Evidence map›Paper›PMID 28579151›Full record

ArticleClinical genitourinary cancer2017

Validation of the Association of RECIST Changes With Survival in Men With Metastatic Castration-Resistant Prostate Cancer Treated on SWOG Study S0421.

Guru Sonpavde, Gregory R Pond, Melissa Plets, Catherine M Tangen, Maha H A Hussain, Primo N Lara, Amir Goldkorn, Mark G Garzotto, Philip C Mack, Celestia S Higano and 8 more

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

Article in Clinical genitourinary cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 3 pooled it
0.6field-weighted citation impact, top 29% 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

6 citing papers in PubMed, 3 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Review
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

18 authors at 15 institutions in 2 countries.

Guru SonpavdeUniversity of Alabama at Birmingham, Birmingham, AL. Electronic address: gsonpavde@uabmc.edu.
Gregory R PondMcMaster University, Hamilton, ON, Canada.
Melissa PletsSWOG Statistical Center, Seattle, WA.
Catherine M TangenSWOG Statistical Center, Seattle, WA.
Maha H A HussainUniversity of Michigan, Ann Arbor, MI.
Primo N LaraUC Davis Cancer Center, Sacramento, CA.
Amir GoldkornUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA.
Mark G GarzottoOregon Health & Science University, Portland, OR.
Philip C MackUC Davis Cancer Center, Sacramento, CA.
Celestia S HiganoSeattle Cancer Care Alliance/University of Washington, Seattle, WA.
Nicholas J VogelzangComprehensive Cancer Centers of Nevada, Las Vegas, NV.
Ian M ThompsonUniversity of Texas Health Science Center at San Antonio, San Antonio, TX.
Przemyslaw W TwardowskiCity of Hope Medical Center, Duarte, CA.
Peter J Van VeldhuizenUniversity of Kansas, Kansas City, KS.
Neeraj AgarwalUniversity of Utah, Salt Lake City, UT.
Michael A CarducciJohns Hopkins Kimmel Cancer Center, Baltimore, MD.
J Paul MonkOhio State University, Columbus, OH.
David I QuinnUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA.
Cancer Research And Biostatistics · USUniversity of California, Davis · USUniversity of Southern California · USCity Of Hope National Medical Center · USComprehensive Cancer Centers of Nevada · USJohns Hopkins University · USMcMaster University · CAOregon Health & Science University · USSeattle Cancer Care Alliance · USThe Ohio State University · USThe University of Texas Health Science Center at San Antonio · USUniversity of Alabama at Birmingham · USUniversity of Kansas · USUniversity of Michigan–Ann Arbor · USUniversity of Utah · 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
CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
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
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
Huntsman Cancer Institute/ University of Utah Network Lead Academic Participating Site ApplicationUG1CA233178 · NCI · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI Matthew Poppe, Heloisa Prado Soares · 2019 to 2026
$4.9M
SOUTHWEST ONCOLOGY GROUP/UNIVERSITY OF CALIFORNIA, DAVISU10CA046441 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI GANDARA, DAVID R · 1988 to 2013
$4.8M
SOUTHWEST ONCOLOGY GROUP--CLINICAL TRIALSU10CA046368 · NCI · CITY OF HOPE NATIONAL MEDICAL CENTER · PI MORTIMER, JOANNE E. · 1988 to 2013
$4.2M
SOUTHWEST ONCOLOGY GROUPU10CA058882 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LENZ, HEINZ JOSEF · 1993 to 2013
$4.0M
NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA046441NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA022433NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA046113NCI NIH HHS U10 CA046368NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA058861NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA142559NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180818NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180828NCI NIH HHS U10 CA180830NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA180830NCI NIH HHS UG1 CA233178NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

backgroundPhase 2 trials evaluating new agents for metastatic castration-resistant prostate cancer (mCRPC) have relied on bone scan and prostate-specific antigen changes to assess activity. Given the increasing detection of measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) changes warrant consideration to evaluate activity. We validated the association of RECIST 1.0 changes with survival in men with mCRPC receiving docetaxel. PATIENTS AND

methodsData for men with measurable disease from the Southwest Oncology Group (SWOG) S0421, a phase 3 trial in men with mCRPC receiving docetaxel and prednisone plus placebo or atrasentan, were used. Cox proportional hazards regression was used to evaluate the association of RECIST 1.0 outcomes within 120 days, ie, unconfirmed partial response (uPR), stable disease, and progressive disease (PD), with overall survival (OS) from day 120, adjusted for prognostic factors.

resultsOverall, 326 men were evaluable for landmark analysis, of whom 23 had PD, 230 stable disease, and 73 uPR. OS beyond day 120 was significantly different (P = .004) among these subgroups, with median (95% confidence interval) OS of 7.1 (3.5-8.8), 13.4 (11.4-15.6), and 16.3 (10.0-19.6) months for those with PD, stable disease, and uPR, respectively. In a multivariable model, the hazard ratio (95% confidence interval) for patients with PD was 2.47 (1.42-4.29) compared to patients with an uPR (P = .002).

conclusionThe association of RECIST 1.0 changes with OS in men with mCRPC receiving docetaxel was validated. Given limitations of bone scan and prostate-specific antigen alterations, improvements in objective RECIST 1.0 changes should be reported in phase 2 trials before launching phase 3 trials.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase III as TopicControlled Clinical Trials as TopicDocetaxelDouble-Blind MethodHumansMaleMiddle AgedPrednisoneProstatic Neoplasms, Castration-ResistantResponse Evaluation Criteria in Solid TumorsSurvival AnalysisTaxoidsDocetaxelPrednisoneTaxoidsCastration-resistantMetastaticProstateRECIST 1.0ResponseSurvival

Identifiers

PMID28579151
PMCPMC5734863
OpenAlexW2612397142

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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.