Evidence map›Paper›PMID 31200838›Full record

ArticleEuropean urology oncology2019

Modeling 1-year Relapse-free Survival After Neoadjuvant Chemotherapy and Radical Cystectomy in Patients with Clinical T2-4N0M0 Urothelial Bladder Carcinoma: Endpoints for Phase 2 Trials.

Marco Bandini, Alberto Briganti, Elizabeth R Plimack, Günter Niegisch, Evan Y Yu, Aristotelis Bamias, Neeraj Agarwal, Srikala S Sridhar, Cora N Sternberg, Ulka Vaishampayan and 6 more

Open access · greenAbstract readMulticenter Study
In one paragraph

Article in European urology oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

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

5 citing papers in PubMed, 14 citations in OpenAlex.

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  4. 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

16 authors at 14 institutions in 6 countries.

Marco BandiniVita-Salute San Raffaele University and Department of Urology, IRCCS San Raffaele Hospital, Milan, Italy. Electronic address: marco.bandini.zoli@gmail.com.
Alberto BrigantiVita-Salute San Raffaele University and Department of Urology, IRCCS San Raffaele Hospital, Milan, Italy.
Elizabeth R PlimackFox Chase Cancer Center, Philadelphia, PA, USA.
Günter NiegischDepartment of Urology, Heinrich-Heine University, Düsseldorf, Germany.
Evan Y YuSeattle Cancer Care Alliance, University of Washington, Seattle, WA, USA.
Aristotelis BamiasUniversity of Athens, Athens, Greece.
Neeraj AgarwalHuntsman Cancer Institute (HCI), University of Utah, Salt Lake City, UT, USA.
Srikala S SridharCancer Clinical Research Unit (CCRU), Princess Margaret Cancer Centre, University Health Network, Toronto, Canada.
Cora N SternbergDepartment of Medical Oncology, San Camillo Forlanini Hospital, Rome, Italy.
Ulka VaishampayanWayne State University/Karmanos Cancer Center, Detroit, MI, USA.
Christine ThéodoreHospital Foch, Suresnes, France.
Jonathan E RosenbergMemorial Sloan-Kettering Cancer Center, New York, NY, USA.
Joaquim BellmuntBladder Cancer Center, Medicine, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Matthew D GalskyMount Sinai School of Medicine, Tisch Cancer Institute, New York, NY, USA.
Francesco MontorsiVita-Salute San Raffaele University and Department of Urology, IRCCS San Raffaele Hospital, Milan, Italy.
Andrea NecchiFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Vita-Salute San Raffaele University · ITCarlo Forlanini Hospital · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITFox Chase Cancer Center · USHarvard University · USHeinrich Heine University Düsseldorf · DEHôpital Foch · FRIcahn School of Medicine at Mount Sinai · USMemorial Sloan Kettering Cancer Center · USNational and Kapodistrian University of Athens · GRSeattle Cancer Care Alliance · USUniversity Health Network · CAUniversity of Utah · USWayne State University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI Julie Lynn Boerner · 1985 to 2026
$68.4M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA022453
6 · The paper itself

Abstract

backgroundSeveral ongoing phase 2 trials are evaluating new neoadjuvant therapy regimens in patients with muscle-invasive bladder cancer (MIBC). The 1-yr recurrence-free survival (RFS) after radical cystectomy (RC), with or without perioperative chemotherapy, can be used to model statistical assumptions and interpret outcomes from these studies.

objectiveTo provide a benchmark for predicting 1-yr RFS in patients with cT2-4N0 MIBC. DESIGN, SETTING, AND

participantsWe identified 950 patients with clinical stage T2-4N0 MIBC undergoing RC at 27 centers between 1990 and 2016. We assessed 1-yr RFS rates for patients managed with no perioperative chemotherapy, neoadjuvant chemotherapy (NAC), adjuvant chemotherapy (AC), or NAC followed by AC. Cox regression analyses tested for 1-yr postsurgical RFS predictors. A Cox-based nomogram was developed to estimate 1-yr RFS and its accuracy was assessed in terms of Harrell's c-index, a calibration plot, and decision curve analysis. We report 1-yr RFS rates across the nomogram tertiles. RESULTS AND LIMITATIONS: The 1-yr RFS rates were 67.9% (95% confidence interval [CI] 64-72) after no perioperative chemotherapy, 76.9% (95% CI 72-83%) after NAC, 77.8% (95% CI 71-85%) after AC, and 57% (95% CI 37-87) after NAC+AC. On multivariable analysis, positive surgical margins (p=0.002), pT stage (p<0.0001), and pN stage (p<.0001) were significantly associated with RFS, while NAC was not (p=0.6). The model including all these factors yielded a c-index of 0.76 (95% CI 0.72-0.79), good calibration, and a high net benefit. The 1-yr RFS rates across nomogram tertiles were 90.5% (95% CI 87-94%), 73.4% (95% CI 68-79%), and 51.1% (95% CI 45-58%), respectively. The results lack external validation.

conclusionsBenchmark 1-yr RFS estimates for phase 2 design of new neoadjuvant trials are proposed and can be used for statistical assumptions, pending external validation. PATIENT SUMMARY: Our prognostic model predicting 1-yr survival free from recurrence of bladder cancer after radical cystectomy, with or without standard chemotherapy, could provide an improvement to the quality of phase 2 clinical trial designs and interpretation of their results.

Indexed as

NomogramsAgedCarcinoma, Transitional CellChemotherapy, AdjuvantClinical Trials, Phase II as TopicCystectomyDisease-Free SurvivalEndpoint DeterminationFemaleHumansMaleMiddle AgedNeoadjuvant TherapyRisk FactorsUrinary Bladder NeoplasmsBladder cancerNomogramPerioperative chemotherapyRelapse-free survivalUrothelial carcinoma

Identifiers

PMID31200838
PMCPMC7552889
OpenAlexW2810579527

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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.