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    Home > Active Ingredient News > Blood System > [Lymphoma micro course 2021ASH first look] After IRV, different courses of treatment are followed according to risk stratification. R-HyperCVAD/MTX is used for young newly-treated MCL patients

    [Lymphoma micro course 2021ASH first look] After IRV, different courses of treatment are followed according to risk stratification. R-HyperCVAD/MTX is used for young newly-treated MCL patients

    • Last Update: 2021-12-07
    • Source: Internet
    • Author: User
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    Hello everyone! Welcome to today's lymphoma micro-class! I am Jin Jie from the First Affiliated Hospital of Zhejiang University School of Medicine
    .

    Today I will introduce to you an abstract from this year's ASH annual meeting, Window 2 study: Ibrutinib combined with rituximab and venaclav (IRV) treatment followed by different courses of treatment according to risk stratification.
    R-HyperCVAD /MTX is used for young patients with newly treated mantle cell lymphoma (MCL)

    .

    The Window 1 study designed by Professor Wang Luhua’s team used ibrutinib combined with rituximab (IR) for 4 cycles of R-HyperCVAD/MTX for young newly-treated MCL patients.
    The complete remission (CR) rate reached 90%

    .

    This time, they hope to further increase the CR rate brought by the chemotherapy-free phase by adding Vinekal.
    Therefore, they designed the Window 2 study to evaluate the use of IRV in young newly-treated MCL patients after the use of IRV according to risk stratification and sequential different courses of treatment R- HyperCVAD/MTX is used as a consolidation therapy for the safety and efficacy.
    It is expected that the three-drug combination therapy without chemotherapy can reduce or reduce the toxicity or side effects of subsequent chemotherapy

    .

    The Window 2 study included 50 patients who were newly treated for MCL
    .

    In the first stage, the patient received 4 cycles of IR treatment
    .

    After 4 cycles, all patients were reassessed and staged
    .

    The patient began to receive IRV from cycle 5, in which Venecla needed a dose escalation
    .

    Patients who reach CR before the 12th cycle will continue to receive 4 cycles of IRV, and then enter the second phase
    .

    Patients can receive up to 12 cycles of IRV, that is, cycles 5-16
    .

    According to the basic situation, patients will be stratified as low-risk: Ki-67≤30%, maximum tumor mass <3 cm, low MIPI score, no high-risk characteristics; high-risk: Ki-67≥50%, TP53, NSD2 or NOTCH gene Mutation, complex karyotype or del(17p), MYC positive, or maximum tumor diameter> 5 cm, or blast/polymorphic tissue morphology, or partial remission (PR) after 12 cycles of the first stage of treatment
    .

    Intermediate risk: Patients who do not meet high-risk or low-risk characteristics
    .

    When entering the second stage of treatment, high-risk patients receive 4 cycles of R-HyperCVAD/MTX as consolidation, intermediate-risk patients receive 2 cycles of R-HyperCVAD/MTX as consolidation, and low-risk patients do not receive chemotherapy
    .

    If the patient progresses in the first stage, he will go directly to the second stage and receive 4 cycles of chemotherapy
    .

    If patients still have PR after receiving 4 cycles of chemotherapy, these patients will no longer be treated according to the protocol, but will still receive follow-up follow-up in this study, and record their posterior-line treatment plan and progression-free survival (PFS) after posterior-line treatment
    .

    After completing the second phase, all patients received IRV maintenance therapy for 2 years
    .

    The primary endpoint of the study is to evaluate the CR rate after IRV introduction therapy
    .

    The evaluation standard for adverse events in this study is the fourth edition of CTCAE
    .

    The research also carried out molecular biology research
    .

    Next, let's take a look at the results disclosed in the Window 2 study in this ASH summary
    .

    The median age of all 50 patients was 57 years (range 35-65)
    .

    Twenty cases were high-risk, 20 were medium-risk, and 10 were low-risk
    .

    18 cases had Ki-67≥30% (36%), 18 cases (36%) had MIPI scores of high or intermediate risk, and 6 cases (12%) had aggressive MCL (blast/polymorphism)
    .

    Of the 24 patients who completed the TP53 test, 8 (33%) had TP53 abnormalities (mutations and/or deletions detected by FISH)
    .

