Clinical decision making in localized prostate cancer is a complicated, multidimensional process in which men often consider their own personal preferences, the advice of their healthcare providers, ...the opinions of their family and friends, and outside information sources. They synthesize all of this within the framework of their own unique socioeconomic situation, their social support network, and their preconceived impressions of their health and the health-care system. This is particularly germane when considering factors that influence a patient’s acceptance of and adherence to active surveillance (AS). We propose a conceptual framework based on a previously described systematic–heuristic theoretical model of decision making in this setting. We identify a number of factors that patients systematically prioritize when considering AS. These include desire for cancer control or cure, age at diagnosis, and concern regarding side effects of treatment. The way patients value these factors and effectively decide on treatment is influenced by more heuristic factors, including physician recommendation, opinion of friends and family members, and overall decision uncertainty. These heuristic factors also play an important role in adherence when a patient elects AS. Finally, some of the factors, particularly the heuristic ones, are potentially modifiable and may serve as targets for future interventions to increase acceptance of and adherence to AS.
Sipuleucel-T, an autologous active cellular immunotherapy, has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer.
In this ...double-blind, placebo-controlled, multicenter phase 3 trial, we randomly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T (341 patients) or placebo (171 patients) administered intravenously every 2 weeks, for a total of three infusions. The primary end point was overall survival, analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen (PSA) and lactate dehydrogenase.
In the sipuleucel-T group, there was a relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval CI, 0.61 to 0.98; P=0.03). This reduction represented a 4.1-month improvement in median survival (25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group). The 36-month survival probability was 31.7% in the sipuleucel-T group versus 23.0% in the placebo group. The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test (hazard ratio, 0.77; 95% CI, 0.61 to 0.97; P=0.02) and after adjustment for use of docetaxel after the study therapy (hazard ratio, 0.78; 95% CI, 0.62 to 0.98; P=0.03). The time to objective disease progression was similar in the two study groups. Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills, fever, and headache.
The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer. No effect on the time to disease progression was observed. (Funded by Dendreon; ClinicalTrials.gov number, NCT00065442.)
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