The association between health-related quality-of-life scores and clinical outcomes in metastatic castration-resistant prostate cancer patients: Exploratory analyses of AFFIRM and PREVAIL studies

Beer, Tomasz M.; Miller, Kurt; Tombal, Bertrand; Cella, David; Phung, De; Holmström, Stefan; Ivanescu, Cristina; Skaltsa, Konstantina; Naidoo, Shevani

doi:10.1016/j.ejca.2017.09.035

Cited by 32 publications

(22 citation statements)

References 34 publications

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“…30 Several previous studies show that HRQoL scores can be prognostic for survival in prostate cancer. 16,[31][32][33] The prognostic value of HRQoL may reflect patient experience beyond conventional clinical characteristics. In the current study, evaluable OS data at the time of data cut-off were not yet mature, with only 28% of expected deaths (n=596).…”

Section: Discussionmentioning

confidence: 99%

“…13 Interestingly, HRQoL has been shown to be prognostic of survival in metastatic castration-resistant prostate cancer, 14,15 a finding that was confirmed by analysis of data from two phase 3 studies of enzalutamide in patients with metastatic castration-resistant prostate cancer. 16,17 In addition, HRQoL is central to cost-utility analysis in many countries and is increasingly influencing reimbursement decisions, especially for oncology treatments. 18 This work reports the results of the patient-reported outcome (PRO) measures used in the PROSPER trial to evaluate pain progression and the impact of prostate cancer-related symptoms on HRQoL in men with non-metastatic castration-resistant prostate cancer treated with enzalutamide.…”

Section: Introductionmentioning

confidence: 99%

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Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial

Tombal

Saad

Penson

et al. 2019

The Lancet Oncology

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Background In the phase 3, double-blind, placebo-controlled PROSPER trial of patients with non-metastatic castration-resistant prostate cancer, enzalutamide significantly improved metastasis-free survival (primary endpoint). Here, we report the results of patient-reported outcome (PRO) measures of this study. Methods Patients ≥18 years of age with non-metastatic castration-resistant prostate cancer and a prostate-specific antigen doubling time of ≤10 months were randomised (2:1) via interactive voice/web recognition system to receive enzalutamide (160 mg/day) or placebo. Randomisation was stratified by prostate-specific-antigen-doubling time (<6 months vs ≥6 months) and baseline use of a bone-targeting agent (yes or no). The primary endpoint was metastasis-free survival (MFS), reported elsewhere. Exploratory endpoints, reported here, included pain progression and health-related quality of life (HRQoL), assessed by the Brief Pain Inventory Short Form (BPI-SF), the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PR25), the Functional Assessment of Cancer Therapy-Prostate (FACT-P), and the EuroQoL 5-Dimensions 5-Levels health questionnaire visual analogue scale (EQ-VAS). Patients completed questionnaires at baseline, Week 17, and every 16 weeks thereafter during treatment. Pre-defined questionnaire thresholds were used to identify clinically meaningful changes. Enrollment for PROSPER is complete and follow-up continues. This trial is registered with ClinicalTrials.gov (NCT02003924). Findings Patients were enrolled from 26 November 2013 to 28 June 2017. Median followup time for all patients was 18•5 months (interquartile range [IQR] 10•7-29•2 months) in the enzalutamide group and 15•1 months (IQR 7•4-25•9 months) in the placebo group. Patients randomised to receive enzalutamide or placebo had similar baseline PRO scores. Changes in 6 Further analyses are needed to determine potential associations between pain, HRQoL, and disease progression in non-metastatic castration-resistant prostate cancer. Implications of all the available evidence As patients with non-metastatic castration-resistant prostate cancer generally have low levels of pre-treatment pain and favourable HRQoL compared to patients with advanced disease, treatments should aim to improve clinical outcomes while maintaining pain control and HRQoL. The demonstrated efficacy, tolerability, and HRQoL profile suggest that enzalutamide represents a treatment option for patients with non-metastatic castrationresistant prostate cancer. PROSPER patient recruitment sites, principal investigators and patients recruited by site* Country Site # Study centre Principal investigator # patients randomised Denmark 421 Herlev Hospital Per Rathenborg

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial

Tombal

Saad

Penson

et al. 2019

The Lancet Oncology

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“… 20 In an analysis of data from the PREVAIL and AFFIRM studies—which were conducted in patients treated with ENZ prior to or post chemotherapy, respectively—overall survival was associated with multiple HRQoL measures, including FACT-P total score. 21 Furthermore, an analysis of three phase III studies in men with CRPC found a significant association between pain interference scores and risk of death. 22 These findings highlight the need to consider PROs when managing mCRPC in order to achieve optimal treatment outcomes and ensure that the balance between benefit and harm are acceptable to patients.…”

