Intravesical Bacillus Calmette-Guérin versus mitomycin C for Ta and T1 bladder cancer

Schmidt, Stefanie; Kunath, Frank; Coles, Bernadette; Draeger, Desiree Louise; Krabbe, Laura‐Maria; Dersch, Rick; Kilian, Samuel; Jensen, Katrin; Dahm, Philipp; Meerpohl, Joerg J

doi:10.1002/14651858.cd011935.pub2

Cited by 30 publications

(23 citation statements)

References 126 publications

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“…Another treatment option for patients with recurrent high-risk NMIBC or BCG-unresponsive disease is intravesical chemotherapy; agents are gemcitabine, mitomycin and valrubicin [3,6,24]. Published results of studies do not report improvements in efficacy with intravesical gemcitabine or mitomycin relative to intravesical BCG in intermediate-to high-risk NMIBC [25][26][27], although intravesical valrubicin can be useful to select patients with CIS [28]. However, a recent meta-analysis to examine the use of intravesical chemotherapy in combination with BCG reported significant improvements in recurrence-free survival (RFS), overall survival (OS) and disease-specific survival (DSS), compared with BCG alone in patients with intermediate-to high-risk NMIBC [29].…”

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confidence: 99%

KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC

et al. 2020

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Background: Nonmuscle-invasive bladder cancer (NMIBC) is the most common form of bladder cancer, with high rates of disease recurrence and progression. Current treatment for high-risk NMIBC involves Bacillus Calmette-Guérin (BCG) therapy, but treatment options are limited for patients with recurrent or BCG-unresponsive disease. Aberrant programmed death 1 signaling has been implicated in BCG resistance and bladder cancer recurrence and progression, and pembrolizumab has shown efficacy in patients with BCG-unresponsive high-risk NMIBC. Aim: To describe the rationale and design for the randomized, comparator-controlled Phase III KEYNOTE-676 study, which will evaluate the efficacy and safety of pembrolizumab in combination with BCG in patients with persistent/recurrent high-risk NMIBC after BCG induction therapy. Trial registration number: NCT03711032

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confidence: 99%

KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC

et al. 2020

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“…While BCG has been associated with more severe and frequent adverse effects compared to other intravesical chemotherapy agents [13], these generally tolerable symptoms have no apparent impact on long-term quality of life [14]. Furthermore, there is no evidence to suggest early BCG administration is associated with adverse events and there were no cases of BCG sepsis in the 153 patients who received BCG within 19 days of TURBT in our present cohort (quartile 1).…”

Section: Discussionmentioning

confidence: 65%

Time interval from transurethral resection of bladder tumour to bacille Calmette–Guérin induction does not impact therapeutic response

et al. 2021

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To investigate bacille Calmette-Gu erin (BCG) tolerability and response with respect to the timing of BCG administration after transurethral resection of bladder tumour (TURBT) in patients with non-muscle-invasive bladder cancer (NMIBC). Patients and MethodsA review of patients with NMIBC at our institution managed with at least 'adequate BCG' (defined by the United States Food and Drug Administration as at least five of six induction instillations, with two additional instillations comprising either maintenance or repeat induction) at our institution from 2000 to 2018 was performed. Time from TURBT to first instillation of induction BCG was stratified by quartile and analysed as a continuous variable. Kaplan-Meier and log-rank tests analysed differences in recurrence-free (RFS) and progression-free survival (PFS). Cox proportional hazards regression models identified associations between risk factors and survival outcomes. ResultsA total of 518 patients received adequate BCG at a median (range) of 26 (6-188) days from TURBT. Overall, 45 patients (9%) developed BCG intolerance at a median (range) 12 (7-33) instillations. When time from TURBT to BCG was stratified into quartiles, there was no difference with respect BCG intolerance (P = 0.966), RFS (P = 0.632) or PFS (P = 0.789). On both uni-and multivariate regression analysis for RFS and PFS, time from TURBT to BCG was not a significant predictor when analysed by quartile or as a continuous variable (the hazard ratio for RFS was 1.00, 95% confidence interval [CI] 0.99-1.00, P = 0.449; and for PFS was 0.99, 95% CI 0.98-1.00, P = 0.074). ConclusionThe rates of tolerability and response to adequate BCG are not predicated by the timing of induction BCG instillation after TURBT. Early administration in properly selected patients is safe and delays do not affect therapeutic response.

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“…46,51 The most common local side effect of BCG instillation is the development of cystitis-like symptoms (urgency, dysuria, and increased urinary frequency) that can be present in up to 71% of patients. 52 The management of BCG-related adverse effects is presented in Table 4.…”

Section: Oncological Outcomes and Bcgmentioning

confidence: 99%

Canadian Urological Association guideline on the management of non-muscle-invasive bladder cancer – Abridged version

Bhindi¹,

Kool²,

Kulkarni³

et al. 2021

CUAJ

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Intravesical Bacillus Calmette-Guérin versus mitomycin C for Ta and T1 bladder cancer

Abstract: Analysis 3.1. Comparison 3 Di erent doses of mitomycin C (MMC) (subgroup analyses), Outcome 1 Time to recurrence (subgroup analyses

Cited by 30 publications

References 126 publications

KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC

KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC

Time interval from transurethral resection of bladder tumour to bacille Calmette–Guérin induction does not impact therapeutic response

Canadian Urological Association guideline on the management of non-muscle-invasive bladder cancer – Abridged version

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