<p><strong> </strong><strong>In mCRPC patients who are asymptomatic or minimally symptomatic, clinicians may offer sipuleucel-T. (<em>Conditional Recommendation; Evidence Level: Grade B</em>)</strong></p>
Discussion
Discussion
<p>Sipuleucel-T is an immunotherapy for the management of mCRPC. Sipuleucel-T immunotherapy is an FDA-approved agent in this setting based upon the results of the IMPACT trial,<sup>25</sup> published in 2010. In this randomized double-blind placebo controlled clinical trial, 512 men with asymptomatic or minimally-symptomatic mCRPC and good functional status were randomized to receive either sipuleucel-T or placebo on a 2:1 basis. Compared to placebo, sipuleucel-T was associated with a relative reduction of 22% in the risk of death (HR=0.78; 95% CI: 0.61 to 0.98 p=0.03). Median survival in the sipuleucel-T arm was 25.8 months compared to 21.7 months in the placebo arm. It is worth noting that patients receiving sipuleucel-T therapy rarely (<10%) exhibit a clinical, serologic or radiographic response, and, as such, should be counseled appropriately not to expect to see a decline in PSA or reduction in radiologic volume of disease when undergoing this treatment. Enrollment was restricted to patients with ECOG performance status scores of 0 or 1 who were asymptomatic or minimally symptomatic; patients with visceral metastases were excluded. As such, sipuleucel-T should only be considered for patients with asymptomatic or minimally symptomatic mCRPC. Sipuleucel-T is not associated with objective anti-tumor activity; its use is not appropriate for patients with large tumor burdens, those with visceral disease or with rapidly progressive disease. The use of sipuleucel-T immunotherapy is not recommended in symptomatic disease that necessitates opioid use, consistent with the FDA indication for this approach.</p>