Sipuleucel-T immunotherapy for castration-resistant prostate cancer
Philip W Kantoff1, Celestia S Higano, Neal D Shore
1Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02115, USA. philip_kantoff@dfci.harvard.edu
The New England Journal of Medicine
|September 8, 2010
Summary
Sipuleucel-T immunotherapy demonstrated a 22% reduction in mortality risk for men with metastatic castration-resistant prostate cancer, improving median survival by 4.1 months. This active cellular immunotherapy offers a significant survival benefit for advanced prostate cancer patients.
Area of Science:
- Immunotherapy
- Oncology
- Clinical Trials
Background:
- Metastatic castration-resistant prostate cancer (mCRPC) presents a significant challenge in treatment.
- Autologous active cellular immunotherapy offers a novel therapeutic approach.
Purpose of the Study:
- To evaluate the efficacy of sipuleucel-T in prolonging overall survival for patients with mCRPC.
- To assess the impact of sipuleucel-T on disease progression in this patient population.
Main Methods:
- A phase 3, double-blind, placebo-controlled, multicenter trial randomly assigned 512 patients with mCRPC.
- Patients received either sipuleucel-T or placebo intravenously every 2 weeks for three infusions.
- Overall survival was the primary end point, analyzed using stratified Cox regression.
Main Results:
- Sipuleucel-T showed a 22% relative reduction in the risk of death (HR, 0.78; P=0.03), improving median survival by 4.1 months.
- 36-month survival probability was higher in the sipuleucel-T group (31.7%) compared to placebo (23.0%).
- Immune responses were observed; adverse events like chills, fever, and headache were more frequent with sipuleucel-T.
Conclusions:
- Sipuleucel-T significantly prolonged overall survival in men with mCRPC.
- No significant effect on the time to disease progression was observed with sipuleucel-T treatment.
