- 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.
- Multicenter, open-label, observational registry PROCEED evaluated sipuleucel-T in 1902 patients with mCRPC.
- Funding: Dendreon Pharmaceuticals LLC.
- 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).
- No comparator group.