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Post by Tony Crispino on Sept 9, 2014 15:41:05 GMT -8
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Post by Allen on Sept 9, 2014 15:54:28 GMT -8
SpecialLady and I on HW were both perplexed by the exclusion of estramustine, which tested well by published reports so far. Perhaps Maha Hussain would be able to explain that, since she was involved in some of the studies on it. There may be Phase III results that have not yet been published.
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Post by Tony Crispino on Sept 9, 2014 16:11:33 GMT -8
With no phase III results as yet I would assume that there would be no inclusion to the guidelines. It first has to get approved by the FDA with clinical evidence. I'll write Maha.
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Post by Allen on Sept 9, 2014 18:22:31 GMT -8
There have been several RCTs with published results on estramustine, but there have been some that I haven't yet seen published. Dr Hussain was part of the study comparing docetaxel+estramustine to mitoxantrone+prednisone. A Phase 2 study in France that had ≥50% PSA response as its primary endpoint found that the addition of estramustine to docetaxel more than doubled the rate of PSA response and was well tolerated. Another Phase 2 study in Italy also found biochemical progression was reduced by 62% for the combination. A 2006 meta-analysis showed a survival advantage to adding estramustine to other chemo. One study suggests that toxicity may be reduced by using lower doses without sacrificing efficacy. A retrospective review found that it was an effective monotherapy after long term ADT and second-line hormone therapy. These would seem to be worth further study. |
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Post by Tony Crispino on Sept 9, 2014 21:26:00 GMT -8
Reading the Petrylak et. al paper shows a heavy casualty rate with treatment related deaths. Since Dan was the primary investigator, and I work with him at SWOG, I will send the question to him as well. It's important to note that the date of this trial is prior to the release of Taxotere by the FDA. I believe that the trial that release TAX327 also showed similar reasults without the grade 5 toxicity rate that Petrylak et al showed. I think to make the best compare the trial would have to be docetaxel +pred v. docetaxel plus estramustine.
So far only a phase 2 was done there.
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Post by Allen on Sept 10, 2014 8:49:26 GMT -8
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Post by Tony Crispino on Sept 10, 2014 15:58:28 GMT -8
That sounds like what I'm thinking, Allen. I think this is why estramustine is out.
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