A PILOT study of 40 patients with non-muscle invasive bladder cancer has shown that two doses of a tuberculosis vaccine after surgery significantly boosts immune response and reduces cancer recurrence, with all vaccinated patients remaining cancer-free after five years.
Bladder cancer, the ninth most common cancer globally, affects over 600,000 people annually. Non-muscle invasive bladder cancer, an early-stage form, typically requires surgery followed by Bacillus Calmette Guerin (BCG) immunotherapy. However, up to 50% of patients experience disease recurrence or progression. The RUTIVAC-1 Trial, presented at the 40th European Association of Urology Congress in Madrid, explored whether an additional non-live TB vaccine could enhance treatment efficacy.
In this randomised controlled trial, researchers administered the TB vaccine alongside standard treatment to half of the 40 participants. The vaccine significantly enhanced BCG-induced immune response compared to the control group. Remarkably, all patients in the TB group remained tumour-free after five years, compared to 13 of 18 patients in the control group. The vaccine was well-tolerated, with only mild injection site reactions and no systemic adverse effects reported.
These promising results suggest that TB vaccination could significantly improve outcomes for bladder cancer patients, particularly those with high-grade T1 tumours. However, the researchers emphasise the need for larger trials to confirm these findings before wider clinical implementation. For urologists and oncologists, this approach represents a potential paradigm shift in bladder cancer management, offering a simple, well-tolerated adjunct to current therapies that could dramatically reduce recurrence rates. Future research should focus on optimising dosing schedules, identifying patient subgroups most likely to benefit, and exploring potential synergies with other immunotherapies.
Reference
Martinez Rodriguez RH et al. TB vaccine before Intravesical BCG boosts Immunity and reduces recurrence in bladder cancer patients. EAU Annual Congress, 23 March, 2025.
