echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Antitumor Therapy > [2021EHA first look] EP645-Ibrutinib treatment of 100 patients with chronic lymphocytic leukemia with abnormal TP53

    [2021EHA first look] EP645-Ibrutinib treatment of 100 patients with chronic lymphocytic leukemia with abnormal TP53

    • Last Update: 2021-06-11
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Hello everyone, welcome to the [Lymphoma Microclass], I am Dr.
    Xu Pengpeng from Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine.

    The European Hematology Annual Conference is the largest international conference in the field of hematology in Europe.
    It is planned to be held from June 9th to 17th this year.

    Today, I will share with you an abstract published at this year's European Hematology Annual Meeting, the outcome of Ibrutinib's first-line treatment of 100 patients with chronic lymphocytic leukemia with abnormal TP53.

    Research background TP53 gene abnormalities, including 17P13 deletion and/or TP53 gene mutation, are poor prognostic biomarkers of chronic lymphocytic leukemia, which are related to genome complexity, early recurrence and shorter survival after chemoimmunotherapy.

    Ibrutinib is the first approved BTK inhibitor to be administered orally once a day.
    Data from nearly 90 patients with newly diagnosed chronic lymphocytic leukemia with abnormal P53 in 5 clinical trials have proven the treatment of Ibrutinib Patients with chronic lymphocytic leukemia with poor prognosis are highly active.

    Research Purpose The purpose of this research is to describe the efficacy and withdrawal rate of Ibrutinib in the treatment of newly treated patients with chronic lymphocytic leukemia with abnormal TP53 in the real world.

    The research method retrospectively analyzed the medical records of patients with chronic lymphocytic leukemia followed by 14 centers of the Campus Chronic Lymphocytic Leukemia Network in Italy, and analyzed the lack of 17P13 (cut-off value 10%) and/or TP53 gene in the treatment of Ibritinib Data from patients with mutant chronic lymphocytic leukemia.

    The primary endpoint is the rate of drug withdrawal, and the secondary endpoints are progression-free survival, time to next treatment, and overall survival.

    The survival after discontinuation of Ibrutinib was evaluated.

    Diagnosis and remission assessment of chronic lymphocytic leukemia were performed according to the 2018 guidelines of the International Working Group on Chronic Lymphocytic Leukemia.

    Adverse events were classified according to the CTCAE v5.
    0 grading system.Research results This study recruited 100 patients with chronic lymphocytic leukemia who were newly treated with abnormal TP53.

    The 51 patients were male, and the median age at the start of ibrutinib treatment was 71 years (range 37-87 years), including 35 patients over 80 years old, with a median CIRS score of 4 (range 0-13), 42 The creatinine clearance rate of 1 patient was <60 mL/min.

    According to Rai's staging, 27 patients were stage III and 18 patients were stage IV.

    In 28 patients, β2-microglobulin was elevated.

    77 patients had no mutation in IGHV, 33 patients had only 17P13 deletion, 22 patients had only TP53 gene mutation, and 45 patients had both 17P13 deletion and TP53 gene mutation.

    The overall response rate was 84%, and the complete response rate confirmed by bone marrow biopsy was 10%.

    With a median follow-up of 24 months, 13 patients relapsed, 10 patients needed further treatment, 2 patients developed Richter transformation, 8 patients died, including 4 due to infection, 1 melanoma, 1 Richter transformation, and 1 sudden death .

    The median progression-free survival, median time to next treatment, and median overall survival were not reached.

    The progression-free survival rates at 12, 24, and 36 months were 91%, 82%, and 75%, respectively.
    The rates of not starting the next treatment were 94%, 89%, and 82%, respectively, and the overall survival rates were 96%, 92%, respectively.
    % And 87% (see Figure 1A).

    We observed that patients over 75 years of age and those who did not respond had shorter progression-free survival.
    For patients over 75 years of age and younger than 75 years of age, the 2-year progression-free survival rates were 69% and 89%, respectively (p = 0.
    04); For responding patients, the 2-year progression-free survival rates were 66% and 85%, respectively (p = 0.
    03).

