- Adjuvant docetaxel without prednisone fails to improve biochemical disease-free survival (BDFS) after radical radiotherapy with androgen deprivation therapy (ADT) in patients with intermediate-/high-risk localized prostate cancer.
- Serious adverse event rate was higher with docetaxel vs placebo.
Why this matters
- Findings do not support docetaxel over surveillance in this setting.
- Multinational phase 3 Scandinavian Prostate Cancer Group study-13: 376 patients with intermediate-/high-risk localized prostate cancer were randomly assigned to receive docetaxel without prednisone or surveillance after radiotherapy+ADT.
- Primary endpoint: PSA progression.
- Funding: Sanofi; Tampere University Hospital.
- Median follow-up was 59 months.
- Docetaxel dose reduction was reported in 51% of patients.
- 5-year estimated biochemical progression rates were 31% with docetaxel and 28% with placebo.
- No difference was observed in BDFS between the 2 groups (HR, 1.14; P=.5).
- Serious adverse events were more frequent in the docetaxel group vs the placebo group (116 vs 41 events).
- 44% of patients experienced grade 3-4 neutropenia, and 16% had febrile neutropenia in the docetaxel group.
- Open-label design.
- OS was not reported.