Both oncologic outcomes and patient-reported outcomes are pivotal in prostate cancer (PCa). However, it remains unknown if there is any association between these two outcomes. In this secondary analysis of a randomized controlled trial, we investigated the association of short-term changes in patient-reported outcome with long-term event-free survival (EFS) and metastasis-free survival (MFS) in localized PCa.
Localized PCa patients with Gleason score ≤7, clinical stage T1b-T3a, and PSA <30 ng/mL were randomized to neoadjuvant and concurrent ADT for 6 months starting 4 months before prostate radiotherapy or concurrent and adjuvant ADT for 6 months starting simultaneously with radiotherapy. Patient-reported symptom burden was evaluated using EORTC QoL questionnaire PR.25. Clinically meaningful deterioration (CMD) was defined as a ≥10-point worsening at any time within 10 months post-randomization regardless of subsequent improvement. Landmark analyses were performed to determine the association of CMD of urinary and bowel symptoms separately with EFS and MFS in patients who responded to baseline questionnaire, were alive and event-free at 10 months.
Overall, 393 patients had responded to baseline QoL questionnaire. One patient died and one patient had failure within 10 months. Therefore, 391 patients were eligible for the landmark analyses. After adjusting for age, Gleason score, PSA, performance status, and treatment group, CMD of urinary symptoms was associated with worse EFS (HR: 1.79, 95%CI: 1.21-2.65) and MFS (HR: 1.69, 95%CI: 1.11-2.57). Considering deaths as competing events, CMD of urinary symptoms was associated with a significant increase in the relative incidence of progression (subdistribution HR: 2.42, 95%CI: 1.12-5.20). However, no association was found between CMD of bowel symptoms and EFS or MFS.
In this study, short-term CMD of urinary symptoms was associated with significantly inferior EFS, MFS and increase in the relative incidence of progression. Further investigations are needed to explore the biological rationale of such association in the context of ADT and radiotherapy.
International journal of radiation oncology, biology, physics. 2021 Nov 14 [Epub ahead of print]
Soumyajit Roy, Daniel E Spratt, Scott C Morgan, Michael Zhou, Leah A D'Souza, Fletcher Drogos, Julia Malone, Scott Grimes, Christopher Gualano, Robert MacRae, Dibya Mukherjee, Shawn Malone
Rush University Medical Center, Chicago, IL, USA. Electronic address: ., University Hospitals Seidman Cancer Center, Cleveland, OH, USA., The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, Canada., Rush University Medical Center, Chicago, IL, USA., The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada., The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, Canada. Electronic address: .