Docetaxel for Nonmetastatic Prostate Cancer: Long-Term Survival Outcomes in the STAMPEDE Randomized Controlled Trial

Area of Science:

• Oncology
• Clinical Trials
• Prostate Cancer Research

Background:

• The STAMPEDE trial previously indicated that upfront docetaxel improves overall survival for prostate cancer patients undergoing long-term androgen deprivation therapy.
• This report presents long-term outcomes focusing on metastatic progression-free survival (mPFS) as a primary endpoint for non-metastatic patients.

Purpose of the Study:

• To evaluate the long-term efficacy and safety of adding docetaxel to standard of care (SOC) in prostate cancer patients.
• To assess the impact on metastatic progression-free survival (mPFS), overall survival, failure-free survival (FFS), and progression-free survival (PFS).

Main Methods:

• A randomized controlled trial comparing SOC (androgen deprivation therapy with or without radiotherapy) to SOC plus docetaxel.
• A total of 690 patients were randomized (460 SOC, 230 SOC plus docetaxel).
• Primary outcome was mPFS, defined by new metastases, skeletal-related events, or prostate cancer death. Secondary outcomes included overall survival, FFS, and PFS. Survival analysis used Cox regression and restricted mean survival time.

Main Results:

• Median follow-up was 6.5 years. No significant advantage for SOC plus docetaxel was observed for mPFS (HR=0.89, P=.43).
• Five-year mPFS was 82% for SOC plus docetaxel versus 77% for SOC.
• SOC plus docetaxel significantly improved FFS (HR=0.70, P=.002) and PFS (P=.03) but not overall survival (HR=0.88, P=.44). Late toxicity (grade 3-5) was similar between groups (29% vs 30%).

Conclusions:

• Adding docetaxel to SOC demonstrates robust improvement in FFS and PFS, previously linked to increased quality-adjusted life-years, without increased late toxicity.
• The addition of docetaxel did not translate into a significant benefit for longer-term outcomes like mPFS or overall survival.
• These findings may inform individualized patient management strategies in prostate cancer treatment.