Evidence map›Paper›PMID 32404868›Full record

ArticleProstate cancer and prostatic diseases2020

Concurrent or layered treatment with radium-223 and enzalutamide or abiraterone/prednisone: real-world clinical outcomes in patients with metastatic castration-resistant prostate cancer.

Neal Shore, Celestia S Higano, Daniel J George, Cora N Sternberg, Fred Saad, Bertrand Tombal, Kurt Miller, Jan Kalinovsky, XiaoLong Jiao, Krishna Tangirala and 1 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Prostate cancer and prostatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02043678 (A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 9% 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.

NCT02043678 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)

TypeinterventionalSponsorBayerRan2014 to 2024Enrolled806ConditionsProstatic NeoplasmsArmsRadium-223 dichloride (Xofigo, BAY88-8223), Matching placebo (normal saline), Abiraterone, Prednisone/Prednisolone
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

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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

11 authors at 10 institutions in 5 countries.

Neal ShoreCarolina Urologic Research Center, Myrtle Beach, SC, USA. nshore@gsuro.com.
Celestia S HiganoDepartment of Medicine, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Daniel J GeorgeDepartments of Medicine and Surgery, Duke Cancer Institute, Duke University, Durham, NC, USA.
Cora N SternbergWeill Cornell Department of Medicine, New York-Presbyterian Hospital, New York, NY, USA.
Fred SaadUniversity of Montreal Hospital Center, Montreal, QC, Canada.
Bertrand TombalDivision of Urology, IREC, Cliniques Universitaires Saint Luc, UCLouvain, Brussels, Belgium.
Kurt MillerCharité Universitätsmedizin Berlin, Urologische Klinik und Hochschulambulanz, Berlin, Germany.
Jan KalinovskyBayer Consumer Care AG, Basel, Switzerland.
XiaoLong JiaoBayer HealthCare Pharmaceuticals, Whippany, NJ, USA.
Krishna TangiralaBayer HealthCare Pharmaceuticals, Whippany, NJ, USA.
Oliver SartorTulane Cancer Center, Tulane University School of Medicine, New Orleans, LA, USA.ORCID http://orcid.org/0000-0002-8777-7343
Bayer (United States) · USBayer (Switzerland) · CHCarolina Urologic Research Center · USCharité - Universitätsmedizin Berlin · DECliniques Universitaires Saint-Luc · BEDuke University · USNewYork–Presbyterian Hospital · USTulane University · USUniversité de Montréal · CAUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn this study, we evaluated real-world data on radium-223 plus abiraterone/prednisone or enzalutamide. Previously, the ERA 223 trial (NCT02043678) demonstrated increased fracture risk with concurrent treatment with radium-223 and abiraterone plus prednisone/prednisolone in patients with metastatic castration-resistant prostate cancer (mCRPC).

methodsWe used the Flatiron Health database to perform a retrospective study of patients with mCRPC treated with radium-223. Treatment with radium-223 plus abiraterone/prednisone or enzalutamide was defined as concurrent if both drugs started within 30 days of one another, or layered when the second drug started ≥30 days after the first. The index date was defined as the day of the first radium-223 dose. Outcome measures included symptomatic skeletal events (SSEs), overall survival (OS), and patterns of treatments received.

resultsOf the 625 patients treated with radium-223, 22% received it together with abiraterone/prednisone and 27% with enzalutamide. When these agents were combined, they were often initiated in a layered fashion (73% layered, 23% concurrent). Prior or concomitant bone health agents (BHAs) were received by 67% and 55% of patients, respectively. Median follow-up was 9 months. Overall, incidence rates for SSEs and pathologic fractures were 0.35 and 0.11 patients per person-year, respectively. Median OS from mCRPC diagnosis was 28.1 months.

conclusionsIn this real-world setting, combination treatments with radium-223 and abiraterone/prednisone or enzalutamide were common. These agents were more commonly given in a layered than a concurrent fashion. Incidence rates for SSEs were reduced when BHAs were used; however, BHAs were underutilized.

Indexed as

AdultAgedAged, 80 and overAndrostenesAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBone Density Conservation AgentsBone NeoplasmsChemoradiotherapyClinical Trials, Phase III as TopicDenosumabHumansMaleMiddle AgedMulticenter Studies as TopicNeoplasm MetastasisabirateroneAndrostenesBenzamidesBone Density Conservation AgentsDenosumabenzalutamideNitrilesPhenylthiohydantoinPrednisoneRadiumRadium-223Zoledronic Acid

Identifiers

PMID32404868
PMCPMC7655504
OpenAlexW3024368357

What OpenQuestion holds

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LicenceCC BY
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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.