Evidence map›Paper›PMID 35737923›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Biochemical Failure Is Not a Surrogate End Point for Overall Survival in Recurrent Prostate Cancer: Analysis of NRG Oncology/RTOG 9601.

William C Jackson, Ming Tang, Matthew J Schipper, Howard M Sandler, Zachary S Zumsteg, Jason A Efstathiou, William U Shipley, Wendy Seiferheld, Himanshu R Lukka, Jean-Paul Bahary and 9 more

Open access · greenAbstract read
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
3.6field-weighted citation impact, top 6% 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

16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 25 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 12 institutions in 2 countries.

William C JacksonDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI.ORCID 0000-0001-8709-5978
Ming TangUniversity of Michigan, Ann Arbor, MI.ORCID 0000-0002-6451-8648
Matthew J SchipperDepartment of Biostatistics, University of Michigan, Ann Arbor, MI.
Howard M SandlerCedars Sinai Medical Center, Los Angeles, CA.ORCID 0000-0002-8193-5769
Zachary S ZumstegCedars Sinai Medical Center, Los Angeles, CA.ORCID 0000-0001-7484-3631
Jason A EfstathiouDepartment of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.ORCID 0000-0003-0996-0350
William U ShipleyDepartment of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Wendy SeiferheldNRG Oncology SDMC, Philadelphia, PA.
Himanshu R LukkaHamilton Health Sciences, Hamilton, ON, Canada.
Jean-Paul BaharyCentre Hospitalier de l'Universite de Montreal, Montreal, QC, Canada.
Anthony L ZietmanDepartment of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Thomas M PisanskyDepartment of Radiation Oncology, Mayo Clinic, Rochester, MN.
Kenneth L ZeitzerEinstein Medical Center, Philadelphia, PA.ORCID 0000-0001-5206-9956
William A HallDepartment of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI.ORCID 0000-0001-7017-6755
Robert T DessDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI.ORCID 0000-0003-2331-3758
Richard D LovettUniversity of Vermont Medical Center, Burlington, VT.
Alexander G BaloghTom Baker Cancer Centre, Calgary, AB, Canada.
Felix Y FengDepartment of Radiation Oncology, University of California San Francisco, San Francisco, CA.ORCID 0000-0002-0963-7687
Daniel E SprattDepartment of Radiation Oncology, University Hospitals, Cleveland, OH.ORCID 0000-0002-5973-4741
University of Michigan · USHarvard University · USCedars-Sinai Medical Center · USCentre Hospitalier de l’Université de Montréal · CAEinstein Medical Center Philadelphia · USHamilton Health Sciences · CAMayo Clinic in Arizona · USMedical College of Wisconsin · USNRG Oncology · USUniversity Hospitals of Cleveland · USUniversity of California, San Francisco · USUniversity of Vermont Medical Center · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Alexey I Nesvizhskii · 1988 to 2026
$178.2M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Elaina Harper · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
Tissue/InformaticsP50CA186786 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Ganesh S Palapattu · 2014 to 2026
$27.6M
Biostatistics Training Program in Cancer ResearchT32CA083654 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Veerabhadran Baladandayuthapani, Kelley McLain Kidwell · 2002 to 2026
$4.3M
NCI NIH HHS P30 CA046592NCI NIH HHS P50 CA186786NCI NIH HHS T32 CA083654NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

purposeMetastasis-free survival (MFS), but not event-free survival, is a validated surrogate end point for overall survival (OS) in men treated for localized prostate cancer. It remains unknown if this holds true in biochemically recurrent disease after radical prostatectomy. Leveraging NRG/RTOG 9601, we aimed to determine the performance of intermediate clinical end points (ICEs) as surrogate end points for OS in recurrent prostate cancer. MATERIALS AND

methodsNRG/RTOG 9601 randomly assigned 760 men with recurrence after prostatectomy to salvage radiation therapy with 2 years of placebo versus bicalutamide 150 mg daily. ICEs assessed were biochemical failure (BF) per NRG/RTOG 9601 (prostate-specific antigen nadir + 0.3-0.5 ng/mL or initiation of salvage hormone therapy; [BF1]) and NRG/RTOG 0534 (prostate-specific antigen nadir+2 ng/mL; [BF2]), distant metastasis (DM), and MFS (DM or death). Surrogacy was assessed by the Prentice criteria and a two-stage meta-analytic approach (condition one assessed at the patient level with Kendall's τ and condition two assessed by randomly dividing the entire trial cohort into 10 pseudo trial centers and calculating the average

resultsBF1, BF2, DM, and MFS satisfied the four Prentice criteria. However, with the two-condition meta-analytic approach, there was strong correlation between MFS and OS (τ = 0.86), moderate correlation between DM and OS (τ = 0.66), and weaker correlation between BF1 (τ = 0.25) or BF2 (τ = 0.40) and OS. Similarly, for condition two, the treatment effect of antiandrogen therapy on MFS and OS were correlated (

conclusionMFS is also a strong surrogate for OS in men receiving salvage radiation therapy for recurrence after prostatectomy. Caution should be used when inferring survival benefit from effects on BF in biochemically recurrent prostate cancer. Lack of comorbidity data did not allow us to assess whether BF in men with no/minimal comorbidity could serve as a surrogate for OS.

Indexed as

Prostate-Specific AntigenProstatic NeoplasmsAndrogen AntagonistsBiomarkersHormonesHumansMaleNeoplasm Recurrence, LocalProstatectomyAndrogen AntagonistsBiomarkersHormonesProstate-Specific Antigen

Identifiers

PMID35737923
PMCPMC9514834
OpenAlexW4283390621

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.