Watchful waiting is non-inferior to BCG in patients with T0 after second transurethral resection

For patients with high-grade T1 bladder cancer without residual tumour after second transurethral resection, watchful waiting was non-inferior to intravesical Bacillus Calmette-Guérin (BCG) in the phase 3 JCOG1019 trial.

The standard treatment of T1 bladder cancer, which comprises ~20% of non-muscle invasive bladder cancer, is transurethral resection of bladder tumour (TURBT) followed by a second transurethral resection and intravesical BCG [1]. However, there is no evidence showing that intravesical BCG is necessary for patients with high-grade pT1 bladder cancer who have T0 histology after the second TUR.

Prof. Hiroshi Kitamura (University of Toyama, Japan) and colleagues aimed to confirm the non-inferiority of watchful waiting to intravesical BCG in patients with high-grade T1 bladder cancer with pT0 after the second TUR in the phase 3 JCOG1019 study (UMIN000006390) [2]. The trial randomised 263 participants with T0 after a second TUR 1:1 to watchful waiting or 8 courses of intravesical BCG (82% completed BCG).

Relapse-free survival (RFS), the primary endpoint, was not different between arms: 5-year RFS was 81.8% in the BCG arm versus 86.5% in the watchful waiting arm (HR 0.69; 95% CI 0.44–1.08; P_{non-inferiority}=0.00102) (see Figure). Likewise, watchful waiting was statistically non-inferior to intravesical BCG for overall survival at 5 years (92.0% vs 91.7%) and metastases-free survival at 5 years (89.7% vs 86.4%).

Figure: Relapse-free survival in JCOG1019 [2]



“These results support watchful waiting as a potential new standard-of-care for patients with high-grade T1 bladder cancer without residual tumours after second TUR,” Prof. Kitamura concluded.

1. Powles TB, et al. Ann Oncol. 2022; 33: 244-258.
2. Kitamura H, et al. JCOG1019: An open-label, non-inferiority, randomised phase III study comparing the effectiveness of watchful waiting (WW) and intravesical Bacillus Calmette-Guérin (BCG) in patients (Pts) with high-grade pT1 (HGT1) bladder cancer with pT0 on the second transurethral resection (TUR) specimen. Abstract 1963O, ESMO Congress 2024, 13–17 September, Barcelona, Spain.

 

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Posted on 4 November 20244 November 2024