The global bacillus Calmette-Guérin (BCG) shortage has prompted the use of alternative treatment strategies for patients with intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC). One such strategy is split-vial dosing which allows several patients to be treated from a single vial of BCG. We evaluated the impact of one-third dose BCG on oncological outcomes in a large cohort of patients with NMIBC treated with adequate BCG in a real-world setting.
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 one-third dose (1/3D) BCG or full dose (FD) BCG. Time to recurrence, time to progression and cancer-specific survival were estimated using Kaplan-Meier methods.
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 EAU prognostic factor risk groups. Cancer-specific survival was similar between patients receiving 1/3D and FD BCG (p=0.320).
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.
BJU international. 2021 Nov 30 [Epub ahead of print]
Niyati Lobo, Kelly K Bree, Patrick J Hensley, Graciela M Nogueras-Gonzalez, Prasanth Abraham, Neema Navai, Colin P Dinney, Ashish M Kamat
Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.