Takeaway
- 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.
Study design
- 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.
Key results
- 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.
Limitations
- Open-label design.
- OS was not reported.
Only healthcare professionals with a Univadis account have access to this article.
You have reached your limit of complementary articles
Free Sign Up Available exclusively to healthcare professionalsLogin to
account
Don’t have an account? Get started