Evidence map›Paper›PMID 25593303›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2015

Improvements in Radiographic Progression-Free Survival Stratified by ERG Gene Status in Metastatic Castration-Resistant Prostate Cancer Patients Treated with Abiraterone Acetate.

Gerhardt Attard, Johann S de Bono, Christopher J Logothetis, Karim Fizazi, Som D Mukherjee, Anthony M Joshua, Dirk Schrijvers, Alfons J M van den Eertwegh, Weimin Li, Arturo Molina and 7 more

Abstract readClinical Trial, Phase III
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

30 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. SEOM clinical guidelines for the treatment of metastatic prostate cancer (2017).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Review
  19. Precision Medicine and Men's Health.American journal of men's health · 2017
    Review
  20. 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

17 authors.

Gerhardt AttardThe Institute of Cancer Research and The Royal Marsden Hospital, London, United Kingdom. gerhardt.attard@icr.ac.uk.
Johann S de BonoThe Institute of Cancer Research and The Royal Marsden Hospital, London, United Kingdom.
Christopher J LogothetisThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Karim FizaziInstitut Gustave Roussy, University of Paris Sud, Villejuif, France.
Som D MukherjeeJuravinski Cancer Centre and McMaster University, Hamilton, Ontario, Canada.
Anthony M JoshuaPrincess Margaret Hospital and University of Toronto, Toronto, Ontario, Canada.
Dirk SchrijversZiekenhuisnetwerk Antwerpen-Middelheim Oncology Clinic, Antwerp, Belgium.
Alfons J M van den EertweghVU University Medical Center, Amsterdam, the Netherlands.
Weimin LiJanssen Research and Development, Spring House, Pennsylvania.
Arturo MolinaJanssen Research and Development, Menlo Park, California.
Thomas W GriffinJanssen Research and Development, Los Angeles, California.
Thian KheohJanssen Research and Development, San Diego, California.
Deborah S RicciJanssen Research and Development, Spring House, Pennsylvania.
Kathy ZelinskyJanssen Research and Development, Spring House, Pennsylvania.
Dana E RathkopfMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York.
Howard I ScherMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, New York.
Charles J RyanHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, California.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Cancer Research UK 13239Cancer Research UK A13239NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeGene fusions leading to androgen receptor-modulated ERG overexpression occur in up to 70% of metastatic castration-resistant prostate cancers (mCRPC). We assessed the association between ERG rearrangement status and clinical benefit from abiraterone acetate. EXPERIMENTAL

designCOU-AA-302 is a phase III trial comparing abiraterone acetate and prednisone versus prednisone in chemotherapy-naïve mCRPC. ERG status was evaluated by FISH on archival tumors. End points included radiographic progression-free survival (rPFS), time to PSA progression (TTPP), rate of ≥50% PSA decline from baseline, and overall survival (OS). Cox regression was used to evaluate association with time-to-event measures and Cochran-Mantel-Haenszel for PSA response.

resultsERG status was defined for 348 of 1,088 intention-to-treat patients. ERG was rearranged in 121 of 348 patients with confirmed ERG status (35%). Cancers with an ERG fusion secondary to deletion of 21q22 and increased copy number of fusion sequences (class 2+ Edel) had a greater improvement in rPFS after abiraterone acetate and prednisone [22 vs. 5.4 months; HR (95% confidence interval, CI), 0.31 (0.15-0.68); P = 0.0033] than cancers with no ERG fusion [16.7 vs. 8.3 months; 0.53 (0.38-0.74); P = 0.0002] or other classes of ERG rearrangement. There was also greater benefit in this subgroup for TTPP.

conclusionsBoth ERG-rearranged and wild-type cancers had a significant improvement in rPFS with abiraterone acetate and prednisone in the COU-AA-302 trial. However, our data suggest that 2+ Edel cancers, accounting for 15% of all mCRPC patients and previously associated with a worse outcome, derived the greatest benefit.

Indexed as

Abiraterone AcetateAgedAntineoplastic AgentsDisease-Free SurvivalDouble-Blind MethodHumansIn Situ Hybridization, FluorescenceKaplan-Meier EstimateMaleMiddle AgedPrednisoneProportional Hazards ModelsProstatic Neoplasms, Castration-ResistantTrans-ActivatorsTranscriptional Regulator ERGAbiraterone AcetateAntineoplastic AgentsERG protein, humanPrednisoneTrans-ActivatorsTranscriptional Regulator ERG

Identifiers

PMID25593303
PMCPMC4384987

What OpenQuestion holds

Textmetadata
LicenceTDM
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.