French Trial Shows Benefit of Adding Short-Term Hormone Therapy to Salvage Radiotherapy for Rising PSA After Prostatectomy
In the phase III GETUG-AFU 16 trial reported in The Lancet Oncology, Carrie et al found that adding short-term androgen suppression therapy to salvage radiotherapy was associated with improved biochemical or clinical progression-free survival among patients with prostate cancer who exhibited rising prostate-specific antigen (PSA) levels after radical prostatectomy.
Study Details
In the open-label trial, 743 patients from 43 sites were randomized between October 2006 and March 2010 to receive radiotherapy alone (n = 374) or with goserelin (Zoladex; n = 369). Patients had received no previous androgen-deprivation therapy or pelvic radiotherapy and had a rising PSA level of 0.2 to < 2.0 μg/L after having a level < 0.1 μg/L for at least 6 months after surgery with no evidence of clinical disease.
Treatment consisted of three-dimensional (3D) conformal radiotherapy or intensity-modulated radiotherapy at 66 Gy in 33 fractions 5 days per week for 7 weeks or radiotherapy plus 10.8 mg of goserelin by subcutaneous injection on the first day of radiotherapy and 3 months later. The primary endpoint was progression-free survival in the intention-to-treat population.
Progression-Free Survival
Median duration of follow-up was 63 months. The 5-year progression-free survival was 80% (95% confidence interval [CI] = 75%–84%) in the radiotherapy/goserelin group vs 62% (95% CI = 57%–67%) in the radiotherapy group (hazard ratio [HR] = 0.50, P < .0001). Subgroup analysis showed a consistent benefit of radiotherapy and goserelin.
The 5-year progression-free survival among low-risk and high-risk patients was 87% and 77% in the radiotherapy/goserelin group and 75% and 58% in the radiotherapy group, respectively. Median overall survival was 58 vs 56 months, and 5-year overall survival was 96% vs 95%, respectively.
Adverse Events
The most common adverse events related to goserelin were hot flushes and sweating, with 8% of patients having an event of grade ≥ 2 (vs none in the radiotherapy group). Grade ≥ 2 hypertension occurred in 2% vs < 1. The most common late adverse events of ≥ grade 3 were genitourinary events (7% vs 8%) and sexual disorders (8% vs 5%).
The investigators concluded: “Adding short-term androgen suppression to salvage radiotherapy benefits men who have had radical prostatectomy and whose PSA rises after a postsurgical period when it is undetectable. Radiotherapy combined with short-term androgen suppression could be considered as a reasonable option in this population.”
The study was funded by the French Ministry of Health, AstraZeneca, and La Ligue Contre le Cancer.
Christian Carrie, MD, of Centre Léon Bérard,Lyon, is the corresponding author of The Lancet Oncology article.
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