Evidence map›Paper›PMID 40934451›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

End Points for the Next-Generation Bladder-Sparing Perioperative Trials for Patients With Muscle-Invasive Bladder Cancer.

Andrea Necchi, Matthew D Galsky, Nazli Dizman, David H Aggen, Neeraj Agarwal, Hikmat Al-Ahmadie, Andrea B Apolo, Leslie Ballas, Rick Bangs, Peter C Black and 34 more

Abstract read
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
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  5. Article
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  8. Review
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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

44 authors.

Andrea NecchiVita-Salute San Raffaele University, Milan, Italy.ORCID 0000-0002-3007-2756
Matthew D GalskyIcahn School of Medicine at Mount Sinai, New York, NY.ORCID 0000-0001-7655-9378
Nazli DizmanThe University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-3907-8513
David H AggenGenitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY.ORCID 0000-0003-3963-5751
Neeraj AgarwalHuntsman Cancer Institute (NCI-CCC), University of Utah, Salt Lake City, UT.ORCID 0000-0003-1076-0428
Hikmat Al-AhmadieDepartment of Pathology, Memorial Sloan-Kettering Cancer Center (MSKCC), New York, NY.ORCID 0000-0002-2938-6627
Andrea B ApoloGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.ORCID 0000-0001-9409-1836
Leslie BallasDepartment of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA.
Rick BangsBladder Cancer Advocacy Network, Bethesda, MD.ORCID 0000-0002-0706-8775
Peter C BlackDepartment of Urologic Sciences, Vancouver Prostate Centre, University of British Columbia, Vancouver, BC, Canada.ORCID 0000-0002-2919-7068
Maurizio BrausiDepartment of Urology, Hesperia Hospital, Modena, Italy.
Giorgio BrembillaDepartment of Radiology, IRCCS San Raffaele Hospital, Milan, Italy.ORCID 0000-0002-9690-8624
Liang ChengDepartment of Surgery (Urology), Brown University Warren Alpert Medical School, Providence, RI.ORCID 0000-0001-6049-5293
Arturo ChitiVita-Salute San Raffaele University, Milan, Italy.ORCID 0000-0002-5806-1856
Alessia CimadamoreDepartment of Medicine, Institute of Pathological Anatomy, University of Udine, Udine, Italy.
Maurizio ColecchiaVita-Salute San Raffaele University, Milan, Italy.
Siamak DaneshmandDepartment of Urology, USC/Norris Comprehensive Cancer Center, Los Angeles, CA.ORCID 0000-0001-6224-9598
Savino Di StasiCatholic University "Our Lady of Good Counsel", Tirana, Albania.ORCID 0000-0001-8426-1571
Jason A EfstathiouDepartment of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.ORCID 0000-0003-0996-0350
Alex FilicevasWorld Bladder Cancer Patient Coalition, Brussels, Belgium.ORCID 0009-0004-8049-3438
Daniel M GeynismanFox Chase Cancer Center-Temple University Health System, Philadelphia, PA.ORCID 0000-0002-1423-5295
Petros GrivasUniversity of Washington, Fred Hutchinson Cancer Center, Seattle, WA.ORCID 0000-0003-3965-3394
Shilpa GuptaTaussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, OH.ORCID 0000-0002-8775-503X
Alexia IasonosDepartment of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY.ORCID 0000-0003-0471-8477
Nick D JamesInstitute of Cancer Research, London, United Kingdom.ORCID 0000-0002-7314-8204
Seth P LernerBaylor College of Medicine, Houston, TX.ORCID 0000-0002-6379-2581
Yohann LoriotEarly Drug Development Department, Gustave Roussy, Villejuif, France.ORCID 0000-0002-8338-1739
Lydia E MakaroffWorld Bladder Cancer Patient Coalition, Brussels, Belgium.ORCID 0000-0001-7381-5743
Fernando MalufHospital Israelita Albert Einstein, São Paulo, Brazil.ORCID 0000-0002-4288-9018
Marco MoschiniDepartment of Urology, IRCCS San Raffaele Hospital, Milan, Italy.
Irina OstrovnayaDepartment of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY.
Sumanta K PalDivision of Medical Oncology, City of Hope Cancer Center, Duarte, CA.ORCID 0000-0002-1712-0848
Elizabeth R PlimackFox Chase Cancer Center-Temple University Health System, Philadelphia, PA.ORCID 0000-0002-7618-0744
Gagan PrakashDepartment of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.ORCID 0000-0003-1722-4337
Sarah P PsutkaDepartment of Urology, University of Washington, Fred Hutchinson Cancer Center, Seattle, WA.ORCID 0000-0002-4207-7490
Jonathan E RosenbergGenitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY.ORCID 0000-0003-2637-4249
Sarmad SadeghiDepartment of Medicine, USC/Norris Comprehensive Cancer Center, Los Angeles, CA.ORCID 0000-0003-2654-1991
Bogdana SchmidtUniversity of Utah, Salt Lake City, UT.
Lawrence H SchwartzDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY.
Guru P SonpavdeAdventHealth Cancer Institute, Orlando, FL.ORCID 0000-0002-1010-9611
Marie-Pier St LaurentDepartment of Urologic Sciences, Vancouver Prostate Centre, University of British Columbia, Vancouver, BC, Canada.ORCID 0000-0002-7823-4857
Dingwei YeDepartment of Urology, Fudan University Shanghai Cancer Center, Shanghai, PR China.ORCID 0000-0003-4974-3780
Philippe E SpiessDepartment of GU Oncology, Moffitt Cancer Center, Tampa, FL.ORCID 0000-0002-5723-1972
Ashish M KamatDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0003-3546-9928

