1: Short-term hormone therapy associated with radiotherapy as salvage treatment after radical prostatectomy: results of the GETUG-AFU 16 phase III randomized trial
Results of the GETUG-AF 16 randomised multicentre phase 3 trial were published in the Lancet this month. The trial investigated the addition of short-term androgen suppression to salvage radiotherapy (RT) on survival in men with rising PSA concentrations after radical prostatectomy.
Over 700 patients were enrolled in the study and randomly assigned to receive RT alone or RT plus goserelin. The average age of both groups was 67 years. All patients received 3D conformal radiotherapy or intensity modulated radiotherapy (IMRT). Patients in the RT plus goserelin group were given goserelin acetate by subcutaneous injection on the first day of irradiation and again after 3 months. Primary endpoints were progression-free survival (clinical or biological progression, or both) and death from any cause.
At final analysis, follow-up was around 5 years. The authors reported no additional serious acute or late genitourinary, gastrointestinal, or cardiovascular toxicities in the RT plus goserelin group. 5-year progression-free survival in the radiotherapy plus goserelin group was significantly higher than in the radiotherapy alone group (80% vs. 62%, respectively). The median duration to relapse was significantly different between the two groups (22 months in the radiotherapy alone group vs. 32 months in the RT plus goserelin group). The results showed no significant differences in health-related quality of life between the two groups. The authors acknowledged the need for longer follow-up, in order to establish the effect of this therapeutic strategy on overall survival, and suggested that combined RT and goserelin treatment could delay the need for more aggressive therapy.