Prediction of Transarterial Chemoembolization (TACE) - Outcome by pre- and postinterventional 13C-Methacetin breath test

BACKGROUND: Liver function is one of the most important parameters for the outcome of transarterial chemoembolization (TACE). The Liver Maximum Capacity (LiMAx) -Test is a bedside test that provides a real-time option for liver function testing. The objective of this pilot study is to investigate the suitability of the LiMAX test for estimating the TACE outcome. OBJECTIVE AND METHODS: 20 patients with intermediate-stage hepatocellular carcinoma (HCC) received a LiMAx test 24 h pre and post TACE. In addition, laboratory values were collected to determine liver function and model for endstage liver disease (MELD) scores. The success of TACE was assessed 6 weeks post intervention by morphological imaging tests using modified response evaluation criteria in solid tumors (mRECIST). RESULTS: Patients with an objective response (OR = CR + PR) according to mRECIST post TACE have significantly higher values in the pre-interventional LiMAx test than patients with a non-OR (PD or SD) post TACE (rb(14) = 0.62, p = 0.01). Higher pre-interventional LiMAx values therefore indicate OR. Patients with a disease control (DC = CR + PR + SD) according to mRECIST post TACE have significantly higher values in the pre-interventional LiMAx test than patients with a non-DC (PD) post TACE (rb(14) = 0.65, p = 0.01). Higher pre-interventional LiMAx values therefore indicate DC. The bi-serial correlations of LiMAx values pre and post TACE with the outcome OR or DC are descriptively stronger than those of MELD with OR or DC. This suggests that the LiMAx test correlates better with the treatment response than the MELD score. CONCLUSIONS: For the first time, we were able to show in our study that patients who are scheduled for TACE could benefit from a LiMAx test to be able to estimate the benefit of TACE. The higher the pre-interventional LiMAx values, the higher the benefit of TACE. On the other hand, laboratory parameters summarized in the form of the MELD score, had significantly less descriptive correlation with the TACE outcome.

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

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.3_suppl.287 ◽

2021 ◽

Vol 39 (3_suppl) ◽

pp. 287-287

Author(s):

Thierry De Baere ◽

Filipe Veloso Gomes ◽

Gontran Verset ◽

Gerardo Tovar-Felice ◽

Katerina Malagari ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Liver Function ◽

Transarterial Chemoembolization ◽

Tumor Response ◽

Objective Response ◽

Progression Free Survival ◽

Close Monitoring ◽

Bridge To Transplant ◽

Level Data ◽

Drug Eluting

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]

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Impact of Baseline ALBI Grade on the Outcomes of Hepatocellular Carcinoma Patients Treated with Lenvatinib: A Multicenter Study

Cancers ◽

10.3390/cancers11070952 ◽

2019 ◽

Vol 11 (7) ◽

pp. 952 ◽

Cited By ~ 40

Author(s):

Kazuomi Ueshima ◽

Naoshi Nishida ◽

Satoru Hagiwara ◽

Tomoko Aoki ◽

Tomohiro Minami ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Liver Function ◽

Adverse Events ◽

Objective Response Rate ◽

Response Rate ◽

Objective Response ◽

Evaluation Criteria ◽

Treatment Discontinuation ◽

The Impact ◽

Group 1

Background: This study investigated the impact of baseline liver function according to the Child–Pugh score and ALBI (albumin-bilirubin) grade on the outcomes of patients with unresectable hepatocellular carcinoma treated with lenvatinib. Methods: A total of 82 lenvatinib treated patients were included. The correlations of baseline liver function according to the Child–Pugh score and ALBI grade with treatment outcomes, including objective response rate per mRECIST (modified Response Evaluation Criteria in the Solid Tumor), time to treatment failure, treatment duration, and likelihood of treatment discontinuation due to adverse events, were assessed in patients with hepatocellular carcinoma treated with lenvatinib. Patients were divided into four groups: (1) Child–Pugh score 5 and ALBI grade 1 (group 1), (2) Child–Pugh score 5 and ALBI grade 2 (group 2), (3) Child–Pugh score 6 (group 3), and (4) Child–Pugh score ≥7 (group 4). Univariate and multivariate analyses were performed to identify the factors contributing to the objective response rate and likelihood of discontinuation due to adverse events. Results: Among the 82 patients analyzed, group 1 had the highest objective response rate (57.1%) and the lowest likelihood of treatment discontinuation because of adverse events (11.1%) among the four groups (p < 0.05 and p < 0.05). Multivariate analysis identified ALBI grade 1 and baseline AFP level <200 ng/mL as the significant predictors of a high objective response rate (p < 0.05 and p < 0.01), and confirmed that patients with ALBI grade 1 had the lowest probability of treatment discontinuation due to adverse events (p < 0.01). Conclusions: Patients with Child–Pugh score of 5 and ALBI grade 1 predicted a higher response rate and lower treatment discontinuation due to adverse events by lenvatinib treatment.

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Development of a Model to Predict Liver Decompensation prior to Transarterial Chemoembolization Refractoriness in Patients with Intermediate-Stage Hepatocellular Carcinoma

GE Portuguese Journal of Gastroenterology ◽

10.1159/000520530 ◽

2021 ◽

pp. 1-9

Author(s):

Joel Ferreira-Silva ◽

Pedro Costa-Moreira ◽

Helder Cardoso ◽

Rodrigo Liberal ◽

Pedro Pereira ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Transarterial Chemoembolization ◽

Objective Response ◽

Intermediate Stage ◽

Line Treatment ◽

First Line ◽

Hepatic Reserve ◽

Liver Decompensation ◽

Pugh Class ◽

First Line Treatment

Introduction: Transarterial chemoembolization (TACE) is the first-line treatment for patients with intermediate-stage hepatocellular carcinoma (HCC). For patients without an adequate response, current finding suggests that treatment with molecular target agents, approved for advanced stage, might present benefits. However, this requires a preserved liver function. This study aims to evaluate possible predictors of early deterioration of hepatic reserve, prior to TACE refractoriness, in a cohort of patients treated with TACE. Methods: Retrospective analysis of 99 patients withChild-Pugh class A and intermediate-stage HCC who underwent TACE as the first-line treatment. All patients were submitted to a biochemical and medical evaluation prior to initial TACE and every month afterward. Response to initial TACE was evaluated at 1 month. The time to Child-Pugh class deterioration before TACE refractoriness was assessed. Results: Ninety-nine patients were included. Objective response rate (ORR) to initial TACE was assessed as present in 59 (63.4%) and as absent in 34 (36.6%) patients. Liver decompensated before TACE refractoriness in 51 (51.5%) patients, and the median time to liver decompensation was 14 (IQR 8–20) months after first TACE. In multivariate analysis, beyond up-to-7 criteria (HR 2.4, p = 0.031), albumin <35 mg/dL (HR 3.5, p < 0.001) and absence of ORR (HR 2.4, p = 0.020) were associated with decreased overall survival free of liver decompensation. Moreover, beyond up-to-7 criteria, albumin <35 mg/dL and absence of ORR associated negatively with 6-month survival free of liver decompensation. Our model created using those variables was able to predict liver decompensation at 6 months with an AUROC of 0.701 (p = 0.02). Conclusions: The absence of ORR after initial TACE, beyond up-to-7 criteria and albumin <35 mg/dL, was a predictive factor for early liver decompensation before TACE refractoriness in our population. Such patients might benefit from treatment escalation to systemic therapy, in monotherapy or in combination with TACE.

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Lenvatinib as an Initial Treatment in Patients with Intermediate-stage Hepatocellular Carcinoma Beyond up-to-seven Criteria and Child-Pugh A Liver Function: A Proof-of-Concept Study

10.20944/preprints201906.0285.v1 ◽

2019 ◽

Author(s):

Masatoshi Kudo ◽

Kazuomi Ueshima ◽

Stephan Chan ◽

Tomohiro Minami ◽

Hirokazu Chishina ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Propensity Score ◽

