Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

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

Rajwa, Pawel ; Borkowetz, Angelika ; Abbott, Thomas ; Alberti, Andrea ; Bjartell, Anders LU ; Brash, James T. ; Campi, Riccardo ; Chilelli, Andrew ; Conover, Mitchell and Constantinovici, Niculae , et al. (2024) In European Urology Open Science 63. p.81-88
Abstract

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... (More)

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.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Androgen receptor signaling inhibitor, Big data, Docetaxel, Hormone sensitive, Metastatic, PIONEER, Prostate cancer
in
European Urology Open Science
volume
63
pages
8 pages
publisher
Elsevier
external identifiers
  • scopus:85188780237
  • pmid:38572301
ISSN
2666-1691
DOI
10.1016/j.euros.2024.02.019
language
English
LU publication?
yes
id
d845304e-bb48-4d78-aad2-80bed43b702c
date added to LUP
2024-04-16 10:16:36
date last changed
2024-04-30 12:13:18
@article{d845304e-bb48-4d78-aad2-80bed43b702c,
  abstract     = {{<p>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.</p>}},
  author       = {{Rajwa, Pawel and Borkowetz, Angelika and Abbott, Thomas and Alberti, Andrea and Bjartell, Anders and Brash, James T. and Campi, Riccardo and Chilelli, Andrew and Conover, Mitchell and Constantinovici, Niculae and Davies, Eleanor and De Meulder, Bertrand and Eid, Sherrine and Gacci, Mauro and Golozar, Asieh and Hafeez, Haroon and Haque, Samiul and Hijazy, Ayman and Hulsen, Tim and Josefsson, Andreas and Khalid, Sara and Kolde, Raivo and Kotik, Daniel and Kurki, Samu and Lambrecht, Mark and Leung, Chi Ho and Moreno, Julia and Nicoletti, Rossella and Nieboer, Daan and Oja, Marek and Palanisamy, Soundarya and Prinsen, Peter and Reich, Christian and Raffaele Resta, Giulio and Ribal, Maria J. and Gómez Rivas, Juan and Smith, Emma and Snijder, Robert and Steinbeisser, Carl and Vandenberghe, Frederik and Cornford, Philip and Evans-Axelsson, Susan and N'Dow, James and Willemse, Peter Paul M.}},
  issn         = {{2666-1691}},
  keywords     = {{Androgen receptor signaling inhibitor; Big data; Docetaxel; Hormone sensitive; Metastatic; PIONEER; Prostate cancer}},
  language     = {{eng}},
  pages        = {{81--88}},
  publisher    = {{Elsevier}},
  series       = {{European Urology Open Science}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1016/j.euros.2024.02.019}},
  doi          = {{10.1016/j.euros.2024.02.019}},
  volume       = {{63}},
  year         = {{2024}},
}