Advanced Prostate Cancer Treated with Intermittent or Continuous Androgen Deprivation in the Randomised FinnProstate Study VII: Quality of Life and Adverse Effects

Abstract

BackgroundIntermittent dosing may reduce the adverse events (AEs) of androgen-deprivation therapy (ADT). ObjectiveTo compare intermittent androgen deprivation (IAD) and continuous androgen deprivation (CAD) with regard to health-related quality of life (QoL). Design, setting, and participantsA total of 852 men with advanced prostate cancer (PCa) were enrolled to receive goserelin acetate 3.6mg every 28 d for 24 wk. A total of 554 patients whose prostate-specific antigen (PSA) decreased to <10 ng/ml or by ≥50% (<20 ng/ml at baseline) were randomised to IAD or CAD. InterventionIn the IAD arm, ADT was resumed for at least 24 wk whenever PSA increased >20 ng/ml or above baseline. Outcome measurements and statistical analysisQoL was monitored with a validated Cleary 30-item questionnaire and analysed by the Mann-Whitney U test, 0.5 standard deviation rule, and repeated measures analysis of variance. AEs and adverse drug reactions (ADRs) were analysed by the chi-square test. Results and limitationsMedian follow-up was 65 mo. Significant differences in QoL emerged in activity limitation, physical capacity, and sexual functioning, favouring IAD. No significant differences emerged in the prevalence of AEs: 87 patients in the IAD arm (31.8%) and 95 in the CAD arm (33.9%) had cardiovascular (CV) AEs (p=0.59), with 25 (9.1%) and 29 (10.4%) withdrawn (p=0.62), and 21 (7.7%) and 24 (8.6%) dying because of a CV event (p=0.70), respectively; bone fractures occurred in 19 (6.9%) and 15 (5.4%) patients (p=0.44), respectively. Hot flushes or night sweats were the most common ADRs (47.1% vs 50.4%; p=0.44). Erectile dysfunction (15.7% vs 7.9%; p=0.042) and depressed mood (2.2 vs 0%; p=0.032) were more common in the IAD arm. ConclusionsIAD showed benefits in the treatment of advanced PCa with respect to QoL. The prevalence of AEs was not significantly lower with IAD. Trial registrationClinicalTrials.gov, NCT00293670.