Liver Function ◽

Propensity Score Matching ◽

Initial Treatment ◽

Objective Response ◽

Unmet Need ◽

Intermediate Stage ◽

Proof Of Concept ◽

Concept Study

Background: Although transcatheter arterial chemoembolisation (TACE) is the standard of care for intermediate-stage hepatocellular carcinoma (HCC), this is a largely heterogeneous disease that includes a subgroup of patients who do not benefit from TACE. The treatment strategy for this subgroup of patients currently remains an unmet need in clinical practice. Here, we performed a proof-of-concept study that lenvatinib may be more favourable treatment option over TACE as an initial treatment in intermediate-stage HCC patients with large or multinodular tumours exceeding the up-to-seven criteria. Methods: This proof-of-concept study included 642 consecutive patients with HCC initially treated with lenvatinib or conventional TACE (cTACE) between January 2006 and December 2018. Of these patients, 176 who received lenvatinib or cTACE as an initial treatment and met the eligibility criteria [unresectable, beyond the up-to-seven criteria, no prior TACE/systemic therapy, no vascular invasion, no extrahepatic spread and Child-Pugh A liver function] were selected for the study. Propensity score matching was used to adjust for patient demographics. Results: After propensity-score matching, outcome of 30 patients prospectively treated with lenvatinib (14 in clinical trials, 1 in early access program and 15 in real world setting) and 60 patients treated with cTACE as the initial treatment was compared. The change of ALBI score from baseline to the end of treatment were -2.61 to -2.61 for 30 patients in lenvatinib group (p = 0.254) and -2.66 to -2.09 in cTACE group (p < 0.01), respectively. The lenvatinib group showed a significantly higher objective response rate (73.3% vs. 33.3%; p < 0.001) and significantly longer median progression-free survival than the cTACE group (16.0 vs. 3.0 months; p < 0.001). Overall survival was significantly longer in the lenvatinib group than in the cTACE group (37.9 vs. 21.3 months; hazard ratio: 0.48, p < 0.01). Conclusion: In patients with large or multinodular intermediate-stage HCC exceeding the up-to-seven criteria with Child-Pugh A liver function, who usually do not benefit from TACE, lenvatinib provides more favorable outcome than TACE.

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Transarterial Chemoembolization Combined with Iodine 125 Seeds Versus Transarterial Chemoembolization Combined with Radiofrequency Ablation in the Treatment of Early- and Intermediate-stage Hepatocellular Carcinoma

10.21203/rs.2.21964/v2 ◽

2020 ◽

Author(s):

chen lei ◽

Xuefeng Kan ◽

Tao Sun ◽

Yanqiao Ren ◽

Yanyan Cao ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Radiofrequency Ablation ◽

Transarterial Chemoembolization ◽

Combined Treatment ◽

Objective Response ◽

Progression Free Survival ◽

Intermediate Stage ◽

Treatment Groups ◽

Pugh Class ◽

Iodine 125

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.

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Drug-eluting Bead transarterial chemoembolization in patients with renal carcinoma

10.21203/rs.3.rs-78708/v1 ◽

2020 ◽

Author(s):

Zhiyu Bao ◽

Haiyan Wu ◽

Zhonghua Qiu ◽

Meng Hu ◽

Yanyan Yang ◽

...

Keyword(s):

Transarterial Chemoembolization ◽

Renal Carcinoma ◽

Objective Response ◽

Evaluation Criteria ◽

Progression Free Survival ◽

Serious Adverse Events ◽

Free Survival ◽

Kaplan Meier ◽

Drug Eluting Beads ◽

Drug Eluting

Abstract Background This study aimed to investigate the efficacy,safety and outcomes of patients with renal carcinoma treated by transarterial chemoembolization using drug eluting beads. Methods Between 2017 and 2020,37 patients(mean age:70.2 years(33–92 years)) with renal carcinoma were enrolled in this study who were treated by transarterial chemoembolization(TACE)using pirarubicin-loaded beads.Clinical response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.The occurrence of adverse reactions was used to assess safety.Overall survival(OS), progression-free survival(PFS) were also calculated based on Kaplan–Meier method. Results All patients were treated with drug-eluting Bead transarterial chemoembolization(DEB-TACE) loaded with pirarubicin using CalliSpheres beads.The objective response rate(ORR) and disease control rate(DCR) were 75.7% and 91.9% respectively at 1 month after DEB-TACE.The median PFS was 13.2 months (95% CI:5.9–20.5 months), and the median OS was 23.6 months (95% CI:18.5–28.7 months).Among the 37 patients,12 had flank pain,5 had fever,5 had nausea and vomiting and 4 had hypertension.There were no serious adverse events. Conclusion DEB-TACE is a safe and feasible treatment for patients with renal carcinoma.

