Efficacy and safety of apatinib combined with TACE in patients with hepatocellular carcinoma refractory to transcatheter arterial chemoembolization.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15504-e15504
Author(s):  
Wei Zhang ◽  
Zhiping Yan
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Transcatheter Arterial Chemoembolization ◽  
Advanced Hepatocellular Carcinoma ◽  
Efficacy And Safety ◽  
Phase 2 Study ◽  
Grade 3 ◽  
Treatment Safety ◽  
Unacceptable Toxicity ◽  
Arterial Chemoembolization

e15504 Background: Effective options for patients with advanced hepatocellular carcinoma (HCC) are urgently needed. Studies have shown that combination of sorafenib with TACE could imorove survival for the treatment of locoregional HCCs. Apatinib is a novel and highly selective inhibitor of VEGFR2 tyrosine kinase. We were aiming to explore the efficacy and safety of apatinib combined with TACE in patients with hepatocellular carcinoma refractory to transcatheter arterial chemoembolization. Methods: This was a single-center single-arm phase 2 study. The key inclusion criteria included: (1) Histologicaly and cytologicaly diagnosed as Hepatocellular carcinoma of the liver ( HCC ) and with at least one imaging examination of measurable lesions, CT or MR scan long diameter of tumor ≥ 10 mm. (2) BCLC B / C; (3) Progressed after at least twice TACE. Eligible pts received apatinib at 500 mg/day for a maximum after TACE 4-7 days, and TACE treatment was performed after 4 days of discontinuation of apatinib until unacceptable toxicity or tumor recurrence. The primary endpoint was time to progression (TTP), which was defined as the time from enrollment to disease progression. The secondary endpoint was overall survival (OS) and treatment safety. Results: From May 27, 2018 to Oct 12, 2019, 22 pts wereenrolled. 5 pts received TACE more than 5 times, and 17 pts received TACE within 4 times. For 20 evaluable pts, two pts achieved partial response (10%), and 13 patients achieved stable disease. The ORR and DCR were 10% and 75%, respectively. At the cutoff data of Nov 4, 2019, 5 pts were still on treatment. 16 recurrenced and 5 death occurred. The mTTP was 5.09 months (95% CI, 3.48-7.16), and the mOS was not reached. Treatment-related adverse events occurred in 12 pts (60%). Seven grade 3 or 4 adverse events were reported (35%), respectively wereascites (2), platelet count decrease (1), elevated ALT/AST (1), hypertension (1), proteinuria (1) and nausea (1). None of the treatment related AEs was fatal. Conclusions: Apatinib combined with TACE might be effective and tolerant in patients with hepatocellular carcinoma refractory to transcatheter arterial chemoembolization. Clinical trial information: NCT03510416.

scholarly journals Efficacy and Safety of the Arsenic Trioxide/Lipiodol Emulsion in the Transcatheter Arterial Chemoembolization Combined with Apatinib in the Treatment of Advanced Hepatocellular Carcinoma

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Zhaonan Li ◽  
Quanjing Chen ◽  
Wenguang Zhang ◽  
Guangyan Si ◽  
Jing Li ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Transcatheter Arterial Chemoembolization ◽  
Tumor Burden ◽  
Advanced Hepatocellular Carcinoma ◽  
Efficacy And Safety ◽  
Advanced Hcc ◽  
Grade 3 ◽  
Lipiodol Emulsion ◽  
Arterial Chemoembolization

Purpose. The goal of this study was to assess the clinical efficacy and safety of the arsenic trioxide (ATO)/lipiodol emulsion in the transcatheter arterial chemoembolization (TACE) combined with apatinib in the treatment of advanced hepatocellular carcinoma (HCC). Methods. From December 2015 to February 2017, a total of 87 patients were consecutively enrolled and underwent ATO-TACE (aTACE) combined with apatinib in the treatment of advanced HCC. The treatment response and adverse events were assessed at the first month and third month after aTACE therapy. Progression-free survival (PFS), overall survival (OS), and treatment-related adverse events were also analyzed. Results. 87 patients (57 men; 30 women) were enrolled in the present study. Compared to that at the pre-aTACE examination, the levels of AST and ALT were elevated at the first week after procedure (65.84 U/L ± 22.93 U/L vs. 54.15 U/L ± 19.60 U/L, p = 0.032 ; 63.44 U/L ± 22.50 U/L vs. 51.60 U/L ± 13.89 U/L, p = 0.027 , respectively). Most of the adverse events were grade 1 or 2 according to National Cancer Institute Common Terminology Criteria for Adverse Event (CTCAE). Of the exception, 4 persons (2%) did have grade 3 hand-foot skin reactions, 1 (1%) had grade 3 diarrhea, 1 (1%) had grade 3 hypertension, and 3 (3%) had grade 3 proteinuria and forced to reduce the dose of apatinib by half. The survival analysis of the combination with aTACE and apatinib therapy found that the median PFS was 10.2 months (95% CI: 8.543–11.857), and the median OS was 23.300 months (95% CI: 20.833–25.767). Additionally, both univariate and multivariate Cox regression revealed that the tumor burden (≤50%) and the patients without portal vein tumor thrombus (PVTT) significantly impacted the patient’s PFS and OS and were related to better survival. Conclusion. aTACE combined with apatinib is a safe and promising treatment approach for patients with advanced HCC. Additionally, tumor burden (≤50%) and the patients without PVTT are associated with better PFS and OS.

