Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial

Hannah L. Rush, Laura Murphy, Alicia K. Morgans, Noel W. Clarke, Adrian D. Cook, Gerhardt Attard, Archie Macnair, David P. Dearnaley, Christopher C. Parker, J. Martin Russell, Silke Gillessen, David Matheson, Robin Millman, Christopher D. Brawley, Cheryl Pugh, Jacob S. Tanguay, Robert J. Jones, John Wagstaff, Sarah Rudman, Joe M. O'SullivanJoanna Gale, Alison Birtle, Andrew Protheroe, Emma Gray, Carla Perna, Shaun Tolan, Neil McPhail, Zaf I. Malik, Salil Vengalil, David Fackrell, Peter Hoskin, Matthew R. Sydes, Simon Chowdhury, Duncan C. Gilbert, Mahesh K. B. Parmar, Nicholas D. James, Ruth E. Langley

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
JournalJournal of Clinical Oncology
Early online date10 Nov 2021
DOIs
Publication statusEarly online date - 10 Nov 2021

Keywords

  • Cancer Research
  • Oncology

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