Sorafenib Plus Hepatic Arterial Infusion Chemotherapy versus                     Sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis:                     A Randomized Trial

Zheng, Kanglian; Zhu, Xu; Fu, Shijie; Cao, Guang; Li, Wen-Qing; Xu, Liang; Chen, Hui; Wu, Di; Yang, Renjie; Wang, Kun; Liu, Wei; Wang, Hongwei; Bao, Quan; Liu, Ming; Hao, Chunyi; Shen, Lin; Xing, Baocai; Wang, Xiaodong

doi:10.1148/radiol.211545

Cited by 90 publications

(113 citation statements)

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“…In the recent years, hepatic arterial infusion chemotherapy (HAIC) has been identified to be alternative strategy of TACE in the management of advanced HCC, which has the advantage over TACE for those with extrahepatic metastasis or macrovascular invasion ( 10 , 11 ). Combination of HAIC and sorafenib has exhibited significant survival benefit compared with sorafenib or HAIC alone, but the 2-year survival rate remains low ( 12 , 13 ).…”

Section: Introductionmentioning

confidence: 99%

Hepatic arterial infusion chemotherapy combined with PD-1 inhibitors and tyrosine kinase inhibitors for unresectable hepatocellular carcinoma: A tertiary medical center experience

et al. 2022

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BackgroundUnresectable hepatocellular carcinoma (u-HCC) still accounts for the majority of newly diagnosed HCC which with poor prognosis. In the era of systemic therapy, combination therapy with programmed cell death protein-1 (PD-1) inhibitors and tyrosine kinase inhibitors (TKIs) has become mainstream. Hepatic arterial infusion chemotherapy (HAIC) as a local treatment has also shown a strong anti-tumor effect. This study aimed to investigate the efficacy and safety of HAIC, PD-1 inhibitors plus TKIs for u-HCC.MethodsThis retrospective study included patients with initially u-HCC between October 2020 to April 2022 who had received at least one cycle of therapy with HAIC, PD-1 inhibitors plus TKIs. The primary outcome included overall response rate (ORR), the disease control rate (DCR), surgical conversion rate, progression-free survival (PFS) and treatment-related adverse events.ResultsA total of 145 patients were included in the study. The median treatment cycle of HAIC and PD-1 inhibitors were 3 and 4, respectively. According to the modified RECIST criteria, the best ORR was 57.2% (83/145), 9 had achieved complete response (CR), DCR was 89.7% (130/145). Median time to achieve CR or PR was 65 days. Surgical conversion rate was 18.6% (27/145), seven patients (7/27,25.9%) achieved pathological complete response (pCR). The median follow-up was 12.5 months (4.5-20 months), and the median PFS was 9.7 months. Subgroup analysis showed that Child-pugh A patients had higher DCR (92.2% vs 79.3%, p=0.041) than Child-pugh B patients, as well as increased successful conversion rate (22.4% vs 3.4%, p=0.019). Patients without vascular invasion and extrahepatic metastases showed higher PR (63.4% vs 43.3%, p<0.05) and ORR (73.2% vs 50.0%, p<0.05) than those with vascular invasion. The ORR (73.2% vs 45.5%, p<0.05) and DCR (95.1% vs 78.8%, p<0.05) were also significantly better than those of patients with extrahepatic metastases. HAIC regimen was not related to efficacy (All p>0.05). The incidence rate of grade 3/4 treatment-related AEs was 17.7% without fatal events.ConclusionThe triple combination therapy of HAIC and PD-1 inhibitors plus TKIs for patients with initially unresectable HCC exhibited satisfactory efficacy with tolerable toxicity.

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Section: Introductionmentioning

confidence: 99%

Hepatic arterial infusion chemotherapy combined with PD-1 inhibitors and tyrosine kinase inhibitors for unresectable hepatocellular carcinoma: A tertiary medical center experience

et al. 2022

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“…[4][5][6] Although effective, it should be noted that patients may not tolerate synchronously combined therapies because of the superimposed treatment toxicities related to their different mechanisms (grade 3/4 adverse events: 53.2%-69.2%). 5,7,8 In our study, the HAIC-FO monotherapy caused a low percentage of grade 3/4 adverse events (20.3%) which might encourage more patients to accept a higher dose of chemotherapy. 9 Low toxicity should be a fundamental quality of any effective treatment recommended for the advanced HCC population, especially for those with decompensated liver function and poor physical status.…”

