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Prostate Cancer treatment details. Immunotherapy. UCSF Comprehensive Cancer Center, San Francisco, California, United States



Survival: 25.9 months
   
Toxicity Grade: 4
   
Treatments: Immunotherapy
   
Drugs:
Country: United States
   
City/State/Province: San Francisco, California
   
Hospital: UCSF Comprehensive Cancer Center
   
Journal: Link
   
Date: 7/2006

Description:
Patients: This phase III trial involved 127 men with with metastatic, asymptomatic hormone refractory prostate cancer. There were two treatment groups: immunotherapy and placebo. The immunotherapy group (82 patients) had a median age of 73 years, and the placebo group (45 patients) had a median age of 71 years. Only a few had received prior chemotherapy (3.7% and 8.9% in the treatment and placebo groups, respectively). After this study treatment, 43.6% of the treated patients and 52.4% of the placebo group received docetaxel-based chemotherapy.

Treatment: One group of patients received the immunotherapy Sipuleucel-T, and the other group received a placebo. Both were given by infusion.

Toxicity: The majority of toxicities were grade 1 or 2, and occurred in 95% of the Sipuleucel-T treated men and 93.3% of the placebo group. Grade 3 and 4 toxicites were experienced by 20 men in the treatment group and 11 men in the placebo group. These included rigors, dyspnea, anemia, pyrexia and fatigue. No treatment related deaths occured and no patients were removed from the trial for toxicity.

Results: The median overall survival time in the Sipuleucel-T treated group was 25.9 months, and was 21.4 months for the placebo-treated group. The median time to progression was 11.7 weeks in the treatment group and 10 weeks in the placebo group.

Support: This study was supported by the Dendreon Corporation, which developed this immunotherapy. Four of the authors are employed by Dendreon Corporation, and all but one author had other relationships with this company, serving as a consultant, being a stock-holder, and/or receiving research funds. In addition, one author also served as a consultant for Novartis and Aventis.

Correspondence: Eric J. Small, MD

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