). Meta-analysis showed that objective response rate (ORR) and disease control rate (DCR) were slightly improved in TACE + sorafenib group (ORR: risk ratio = 1.24; 95% confidence interval: 1.08–1.42; P = 0.002; DCR: risk ratio = 1.09; 95% confidence interval: 1.01–1.18; P = 0.02). The combination therapy obviously improved time to progression (TTP) (hazard ratio: 0.73; 95% confidence interval: 0.55–0.96; P = 0.03) and progression-free survival (PFS) (hazard ratio 0.62; 95% confidence interval: 0.52–0.73, P < 0.00001) but not overall survival (OS) (hazard ratio: 0.93; 95% confidence interval: 0.59–1.46; P = 0.75) or time to untreatable progression (TTUP) (hazard ratio: 0.76; 95% confidence interval: 0.31–1.89; P = 0.56). In addition, the incidence of adverse reactions (AEs) in combination group were higher than TACE + placebo / alone group. Furthermore, the subgroup analysis showed that the heterogeneity of TTP was notably decreased (pre-TACE: P = 0.12, I2 = 48%; post-TACE: P = 0.58, I2 = 0%), and the hazard ratio was 0.59 (95% confidence interval: 0.51–0.68; P < 0.00001) in pre-TACE subgroup which indicated that combination before TACE significantly prolonged TTP but not in combination after TACE (hazard ratio: 0.88; 95% confidence interval: 0.62–1.24; P = 0.46). In term of AEs, sensitivity analysis indicated that the risk ratio for hand-foot skin reaction, diarrhea, rash/desquamation, and hypertension was 7.41, 2.58, 2.14, 1.55 in pre-TACE subgroup respectively and was 11.34, 3.26, 3.61, 4.11 in post-TACE subgroup respectively (All P < 0.05). ConclusionThe combination of TACE and sorafenib significantly can improve TTP and PFS, and reduce the level of risk of adverse reactions of unresectable HCC, especially in the combination before TACE.

The safety and efficacy of transarterial chemoembolisation with bleomycin for hepatocellular carcinoma unresponsive to doxorubicin: a prospective single-centre study

To investigate the safety and efficacy of transarterial chemoembolisation (TACE) with bleomycin for hepatocellular carcinoma (HCC) unresponsive to doxorubicin. A randomised controlled trial was undertaken of HCC patients resistant to TACE with doxorubicin to assess the survival benefits of the experimental group (TACE with bleomycin) compared with the control group (TACE with doxorubicin). One hundred and seventy patients were allocated randomly between December 2015 and December 2017, and 80 patients of each group were analysed. The modified response evaluation criteria in solid tumours (mRECIST) was used to evaluated the tumour response every 4-6 weeks. The primary endpoint was median progression-free survival (mPFS) and median overall survival (mOS). Safety was assessed by post-procedure complications. The study was completed in October 2018. Objective response rate (ORR) of the experimental group was 27.5% (22/80), mPFS and mOS was 5.8 and 8.1 months. ORR of the control group was 7.5% (6/80), mPFS and mOS was 2.9 and 4 months. The ORR were significantly different between two groups (χ2=0.348, p<0.05). The differences of mPFS and mOS between the two groups were statistically significant (χ2=2.865, p<0.05 and χ2=0.926, p<0.05, respectively). There were no significant difference in post-procedure complications (p>0.05) and no major complications occurred. It is suggested that TACE with bleomycin is a safe and effective method for HCC and bleomycin can be a second-line chemotherapeutic agent for the HCC patients unresponsive to TACE with doxorubicin.

LBA37 IMMUTACE: A biomarker-orientated, multi center phase II AIO study of transarterial chemoembolization (TACE) in combination with nivolumab performed for intermediate stage hepatocellular carcinoma (HCC)

Immunotherapy based combinations recently revolutionized the treatment of patients (pts) with advanced HCC, but its significance in earlier stages remains to be determined. TACE is commonly used as first line treatment in intermediate HCC, but outcome of pts treated with TACE in real-life cohorts is still poor with a median overall survival (OS) below 20 months. The release of neoantigens following local treatments is projected to trigger synergistic effects with anti-PD-1 antibodies, thus providing a rational for the combination of immunotherapy with TACE. The aim of this study was to determine the safety and efficacy of TACE with nivolumab. This is a phase II trial, that recruited 59 pts at 10 sites in Germany between 06/2018 and 06/2020. Pts received up to 2 TACE treatments followed by nivolumab (240 mg/ Q2W), initiated on day 2-3 after the first TACE session and continued until progression for a maximum treatment duration of two years. One additional local treatment was allowed upon first progression. Primary endpoint (EP) was ORR (mRECIST; with an ORR exceeding 55% as promising for further investigations). Secondary EPs include PFS, TTFS, OS, QoL, and safety/tolerability. Tumor tissue was obtained at baseline and blood samples were collected longitudinally and subjected to an extensive biomarker analysis. 49 pts (14.3% HCV and 8.2% HBV) were enrolled and received at least one dose of nivolumab. Median tumor size was 3 cm (0.6 – 14.7 cm) and median no. 3 (1 – 12). ORR was 71%. At a median follow-up of 14.6 months, mPFS was 6.14 mo (95% CI; 5.16 – 7.56; 41 events). Provisional mOS was 28.32 mo (95% CI; 20.60 – not estimable; 18 events). Grade ≥3 treatment-related adverse events occurred in 34.7% of pts. Correlative analysis of efficacy with genetic alterations, gene expression signatures and immune cell populations is ongoing. The study met its primary EP and provides evidence for the efficacy of TACE in combination with nivolumab without new safety signals in pts with intermediate HCC and no prior systemic therapy. Our findings support further evaluation of nivolumab-based combinations for the treatment of intermediate HCC.

