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    Home > Active Ingredient News > Digestive System Information > 2021 BOC/BOA Professor Yuan Ying: Talking about the FIRE-4.5 study-new progress in the treatment of patients with BRAF V600E mutant mCRC

    2021 BOC/BOA Professor Yuan Ying: Talking about the FIRE-4.5 study-new progress in the treatment of patients with BRAF V600E mutant mCRC

    • Last Update: 2021-08-08
    • Source: Internet
    • Author: User
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    From July 2nd to 3rd, 2021, the "2021 China Clinical Oncology Annual Progress Seminar (BOC) and Best of ASCO® 2021 China" was successfully held in Chengdu, the land of abundance
    .

    The conference invited domestic oncology experts from various fields to comment on the wonderful research in the 2021 ASCO meeting; at the same time, there is a Chinese clinical oncology annual progress report link, which is selected by CSCO for the 2020 Chinese clinical oncology annual progress and Chinese experts’ international The clinical research of the conference report was summarized and discussed
    .

    At this meeting, Yimaitong invited Professor Yuan Ying from the Second Affiliated Hospital of Zhejiang University School of Medicine to interpret the latest progress in the diagnosis and treatment of colorectal cancer
    .

    Expert Profile Professor Yuan Ying, Director of Oncology Department of Zhejiang Medical Second Hospital, Doctor of Oncology, Chief Physician, Doctoral Supervisor, Deputy Director of the Key Laboratory of Malignant Tumor Early Warning and Intervention, Ministry of Education Main academic part-time job: Executive Deputy Editor-in-Chief and Editorial Department of "Journal of Practical Oncology" Director, Standing Committee of the Chinese Anti-Cancer Association Cancer Clinical Chemotherapy Professional Committee Member of the Standing Committee of the Colorectal Cancer Professional Committee of the Chinese Anti-Cancer Association, Head of the Genetics Group Member of the Standing Committee of the Chinese Anti-Cancer Association Family Hereditary Oncology Committee Standing Committee of the Chinese Anti-Cancer Association Cancer Targeted Therapy Professional Committee Standing Committee, China Council Member, Clinical Oncology Society (CSCO), CSCO Colorectal Cancer Expert Committee, Vice Chairman, CSCO Gastric Cancer Expert Committee, Standing Committee, CSCO Pancreatic Cancer Expert Committee, Member, Chinese Medical Doctor Association, Colorectal Tumor Genetics Committee, Chairman, Zhejiang Medical Association, Oncology Branch, Zhejiang Province Chairman of the Anti-Cancer Association Tumor Metastasis Professional Committee Deputy Chairman of the Zhejiang Anti-Cancer Association Medical Oncology Committee and Chairman of the Youth Committee Academic Achievements: Published 200+ articles, 100+ SCI papers; First-class scientific and technological progress in Yunnan Province in 2018 Award (ranked third); 2016 First China Cancer Young Scientist Award; 2011 Zhejiang Youth Science and Technology Award; 2005 National Science and Technology Progress Second Prize (ranked fourth); 2003 Zhejiang Science and Technology Progress First Prize ( Ranked No.
    1); In 1997, the South California Colorectal Surgeons Association Award; In 2004, he was selected as the provincial "151" talent project (second echelon)
    .

    About 5% to 10% of metastatic colorectal cancer (mCRC) have BRAF mutations, the most common of which is BRAF V600E mutation, accounting for about 90%.
    This mutation indicates a poor prognosis in patients
    .

    The first-line treatment plan for BRAF V600E mutant mCRC patients is currently inconclusive.
    The FIRE-4.
    5 study announced at the ASCO annual meeting in 2021 compared FOLFOXIRI combined with cetuximab vs.
    BRAF V600E mutant mCRC patients who have not previously received treatment .
    The efficacy of FOLFOXIRI combined with bevacizumab
    .

    Prior to this, some retrospective studies and small-sample studies showed that the three-drug regimen combined with anti-EGFR monoclonal antibody showed a very good response rate (ORR).
    Therefore, the research design of FIRE-4.
    5 is positioned very high, and the researchers hope that the three-drug combination with Cittal Compared with the three drugs combined with Bevacizumab, the ORR can be increased by 37.
    5%
    .

    However, the results of the study showed that from the primary endpoint ORR, 66.
    7% of the bevacizumab group and 52% of the cetuximab group.
    Although not statistically significant, the value of the bevacizumab group was higher.
    In the cetuximab group
    .

    From the perspective of progression-free survival (PFS), the difference between the two groups was more obvious, with PFS of 8.
    3 months in the bevacizumab group and 5.
    9 months in the cetuximab group (P=0.
    03)
    .

    From the perspective of overall survival (OS), the bevacizumab group is more likely to benefit
    .

    Therefore, although FIRE-4.
    5 is a randomized controlled phase II clinical study, it also fills the gap in the field of first-line treatment for patients with BRAF V600E mutant mCRC, and basically clarifies that the first-line treatment of these patients should still use three-drug combination anti-angiogenesis drugs.
    , In order to obtain the best effect
    .

    Study introductionResearch background The FIRE-4.
    5 (AIO KRK-0116) study compared FOLFOXIRI (fluorouracil + leucovorin + oxaliplatin + irinotecan) in combination with cetuximab or benzalkonium in newly treated patients with BRAF V600E mutant mCRC Efficacy of Vallizumab
    .

     Research method In this 1:2 randomized, controlled, open phase II trial, the enrolled patients were randomly divided into groups according to 1:2, and received FOLFOXIRI treatment every two weeks according to the following plan: Irinotecan 150 mg/m2 (30-90 Minutes, day 1), leucovorin 400 mg/m2 (120 minutes, day 1), oxaliplatin 85 mg/m2 (120 minutes, day 1), 5-fluorouracil 3000 mg/m2, 48 hours
    .

    Group A is FOLFOXIRI combined with bevacizumab (5 mg/kg body weight, once every 2 weeks), group B is FOLFOXIRI combined with cetuximab (loading dose is 400 mg/m2, then 250 once a week) mg/m2)
    .

    Before maintenance treatment, FOLFOXIRI is applied for a maximum of 12 cycles
    .

    According to the RECIST 1.
    1 standard, the primary endpoint is the benefit of group B in terms of ORR, and the secondary endpoints include PFS, OS, and tolerability
    .

     From November 2016 to December 2020, 108 patients from 90 German centers and 10 French centers were enrolled (35 cases in group A and 73 cases in group B)
    .

    No new or unexpected side effects were observed
    .

    The ORR did not reach the primary observation endpoint, and the ORRs in the two groups were 66.
    7% and 52.
    0% (P=0.
    23)
    .

    The median PFS of group A was significantly better than that of group B (8.
    3 months vs.
    5.
    9 months; log rank P=0.
    03; HR 1.
    8)
    .

    Although the OS has not yet been reached, the median OS is comparable at the time of analysis
    .

    Patients with primary tumors located in the left colon are comparable to bevacizumab or cetuximab, but patients with primary tumors located in the right colon have a trend of better efficacy in combination therapy with bevacizumab
    .

     Research conclusions FIRE-4.
    5 is the first prospective randomized study to study the first-line efficacy of FOLFOXIRI combined with targeted therapy in patients with BRAF V600E mutant mCRC
    .

    FOLFOXIRI combined with bevacizumab or cetuximab showed different efficacy in the treatment of mCRC with BRAF V600E mutation in the left and right half, showing the initial tumor heterogeneity
    .

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