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