Reduced-dose bacillus Calmette-Guérin (BCG) in an era of BCG shortage: real-world experience from a tertiary cancer centre

Niyati Lobo, Kelly K. Bree, Patrick J. Hensley, Graciela M. Nogueras-Gonzalez, Prasanth Abraham, Neema Navai, Colin P. Dinney, Ashish M. Kamat

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


Objective: To evaluate the impact of one-third-dose (1/3D) bacillus Calmette-Guérin (BCG) on oncological outcomes in a large cohort of patients with non-muscle-invasive bladder cancer (NMIBC) treated with adequate BCG (as defined by the US Food & Drug Administration (FDA)) in a real-world setting. Patients and Methods: We performed an institutional review board-approved review of patients with NMIBC treated with adequate BCG at our institution between 2000 and 2020. Patients were stratified according to whether they had received 1/3D BCG or full-dose (FD) BCG. Time to recurrence, time to progression and cancer-specific survival were estimated using Kaplan–Meier methods. Results: Of 563 patients with NMIBC treated with adequate BCG, 150 (26.6%) received 1/3D and 413 (73.4%) received FD. The use of 1/3D BCG did not adversely affect time to recurrence (P = 0.449) or time to progression (P = 0.716), and this remained consistent when patients were stratified by individual 2021 European Association of Urology (EAU) prognostic factor risk groups. Cancer-specific survival was similar in patients receiving 1/3D and those receiving FD BCG (P = 0.320). Conclusion: The use of 1/3D BCG was not associated with adverse oncological outcomes in a large cohort of patients receiving adequate BCG for intermediate- and high-risk NMIBC. Based on this real-world experience, risk-stratified split-vial dosing may represent a valuable approach for other institutions facing BCG shortages whilst also providing reassurance to patients who may be concerned about suboptimal outcomes.

Original languageEnglish
Pages (from-to)323-330
Number of pages8
JournalBJU International
Issue number3
StatePublished - Sep 2022

Bibliographical note

Funding Information:
The authors report the following financial interests: 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 the University of Texas MD Anderson Cancer Center related to the use of genetic alterations as a predictive biomarker for response to Nadofaragene firadenovac. Ashish M. Kamat is a consultant or advisory board member for Abbott Molecular, Arquer Diagnostics, ArTara Therapeutics, Asieris Pharmaceuticals, AstraZeneca, BioClin Therapeutics, Bristol Myers Squibb, Cepheid, Cold Genesys, Eisai, Engene, Ferring Pharmaceuticals, FerGene, Imagine Pharma, Janssen, MDxHealth, Medac, Merck, Pfizer, Photocure, ProTara Therapeutics, Roviant Sciences, Seattle Genetics, Sessen Bio, Theralase Technologies, TMC Innovation and US Biotest. A.M.K. has received grants and/or research support from Adolor Corporation, Bristol Myers Squibb, FKD Industries, Heat Biologics, Merck, Photocure, SWOG/NIH, Specialized Programs of Research Excellence (SPORE) and AIBCCR. A.M.K. also holds the patent for Cytokine Predictors of Response to Intravesical Therapy (CyPRIT) joint with the UT MD Anderson Cancer Center. in situ

Funding Information:
This research was supported by the Wayne B. Duddlesten Professorship in Cancer Research and the Raymond and Maria Floyd Bladder Cancer Research Foundation to Ashish M. Kamat, the Urology Foundation Fulbright Scholar Award to Niyati Lobo and a Cancer Center Support Grant (NCI Grant P30 CA016672) to Graciela M. Nogueras‐Gonzalez.

Publisher Copyright:
© 2021 The Authors BJU International © 2021 BJU International.


  • BCG shortage
  • bacillus Calmette-Guérin
  • non-muscle-invasive bladder cancer
  • reduced dose

ASJC Scopus subject areas

  • Urology


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