scholarly journals Efficacy and Safety of DEB-TACE for Patients With Hepatocellular Carcinoma With the Largest Tumor Diameter ≥7 cm

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.

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.


2019 ◽  
Vol 11 ◽  
pp. 175883591988900
Author(s):  
Hsin-Lun Lee ◽  
Jo-Ting Tsai ◽  
Chun-You Chen ◽  
Ying-Chun Lin ◽  
Chin-Beng Ho ◽  
...  

Background: Stereotactic ablative radiotherapy (SABR) can deliver tumoricidal doses and achieve long-term control in early hepatocellular carcinoma (HCC). However, limited studies have investigated the safety and effectiveness of SABR in patients with advanced diseases that is unsuitable for transarterial chemoembolization (TACE). Methods: In this observational study, we reviewed the medical records of patients with Barcelona Clinic Liver Cancer (BCLC) stage C disease treated with linear accelerator-based SABR between 2008 and 2016. Their tumors were either refractory to TACE or TACE was contraindicated. Overall survival (OS), in-field progression-free survival (IFPFS), and out-field progression-free survival were calculated using Kaplan–Meier analysis. The Cox regression model was used to examine the effects of variables. Treatment-related toxicities were scored according to the Common Terminology Criteria for Adverse Events (version 4.03) and whether patients developed radiation-induced liver disease (RILD) after SABR. Results: This study included 32 patients. The mean maximal tumor diameter and tumor volumes were 4.7 cm and 135.9 ml, respectively. Patients received linear accelerator-based SABR with a median prescribed dose of 48 Gy (30–60 Gy) in three to six fractions. Based on the assessment of treatment response by using the Response Evaluation Criteria in Solid Tumors (version 1.1), 19% of patients achieved a complete response and 53% achieved a partial response. After a median follow-up of 18.1 months (4.0–65.9 months), 10, 19, and 9 patients experienced in-field failure, out-field hepatic recurrence, and extrahepatic metastases, respectively. The estimated 2-year OS and IFPFS rates were 54.4% and 62.7%, respectively. In a multivariate analysis, a pretreatment Cancer of the Liver Italian Program (CLIP) score of ⩾2 ( p = 0.01) was a prognostic factor for shorter OS, and a biologically effective dose (BED) of < 85 Gy10 ( p = 0.011) and a Child–Pugh score of ⩾6 ( p = 0.014) were prognostic factors for inferior IFPFS. In this study five and eight patients developed classic and nonclassic RILD, respectively. Conclusions: SABR can serve as a salvage treatment for patients with HCC with BCLC stage C disease unsuitable for TACE, in particular, in those with a baseline CLIP score of ⩽1. A BED10 of ⩾85 Gy is an appropriate prescribed dose for tumor control. Because out-field relapse is the major cause of treatment failure, SABR in combination with novel systemic modalities should be investigated in future studies.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15635-e15635 ◽  
Author(s):  
Feng Shi ◽  
Shanshan Lian ◽  
Peihong Wu ◽  
Lujun Shen

e15635 Background: Transarterial chemoembolization (TACE) is currently the first-line treatment for patients with intermediate (BCLC stage B) hepatocellular carcinoma (HCC). However, the prognosis of patients with intermediate HCC remains unsatisfactory, because TACE was limited by its lack of ability to achieve complete tumor necrosis. In this study, we retrospectively compare the outcome of TACE with or without microwave ablation (MWA) in the treatment of intermediate HCC. Methods: Included in this study were 140 patients with intermediate stage HCC who underwent initial TACE and were potentially amendable for MWA (the sum of the size of the largest tumor in centimeters and the number of tumors should be no more than nine; and a total tumor diameter ≤11 cm) between January 2005 and February 2015. 75 patients were treated with following MWA (TACE-MWA), and the remaining 65 patients were treated with TACE alone. Cumulative overall survival (OS) and progression-free survival (PFS) rates were compared. Results: The respective 1-, 3-, and 5-year OS rates were 80%, 30%, and 20% in the TACE group; and 96%, 69%, and 48% in the TACE-MWA group (Fig. 2). The OS was statistically significantly better in the TACE-MWA group compared with the TACE group (P < 0.001). The respective 1-, 3-, and 5-year PFS rates were 53%, 13%, and 0% in the TACE group; and 59%, 27%, and 17% in the TACE-MWA group (Fig. 3B). PFS rates between the two groups did not differ significantly (P = 0.069). Conclusions: MWA following initial TACE prolongs OS and PFS of patients with potentially amendable intermediate HCC.


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.


Author(s):  
Osman Öcal ◽  
Kerstin Schütte ◽  
Juozas Kupčinskas ◽  
Egidijus Morkunas ◽  
Gabija Jurkeviciute ◽  
...  

