My comment about Gleasons score was incorrect. One of the 10 prognostic factors in the nomogram was tumor grade, which meant either high or low Gleasons score, Its relevance was similar to the previous Halabi nomogram of 7 prognostic factors, that is, if Glaesons score was at the high end of its range, it added the lowest points (8) to the total sum. The new nomogram included several new prognostic markers including docetaxel use, baseline pain, mode of progression, number of metastatic disease types and PSA Doubling Time that were not included in the Halabi nomogram. However, the concordance index of 0.69 was not an improvement over the Halabi probability of accuracy.The authors conclude that the lack of better predictive ability in spite of the 10 factors that were statistically significant suggests that other important biomarkers have still not been factored in. Regretfully, that probably means that lengthy randomized clinical trials in HRPC with survival as an endpoint will continue to be needed for FDA approval until and unless some composite or standalone surrogate marker(s)with better correlation to patient survival or other meaningful clinical benefit are validated. Given the recent failures of both satraplatin and Asentar, Provenge and GVAX, if either or both are successful, could become new standards of care in AIPC/HRPC for years to come.
Another interesting fact in the study was that at the time of completing the study in November 2006, four years after accrual of the last of 1006 patients in the TAX327 pivotal Ph 3 trial, 800 deaths had occurred, and thus 20% of enrollees were surviving long term, with the longest time to survival in 11/06 being 70.8 months.
AI
