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Apr 30, 2010 07:47PM
lucy88, I have no desire to have a war of words or ideas with you. I will, however, point out that we're using the term "experimental" in two different ways, and also clarify some of the data. First, "experimental" in the biomed community means that a drug has not yet been demonstrated to be good for any particular thing and is not yet approved by regulatory bodies like the FDA in the US for prescriptions by doctors. This is the sense in which I'm using the term.
That said...There are numerous completed clinical trials of Arimidase that have demonstrated that, in certain BC women (postmenopausal, early stage BC, localized disease, and similar), Arimidase as adjuvant therapy was better than tamoxifen at reducing recurrences, and as good as tamoxifen at reducing breast cancer mortality. In other words, the data show both reduction in recurrances and reduction in BC-caused deaths, the first actually better than tamox, and the latter as well as tamox. On the basis of such completed trials, Arimidase was approved for adjuvant use in the types of BC patients that had been tested.
You seem to be upset that the clinical trials have not compared Arimidase to a placebo group (no treatment), rather than to tamoxifen. That's understandable, however, the reason that wasn't and isn't done is because it would have been unethical for a clinical trial to give one of the groups of women nothing (placebo) rather than a drug that had already been proven to save lives (tamoxifen). Indeed, the regulatory bodies (FDA) would not have allowed such a trial, as it would have condemned some of the placebo-group patients to death unnecessarily. The final logic is thus: tamoxifen has been proven to reduce BC-caused death very significantly (see below), and head-to-head trials showed arimidex is equal to tamoxifen wrt reducing BC-caused death, therefore arimidex also reduces BC-caused deaths. In addition, in the populations tested, Arimidase was found to reduce recurrances in even more women than tamoxifen did. Therefore, for postmenopausal women w/early stage, localized cancers, the field now typically considers the "best" (to treat the BC) drug to be arimidase (or other AI's) over tamoxifen. Obviously, the choice of whether it's best for any given woman is that woman's choice based on all her considerations of side effects, risks, etc.
As for whether there continues to be experiments on Arimidase, I absolutely agree that new clinical trials (yes, experiments) continue, as the company looks to see how many other BC situations it might be good for (and perhaps other cancers too), and to see how longer-term survival statistics will play out. And in that sense it is indeed still an experimental drug.
FYI, you can find a summary of 30+ yrs of tamoxifen data (to which Arimidase is being compared) here: http://www.ncbi.nlm.nih.gov/pubmed/15894097, with the important mortality summary sentence being: "For ER-positive disease only, allocation to about 5 years of adjuvant tamoxifen reduces the annual breast cancer death rate by 31% (SE 3), largely irrespective of the use of chemotherapy and of age (<50, 50-69, > or =70 years), progesterone receptor status, or other tumour characteristics."
Single MX, implant reconstruction
9/2009, IDC, <1cm, Stage I, Grade 1, 0/7 nodes, ER+/PR+, HER2-