Editing Non-Muscle Invasive Bladder Cancer (section)

===== Indications =====
* '''<span style="color:#ff0000">See</span> [[CUA/AUA: Non-muscle Invasive Bladder Cancer (2021 CUA/2016 AUA))|2016 AUA/2021 CUA NMBIC]] <span style="color:#ff0000">Guideline Notes</span>'''
* '''Campbell’s'''
** '''The AUA guidelines panel supported BCG as the preferred initial treatment option for CIS'''
** '''Treatment of residual tumour'''
*** '''Intravesical BCG can effectively treat residual papillary lesions but should not be used as a substitute for surgical resection'''
** '''<span style="color:#ff0000">Maintenance BCG</span>'''
*** '''The optimal dose and the treatment schedule for BCG are undetermined, but results are better with maintenance therapy, if tolerated'''
*** '''<span style="color:#ff00ff">SWOG 8507'''
**** '''Population: 550 patients'''
**** '''Randomized to <span style="color:#ff0000">induction (weekly x 6 weeks)</span> vs. induction + maintenance'''
***** '''<span style="color:#ff0000">Maintenance therapy consisted of intravesical</span> and percutaneous <span style="color:#ff0000">BCG each week for 3 weeks given 3, 6, 12, 18, 24, 30 and 36 months from initiation of induction therapy.</span>'''
**** '''Results'''
***** '''5-year recurrence-free survival 41% in induction only and 60% in induction + maintenance; <span style="color:#ff0000">absolute risk reduction in recurrence of 19%</span>'''
***** '''Only 16% of patients tolerated the full dose-schedule regimen. Two thirds of the patients who stopped BCG because of side effects did so in the first 6 months, suggesting that the side effects do not increase appreciably with additional time on therapy.'''
**** '''Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study. [https://pubmed.ncbi.nlm.nih.gov/10737480/ J Urol. 2000 Apr;163(4):1124-9.]'''
*** '''BCG''' '''dose reduction''' 
**** '''In general, a decrease in toxicity with no statistical difference in efficacy has been noted in small series'''
**** '''CUA: Several European studies have demonstrated that the BCG dose can be reduced to one-third or one-quarter with a reduction in toxicity but comparable efficacy.'''
***** '''However, Morales and colleagues have shown that dose reduction is associated with decreased efficacy in North American patients. Recently, a randomized trial of 1355 patients with intermediate and high-risk NMIBC compared full-dose and one-third dose BCG and 1-year and 3-year maintenance. This trial showed that a 3-year maintenance of full-dose BCG had superior recurrence-free rates without increased toxicity. No differences in progression or overall survival were demonstrated.'''
**** '''AUA: In favor of standard dose BCG, a meta-analysis demonstrated improved recurrence free survival with standard dose as compared to a reduced dose but no difference in progression free survival.'''
***** '''The largest individual study of 1,355 patients (EORTC 30962) compared different BCG strengths (full dose versus 1/3 dose) and different BCG maintenance schedules (1 year versus 3 years) and found no difference in recurrence free survival between 1/3 dose and full dose administered for either 1 year or 3 years. However, in high-risk patients (patients with high grade, T1 tumors), the 3 year full dose schedule had an improved recurrence free survival as compared to the 1 year 1/3 dose schedule, leading the authors to recommend full dose BCG in this patient subgroup'''