[AlaskaAngel]

Hi Robin.

The clinical trial criteria excluded those who were node-negative and less than 2 cm. However, at the same time, the criteria for doing chemotherapy was set at 1 cm or greater for node-negatives (and in some cases even as low as 0.5 cm).

So on the one hand those falling in this group were being told that the risk was substantial enough to recommend chemotherapy, and in particular a drug known to cause some risk of heart problems (Adriamycin/doxyrubicin), and on the other hand the same group of patients was being told that their risk was not high enough to allow them to participate in the clinical trial to see if they would benefit from having Herceptin.

This created a group of people from the past for whom there is no clinical trial data to say that Herceptin either helps or hurts more. A group that exists in a vacuum. A group that was pointedly left out of the ASCO recommendations about Herceptin.

However, we do know that anyone who is HER2+++ and is either recently diagnosed or who is less than 6 months out from completing treatment IS recommended to have Herceptin.

In addition, testing for HER2/neu has been somewhat unreliable since various tests were not being done accurately in some places. This was verified when selecting HER2 positive patients for clinical trials when somewhere between 17% and 23% of those selected were found to have inaccurate test results when retested. The recommendation was that for the highest accuracy the test should be analyzed at a lab that analyzed HER2 tests frequently and consistently (in other words, at major cancer centers). Usually the FISH test is considered more reliable than the IHC.

In addition a fair number of patients who fall in the node-negative, less-than-2-cm group don't know if they are HER2 or not because they were never tested or were never told.

So for all of the above people, the value of Herceptin is not known.

AlaskaAngel