ReviewESMO open2026
Safety profile of BCG with or without immunotherapy in non-muscle-invasive bladder cancer (NMIBC): a systematic review and meta-analysis.
Review in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIntravesical bacillus Calmette-Guérin (BCG) is the standard of care for BCG-naïve high-risk non-muscle-invasive bladder cancer (NMIBC). Recent phase III trials showed reduced disease recurrence with the addition of immune checkpoint inhibitors (ICIs) to BCG induction plus maintenance but with increased toxicity. We carried out a systematic review and meta-analysis to assess the safety of this treatment intensification. PATIENTS AND
methodsRandomized phase II-III trials comparing BCG plus anti-programmed cell death protein 1/programmed death-ligand 1 ICIs with BCG alone in BCG-naïve high-risk NMIBC were identified through MEDLINE/PubMed, American Society of Clinical Oncology, and European Society for Medical Oncology databases up to November 2025. Outcomes included the incidence and relative risk (RR) of treatment-related adverse events (TRAEs), immune-related adverse events (irAEs), serious adverse events (SAEs), treatment discontinuation, and the impact of the BCG schedule.
resultsThree phase III trials including 1895 patients were analyzed. Compared with BCG alone, BCG plus ICIs significantly increased the risk of any-grade TRAEs [RR 1.25, 95% confidence interval (CI) 1.20-1.31, P < 0.00001], grade ≥3 TRAEs (RR 4.02, 95% CI 3.06-5.30, P < 0.00001), SAEs (RR 4.54, 95% CI 2.09-9.85, P = 0.0001), any-grade irAEs (RR 15.18, 95% CI 4.34-53.14, P < 0.0001), grade ≥3 irAEs (RR 9.99, 95% CI 2.12-47.14, P = 0.004), and treatment discontinuation (RR 2.87, 95% CI 1.50-5.52, P = 0.002). Toxicity was mainly driven by systemic immune-mediated events, whereas local BCG-related urinary adverse events were largely comparable between groups.
conclusionsAdding ICIs to intravesical BCG in BCG-naïve high-risk NMIBC increases treatment-related toxicity, mainly due to immune-mediated adverse events, without substantially worsening local urinary tolerability. Careful patient selection and multidisciplinary management are essential when adopting this treatment optimization.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.