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Lenvatinib for Hepatocellular Carcinoma: A Literature Review

Pharmaceuticals ◽

10.3390/ph14010036 ◽

2021 ◽

Vol 14 (1) ◽

pp. 36

Author(s):

Takeshi Hatanaka ◽

Atsushi Naganuma ◽

Satoru Kakizaki

Keyword(s):

Hepatocellular Carcinoma ◽

Overall Survival ◽

Liver Cancer ◽

Liver Function ◽

Adverse Events ◽

Therapeutic Response ◽

Objective Response ◽

Intermediate Stage ◽

Tumor Burden ◽

Asia Pacific

Lenvatinib, which is an oral multikinase inhibitor, showed non-inferiority to the sorafenib in terms of overall survival (OS) and a higher objective response rate (ORR) and better progression-free survival (PFS) in patients with hepatocellular carcinoma (HCC). A good liver function and Barcelona Clinic Liver Cancer (BCLC) intermediate stage were the key factors in achieving therapeutic efficacy. The management of adverse events plays an important role in continuing lenvatinib treatment. While sequential therapies contributed to prolonging overall survival, effective molecular targeted agents for the administration after lenvatinib have not been established. Repeated transcatheter arterial chemoembolization (TACE) was associated with a decline in the liver function and poor therapeutic response in BCLC intermediate patients. Recently, the Asia-Pacific Primary Liver Cancer Expert (APPLE) Consensus Statement proposed the criteria for TACE unsuitability. Upfront systemic therapy may be better for the BCLC intermediate stage HCC patients with a high tumor burden, while selective TACE will be recommended for obtaining a curative response in patients with a low tumor burden. This article reviews the therapeutic response, management of adverse events, post-progression treatment after Lenvatinib, and treatment strategy for BCLC intermediate stage HCC.

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Ramucirumab for patients with intermediate-stage hepatocellular carcinoma (HCC) and elevated alpha fetoprotein (AFP): Pooled results from two phase III studies (REACH and REACH-2).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.549 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 549-549

Author(s):

Masatoshi Kudo ◽

Richard S. Finn ◽

Manabu Morimoto ◽

Kun-Ming Rau ◽

Masafumi Ikeda ◽

...

Keyword(s):

Liver Function ◽

Meta Analysis ◽

Objective Response ◽

Intermediate Stage ◽

Phase Iii ◽

Locoregional Therapy ◽

Two Phase ◽

Linear Predictor ◽

Bclc Staging ◽

Grade 3

549 Background: Intermediate-stage HCC, as defined as Barcelona Clinic Liver Cancer (BCLC) Stage B, is a heterogeneous disease in terms of liver function and tumor load. REACH (NCT01140347) and REACH-2 (NCT02435433) investigated ramucirumab (RAM) in patients (pts) with HCC after prior sorafenib (SOR), with REACH-2 enrolling only pts with baseline AFP ≥400 ng/mL. An exploratory analysis of outcomes by BCLC stage was performed. Methods: All pts had HCC (BCLC stage C or B disease refractory/not amenable to locoregional therapy), Child-Pugh A, ECOG PS 0-1, and prior SOR. Pts were randomized to RAM 8 mg/kg or Placebo (P) Q2W. A pooled meta-analysis of independent pt data (stratified by study) from REACH-2 and REACH (AFP ≥400 mg/mL) was performed. Prognosis of BCLC staging in overall survival (OS) was evaluated by multivariate Cox PH model (adjusted for baseline AFP and treatment (trt) arm); Trt effects in BCLC stage B and C by Cox PH model; median OS/PFS were estimated by Kaplan-Meier method. Objective response rate (ORR) per RECIST v1.1, disease control rate (DCR), and adverse events (AEs) were also reported by BCLC. Liver function was assessed at baseline and prior to each trt with the Albumin-Bilirubin (ALBI) linear predictor. Results: Baseline characteristics were generally balanced between trt arms in each BCLC stage. BCLC staging trended as an independent prognosis factor for OS [B v C; HR = 0.756 (0.546, 1.046)]. A consistent trt benefit for RAM v P was observed across staging (Table). Grade ≥3 AEs were consistent with observations from both individual studies; hypertension was the most frequent grade ≥3 AE. No difference in liver function, as measured by ALBI, was observed between trt arms in either BCLC stage. Conclusions: Acknowledging limitations of sample size, RAM provided a survival benefit irrespective of BCLC stage. RAM was well tolerated and did not alter liver function compared to P. Clinical trial information: NCT01140347, NCT02435433. [Table: see text]

