Evidence map›Paper›PMID 21802835›Full record

Trial reportEuropean urology2011

TMPRSS2-ERG status in circulating tumor cells as a predictive biomarker of sensitivity in castration-resistant prostate cancer patients treated with abiraterone acetate.

Daniel C Danila, Aseem Anand, Clifford C Sung, Glenn Heller, Margaret A Leversha, Long Cao, Hans Lilja, Arturo Molina, Charles L Sawyers, Martin Fleisher and 1 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in European urology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 89 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 1 pooled it
17.5field-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.

NCT00474383 phase2completednot on this map

A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

TypeinterventionalSponsorCougar Biotechnology, Inc.Ran2006 to 2011Enrolled47ConditionsProstate NeoplasmsArmsAbiraterone acetate, Glucocorticoid
NCT00485303 phase2completednot on this map

A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

TypeinterventionalSponsorCougar Biotechnology, Inc.Ran2007 to 2011Enrolled58ConditionsProstatic Neoplasms, Prostate CancerArmsAbiraterone acetate, Prednisone
3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 1 synthesis or guideline pooled it, 191 citations in OpenAlex.

  1. The TMPRSS2:ERG rearrangement, ERG expression, and prostate cancer outcomes: a cohort study and meta-analysis.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2012
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  18. Oncology letters · 2021
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29 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Daniel C DanilaGenitourinary Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10065, USA.
Aseem Anand
Clifford C Sung
Glenn Heller
Margaret A Leversha
Long Cao
Hans Lilja
Arturo Molina
Charles L Sawyers
Martin Fleisher
Howard I Scher
Memorial Sloan Kettering Cancer Center · USCornell University · US

Funding

SPORE In Prostate CancerP50CA092629 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Yu Chen, MICHAEL J MORRIS · 2001 to 2026
$63.0M
NCI NIH HHS P50 CA092629NCI NIH HHS P50 CA92629
6 · The paper itself

Abstract

backgroundAbiraterone acetate (AA) is an androgen biosynthesis inhibitor shown to prolong life in patients with castration-resistant prostate cancer (CRPC) already treated with chemotherapy. AA treatment results in dramatic declines in prostate-specific antigen (PSA) in some patients and no declines in others, suggesting the presence of molecular determinants of sensitivity in tumors.

objectiveTo study the role of transmembrane protease, serine 2 (TMPRSS2)-v-ets erythroblastosis virus E26 oncogene homolog (ERG) fusion, an androgen-dependent growth factor, in circulating tumor cells (CTCs) as a biomarker of sensitivity to AA. DESIGN, SETTING, AND

participantsThe predictive value of TMPRSS2-ERG status was studied in 41 of 48 men with postchemotherapy-treated CRPC enrolled in sequential phase 2 AA trials.

interventionPatients received AA 1000 mg daily and continuously. MEASUREMENTS: TMPRSS2-ERG status was characterized by a sensitive, analytically valid reverse transcription polymerase chain reaction assay in CTCs enriched from ethylene-diaminetetraacetic acid anticoagulated blood obtained prior to AA treatment. Outcomes were measured by PSA Working Group 1 criteria. RESULTS AND LIMITATIONS: Standard procedures for specimen acquisition, processing, and testing using the validated TMPRSS2-ERG assay on a multiplex platform gave intra-assay and interassay coefficients of variation <7%. TMPRSS2-ERG fusion was present in 15 of 41 patients (37%), who had a median baseline CTC count of 17 (interquartile range: 7-103 cells per 7.5 ml). A PSA decline ≥50% was observed in 7 of 15 patients (47%) with the fusion and in 10 of 26 patients (38%) without the fusion. Although limited by the low number of patients, a posttherapy CTC count of less than five per 7.5 ml was prognostic for longer survival relative to a CTC count five or more. TMPRSS2-ERG status did not predict a decline in PSA or other clinical outcomes.

conclusionsMolecular profiles of CTCs with an analytically valid assay identified the presence of the prostate cancer-specific TMPRSS2-ERG fusion but did not predict for response to AA treatment. This finding demonstrates the role of CTCs as surrogate tissue that can be obtained in a routine practice setting.

trial registrationClinicalTrials.gov: NCT00474383 (COU-AA-003), NCT00485303 (COU-AA-004).

Indexed as

OrchiectomyAbiraterone AcetateAndrostadienesAntineoplastic Agents, HormonalBiomarkers, TumorChemotherapy, AdjuvantEnzyme InhibitorsGenetic MarkersHumansIn Situ Hybridization, FluorescenceKaplan-Meier EstimateMaleNeoplastic Cells, CirculatingNew York CityOncogene Proteins, FusionPatient SelectionAbiraterone AcetateAndrostadienesAntineoplastic Agents, HormonalBiomarkers, TumorCYP17A1 protein, humanEnzyme InhibitorsGenetic MarkersOncogene Proteins, FusionSteroid 17-alpha-HydroxylaseTMPRSS2-ERG fusion protein, human

Identifiers

PMID21802835
PMCPMC3185163
OpenAlexW2059381583

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.