Prostate cancer: sipuleucel-T efficacy confirmed in real-world study

  • Cancer
  • 5 Sep 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Real-world data confirm efficacy and safety of sipuleucel-T infusion in patients with metastatic castration-resistant prostate cancer (mCRPC).
  • Lower baseline PSA was associated with significant OS advantage.

Why this matters

  • Findings are consistent with those of the IMPACT trial.
  • Sipuleucel-T is indicated for the treatment of asymptomatic or minimally symptomatic mCRPC.

Study design

  • Multicenter, open-label, observational registry PROCEED evaluated sipuleucel-T in 1902 patients with mCRPC.
  • Funding: Dendreon Pharmaceuticals LLC.

Key results

  • Median baseline PSA level was 15.0 ng/mL.
  • 1255 patients died over a median follow-up of 46.6 months.
  • The median OS was 30.7 (95% CI, 28.6-32.2) months.
  • 76.8% of deaths were due to disease progression.
  • Median cancer-specific survival was 42.7 (95% CI, 39.4-46.2) months.
  • 13.7% of patients experienced serious adverse events (SAEs); 3.9% had treatment-related SAEs.
  • 2.8% of patients reported cerebrovascular events; rate per 100 person-years was 1.2 (95% CI, 0.9-1.6).
  • Median OS was longest in patients with baseline PSA of ≤5.27 ng/mL (47.7 months) and consistently decreases with increasing PSA:
    • 5.28-15.08 ng/mL: 33.2 months (HR, 1.6; 95% CI, 1.3-1.9),
    • 15.09-46 ng/mL: 27.2 months (HR, 2.0; 95% CI, 1.7-2.4), and
    • >46 ng/mL: 18.4 months (HR, 3.0; 95% CI, 2.6-3.6).

Limitations

  • No comparator group.