QOL Improved with 18 versus 36 Months of Hormonal Therapy in Patients with High-Risk Prostate Cancer, Confirming Earlier Efficacy Evidence

Alice Goodman

March 2014, Vol 5, No 2 - Prostate Cancer

San Francisco, CA—Longer-term follow-up of a large randomized phase 3 trial suggests that quality of life (QOL) is improved when patients with high-risk prostate cancer have a shorter versus longer course of androgen-deprivation therapy (ADT) plus radiotherapy as primary treatment. In this follow-up study, 18 months of ADT were found to improve QOL versus 36 months of ADT when added to radiotherapy.

These results build on the efficacy results presented in 2013 showing identical 5- and 10-year disease-specific survival in patients with high-risk prostate cancer who received 18 months of ADT versus 36 months of ADT. In addition, the rates of overall survival and biochemical failure at 5 and 10 years were similar between the 2 groups.

When the efficacy results were presented last year, they generated much discussion among experts, who suggested that shorter courses are more desirable, but more definitive evidence was needed before changing the standard from 2 or 3 years down to 18 months. Patients should be educated about their options and should be given the supportive evidence, they noted. Given the high rate of adverse events associated with ADT, reducing the duration of treatment down from the 24- to 36-month range is attractive, but the optimal threshold needs more definite evidence, they said.

At the 2014 Genitourinary Cancers Symposium, Abdenour Nabid, MD, of the Centre Hospitalier Universitaire de Sherbrooke, Québec, Canada, presented QOL data from the prospective follow-up study. This analysis included 630 men with high-risk prostate cancer who were randomized in a 1:1 ratio to 18 months versus 36 months of ADT. The median follow-up was 79 months.

Approximately 73% of patients completed QOL questionnaires. Domains that significantly favored shorter duration of ADT (P <.01 for all vs 36 months) were found in 6 of 21 scales (physical, emotional, and social functioning; fatigue; hormonal treatment–related symptoms; and sexual activity), as well as 14 of 55 items (including trouble with long walks, stay in bed during the day, weakness, tenseness, irritability, depressed, close to a toilet, blood in stools, hot flushes, enlarged breasts, interest in sex, sexually active, and enjoyable sex).

Dr Nabid said that these QOL differences, together with the improved survival evidence, favor reducing the duration of ADT to 18 months in men with high-risk prostate cancer who are also receiving radiotherapy. He is convinced, he noted, by this study that 18 months is appropriate.