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Top Line: Does docetaxel and androgen deprivation therapy (ADT) prior to radical prostatectomy improve biochemical progression-free survival (BPFS) in men following a high-risk prostatectomy?
The Study: Well, it depends on how you look at it. In CALGB 90203, nearly 800 men planned for radical prostatectomy for localized, high-risk prostate cancer were randomized to +/- neoadjuvant docetaxel and ADT. By “high-risk,” here they mean men with <60% chance of BPFS at 5 years per the Kattan Nomogram. When that proportion of patients proved smaller than expected, all men with GS 8+ disease were ultimately included—which may explain the underwhelming findings. Docetaxel was given for 6 cycles along with 18-24 weeks of an LHRH agonist or antagonist. Here’s where things get complicated. First of all, there was no difference in the primary endpoint of BPFS at 3 years, defined as a PSA >0.2 increasing on 2 separate occasions ≥3 months apart. The problem is that 6% of the neoadjuvant arm and 11% of the surgery alone arm received adjuvant radiation ≤6 months post-op, and roughly half received salvage therapy >6 months post-op but before meeting the definition of the primary endpoint. When salvage therapy was counted as an event, median event-free survival was more than doubled with neoadjuvant therapy (4.5 years) versus without (1.8 years), and there were significantly fewer metastatic events. And while risk of death was technically lower after neoadjuvant therapy (HR 0.61), most mortality events were not related to prostate cancer.
TBL: Neoadjuvant docetaxel and ADT prior to radical prostatectomy for high-risk prostate cancer reduces the risk of additional therapies, but without a clear overall improvement in treatment outcomes. | Eastham, J Clin Oncol 2020