Objectives: To examine the utility and efficacy of a multifaceted protocol for the administration of intravesical bacillus Calmette-Guerin (BCG) for non-muscle-invasive bladder cancer (NMIBC).
Subjects and methods: A multicenter retrospective review was conducted among 83 patients undergoing Fremantle protocol intravesical BCG for NMIBC within 4 major hospitals in Western Australia between January 2016 and December 2018. The Fremantle protocol consists of weekly BCG instillations for 6 weeks during the induction phase, followed by monthly BCG instillations for 10 months during the maintenance phase with integrated clearance-to-proceed algorithms for urine MSU checks, flexible cystoscopies performed at 3 monthly intervals during maintenance BCG, and repeat GA cystoscopies with four quadrant bladder biopsies routinely obtained following the completion of induction and maintenance treatment.
Results: For patients undergoing Fremantle protocol BCG, 98.8% (82/83) and 75.9% (63/83) of patients completed their induction and maintenance courses of BCG, respectively. Induction BCG was delivered over a median duration of 35 days (range 34-84 days), and maintenance BCG was delivered over a median duration of 266 days (range 1-682 days). The tumor recurrence rate was 10.8% (9/83) at the time of post-induction biopsies, 2.4% (2/83) during maintenance treatment, 0% (0/60) at the time of post-maintenance biopsies, and 8.8% (5/57) after a median further follow-up of 16 months (range 0-51 months).
Conclusion: The Fremantle protocol appears to be a safe and effective BCG regimen with several advantages over other BCG protocols, including high completion rates, low recurrence rates, and being highly pragmatic.
Keywords: Mycobacterium bovis; cystoscopy; immunotherapy; neoplasms; urinary bladder.
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