The Absolute Effect / Prostate Cancer / Medical
In high-risk localized prostate cancer treated with ADT and radiotherapy, does adding adjuvant docetaxel improve survival?
563 eligible patients were analysed from 612 accrued; randomized phase III trial in high-risk localized disease. Most patients had Gleason 9–10 disease.
Both groups received androgen suppression plus external-beam radiotherapy. The experimental arm added adjuvant docetaxel.
At 10 years, overall survival was 64% with ADT + RT versus 69% with ADT + RT + docetaxel: absolute difference 5 percentage points. HR 0.89 (90% CI 0.70–1.14), one-sided p=0.22. Because the proportional-hazards assumption was not stable and the confidence interval crosses no effect, a fixed-time NNT of 20 should be treated only as a descriptive calculation, not a robust treatment-effect estimate.
Ten-year distant metastasis incidence was 22% versus 20% (p=0.29), and DFS did not differ significantly.
Grade 5 toxicity occurred in two patients in the docetaxel arm and none in control in the long-term report. The original treatment strategy also added substantial chemotherapy-related acute toxicity.
The initial shorter-term signal for docetaxel did not translate into a statistically significant long-term OS benefit. This trial is a useful example of why mature absolute outcomes can change the interpretation of an initially promising intensification strategy.
Long-term NRG/RTOG 0521 report.
Long-term follow-up did not confirm a durable overall-survival advantage from adding adjuvant docetaxel after radiotherapy plus ADT for high-risk localized prostate cancer. Adjuvant docetaxel is not a routine standard in this setting; current treatment emphasizes appropriate definitive RT, long-course ADT and selected systemic intensification according to risk and guideline evidence.