Adjuvant Androgen-Deprivation Therapy for Prostate Cancer: Should Docetaxel Be Added?
Mené en France sur 254 patients atteints d'un cancer de la prostate à haut risque et présentant un taux de PSA en augmentation après un traitement localisé (âge médian : 64 et 66 ans), cet essai de phase III évalue l'efficacité, du point de vue de la survie sans progression du PSA, et la toxicité de l'ajout du docétaxel à une thérapie anti-androgénique (durée médiane de suivi : 10,5 ans)
In this issue of JAMA Oncology, Oudard et al report on patients with the earliest form of potentially metastatic prostate cancer: those without castration (androgen dependent) with no detectable metastases who have developed rising prostate-specific antigen (PSA) levels. The hypothesis in 2003 was that early use of docetaxel could increase the rate of cure. Two hundred fifty patients were randomized to receive androgen-deprivation therapy (ADT) for 1 year or ADT for 1 year plus docetaxel for 6 cycles. There was no survival advantage with the addition of docetaxel or delay in the development of metastases, although there was a 15% reduction in PSA relapse. At a median follow-up of 10.5 years, survival was better than expected, there was no sign of separation of the survival curves between the treatment groups, and no significant between-arm difference in radiographic progression-free survival was noted (hazard ratio [HR], 0.99; 95% CI, 0.71-1.39; P = .95). The authors concluded that “Addition of docetaxel to androgen deprivation therapy seems unwarranted in patients with high-risk prostate cancer without metastases in the absence of better predictors of risk for metastatic disease.” Is such a conclusion warranted?
JAMA Oncology , commentaire, 2018