Impact of COVID-19 Pandemic on Intervals and Outcomes of Repeated Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma

PurposeGiven that the novel coronavirus disease (COVID-19) pandemic has disrupted operations globally, an institution’s ability to repeat transarterial chemoembolization (TACE) for patients with hepatocellular carcinoma (HCC) has also been affected. The aim of this study was to evaluate the impact of the COVID-19 on the intervals and outcomes of TACE in HCC patients.Materials and MethodsThis retrospective study included 154 HCC patients who underwent follow-up after TACE treatment from January 2020 to March 2020 (n = 71, study group) and January 2019 to March 2019 (n = 83, control group) at two institutions in China. The endpoints included the follow-up interval and overall response rate (ORR). Multivariate logistic regression analyses were performed to identify independent risk factors for a worse ORR. The cut-off point was determined to divide follow-up durations into long- and short-intervals.ResultsThe median follow-up interval was 82.0 days (IQR, 61–109) in the study group, which was significantly longer than 66.0 days (IQR, 51–94) in the control group (P = 0.004). The ORR was 23.9 and 39.8% in the study and control group, respectively (P = 0.037). The cut-off value was 95 days. The grouping (OR, 2.402; 95% CI, 1.040–5.546; P = 0.040), long interval (OR, 2.573; 95% CI, 1.022–6.478; P = 0.045), and China liver cancer staging system (OR, 2.500; 95% CI, 1.797–3.480; P <0.001) were independent predictors for the efficacy of TACE treatment.ConclusionsThe COVID-19 pandemic causes a longer follow-up interval in general, which may further lead to a lower ORR in HCC patients. Those with a follow-up interval of >95 days tend to have a worse prognosis.

Caudate Lobe Hepatocellular Carcinoma Treated with Sequential Transarterial Chemoembolization and Iodine 125 Seeds Implantation: A Single-Center Retrospective Study.

PurposeResection of the hepatocellular carcinoma (HCC) in the caudate lobe (CL) is challenging even for accomplished surgeons. This retrospective study evaluated the safety and efficacy of transarterial chemoembolization (TACE) and iodine 125 seeds implantation (ISI) for unresectable or “ablation unsuitable” HCC-CL detected at the initial presentation in clinical practice.Patients and MethodsA total of 20 HCC-CL patients undergoing sequential TACE and ISI from January 2014 to October 2018 were enrolled in this study. The overall survival (OS), progression-free survival (PFS), tumor response rate, and complication rates were analyzed and compared to non-caudate lobe (NCL) HCC patients. Multivariate analyses for potential clinical and radiological factors were performed using the Cox proportional hazard model.ResultsThe technical success rate was 100%, as all the patients received 28 ISI treatments. The median OS was 35 months. The 1-, 3-, and 5-year OS rates were 100%, 63.2%, and 11.1%, respectively. The median PFS was 16 months. The objective response rate was 60.0%. The puncture tract bleeding (2/20) and pneumothorax (1/20) were the most common complications in operation, but no operation-related deaths occurred. One year after the surgery, biliary tract injury occurred in 1 patient, necessitating percutaneous biliary intervention. No statistical difference was observed between the CL and NCL groups. Multivariable analysis revealed that Barcelona Clinic Liver Cancer stage B and tumor size >3 cm were two significant factors associated with OS.ConclusionSequential TACE and ISI were associated with the survival benefits in HCC-CL and should be considered as a reliable therapy for surgeons and interventional radiologists.

Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma with Portal Vein Tumor Thrombosis: A Tertiary Care Center Experience.

