Evidence map›Paper›PMID 30637501›Full record

Trial reportEuropean journal of nuclear medicine and molecular imaging2019

Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice.

Sabina Dizdarevic, Peter Meidahl Petersen, Markus Essler, Annibale Versari, Jean-Cyril Bourre, Christian la Fougère, Riccardo Valdagni, Giovanni Paganelli, Samer Ezziddin, Ján Kalinovský and 2 more

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in European journal of nuclear medicine and molecular imaging, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 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

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Pain Outcomes in Patients with Metastatic Castration-Resistant Prostate Cancer Treated withJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2023
    Observational
  9. Article
  10. Review
  11. Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022
    Article
  12. Administration of radium-223 and the prognosis in Japanese bone metastatic castration-resistant prostate cancer patients: A large database study.International journal of urology : official journal of the Japanese Urological Association · 2022
    Article
  13. Review
  14. Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022
    Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. The Role of Theranostics in Prostate Cancer.Seminars in radiation oncology · 2021
    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

12 authors at 12 institutions in 6 countries.

Sabina DizdarevicDepartment of Imaging and Nuclear Medicine, Royal Sussex County Hospital, Brighton and Sussex University Hospitals NHS Trust, Eastern Road, Brighton, BN2 5BE, UK. sabina.dizdarevic@bsuh.nhs.uk.ORCID http://orcid.org/0000-0002-6715-3744
Peter Meidahl PetersenRigshospitalet, Copenhagen, Denmark.
Markus EsslerUniversitätsklinikum Bonn, Bonn, Germany.
Annibale VersariAzienda Unità Sanitaria Locale - IRCCS di, Reggio Emilia, Italy.
Jean-Cyril BourreCentre Hospitalier Métropole Savoie, Chambery, France.
Christian la FougèreUniversitätsklinikum Tübingen, Tübingen, Germany.
Riccardo ValdagniUniversità degli Studi di Milano and Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Giovanni PaganelliIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy.
Samer EzziddinUniversitätsklinikum des Saarlandes, Homburg, Germany.
Ján KalinovskýBayer, Basel, Switzerland.
Inga BayhBayer AG, Wuppertal, Germany.
Yong DuRoyal Marsden Hospital, London, UK.
Azienda Sanitaria Unità Locale di Reggio Emilia · ITBayer (Germany) · DEBayer (Switzerland) · CHBrighton and Sussex Medical School · GBCentre Hospitalier Métropole Savoie · FRIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITRigshospitalet · DKRoyal Marsden Hospital · GBUniversitätsklinikum des Saarlandes · DEUniversitätsklinikum Tübingen · DEUniversity Hospital Bonn · DEUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeREASSURE is a global, prospective, non-interventional study to assess long-term safety of radium-223 in patients with bone metastatic castration-resistant prostate cancer. Here we report an interim analysis of patients according to previous use of chemotherapy.

methodsRadium-223 was administered in routine clinical practice. Interim safety analysis was planned after enrolment of the first 600 patients. Patient characteristics and safety data by previous administration of chemotherapy (docetaxel and/or cabazitaxel) were investigated.

resultsThis interim analysis included 583 patients. Median duration of observation was 7 months (range, 0-20). Nineteen patients treated with concomitant chemotherapy were excluded, 564 (97%) were eligible for exploratory analysis according to prior use of chemotherapy; 190 (34%) had previously received and completed chemotherapy, and 374 (66%) had not. In the prior versus no prior chemotherapy group, a higher proportion of patients had an Eastern Cooperative Oncology Group performance status of ≥2 (22% vs 11%) and > 20 metastatic lesions (26% vs 15%), median alkaline phosphatase (162.0 vs 115.0 U/L) and prostate-specific antigen (132.0 vs 40.2 ng/mL) levels were higher, and a lower proportion completed 6 radium-223 injections (45% vs 63%). Drug-related treatment-emergent adverse events (TEAEs) occurred in 63 and 48%, and haematological drug-related TEAEs in 21 and 9% of patients who had or had not previously received chemotherapy. Four drug-related deaths were reported, all in the prior chemotherapy group.

conclusionsThe short-term safety profile of radium-223 in routine clinical practice was comparable to other clinical studies, irrespective of prior chemotherapy use. Haematological TEAEs occurred more frequently in the prior chemotherapy group, presumably due to decreased bone marrow function as a consequence of more advanced disease and prior exposure to cytotoxic therapy. Patients who had not previously received chemotherapy appeared to have a lower burden of disease at baseline, and a lower proportion discontinued radium-223 treatment.

Indexed as

SafetyAdultAgedAged, 80 and overAlpha ParticlesHumansMaleMiddle AgedProstatic Neoplasms, Castration-ResistantRadiumTime FactorsTreatment OutcomeRadiumRadium-223CabazitaxelCurrent practiceDocetaxelMetastatic prostate cancerRadium-223Treatment sequence

Identifiers

PMID30637501
PMCPMC6451709
OpenAlexW2909895382

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.