FOXAI: a phase II trial evaluating the efficacy and safety of hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin for advanced hepatocellular carcinoma

Lyu, Ning; Lin, Yifan; Kong, Yanan; Zhang, Zhenfeng; Liu, Longzhong; Zheng, Lie; Mu, Luwen; Wang, Jianpeng; Li, Xishan; Pan, Tao; Xie, Qiankun; Liu, Yaru; Lin, Aihua; Wu, Peihong; Zhao, Ming

doi:10.1136/gutjnl-2017-314138

Cited by 86 publications

(60 citation statements)

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“…More likely, TACE exerts systemic effect through arterio-venous shunt or altering tumor microenvironment, thereby impairing host immune regulation ( 29 ). HAIC is a strategy of local treatment through hepatic artery with systemic chemotherapy dosage, which has achieved good clinical effect in advanced HCC ( 30 ). HAIC is characterized by use of the same large-dose chemotherapy drugs as systemic chemotherapy with high local concentration, as well as exerting negative impact on the local immune microenvironment that similar to TACE, which might explain why HAIC can bring about HBV reactivation to some extent.…”

Section: Discussionmentioning

confidence: 99%

Effects of Antiviral Therapy on HBV Reactivation and Survival in Hepatocellular Carcinoma Patients Undergoing Hepatic Artery Infusion Chemotherapy

et al. 2021

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BackgroundThis study aimed to investigate the influence of hepatic artery infusion chemotherapy (HAIC) on hepatitis B virus (HBV) reactivation in hepatitis B surface antigen (HBsAg) positive patients with primary hepatocellular carcinoma (HCC) as well as evaluate the role of antiviral prophylaxis in these patients.MethodsWe enrolled 170 HBsAg-positive advanced HCC patients receiving HAIC using mFOLFOX regimen, of which 137 patients received antiviral prophylaxis. Risk factors for HBV reactivation were analyzed. The overall survival (OS) from the first application of HAIC were compared between antiviral and non-antiviral groups.ResultsA total of 25 patients (14.7%) developed HBV reactivation after HAIC, of which 16 patients received antiviral treatment and nine patients did not. The incidence of HBV reactivation was 11.7% (16/137) in antiviral group and 27.3% (9/33) in non-antiviral group respectively. No antiviral prophylactic was the only significant risk factor for HBV reactivation (OR=12.35, 95% confidence interval (CI) 4.35–33.33, p<0.001). Patients in antiviral group received more cycles of HAIC compared with non-antiviral group (3.11 ± 1.69 vs 1.75 ± 1.18, p<0.05) at the time of HBV reactivated. Seven of the 25 HBV reactivation patients developed hepatitis. OS in antiviral group was significantly longer than that of non-antiviral group (median 16.46 vs 10.68 months; HR=0.57; 95% CI, 0.36–0.91; p<0.05).ConclusionsHBV reactivation is more prone to occur in the HBsAg-positive HCC patients undergoing HAIC without antiviral prophylaxis. Regular monitoring of HBV DNA and antiviral prophylaxis are suggested to prevent HBV reactivation as well as prolong the OS of these patients.Name of the Trial RegisterHAIC Using Oxaliplatin Plus Fluorouracil/Leucovorin for Patients with Locally Advanced HCC.Clinical Trial Registrationhttps://www.clinicaltrials.gov/, identifier NCT 02436044

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Section: Discussionmentioning

confidence: 99%

Effects of Antiviral Therapy on HBV Reactivation and Survival in Hepatocellular Carcinoma Patients Undergoing Hepatic Artery Infusion Chemotherapy

et al. 2021

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“…In an open-label multicenter study, lenvatinib plus pembrolizumab surprisingly showed a median overall survival (OS) of 22 months and a median progression-free survival (PFS) of 8.6 months in patients with unresectable hepatocellular carcinoma ( 6 ). In recent years, hepatic artery infusion chemotherapy (HAIC) has attracted attention due to high response rates and favorable survival for advanced HCC ( 7 ). Several randomized clinical trials have shown that HAIC combined with sorafenib yields significantly better survival compared to sorafenib monotherapy ( 8 , 9 ).…”

