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Remark by Maria Wetzel, Advocate
Somehow we have to change the paradigm that more is
better. With the clinical trials for newer targeted therapies being
set up, it seems that now is the time to look at dose and duration.
We'll never go back to looking at minimal effective doses for the
chemotherapeutics. Even the notorious Xeloda suggested dose still
stands, even though it quite often/most often needs to be dropped.
Ann's NOTE: Several advocates, Musa Mayer and I included, have noted that although Xeloda was approved by FDA at 2500 mg twice a day (BID), doctors said to be "in the know" understand that this dose is highly toxic and that MUCH lower doses will have a more beneficial effect.
Another advocate pointed out that Letrozole may have the same issue - approved at a higher dose than needed for treatment. FDA has NO mechanism to change the dose after approval - the pharmaceutical company must resubmit a study to show the benefit of the lower dose. How often will we see that happen?
December 2006
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