Recent Updates
Active Surveillance Matches BCG Therapy for Select Patients With High-Grade T1 Bladder Cancer
A phase 3 trial found active surveillance was noninferior to BCG for select high-grade T1 bladder cancer patients after complete tumor removal.
The landmark JCOG1019 phase 3 trial challenges the traditional approach to treating high-grade T1 bladder cancer by demonstrating that active surveillance (AS) is just as effective as intravesical Bacillus Calmette-Guérin (BCG) therapy in carefully selected patients.
For those who underwent complete tumor removal during initial transurethral resection (TURB) and showed no residual disease after a second TURB, AS provided comparable survival outcomes while significantly reducing treatment-related toxicity.
The trial enrolled 513 patients, randomizing 263 of them into either AS or 8 weeks of BCG induction therapy without maintenance. Over a median follow-up of 48 months, AS proved noninferior to BCG in invasive relapse-free survival (hazard ratio, 0.69; P=.001). Importantly, AS showed a markedly better safety profile, with fewer adverse events overall (50% vs 90%) and similar rates of severe events (grade ≥3, 3.1% vs. 3.8%).
For oncology teams, these findings suggest that AS can be a viable alternative for patients with high-grade T1 bladder cancer who have no residual disease on second TURB. This approach not only minimizes overtreatment but also reduces reliance on BCG—a critical consideration given ongoing global shortages. AS could represent a shift toward more individualized, risk-adapted care for this patient population.
While AS is not yet the standard of care, this trial provides strong evidence to support its use in highly selected cases. By integrating these findings into clinical practice, oncology teams can offer patients safer, effective treatment options that align with their unique needs.
Active surveillance is emerging as a practical and patient-friendly strategy for managing select cases of high-grade T1 bladder cancer, giving oncology teams more flexibility in delivering tailored care.
Reference
Kitamura H, Tsukamoto T, Kakehi Y, et al. Active surveillance versus intravesical bacillus Calmette-Guérin for high-grade T1 bladder cancer with negative second transurethral resection: the randomized noninferiority phase 3 JCOG1019 Trial. Eur Urol. 2026;89:437-445. Online ahead of print.
The landmark JCOG1019 phase 3 trial challenges the traditional approach to treating high-grade T1 bladder cancer by demonstrating that active surveillance (AS) is just as effective as intravesical Bacillus Calmette-Guérin (BCG) therapy in carefully selected patients.
For those who underwent complete tumor removal during initial transurethral resection (TURB) and showed no residual disease after a second TURB, AS provided comparable survival outcomes while significantly reducing treatment-related toxicity.
The trial enrolled 513 patients, randomizing 263 of them into either AS or 8 weeks of BCG induction therapy without maintenance. Over a median follow-up of 48 months, AS proved noninferior to BCG in invasive relapse-free survival (hazard ratio, 0.69; P=.001). Importantly, AS showed a markedly better safety profile, with fewer adverse events overall (50% vs 90%) and similar rates of severe events (grade ≥3, 3.1% vs. 3.8%).
For oncology teams, these findings suggest that AS can be a viable alternative for patients with high-grade T1 bladder cancer who have no residual disease on second TURB. This approach not only minimizes overtreatment but also reduces reliance on BCG—a critical consideration given ongoing global shortages. AS could represent a shift toward more individualized, risk-adapted care for this patient population.
While AS is not yet the standard of care, this trial provides strong evidence to support its use in highly selected cases. By integrating these findings into clinical practice, oncology teams can offer patients safer, effective treatment options that align with their unique needs.
Active surveillance is emerging as a practical and patient-friendly strategy for managing select cases of high-grade T1 bladder cancer, giving oncology teams more flexibility in delivering tailored care.
Reference
Kitamura H, Tsukamoto T, Kakehi Y, et al. Active surveillance versus intravesical bacillus Calmette-Guérin for high-grade T1 bladder cancer with negative second transurethral resection: the randomized noninferiority phase 3 JCOG1019 Trial. Eur Urol. 2026;89:437-445. Online ahead of print.