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confidence: 54%

Reply to O. Sütcüoğlu et al

Lyu¹,

Zhao

2022

JCO

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Reply to O. S ütc üo glu et alWe appreciate S ütc üo glu et al 1 for their interest in our randomized phase III study that demonstrated the clinical superiority of the arterial infusion chemotherapy of infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX; HAIC-FO) compared with multikinase tyrosine inhibitor sorafenib in advanced hepatocellular carcinoma (HCC; FOHAIC-1). 2 According to our retrospective study, patients with lung metastases treated with HAIC-FO had shorter survival than those without. 3 S ütc üo glu et al 1 expressed concern regarding this issue in the FOHAIC-1 study, and, therefore, we performed a subgroup analysis comparing the survival of patients with lung metastases between the two groups. After recalculation, we further confirmed that lung metastasis is a poor prognosis factor in the HAIC-FO arm (hazard ratio, 1.622; 95% CI, 1.017 to 2.586; P 5 .042). HAIC-FO presented better and more stable responses than sorafenib as both progression-free and intrahepatic progression-free survival were longer in patients with lung metastases. Nevertheless, the overall survival between groups was not statistically different (Table 1). As this is a post hoc subgroup analysis, the results should be interpreted with caution.

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“…For example, the basal prognosis of such patients is three months for Vp4 and six months for Vp3 (right or left portal vein invasion) [22]. The previously reported prognosis of patients with major PVTT-HCC treated with sorafenib was 6.5 months [23]. The prognosis for other 1 st line systemic treatments, such as lenvatinib and atezolizumab plus bevacizumab combination therapy, is also approximately six months [7,24].…”

Section: Discussionmentioning

confidence: 99%

Hepatic Arterial Infusion Chemotherapy New-FP for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombus

Iwamoto

Niizeki

Nagamatsu

et al. 2022

Preprint

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Background/Purpose: Although macrovascular invasion (MVI), particularly major portal vein tumor thrombus (PVTT), is a critical tumor condition in hepatocellular carcinoma (HCC), determining the optimal treatment is an unmet medical need. We aimed to compare the efficacy of hepatic arterial infusion chemotherapy (HAIC) regimens New-FP (fine-powder cisplatin/ lipiodol suspension and 5-fluorouracil) and sorafenib for MVI-HCC and major PVTT-HCC in patients with preserved liver function. Methods: We retrospectively analyzed 1,709 consecutively presenting patients with HCC who were initially treated with New-FP or sorafenib (March 2009 to June 2019). Overall survival and prognostic factors were assessed in both groups after propensity score matching (n=198 each). Subgroup analyses were conducted in four groups: cohort 1 (no MVI or extrahepatic spread [EHS]), cohort 2 (MVI only), cohort 3 (EHS only), and cohort 4 (MVI and EHS). Cohort 5 evaluated major PVTT (including EHS). Results: The New-FP group had a longer median survival time (MST) than the sorafenib group (New-FP, 18 months; sorafenib, nine months; p<0.0001). New-FP demonstrated a statistically longer MST compared with sorafenib in cohorts 2 and 4. In cohort 5, the MST of the New-FP group was 16 months, while that of sorafenib was six months (p<0.0001). For major PVTT-HCC, the objective response rate for New-FP was 73.0%. The MST of patients who achieved a complete response with New-FP (16.6%) was 59 months. Conclusion: New-FP showed significant efficacy for MVI-HCC, including major PVTT-HCC. Even in the era of systemic treatment, HAIC using New-FP is a promising modality for patients with advanced HCC.

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Sorafenib Plus Hepatic Arterial Infusion Chemotherapy versus Sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis: A Randomized Trial

Cited by 90 publications

References 31 publications

Hepatic arterial infusion chemotherapy combined with PD-1 inhibitors and tyrosine kinase inhibitors for unresectable hepatocellular carcinoma: A tertiary medical center experience

Hepatic arterial infusion chemotherapy combined with PD-1 inhibitors and tyrosine kinase inhibitors for unresectable hepatocellular carcinoma: A tertiary medical center experience

Reply to O. Sütcüoğlu et al

Hepatic Arterial Infusion Chemotherapy New-FP for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombus

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