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Homepage – Forum Forums Research, Clinical Trials, and New Treatments Heath Canada approved immunotherapy as adjuvant treatment for cystectomy

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    It looks like Health Canada approved Nivolumab (Opdivo (R))  immune checkpoint inhibitor by Bristle Meyers Squibb as adjuvant chemotherapy  for high risk bladder cancer after cystectomy.  Nivolumab is available immediately through compassion access while funding is reviewed.  Tweeted by Dr. Peter Black

    Nivolumab for adjuvant treatment had been approved in the US on August 19,2021 as the result of the clinical trial CHECKMATE-274 (NCT02632409) and for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection.   I do not know exact eligibility criteria but definitely sounds worth while to check it with your urologist if you are going to have radical cystectomy now or if you had radical cystectomy recently.  My understanding is the patients who had cystectomy within 120 days were included in the clinical trial, so those patients would likely be eligible.

    In the clinical trial, 709 patients were assigned to receive 20mg of Nivolumab or placebo as infusion every 2 weeks for up to 1 year.  The primary end points were disease free survival among all patients and among those with PD-L1 expression level of 1% or more.

    The result shows  as follows

    • 6 month disease free survival in the Intention-to-Treat Population  :  74.9% among Nivolumab group and 60.3% among Placebo group.    ** note I have not figured our what Intention to Treat means.
    • 6 month disease free survival in patients wit PD-L1 of 1% or More    :  74.5% among Nivolumab group and 55.7% among Placebo group.

    Eligibility for the treatment is not clear for me, but  below are the list of eligibility for the clinical trial which likely apply to the eligibility of the treatment.  Your urologist can figure it out for you.

    • Patients must have had radical cystectomy within 120 days of the start of the treatment
    • Patients who had radical cystectomy with or without neoadjuvant cisplatin-based chemotherapy are likely included.
    • Patients must have had pathological evidence of urothelial carcinoma (originating in the bladder, ureter, or renal pelvis) with a high risk of recurrence (pathological stage of pT3, pT4a, or pN+ and patient not eligible for or declined adjuvant cisplatin-based combination chemotherapy for patients who had not received neoadjuvant cisplatin-based chemotherapy and pathological stage of ypT2 to ypT4a or ypN+ for patients who received neoadjuvant cisplatin)   ** all muscle invasive bladder cancer patients are included except T2   ** I do not fully understand this part

    Nivolumab (240 mg) or placebo is administered every 2 weeks as a 30-minute intravenous infusion for up to 1 year or until disease recurrence or till discontinuation due to severe side effcects.   The side effects of Nivolumab (Opdivo)   and Pembrolisumab (Keytruda) should be similar as both are PD-1 immune check point inhibitors ** my comment.

    Above is the summary of Nivolumab for Adjuvant therapy after radical cystectomy.   I will apology ahead of some errors and omissions.

    Anyway talk to your urologist if you are planning to have radical cystectomy or you had cystectomy recently like this year.


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