Quality of Life in men with prostate cancer randomly allocated to receive Docetaxel or Abiraterone in the STAMPEDE Trial
Authors
Rush, Hannah LMurphy, 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
Issue Date
2021-11-10
Metadata
Show full item recordAbstract
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.Journal
Journal of Clinical OncologyAdditional Links
https://ascopubs.org/doi/abs/10.1200/JCO.21.00728Type
Journal articleLanguage
enDescription
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.ISSN
0732-183XEISSN
1527-7755Sponsors
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.ae974a485f413a2113503eed53cd6c53
10.1200/jco.21.00728