Abstract Purpose To explore the potential correlation between baseline interleukin (IL) values and overall survival or objective response in patients with hepatocellular carcinoma (HCC) receiving sorafenib. Methods A subset of patients with HCC undergoing sorafenib monotherapy within a prospective multicenter phase II trial (SORAMIC, sorafenib treatment alone vs. combined with Y90 radioembolization) underwent baseline IL-6 and IL-8 assessment before treatment initiation. In this exploratory post hoc analysis, the best cut-off points for baseline IL-6 and IL-8 values predicting overall survival (OS) were evaluated, as well as correlation with the objective response. Results Forty-seven patients (43 male) with a median OS of 13.8 months were analyzed. Cut-off values of 8.58 and 57.9 pg/mL most effectively predicted overall survival for IL-6 and IL-8, respectively. Patients with high IL-6 (HR, 4.1 [1.9–8.9], p < 0.001) and IL-8 (HR, 2.4 [1.2–4.7], p = 0.009) had significantly shorter overall survival than patients with low IL values. Multivariate analysis confirmed IL-6 (HR, 2.99 [1.22–7.3], p = 0.017) and IL-8 (HR, 2.19 [1.02–4.7], p = 0.044) as independent predictors of OS. Baseline IL-6 and IL-8 with respective cut-off values predicted objective response rates according to mRECIST in a subset of 42 patients with follow-up imaging available (IL-6, 46.6% vs. 19.2%, p = 0.007; IL-8, 50.0% vs. 17.4%, p = 0.011). Conclusion IL-6 and IL-8 baseline values predicted outcomes of sorafenib-treated patients in this well-characterized prospective cohort of the SORAMIC trial. We suggest that the respective cut-off values might serve for validation in larger cohorts, potentially offering guidance for improved patient selection.


2021 ◽  
Vol 11 ◽  
Author(s):  
Xin Zheng ◽  
Yanqiao Ren ◽  
Hanqing Hu ◽  
Kun Qian

BackgroundThe purpose of this study was to compare the efficacy and safety of transarterial chemoembolization (TACE) in combination with radiofrequency ablation (RFA) (TACE-RFA) and repeat hepatectomy in the treatment of recurrent hepatocellular carcinoma (HCC) after curative resection.MethodsThis retrospective study evaluated consecutive medical records of patients who received either TACE-RFA or repeat hepatectomy between January 2010 and May 2021. Overall survival (OS), progression-free survival (PFS), and complications were compared.ResultsOf the 2672 patients who received either TACE-RFA or repeat hepatectomy, 111 eligible patients were included in our study, 63 in the TACE-RFA group and 48 in the repeat hepatectomy group. The median OS was 38 months in the TACE-RFA group and 42 months in the repeat hepatectomy group, with no statistically difference between the two groups (P=0.45). Meanwhile, there was also no statistically significant difference in PFS between the two groups (P=0.634). Although both groups achieved similar outcomes, the rate of major complications was significantly higher in the repeat hepatectomy group (P=0.003).ConclusionsPatients with recurrent HCC in the TACE-RFA group and the repeat hepatectomy group had similar OS and PFS regardless of the patient’s tumor diameter, but the TACE-RFA group was safer and more minimally invasive.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21587-e21587
Author(s):  
Ting Ye ◽  
Jieying Zhang ◽  
Xinyi Liu ◽  
Mengmei Yang ◽  
Yuhan Zhou ◽  
...  

e21587 Background: Immunotherapies targeting immune checkpoint receptors have become the cornerstone of systemic treatment options for malignant melanoma. The response to these immunotherapies may correlate with driver mutations. MAP2K1/2 genes are mutated in approximately 10% of melanomas, however, the impact of MAP2K1/2 gene alterations on the efficiency of immunotherapy has not been clarified. Methods: Six metastatic melanoma clinical cohorts treated with ICIs were included to investigate the association between clinical efficacy of immunotherapy and MAP2K1/2 mutations. Survival analyses were conducted in cohorts receiving two kinds of ICB agents, namely anti-CTLA-4 or anti-PD-1. RNA expression profiling from these cohorts and from the TCGA melanoma cohort were used to explore the potential mechanism related to immune activation. Results: In an independent anti-CTLA-4-treated cohort (n = 110), we found that MAP2K1/2 mutations are predictive of high objective response rate (17.6% vs 1.3%, p = 0.0185) and long progression-free survival [median OS, 49.2 months vs 8.3 months; hazard ratio (HR) = 0.37; 95% CI, 0.15–0.91; p = 0.0307] and overall survival (median PFS, 19.4 months vs 2.8 months; HR = 0.2; 95% CI, 0.05–0.83; p = 0.0262). This predictive value was further validated in a pooled anti-CTLA-4-treated cohort (n = 235) in terms of overall survival (median OS, 49.3 months vs 22.0 months; HR = 0.44; 95% CI, 0.22–0.91; p = 0.0255). However, no correlation between MAP2K1/2 mutations and overall survival was observed in the anti-PD-1-treated cohort (n = 285). Subgroup Cox regression analysis indicated that MAP2K-mutated patients receive less benefit from the anti-PD-1 monotherapy than from the anti-CTLA-4 treatment (median OS, 27.0 months vs 49.3 months; HR = 3.26; 95% CI, 1.18–9.02; p = 0.0225), which was contrary to the result obtained for the total population. Furthermore, transcriptome profiling analysis revealed that MAP2K-mutated tumors are enriched in CD8+ T cells, B cells, and neutrophil cells and also express high levels of CD33 and IL10, which might be the underlying mechanism for melanoma patients with MAP2K1/2-mutated benefit more from anti-CTLA-4 treatment. Conclusions: We identified mutations in MAP2K1/2 genes as the independent predictive factors for anti-CTLA-4 therapy in melanoma patients and found that anti-CTLA-4 treatment in patient harbouring MAP2K1/2 mutations might be more effective than the anti-PD-1 therapy.