scholarly journals Efficacy and Safety of Radiotherapy Plus Anti-PD1 Versus Transcatheter Arterial Chemoembolization Plus Sorafenib For Advanced Hepatocellular Carcinoma: a Real-World Study

2021 ◽  
Author(s):  
Jian-Xu Li ◽  
Wen-Xiang Deng ◽  
Shi-Ting Huang ◽  
Xiao-Feng Lin ◽  
Mei-Ying Long ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Real World ◽  
Transcatheter Arterial Chemoembolization ◽  
Objective Response ◽  
Advanced Hepatocellular Carcinoma ◽  
Efficacy And Safety ◽  
Advanced Hcc ◽  
Sorafenib Group ◽  
Arterial Chemoembolization

Abstract Background: The combination of transcatheter arterial chemoembolization (TACE) plus sorafenib prolonged progression-free survival (PFS) and overall survival (OS) than sorafenib or TACE monotherapy for patients with hepatocellular carcinoma (HCC). This study assessed the efficacy and safety of radiotherapy (RT) plus monoclonal antibody against programmed cell death 1 (anti-PD1) versus TACE plus sorafenib for patients with advanced HCC.Methods: Patients with advanced HCC who treated with RT plus anti-PD1 and TACE plus sorafenib were enrolled. Objective response rate (ORR), PFS, disease control rate (DCR) and OS were calculated to assess the antitumor response and the treatment-related adverse events to the safety.Results: Between January 2018 to March 2021, 37 patients underwent RT plus anti-PD1 and 41 patients underwent TACE plus sorafenib. The baseline characteristics between the two groups were comparable. The ORR and DCR were significantly higher in the RT+PD1 group than the TACE plus sorafenib group according to RECIST 1.1 (54.05% vs 12.20%, P < 0.001; 70.27% vs 46.37%, P = 0.041; respectively) and according to mRECIST (56.76% vs 31.71%, P = 0.039; 70.27% vs 46.37%, P = 0.041; respectively). RT plus anti-PD1 provided significantly better PFS (HR, 0.51; 95% CI 0.30-0.86; p=0.017) than TACE plus sorafenib. Moreover, patients with RT plus anti-PD1 had significantly higher 3-, 6-, and 9-month OS rates than those with TACE plus sorafenib(97.3% vs 92.30%, P < 0.001; 91.89% vs 68.60%, P < 0.001; 75.5% vs 60.60%, P < 0.001; respectively). The median OS was more favorable 17.4 months for the RT+PD1 group and 11.9 months for the TACE plus sorafenib group. No treatment-related death was observed. Grade 3 or more treatment-related adverse events (TRAEs) occurred significantly less in patients in the RT+PD1 group than the TACE plus sorafenib group (29.7% vs 75.6%, p < 0.001), and all TRAEs were manageable.Conclusions: In this real-world study, RT plus anti-PD1 showed significantly promising efficacy and manageable safety than TACE plus sorafenib in patients with advanced HCC. Toxicities were manageable, with no unexpected safety signals. The study provides evidence on a new therapeutic method in the treatment of advanced HCC.

scholarly journals Combination of Sorafenib, Camrelizumab, Transcatheter Arterial Chemoembolization, and Stereotactic Body Radiation Therapy as a Novel Downstaging Strategy in Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Case Series Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Yun Huang ◽  
Zeyu Zhang ◽  
Weijun Liao ◽  
Kuan Hu ◽  
Zhiming Wang
Keyword(s):  
Hepatocellular Carcinoma ◽  
Combination Therapy ◽  
Adverse Events ◽  
Tumor Thrombus ◽  
Stereotactic Body Radiation Therapy ◽  
Transcatheter Arterial Chemoembolization ◽  
Case Series ◽  
Advanced Hepatocellular Carcinoma ◽  
Advanced Hcc ◽  
Arterial Chemoembolization