    Forty-eight patients received IRV, the best overall response rate (ORR) was 96%, and the CR rate was 92%
    .

    In the second stage, the best ORR is maintained at 96% (CR rate: 92%, PR rate: 4%)
    .

    The median number of cycles for patients to achieve the best remission with IRV was 8 cycles (range 2-12)
    .

    Fifteen patients (30%) did not receive the second part of chemotherapy, 2 patients (4%) received 1 cycle of chemotherapy, 16 patients (32%) received 2 cycles of chemotherapy, and 13 patients (26%) received 4 Cycle chemotherapy
    .

    At a median follow-up of 24 months, the median PFS and overall survival (OS) did not reach (2-year PFS rate: 92%, 2-year OS rate: 90%)
    .

    There were no significant differences in PFS or OS among patients with high or low Ki-67, whether patients had abnormal TP53, and patients with different risk strata
    .

    The median PFS (P=0.
    01) and OS (P=0.
    03) of patients with blast/polymorphic MCL were significantly shorter than those of patients with classic MCL

    .

    Thirteen patients (26%) withdrew from the trial, of which 5 were due to adverse events, 3 died, 2 were selected by patients, 2 were lost to follow-up, and 1 had disease progression
    .

    A total of 5 patients died (3 cases occurred during the trial and 2 cases occurred after withdrawal from the trial, namely disease progression and new coronary pneumonia)
    .

    Grade 3-4 adverse events that occurred in the first stage included bone marrow suppression (10%), fatigue (10%), muscle pain (10%), rash (10%), and mucositis (3%)
    .

    One patient developed grade 3 atrial flutter in the first stage
    .

    No grade 3-4 bleeding or congestion occurred
    .

    In general, the IRV three-drug combination therapy has brought continuous deep relief to young newly-treated MCL patients
    .

    The data of the Window 2 program suggest that low-risk patients do not need further chemotherapy, but this conclusion needs to be confirmed by longer follow-up data
    .

    According to risk stratification, chemotherapy of different intensities significantly improved the survival of all patients
    .

    We look forward to more data disclosure in Window 2 research
    .

    Today’s lymphoma micro-class is here, thank you for watching! Professor Jin Jie, Doctor of Medicine, Professor, Chief Physician, and Doctoral Supervisor Director of the Department of Hematology, The First Affiliated Hospital of Zhejiang University School of Medicine, Director of the Lymphoma Center, The First Affiliated Hospital of Zhejiang University School of Medicine, Director, Zhejiang Hematology Medical Research Center, Zhejiang Hematological Oncology (Diagnosis and Treatment) Director of the Key Laboratory Director of the Department of Hematology, Zhejiang University School of Medicine, National Key Clinical Discipline-Leader of the Department of Hematology, Zhejiang Medical First Hospital, Zhejiang Key Innovation Team-Leukemia Basic and Clinical Research Innovation Team Leader, Enjoy the Special Government Allowance of the State Council Advanced National Health System Workers National March 8th Red-Banner Bearer The 7th and 9th Standing Committee of the Hematology Society of Chinese Medical Association Chairman of the Hematology Committee of the Chinese Women Physicians Association Former Chairman of the Hematology Transformation Committee of the Chinese Anti-Cancer Association Former Chairman of the Chinese Society of Clinical Oncology (CSCO) Deputy Chairman of the Anti-leukemia Special Committee, Chinese Medical Doctor Association, Deputy Chairman of the Society of Hematology Integration, Chinese Society of Clinical Oncology (CSCO), Standing Member of the Anti-Lymphoma Special Committee, Chairman of the Hematology Branch of the Zhejiang Medical Association, published more than 260 SCI income papers, among the first / corresponding author SC published more than 130 papers in internationally renowned journal Cell, Lancet Oncology, JCO, Blood , Leukemia and other magazines
    .

    The first winner won 1 National Science and Technology Progress Award and 9 Zhejiang Science and Technology Progress Awards 1-3
    .

    Reference source: Wang M, et al.
    2021 ASH Abstract 3525.
    Statement: Xi'an Janssen does not recommend off-label use of drugs CRC: MED-ONC-CN-2524, approved on 2021-11-8 stamp "Read the original text", we will make progress together
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