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    Home > Active Ingredient News > Antitumor Therapy > NEJM: Nivolumab for adjuvant treatment after radical resection of high-risk muscle invasive urothelial carcinoma

    NEJM: Nivolumab for adjuvant treatment after radical resection of high-risk muscle invasive urothelial carcinoma

    • Last Update: 2021-06-10
    • Source: Internet
    • Author: User
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    Muscle invasive urinary passage standard treatment for patients with epithelial cancer radical surgery, cancer of the bladder, including bladder or urinary tract tumor resection radical nephrectomy, but more than 50% of the pathological evidence of tumor invasion by intrinsic muscles involves areas or Patients with lymph nodes will have metastatic recurrence after surgery.
    Adjuvant chemotherapy is beneficial to prolong the disease-free survival rate of locally advanced patients, but its clinical application is not yet universal.
    Recently, researchers investigated the effect of nivolumab adjuvant chemotherapy after radical resection of high-risk muscle invasive urothelial cancer.

    Muscle invasive urinary passage standard treatment for patients with epithelial cancer radical surgery, cancer of the bladder, including bladder or urinary tract tumor resection radical nephrectomy, but more than 50% of the pathological evidence of tumor invasion by intrinsic muscles involves areas or Patients with lymph nodes will have metastatic recurrence after surgery.
    Adjuvant chemotherapy is beneficial to prolong the disease-free survival rate of locally advanced patients, but its clinical application is not yet universal.
    Recently, researchers investigated the effect of nivolumab adjuvant chemotherapy after radical resection of high-risk muscle invasive urothelial cancer.
    Recently, researchers investigated the effect of nivolumab adjuvant chemotherapy after radical resection of high-risk muscle invasive urothelial cancer.
    Recently, researchers investigated the effect of nivolumab adjuvant chemotherapy after radical resection of high-risk muscle invasive urothelial cancer.

    This study is a phase III , multi-center, double-blind, randomized, controlled trial.
    Patients with muscular invasive urothelial carcinoma who underwent radical surgery participated and were randomized to
    receive nivolumab ( 240 mg intravenously ) or comfort every 2 weeks.
    The agent lasts for 1 year.
    Allow cisplatin-based neoadjuvant chemotherapy before entering the trial.
    The primary endpoint of the study is the disease-free survival rate of all patients and those with PD-L1 expression levels of 1% or more.
    The secondary endpoint is the survival rate without extraurinary tract recurrence.

    This study is a phase III , multi-center, double-blind, randomized, controlled trial.
    Patients with muscular invasive urothelial carcinoma who underwent radical surgery participated and were randomized to
    receive nivolumab ( 240 mg intravenously ) or comfort every 2 weeks.
    The agent lasts for 1 year.
    Allow cisplatin-based neoadjuvant chemotherapy before entering the trial.
    The primary endpoint of the study is the disease-free survival rate of all patients and those with PD-L1 expression levels of 1% or more.
    The secondary endpoint is the survival rate without extraurinary tract recurrence.

    353 patients received nivolumab treatment and 356 patients received placebo.
    In all populations, the median disease-free survival of the
    nivolumab group was 20.
    8 months, and that of the placebo group was 10.
    8 months.
    The percentage of patients who were alive and disease-free at 6 months was 74.
    9%
    in the nivolumab group and 60.
    3% in the
    placebo group (the risk ratio of disease recurrence or death was 0.
    70
    ).
    Among
    patients with PD-L1 expression level ≥ 1% , the percentages of patients who were alive and disease-free at 6 months were 74.
    5%
    and 55.
    7%
    (hazard ratio 0.
    55
    ).
    In all populations, the median survival without extraurinary tract recurrence was
    22.
    9
    months in the nivolumab group and 13.
    7
    months in the placebo group .
    The percentage of patients who were alive at 6 months without extraurinary tract recurrence was 77.
    0%
    in the nivolumab group and 62.
    7% in the
    placebo group (the risk ratio of extraurinary tract recurrence or death was 0.
    7
    ).
    In
    patients with PD-L1 expression level ≥ 1% ,The percentages of patients who were alive at 6 months without recurrence outside the urinary tract were 75.
    3%
    and 56.
    7%
    (hazard ratio 0.
    55
    ).
    17.
    9%
    of patients in the nivolumab group had treatment-related adverse events of grade 3 or higher, compared with 7.
    2% in the
    placebo group .
    There were two treatment-related pneumonia deaths in the nivolumab group.

    353 patients received nivolumab treatment and 356 patients received placebo.
    In all populations, the median disease-free survival of the nivolumab group is
    in all populations, and the median disease-free survival of the nivolumab group is in all populations, and the median disease-free survival of the nivolumab group is in all populations.
    The disease survival period was
    20.
    8 months, compared with 10.
    8 months in the placebo group.
    20.
    8 months, compared with 10.
    8 months in the placebo group.
    The percentage of patients who were alive and disease-free at 6 months was 74.
    9%
    in the nivolumab group and 60.
    3% in the
    placebo group (the risk ratio of disease recurrence or death was 0.
    70
    ).
    Among
    patients with PD-L1 expression level ≥ 1% , the percentages of patients who were alive and disease-free at 6 months were 74.
    5%
    and 55.
    7%, respectively
    (hazard ratio 0.
    55
    ).
    In all populations, the median survival without extraurinary tract recurrence was
    22.
    9
    months in the nivolumab group and 13.
    7
    months in the placebo group .
    The percentage of patients who were alive at 6 months without extraurinary tract recurrence was 77.
    0%
    in the nivolumab group and 62.
    7% in the
    placebo group (the risk ratio of extraurinary tract recurrence or death was0.
    7
    ).
    Among
    patients with PD-L1 expression level ≥ 1%, the percentages of patients who were alive at 6 months without recurrence outside the urinary tract were 75.
    3%
    and 56.
    7%
    (hazard ratio 0.
    55
    ).
    17.
    9%
    of patients in the nivolumab group had treatment-related adverse events of grade 3 or higher, compared with 7.
    2% in the
    placebo group .
    There were two treatment-related pneumonia deaths in the nivolumab group.

    Differences in disease-free survival between all populations and PD-L1 positive populations

    Differences in disease-free survival between all populations and PD-L1 positive populations

    In patients with high-risk muscle invasive urothelial cancer who have undergone radical surgery, adjuvant nivolumab treatment can significantly prolong the disease-free survival of the patients .

    In patients with high-risk muscle invasive urothelial cancer who have undergone radical surgery, adjuvant nivolumab treatment can significantly prolong the disease-free survival of the patients .
    In patients with high-risk muscular invasive urothelial cancer who have undergone radical surgery, adjuvant nivolumab treatment can significantly prolong the disease-free survival of the patient.
    Among patients with high-risk muscular invasive urothelial cancer who have undergone radical surgery , Adjuvant therapy with nivolumab can significantly prolong the disease-free survival of patients

    Original source:

    Original source:

    Dean F.
    Bajorin et al.
    Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma.
    N Engl J Med, June 3, 2021.

    Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma.


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