Comparative quality of life in patients randomized contemporaneously to docetaxel or abiraterone in the STAMPEDE trial.

Abstract

14 Background: Docetaxel (DOC) and abiraterone (ABI) both improve overall survival (OS) in men with locally advanced or metastatic hormone-sensitive prostate cancer (HSPC) but no head to head trials compare the 2 agents. STAMPEDE, a multi-arm multi-stage platform trial, recruited patients (pts) to treatments including DOC or ABI between Nov-11 and Mar-13. There was no evidence OS differed between DOC or ABI, thus quality of life (QOL) may increasingly inform treatment options. Methods: QOL scores were analysed in pts contemporaneously randomised to receive DOC or ABI, in addition to standard of care treatment. Self-assessment QOL questionnaires EORTC QLQ C30 and PR25 were completed during treatment and follow-up. These analyses focus on average global QOL over the first 2 years after randomisation, using repeated measures analysis, plus cross-sectional analyses at 3, 6, 12 and 24 months. A score difference of ≥4 points was pre-defined as clinically meaningful. Results: 173 men randomised to DOC and 342 men randomised to ABI participated in the QOL sub-study and contributed to this analysis. Baseline characteristics and proportion of missing data were similar between groups. Baseline global QOL scores were similar (mean (sd): DOC 77.8 (20) and ABI 78.0 (19.3)). Average global QOL over 2 years was higher in pts randomised to ABI than DOC, although the difference was statistically significant it did not meet the pre-defined clinical parameter (+3.9, 95%CI 0.6 to 7.1, p=0.021). Cross-sectional analyses showed clinically meaningful superior QOL in the ABI group at 3 and 6 months (+6.6, 95%CI 2.6 to 10.7, p=0.001; +8.0, 95%CI 3.6 to 12.3, p<0.001), but not at 1 or 2 years (+1.3, 95%CI -3.0 to 5.6, p=0.545; +4.5, 95%CI -0.25 to 9.2, p=0.063). An exploratory analysis indicated average QOL for pts with metastatic disease (n=207) was better in the ABI group (+4.44, 95%CI 0.2 to 8.6, p=0.036). Conclusion: Global QOL was significantly higher in the first 2 years of treatment for the ABI group compared to the DOC group, though did not meet the pre-defined clinically meaningful threshold. The majority of difference was seen in the first year of treatment. This should be considered when discussing treatment options with pts. Clinical trial information: NCT00268476.

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Advances and Treatment Strategies in the First-Line Setting

“…The STAMPEDE investigators compared QoL scores (using EORTC QLQ-C30 and -PR25 health-related quality of life questionnaires) of a contemporaneous cohort of patients recruited to receive docetaxel and abiraterone. The average global QoL over 2 years was higher in patients randomised to abiraterone, with a cross-sectional analysis showing clinically meaningful superior QoL in the abiraterone group at 3-6 months [44]. QoL was directly assessed by the FACT-P (a 12-item prostate cancer-specific scale) score in both the ARCHES and TITAN trials; the QoL scores did not differ between the intervention and control arms.…”

Living with Advanced Hormone-Sensitive Prostate Cancer and Treatment with Abiraterone and Androgen Deprivation Therapy: The Patient, Nursing and Physician Perspective

“…In their respective clinical trials, the quality of life assessment demonstrated comparable or better outcomes than ADT monotherapy [14,15]. Abiraterone demonstrated a superior quality of life to docetaxel within the STAMPEDE study up to 2 years of treatment, and particularly within the first year of treatment administration [16].…”

Evaluation of Cognitive Function in Trials Testing New-Generation Hormonal Therapy in Patients with Prostate Cancer: A Systematic Review

“…QoL was evaluated with EORTC C30 and EORTC P25 questionnaires. However, even if EORTC C30 includes evaluation of cognitive functioning, the results about this functional scale have not yet been reported [ 37 ].…”