Key clinical point: Neoadjuvant chemohormonal therapy (androgen deprivation plus docetaxel) was not associated with significant improvement in 3-year biochemical progression-free survival (BPFS) in patients with localized high-risk prostate cancer undergoing radical prostatectomy (RP).
Major finding: No difference was observed between the neoadjuvant and surgery-alone groups in 3-year BPFS (89% vs. 84%; P = .11) and 5-year BPFS (81% vs. 74%; 95% confidence interval for the difference, −1% to 16%) at a median follow-up of 6.1 years.
Study details: In this phase 3 trial, 788 patients with clinically localized, high-risk prostate cancer were randomly assigned (1:1) to receive RP alone or neoadjuvant chemohormonal therapy and RP (neoadjuvant group).
Disclosures: The study was supported by the National Cancer Institute of the National Institutes of Health and in part by funds from Sanofi. The authors reported relationships with multiple pharmaceutical companies.
“Numerous studies have demonstrated various benefits to moving systemic therapy earlier in the treatment course of prostate cancer. As not all men who undergo radical prostatectomy are cured, the study authors conducted a randomized clinical trial to evaluate whether addition of docetaxel plus androgen deprivation (ADT) in the neoadjuvant setting could result in improved outcomes. While overall biochemical progression-free survival (BPFS), metastasis-free survival, and overall survival were improved by the addition of systemic therapy, the primary endpoint (improved 3-year BPFS) was not met. The authors noted that salvage radiation was utilized frequently off study, likely affecting the primary endpoint. While the study did not meet the primary endpoint, there were positives identified in the other endpoints that support further study of the neoadjuvant treatment concept in this heterogeneous disease.”
Mark Klein, MD
Eastham JA et al. J Clin Oncol. 2020 Jul 24. doi: 10.1200/JCO.20.00315.