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    Home > Active Ingredient News > Digestive System Information > Voice of China Zhao Ming and Professor Li Shaohua lead the study of hepatic arterial infusion chemotherapy and contribute to China

    Voice of China Zhao Ming and Professor Li Shaohua lead the study of hepatic arterial infusion chemotherapy and contribute to China

    • Last Update: 2021-06-18
    • Source: Internet
    • Author: User
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    The 2021 American Society of Clinical Oncology (ASCO) annual meeting will be held online from June 4th to 8th.
    As one of the largest and most popular events in oncology, the ASCO annual meeting will show scholars from all walks of life the latest cutting-edge progress
    .

    In the field of liver cancer, a total of 2 studies related to hepatic arterial infusion chemotherapy (HAIC) in China were selected for the 2021ASCO oral report, both from the Sun Yat-sen University Cancer Center
    .

    Abstract 4007 | FOHAIC-1 Study: Oxaliplatin combined with fluorouracil for hepatic arterial infusion chemotherapy versus sorafenib in the treatment of advanced hepatocellular carcinoma (HCC) Professor Ming Zhao, Sun Yat-sen University Cancer Center Background: Advanced HCC usually has a huge amount at first diagnosis Liver masses and large blood vessels infiltrated, but less extrahepatic metastases (77.
    5% vs 37.
    9%)
    .

     However, in the IMbrave150, SHARP and Asia-Pacific SHARP studies, the proportion of extrahepatic metastases reached 63%, 53%, and 68.
    7%, respectively, while large vessel infiltration accounted for only 38%, 36%, and 36%
    .

    Unlike previous and ongoing phase III clinical trials that explore the best systemic medications in the first-line treatment of advanced HCC, this study is mainly aimed at people with heavy intrahepatic tumor burden
    .

    Methods: In this open-label phase III trial, the enrolled patients were randomized to receive FOLFOX regimen of hepatic arterial infusion chemotherapy (HAIC-FO) or sorafenib at a ratio of 1:1
    .

    It is recommended that patients in the HAIC-FO group receive biopsy of tumor tissue and normal tissue to find potential genomic biomarkers to predict treatment response
    .

    Results: From May 2017 to May 2020, a total of 551 patients were recruited
    .

    260 eligible patients were randomly assigned to receive HAIC-FO (n = 130) or sorafenib (n = 132) treatment and were included in the intention-to-treat population
    .

    82.
    8% of patients had large vessel invasion with or without extrahepatic metastasis
    .

    The median tumor diameter in the HAIC-FO group was 11.
    7 cm (IQR 8.
    3-14.
    0), and in the sorafenib group was 10.
    8 cm (8.
    7-13.
    6) (P = 0.
    439); the proportion of patients with liver tumor volume involvement> 50% in the two groups They were 41.
    5% and 39.
    4% (P = 0.
    724)
    .

    At the time of the data cutoff (October 31, 2020, there were 190 deaths [79 deaths in the HAIC-FO group and 111 deaths in the sorafenib group]), the average overall survival of patients treated with HAIC-FO The period (OS) was 13.
    9 months (95%CI 10.
    6-17.
    2), and patients receiving sorafenib were 8.
    2 months (7.
    5-9.
    0) (HR 0.
    408 [95%CI 0.
    301-0.
    552], P <0.
    001)
    .

    In the HAIC-FO group, 16 patients (accounting for 12.
    3% of the 130 patients) had reduced tumor stage, and 15 of them (93.
    8%) received radical surgery or ablation, and the median OS reached 20.
    4 months.
    The 1-year OS rate was 93.
    8%; the progression-free survival (PFS) was 16.
    4 months, and the 1-year PFS rate was 68.
    8%
    .

    Subgroup analysis showed that the median OS of patients with high-risk factors receiving HAIC-FO treatment was 10.
    8 months, which was significantly longer than the sorafenib group's 5.
    7 months
    .

    The HAIC-FO group is conducting predictive biomarker analysis based on whole-genome sequencing
    .

    Conclusion: This randomized phase III study proved that in the first-line treatment of newly diagnosed advanced HCC, HAIC-FO has better efficacy and survival rate than sorafenib, which indicates that patients with heavier intrahepatic tumor burden should use HAIC-FO as a single agent The treatment is better than sorafenib
    .

     Abstract 4008 | Neoadjuvant FOLFOX trans-arterial infusion chemotherapy can improve the prognosis of patients with resectable BCLC A/B HCC that exceeds the Milan standard.
    Professor Li Shaohua, Sun Yat-sen University Cancer Center Background: Surgical treatment is a resectable BCLC A/B that exceeds the Milan standard.
    The only radical cure for patients with early HCC, its curative effect is still not satisfactory
    .

    This study aims to explore the effectiveness and safety of preoperative neoadjuvant FOLFOX regimen transarterial infusion chemotherapy (TAI) in these patients
    .

    Methods: In this multi-center, prospective, phase III, randomized, open-label, controlled clinical trial, patients with resectable BCLC A/B HCC that exceed Milan standards were randomly assigned 1:1 before hepatectomy Receive neoadjuvant TAI (NT group) or direct surgery (OP group)
    .

    The primary endpoint is OS, and the secondary endpoints are PFS, recurrence-free survival (RFS), and safety
    .

    Results: From March 2016 to July 2020, 208 patients from 5 Chinese hospitals were randomly assigned to the NT group (n = 104) or OP group (n = 104), of which 99 were in the NT group and 100 were in the OP group Include the efficacy and safety analysis
    .

    The clinicopathological characteristics of the two groups are balanced
    .

    The 1-year, 2-year, and 3-year OS rates in the NT group were 92.
    9%, 78.
    6%, and 63.
    5%, respectively, and the OP group were 79.
    5%, 62.
    0%, and 46.
    3%, respectively
    .

    The 6-month, 12-month, and 18-month PFS rates of the NT group were 77.
    6%, 50.
    4%, and 47.
    4%, respectively, and the OP group were 52.
    7%, 42.
    8%, and 34.
    8%, respectively
    .

    The OS and PFS of the NT group were significantly better than those of the OP group (p values ​​were 0.
    016 and 0.
    017, respectively)
    .

    The 6-month, 12-month, and 18-month RFS rates of the NT group were 63.
    8%, 47.
    3%, and 47.
    3%, respectively, and the OP group were 52.
    7%, 42.
    8%, and 34.
    8%, respectively
    .

    There was no difference in RFS between the two groups (p = 0.
    385)
    .

    No patients in the NT group had serious adverse events related to TAI of grade 3 or higher
    .

    Adverse events related to surgery were similar between the two groups (p = 0.
    300)
    .

    Conclusion: Neoadjuvant TAI before liver resection may bring survival benefits to patients with resectable BCLC stage A/B HCC who exceed the Milan standard
    .

    References: 1.
    Hepatic arterial infusion chemotherapy of oxaliplatin plus fluorouracil versus sorafenib in advanced hepatocellular carcinoma: A biomolecular exploratory, randomized, phase 3 trial (The FOHAIC-1 study).
    .
    2021 ASCO.
    Abstr 4007.
    2.
    Neoadjuvant transarterial infusion chemotherapy with FOLFOX could improve outcomes of resectable BCLC stage A/B hepatocellular carcinoma patients beyond Milan criteria: An interim analysis of a multi-center, phase 3, randomized, controlled clinical trial.
    .
    2021 ASCO.
    Abstr 4008.

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