Section: Introductionmentioning

confidence: 99%

Hepatic Arterial Infusion Chemotherapy Combined With PD-1 Inhibitors Plus Lenvatinib Versus PD-1 Inhibitors Plus Lenvatinib for Advanced Hepatocellular Carcinoma

et al. 2021

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BackgroundLenvatinib combined with programmed cell death protein-1 (PD-1) inhibitors has resulted in good survival outcomes in the treatment of unresectable hepatocellular carcinoma (HCC). Hepatic artery infusion chemotherapy (HAIC) has also attracted attention due to its high response rates and favorable survival for advanced HCC patients. The present study aimed to compare the efficacy of HAIC combined with PD-1 inhibitors plus lenvatinib (HPL) and PD-1 inhibitors plus lenvatinib (PL) in patients with advanced HCC.MethodsBetween July 2018 and December 2019, patients diagnosed with advanced HCC who initially received HPL or PL treatment were reviewed for eligibility. Efficacy was evaluated according to tumor response and survival.ResultsIn total, 70 patients met the criteria and were included in the present study, and they were divided into the HPL group (n = 45) and PL group (n = 25). The overall response rate (40.0 vs. 16.0%, respectively; p = 0.038) and disease control rate (77.6 vs. 44.0%, respectively; p < 0.001) were higher in the HPL group than in the PL group. The median overall survival was 15.9 months in the HPL group and 8.6 months in the PL group (p = 0.0015; HR = 0.6; 95% CI 0.43–0.83). The median progression-free survival was 8.8 months in the HPL group and 5.4 months in the PL group (p = 0.0320; HR = 0.74; 95% CI 0.55–0.98).ConclusionCompared to PL, HPL was associated with a significantly better treatment response and survival benefits for patients with advanced HCC.

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“…In recent years, hepatic artery infusion chemotherapy (HAIC) has attracted much attention because of its high response rate and excellent long-term survival rate in the treatment of advanced hepatoma. A prospective, multicenter, phase II study conducted by Lyu and coworkers showed hepatic artery infusion (HAI) of oxaliplatin plus fluorouracil/leucovorin (FOLFOX) was effective and well tolerated for advanced hepatoma 170. The 6-month and 12-month survival rates of patients receiving HAI of FOLFOX (HAIF) were 71.4% and 55.1%, respectively.…”

Section: Chemotherapy and Molecular Targeted Therapy Of Hepatoma Withmentioning

confidence: 99%

Evaluation of Polymer Nanoformulations in Hepatoma Therapy by Established Rodent Models

Wang

Zhang

et al. 2019

Theranostics

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Hepatoma is one of the most severe malignancies usually with poor prognosis, and many patients are insensitive to the existing therapeutic agents, including the drugs for chemotherapy and molecular targeted therapy. Currently, researchers are committed to developing the advanced formulations with controlled drug delivery to improve the efficacy of hepatoma therapy. Numerous inoculated, induced, and genetically engineered hepatoma rodent models are now available for formulation screening. However, animal models of hepatoma cannot accurately represent human hepatoma in terms of histological characteristics, metastatic pathways, and post-treatment responses. Therefore, advanced animal hepatoma models with comparable pathogenesis and pathological features are in urgent need in the further studies. Moreover, the development of nanomedicines has renewed hope for chemotherapy and molecular targeted therapy of advanced hepatoma. As one kind of advanced formulations, the polymer-based nanoformulated drugs have many advantages over the traditional ones, such as improved tumor selectivity and treatment efficacy, and reduced systemic side effects. In this article, the construction of rodent hepatoma model and much information about the current development of polymer nanomedicines were reviewed in order to provide a basis for the development of advanced formulations with clinical therapeutic potential for hepatoma.

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FOXAI: a phase II trial evaluating the efficacy and safety of hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin for advanced hepatocellular carcinoma

Cited by 86 publications

References 9 publications

Effects of Antiviral Therapy on HBV Reactivation and Survival in Hepatocellular Carcinoma Patients Undergoing Hepatic Artery Infusion Chemotherapy

Effects of Antiviral Therapy on HBV Reactivation and Survival in Hepatocellular Carcinoma Patients Undergoing Hepatic Artery Infusion Chemotherapy

Hepatic Arterial Infusion Chemotherapy Combined With PD-1 Inhibitors Plus Lenvatinib Versus PD-1 Inhibitors Plus Lenvatinib for Advanced Hepatocellular Carcinoma

Evaluation of Polymer Nanoformulations in Hepatoma Therapy by Established Rodent Models

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