    28 patients discontinued treatment, of which 20 patients were due to adverse events (including 8 infections, 5 atrial fibrillation, 4 others, and 3 deaths), 6 patients were due to disease progression, and 2 were Richter transformation.

    At 12 months and 24 months after treatment, the cumulative withdrawal rates of the entire cohort were 18% and 32%, respectively.

    The discontinuation rates caused by adverse events were 17% and 26%, respectively, the discontinuation rates caused by disease recurrence were 1% and 5%, and the discontinuation rates caused by Richter transformation were 1% and 3%, respectively (see Figure 1B).

    Patients who discontinued ibrutinib treatment due to adverse events had shorter progression-free survival and shorter overall survival (p <0.
    0001).

    After a median of 14 months of observation after discontinuation of ibrutinib, the estimated median progression-free survival and time to next treatment were 11 and 20 months, respectively (see Figure 1C).

    A total of 22 infections occurred in the entire cohort (9 cases ≥ grade 3), 8 cases of atrial fibrillation, 8 cases of minor events, and no major events.

    Research conclusions We reported the largest real-world study of Ibrutinib in the treatment of newly treated patients with chronic lymphocytic leukemia with abnormal TP53, confirming the efficacy of Ibrutinib in this subgroup.

    Ibrutinib treated 100 patients with newly treated chronic lymphocytic leukemia with abnormal TP53, the overall remission rate was 84%, and the complete remission rate confirmed by bone marrow biopsy was 10%.

    At a median follow-up of 24 months, the PFS rates at 12, 24, and 36 months were 91%, 82%, and 75%, respectively, and the rates of not starting the next treatment were 94%, 89%, and 82%, respectively, and the OS rates were respectively These are 96%, 92% and 87%.

    It is not uncommon for ibrutinib to stop treatment, but only a few patients require further treatment.

    Patients who discontinued ibrutinib treatment due to adverse events have a shorter survival time.

    In 2017, ibrutinib was approved in China.
    As the world’s first BTK inhibitor, ibrutinib has excellent clinical efficacy and good safety.
    As the world’s only BTK inhibitor with an 8-year follow-up, ibrutinib Its efficacy and safety have been tested for a long time.

    The indications currently approved for ibrutinib in China include chronic lymphocytic leukemia, Waldenstrom's macroglobulinemia, and relapsed and refractory mantle cell lymphoma.
    The three indications have been included in medical insurance, which will significantly reduce the treatment of lymphoma patients in my country Economic burden.

    With the widespread use of ibrutinib, more and more lymphoma patients can regain their hope of survival.

     This is the end of this lymphoma micro-class, thank you! Professor Xu Pengpeng, deputy chief physician of the Department of Hematology, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, doctor of medicine, master supervisor, visiting scholar, University of Nebraska School of Medicine, U.
    S.
    Secretary of Lymphocyte Disease Group, Chinese Society of Hematology, Chinese Society of Clinical Oncology Leukemia and Anti-Lymphoma Alliance Youth Member, Shanghai Anti-Cancer Association Lymphoma Professional Committee, Youth Committee, Youth Committee, Shanghai Medical Association Hematology Branch, Secretary and Evaluation Expert, Shanghai Hematology Clinical Quality Control Center, Shanghai Eighth Batch of Aid to Tibet Cadre talent, once served as the director of the Department of Hematology of the People’s Hospital of Xigaze City, Tibet Autonomous Region, and the deputy director of the central laboratory, presided over the National Natural Science Foundation of China, and the first or corresponding author of the project funded by the Shanghai Municipal Health Commission and the Education Commission.
    More than 20 papers published in well-known journals: 2021 EHA ABSTRACT: EP645CRC: MED-ONC-CN-2145, Expiration Date: 2022/5/20CRC: MED-ONC-CN-2201, Expiration Date: 2022/5/26 stamp "Read the original", we make progress together
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.