Editorial Comments to “Real‐World Comparison of Survival Outcomes Between Radical Cystectomy and Intravesical Bacillus Calmette‐Guérin ( BCG ) Therapy in BCG ‐Naïve or ‐Unresponsive Non‐Muscle‐Invasive Bladder Cancer”

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Authors: Naoki Fujita
Cited by: 0
References: 5

Abstract

Determining the optimal initial and salvage treatment strategies for high-risk non-muscle-invasive bladder cancer (HR-NMIBC) remains a difficult clinical issue. The absence of definitive randomized trials directly comparing intravesical Bacillus Calmette-Guérin (BCG) with radical cystectomy (RC) has forced clinicians to rely on retrospective analyses and institutional experience. Within this context, the study by Miyake and colleagues provides important real-world evidence from a large Japanese cohort, evaluating outcomes across three clinically relevant groups: BCG-naïve standard HR-NMIBC, BCG-naïve highest-risk NMIBC, and BCG-unresponsive NMIBC [1]. Their work offers timely insight into treatment selection in a population with distinct practice patterns and BCG response characteristics. A major strength of this study is its use of two nationwide, multicenter databases within the Japanese Urological Oncology Group. The authors applied rigorous exclusion criteria to minimize the influence of occult muscle-invasive disease in the RC cohort, a factor that has complicated earlier retrospective comparisons. The use of propensity score matching further enhanced comparability between treatment groups, strengthening the validity of the observed outcomes. One notable finding is that BCG was associated with better overall survival than RC in the standard HR-NMIBC cohort. Although this may appear counterintuitive in light of earlier Western studies supporting early RC [2], the result aligns with contemporary guideline recommendations, which endorse intravesical BCG as the standard of care for standard HR-NMIBC and reserve RC for patients with very high-risk features [3]. Given the substantial long-term functional and quality-of-life consequences of RC [4], these data reinforce the importance of careful patient selection instead of defaulting to surgery. In the highest-risk cohort, adjusted analyses revealed no significant differences in metastasis-free or overall survival between RC and BCG. While subgroup analyses suggested that certain pathological features may favor RC, the overall equivalence between treatments underscores the need for individualized decision-making. Patient preference, comorbidity, and the feasibility of intensive surveillance should all be considered. The present findings suggest that, in selected highest-risk patients, an initial bladder-sparing approach may not necessarily compromise survival, provided that timely intervention remains feasible. The analysis of BCG-unresponsive NMIBC is also clinically meaningful. Although adjusted survival outcomes did not differ significantly between salvage RC and BCG rechallenge, the divergence of long-term survival curves in favor of RC warrants attention. This pattern is consistent with prior reports [5], and is particularly relevant in Japan, where alternative intravesical agents and gene-based therapies are not yet widely accessible. These findings highlight the importance of early counseling regarding RC for patients with truly refractory disease. The retrospective design and heterogeneity of BCG regimens represent unavoidable limitations. Nevertheless, the scale and methodological rigor of this work make it one of the most informative comparative analyses to date. Rather than advocating for a universal shift toward or away from RC, this study supports a nuanced, risk-adapted strategy in which BCG remains appropriate for many patients, while RC retains a critical role for those with aggressive or treatment-refractory disease. Conceptualization: Naoki Fujita. Project administration: Naoki Fujita. Writing – original draft: Naoki Fujita. Writing – review and editing: Naoki Fujita. The author declares no conflicts of interest. This article is linked to Miyake et al. papers. To view this article, visit https://doi.org/10.1111/iju.70314.

Fields of Study & Subjects

Bladder and Urothelial Cancer Treatments Urinary Bladder and Prostate Research Urinary and Genital Oncology Studies

Publication details

Journal / source
International Journal of Urology
Volume
33
Issue
1
Pages
e70358–e70358
Publication date
1 January 2026
Language
EN