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Does anyone have thoughts about participating in stage 1 clinical trials? Lesions in my liver are no longer responding to standard chemo treatments, and my oncologist is now suggesting I participate in a stage 1 clinical trial.
At the 2009 American Society of Clinical Oncology (ASCO) breast cancer symposium, in San Francisco, there was a Keynote Address by Martine PIccart-Gebhart of the Jules Bordet Institute.
The speaker made the point that only 8% of new drugs entering Phase I trials ever make it to marketing and this percentage is even lower for cancer drugs, because current drug testing is inefficient, with many drugs failing late in development, with these expensive failures owing, in large measure, to ineffective drugs and poor patient selection (i.e, lack of prognostic and predictive markers for response to therapy).
The speaker went on to note that little progress has been made in identifying which therapeutic strategies are likely to be effective for individual patients. The speaker concluded that identifying markers that can predict response to a particular drug remains a great challenge.
There was nothing presented at this meeting which reported any progress at all in "drug selection" through the use of molecular profiling. When microarrays and high throughput RT-PCR emerged some years back, you'd think that there would be quite a bit of progress by now. Sad to say, there has not.
However, a study was presented at the symposium about progress in "drug selection" through the use of cell-based functional profiling. The data clearly showed the utility of cell culture assays in "targeting" chemotherapy to patient sub-groups who are most likely to benefit from treatment with given individual drugs.
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&conf ID=70&abstractID=40486
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