In an analysis from the STAMPEDE trial reported in the Journal of Clinical Oncology, Rush et al found that global quality of life was better with abiraterone acetate vs docetaxel, both given with prednisone/prednisolone and standard-of-care androgen-deprivation therapy, in men with locally advanced or metastatic hormone-sensitive prostate cancer.
As stated by the investigators: “Docetaxel and abiraterone acetate plus prednisone or prednisolone both improve survival when commenced alongside … [standard-of-care] androgen-deprivation therapy in locally advanced or metastatic hormone-sensitive prostate cancer. Thus, patient-reported … [quality-of-life] data may guide treatment choices.”
Study Details
Between November 2011 and March 2013, a group of patients within STAMPEDE were contemporaneously enrolled with the potential to be randomly assigned to receive either six cycles of docetaxel with daily prednisone/prednisolone plus standard of care or daily abiraterone acetate with prednisone/prednisolone (AAP) plus standard of care, providing an opportunity for potential comparative analysis.
Although not directly preplanned, an analysis among those who were randomly assigned found no evidence of difference in overall survival. In the current analysis, global quality of life was measured with the EORTC QLQ-C30 questionnaire, with scores standardized to a 0–100 scale (higher = better quality of life). A clinically meaningful difference in quality of life was defined as a difference of more than 4 points. The primary outcome measure was a difference in global quality of life over the 2 years after random assignment.
Key Findings
A total of 342 patients were randomly allocated to receive AAP plus the standard of care and 173 patients were randomly assigned to receive docetaxel plus the standard of care. Mean baseline global quality-of-life scores were 78.0 in the AAP/standard-of-care group vs 77.8 in the docetaxel/standard-of-care group.
Over the 2 years after random assignment, the mean global quality-of-life scores were 74.5 in the AAP/standard-of-care group vs 70.6 in the docetaxel/standard-of-care group, yielding a difference of 3.9 points (95% confidence interval [CI] = 0.5–7.2, P = .02) favoring AAP/standard of care; the difference fell short of the > 4 point difference indicating the finding was clinically meaningful.
Clinically meaningful differences in mean global quality-of-life scores favoring AAP/standard of care were observed over the first year (difference = 5.7 points, 95% CI = 3.0–8.5, P < .001), with notable differences at 12 weeks (difference = 7.0 points, 95% CI = 3.0–11.0, P = .001) and 24 weeks (8.3 points, 95% CI = 4.0–12.6, P < .001).
Over 2 years, differences in mean quality-of-life scores were 4.5 points (95% CI = 1.3–7.7, P = .006) in physical functioning domain scores, 5.0 points (95% CI = 1.3–8.7, P = .008) in social functioning domain scores, 5.8 points (95% CI = 1.6–9.9, P = .006) in role functioning domain scores, −0.2 points (95% CI = −3.4 to 3.0, P = .920) in cognitive functioning domain scores, and 0.2 points (95% CI = −3.1 to 3.6, P = .885) in emotional functioning domain scores.
The investigators concluded: “Patient-reported [quality of life] was superior for patients allocated to receive AAP [plus the standard of care], compared with docetaxel [plus the standard of care] over a 2-year period, narrowly missing the predefined value for clinical significance. Patients receiving AAP [plus the standard of care] reported clinically meaningful higher global [quality-of-life] scores throughout the first year following random assignment.”
Ruth E. Langley, PhD, of the MRC Clinical Trials Unit, Institute of Clinical Trials & Methodology at University College London, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The STAMPEDE trial is supported by Cancer Research UK, UK Medical Research Council, NIHR Clinical Research Network, Swiss Group for Clinical Cancer Research and by Novartis, Sanofi-Aventis, Pfizer, Janssen, Clovis Oncology, and Astellas. For full disclosures of the study authors, visit ascopubs.org.
