Comparison of treatment response, survival profiles as well as safety profiles between CalliSpheres® microspheres transarterial chemoembolization and conventional transarterial chemoembolization in huge hepatocellular carcinoma

2020 ◽  
Author(s):  
Xuhua Duan ◽  
Juanfang Liu ◽  
Xinwei Han ◽  
Jianzhuang Ren ◽  
Hao Li ◽  
...  

Abstract Background: This study aimed to compare treatment response, survival and safety profiles between drug-eluting beads transarterial chemoembolization (DEB-TACE) with CalliSpheres® microspheres (CSM) and conventional TACE (cTACE) in huge hepatocellular carcinoma (HCC) patients.Methods: 71 patients with huge HCC underwent DEB-TACE or cTACE were consecutively enrolled. 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. Results: DEB-TACE presented with higher objective response rate (ORR) and disease control rate (DCR) compared to cTACE. Regarding survival profiles, the short-term mortality rate was lower, and PFS as well as OS were longer in DEB-TACE group compared with cTACE group. Multivariate Cox’s regression further illustrated that DEB-TACE vs cTACE was an independent protective factor for PFS and OS. As for safety profiles, patients’ liver function injury was reduced in DEB-TACE group compared with cTACE group. The incidence of fever was lower and CINV were less severe in DEB-TACE group compared with cTACE group, while no difference in occurrence of liver abscess, increase of ascites or moderate pain between two groups was observed. Conclusion: DEB-TACE with CSM presents with better treatment response, survival profiles as well as safety profiles compared to cTACE in treatment for huge HCC patients.

2020 ◽  
Author(s):  
Wei Chen ◽  
Bei Lu ◽  
Mengzeng Zhang ◽  
Zhenguo Hou

Abstract Objective: To explore the effectiveness and safety of DEB-TACE in patients with primary huge hepatocellular carcinoma. Methods: From January 2017 to January 2019, 87 patients with huge unresectable HCC were retrospectively analyzed. 48 cases received drug-elutted beads for transarterial chemoembolization (DEB-TACE group), and 39 cases received conventional transarterial chemoembolization (c-TACE group). The tumor treatment response, overall survival (OS), progression-free survival (PFS), the incidence of adverse events (AEs) were compared between the two groups and the factors influencing OS were analyzed. Results: The median follow-up was 295 days (ranges 78 to 603 days). There was no statistical difference in baseline characteristics and follow-up treatment between the two groups. The objective response rate(ORR) of DEB-TACE group was higher than that of c-TACE group within 3 months after treatment. The change was similar in the incidence of AEs between the two groups; DEB-TACE group showed longer PFS and OS than c-TACE group. Cox-regression multivariate analysis showed that DEB-TACE was an important factor affecting the overall survival. Conclusion: DEB-TACE prolonged the survival time of patients with huge unresectable HCC and could be a better choice than c-TACE without increasing the incidence of AEs.


2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 287-287
Author(s):  
Thierry De Baere ◽  
Filipe Veloso Gomes ◽  
Gontran Verset ◽  
Gerardo Tovar-Felice ◽  
Katerina Malagari ◽  
...  

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 > 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]


2021 ◽  
Vol 11 ◽  
Author(s):  
Bin Liang ◽  
Joyman Makamure ◽  
Shenglei Shu ◽  
Lijie Zhang ◽  
Tao Sun ◽  
...  

