We evaluated the noninferiority of active surveillance (AS) in comparison to intravesical bacillus Calmette-Guérin (BCG) in terms of recurrence and progression for patients with high-grade T1 (HG T1) bladder cancer at initial transurethral resection of the bladder (TURB) and no residual tumor at second TURB.
After initial evaluation, participants diagnosed with HG T1 bladder cancer who had undergone complete eradication of visible tumors underwent a second TURB. Those with specimens showing T0 were randomized to either AS or to intravesical BCG for 8 wk without maintenance therapy. The primary endpoint was invasive relapse-free survival (iRFS).
In total, 513 participants were enrolled in the initial evaluation. After second TURB, 263 participants were enrolled and randomized. AS was noninferior to BCG in terms of iRFS (hazard ratio 0.69, 90% confidence interval 0.44-1.08; p = 0.001). Rates of adverse events were 50% and 90% for any grade, and in 3.1% and 3.8% for grade ≥3 events in the AS and BCG arms, respectively. The protocol treatment in the control arm was not the current standard.
In this highly selected patient population, AS was noninferior to eight-dose intravesical BCG induction therapy in terms of iRFS for T1 disease or deeper intravesical and/or extravesical recurrence. The safety profile of AS was better than that of BCG. These findings indicate that AS represents a potentially viable therapeutic strategy for selected patients with HG T1 bladder cancer for whom second TURB demonstrates the absence of residual disease.
European urology. 2026 Jan 21 [Epub]
Hiroshi Kitamura, Taiji Tsukamoto, Yoshiyuki Kakehi, Junki Mizusawa, Taro Shibata, Keita Sasaki, Toshiki Tanikawa, Katsuyoshi Hashine, Kiyohide Fujimoto, Naoya Masumori, Takashi Kobayashi, Tomonori Habuchi, Takahiro Kimura, Mikio Sugimoto, Atsushi Takahashi, Hisanobu Adachi, Yoshiyuki Matsui, Shingo Hatakeyama, Akihiro Ito, Masatoshi Eto, Hiroyuki Nishiyama, Urologic Oncology Study Group of the Japan Clinical Oncology Group
Department of Urology, Faculty of Medicine, University of Toyama, Toyama, Japan. Electronic address: ., Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan., Department of Urology, Faculty of Medicine, Kagawa University, Kagawa, Japan., Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan., Department of Urology, Niigata Cancer Center Hospital, Niigata, Japan., Department of Urology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan., Department of Urology, Nara Medical University, Nara, Japan., Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan., Department of Urology, Akita University Graduate School of Medicine, Akita, Japan., Department of Urology, Jikei University School of Medicine, Tokyo, Japan., Department of Urology, Hakodate Goryoukaku Hospital, Hakodate, Japan., Department of Urology, Miyagi Cancer Center, Miyagi, Japan., Department of Urology, National Cancer Center Hospital, Tokyo, Japan., Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan., Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan., Department of Urology, Graduate School of Medical Sciences, Kyusyu University, Fukuoka, Japan., Department of Urology, Institute of Medicine, University of Tsukuba, Tsukuba, Japan.