| Title: |
Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial |
| Authors: |
Rush, HL; Murphy, L; Morgans, AK; Clarke, NW; Cook, AD; Attard, G; Macnair, A; Dearnaley, DP; Parker, CC; Russell, JM; Gillessen, S; Matheson, D; Millman, R; Brawley, CD; Pugh, C; Tanguay, JS; Jones, RJ; Wagstaff, J; Rudman, S; O'Sullivan, JM; Gale, J; Birtle, A; Protheroe, A; Gray, E; Perna, C; Tolan, S; McPhail, N; Malik, ZI; Vengalil, S; Fackrell, D; Hoskin, P; Sydes, MR; Chowdhury, S; Gilbert, DC; Parmar, MKB; James, ND; Langley, RE |
| Source: |
Journal of Clinical Oncology (2021) (In press). |
| Publication Year: |
2021 |
| Collection: |
University College London: UCL Discovery |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/10138649/1/jco.21.00728.pdf; https://discovery.ucl.ac.uk/id/eprint/10138649/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/10138649/1/jco.21.00728.pdf; https://discovery.ucl.ac.uk/id/eprint/10138649/ |
| Rights: |
open |
| Accession Number: |
edsbas.EA83723 |
| Database: |
BASE |