Quality of Life in Men With Prostate Cancer Randomly Allocated to Receive Docetaxel or Abiraterone in the STAMPEDE Trial.
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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 K B, James Nicholas D, Langley Ruth E
Аннотация
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.