Evidence map›Paper›PMID 31902714›Full record

ArticleClinical genitourinary cancer2020

Adverse Events Associated With Radium-223 in Metastatic Prostate Cancer: Disproportionality Analysis of FDA Data Reflecting Worldwide Utilization.

Minh-Phuong Huynh-Le, Randall C Shults, Michael J Connor, Jona A Hattangadi-Gluth

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical genitourinary cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.7field-weighted citation impact, top 15% 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

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Review of PalliativeJournal of nuclear medicine technology · 2021
    Observational
  3. Article
  4. Article
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

4 authors at 1 institution in 1 country.

Minh-Phuong Huynh-LeDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, CA.
Randall C ShultsDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, CA.
Michael J ConnorDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, CA.
Jona A Hattangadi-GluthDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, CA. Electronic address: jhattangadi@ucsd.edu.
University of California San Diego · US

Funding

UC San Diego Clinical and Translational Research InstituteKL2TR001444 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DEPP, COLIN A. · 2015 to 2024
$15.4M
Image-Guided Cognitive-Sparing Radiosurgery for Brain Metastases: Avoidance of Eloquent White Matter and Hippocampal RegionsR01CA238783 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI HATTANGADI-GLUTH, JONA A · 2019 to 2021
$737k
NCATS NIH HHS KL2 TR001444NCI NIH HHS R01 CA238783
6 · The paper itself

Abstract

backgroundRadionuclide radium-223 improves survival in men with metastatic castrate-resistant prostate cancer. The United States (US) Food and Drug Administration Adverse Events Reporting System (FAERS) is a post-market pharmacovigilance database valuable for adverse event (AE) assessments. We analyzed FAERS to identify disproportionate AE signals related to radium-223, and to explore radium-223's international utilization. MATERIALS AND

methodsWe identified 2182 radium-223 cases associated with AE(s) from 2013 to 2018. The duration of radium-223 therapy was calculated. Reporting odds ratio (ROR) and proportional reporting ratio (PRR), with 95% confidence intervals (CIs), were calculated for AEs of interest. ROR shows disproportionate signals if the lower limit of the 95% CI > 1. PRR shows disproportionate signals if PRR ≥ 2, χ

resultsA majority (60.8%) of events occurred outside the US. Among patients with radium-223-associated AEs, the median therapy duration was only 56 days (corresponding to 2-3 treatment cycles). Disproportionate signals were detected for general health deterioration (ROR, 5.03; 95% CI, 4.23-5.98 and PRR, 4.94; 95% CI, 4.16-5.87), bone pain (ROR, 4.53; 95% CI, 3.67-5.59 and PRR, 4.48; 95% CI, 3.63-5.53), and hematologic AEs including anemia (ROR, 2.89; 95% CI, 2.55-3.27 and PRR, 2.80; 95% CI, 2.48-3.17), thrombocytopenia (ROR, 3.22; 95% CI, 2.77-3.74 and PRR, 3.16; 95% CI, 2.72-3.67), and pancytopenia/bone marrow failure (ROR, 4.83; 95% CI, 4.11-5.67 and PRR, 4.73; 95% CI, 4.03-5.55). There were no enforcement actions for radium-223.

conclusionsPatients with metastatic castrate-resistant prostate cancer experiencing AEs are only receiving one-half the prescription dose of radium-223 required for survival benefit. Radium-223 is associated with health deterioration, bone pain, and hematologic AEs. Real-world analyses are important for ongoing radium-223 risk-benefit assessments.

Indexed as

AgedAged, 80 and overDrug-Related Side Effects and Adverse ReactionsFollow-Up StudiesGlobal HealthHumansMaleMiddle AgedNeoplasm MetastasisPharmacovigilancePrognosisProstatic NeoplasmsRadiumRisk AssessmentSurvival RateUnited StatesRadiumRadium-223Disproportionality analysisFAERSPharmacovigilanceRadium-223Unsealed source radiotherapy

Identifiers

PMID31902714
PMCPMC7272257
OpenAlexW2994239644

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.