Evidence map›Paper›PMID 33423945›Full record

ArticleEuropean urology oncology2021

A New Prognostic Model in Patients with Advanced Urothelial Carcinoma Treated with First-line Immune Checkpoint Inhibitors.

Ali Raza Khaki, Ang Li, Leonidas N Diamantopoulos, Natalie J Miller, Lucia Carril-Ajuria, Daniel Castellano, Ivan De Kouchkovsky, Vadim Koshkin, Joseph Park, Ajjai Alva and 37 more

Open access · greenAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in European urology oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
11.1field-weighted citation impact, top 1% 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

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.

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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

47 authors at 20 institutions in 5 countries.

Ali Raza KhakiDivision of Medical Oncology, Department of Medicine, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, University of Washington, Seattle, WA, USA.
Ang LiSection of Hematology/Oncology, Department of Medicine, Baylor College of Medicine, Houston, TX, USA.
Leonidas N DiamantopoulosDepartment of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Natalie J MillerDepartment of Medicine, University of Washington, Seattle, WA, USA.
Lucia Carril-AjuriaHospital Universitario 12 de Octubre, Madrid, Spain.
Daniel CastellanoHospital Universitario 12 de Octubre, Madrid, Spain.
Ivan De KouchkovskyDivision of Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Vadim KoshkinDivision of Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Joseph ParkDivision of Oncology, Department of Medicine, University of Michigan, Ann Arbor, MI, USA.
Ajjai AlvaDivision of Oncology, Department of Medicine, University of Michigan, Ann Arbor, MI, USA.
Mehmet A BilenWinship Cancer Institute of Emory University, Atlanta, GA, USA.
Tyler StewartDivision of Oncology, Department of Medicine, University of California, San Diego, La Jolla, CA, USA.
Victor SantosDivision of Oncology, Department of Medicine, University of Utah, Salt Lake City, UT, USA.
Neeraj AgarwalDivision of Oncology, Department of Medicine, University of Utah, Salt Lake City, UT, USA.
Jayanshu JainDepartment of Medicine, University of Iowa, Iowa City, IA, USA.
Yousef ZakhariaDivision of Oncology, Department of Medicine, University of Iowa, Iowa City, IA, USA.
Rafael Morales-BarreraVall d'Hebron Institute of Oncology, Vall d' Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.
Michael DevittDivision of Hematology/Oncology, Department of Medicine, University of Virginia School of Medicine, Charlottesville, VA, USA.
Ariel NelsonDivision of Medical Oncology, Seidman Cancer Center at Case Comprehensive Cancer Center, Cleveland, OH, USA; Division of Hematology and Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.
Christopher J HoimesDivision of Medical Oncology, Seidman Cancer Center at Case Comprehensive Cancer Center, Cleveland, OH, USA; Division of Medical Oncology, Duke University, Durham, NC, USA.
Evan ShreckDepartments of Medical Oncology and Urology, Montefiore Medical Center, Bronx, NY, USA.
Benjamin A GartrellDepartments of Medical Oncology and Urology, Montefiore Medical Center, Bronx, NY, USA.
Alex SankinDepartments of Medical Oncology and Urology, Montefiore Medical Center, Bronx, NY, USA.
Abhishek TripathiStephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Roubini ZakopoulouDepartment of Clinical Therapeutics, Alexandra General Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
Aristotelis Bamias2nd Propaedeutic Department of Internal Medicine, ATTIKON University Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
Alejo Rodriguez-VidaMedical Oncology Department, Hospital del Mar Research Institute, Barcelona, Spain.
Alexandra DrakakiDivision of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Sandy LiuDivision of Hematology/Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Vivek KumarDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Mark P LythgoeDepartment of Surgery and Cancer, Imperial College London, London, UK.
David J PinatoDepartment of Surgery and Cancer, Imperial College London, London, UK.
Jure MurgicDepartment of Oncology and Nuclear Medicine, University Hospital Center Sestre Milosrdnice, School of Dental Medicine, Zagreb, Croatia.
Ana FröbeDepartment of Oncology and Nuclear Medicine, University Hospital Center Sestre Milosrdnice, School of Dental Medicine, Zagreb, Croatia.
Monika JoshiDivision of Hematology/Oncology, Department of Medicine, Penn State Cancer Institute, Hershey, PA, USA.
Pedro Isaacsson VelhoDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Noah HahnDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Lucia Alonso BuznegoHospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.
Ignacio DuranHospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.
Marcus MosesDepartment of Medicine, Section of Hematology/Oncology, Tulane University, New Orleans, LA, USA.
Pedro BarataDepartment of Medicine, Section of Hematology/Oncology, Tulane University, New Orleans, LA, USA.
Matthew D GalskyDivision of Oncology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Guru SonpavdeGenitourinary Oncology Program, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Evan Y YuDivision of Medical Oncology, Department of Medicine, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, University of Washington, Seattle, WA, USA.
Veena ShankaranDivision of Medical Oncology, Department of Medicine, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, University of Washington, Seattle, WA, USA.
Gary H LymanDivision of Medical Oncology, Department of Medicine, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, University of Washington, Seattle, WA, USA.
Petros GrivasDivision of Medical Oncology, Department of Medicine, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, University of Washington, Seattle, WA, USA. Electronic address: pgrivas@uw.edu.
Hospital Universitario 12 De Octubre · ESMontefiore Medical Center · USImperial College London · GBNational and Kapodistrian University of Athens · GRSeattle Cancer Care Alliance · USSidney Kimmel Comprehensive Cancer Center · USUniversity Hospital Centre Zagreb · HRUniversity of California, Los Angeles · USUniversity of California, San Francisco · USUniversity of Iowa · USUniversity of Michigan–Ann Arbor · USUniversity of Utah · USUniversity of Washington · USBaylor College of Medicine · USDana-Farber Cancer Institute · USEmory University · USFred Hutch Cancer Center · USHarvard University · USHospital Del Mar · ESIcahn School of Medicine at Mount Sinai · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Transform Dissemination and Implementation Science in CTSA ProgramsUL1TR002319 · NCATS · UNIVERSITY OF WASHINGTON · PI John K. Amory · 2017 to 2026
$100.0M
TRAINING IN CANCER BIOLOGY &TRANSPLANTATIONT32CA009515 · NCI · UNIVERSITY OF WASHINGTON · PI NANCY ELLEN DAVIDSON, Effie W Petersdorf · 1985 to 2026
$16.2M
NCATS NIH HHS UL1 TR001863NCATS NIH HHS UL1 TR002319NCI NIH HHS T32 CA009515Wellcome TrustWellcome Trust PS3416
6 · The paper itself

