The prognostic significance of non-muscle-invasive bladder cancer (NMIBC) recurrence after a prolonged disease-free interval following intravesical Bacillus Calmette-Guérin (BCG) therapy remains unclear. This multicenter study evaluated the impact of late recurrence after BCG therapy on oncological outcomes.
This retrospective multicenter study used the Japan Urological Oncology Group database. Among 3226 patients treated with intravesical BCG for NMIBC, 238 with non-muscle-invasive intravesical recurrence ≥1 year after initial BCG therapy were analyzed, after excluding those with muscle-invasive recurrence at first recurrence. Patients were stratified by time to recurrence: 1-2 years and ≥ 2 years. Progression-free survival (PFS) and cancer-specific survival (CSS) were assessed using Kaplan-Meier and Cox proportional hazards analyses.
During a median follow-up of 72.7 months, the 5-year PFS and CSS rates were 90.8% and 91.5%, respectively. PFS did not differ significantly between the 1-2-year and ≥ 2-year recurrence groups (log-rank p = 0.300). In contrast, recurrence ≥2 years was associated with significantly worse CSS than recurrence at 1-2 years (log-rank P = .018) and was a significant predictor of worse CSS in univariate analysis (hazard ratio, 8.06; 95% confidence interval, 1.02-62.6; P = .047). Repeat BCG therapy did not significantly improve PFS or CSS in patients with recurrence ≥2 years.
NMIBC recurrence occurring ≥2 years after initial BCG therapy may be associated with poorer cancer-specific survival despite similar progression-free survival. Late recurrence should not automatically be considered a favorable prognostic subgroup, and careful surveillance and risk stratification are warranted.
Japanese journal of clinical oncology. 2026 Aug 07 [Epub ahead of print]
Yoshinori Ikehata, Naotaka Nishiyama, Makito Miyake, Nobutaka Nishimura, Kita Yuki, Soichiro Shimura, Yuta Inoue, Takashi Matsumoto, Shugo Yajima, Yoshiyuki Nagumo, Shuichi Morizane, Takuma Sato, Masato Fujii, Tomokazu Sazuka, Shingo Hatakeyama, Katsuyoshi Hashine, Atsushi Yamagishi, Rikiya Taoka, Yoshiyuki Matsui, Kiyohide Fujimoto, Hiroyuki Nishiyama, Keiichiro Mori, Takahiro Kimura, Hiroshi Kitamura, Japanese Urological Oncology Group
Department of Urology, Faculty of Medicine, University of Toyama, 2630 Sugitani, Toyama, Toyama, 930-0194, Japan., Department of Urology, Nara Medical University, 840 Shijocho, Kashihara, Nara, 634-8521, Japan., Department of Urology, Kyoto University Graduate School of Medicine, Yoshidakonoecho, Sakyo-ku, Kyoto, Kyoto, 606-8501, Japan., Department of Urology, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0373, Japan., Department of Urology, Kyoto Prefectural University of Medicine, 465 Kajii‑cho, Kamigyo‑ku, Kyoto, 602‑0841, Japan., Department of Urology, Graduate School of Medical Sciences, Kyushu University, 3‑1‑1 Maidashi, Higashi‑ku, Fukuoka 812‑8582, Japan., Department of Urology, National Cancer Center Hospital East, 6‑5‑1 Kashiwanoha, Kashiwa, Chiba 277‑8577, Japan., Department of Urology, Faculty of Medicine, University of Tsukuba, 1‑1‑1 Tennodai, Tsukuba, Ibaraki 305‑8577, Japan., Division of Urology, Department of Surgery, Faculty of Medicine, Tottori University, 86 Nishimachi, Yonago, Tottori 683‑8503, Japan., Department of Urology, Tohoku University, 2‑1 Seiryo‑cho, Aoba‑ku, Sendai 980‑8575, Japan., Department of Urology, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake‑cho, Miyazaki, Miyazaki 889‑1692, Japan., Department of Urology, Chiba University Graduate School of Medicine, 1‑8‑1 Inohana, Chuo‑ku, Chiba, Chiba 260‑8670, Japan., Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifu‑cho, Hirosaki, Aomori 036‑8562, Japan., Department of Urology, National Hospital Organization Shikoku Cancer Center, 160 Kou Minami‑Umemoto‑cho, Matsuyama, Ehime 791‑0280, Japan., Department of Urology, Yamagata University Faculty of Medicine, 2‑2‑2 Iida‑Nishi, Yamagata 990‑9585, Japan., Department of Urology, Faculty of Medicine, Kagawa University, 1750‑1 Ikedo, Miki‑cho, Kida‑gun, Kagawa 761‑0793, Japan., Department of Urology, National Cancer Center Hospital, 5‑1‑1 Tsukiji, Chuo‑ku, Tokyo 104‑0045, Japan., Department of Urology, The Jikei University School of Medicine, 3‑19‑18 Nishi‑Shimbashi, Minato‑ku, Tokyo 105‑8471, Japan.