Objectives: To investigate bacille Calmette–Guérin (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 Methods: A 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. Results: A 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). Conclusion: The 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.
|Number of pages||8|
|State||Published - Nov 2021|
Bibliographical noteFunding Information:
This research was supported by the Wayne B. Duddlesten Professorship in Cancer Research, the Raymond and Maria Floyd Bladder Cancer Research Foundation Grant to Ashish M. Kamat, National Institutes of Health (NIH)/National Cancer Institute (NCI) University of Texas MD Anderson Specialized Programs of Research Excellence (SPORE) in Genitourinary Cancer (Bladder) (P50CA091846) to Colin P. Dinney, and a Urology Care Foundation Research Scholars Award to Patrick J. Hensley (IRG 85‐001‐25).
This research was supported by the Wayne B. Duddlesten Professorship in Cancer Research, the Raymond and Maria Floyd Bladder Cancer Research Foundation Grant to Ashish M. Kamat, National Institutes of Health (NIH)/National Cancer Institute (NCI) University of Texas MD Anderson Specialized Programs of Research Excellence (SPORE) in Genitourinary Cancer (Bladder) (P50CA091846) to Colin P. Dinney, and a Urology Care Foundation Research Scholars Award to Patrick J. Hensley (IRG 85-001-25).
The authors report the following financial interests: Kelly K. Bree: Stratify genomics – consultant. Roger Li: Clinical trial protocol committee – CG Oncology; scientific advisor/consultant – BMS, Ferring, Fergene, Arquer Diagnostics. Colin P. Dinney: National Cancer Institutes and University of East Finland Faculty of Health Sciences research funding; grant and personal fees from FKD Therapies; creator of intellectual property owned by UT/MDACC related to the use of genetic alterations as a predictive biomarker for response to Nadofaragene firadenovac. Ashish M. Kamat: personal fees from Abbott Molecular, Arquer, ArTara, Asieris, Astra Zeneca, BioClin Therapeutics, Cepheid, Cold Genesys, Eisai, Engene, Inc., Ferring, FerGene, Imagin, Janssen, MDxHealth, Medac, Nucleix, Pfizer, ProTara, Roviant, Seattle Genetics, Sessen Bio, Theralase, TMC Innovation, US Biotest; personal fees and other from Merck, BMS, Photocure; other from Adolor, Heat Biologics, FKD Industries; grants from CEC Oncology; and patent for CyPRIT‐Cytokine Panel for Response to Intravesical Immunotherapy pending.
© 2021 The Authors BJU International © 2021 BJU International
- bacille Calmette–Guérin
- bladder cancer
- intravesical therapy
- transurethral resection of bladder tumour
ASJC Scopus subject areas