Editing Non-Muscle Invasive Bladder Cancer (section)

===== Efficacy =====
*'''<span style="color:#ff0000">Superior to chemotherapy to reduce recurrence (ARR 25% vs. 12%), and only agent to reduce progression (ARR 4%)</span>'''

====== Recurrence ======
* '''<span style="color:#ff00ff">Cochrane review</span>'''
** 6 randomized trials involving 585 patients
** The total number of patients presenting with tumour recurrence at 12 months was 79 (26%) in the BCG plus TUR group and 144 (51%) in the TUR alone group (absolute risk reduction in recurrence of 25%)
** Intravesical Bacillus Calmette-Guerin in Ta and T1 Bladder Cancer. [https://pubmed.ncbi.nlm.nih.gov/11034738/ Cochrane Database Syst Rev. 2000;(4):CD001986.]
* '''BCG has been shown to be superior to doxorubicin or epirubicin and similar to mitomycin with regard to preventing recurrence.'''

====== Progression ======
* '''<span style="color:#ff00ff">SWOG-8216/38</span>'''
** 262 patients
** Randomized to 1 year maintenance doxorubicin vs. 1-years BCG
** Results:
*** Progression rate 15% BCG vs. 37% doxorubicin
** A randomized trial of intravesical doxorubicin and immunotherapy with bacille Calmette-Guérin for transitional-cell carcinoma of the bladder. [https://pubmed.ncbi.nlm.nih.gov/1922207/ N Engl J Med. 1991 Oct 24;325(17):1205-9.]
* '''<span style="color:#ff00ff">Meta-analysis of trials evaluating BCG on risk of NMIBC progression</span>'''
** 24 trials with progression information on 4,863 patients
** Results:
*** Based on a median follow-up of 2.5 years and a maximum of 15 years, progression rate 10% BCG vs. 14% control (OR 0.73, p = 0.001'''), absolute risk reduction in progression of 4%.''' The percent of patients with progression was low reflecting the short follow-up and relatively low risk patients entered in many of the trials. The size of the treatment effect was similar in patients with papillary tumors and in those with carcinoma in situ. '''However, only patients receiving maintenance BCG benefited from reduced risk of progression.'''
*** There was no statistically significant difference in treatment effect for either overall survival or death due to bladder cancer.
** Intravesical bacillus Calmette-Guerin reduces the risk of progression in patients with superficial bladder cancer: a meta-analysis of the published results of randomized clinical trials. [https://pubmed.ncbi.nlm.nih.gov/12394686/ J Urol. 2002 Nov;168(5):1964-70.]
* '''Increased risk of side effects compared to intravesical chemotherapy; BCG should be used cautiously for patients with low-risk disease because of concern about side effects'''
** BCG has a greater risk of adverse events, both local (granulomatous cystitis, dysuria, hematuria) and systemic (fever), as compared to most intravesical chemotherapies. Thus, when the recurrence risk is moderate and intravesical therapy is felt appropriate, a better-tolerated intravesical chemotherapy may have a better risk to benefit ratio than BCG when the primary goal is to prevent recurrence.
** '''<span style="color:#ff00ff">Cochrane Review on BCG vs. MMC in NMIBC</span>'''
*** 6 trials involving 1527 patients
*** Results
**** Tumour recurrence was significantly reduced with intravesical BCG compared to MMC only in the subgroup of patients at high risk of tumour recurrence. However, there was no difference in terms of disease progression or survival, and the decision to use either agent might be based on adverse events and cost.
*** Intravesical bacillus Calmette-Guerin versus mitomycin C for Ta and T1 bladder cancer. [https://pubmed.ncbi.nlm.nih.gov/12917955/ Cochrane Database Syst Rev. 2003;(3):CD003231.]