Evidence map›Paper›PMID 26609008›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2016

Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials.

K Fizazi, T W Flaig, M Stöckle, H I Scher, J S de Bono, D E Rathkopf, C J Ryan, T Kheoh, J Li, M B Todd and 3 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2016. 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 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 pooled it
4.3field-weighted citation impact, top 5% 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.

NCT00638690 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

TypeinterventionalSponsorCougar Biotechnology, Inc.Ran2008 to 2012Enrolled1,195ConditionsProstatic NeoplasmsArmsPlacebo, Abiraterone acetate, Prednisone/prednisolone
NCT00887198 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

TypeinterventionalSponsorJanssen Research & Development, LLCRan2009 to 2017Enrolled1,088ConditionsProstate CancerArmsAbiraterone acetate, Placebo, Prednisone
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
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  8. Abiraterone and enzalutamide in the first line therapy of metastatic castration resistant prostate cancer.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2024
    Article
  9. Observational
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  11. Article
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  14. Age, Gleason Score, and PSA are important prognostic factors for survival in metastatic castration-resistant prostate cancer. Results of The Uroncor Group (Uro-Oncological Tumors) of the Spanish Society of Radiation Oncology (SEOR).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 7 countries.

K FizaziInstitut Gustave Roussy, University of Paris Sud, Villejuif, France karim.fizazi@igr.fr.
T W FlaigUniversity of Colorado Cancer Center, University of Colorado School of Medicine, Aurora, USA.
M StöckleSaarland University, Homburg/Saar, Germany.
H I ScherMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, USA.
J S de BonoThe Institute of Cancer Research and The Royal Marsden Hospital, Sutton, UK.
D E RathkopfMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, USA.
C J RyanHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco.
T KheohJanssen Research & Development, San Diego.
J LiJanssen Research & Development, Raritan.
M B ToddJanssen Global Services, Raritan.
T W GriffinJanssen Research & Development, Los Angeles.
A MolinaJanssen Research & Development, Menlo Park, USA.
C H OhlmannSaarland University, Homburg/Saar, Germany.
Janssen (United States) · USMemorial Sloan Kettering Cancer Center · USSaarland University · DEGlobal Services (Slovakia) · SKInstitute of Cancer Research · GBJanssen (Belgium) · BEJanssen (Switzerland) · CHUniversité Paris-Sud · FRUniversity of California, San Francisco · USUniversity of Colorado Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundThe usefulness of Gleason score (<8 or ≥8) at initial diagnosis as a predictive marker of response to abiraterone acetate (AA) plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) was explored retrospectively. PATIENTS AND

methodsInitial diagnosis Gleason score was obtained in 1048 of 1195 (COU-AA-301, post-docetaxel) and 996 of 1088 (COU-AA-302, chemotherapy-naïve) patients treated with AA 1 g plus prednisone 5 mg twice daily by mouth or placebo plus prednisone. Efficacy end points included radiographic progression-free survival (rPFS) and overall survival (OS). Distributions and medians were estimated by Kaplan-Meier method and hazard ratio (HR) and 95% confidence interval (CI) by Cox model.

resultsBaseline characteristics were similar across studies and treatment groups. Regardless of Gleason score, AA treatment significantly improved rPFS in post-docetaxel [Gleason score <8: median, 6.4 versus 5.5 months (HR = 0.70; 95% CI 0.56-0.86), P = 0.0009 and Gleason score ≥8: median, 5.6 versus 2.9 months (HR = 0.58; 95% CI 0.48-0.72), P < 0.0001] and chemotherapy-naïve patients [Gleason score <8: median, 16.5 versus 8.2 months (HR = 0.50; 95% CI 0.40-0.62), P < 0.0001 and Gleason score ≥8: median, 13.8 versus 8.2 months (HR = 0.61; 95% CI 0.49-0.76), P < 0.0001]. Clinical benefit of AA treatment was also observed for OS, prostate-specific antigen (PSA) response, objective response and time to PSA progression across studies and Gleason score subgroups.

conclusionOS and rPFS trends demonstrate AA treatment benefit in patients with pre- or post-chemotherapy mCRPC regardless of Gleason score at initial diagnosis. The initial diagnostic Gleason score in patients with mCRPC should not be considered in the decision to treat with AA, as tumour metastases may no longer reflect the histology at the time of diagnosis. CLINICAL TRIALS NUMBER: COU-AA-301 (NCT00638690); COU-AA-302 (NCT00887198).

Indexed as

Abiraterone AcetateAdultAgedAged, 80 and overAndrostenolsAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDouble-Blind MethodHumansMaleMiddle AgedNeoplasm GradingNeoplasm MetastasisPrednisoneProstatic Neoplasms, Castration-ResistantAbiraterone AcetateAndrostenolsPrednisoneabiraterone acetatechemotherapy-naïveGleason scorepost-chemotherapyprostate cancer

Identifiers

PMID26609008
PMCPMC6279107
OpenAlexW2187005893

What OpenQuestion holds

Textmetadata
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.