Résumé
Few studies compared short-term androgen deprivation (STADT) with high-dose radiotherapy (STADT-RT) versus high dose radiotherapy (RT) alone in localized prostate cancer.
The GETUG 14 study randomized 376 patients between RT (n=191) and STADT-RT (n=179). RT dose was 80Gy in both arms and STADT was 4-month flutamide, starting 2 months before irradiation and 4-month triptorelin, starting with irradiation. Disease-free survival (DFS) was the primary endpoint. Secondary endpoints were overall survival (OS), biochemical failure-free survival (BFFS), metastasis-free survival (MFS), toxicity and quality of life.
With a median follow-up of 84 months, five-year DFS was 76% in RT arm versus 84% in STADT-RT arm (hazard radio (HR)=0.64; (95% CI 0.43–0.89); P=0.02). ADT had a positive impact on BFS (HR=0.45; P=0.001) and MFS (HR=0.5; P=0.09) but not on OS (HR=1.22; P=0.54). No difference was fond in terms of gastro intestinal (26% of grade>1 in both arm, P=0.97) and genito-urinary toxicity (39% for RT and 42% for STADT-RT, P=0.55). Similarly, no difference was found in quality of life.
STADT improves DFS in intermediate and high-risk prostate cancer patients receiving high dose (80Gy) RT, without any deterioration in the safety profile.