Immediate treatment with androgen-deprivation therapy (ADT) for men with asymptomatic non-curable prostate cancer did not have major effects on quality of life (QOL) compared with delayed use of ADT, according to a phase III trial. There were early detriments with regard to some specific hormone treatment–related symptoms, but over the long term the global assessments of QOL were similar.
“The commencement of ADT has the potential to cause morbidity and loss of QOL in men with no symptoms from their disease,” wrote study authors led by Gillian M. Duchesne, MD, of the Peter MacCallum Cancer Centre in Melbourne, Australia. “The optimal timing and type of intervention has not been established for these patients.”
The TOAD trial (Timing of Androgen Deprivation) randomized 293 men in three countries to either immediate (142 patients) or delayed ADT (151 patients); previous reports on its primary survival outcomes showed an advantage in overall survival with immediate treatment. All men had either prostate-specific antigen (PSA)-only relapse after definitive treatment, or de novo non-curable disease. Results of the trial were published online ahead of print in Lancet Oncology.
The study involved two EORTC QOL questionnaires, the QLQ-C30 and the PR25; patients completed these before randomization, every 6 months for the first 2 years, and then annually for another 3 years.
There were no clinically significant or statistically significant differences with regard to global health-related QOL over the study’s first 2 years. At the 5-year follow-up, the adjusted mean score (higher scores indicate improved outcomes) for global QOL was 70.83 with immediate therapy, and 72.39 with delayed therapy (P = .297). Physical functioning was also similar, with a mean score of 84.51 with immediate therapy and 84.70 with delayed ADT (P = .873).
There were some specific areas in which the delayed group fared better. The adjusted mean sexual activity score was 13.93 with immediate therapy and 24.65 with delayed therapy (P < .0001). Hormone treatment–related symptoms were also better with delayed therapy, with an adjusted mean score of 10.15 compared with 14.55 with immediate therapy (in this case, higher score indicates worsened QOL; P < .0001). These differences in mean score were due to significant gaps in the earlier follow-up period, at 6 and 12 months.
Mean fatigue and pain scores were no different between the groups, and sexual function was also similar.
“The use of immediate ADT in the management of asymptomatic but incurable prostate cancer was associated with early detriments in hormone treatment–related symptoms and sexual activity, but had no demonstrable adverse effects on other aspects of functioning or global ratings of health-related QOL,” the authors concluded. “These results provide useful information for discussions with men considering when to start ADT.”