Hannah L Rush1, Laura Murphy1, Alicia K Morgans2, Noel W Clarke3, Adrian D Cook1, Gerhardt Attard4, Archie Macnair1,5, David P Dearnaley6, Christopher C Parker6, J Martin Russell7, Silke Gillessen8, David Matheson9, Robin Millman1, Christopher D Brawley1, Cheryl Pugh1, Jacob S Tanguay10, Robert J Jones7, John Wagstaff10, Sarah Rudman5, Joe M O'Sullivan11, Joanna Gale12, Alison Birtle13,14, Andrew Protheroe15, Emma Gray16, Carla Perna17, Shaun Tolan18, Neil McPhail19, Zaf I Malik18, Salil Vengalil20, David Fackrell21, Peter Hoskin14,22, Matthew R Sydes1, Simon Chowdhury5, Duncan C Gilbert1, Mahesh K B Parmar1, Nicholas D James6, Ruth E Langley1. 1. MRC Clinical Trials Units at University College London, London, United Kingdom. 2. Northwestern University, Chicago, IL. 3. The Christie and Salford Royal NHS Foundation Trusts, Manchester, United Kingdom. 4. UCL Cancer Institute, London, United Kingdom. 5. Guys and St Thomas' NHS Foundation Trust, London, United Kingdom. 6. Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, United Kingdom. 7. Institute of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, Scotland. 8. Oncology Institute of Southern Switzerland, Bellinzona, Switzerland. 9. University of Wolverhampton, Wolverhampton, United Kingdom. 10. Velindre Cancer Centre, Cardiff, Wales. 11. Patrick G. Johnston Centre for Cancer Research, Queen's University Belfast, United Kingdom. 12. Portsmouth Hospital University Trust, Portsmouth, United Kingdom. 13. Rosemere Cancer Centre, Lancs Teaching Hospitals, Preston, United Kingdom. 14. University of Manchester, Manchester, United Kingdom. 15. Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom. 16. Musgrove Park Hospital, Taunton, United Kingdom. 17. Royal Surrey Hospital Foundation Trust, Guildford, United Kingdom. 18. The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, United Kingdom. 19. Raigmore Hospital, Inverness, Scotland. 20. University Hospital North Midlands NHS Trust, Stoke-on-Trent, United Kingdom. 21. University Hospital Birmingham, Birmingham, United Kingdom. 22. Mount Vernon Cancer Centre and University of Manchester, Manchester, United Kingdom.
Abstract
PURPOSE: Docetaxel and abiraterone acetate plus prednisone or prednisolone (AAP) both improve survival when commenced alongside standard of care (SOC) androgen deprivation therapy in locally advanced or metastatic hormone-sensitive prostate cancer. Thus, patient-reported quality of life (QOL) data may guide treatment choices. METHODS: A group of patients within the STAMPEDE trial were contemporaneously enrolled with the possibility of being randomly allocated to receive either docetaxel + SOC or AAP + SOC. A mixed-model assessed QOL in those who had completed at least one QLQ-C30 + PR25 questionnaire. The primary outcome measure was difference in global-QOL (QLQ-C30 Q29&30) between patients allocated to docetaxel + SOC or AAP + SOC over the 2 years after random assignment, with a predefined criterion for clinically meaningful difference of > 4.0 points. Secondary outcome measures included longitudinal comparison of functional domains, pain, and fatigue, plus global-QOL at defined timepoints. RESULTS: Five hundred fifteen patients (173 docetaxel + SOC and 342 AAP + SOC) were included. Baseline characteristics, proportion of missing data, and mean baseline global-QOL scores (docetaxel + SOC 77.8 and AAP + SOC 78.0) were similar. Over the 2 years following random assignment, the mean modeled global-QOL score was +3.9 points (95% CI, +0.5 to +7.2; P = .022) higher in patients allocated to AAP + SOC. Global-QOL was higher for patients allocated to AAP + SOC over the first year (+5.7 points, 95% CI, +3.0 to +8.5; P < .001), particularly at 12 (+7.0 points, 95% CI, +3.0 to +11.0; P = .001) and 24 weeks (+8.3 points, 95% CI, +4.0 to +12.6; P < .001). CONCLUSION: Patient-reported QOL was superior for patients allocated to receive AAP + SOC, compared with docetaxel + SOC over a 2-year period, narrowly missing the predefined value for clinical significance. Patients receiving AAP + SOC reported clinically meaningful higher global-QOL scores throughout the first year following random assignment.
PURPOSE: Docetaxel and abiraterone acetate plus prednisone or prednisolone (AAP) both improve survival when commenced alongside standard of care (SOC) androgen deprivation therapy in locally advanced or metastatic hormone-sensitive prostate cancer. Thus, patient-reported quality of life (QOL) data may guide treatment choices. METHODS: A group of patients within the STAMPEDE trial were contemporaneously enrolled with the possibility of being randomly allocated to receive either docetaxel + SOC or AAP + SOC. A mixed-model assessed QOL in those who had completed at least one QLQ-C30 + PR25 questionnaire. The primary outcome measure was difference in global-QOL (QLQ-C30 Q29&30) between patients allocated to docetaxel + SOC or AAP + SOC over the 2 years after random assignment, with a predefined criterion for clinically meaningful difference of > 4.0 points. Secondary outcome measures included longitudinal comparison of functional domains, pain, and fatigue, plus global-QOL at defined timepoints. RESULTS: Five hundred fifteen patients (173 docetaxel + SOC and 342 AAP + SOC) were included. Baseline characteristics, proportion of missing data, and mean baseline global-QOL scores (docetaxel + SOC 77.8 and AAP + SOC 78.0) were similar. Over the 2 years following random assignment, the mean modeled global-QOL score was +3.9 points (95% CI, +0.5 to +7.2; P = .022) higher in patients allocated to AAP + SOC. Global-QOL was higher for patients allocated to AAP + SOC over the first year (+5.7 points, 95% CI, +3.0 to +8.5; P < .001), particularly at 12 (+7.0 points, 95% CI, +3.0 to +11.0; P = .001) and 24 weeks (+8.3 points, 95% CI, +4.0 to +12.6; P < .001). CONCLUSION: Patient-reported QOL was superior for patients allocated to receive AAP + SOC, compared with docetaxel + SOC over a 2-year period, narrowly missing the predefined value for clinical significance. Patients receiving AAP + SOC reported clinically meaningful higher global-QOL scores throughout the first year following random assignment.
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