Monday, June 2, 2014

The Results are In

Have you ever gone to the doctor looking for an answer only to leave with more questions?  I have. 

Though I spend a lot of time in oncology clinics, I don't really understand how they work. What is the goal?  Is it to just keep me sated and comfy until I run out of time OR is it to go into this battle like a warrior and kick some cancer ass?  I wonder about that.  Many times, I feel my oncologist is walking into my exam room like a person doing improv, without a definite plan, like he is thinking on his feet, which in reality may just be the way he thinks, but that approach leaves me wondering and fills me with questions.    

I don't pretend to be an passive patient with an introverted husband.  I am not afraid to stand up for myself and Mark researches breast cancer like my life depends on it... and maybe it does.  I am being worked up for a type of therapy I remember Mark asking about on one of my very first clinic visits almost 5 years ago.  We were told I had to try other therapies first and, as you know, I did.  

Some scientific info from the FoundationOne Website:

About The Test

Foundation Medicine Test: FoundationOne (Test) was developed and its performance characteristics determined by Foundation Medicine, Inc. (Foundation Medicine). The Test has not been cleared or approved by the United States Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. The Test may be used for clinical purposes and should not be regarded as purely investigational or for research only. Foundation Medicine’s clinical reference laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high- complexity clinical testing.
Diagnostic Significance/Lack of Significance of Reported Biomarkers: Foundation Medicine’s Test identifies alterations to select cancer-associated genes or portions of genes (biomarkers). In some cases, the Test identifies biomarkers that lack detectable evidence of cancer- associated alterations. These alterations (and, in some cases, lack of alterations) are reported to a patient’s treating physician in this report (Report).
Qualified Alteration calls: An alteration denoted as “amplification – equivocal” implies that the FoundationONE assay data provide some, but not unambiguous, evidence that the copy number of a gene exceeds the threshold for identifying copy number amplification. The threshold used in FoundationOne for identifying a copy number amplification is five (5) for ERBB2 and six (6) for all other genes. Conversely, an alteration denoted as “loss – equivocal” implies that the FoundationONE assay data provide some, but not unambiguous, evidence for homozygous deletion of the gene in question. An alteration denoted as “sub-clonal” is one that the FoundationONE analytical methodology has identified as being present in <10% of the assayed tumor DNA.
The Report incorporates analyses of peer-reviewed studies and other publicly available information provided to Foundation Medicine by N-of-One, Inc. (N-of-One); these analyses and information may include associations between a molecular alteration (or lack of alteration) and one or more drugs with potential clinical benefit (or potential lack of clinical benefit), including drug candidates that are being studied in clinical research. Additional information from N-of-One is available on its website at www.n-of-one.com


After two bone biopsies and seven weeks of waiting, we now have a 25 page report from FoundationOne. The results showed 10 alterations. Dr Laudi said there are currently 2 clinical trials that target these genes, however, they are not offered in Minnesota.  One is in Pennsylvania and the other is in Arizona with the possibility of an additional clinical trial at the Mayo. As with all clinical trials a person has to meet the specific trial criteria.  For example, some trials limit the numbers of previous chemos or other types of treatment a person has had, such as radiation.  They don't want too many variables. 

Due to an increase in bone pain in my left hip and right shoulder, I will start the Doxil (lipid encapsulated Doxorubicin) and get an MRI. Dr. Laudi is calling doctors in Pennsylvania and Arizona and setting up an appointment at the Mayo.

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