Post-operative salvage androgen deprivation and radiotherapy for prostate cancer
Mené en France sur 743 patients atteints d'un cancer de la prostate traité par prostatectomie radicale (durée médiane de suivi : 112 mois), cet essai multicentrique de phase III évalue l'intérêt, du point de vue de la survie sans maladie, d'ajouter la goséréline à une radiothérapie de sauvetage
This trial evaluated the effect on progression-free survival of adding 6 months of androgen deprivation therapy (consisting of the administration of goserelin, a luteinizing hormone-releasing hormone agonist [LHRHa]) to salvage radiotherapy in men with initially undetectable concentrations of post-operative prostate-specific antigen (PSA), then increasing to between 0·2 ng/mL and 2 ng/mL. Progression was defined as biochemical (PSA concentration 0·5 ng/mL above nadir); local (within the prostatic bed), regional (in pelvic lymph nodes), or distant (lymph nodes beyond the pelvis, bone, or viscera); or death from any cause measured from the date of randomisation. Secondary prespecified outcomes included metastasis-free survival and overall survival. Time to metastasis was defined as time from randomisation to documentation of disease outside the prostatic bed, including pelvic nodal recurrence or death from any cause. Importantly, annual or systematic scans were not required during follow-up to assess for and document metastasis, and patients with biochemical relapse or who reported pain, or both, could be scanned using CT and bone scan at the discretion of the treating physician . The authors found significant improvements in both progression-free survival (hazard ratio [HR] 0·54, 95% CI 0·43–0·68; p<0·0001) and metastasis-free survival (0·73, 0·54–0·98; p=0·0339) in the radiotherapy plus goserelin group versus the radiotherapy alone group, but not in overall survival (0·93, 0·63–1·39; p=0·73).
The Lancet Oncology , commentaire, 2018