Evidence map›Paper›PMID 41491719›Full record

SynthesisWorld journal of urology2026

First-line treatments for BCG-naïve non-muscle invasive bladder cancer: a systematic review and meta-analysis.

Navid Roessler, Brigida A Maiorano, Marcin Miszczyk, Keiichiro Miyajima, Shota Inoue, Markus von Deimling, Malte W Vetterlein, Margit Fisch, Marco Moschini, Pawel Rajwa and 7 more

Abstract readSystematic ReviewMeta-AnalysisReview
In one paragraph

Synthesis in World journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Navid RoesslerDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Brigida A MaioranoDepartment of Medical Oncology, IRCCS San Raffaele Hospital, Milan, Italy.
Marcin MiszczykDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Keiichiro MiyajimaDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Shota InoueDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Markus von DeimlingDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Malte W VetterleinDepartment of Urology, Medical University Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Margit FischDepartment of Urology, Medical University Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Marco MoschiniDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Pawel RajwaDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Andrea NecchiDepartment of Medical Oncology, IRCCS San Raffaele Hospital, Milan, Italy.
Morgan RoupretGRC 5 Predictive Onco-Uro, Department of Urology, AP-HP, Pitié Salpétrière Hospital, Sorbonne University, Paris, France.
Benjamin PradereDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
David D'AndreaDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Paolo GonteroDepartment of Urology, University of Torino School of Medicine, Città della Salute e della Scienza, Torino, Italy.
Pierre I KarakiewiczCancer Prognostics and Health Outcomes Unit, Division of Urology, University of Montréal Health Center, Montréal, QC, H2X 0A9, Canada.
Shahrokh F ShariatDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria. shahrokh.shariat@meduniwien.ac.at.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate novel intravesical and systemic combination therapies for improving outcomes in BCG-naïve patients with non-muscle invasive bladder cancer (NMIBC), this systematic review and meta-analysis assessed first-line treatment strategies, including combinations with systemic immune-checkpoint inhibitors (ICIs).

methodsIn this prospectively registered review (CRD420251163026), MEDLINE, Embase, Web of Science, and the ESMO 2025 abstract book were searched for randomized controlled trials (RCTs) evaluating first-line therapies in BCG-naïve NMIBC. Meta-analyses estimated HRs for recurrence-related time-to-event outcomes (disease-free and event-free survival). Grade ≥ 3 treatment-related adverse events were pooled as relative risks (RRs). Risk of bias was assessed using the Cochrane RoB 2 tool.

resultsOut of 5202 records screened, six RCTs including 3485 patients were eligible. Modifications to intravesical BCG alone (three trials, n = 895) did not significantly improve recurrence-related outcomes. Systemic ICIs given additional to intravesical BCG significantly reduced recurrence-related events compared to BCG alone (HR 0.77, 95%CI 0.6–0.97, n = 1899; number needed to treat at two years: 25), but increased grade ≥ 3 treatment-related adverse events by a statistically and clinically significant margin (RR 3.97, 95% CI 2.53–6.22, n = 1879; number needed to treat to harm one patient: 5). Sensitivity analysis using the ALBAN alternative endpoint of high-grade recurrence-free survival yielded HR 0.78 (95% CI 0.59–1.02), not reaching statistical significance. Limitations included heterogeneity in trial design and endpoint definitions.

conclusionIn BCG-naïve NMIBC, systemic ICIs combined with intravesical BCG improve recurrence-related outcomes but are offset by a substantially increased risk of severe treatment-related adverse events. These findings highlight the need for careful, risk-based, biomarker-guided patient selection to balance over- and undertreatment within a shared decision-making process.

Indexed as

BCG VaccineImmune Checkpoint InhibitorsNon-Muscle Invasive Bladder NeoplasmsUrinary Bladder NeoplasmsAdjuvants, ImmunologicAdministration, IntravesicalHumansAdjuvants, ImmunologicBCG VaccineImmune Checkpoint InhibitorsBacillus calmette guérinImmune checkpoint inhibitorsImmunotherapyTreatment outcomeUrinary bladder neoplasms

Identifiers

PMID41491719
PMCPMC12769649

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.