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Bladder Cancer ProgramZIABC011351 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI APOLO, ANDREA · 2010 to 2025
$9.4M
Intramural NIH HHS ZIA BC011351NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeThe evolving treatment landscape of muscle-invasive bladder cancer (MIBC) increasingly warrants novel trial design to evaluate perioperative strategies aimed at bladder preservation. To establish standardized outcome measures for evaluating organ preservation strategies in MIBC, the International Bladder Cancer Group (IBCG) and the Global Society of Rare Genitourinary Tumors (GSRGT) assembled an international, multidisciplinary consensus panel.

methodsThe IBCG and GSRGT gathered global bladder cancer experts and patient advocates to establish a framework for risk-adapted bladder-sparing treatment approaches for MIBC. Working groups reviewed the literature and developed draft recommendations, which were discussed at a live meeting in December 2024 in Milan. This was followed by voting by the members using a modified Delphi process. Recommendations achieving ≥75% agreement during the meeting were further refined and presented.

resultsClinical complete response (cCR) definition should encompass the absence of high-grade malignancy on pathology and malignant cells on urine cytology and no evidence of local or metastatic disease on cross-sectional imaging. Although cCR remains immature as a primary or coprimary end point in registrational trials, it could serve as a suitable end point in early-phase studies and risk-adapted investigations. Event-free survival (EFS) remains the preferred primary end point as it could reliably capture the durability of clinically meaningful benefit after omittance of surgical consolidation or chemoradiation. Given the composite nature of EFS, events should be prespecified, evaluated in an intention-to-treat approach, and meticulously collected. Continuous assessment of individual patient preferences should begin at the outset of perioperative therapy discussions, with informed decision making prioritized throughout.

conclusionThe consensus definition of cCR and the framework presented in this study can serve as a foundation for thorough testing of risk-adapted bladder-sparing treatment paradigms for MIBC.

Indexed as

Organ Sparing TreatmentsUrinary Bladder NeoplasmsClinical Trials as TopicEndpoint DeterminationHumansNeoplasm InvasivenessPerioperative Care

Identifiers

PMID40934451
PMCPMC12431632

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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.