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Initial lenvatinib therapy with no prior TACE in patients with intermediate-stage hepatocellular carcinoma beyond up-to-seven criteria and Child-Pugh A liver function: A proof-of-concept study.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.522 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 522-522

Author(s):

Masatoshi Kudo ◽

Kazuomi Ueshima ◽

Stephen Lam Chan ◽

Tomoko Aoki ◽

Satoru Hagiwara ◽

...

Keyword(s):

Propensity Score ◽

Liver Function ◽

Propensity Score Matching ◽

Initial Treatment ◽

Objective Response ◽

Progression Free Survival ◽

Intermediate Stage ◽

Hepatic Function ◽

Phase Iii ◽

Eligibility Criteria

522 Background: Intermediate-stage HCC is a heterogenous population with subgroups of patients that do not benefit from TACE. Hence, we conducted a matched cohort study to compare the efficacy of lenvatinib to TACE in intermediate-stage HCC patients with large or multinodular tumours exceeding the up-to-7 criteria. Methods: This study first identified 642 consecutive patients with HCC initially treated with lenvatinib or conventional TACE (cTACE) between January 2006 and December 2018. Of these patients, 176 who received lenvatinib or cTACE as an initial treatment and met the eligibility criteria [unresectable, beyond the up-to-7 criteria, without prior TACE/systemic therapy, no vascular invasion, no extrahepatic spread and Child-Pugh A liver function] were selected. Propensity score matching was used to adjust for patients’ demographics. Results: After propensity-score matching, outcome of 30 patients prospectively treated with lenvatinib (14 in clinical trials [1 Phase II and 13 Phase III REFLECT trial], 1 in early access program and 15 in real world setting) and 60 patients treated with cTACE as the initial treatment was compared. The lenvatinib group showed a higher objective response rate (73.3% vs. 33.3%; p < 0.001) and longer median progression-free survival than the cTACE group (16.0 vs. 3.0 months; p < 0.001). Median overall survival was also significantly longer in the lenvatinib group than in the cTACE group (37.9 vs. 21.3 months; hazard ratio: 0.48, p < 0.01). The change of ALBI score from baseline to the end of treatment were -2.61 to -2.61 for 30 patients in lenvatinib group (p = 0.254) and -2.66 to -2.09 in cTACE group (p < 0.01), respectively. Conclusions: In patients with large or multinodular intermediate-stage HCC exceeding the up-to-7 criteria with Child-Pugh A liver function, who usually do not benefit from TACE, lenvatinib is associated with better outcome than TACE. In particular, leventinib is associated with preservation of hepatic function during treatment while TACE is associated with deterioration of hepatic function.

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

10.21203/rs.2.21921/v1 ◽

2020 ◽

Author(s):

Xuhua Duan ◽

Juanfang Liu ◽

Xinwei Han ◽

Jianzhuang Ren ◽

Hao Li ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Liver Function ◽

Treatment Response ◽

Transarterial Chemoembolization ◽

Protective Factor ◽

Objective Response ◽

Progression Free Survival ◽

Cox's Regression ◽

Tace Group ◽

Huge Hepatocellular Carcinoma

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.

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