Localized prostate cancer: adjuvant chemotherapy prolongs PFS in some high-risk patients

  • Lin DW & al.
  • Eur Urol
  • 7 Jan 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In high-risk patients with prostate cancer undergoing radical prostatectomy, adjuvant chemotherapy with docetaxel and prednisone:
    • Fails to extend overall PFS.
    • But shows PFS benefit in patients with Gleason grade ≤7 or pathologic tumor stage ≥T3b.
  • Lower accrual reduced the study power to detect treatment benefit.

Why this matters

  • High recurrence rates are seen in high-risk patients with localized disease, and early adjuvant treatment may improve outcome in some patients.

Study design

  • Phase 3 CSP #553 study of 298 high-risk patients with localized prostate adenocarcinoma, randomly assigned to either chemotherapy (docetaxel+prednisone) or standard of care. 
  • Primary outcome: PFS.
  • Funding: US Department of Veterans Affairs.

Key results

  • Median follow-up: 59.1 months.
  • 35% had pathologic ≥pT3b disease, and 35% had Gleason score ≥8.
  • Adjuvant chemotherapy showed no statistical difference in PFS vs standard of care (55.5 vs 42.2 months; aHR, 0.80; P=.18).
  • PFS was significantly longer with adjuvant chemotherapy in patients with:
    • Tumor stage ≥pT3b:
      • 47.2 vs 29.2 months;
      • aHR, 0.54 (95% CI, 0.32-0.92).
    • Gleason score ≤7:
      • 81.8 vs 36.8 months;
      • aHR, 0.65 (95% CI, 0.43-0.99).
  • 67% of patients experienced treatment-related grade ≥3 adverse events, most commonly neutropenia, hyperglycemia, and infections.
  • Serious adverse event rate was similar between groups.

Limitations

  • Slow accrual.