Section: Discussionmentioning

confidence: 99%

Impact of abiraterone acetate plus prednisone or enzalutamide on fatigue and cognition in patients with metastatic castration-resistant prostate cancer: initial results from the observational AQUARiUS study

et al. 2018

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IntroductionAbiraterone acetate plus prednisone (AAP) and enzalutamide (ENZ) are commonly prescribed for metastatic castration-resistant prostate cancer (mCRPC). Data comparing their effects on patient-reported outcomes (PROs) from routine clinical practice are limited.MethodsAQUARiUS (NCT02813408) is an ongoing, two-cohort, prospective, observational, non-randomised, multicentre, phase IV European study assessing the effects of AAP and ENZ on PROs in 211 patients with mCRPC over 12 months. Patients receive AAP or ENZ per routine clinical practice. Data on cognition, fatigue, pain and health-related quality of life are measured using the Functional Assessment of Cancer Therapy-Cognitive Function, Brief Fatigue Inventory-Short Form, Brief Pain Inventory-Short Form and European Organization for Research and Treatment of Cancer Quality of Life-C30 questionnaires, respectively.ResultsThis 3-month analysis was conducted in 105 patients; 46 received AAP and 59 received ENZ. There were statistically significant differences in mean change from baseline favouring AAP over ENZ at months 1, 2 and 3 for perceived cognitive impairments and cognitive functioning. At each time-point, ENZ-treated patients had a significantly higher risk of experiencing clinically meaningful worsening in perceived cognitive impairments versus those receiving AAP.Statistically significant differences in mean change from baseline favouring AAP over ENZ were seen for usual level of fatigue and fatigue interference at months 2 and 3 and for current fatigue and worse level of fatigue at month 3. Differences favouring AAP versus ENZ were seen for the fatigue scale of the QLQ-C30 questionnaire (months 1 and 3). There was a significantly higher risk of clinically meaningful worsening in usual level of fatigue with ENZ versus AAP at month 3.No significant differences between cohorts were observed for pain (BPI-SF) at any time-point.ConclusionThis analysis suggests more favourable outcomes with AAP versus ENZ for cognition and fatigue in the first 3 months of treatment initiation for mCRPC. These findings require confirmation from future analyses of data from AQUARiUS from a larger number of patients with a longer follow-up period.

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“…In addition, the change score is also appropriate to make a statement about the survival of cancer patients. Various studies have already shown that an improvement in HRQoL in the course of therapy leads to longer survival [24,37,38]. We could prove exactly the opposite, i.e., that patients who deteriorate in their quality of life during the course of therapy survive longer than those who showed self-reported improvement in quality of life.…”

Section: Discussionmentioning

confidence: 72%

Deterioration of Health‐Related Quality of Life Scores under Treatment Predicts Longer Survival

Jörling

Rutzner

Hecht

et al. 2020

BioMed Research International

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Objectives. Baseline health-related quality of life (HRQoL) scores predict survival, which has already been demonstrated in various studies. However, we were interested in whether changes in baseline scores during treatment are also significant predictors of survival. Methods and Materials. We analysed the data of 400 consecutive cancer patients receiving radiochemotherapy. Leading diagnoses were head and neck cancer (34.5%), rectal cancer (24.5%), and lung cancer (13%). HRQoL was studied at baseline, six weeks after therapy and after each completed year after the start of therapy until drop out of the study using the EORTC QLQ-C30 questionnaire. The change score was calculated as the baseline score subtracted from the score after therapy. Statistics included Kaplan-Meier estimates and Cox regression. Results. High global health status (p=0.005) and low pain scores (p=0.040) at baseline were related to favourable overall survival. Change scores of role functioning (p=0.027), global health status (p<0.018), and pain (p<0.001) were predictive of overall survival. Pain was the superior predictor of survival (p=0.001) among all variables and QoL scores studied by multivariate analysis. A deterioration in pain was associated with a 2.8 times higher chance of survival (HR 0.36). Conclusions. Deterioration of HRQoL baseline pain score by cancer treatment is a favourable and superior prognostic factor for survival.

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The association between health-related quality-of-life scores and clinical outcomes in metastatic castration-resistant prostate cancer patients: Exploratory analyses of AFFIRM and PREVAIL studies

Cited by 32 publications

References 34 publications

Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial

Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial

Impact of abiraterone acetate plus prednisone or enzalutamide on fatigue and cognition in patients with metastatic castration-resistant prostate cancer: initial results from the observational AQUARiUS study

Deterioration of Health‐Related Quality of Life Scores under Treatment Predicts Longer Survival

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