Abstract
40 Background: Sipuleucel-T (SipT) prolongs survival of men with metastatic castrate-resistant prostate cancer (CRPC). We prospectively collected CTC, LDH, and inflammatory markers as part of an audit to investigate changes after SipT treatment compared to baseline. Methods: Men with CRPC had blood drawn routinely before and after SipT treatment. CTC were run using Veridex assay. LDH, C-reactive protein (CRP) and β2-microglobulin (β2m) were measured in a reference lab. Wilcoxon Signed Rank Test was used to compare pre- and post-treatment (median 3.5 weeks after final infusion) levels. Results: 61 men received SipT at USC from June 2010 to July 2012 and were included in the analysis. Median pre-SipT PSA level was 24.9 and 47% had Gleason 8-9; 20% had received chemotherapy. 18 men had detectable CTCs pre SipT (range 1-170). CTC count declined in 7 men, increased in 6 men, and stayed stable in 2 men (3 inevaluable); in 3 cases the change crossed men over from unfavorable ( >5) to favorable count. PSA declines were noted in 10 men (16.4%) ranging from -0.5% to 99%. Change in CTC and PSA was discordant in 4 cases of 13. When CTC stayed stable PSA increased in 5 and decreased in 5 cases. Median CRP was 0.5 pre and 0.23 post SipT (p=0.025) and β2m was 1.74 pre and 2.01 post (p=0.02). Increased CRP was correlated with decreased CTC (r=0.7, p=0.003 Spearman test) but β2m changes were not (r=0.45, p=0.08 Spearman) and there was no correlation between changes in the inflammation markers and PSA decline. LDH did not change significantly. The relationship between infusion reaction, eosinophilia and inflammatory markers will be presented. Conclusions: We found that CTC counts can decline after SipT treatment, including conversion from unfavorable to favorable range, and can change independently of PSA. Correlation of CTCs with outcomes in a prospective study is warranted to explore this as a potential biomarker. [Table: see text]
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