Localized prostate cancer: adjuvant docetaxel fails to reduce progression

  • Kellokumpu-Lehtinen P& et al.
  • Eur Urol
  • 20 Aug 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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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.

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