Friday, February 1, 2008

HER2 status from Moffit pathology report

I am totally confused and just got this pathology report a friday evening ( will reach out for my oncologist next week)

I had my biopsy on 8/1/07 and the result of the Her2 with IHC was .9 so it was stated that I am her2/neu negative.

However as I was seeking a second opinion from another major cancer center (Moffitt) for my future treatment options ( rads) they requested my slides and following is the report that they faxed to me...

I am not sure what this really means, IHC(the technique that was initially used) was not borderline it was .9 so I do not even know why they decided to do the FISH(which is the next test that is done once the IHC is borderline). What is the next step for equivocal FISH result ? how can the IHC be clearly negative ( .9) and FISH be equivocal -- which I am not sure what that even means in this context arghhh...
I do NOT want to do Herception ( which I should have been doing with the chemo if I am HER+.. )

HER2/neu by FISH: EQUIVOCAL

Ratio of HER2/neu signals to chromosome 17: 1.7
The average of Her-2/neu copies per cell: 1.1
The cutoff point for reassessing Her-2/neu gene amplification is a her-2/cen17 ratio of 2.0

Some google info:

"The original FISH test results were defined as either positive or negative, but an intermediate range (from hereon referred to as equivocal range) has since been described and the clinical significance of this observation remains unclear.34-3
[16:42] arditiaylin: This strategy classifies patients as having HER2-positive disease based on positive results with either test. It is recognized that current data are insufficient to define whether these patients represent true- or false-positives

It is also clear from the panel discussion and literature review that patients with equivocal HER2 test results constitute a poorly studied subgroup with uncertain association of test scores to benefit from HER2-directed therapy.60 The panel suggested that further studies of this patient group would be promoted by defining these test results as equivocal or borderline. The panel elected to use the term equivocal to avoid confusion with borderline positive and borderline negative terminology which is sometimes used in the interpretation of FISH assays. Equivocal results of a single test require additional action which should be specified in the initial report. Equivocal IHC samples must be confirmed by FISH analysis of the sample. Equivocal FISH samples are confirmed by counting additional cells or repeating the FISH test. If FISH remains equivocal after additional cells counted or assay repeated, confirmatory IHC is recommended so that HER2 protein expression is known for the sample with true equivocal gene amplification status. "

" An important gap in the literature identified by the panel concerns those patients with test results in the intermediate or equivocal range. The decision to treat with specific therapies like trastuzumab is by necessity dichotomous (yes or no). However, HER2 test results are derived from a continuous variable, which can be expected to lead to some results falling into a gray area. Adding to this confusion is the fact that there is significant variation in the intermediate ranges for both the IHC and FISH assays. "

"The results of these surveys have shown that there is variation in laboratory performance, particularly for immunohistochemical assays with equivocal positive results or FISH testing with borderline results. The variation in immunohistochemical testing is greater than the variation in FISH testing. These results need to be interpreted with caution; however, as far fewer labs perform FISH than perform IHC, and FISH testing tends to be done in higher volume laboratories. The voluntary enrollment in this educational program leads to only a minority of laboratories doing this testing. Although the exact number of laboratories involved in HER2 testing is unknown, it is thought that about 2,000 laboratories perform HER2 IHC and about 500 laboratories perform HER2 FISH testing in the United States. "

If someone else says that I am in the gray area in anything I will surely rip their heads off !!

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