BackgroundDrug-eluting embolic transarterial chemoembolization (DEE-TACE) is an advance in TACE technique. However, at present there is insufficient evidence to support that DEE-TACE is superior to conventional TACE (cTACE) for hepatocellular carcinoma (HCC). The aim of this meta-analysis is to evaluate the efficacy and safety of TACE with CalliSpheres® microspheres (CSM-TACE) compared with cTACE in patients with HCC.Data SourcesPubMed, Embase, Web of Science, CNKI and Wanfang Databases were searched to identify relevant articles published before March 26, 2020. The data regarding treatment response, survival profile, adverse events and liver function indexes were retrieved.ResultsA total of 16 studies with 1454 HCC patients (722 treated with CSM-TACE and 732 with cTACE) were included. Patients receiving CSM-TACE had higher 1-month complete response (CR), objective response rate (ORR), disease control rate (DCR) (odds ratio (OR): 2.00, 95% confidence interval (95% CI): 1.29–3.09; OR: 2.87, 95% CI: 2.15–3.83; OR: 2.01, 95% CI: 1.37–2.95, respectively), 3-month CR, ORR, DCR (OR: 4.04, 95%CI: 2.46–6.64; OR: 3.39, 95%CI: 2.45–4.70; OR: 1.71, 95%CI: 1.14–2.55 respectively), and 6-month CR, ORR, DCR (OR: 4.02, 95%CI: 2.26–7.16; OR: 3.00, 95%CI: 2.05–4.38; OR: 2.66, 95%CI: 1.70–4.16 respectively) than those treated with cTACE. Furthermore, CSM-TACE exhibited a trend toward improved progression free survival (hazard ratio (HR): 0.86, 95%CI: 0.67–1.11) and overall survival (HR: 0.79, 95%CI: 0.59–1.07) over cTACE although these differences did not reach statistical significance. In terms of safety, the two TACE treatments showed similar post-treatment pain (OR: 0.84, 95%CI: 0.55–1.28), fever (OR: 0.99, 95%CI: 0.60–1.63), nausea/vomiting (OR: 0.84, 95% CI: 0.60–1.17), as well as 1-month follow-up alanine aminotransferase (Mean difference (MD): −3.66, 95%CI: −10.38–3.07), aspartate aminotransferase (MD: −2.30, 95%CI: −8.91–4.31) and total bilirubin (MD: −0.15, 95%CI: −2.26–1.96).ConclusionCSM-TACE displays superior treatment response, non-inferior survival profile and safety over cTACE in HCC patients.


2021 ◽  
Author(s):  
Yanqiao Ren ◽  
Ziyi Liu ◽  
Joyman Makamure ◽  
Xuefeng Kan ◽  
Songlin Song ◽  
...  

Abstract Purpose: To evaluate the efficacy and safety of camrelizumab addition to transarterial chemoembolization (TACE) in treatment of hepatocellular carcinoma (HCC) with TACE-related untreatable progression (UP).Methods: Patients with HCC who received addition of camrelizumab due to UP after initial TACE treatment were enrolled at our institution between May 2019 and January 2021. Patients were assessed for tumor response, progression-free survival (PFS), and adverse events. Risk factors for PFS were evaluated with logistic regression analysis.Results: A total of 41 patients were included. The objective response rate and disease control rate were 24.4% and 61.0% at 2-3 months, and 12.2% and 58.5% at 6 months, respectively. The median PFS of the patients were 6 months (95% CI: 3.8 months, 8.2 months). Of the 41 patients, 23 patients received camrelizumab combined with TACE (hereafter, camrelizumab-TACE), in whom 52 combined TACE procedures were performed, with a median of 2 procedures (range, 1-6) per patient. The remaining 18 patients received camrelizumab alone due to TACE contraindications. Multivariable analysis indicated that camrelizumab-TACE was an independent prognostic factor for PFS. Subgroup analysis showed a median PFS of 8 months in the camrelizumab-TACE group and 3 months in the camrelizumab monotherapy group (P<0.001). No treatment-related mortalities occurred. Seventeen patients (41.5%) developed at least one type of adverse events after treatment with camrelizumab, with reactive cutaneous capillary endothelial proliferation (n=14, 34.1%) being the most common adverse events.Conclusions: Addition of camrelizumab to TACE offered an effective and safe treatment for HCC with UP.


2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Furong Liu ◽  
Minshan Chen ◽  
Jie Mei ◽  
Li Xu ◽  
Rongping Guo ◽  
...  

Background. Due to the heterogeneity of patients with Barcelona clinic liver cancer (BCLC) intermediate-stage hepatocellular carcinoma (HCC), Bolondi criteria were proposed and patients were divided into four substages. The purpose of this study was to compare the survival of substage B1 patients who were initially treated with a combination of transarterial chemoembolization (TACE) and radiofrequency ablation (RFA) (TACE-RFA) or TACE alone. Methods. 404 patients with stage B1 HCC were retrospectively analyzed from January 2005 to December 2012. 209 patients received TACE-RFA, and 195 received TACE alone as initial treatment. The overall survival (OS) and progression-free survival (PFS) rates were estimated by the Kaplan–Meier method and compared by the log-rank test. Results. 1-, 3-, and 5-year OS rates were 83.7%, 45.8%, and 24.8% in the TACE-RFA group and 80.7%, 26.4%, and 16.7% in the TACE group, respectively (P=0.003). The corresponding PFS rates were 71.8%, 26.6%, and 13.0% and 59.1%, 11.0%, and 2.2% in the TACE-RFA group and TACE group, respectively (P<0.001). Multivariate regression analysis indicated that tumor size (OS: hazard ratio (HR) = 0.683, P=0.001; PFS: HR = 0.761, P=0.013), along with treatment allocation (OS: HR = 0.701, P=0.003; PFS: HR = 0.620, P<0.001), was the independent prognostic factor for both OS and PFS. Conclusions. Combination TACE and RFA treatment yielded better survival than TACE alone for patients with stage B1 HCC according to the Bolondi criteria.