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]


2019 ◽  
Vol 2019 ◽  
pp. 1-7
Author(s):  
Lei Liu ◽  
Enxin Wang ◽  
Lin Li ◽  
Dongyu Chen ◽  
Kun Peng ◽  
...  

Background. Combination therapy of transarterial chemoembolization plus sorafenib (TACE-S) has been proven to be safe and effective for hepatocellular carcinoma (HCC); however, this combination therapy is associated with a high incidence of adverse events (AEs). Our study focused on the relationships between AEs and treatment outcomes and aimed to discover AE-based clinical markers that can predict the survival benefits of combination treatment. Methods. From January 2010 to June 2014, a total of 235 HCC patients treated with TACE-S were retrospectively enrolled. Major sorafenib-related AEs were prospectively recorded, and their correlations with overall survival (OS) were analysed using time-dependent covariate Cox regression analyses. Results. The majority of the patients (200, 85.1%) were male, and the median age was 51 years old. After two years of follow-up, the median OS of the study population reached 12.4 months. In all, 218 patients (92.8%) presented at least one AE, and 174 (74.0%) suffered AEs ≥2 grade. Based on time-dependent multivariate analyses, the development of hand-foot skin reaction (HFSR) ≥2 grade (HR = 0.43, 95% CI: 0.32–0.58, P<0.001) and diarrhoea ≥1 grade (HR = 0.72, 95% CI: 0.53–0.97, P=0.029) were identified as independent predictors of prolonged OS. Moreover, patients who developed both HFSR ≥2 grade and diarrhoea ≥1 grade achieved better outcomes than those patients who developed either or neither of these AEs (HR = 1.51, 95% CI: 1.11–2.06, P=0.009). Conclusions. The development of HFSR ≥2 grade or diarrhoea ≥1 grade during TACE-S treatment indicated prolonged OS, and these AEs should be considered important clinical markers for predicting patient prognoses.


2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Hai-Ge Zhang ◽  
Ping Yang ◽  
Tao Jiang ◽  
Jian-Ying Zhang ◽  
Xue-Juan Jin ◽  
...  

Purpose. To investigate whether lymphocyte nadir induced by radiation is associated with survival and explore its underlying risk factors in patients with hepatocellular carcinoma (HCC). Methods. Total lymphocyte counts were collected from 184 HCC patients treated by radiotherapy (RT) with complete follow-up. Associations between gross tumor volumes (GTVs) and radiation-associated parameters with lymphocyte nadir were evaluated by Pearson/Spearman correlation analysis and multiple linear regression. Kaplan–Meier analysis, log-rank test, as well as univariate and multivariate Cox regression were performed to assess the relationship between lymphocyte nadir and overall survival (OS). Results. GTVs and fractions were negatively related with lymphocyte nadir (p<0.001 and p=0.001, respectively). Lymphocyte nadir and Barcelona Clinic Liver Cancer (BCLC) stage were independent prognostic factors predicting OS of HCC patients (all p<0.001). Patients in the GTV ≤55.0 cc and fractions ≤16 groups were stratified by lymphocyte nadir, and the group with the higher lymphocyte counts (LCs) showed longer survival than the group with lower LCs (p<0.001 and p=0.006, respectively). Patient distribution significantly differed among the RT fraction groups according to BCLC stage (p<0.001). However, stratification of patients in the same BCLC stage by RT fractionation showed that the stereotactic body RT (SBRT) group achieved the best survival. Furthermore, there were significant differences in lymphocyte nadir among patients in the SBRT group. Conclusions. A lower lymphocyte nadir during RT was associated with worse survival among HCC patients. Smaller GTVs and fractions reduced the risk of lymphopenia.


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