Evidence map›Paper›PMID 42652203›Full record

ReviewBiomedicines2026

Gemcitabine-Based Bladder Preservation in BCG-Unresponsive High-Risk NMIBC: Evidence, Limitations, and Clinical Positioning.

Aris Kaltsas, Konstantinos Papathanasiou, Ilias Giannakodimos, Athanasios Zachariou, Nguyen Phuc Cam Hoang, Mai Ba Tien Dung, Tran Vinh Hung, Michael Chrisofos, Nikolaos Sofikitis, Fotios Dimitriadis

Abstract readReview
In one paragraph

Review in Biomedicines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Aris KaltsasThird Department of Urology, Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, 12462 Athens, Greece.ORCID 0000-0003-4651-312X
Konstantinos PapathanasiouFirst Department of Urology, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.
Ilias GiannakodimosThird Department of Urology, Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, 12462 Athens, Greece.ORCID 0000-0003-2267-8464
Athanasios ZachariouDepartment of Urology, Faculty of Medicine, School of Health Sciences, University of Ioannina, 45110 Ioannina, Greece.ORCID 0000-0002-5287-4450
Nguyen Phuc Cam HoangDepartments of Andrology and Urology, Binh Dan Hospital, Ho Chi Minh City 70000, Vietnam.
Mai Ba Tien DungDepartments of Andrology and Urology, Binh Dan Hospital, Ho Chi Minh City 70000, Vietnam.ORCID 0000-0001-8605-2968
Tran Vinh HungDepartments of Andrology and Urology, Binh Dan Hospital, Ho Chi Minh City 70000, Vietnam.
Michael ChrisofosThird Department of Urology, Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, 12462 Athens, Greece.
Nikolaos SofikitisDepartment of Urology, Faculty of Medicine, School of Health Sciences, University of Ioannina, 45110 Ioannina, Greece.
Fotios DimitriadisDepartment of Urology, Faculty of Medicine, School of Health Sciences, University of Ioannina, 45110 Ioannina, Greece.ORCID 0000-0003-1198-9144

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) is a high-risk disease state for which early radical cystectomy remains the guideline-supported oncologic reference in surgically fit patients. Bladder-sparing therapy is necessary for patients ineligible for or declining cystectomy, but it is a preference-sensitive trade-off rather than an equivalent alternative: failure may permit high-grade recurrence, progression, and loss of a curative window. This targeted narrative review synthesizes the evidence for intravesical gemcitabine monotherapy, sequential gemcitabine-docetaxel, and the sustained-release gemcitabine intravesical system TAR-200/INLEXZO, updated through 4 August 2026. Because the review is not systematic and the evidence is dominated by single-arm and retrospective studies, cross-study comparisons are descriptive and establish neither superiority nor equivalence; many gemcitabine studies enrolled mixed BCG-failure cohorts that do not satisfy the contemporary definition. Gemcitabine monotherapy is active but shows declining disease control over time. Sequential gemcitabine-docetaxel has accumulated substantial multicenter observational experience, yet a 2026 retrospective comparison did not demonstrate improved high-grade recurrence-free survival over gemcitabine alone. TAR-200 achieved a centrally confirmed complete response at any time in 82.4% of patients, with a median duration of response of 25.8 months in the single-arm phase 2b SunRISe-1 study and is approved in the United States as INLEXZO for BCG-unresponsive carcinoma in situ with or without papillary tumors; no approved agent holds a papillary-only indication. Comparative patient-reported outcome evidence remains limited, and molecular markers, urinary tumor DNA and transcriptomic subtypes remain investigational rather than validated selection tools. Bladder-sparing treatment should therefore be phenotype- and label-aware, time-limited, and coupled to intensive surveillance with predefined triggers for cystectomy.

Indexed as

BCG-unresponsivebladder preservationdocetaxelgemcitabineINLEXZOnon-muscle-invasive bladder cancerpatient-reported outcomesradical cystectomyTAR-200

Identifiers

PMID42652203
PMCPMC13509982

What OpenQuestion holds

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Registered trials

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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.