Umeå University's logo

umu.sePublications
System disruptions
We are currently experiencing disruptions on the search portals due to high traffic. We are working to resolve the issue, you may temporarily encounter an error message.
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • apa-6th-edition.csl
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Research protocol for an observational health data analysis on the adverse events of systemic treatment in patients with metastatic hormone-sensitive prostate cancer: big data analytics using the PIONEER platform
Department of Urology, Medical University of Silesia, Zabrze, Poland; Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Department of Urology, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany.
European Association of Urology, Nijmegen, Netherlands.
Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy.
Show others and affiliations
2024 (English)In: European Urology Open Science, ISSN 2666-1691, E-ISSN 2666-1683, Vol. 63, p. 81-88Article in journal (Refereed) Published
Abstract [en]

Combination therapies in metastatic hormone-sensitive prostate cancer (mHSPC), which include the addition of an androgen receptor signaling inhibitor and/or docetaxel to androgen deprivation therapy, have been a game changer in the management of this disease stage. However, these therapies come with their fair share of toxicities and side effects. The goal of this observational study is to report drug-related adverse events (AEs), which are correlated with systemic combination therapies for mHSPC. Determining the optimal treatment option requires large cohorts to estimate the tolerability and AEs of these combination therapies in “real-life” patients with mHSPC, as provided in this study. We use a network of databases that includes population-based registries, electronic health records, and insurance claims, containing the overall target population and subgroups of patients defined by unique certain characteristics, demographics, and comorbidities, to compute the incidence of common AEs associated with systemic therapies in the setting of mHSPC. These data sources are standardised using the Observational Medical Outcomes Partnership Common Data Model. We perform the descriptive statistics as well as calculate the AE incidence rate separately for each treatment group, stratified by age groups and index year. The time until the first event is estimated using the Kaplan-Meier method within each age group. In the case of episodic events, the anticipated mean cumulative counts of events are calculated. Our study will allow clinicians to tailor optimal therapies for mHSPC patients, and they will serve as a basis for comparative method studies.

Place, publisher, year, edition, pages
Elsevier, 2024. Vol. 63, p. 81-88
Keywords [en]
Androgen receptor signaling inhibitor, Big data, Docetaxel, Hormone sensitive, Metastatic, PIONEER, Prostate cancer
National Category
Clinical Medicine Cancer and Oncology
Identifiers
URN: urn:nbn:se:umu:diva-222894DOI: 10.1016/j.euros.2024.02.019PubMedID: 38572301Scopus ID: 2-s2.0-85188780237OAI: oai:DiVA.org:umu-222894DiVA, id: diva2:1848929
Funder
EU, Horizon 2020Available from: 2024-04-05 Created: 2024-04-05 Last updated: 2025-02-18Bibliographically approved

Open Access in DiVA

fulltext(769 kB)64 downloads
File information
File name FULLTEXT01.pdfFile size 769 kBChecksum SHA-512
6643403a93f151a191a244e600eeccaa4e036ef1d78a646cbed8c8b4dbce7ae703ec3e8be075efa2737626ac9c5376a1e1b2ce182d6d42660784c3c9140d475e
Type fulltextMimetype application/pdf

Other links

Publisher's full textPubMedScopus

Authority records

Josefsson, Andreas

Search in DiVA

By author/editor
Josefsson, Andreas
By organisation
Wallenberg Centre for Molecular Medicine at Umeå University (WCMM)Department of Diagnostics and Intervention
In the same journal
European Urology Open Science
Clinical MedicineCancer and Oncology

Search outside of DiVA

GoogleGoogle Scholar
Total: 64 downloads
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

doi
pubmed
urn-nbn

Altmetric score

doi
pubmed
urn-nbn
Total: 377 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • apa-6th-edition.csl
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf