📃 Paper Title: Treatment of High-grade Non-muscle-invasive Bladder Carcinoma by Standard Number and Dose of BCG Instillations Versus Reduced Number and Standard Dose of BCG Instillations: Results of the European Association of Urology Research Foundation Randomised Phase III Clinical Trial "NIMBUS"
🧍 Author: Marc-Oliver Grimm
🕒 Year: 2020
📚 Journal: European Urology
🌎 Country: Germany
ㅤContext to the study:
Can you tell me about a trial that investigated the standard number and dosage of BCG Instillations for the treatment of Bladder Cancer?
ㅤ✅ Take-home message of study:
Take Home Messages (plain language summary):
Bacillus Calmette-Guérin treatment is implemented in high grade non-muscle-invasive bladder cancer to reduce the risk of recurrence and progression.
Reducing the number of BCG treatments to 9 from the standard of 15 leads to inferior outcomes in treatment of high grade non-muscle-invasive bladder cancer.
ㅤ Non-blinded Prospective randomised control trial
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Study participants:
Total of 345 patients.
51 sites, across 5 countries.
Recruitment between December 2013 and July 2019.
Inclusion:
BCG-naïve
high-grade Ta or T1, primary or recurrent, single or multiple urothelial papillary carcinoma, with or without carcinoma in situ
Exclusion:
previous systemic or multi-instillation intravesical chemotherapy
tumours in upper urinary tract or prostatic urethra or other malignancy or localised prostate cancer
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Key study outcomes:
Median follow-up: 12 months
Primary endpoint: Time to first recurrence
Recurrence found in:
27% of patients receiving a reduced number (9) of BCG instillations
12% of patients receiving standard number (15) of BCG instillations.
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Study Limitations:
Relatively small sample size.
Lack of a central pathology review.
Unstratified use of photodynamic diagnostics.
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