Abstract
This post-hoc analysis of the iBLAD trial investigates the association of patient-reported symptoms with survival in bladder cancer (BC) patients during and after oncological treatment.
Patient-reported outcomes (PRO) are increasingly being used in clinical and research settings to assess self-reported symptoms during oncological treatment [Citation1,Citation2]. The FDA and EMA recommend the inclusion of PROs in all clinical research studies [Citation3,Citation4]. Furthermore, the active use of PROs compared to standard care for symptom-handling during cancer therapy has been shown to improve QoL and even survival [Citation5,Citation6]. More studies have demonstrated how PROs can be used as a complementary tool to assess, monitor and manage symptoms during oncological treatment [Citation7–10].
Several studies have also shown that patient-reported outcome measures can serve as a prognostic tool [Citation6,Citation9,Citation11–13]. PRO measures associated with decreased survival include fatigue, global health, quality of life, pain, loss of appetite and physical function [Citation6,Citation9,Citation11,Citation13–15].
This study aims to evaluate the prognostic significance of patient self-reported symptom scores using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE, henceforth PRO) and secondly to identify symptoms associated with reduced survival in BC.
Patient-reported outcomes (PRO) are increasingly being used in clinical and research settings to assess self-reported symptoms during oncological treatment [Citation1,Citation2]. The FDA and EMA recommend the inclusion of PROs in all clinical research studies [Citation3,Citation4]. Furthermore, the active use of PROs compared to standard care for symptom-handling during cancer therapy has been shown to improve QoL and even survival [Citation5,Citation6]. More studies have demonstrated how PROs can be used as a complementary tool to assess, monitor and manage symptoms during oncological treatment [Citation7–10].
Several studies have also shown that patient-reported outcome measures can serve as a prognostic tool [Citation6,Citation9,Citation11–13]. PRO measures associated with decreased survival include fatigue, global health, quality of life, pain, loss of appetite and physical function [Citation6,Citation9,Citation11,Citation13–15].
This study aims to evaluate the prognostic significance of patient self-reported symptom scores using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE, henceforth PRO) and secondly to identify symptoms associated with reduced survival in BC.
| Original language | English |
|---|---|
| Journal | Acta Oncologica |
| Volume | 62 |
| Issue number | 7 |
| Pages (from-to) | 814-819 |
| Number of pages | 6 |
| ISSN | 0284-186X |
| DOIs | |
| Publication status | Published - 2023 |
Bibliographical note
Funding Information:The iBLAD study and this post-hoc analysis was funded by The Danish Cancer Society, Dagmar Marshalls Fond, Einar Willumsens Mindelegat, A.P. Møller Lægefonden, Christian Larsen og Dommer Ellen Larsens Legat, Rigshospitalets Fond til støtte for onkologiske formaal, Onkologisk Forskningsfond and Rigshospitalets Jubilæumsfond, Fabrikant Einar Willumsens Mindelegat; Kræftens Bekæmpelse. None of the funding sources played a role in the planning, conduction of the study, analyses of the data or writing of the manuscript. We thank the statisticians at the Section of Biostatistics at University of Copenhagen for assisting with the formal analysis.