Surrogacy Case Study: Prostate Specific Antigen (PSA ... - Isped
Surrogacy Case Study: Prostate Specific Antigen (PSA ... - Isped
Surrogacy Case Study: Prostate Specific Antigen (PSA ... - Isped
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<strong>PSA</strong> response or <strong>PSA</strong>-V<br />
surrogate for survival in HRPC?<br />
• Meta-analytic validation in 2 studies of liarozole versus<br />
CPA/FLU (1)<br />
• <strong>PSA</strong> response (50% decline) not a surrogate for OS<br />
• SWOG-9916: Docetaxel+Estramustine vs M+P (2)<br />
• <strong>PSA</strong> response (first 3 m) not a surrogate for OS<br />
• <strong>PSA</strong> velocity (first 3 m) is a surrogate for OS by Prentice<br />
criteria and should be further investigated<br />
• Tax 327: Docetaxel(D)(q1s)+Prednisone(P) vs D(q3s)+P vs<br />
Mitoxantrone(M)+P (3)<br />
• <strong>PSA</strong> response (50% decline from entry) not validated as<br />
surrogate for OS<br />
• Other changes in <strong>PSA</strong> or <strong>PSA</strong> kinetics are weaker<br />
surrogates<br />
1. Buyse M. et al In Biomarkers in Clinical Drug Development. Springer-Verlag, 2003<br />
2. Crawford et al. ASCO 2004, abs. 4505, Petrylak DP. J Natl Cancer Inst 2006.<br />
3. Roessner M et al. ASCO 2005, abs. 391s.; Armstrong AJ et al. JCO 2007
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