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

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.

Trial registration: ClinicalTrials.gov NCT00268476.

Fig 1

CONSORT diagram. AAP, abiraterone acetate plus prednisolone or prednisone; ADT, androgen deprivation therapy; M1, Metastatic prostate cancer; QOL, quality of life; RT, radiotherapy; SOC, standard of care; ZA, zoledronic acid.

Fig 2

Longitudinal analysis using a mixed-model approach of global-QOL scores. The red line shows global-QOL score for patients treated with AAP + SOC, whereas the blue line shows global-QOL score for patients treated with docetaxel + SOC over the 2 years following random assignment. The red and blue shaded areas show the 95% CI around each line. The black line shows global-QOL for patients receiving SOC alone. Higher scores indicate better QOL. The difference is calculated by subtracting the docetaxel + SOC score from the AAP + SOC score; a positive difference represents a higher QOLfor patients treated with AAP + SOC and negative difference represents a higher QOL for patients receiving docetaxel + SOC. All scores are corrected as per QLQ-C30 guidelines to range from 0 to 100. AAP, abiraterone acetate plus prednisone or prednisolone; QOL, quality of life; SOC, standard of care.

Fig 3

Longitudinal analysis showing QOL score for each functional domain over 2 years, separating scores for patients treated with docetaxel + SOC versus AAP + SOC. Higher scores indicate better quality of life. All scores are corrected as per QLQ-C30 guidelines to range from 0 to 100. Thedifference over2years is calculated by subtracting the docetaxel + SOC score from the AAP + SOC score; positive scores represent a higher QOL for patients treated with AAP + SOC and negative scores indicate a higher QOL for patients treated with docetaxel + SOC: (A) physical functioning domain, (B) social functioning domain, (C) role functioning domain, (D) cognitive functioning domain, and (E) emotional functioning domain. AAP, abiraterone acetate plus prednisone or prednisolone; QOL, quality of life; SOC, standard of care.

Fig 4

Longitudinal analysis showing QOL score for pain and fatigue symptoms over 2 years, separating scores for patients treated with docetaxel + SOC versus AAP + SOC. The difference over 2 years is calculated by subtracting the docetaxel + SOC score from the AAP + SOC score; a positive difference represents a higher symptom score for patients treated with AAP + SOC and a negative difference indicates a higher symptom score for patients receiving docetaxel + SOC. Higher scores indicate worse symptoms and quality of life. All scores are corrected as per QLQ-C30 guidelines to range from 0 to 100: (A) pain symptoms and (B) fatigue symptoms. AAP, abiraterone acetate plus prednisone or prednisolone; QOL, quality of life; SOC, standard of care.