Localized high-risk prostate cancer: neoadjuvant chemohormonal therapy fails phase 3

  • Eastham JA & al.
  • J Clin Oncol
  • 24 Jul 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Neoadjuvant chemohormonal therapy before radical prostatectomy (RP) fails to delay biochemical relapse in patients with localized high-risk prostate cancer vs RP alone.

Why this matters

  • Adjuvant androgen deprivation therapy alone does not improve biochemical PFS (BPFS) in these patients.
  • Adding docetaxel improved outcomes in phase 1 and 2 trials.

Study design

  • 788 patients with clinically localized, high-risk prostate cancer were randomly assigned to RP alone or neoadjuvant chemohormonal therapy (androgen deprivation plus docetaxel) and RP (neoadjuvant group).
  • Primary outcome: 3-year BPFS.
  • Funding: National Cancer Institute.

Key results

  • Median follow-up was 6.1 years.
  • No difference was observed between the neoadjuvant and surgery-alone groups in:
    • 3-year BPFS (89% vs 84%; P=.11).
    • 5-year BPFS (81% vs 74%; 95% CI for the difference, −1% to 16%).
  • Patients in the neoadjuvant group showed improved event-free survival:
    • Median, 4.53 vs 1.81 years.
    • HR, 0.61 (95% CI, 0.48-0.78).
  • Grade 3 and 4 adverse event rates during chemotherapy were 26% and 19%, respectively.
    • The most common grade 3/4 adverse events were neutropenia (23%), hyperglycemia (6%), fatigue (4%), and febrile neutropenia (4%).

Limitations

  • 48% of patients received salvage treatment before reaching study endpoint.