Evidence map›Paper›PMID 24616308›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014

Circulating tumor cell counts are prognostic of overall survival in SWOG S0421: a phase III trial of docetaxel with or without atrasentan for metastatic castration-resistant prostate cancer.

Amir Goldkorn, Benjamin Ely, David I Quinn, Catherine M Tangen, Louis M Fink, Tong Xu, Przemyslaw Twardowski, Peter J Van Veldhuizen, Neeraj Agarwal, Michael A Carducci and 10 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00134056 (Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer), which is not on this map. Cited by 161 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
161citing papers in PubMed, 4 pooled it
32.6field-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.

NCT00134056 phase3completednot on this map

Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2006 to 2016Enrolled1,038ConditionsMetastatic Cancer, Prostate CancerArmsatrasentan hydrochloride, docetaxel, prednisone, placebo
3 · Its place in the literature

Who cites it

161 citing papers in PubMed, 4 syntheses or guidelines pooled it, 332 citations in OpenAlex.

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  16. Circulating tumor cell biomarker panel as an individual-level surrogate for survival in metastatic castration-resistant prostate cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
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101 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 1 institution in 1 country.

Amir GoldkornAmir Goldkorn, David I. Quinn, and Tong Xu, University of Southern California Keck School of Medicine and Norris Comprehensive Cancer Center, Los Angeles; Przemyslaw Twardowski, City of Hope, Duarte; Philip C. Mack and Primo Lara Jr, University of California, Davis, Sacramento, CA; Benjamin Ely and Catherine M. Tangen, Southwest Oncology Group Statistical Center; Celestia S. Higano, Puget Sound Oncology Consortium, Seattle Cancer Care Alliance, and University of Washington, Seattle, WA; Louis M. Fink, Nevada Cancer Institute; Nicholas J. Vogelzang, Comprehensive Cancer Centers of Nevada and US Oncology Research, Las Vegas, NV; Peter J. Van Veldhuizen, University of Kansas Cancer Center, Westwood, KS; Neeraj Agarwal, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Michael A. Carducci, Johns Hopkins Kimmel Cancer Center and Eastern Cooperative Oncology Group, Baltimore, MD; J. Paul Monk III, Ohio State University and Cancer and Leukemia Group B, Columbus, OH; Ram H. Datar and Richard J. Cote, University of Miami Miller School of Medicine, Miami, FL; Mark Garzotto, Portland Veterans Affairs Medical Center, Portland, OR; Maha Hussain, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; and Ian Murchie Thompson Jr, University of Texas Health Science Center at San Antonio, San Antonio, TX.
Benjamin Ely
David I Quinn
Catherine M Tangen
Louis M Fink
Tong Xu
Przemyslaw Twardowski
Peter J Van Veldhuizen
Neeraj Agarwal
Michael A Carducci
J Paul Monk
Ram H Datar
Mark Garzotto
Philip C Mack
Primo Lara
Celestia S Higano
Maha Hussain
Ian Murchie Thompson
Richard J Cote
Nicholas J Vogelzang
City of Hope · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Fumito Ito · 1985 to 2026
$181.4M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 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 Catherine M. Tangen · 2014 to 2026
$115.2M
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Laura Marcu · 2002 to 2026
$84.9M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
NCI NIH HHS CA014089-38NCI NIH HHS CA11083NCI NIH HHS CA12644NCI NIH HHS CA128567NCI NIH HHS CA14028NCI NIH HHS CA16116NCI NIH HHS CA16385NCI NIH HHS CA20319NCI NIH HHS CA21115NCI NIH HHS CA22433NCI NIH HHS CA31946NCI NIH HHS CA31949NCI NIH HHS CA35090NCI NIH HHS CA35128NCI NIH HHS CA35176,NCI NIH HHS CA35192NCI NIH HHS CA35281NCI NIH HHS CA35421NCI NIH HHS CA37981NCI NIH HHS CA42777NCI NIH HHS CA45377NCI NIH HHS CA45450NCI NIH HHS CA45808NCI NIH HHS CA46282NCI NIH HHS CA46368NCI NIH HHS CA58416NCI NIH HHS CA58723NCI NIH HHS CA58861NCI NIH HHS CA58882NCI NIH HHS CA63845NCI NIH HHS CA63848NCI NIH HHS CA68183NCI NIH HHS CA74647NCI NIH HHS CA76429NCI NIH HHS CA76447NCI NIH HHS CA76448NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA013612NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035176NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA045807NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA063844NCI NIH HHS N01 CA067575NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA014089NCI NIH HHS P30 CA093373NCI NIH HHS R01 CA141077NCI NIH HHS R01 CA141077-03NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA013612NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA016385NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA022433NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035128NCI NIH HHS U10 CA035176NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA035192NCI NIH HHS U10 CA035281NCI NIH HHS U10 CA035421NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037981NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA042777NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045450NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046368NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA058416NCI NIH HHS U10 CA058861NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA063844NCI NIH HHS U10 CA063845NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA068183NCI NIH HHS U10 CA074647NCI NIH HHS U10 CA076447NCI NIH HHS U10 CA128567NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180888
6 · The paper itself

Abstract

purposeCirculating tumor cell (CTC) enumeration has not been prospectively validated in standard first-line docetaxel treatment for metastatic castration-resistant prostate cancer. We assessed the prognostic value of CTCs for overall survival (OS) and disease response in S0421, a phase III trial of docetaxel plus prednisone with or without atrasentan. PATIENTS AND

methodsCTCs were enumerated at baseline (day 0) and before cycle two (day 21) using CellSearch. Baseline counts and changes in counts from day 0 to 21 were evaluated for association with OS, prostate-specific antigen (PSA), and RECIST response using Cox regression as well as receiver operator characteristic (ROC) curves, integrated discrimination improvement (IDI) analysis, and regression trees.

resultsMedian day-0 CTC count was five cells per 7.5 mL, and CTCs < versus ≥ five per 7.5 mL were significantly associated with baseline PSA, bone pain, liver disease, hemoglobin, alkaline phosphatase, and subsequent PSA and RECIST response. Median OS was 26 months for < five versus 13 months for ≥ five CTCs per 7.5 mL at day 0 (hazard ratio [HR], 2.74 [adjusting for covariates]). ROC curves had higher areas under the curve for day-0 CTCs than for PSA, and IDI analysis showed that adding day-0 CTCs to baseline PSA and other covariates increased predictive accuracy for survival by 8% to 10%. Regression trees yielded new prognostic subgroups, and rising CTC count from day 0 to 21 was associated with shorter OS (HR, 2.55).

conclusionThese data validate the prognostic utility of CTC enumeration in a large docetaxel-based prospective cohort. Baseline CTC counts were prognostic, and rising CTCs at 3 weeks heralded significantly worse OS, potentially serving as an early metric to help redirect and optimize therapy in this clinical setting.

Indexed as

Neoplastic Cells, CirculatingAgedAntineoplastic AgentsAtrasentanBiomarkers, TumorCastrationCell CountDisease ProgressionDocetaxelDouble-Blind MethodDrug Therapy, CombinationHumansMaleMiddle AgedNeoplasm GradingPrognosisAntineoplastic AgentsAtrasentanBiomarkers, TumorDocetaxelPyrrolidinesTaxoids

Identifiers

PMID24616308
PMCPMC3970171
OpenAlexW2103793201

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Registered trials

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.