Evidence map›Paper›PMID 37414705›Full record

Trial reportEuropean urology2023

Long-term Outcomes from a Phase 2 Study of Neoadjuvant Chemotherapy for Muscle-invasive Bladder Cancer (SWOG S1314; NCT02177695).

Thomas W Flaig, Catherine M Tangen, Siamak Daneshmand, Ajjai Shivaram Alva, M Scott Lucia, David James McConkey, Dan Theodorescu, Amir Goldkorn, Matthew I Milowsky, Rick Bangs and 7 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in European urology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06889623 (Impact of Immediate Cisplatin/Gemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
5.7field-weighted citation impact, top 3% of its field
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.

NCT06889623 narecruitingnot on this mapstarted 2024, after this paper: background citation

Impact of Immediate Cisplatin/Gemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer: an Open-label, Single-arm, Prospective Trial

TypeinterventionalSponsorChanghai HospitalRan2024 to 2028Enrolled72ConditionsNMIBCArmsImmediate postoperative chemotherapy
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Phase II Trial of Risk-Enabled Therapy After Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer (RETAIN 1).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 1 country.

Thomas W FlaigSchool of Medicine, University of Colorado, Aurora, CO, USA. Electronic address: thomas.flaig@ucdenver.edu.
Catherine M TangenFred Hutchinson Cancer Research Center, Seattle, WA, USA.
Siamak DaneshmandDepartment of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Ajjai Shivaram AlvaUniversity of Michigan, Ann Arbor, MI, USA.
M Scott LuciaSchool of Medicine, University of Colorado, Aurora, CO, USA.
David James McConkeyJohns Hopkins School of Medicine, Baltimore, MD, USA.
Dan TheodorescuCedars-Sinai Cancer, Los Angeles, CA, USA.
Amir GoldkornDivision of Medical Oncology, Department of Medicine, Keck School of Medicine and Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.
Matthew I MilowskyUniversity of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Rick BangsSouthwestern Oncology Group, San Antonio, TX, USA.
Gary R MacVicarIllinois CancerCare PC, Peoria, IL, USA.
Bruno R BastosCleveland Clinic Florida, Weston, FL, USA.
Jared S FowlesColorado State University, Fort Collins, CO, USA.
Daniel L GustafsonColorado State University, Fort Collins, CO, USA.
Melissa PletsFred Hutchinson Cancer Research Center, Seattle, WA, USA.
Ian M ThompsonCHRISTUS Medical Center Hospital, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
Seth P LernerScott Department of Urology, Dan L Duncan Cancer Center, Baylor College of Medicine, Houston, TX, USA.
Colorado State University · USFred Hutch Cancer Center · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Southern California · USBaylor College of Medicine · USCedars-Sinai Medical Center · USCleveland Clinic Florida · USIllinois CancerCare · USJohns Hopkins University · USSWOG Cancer Research Network · USThe University of Texas Health Science Center at San Antonio · USUniversity of Michigan · USUniversity of North Carolina at Chapel Hill · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
NCI National Clinical Trials Network - Lead Academic Participating SiteUG1CA233324 · NCI · UNIVERSITY OF COLORADO DENVER · PI ANTHONY D ELIAS · 2019 to 2026
$5.2M
NCTN LAPS at Johns HopkinsUG1CA233196 · NCI · JOHNS HOPKINS UNIVERSITY · PI DEBORAH K ARMSTRONG, Julie Renee Brahmer · 2019 to 2026
$4.6M
Hutchinson Center as Lead Academic Participating Site (UG1)UG1CA233328 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Evan Yu · 2019 to 2026
$4.3M
UNC Lead Academic Participating SiteUG1CA233373 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A, DEES, ELIZABETH CLAIRE · 2019 to 2025
$3.5M
NCTN - Network Lead Academic Participating Site: USCUG1CA180830 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Anthony Boutros El-Khoueiry, Amir Goldkorn · 2019 to 2026
$3.2M
NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA180830NCI NIH HHS UG1 CA233160NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233324NCI NIH HHS UG1 CA233328NCI NIH HHS UG1 CA233373
6 · The paper itself

Abstract

backgroundThe COXEN gene expression model was evaluated for prediction of response to neoadjuvant chemotherapy for muscle-invasive bladder cancer (MIBC).

objectiveTo conduct a secondary analysis of the association of each COXEN score with event-free survival (EFS) and overall survival (OS) and by treatment arm. DESIGN, SETTING, AND

participantsThis was a randomized phase 2 trial of neoadjuvant gemcitabine-cisplatin (GC) or dose-dense methotrexate-vinblastine-adriamycin-cisplatin (ddMVAC) in MIBC.

interventionPatients were randomized to ddMVAC (every 14 d) or GC (every 21 d), both for four cycles. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: EFS events were defined as progression or death before scheduled surgery, a decision to not undergo surgery, recurrence, or death due to any cause after surgery. Cox regression was used to evaluate the COXEN score or treatment arm association with EFS and OS. RESULTS AND LIMITATIONS: A total of 167 evaluable patients were included in the COXEN analysis. The COXEN scores were not significantly prognostic for OS or EFS in the respective arms, but the GC COXEN score had a hazard ratio (HR) of 0.45 (95% confidence interval [CI] 0.20-0.99; p = 0.047) when the arms were pooled. In the intent-to-treat analysis (n = 227), there was no significant difference between ddMVAC and GC for OS (HR 0.87, 95% CI 0.54-1.40; p = 0.57) or EFS (HR 0.86, 95% CI 0.59-1.26; p = 0.45). Among the 192 patients who underwent surgery, pathologic response (pT0 vs downstaging vs no response) was strongly correlated with superior postsurgical survival (5-yr OS 90%, 89% and 52%, respectively).

conclusionsThe COXEN GC score has prognostic value for patients receiving cisplatin-based neoadjuvant treatment. The randomized, prospective design provides estimates of OS and EFS for GC and ddMVAC in this population. Pathologic response (<pT2) performed well as an intermediate endpoint in this modern cohort. For expediency in evaluating new regimens, pathologic response should continue to be used in phase 2 trials. PATIENT SUMMARY: In this study, we evaluated a biomarker to predict the response to chemotherapy. The results did not meet the preset study parameters, but our study provides information on clinical outcomes with the use of chemotherapy before surgery for bladder cancer.

Indexed as

Neoadjuvant TherapyUrinary Bladder NeoplasmsCisplatinCystectomyDeoxycytidineHumansMusclesNeoplasm InvasivenessRetrospective StudiesTreatment OutcomeCisplatinDeoxycytidineBiomarkersCystectomyNeoadjuvant chemotherapyUrinary bladder cancer

Identifiers

PMID37414705
PMCPMC10659139
OpenAlexW4383106392

What OpenQuestion holds

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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.