2020 ◽  
Author(s):  
jinxin fu ◽  
yan wang ◽  
jinlong zhang ◽  
kai yuan ◽  
jieyu yan ◽  
...  

Abstract Purpose To investigate the safety and efficacy of transarterial chemoembolization (TACE) with bleomycin for hepatocellular carcinoma (HCC) unresponsive to doxorubicin.Methods We did a randomized controlled trial in 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). 170 patients were allocated randomly between December 2015 and December 2017 and 80 patients of each group were accomplished and analyzed finally. The modified response evaluation criteria in solid tumors (mRECIST) was used to evaluated the tumor 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.Results The study was stopped 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 4.0 months. The ORR were significantly different between two grous ( 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.Conclusion 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.


2019 ◽  
Vol 18 ◽  
pp. 153303381983075 ◽  
Author(s):  
Hua Xiang ◽  
Lin Long ◽  
Yuanhui Yao ◽  
Zhiyong Fang ◽  
Zhiming Zhang ◽  
...  

The aim of this study was to compare the treatment response, survival, liver function, and adverse event incidence of drug-eluting bead transcatheter arterial chemoembolization using CalliSpheres microspheres with conventional transcatheter arterial chemoembolization in patients with hepatocellular carcinoma. Seventy-three patients with hepatocellular carcinoma who received drug-eluting bead transcatheter arterial chemoembolization (using CalliSpheres microspheres) or conventional transcatheter arterial chemoembolization treatment were consecutively enrolled. Treatment response was assessed by modified Response Evaluation Criteria in Solid Tumors at month 1/month 3/month 6; posttreatment, liver function indexes, and adverse events were recorded. Progression-free survival and overall survival were also calculated. Objective response rate of patients at months 1, 3, and 6, disease control rate of patients and objective response rate of nodules at month 3 were increased in drug-eluting bead transcatheter arterial chemoembolization group compared with conventional transcatheter arterial chemoembolization group. In addition, drug-eluting bead transcatheter arterial chemoembolization using CalliSpheres microspheres was an independent factor for predicting better objective response rate at month 1. Patients in drug-eluting bead transcatheter arterial chemoembolization group achieved longer progression-free survival and similar overall survival compared to those in conventional transcatheter arterial chemoembolization group; Cox proportional hazards regression model analyses revealed that drug-eluting bead transcatheter arterial chemoembolization using CalliSpheres microspheres was associated with better progression-free survival while it did not affect overall survival. Meanwhile, most of the occurrences of abnormal liver function indexes were similar between 2 groups, whereas drug-eluting bead transcatheter arterial chemoembolization group had a higher percentage of patients with total bile acid ≥2 upper limit of normal compared to conventional transcatheter arterial chemoembolization group at month 1. Moreover, the adverse event incidences between 2 groups were similar. In conclusion, drug-eluting bead transcatheter arterial chemoembolization using CalliSpheres microspheres achieves better treatment response and progression-free survival while equal safety compared to conventional transcatheter arterial chemoembolization in patients with hepatocellular carcinoma.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Jun Dong ◽  
Xiaofeng Zhai ◽  
Zhe Chen ◽  
Qun Liu ◽  
Hua Ye ◽  
...  

The aim of this study is to examine the safety and efficacy of Cinobufacini injection in transarterial chemoembolization (TACE) for treatment of huge hepatocellular carcinoma (HCC). Clinical data of 56 consecutive patients with HCC larger than 10 cm who had been treated with TACE between December 2010 and August 2014 were retrospectively analyzed. Among these patients, 31 belonged to the Cinobufacini group and 25 belonged to the epirubicin group. The clinical efficacy, survival time, and adverse events in patients in the two groups were compared. The objective response rate in the Cinobufacini group was significantly higher than that in the epirubicin group (53.6% versus 23.1%,P=0.022). The median survival time (10.6 versus 14.1 months,χ2=0.092,P=0.762) and the median time to progression (4.9 versus 5.7 months,χ2=0.097,P=0.756) were similar between the groups. The incidence rate of adverse events was lower in the Cinobufacini group than in the epirubicin group (P<0.05). The short-term clinical efficacy of Cinobufacini is better than that of epirubicin in TACE for treating huge HCC, while their long-term clinical efficacy is similar. However, lower incidence of adverse events was noted in TACE using Cinobufacini rather than epirubicin.


