Evidence map›Paper›PMID 26965562›Full record

ArticleEuropean urology2016

Low Incidence of Corticosteroid-associated Adverse Events on Long-term Exposure to Low-dose Prednisone Given with Abiraterone Acetate to Patients with Metastatic Castration-resistant Prostate Cancer.

Karim Fizazi, Kim N Chi, Johann S de Bono, Leonard G Gomella, Kurt Miller, Dana E Rathkopf, Charles J Ryan, Howard I Scher, Neal D Shore, Peter De Porre and 6 more

Open access · greenAbstract read
In one paragraph

Article in European urology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 4% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. The Effect of Corticosteroids on Prostate Cancer Outcome Following Treatment with Enzalutamide: A Multivariate Analysis of the Phase III AFFIRM Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Article
  7. Review
  8. Article
  9. Review
  10. Cancer control : journal of the Moffitt Cancer Center
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 12 institutions in 6 countries.

Karim FizaziInstitut Gustave Roussy, University of Paris Sud, Villejuif, France. Electronic address: karim.fizazi@igr.fr.
Kim N ChiBC Cancer Agency, Vancouver, BC, Canada.
Johann S de BonoThe Institute of Cancer Research and The Royal Marsden Hospital, Sutton, UK.
Leonard G GomellaSidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA.
Kurt MillerCharité-Universitätsmedizin Berlin, Berlin, Germany.
Dana E RathkopfMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
Charles J RyanHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.
Howard I ScherMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.
Neal D ShoreCarolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC, USA.
Peter De PorreJanssen Research & Development, Beerse, Belgium.
Anil LondheJanssen Research & Development, Horsham, PA, USA.
Tracy McGowanJanssen Scientific Affairs, Horsham, PA, USA.
Nonko PelhivanovJanssen Research & Development, Raritan, NJ, USA.
Robert CharnasJanssen Research & Development, Los Angeles, CA, USA.
Mary B ToddJanssen Global Services, Raritan, NJ, USA.
Bruce MontgomeryUniversity of Washington, Seattle, WA, USA.
Janssen (United States) · USBC Cancer Agency · CACarolina Urologic Research Center · USCharité - Universitätsmedizin Berlin · DECornell University · USInstitute of Cancer Research · GBJanssen (Belgium) · BEMemorial Sloan Kettering Cancer Center · USThomas Jefferson University · USUCSF Helen Diller Family Comprehensive Cancer Center · USUniversité Paris-Sud · FRUniversity of Washington · US

Funding

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

Abstract

backgroundAbiraterone acetate (AA) is the prodrug of abiraterone, which inhibits CYP17A1 and testosterone synthesis and prolongs the survival of patients with metastatic castration-resistant prostate cancer (mCRPC). AA plus prednisone (P) (AA+P) is approved for the treatment of patients with mCRPC.

objectiveTo investigate whether long-term use of low-dose P with or without AA leads to corticosteroid-associated adverse events (CA-AEs) in mCRPC patients. DESIGN, SETTING, AND

participantsThe study included 2267 patients in COU-AA-301 and COU-AA-302. We used an inclusive Standardized MedDRA Queries-oriented approach to identify 112 preferred terms for known CA-AEs, and assessed the incidence of CA-AEs during 3-mo exposure intervals and across all P exposure levels.

interventionAll 2267 patients received 5mg of P twice daily, and 1333/2267 received AA (1g) plus P. RESULTS AND LIMITATIONS: The CA-AE incidence after any P exposure was 25%, 26%, and 23% for any grade, and 5%, 5%, and 4% for grade ≥3 CA-AEs for all patients and the AA+P and P alone groups, respectively. The most common any-grade CA-AEs were hyperglycemia (7.4%, 7.8%, and 6.9% for all patients, AA+P, and P alone, respectively) and weight increase (4.3%, 3.9%, and 4.8%, respectively). When assessed by duration of exposure (3-mo intervals up to ≥30 mo), no discernable trend was observed for CA-AEs, including hyperglycemia and weight increase. The investigator-reported study discontinuation rate due to CA-AEs was 11/2267 (0.5%), and one patient had a CA-AE resulting in death.

conclusionsLow-dose P given with or without AA is associated with low overall incidence of CA-AEs. The frequency of CA-AEs remained low with increased duration of exposure to P. PATIENT SUMMARY: We assessed adverse events in patients with metastatic castration-resistant prostate cancer during long-term treatment with a low dose of a corticosteroid. We found that long-term treatment with this low-dose corticosteroid is safe and tolerable.

Indexed as

Abiraterone AcetateAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsHumansHyperglycemiaMaleMiddle AgedPrednisoneProstatic Neoplasms, Castration-ResistantTime FactorsWeight GainAbiraterone AcetatePrednisoneAbiraterone acetateAdverse eventsCorticosteroidsGlucocorticoidLong termMetastatic castration-resistant prostate cancerTolerability

Identifiers

PMID26965562
PMCPMC5570464
OpenAlexW2295669653

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.