More detailed information about the study
Health-related quality of life (HRQoL) in a randomised phase 3 trial of enzalutamide with standard first line therapy for metastatic, hormone-sensitive prostate cancer (mHSPC)
Health-related quality of life was a key secondary outcome in the ANZUP-led ENZAMET trial.
HRQoL of participants in the ENZAMET trial was evaluated using three measures developed by the European Organisation for Research and Treatment of Cancer (EORTC) and the EuroQol Group to determine the different treatment effects of the two participating patient groups.
The following questionnaires were used to comprehensively assess HRQoL:
- The EORTC Core Quality of Life questionnaire (QLQ-C30) a general measure of HRQoL used across cancer populations, includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), and a global health and quality-of-life scale. Symptoms commonly reported by patients (dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), are assessed along with the financial impact of the disease and treatment.
- The EORTC Prostate Cancer Module (QLQ-PR25) asks 25 questions to assess HRQoL specific to men with prostate cancer. It includes rating scales assessing urinary and bowel symptoms, hormone treatment symptoms, sexual function, and use of incontinence aids.
- The EQ-5D-5L questionnaire is a standardised, self-rated measure of health status designed to provide a score for use in evaluation of the economic costs of the treatment. It provides a descriptive classification based on self-assessment of 5 categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5 level rating scale.
The addition of enzalutamide (versus non-steroidal anti-androgen therapy (NSAA: bicalutamide, nilutamide, or flutamide)) to testosterone suppression saw:
Enzalutamide added to testosterone suppression alone:
- Global health and quality of life was maintained;
- Improved deterioration-free survival (defined as the time from when the patient was randomised to their first significant worsening of physiological signs and symptoms, or death);
- The early impairments in specific aspects of HRQoL did not outweigh the subsequent benefits of delayed clinical progression;
- Deterioration-free survival benefits at 3 years were smaller with treatment with early docetaxel than without it, however these difference were not beyond the play of chance.
For men who are candidates for docetaxel treatment when starting testosterone suppression:
- Is an appropriate option for men with metastatic hormone-sensitive prostate cancer starting testosterone suppression alone.
- Longer follow-up is needed to determine if the delays in disease progression and in the time to clinical deterioration with enzalutamide and concurrent early docetaxel treatment also results in improved overall survival beyond 3 years.