Abstract

backgroundWhile immune checkpoint inhibitors (ICIs) are approved in the first-line (1L) setting for cisplatin-unfit patients with programmed death-ligand 1 (PD-L1)-high tumors or for platinum (cisplatin/carboplatin)-unfit patients, response rates remain modest and outcomes vary with no clinically useful biomarkers (except for PD-L1).

objectiveWe aimed to develop a prognostic model for overall survival (OS) in patients receiving 1L ICIs for advanced urothelial cancer (aUC) in a multicenter cohort study. DESIGN, SETTING, AND

participantsPatients treated with 1L ICIs for aUC across 24 institutions and five countries (in the USA and Europe) outside clinical trials were included in this study. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used a stepwise, hypothesis-driven approach using clinician-selected covariates to develop a new risk score for patients receiving ICIs in the 1L setting. Demographics, clinicopathologic data, treatment patterns, and OS were collected uniformly. Univariate Cox regression was performed on 18 covariates hypothesized to be associated with OS based on published data. Variables were retained for multivariate analysis (MVA) if they correlated with OS (p < 0.2) and were included in the final model if p < 0.05 on MVA. Retained covariates were assigned points based on the beta coefficient to create a risk score. Stratified median OS and C-statistic were calculated. RESULTS AND LIMITATIONS: Among 984 patients, 357 with a mean age of 71 yr were included in the analysis, 27% were female, 68% had pure UC, and 13% had upper tract UC. Eastern Cooperative Oncology Group performance status ≥2, albumin <3.5 g/dl, neutrophil:lymphocyte ratio >5, and liver metastases were significant prognostic factors on MVA and were included in the risk score. C index for new 1L risk score was 0.68 (95% confidence interval 0.65-0.71). Limitations include retrospective nature and lack of external validation.

conclusionsWe developed a new 1L ICI risk score for OS based on data from patients with aUC treated with ICIs in the USA and Europe outside of clinical trials. The score components highlight readily available factors related to tumor biology and treatment response. External validation is being pursued. PATIENT SUMMARY: With multiple new treatments under development and approved for advanced urothelial carcinoma, it can be difficult to identify the best treatment sequence for each patient. The risk score may help inform treatment discussions and estimate outcomes in patients treated with first-line immune checkpoint inhibitors, while it can also impact clinical trial design and endpoints. TAKE  HOME MESSAGE: A new risk score was developed for advanced urothelial carcinoma treated with first-line immune checkpoint inhibitors. The score assigned Eastern Cooperative Oncology Group performance status ≥2, albumin <3.5 g/dl, neutrophil:lymphocyte ratio >5, and liver metastases each one point, with a higher score being associated with worse overall survival.

Indexed as

Carcinoma, Transitional CellUrinary Bladder NeoplasmsAgedCohort StudiesFemaleHumansImmune Checkpoint InhibitorsPrognosisRetrospective StudiesImmune Checkpoint InhibitorsBladder cancerImmunotherapyOutcome researchPrognostic modelUrothelial carcinoma

Identifiers

PMID33423945
PMCPMC8169524
OpenAlexW3118924526

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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.