Abstract
Background: In the ARAMIS trial, darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT significantly improved metastasis-free survival (MFS), overall survival (OS) and time to pain progression in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Herein, we present analyses of patient-reported health-related quality of life (HRQoL) outcomes. Patients and methods: This double-blind, placebo-controlled, phase III trial randomised patients with nmCRPC and prostate-specific antigen doubling time ≤10 months to darolutamide 600 mg (n = 955) twice daily or matched placebo (n = 554) while continuing ADT. The primary end-point was MFS; the secondary end-points included OS and time to pain progression. In this analysis, HRQoL was assessed by the time to deterioration using the Functional Assessment of Cancer Therapy–Prostate (FACT-P) prostate cancer subscale (PCS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Cancer Module (EORTC QLQ-PR25) subscales. Results: Darolutamide significantly prolonged time to deterioration of FACT-P PCS versus placebo (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.70–0.91; P = 0.0005) at the primary analysis (cut-off date: 3rd September 2018). Time to deterioration of EORTC QLQ-PR25 outcomes showed statistically significant delays with darolutamide versus placebo for urinary (HR 0.64, 95% CI 0.54–0.76; P < 0.0001) and bowel (HR 0.78, 95% CI 0.66–0.92; P = 0.0027) symptoms. Time to worsening of hormonal treatment–related symptoms was similar between the two groups. Conclusion: In patients with nmCRPC who are generally asymptomatic, darolutamide maintained HRQoL by significantly delaying time to deterioration of prostate cancer–specific quality of life and disease-related symptoms versus placebo.
| Original language | English |
|---|---|
| Pages (from-to) | 138-146 |
| Number of pages | 9 |
| Journal | EUROPEAN JOURNAL OF CANCER |
| Volume | 154 |
| DOIs | |
| Publication status | Published - Sept 2021 |
| Publication type | A1 Journal article-refereed |
Funding
This study was funded by Bayer AG and Orion Pharma. Manuscript writing support was provided to the authors and funded by Bayer AG (no grant numbers apply).The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: MRS has received grants and personal fees from Bayer, Amgen, Janssen and Lilly, and personal fees from Astellas Pharma, Novartis and Pfizer. NS has received personal fees and non-financial support from Bayer and Janssen, personal fees from Tolmar, Ferring, Medivation, Amgen, Pfizer, AstraZeneca, Genentech/Roche, Myovant Sciences, Astellas Pharma and Merck, and non-financial support from Dendreon. TLT has received grants from Bayer, Lidds AB and Astellas Pharma, and personal fees from Janssen. AU and SP have no conflicts of interest to disclose. EV has received grants and personal fees from Orion Pharma, and grants from Bayer, Ipsen and Janssen. MJ has received grants from Bayer, Ipsen and Janssen. ML has received grants, personal fees and non-financial support from Bayer and Janssen, personal fees and non-financial support from Astellas Pharma, non-financial support from Roche and grants from Medivation, Myovant Sciences and Pfizer. BA has received grants, personal fees and non-financial support from Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Ferring, Janssen, MSD, Pfizer and Sanofi, and grants from Bavarian Nordic and Icon clinical Research. IK is an employee of Bayer AG. MA-LB and AFM are employees of Bayer HealthCare. DO and JB are employees of the Research Triangle Institute Health Solutions. AS and TS are employees of Orion Pharma. KF has received personal fees and non-financial support from Janssen and Amgen, and personal fees from Bayer, Astellas Pharma, Sanofi, Orion Pharma, Curevac, AstraZeneca, ESSA and Roche. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: MRS has received grants and personal fees from Bayer, Amgen, Janssen and Lilly, and personal fees from Astellas Pharma, Novartis and Pfizer. NS has received personal fees and non-financial support from Bayer and Janssen, personal fees from Tolmar, Ferring, Medivation, Amgen, Pfizer, AstraZeneca, Genentech/Roche, Myovant Sciences, Astellas Pharma and Merck, and non-financial support from Dendreon. TLT has received grants from Bayer, Lidds AB and Astellas Pharma, and personal fees from Janssen. AU and SP have no conflicts of interest to disclose. EV has received grants and personal fees from Orion Pharma, and grants from Bayer , Ipsen and Janssen . MJ has received grants from Bayer , Ipsen and Janssen . ML has received grants, personal fees and non-financial support from Bayer and Janssen , personal fees and non-financial support from Astellas Pharma , non-financial support from Roche and grants from Medivation, Myovant Sciences and Pfizer . BA has received grants, personal fees and non-financial support from Astellas Pharma , AstraZeneca , Bayer , Bristol-Myers Squibb , Ferring , Janssen , MSD , Pfizer and Sanofi , and grants from Bavarian Nordic and Icon clinical Research . IK is an employee of Bayer AG. MA-LB and AFM are employees of Bayer HealthCare. DO and JB are employees of the Research Triangle Institute Health Solutions. AS and TS are employees of Orion Pharma. KF has received personal fees and non-financial support from Janssen and Amgen , and personal fees from Bayer, Astellas Pharma, Sanofi, Orion Pharma, Curevac, AstraZeneca, ESSA and Roche. This study was funded by Bayer AG and Orion Pharma . Manuscript writing support was provided to the authors and funded by Bayer AG (no grant numbers apply).
Keywords
- Bowel symptoms
- Darolutamide
- Hormonal treatment–related symptoms
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Quality of life
- Urinary symptoms
Publication forum classification
- Publication forum level 2
ASJC Scopus subject areas
- Oncology
- Cancer Research