Background and AimAlthough the treatment effect and availability of therapeutic options for advanced hepatocellular carcinoma (HCC) are limited, the downstaging strategy may improve patient prognosis. This study aimed to investigate the potential of combination therapy as a downstaging strategy for treating advanced HCC with portal vein tumor thrombus (PVTT).MethodsThis retrospective case series included patients having advanced HCC with PVTT, who received the combination therapy of sorafenib, camrelizumab, transcatheter arterial chemoembolization (TACE), and stereotactic body radiation therapy (SBRT) from January 2019 to December 2019 in Xiangya Hospital, Central South University. The downstaging rate, treatment responses, progression-free survival (PFS), overall survival (OS), disease control rate, and toxicities were evaluated.ResultsOf the 13 patients, HCC downstaging was achieved in 4 (33.3%) patients who later received hepatectomy. The overall response rate was 41.7%, and the disease control rate was 50.0%. The median PFS time was 15.7 months, with a 1-year PFS rate of 58.3%, whereas the median OS was not reached after 1 year (1-year OS, 83.3%). No severe adverse events or grade 3–4 adverse effect was observed in 12 of the 13 enrolled patients; therapy had to be discontinued in only one patient due to adverse events, who was excluded from the study. The most common adverse effect was fever (n = 4, 33.3%), followed by skin reaction (n = 3, 25%).ConclusionA combination therapy comprising sorafenib, camrelizumab, TACE, and SBRT is an effective downstaging strategy for advanced HCC with PVTT and is associated with few adverse events.

A retrospective study on the efficacy and safety of sorafenib or lenvatinib combined with sintilimab in patients with advanced hepatocellular carcinoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16127-e16127
Author(s):  
Zhen Zeng ◽  
Linzhi Zhang ◽  
Tong Wu ◽  
Jiamin Cheng ◽  
Yan Chen ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Retrospective Study ◽  
Adverse Events ◽  
Controlled Trial ◽  
Performance Status ◽  
Objective Response ◽  
Advanced Hepatocellular Carcinoma ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Grade 3

e16127 Background: To evaluate the efficacy and safety of sorafenib or lenvatinib combined with sintilimab in patients with advanced hepatocellular carcinoma. Methods: This retrospective study included patients with advanced/metastatic hepatocellular carcinoma who received sintilimab (iv. 200 mg, Q3W) combined with sorafenib (oral, 400 mg twice-daily) (cohort A) or lenvatinib (oral, 12 mg/day for bodyweight≥60 kg or 8 mg/day for bodyweight < 60 kg) (cohort B) as first line therapy between March 2019 to December 2020 in the 5th medical center of the PLA general hospital of China. The primary endpoint was Progression-Free Survival (PFS), and the secondary endpoints included the Objective Response Rate (ORR), Disease Control Rate (DCR), Overall Survival (OS), Time to Progression (TTP) and safety. Results: 45 patients were enrolled, of which 29 were in the cohort A and 16 were in the cohort B. Except for the extrahepatic metastasis (62.1% vs 25.0%, P= 0.029), there were no significant differences in age, gender, weight, ECOG performance status, Child-Pugh, BCLC staging, and the proportion of previous treatment regimens between the two cohorts. The mean (±SD) exposure cycles in the two cohorts were 7.2±6.7 vs 7.1±4.7 ( P= 0.584). The median PFS of cohort A (8.2 months, 95%CI 3.1-19.5) was longer than that of cohort B (5.2 months, 95%CI 2.0-10.8), but there was no significant difference (HR 0.55, 95%CI 0.24-1.29, P = 0.161). However, there was no significant difference between the two cohorts in ORR (24.1% vs 6.3%, P= 0.226), DCR (82.8% vs 75.0%, P= 0.700) and median TTF (8.2 vs 4.6months, HR 0.49, 95%CI 0.21- 1.10, P= 0.074). OS data were not yet mature. There was no significant difference in the incidence of all grades and grade 3-4 adverse events between the two cohorts. The most common grade 3-4 adverse events in the two cohorts were hand-foot syndrome (17.2%, 5/29) and lung infection (12.5%, 2/16). There was 1 patient (immune hepatitis) in cohort A and 2 patients (pulmonary infection) in cohort B leading to treatment interruption due to adverse events, and no deaths due to treatment. Conclusions: Sorafenib or lenvatinib combined with sintilimab showed a good efficacy and safety in patients with advanced hepatocellular carcinoma, the safety and tolerability profiles were consistent with those previously observed. Sorafenib plus sintilimab provided an improved PFS versus lenvatinib, which requires a large sample of randomized controlled trial to confirm.[Table: see text]

scholarly journals Improved Efficacy of Transcatheter Arterial Chemoembolization Using Warmed Miriplatin for Hepatocellular Carcinoma