2020 ◽  
Author(s):  
chen lei ◽  
Xuefeng Kan ◽  
Tao Sun ◽  
Yanqiao Ren ◽  
Yanyan Cao ◽  
...  

Abstract Background:Transarterial chemoembolization (TACE), radiofrequency ablation (RFA), and iodine 125 seeds implantation are options treatments for hepatocellular carcinoma (HCC). The aim of this study is to compare the efficacy of the combined treatment of TACE with iodine 125 seeds implantation (TACE-iodine 125) with TACE with RFA (TACE-RFA) in patients with early- and intermediate-stage HCC. Methods: The study included 112 patients who were diagnosed with early- and intermediate-stage HCC from January 1, 2014, to May 31, 2018. Among them, 38 patients were treated with TACE-Iodine 125, and 74 with TACE-RFA. The efficacy of the two treatment groups was retrospectively analyzed. To reduced the selective bias, a propensity score matching (PSM) analysis and inverse probability of treatment weighting (IPTW) method were used to compare the outcomes between the two groups.Results: In the absence of PSM and IPTW, the median overall survival (OS) and progression-free survival (PFS) of the TACE-RFA group were slightly longer than those of the TACE-Iodine 125 group (OS: 41 months vs. 36 months; PFS: 18 months vs. 15 months). However, there were no statistically significant differences in the median OS, PFS, and objective response rate (ORR) between the two groups (P > 0.05). After adjusting the age, gender, Child-Pugh class, Barcelona Clinic Liver Cancer (BCLC) stage, and Alpha-fetoprotein (AFP), TACE-Iodine 125 treatment was not associated with a significant increasing the risks of death (HR: 0.763; 95%CI: 0.403,1.345, P = 0.320) and recurrence (HR: 1.020; 95%CI: 0.645,1.611, P = 0.934). After PSM, 35 matched pairs of patients were obtained, and there were no statistically significant differences in the median OS and PFS between the two groups. After IPTW, similar results presented.Conclusions: The combination of TACE with iodine 125 seeds implantation may represent an effective treatment for patients with early- and intermediate-stage HCC.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16611-e16611
Author(s):  
Wenbo Guo ◽  
Song Chen

e16611 Background: HCC is one of the most common cancer among all the malignant tumor, while the efficacy of TACE alone for unresectable HCC patients still remains unsatisfactory. With the development of targeted drug, more and more targeted drugs are applying to the treatment of HCC. Objective: The aim of the stidy is to investigate the efficacy and safety of transarterial chemoembolization (TACE) combined with Anlotinib versus TACE alone in patients with unresectable HCC. Methods: This single-center retrospective study involved 82 patients with unresectable HCC who underwent TACE alone (TA group; n=46) or TACE combined with Anlotinib (TC group; n=36) between Jan 2018 and Jan 2019. The primary outcomes were progression-free survival (PFS) and overall survival (OS), while the secondary outcomes included the objective response rate (ORR), the disease control rate (DCR) and main complications. Results: The TC group showed relatively higher PFS than the TA group (7.35months vs. 5.54 months, p=0.035). The 3-month survival rate was not statistically different between the two groups (97.2% vs. 93.5%, p=0.627), while both the 6-month survival rate and 1-year survival rate were significantly higher in the TC group than in the TA group (83.3% vs. 56.5%, p=0.016; 66.7% vs. 19.6%, p<0.01). ORR in the TA group was significantly higher than in the TC group (77.8% vs. 32.6%, p<0.01), while the two groups showed no statistical difference in DCR (94.4% vs. 82.6%, p=0.17). No treatment-related mortality or grade 4 adverse event was observed, but grade 3 adverse events occurred in two patients in the TC group (one suffered with erythra, and another suffered with hand-foot-skin reaction). Both of them disappeared after prompt treatment. Conclusions: TACE combined with Anlotinib is safe and may improve outcomes for unresectable HCC patients comparing with TACE alone. It still needs more further randomized controlled trials to clarify the potential role of Anlotinib in hepatocellular carcinoma. Key words: Hepatocellular carcinoma; Anlotinib; Transarterial chemoembolization


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