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Quality of Life in men with prostate cancer randomly allocated to receive Docetaxel or Abiraterone in the STAMPEDE Trial

Rush, Hannah L
; 
Murphy, Laura
; 
Morgans, Alicia K
; 
Clarke, Noel W
; 
Cook, Adrian D
; 
Attard, Gerhardt
; 
Macnair, Archie
; 
Dearnaley, David P
; 
Parker, Christopher C
; 
Russell, J Martin
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Authors
Rush, Hannah L
 Murphy, Laura
 Morgans, Alicia K
 Clarke, Noel W
 Cook, Adrian D
 Attard, Gerhardt
 Macnair, Archie
 Dearnaley, David P
 Parker, Christopher C
 Russell, J Martin
 Gillessen, Silke
 Matheson, David
 Millman, Robin
 Brawley, Christopher D
 Pugh, Cheryl
 Tanguay, Jacob S
 Jones, Robert J
 Wagstaff, John
 Rudman, Sarah
 O'Sullivan, Joe M
 Gale, Joanna
 Birtle, Alison
 Protheroe, Andrew
 Gray, Emma
 Perna, Carla
 Tolan, Shaun
 McPhail, Neil
 Malik, Zaf I
 Vengalil, Salil
 Fackrell, David
 Hoskin, Peter
 Sydes, Matthew R
 Chowdhury, Simon
 Gilbert, Duncan C
 Parmar, Mahesh KB
 James, Nicholas D
 Langley, Ruth E
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Epub Date
Issue Date
2021-11-10
Submitted date
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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.
Citation
Rush, H., Murphy, L., Morgans, A. K., Clarke, N. W. et al (2021) Quality of Life in men with prostate cancer randomly allocated to receive Docetaxel or Abiraterone in the STAMPEDE Trial, Journal of Clinical Oncology, 40(8), pp. 825-836.
Publisher
American Society of Clinical Oncology (ASCO)
Journal
Journal of Clinical Oncology
Research Unit
URI
http://hdl.handle.net/2436/624443
DOI
10.1200/jco.21.00728
PubMed ID
PubMed Central ID
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https://ascopubs.org/doi/abs/10.1200/JCO.21.00728
Type
Journal article
Language
en
Description
This is a copy of an article published by American Society of Clinical Oncology in Journal of Clinical Oncology on 10/11/2021, available online: https://ascopubs.org/doi/abs/10.1200/JCO.21.00728 For re-use please see the publisher's terms and conditions.
Series/Report no.
ISSN
0732-183X
EISSN
1527-7755
ISBN
ISMN
Gov't Doc #
Sponsors
The STAMPEDE trial is sponsored by the UK Medical Research Council (MRC_MC_UU_12023/25) and conducted by the MRC Clinical Trials Unit at UCL. The trial is supported by CRUK (CRUK_A12459), the MRC, the NIHR Clinical Research Network, and the Swiss Group for Clinical Cancer Research (SAKK). P.J.H. is supported by NIHR Manchester Biomedical Research Center. The trial also receives industry collaboration and support from Novartis, Sanofi-Aventis, Pfizer, Janssen, Clovis Oncology, and Astellas.
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