The CEGE YMB stated Feuerstein referenced the following article in his comments: http://www.slate.com/id/2181789 I posted some comments after reading the reference:
1. Most cancer studies don't have a reliable nomogram such as the Halabi nomogram with which to compare actual to projected results as in AIPC.
2. Sometimes Ph 3 results surprise for the better. Witness the fact that DNDN's Provenge didn't achieve the same delay in progression that was achieved in Ph2, but did far better in survival, which was not measured in Ph2.
3.Unless you follow Soviet consumer theory, reducing a patient's choices of experimental clinical trials in cancer will not increase enrollment by requiring larger, longer and more expensive randomized Ph2 clinical trials beyond the 5% participating now and may very well reduce it. The FDA's adoptive clinical trial process goes the other way. If modern genetic and proteomic diagnostics are used as a trial proceeds, the trial can advance faster if such diagnostics can target patients who are getting the most benefit from a trial in progress.
4. Vital 1 began enrollment in July 2004 and just passed it interim point where it would have been stopped if the Taxotere control arm, which uses a faster acting cytotoxic than the delayed ramp up of an immunotherapy, had significantly better survival than GVAX. OTOH, data analyzing the use of Taxotere after either GVAX or Provenge has been shown in the last two years to significantly enhance survival. Since the subsequent use of Taxotere in the Vital 1 experimental arm is permitted, Vital 1 docs have the opportunity of applying this knowledge rapidly for the benefit of patients.
5. IMO at best, the article's rationale might be applied where a similar approach is tweaked to try for a marginal improvement, such as varying cytotoxic chems. Fuerstein should look at the remarkable consistency in the results of immunotherapies followed by Taxotere in AIPC. The one third of the 147 Provenge patients in the DNDN 9901 and 9902a Ph 3 trials who had the Provenge followed by Taxotere combination saw median survival increase by 14 months to 34 months over patients taking Taxotere alone. These results are consistent with the 35 high dose GVAX ph 2 Patients showing a median survival of 34.9/ 35 months, 30% of whom received a subsequent taxane.
The truth of the matter is that there are few areas of research and development in modern science where generalizations such as are reached in this article produce meaningful results in the most efficient way. JMHO.
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