Associations Between Quality of Life and Disease Progression in Metastatic Hormone-sensitive Prostate Cancer: Insights from ARASENS and ARANOTE Trials.
1/5 보강
[BACKGROUND] Maintaining quality of life (QoL) is an important treatment goal in metastatic hormone-sensitive prostate cancer (mHSPC).
- 95% CI 1.76-3.78
APA
Morgans AK, Ekberg S, et al. (2026). Associations Between Quality of Life and Disease Progression in Metastatic Hormone-sensitive Prostate Cancer: Insights from ARASENS and ARANOTE Trials.. European urology oncology. https://doi.org/10.1016/j.euo.2026.03.009
MLA
Morgans AK, et al.. "Associations Between Quality of Life and Disease Progression in Metastatic Hormone-sensitive Prostate Cancer: Insights from ARASENS and ARANOTE Trials.." European urology oncology, 2026.
PMID
41956912
Abstract
[BACKGROUND] Maintaining quality of life (QoL) is an important treatment goal in metastatic hormone-sensitive prostate cancer (mHSPC). Evidence remains limited regarding longitudinal QoL changes, prognostic value, and contribution to treatment benefit.
[OBJECTIVE] We examined longitudinal QoL patterns, their association with castration resistance or death (CROD) and radiological progression or death (rPFS), and the contribution of QoL to the effect of darolutamide.
[DESIGN, SETTING AND PARTICIPANTS] We analyzed data from two randomized phase III trials: ARASENS (ADT + docetaxel ± darolutamide) and ARANOTE (ADT ± darolutamide).
[OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS] QoL was assessed using NCCN-FACT FPSI-17 (ARASENS) and FACT-P (ARANOTE). Joint models linked QoL with CROD (ARASENS) and rPFS (ARANOTE), accounting for informative missingness.
[RESULTS AND LIMITATIONS] Patients receiving darolutamide maintained higher QoL versus those receiving placebo. QoL decline meeting the minimally important difference (MID) was associated with higher CROD rate and shorter rPFS (HR 2.58 [95% CI: 1.76-3.78] and HR 1.32 [1.00-1.75], respectively). Higher baseline QoL was associated with improved rPFS for FACT-P (HR 0.84 [0.76-0.92] per MID) but no clear association was observed for NCCN-FACT FPSI-17 (HR 0.95 [0.89-1.02]). Joint modeling indicated that the total effect of darolutamide was largely driven by a direct component, with a smaller indirect component related to preserved QoL. Interpretation is limited by differences in disease progression definitions and QoL instruments between trials.
[CONCLUSIONS] Darolutamide improved CROD/rPFS while maintaining QoL better than placebo. QoL decline preceded progression, supporting routine QoL monitoring as an early marker of disease progression.
[OBJECTIVE] We examined longitudinal QoL patterns, their association with castration resistance or death (CROD) and radiological progression or death (rPFS), and the contribution of QoL to the effect of darolutamide.
[DESIGN, SETTING AND PARTICIPANTS] We analyzed data from two randomized phase III trials: ARASENS (ADT + docetaxel ± darolutamide) and ARANOTE (ADT ± darolutamide).
[OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS] QoL was assessed using NCCN-FACT FPSI-17 (ARASENS) and FACT-P (ARANOTE). Joint models linked QoL with CROD (ARASENS) and rPFS (ARANOTE), accounting for informative missingness.
[RESULTS AND LIMITATIONS] Patients receiving darolutamide maintained higher QoL versus those receiving placebo. QoL decline meeting the minimally important difference (MID) was associated with higher CROD rate and shorter rPFS (HR 2.58 [95% CI: 1.76-3.78] and HR 1.32 [1.00-1.75], respectively). Higher baseline QoL was associated with improved rPFS for FACT-P (HR 0.84 [0.76-0.92] per MID) but no clear association was observed for NCCN-FACT FPSI-17 (HR 0.95 [0.89-1.02]). Joint modeling indicated that the total effect of darolutamide was largely driven by a direct component, with a smaller indirect component related to preserved QoL. Interpretation is limited by differences in disease progression definitions and QoL instruments between trials.
[CONCLUSIONS] Darolutamide improved CROD/rPFS while maintaining QoL better than placebo. QoL decline preceded progression, supporting routine QoL monitoring as an early marker of disease progression.
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- Advances in Androgen Deprivation Therapy-Sparing Strategies: Ongoing Studies in Metastatic Castration-Sensitive Prostate Cancer.
- Disease progression patterns and association of prostate-specific antigen level with risk of progression in nonmetastatic castration-resistant prostate cancer.
- Does Physician Documentation of Patients' Prostate-Specific Antigen Doubling Time Affect Treatment Decisions in High-Risk Biochemically Recurrent Prostate Cancer?
- Pain and health-related quality-of-life outcomes with darolutamide in metastatic hormone-sensitive prostate cancer (ARANOTE): secondary and exploratory analyses of a multicentre, randomised, placebo-controlled, phase 3 trial.