Background Portal vein tumor thrombosis (PVTT) is a common complication of hepatocellular carcinoma (HCC) occurring in 30 to 40% of cases. The presence of PVTT in HCC is regarded as an advanced disease that confers poor prognosis and survival. Transarterial chemoembolization (TACE) has traditionally been considered to be contraindicated in cases of PVTT, due to the risk of hepatic infarction, and further deteriorate liver function. We evaluated safety, technical efficacy, and outcomes of TACE in HCC with PVTT. Methods From search results of the hospital database, out of 652 patients who underwent TACE for HCC, 73 patients of HCC with PVTT were retrospectively evaluated. Post-TACE tumor response by computed tomography (CT)/magnetic resonance imaging (MRI) imaging as per modified response evaluation criteria in solid tumors (mRECIST) criteria, if any occurrence of acute hepatic failure was assessed. Prognostic factors influencing survival were also determined. Results In our study population, the mean age of the patients was 58 years. The 12- and 24-month survival rates were 59 and 14%, respectively, with an overall median survival of 12.3 months. A total of 58.9% patients had branch portal vein tumor thrombus and 41.1% had tumor thrombus in the main portal vein. We did not encounter any mortality or acute liver failure following TACE in a 30-day period. Both univariate and multivariate analysis revealed Child–Pugh score ( p = 0.01) and the extent of tumoral thrombus ( p 0.004) as a significant prognostic factor. Patients with branch PVTT, no ascites, and Child–Pugh A had better survival than those having main portal vein tumor thrombus, ascites, and Child–Pugh B. Conclusion Our study concluded that TACE can achieve good disease control and improved survival in HCC with portal vein invasion despite being considered as a relative contraindication. Technical expertise, selection of patients, such as superselective catheterization and preserved liver function, are the key factors for a safe therapeutic procedure. Child–Pugh score and extent of portal vein invasion were the significant prognostic factors determining survival.

Hsa‑circRNA‑G004213 promotes cisplatin sensitivity by regulating miR‑513b‑5p/PRPF39 in liver cancer.

In recent years, increasing evidence has confirmed that exosomal circular RNAs (circRNAs) serve a crucial role in the prognostic prediction and diagnosis of liver cancer (LC). The present study compared the expression patterns of exosomal circRNAs during transarterial chemoembolization (TACE). CircRNA sequencing analysis identified 390 differentially expressed circRNAs between the prior TACE and following the first TACE operation groups and 489 differentially expressed circRNAs between the prior to TACE and following the second TACE operation groups. Gene Ontology analysis of the differentially expressed circRNAs demonstrated that they were associated with fatty acid metabolism, receptor binding and membrane protein complexes. Kyoto Encyclopedia of Genes and Genomes pathway analysis predicted that protein digestion and absorption pathways were activated following TACE. A novel gene was screened out; hsa-circRNA-G004213 (circ-G004213) was significantly upregulated following TACE (fold change >10, P<0.01). Further analysis found circ-G004213 significantly increased the cisplatin sensitivity of HepG2 cells and positively associated with the prognosis of tumor-bearing mice. Based on the potential downstream miRNAs and mRNAs, the circRNA-miRNA-mRNA network was constructed. It was demonstrated that circ-G004213 regulated cisplatin resistance via the miR-513b-5p/PRPF39 axis. Finally, the present study confirmed that circ-G004213 was positively associated with the prognosis of patients with LC following TACE. Therefore, circ-G004213 may be used as an indicator for predicting the efficacy of TACE.

Safety, tolerability and efficacy of transarterial chemoembolization using anthracyclines-loaded drug eluting microspheres for treatment of patients with unresectable hepatocellular carcinoma: Pooled analyses.

287 Background: Transarterial chemoembolization either with Lipiodol (cTACE) or with drug eluting microspheres (DEM-TACE) is indicated for the treatment of hepatocellular carcinoma (HCC) not amenable to curative treatments in patients with preserved liver function. Safety of TACE is becoming more important with its increased use as a bridge to transplant or downstaging to resection, but also for preservation of liver function in case of subsequent immuno-combination therapies. LifePearl microspheres is a novel DEM comprised of polyethylene-glycol with reported good safety profile and efficacy in smaller series. Our purpose was to assess safety and efficacy of TACE using anthracycline loaded LifePearl for the treatment of patients with unresectable HCC in a pooled analysis of studies with available more than 500 patient’s level data. Methods: We pooled patient level data from 5 single arm studies. Safety was assessed by close monitoring of adverse events according to CTCAE (v4.03). Tumor response was assessed, according to mRECIST and RECIST1.1 and analyzed as best overall response to account for differences in time of imaging follow-up between studies. The Kaplan-Meier method was used to estimate event rates for time to event outcomes: progression free survival (PFS), time to unTACEable progression (TTUP) and overall survival (OS) censoring patients at time of surgery or transplantation. Results: Out of 586 patients, 85.5%, 13.5% and 1.0% were Child Pugh A, B and C, respectively. BCLC stages 0, A, B and C were 13.6%, 43.4%, 41.1% and 1.9% respectively. The mean number of HCC lesions was 2.1±1.5 and mean sum of tumor diameters was 49.3±32.9mm. In 19% of patients alpha-feto protein level was &gt; 200ng/ml. A mean of 1.9±1.3 DEM-TACEs were performed per patient. A total of 197 events were reported including 2.6 % grade 4 and 1.5% grade 5, mostly related to post-embolization syndrome. Complete response, partial response and stable disease were 60.2%, 27.1% and 7.4% respectively providing an objective response and disease control rates of 87,3% and 94,7% respectively. 10% of patients were transplanted or resected. Median OS, PFS and TTUP is indicated in the table below. OS was 89.2%, 80.2% and 69.7% at 12, 18 and 24 months respectively. Conclusions: The treatment of patients with unresectable HCC with anthracycline loaded LifePearl showed good tolerance with acceptable toxicity and high tumor response rate that translated into promising PFS, TTUP and OS. [Table: see text]