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Daisuke Yasui ◽  
Satoru Murata ◽  
Shiro Onozawa ◽  
Takahiko Mine ◽  
Tatsuo Ueda ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Odds Ratio ◽  
Transcatheter Arterial Chemoembolization ◽  
Response Rate ◽  
Objective Response ◽  
Alanine Transaminase ◽  
Efficacy And Safety ◽  
The Common ◽  
Arterial Chemoembolization

The aim of this study was to evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) using warmed and nonwarmed miriplatin for hepatocellular carcinoma. Eighty patients (117 nodules), treated between January 2010 and June 2013, were evaluated. Thirty-two and 85 nodules were treated with nonwarmed and warmed miriplatin, respectively. The efficacy of TACE was evaluated on a per nodule basis according to treatment effect (TE). Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. TE grades were significantly improved in the warmed group compared to the nonwarmed group (nonwarmed: TE 4, 12.5%; TE 3, 0%; TE 2, 15.6%; TE 1, 71.9%; warmed: TE 4, 34.1%; TE 3, 5.9%; TE 2, 9.4%; TE 1, 50.6%;P=0.017) . Multivariate analysis revealed significant impact of warming miriplatin on objective response rate (odds ratio, 12.35; 95% confidence interval, 2.90–90.0;P=0.0028). CTCAE grades of elevated aspartate and alanine transaminase after TACE were significantly higher in the warmed group (P=0.0083and 0.0068, resp.); however, all adverse events were only transient. The use of warmed miriplatin in TACE significantly improved TE without causing serious complications.

scholarly journals Efficacy and safety of a monodisperse solid-in-oil-in-water emulsion in transcatheter arterial chemoembolization in a rabbit VX2 tumor model

2019 ◽  
Author(s):  
Daisuke Yasui ◽  
Aya Yamane ◽  
Hiroshi Itoh ◽  
Masayuki Kobayashi ◽  
Shin-ichiro Kumita
Keyword(s):  
Adverse Events ◽  
Transcatheter Arterial Chemoembolization ◽  
Iodine Concentration ◽  
Control Group ◽  
Efficacy And Safety ◽  
Water Emulsion ◽  
Left Liver Lobe ◽  
Vx2 Tumor ◽  
Experimental Group ◽  
Arterial Chemoembolization

AbstractTranscatheter arterial chemoembolization (TACE) is a standard treatment for unresectable hepatocellular carcinoma; however, it does not always result in tumor control. Nevertheless, treatment outcome can be improved with monodisperse emulsions of anticancer agents. In this study, the efficacy and safety of a monodisperse miriplatin-Lipiodol emulsion were evaluated in Japanese white rabbits. VX2 tumor was implanted into the left liver lobe of each rabbit. The animals were divided into control and experimental groups (of five animals each) and respectively administered a conventional miriplatin suspension or the emulsion via the left hepatic artery. Computed tomography (CT) was performed before, immediately after, and two days following TACE. All rabbits were sacrificed two days after the procedure. Each tumor was removed and cut in half for assessment of iodine concentration in one half by mass spectroscopy and evaluation of Lipiodol accumulation and adverse events in the other half. Mean Hounsfield unit (HU) values were measured using plain CT images taken before and after TACE. Iodine concentration was higher in the experimental group [1100 (750–1500) ppm] than in the control group [840 (660–1800) ppm]. Additionally, the HU value for the experimental group was higher than that for the control group immediately after [199.6 (134.0– 301.7) vs. 165.3 (131.4–280.5)] and two days after [114.2 (56.1–229.8) vs. 58.3 (42.9–132.5)] TACE. Cholecystitis was observed in one rabbit in the control group. Ischemic bile duct injury was not observed in any group. The results show that Lipiodol accumulation and retention in VX2 tumor may be improved by using a monodisperse emulsion. Moreover, no significant adverse events are associated with the use of the emulsion.

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