Evidence map›Paper›PMID 32552276›Full record

SynthesisJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Event-Free Survival, a Prostate-Specific Antigen-Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation.

Wanling Xie, Meredith M Regan, Marc Buyse, Susan Halabi, Philip W Kantoff, Oliver Sartor, Howard Soule, Donald Berry, Noel Clarke, Laurence Collette and 17 more

Open access · greenAbstract readMeta-Analysis
In one paragraph

Synthesis in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 4% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
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  5. Observational
  6. Article
  7. Article
  8. Article
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  12. Article
  13. Biochemical Recurrence Surrogacy for Clinical Outcomes After Radiotherapy for Adenocarcinoma of the Prostate.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Article
  14. Article
  15. Article
  16. Biochemical Failure Is Not a Surrogate End Point for Overall Survival in Recurrent Prostate Cancer: Analysis of NRG Oncology/RTOG 9601.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Article
  17. Article
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  19. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 20 institutions in 6 countries.

Wanling XieDivision of Biostatistics, Dana-Farber Cancer Institute, Boston, MA.
Meredith M ReganDivision of Biostatistics, Dana-Farber Cancer Institute, Boston, MA.
Marc BuyseInternational Drug Development Institute, Louvain la Neuve, Belgium.
Susan HalabiDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC.
Philip W KantoffDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY.
Oliver SartorDepartments of Medicine & Urology, Tulane University, New Orleans, LA.
Howard SouleProstate Cancer Foundation, Santa Monica, CA.
Donald BerryDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Noel ClarkeUrological Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom.
Laurence ColletteEuropean Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
Anthony D'AmicoDepartment of Radiation Oncology, Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, MA.
Richard De Abreu LourencoCentre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, NSW, Australia.
James DignamDepartment of Public Health Science, University of Chicago, Chicago, IL.
Mario EisenbergerSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD.
Nicholas JamesUniversity Hospitals Birmingham, Birmingham, United Kingdom.
Karim FizaziDepartment of Cancer Medicine, Institut Gustave Roussy, Villejuif, France.
Silke GillessenDivision of Cancer Sciences, University of Manchester and The Christie, Manchester, United Kingdom.
Yohann LoriotDepartment of Cancer Medicine, Institut Gustave Roussy, Villejuif, France.
Nicolas MottetUrology Oncology, University Jean Monnet, St Etienne, France.
Wendy ParulekarCanadian Cancer Trials Group, Cancer Research Institute, Queen's University, Kingston, Ontario, Canada.
Howard SandlerRadiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA.
Daniel E SprattUniversity of Michigan, Ann Arbor, MI.
Matthew R SydesMedical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, United Kingdom.
Bertrand TombalInstitut de Recherche Clinique, Université Catholique de Louvain, Brussels, Belgium.
Scott WilliamsRadiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.
Christopher J SweeneyLank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, MA.
ICECaP Working Group
Dana-Farber Cancer Institute · USInstitut Gustave Roussy · FRCedars-Sinai Medical Center · USDana-Farber Brigham Cancer Center · USDuke University · USEuropean Organisation for Research and Treatment of Cancer · BEInternational Drug Development Institute (Belgium) · BEJohns Hopkins University · USMedical Research Council · GBMemorial Sloan Kettering Cancer Center · USNIHR Surgical Reconstruction and Microbiology Research Centre · GBPeter MacCallum Cancer Centre · AUProstate Cancer Foundation · USQueen's University · CAThe Christie NHS Foundation Trust · GBThe University of Texas MD Anderson Cancer Center · USTulane University · USUCLouvain · BEUniversité Jean Monnet · FRUniversity of Chicago · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeRecently, we have shown that metastasis-free survival is a strong surrogate for overall survival (OS) in men with intermediate- and high-risk localized prostate cancer and can accelerate the evaluation of new (neo)adjuvant therapies. Event-free survival (EFS), an earlier prostate-specific antigen (PSA)-based composite end point, may further expedite trial completion.

methodsEFS was defined as the time from random assignment to the date of first evidence of disease recurrence, including biochemical failure, local or regional recurrence, distant metastasis, or death from any cause, or was censored at the date of last PSA assessment. Individual patient data from trials within the Intermediate Clinical Endpoints in Cancer of the Prostate-ICECaP-database with evaluable PSA and disease follow-up data were analyzed. We evaluated the surrogacy of EFS for OS using a 2-stage meta-analytic validation model by determining the correlation of EFS with OS (patient level) and the correlation of treatment effects (hazard ratios [HRs]) on both EFS and OS (trial level). A clinically relevant surrogacy was defined a priori as an

resultsData for 10,350 patients were analyzed from 15 radiation therapy-based trials enrolled from 1987 to 2011 with a median follow-up of 10 years. At the patient level, the correlation of EFS with OS was 0.43 (95% CI, 0.42 to 0.44) as measured by Kendall's tau from a copula model. At the trial level, the

conclusionEFS is a weak surrogate for OS and is not suitable for use as an intermediate clinical end point to substitute for OS to accelerate phase III (neo)adjuvant trials of prostate cancer therapies for primary radiation therapy-based trials.

Indexed as

Endpoint DeterminationAgedDisease ProgressionHumansKallikreinsMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPredictive Value of TestsProgression-Free SurvivalProstate-Specific AntigenProstatic NeoplasmsRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsKallikreinsKLK3 protein, humanProstate-Specific Antigen

Identifiers

PMID32552276
PMCPMC8265328
OpenAlexW3036153593

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.