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Modified BCG Regimen Yields Acceptable Oncologic Outcomes Among Patients With High-Risk Non-Muscle-Invasive Bladder Cancer
According to a phase 2 clinical trial, the use of 12 instillations of bacillus Calmette-Guèrin (BCG) therapy may provide an alternative treatment option to the standard induction plus 3 years of maintenance therapy.
Andrew Katims, MD, MPH, Memorial Sloan Kettering Cancer Center, New York, and coauthors wrote, “With the ongoing bacillus Calmette-Guèrin shortage, alternate therapeutic options for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are needed.”
In this clinical trial, 81 patients were enrolled to receive 2 induction courses, 12 intravesical instillations, of BSG without maintenance therapy. The main outcomes were recurrence-free survival (RFS) and cancer-specific survival (CSS) as assessed by a landmark analysis at 7.5 months.
Of 77 patients, 63 were able to complete all 12 instillations. There was a 91% complete response rate at 6 months. There were 75 patients evaluable for long-term follow-up analysis. There were 21 patients who experienced a high-grade recurrence, resulting in a 5-year RFS rate of 69%. There were 3 deaths due to bladder cancer which yielded a CSS rate of 97%. On a regimen of 2 induction courses, there was a reduction in the amount of BCG vials used, from 27 vials to 12 vials per patient.
Dr Katims et al concluded, “Twelve induction instillations of BCG without maintenance for patients with high-risk NMIBC reduced the number of vials needed per patient while providing acceptable oncologic outcomes.” They went on, “Given the ongoing BCG shortage, this modified regimen may provide a suitable alternative in this setting.”
Source:
Katims AB, Tallman J, Vertosick E, et al. Response to 2 induction courses of bacillus Calmette-Guèrin therapy among patients with high-risk non-muscle-invasive bladder cancer: 5-year follow-up of a phase 2 clinical trial. JAMA Oncol. Published online February 15, 2024. doi:
