Evidence map›Paper›PMID 28466536›Full record

SynthesisBritish journal of haematology2017

A retrospective analysis of 3954 patients in phase 2/3 trials of bortezomib for the treatment of multiple myeloma: towards providing a benchmark for the cardiac safety profile of proteasome inhibition in multiple myeloma.

Jacob P Laubach, Javid J Moslehi, Sanjeev A Francis, Jesús F San Miguel, Pieter Sonneveld, Robert Z Orlowski, Philippe Moreau, Laura Rosiñol, Edward A Faber, Peter Voorhees and 14 more

Open access · bronzeAbstract readMeta-Analysis
In one paragraph

Synthesis in British journal of haematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
4.7field-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

29 citing papers in PubMed, 48 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Review
  6. Coronary atherosclerosis and chemotherapy: From bench to bedside.Frontiers in cardiovascular medicine · 2023
    Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Cardiotoxicity of chemotherapy and targeted agents.American journal of cancer research · 2021
    Review
  15. Article
  16. Review
  17. Hypertension management in cardio-oncology.Journal of human hypertension · 2020
    Review
  18. Review
  19. Observational
  20. Prospective Study of Cardiac Events During Proteasome Inhibitor Therapy for Relapsed Multiple Myeloma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
    Observational
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

24 authors at 15 institutions in 4 countries.

Jacob P LaubachDana-Farber Cancer Institute, Boston, MA, USA.ORCID 0000-0001-7565-2052
Javid J MoslehiCardiovascular Division, Vanderbilt-Ingram Cancer Center, Cardio-Oncology Program, Vanderbilt University School of Medicine, Nashville, TN, USA.
Sanjeev A FrancisFormerly Cardio-Oncology Program, Massachusetts General Hospital, Boston, MA, USA.
Jesús F San MiguelClinica Universidad de Navarra, IDISNA, Centro Investigación Medica Aplicada (CIMA), Pamplona, Spain.
Pieter SonneveldDepartment of Haematology, Erasmus Medical Centre, Rotterdam, The Netherlands.
Robert Z OrlowskiDepartment of Lymphoma/Myeloma, The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA.
Philippe MoreauUniversity Hospital Nantes, Nantes, France.ORCID 0000-0003-1780-8746
Laura RosiñolHospital Clínic de Barcelona, IDIBAPS, Barcelona, Spain.
Edward A FaberOncology/Hematology Care, Cincinnati, OH, USA.
Peter VoorheesDepartment of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Charlotte, NC, USA.
Maria-Victoria MateosInstituto de Investigación Biomédica de Salamanca, Instituto de Biología Molecular y Celular del Cáncer, Hospital Universitario Salamanca, Universidad de Salamanca-Consejo Superior de Investigaciones Cientificas, Salamanca, Spain.
Loreta MarquezJanssen Research & Development LLC, Raritan, NJ, USA.
Huaibao FengJanssen Research & Development LLC, Raritan, NJ, USA.
Avinash DesaiJanssen Global Services LLC, Raritan, NJ, USA.
Helgi van de VeldeMillennium Pharmaceuticals Inc., Cambridge, MA, USA.
Jennifer ElliottMillennium Pharmaceuticals Inc., Cambridge, MA, USA.
Hongliang ShiMillennium Pharmaceuticals Inc., Cambridge, MA, USA.
Edward DowFoundation Medicine, Inc., Cambridge, MA, USA.
Nishith JobanputraMillennium Pharmaceuticals Inc., Cambridge, MA, USA.
Dixie-Lee EsseltineMillennium Pharmaceuticals Inc., Cambridge, MA, USA.
Liviu NiculescuMillennium Pharmaceuticals Inc., Cambridge, MA, USA.
Kenneth C AndersonDana-Farber Cancer Institute, Boston, MA, USA.
Sagar LonialWinship Cancer Institute of Emory University, Atlanta, GA, USA.
Paul G RichardsonDana-Farber Cancer Institute, Boston, MA, USA.
Millennium Engineering and Integration (United States) · USDana-Farber Cancer Institute · USJanssen (United States) · USCentre Hospitalier Universitaire de Nantes · FRClinica Universidad de Navarra · ESConsejo Superior de Investigaciones Científicas · ESEmory University · USErasmus University Rotterdam · NLFoundation Medicine (United States)Hospital Clínic de Barcelona · ESLevine Cancer Institute · USMassachusetts General Hospital · USOncology Hematology Care · USThe University of Texas MD Anderson Cancer Center · USVanderbilt University · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

This retrospective analysis aimed to establish the overall cardiac safety profile of bortezomib using patient-level data from one phase 2 and seven phase 3 studies in previously untreated and relapsed/refractory multiple myeloma (MM). Seven clinically relevant primary [congestive heart failure (CHF), arrhythmias, ischaemic heart disease (IHD), cardiac death] and secondary (hypertension, dyspnoea, oedema) cardiac endpoints were defined based on MedDRA v16.0 preferred terms. 2509 bortezomib-treated patients and 1445 patients in non-bortezomib-based control arms were included. The incidence of grade ≥3 CHF was 1·3-4·0% in studies in relapsed/refractory MM and 1·2-4·7% in previously untreated MM (2·0-7·6% all grades), with no significant differences between bortezomib- and non-bortezomib-based arms in comparative studies. Incidences of arrhythmias (1·3-5·9% grade ≥2; 0·6-4·1% grade ≥3), IHD (1·2-2·9% all grades; 0·4-2·7% grade ≥3) and cardiac death (0-1·4%) were low, with no differences between bortezomib-based and non-bortezomib-based arms. Higher rates of oedema (mostly grade 1/2) were seen in bortezomib-based versus non-bortezomib-based arms in one study and a pooled transplant study analysis. Logistic regression analyses of comparative studies showed no impact on cardiac risk with bortezomib-based versus non-bortezomib-based treatment. Bortezomib-based treatment was associated with low incidences of cardiac events.

Indexed as

Antineoplastic AgentsBenchmarkingBortezomibCardiovascular DiseasesClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDyspneaHeart FailureHumansMultiple MyelomaProteasome InhibitorsRetrospective StudiesRisk FactorsAntineoplastic AgentsBortezomibProteasome Inhibitorsbortezomibcardiaccardio-oncologymultiple myeloma

Identifiers

PMID28466536
PMCPMC6812508
OpenAlexW2611337374

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.