More info on Bayer test from Dr. Carney (Walt)

Friends,

I wrote Walter Carney again, asking him the questions from Sue, SusanAnne Steph. Here is my partial e-mail to him and his very generous reply.
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From Sue: This serum test is currently approved for only metastatic disease correct? I'm not quite clear why it wouldn't be useful to monitor earlier stage cancer in conjunction with tumor markers? Couldn't our oncologists order the test "off label" just like some did with Herceptin?

From SusanAnne: For we who have not previously had herceptin could the bayer test be of some use. I know we have talked about this alot but it is important. For those of us early stage her2+++ that finished chemo more than 1 year ago could the bayer serum test give some indication of whether or not we should strongly consider herceptin now?

From Steph N: The FISH test gives a lot of detailed information about the HER2 activity in a patient. Does the Bayer or other test also measure for the same components? Or just give the level of HER2 present in the blood?



Hi Lisa. I'm glad my comments could be helpful. I hope the following helps.

Questions from Sue.

Yes, the test is cleared by the US FDA for the management and monitoring of serum HER-2/neu in patients with metastatic breast cancer.
Bayer is currently conducting clinical trials to determine if measuring serum
HER-2/neu in the adjuvant setting will have clinical utility. if our studies
indicate that it can be, then we will pursue permission from the US FDA for approval to use it for that purpose.

My hope is that someday, baseline serum HER-2/neu values will be obtained at the Diagnosis of primary breast cancer and that patients will be monitored for life. however, before that can happen it is the responsibility of Bayer to prove to the FDA that such a test is safe and effective and can be used for that indication.

Bayer does not endorse the use of tests " off label". As we all know, the FDA is there to protect us and ensure that we are protected from false claims of drugs and tests. The FDA looks for good science and is not a barrier but a very helpful agency that works with companies like Bayer to deliver the best tests that are safe and effective. In getting the serum HER-2/neu test cleared by the FDA I found them to be highly professional and helpful. In many cases "off label" does harm.

SusanAnne. Currently, Bayer is involved in clinical trials to determine if
measuring serum HER-2/neu in the adjuvant setting will have clinical value. My hope is that serum HER-2/neu as a Biomarker for HER-2/neu positive tumors will be used one day to help determine who should receive anti-HER-2/neu therapies such as Herceptin and the new anti-HER-2/neu drug in clinical trials by GSK called Lapatinib. We are very hopeful that many of the anti-HER-2/neu drugs in development will be even more helpful than Herceptin.

Steph N.
The FISH test is only preformed on the primary breast tumor. The FISH test
tells us how many copies of the HER-2/neu gene are in the cell. The gene or the HER-2/neu DNA then makes RNA. RNA makes the HER-2/neu protein which sits on the surface of the cell. Herceptin attacks the HER-2/neu protein on the cell surface . So the FISH test and IHC test only tell us the HER-2/neu status of the original breast cancer. Later in life when the HER-2/neu positive breast cancer has spread to other parts of the body ( metastatic breast cancer) the FISH and IHC tests aren't used. Therefore the only test that can monitor changes in the circulating form of HER-2/neu test is the serum HER-2/neu test. The serum HER-2/neu test is the ONLY test FDA cleared that can actually monitor changes in the HER-2/neu positive tumor by measuring changes of the protein in the serum.
So FISH measures the gene, IHC measures the internal portion of the HER-2/neu protein in the primary tumor. The serum HER-2/neu test measures the external portion of the HER-2/neu protein that sits on the cell ( and is released into the blood stream for reasons we do not yet understand) and that is actually the place where Herceptin binds and attacks the cancer cell. The FISH test tells us information about the number of HER-2/neu genes in the primary tumor, which is removed by surgery. FISH and IHC tell nothing about the changing status of a HER-2/neu tumor once the primary tumor is removed and tells us nothing about the tumors that cause metastatic breast cancer.

Lisa, I hope these are informative and helpful. Since I invented the serum
HER-2/neu test back in the mid 80's, i see lots of value for this test from the time of breast cancer diagnosis to metastatic cancer, however, we at Bayer still have plenty of research to do to convince the FDA, oncologists and patients that serum HER-2/neu will have value pre-metastatic breast cancer. By the way we have developed other tests, for instance a test that measures the external portion of EGFR in the serum .

let me know if these explanations are clear or if you have any additional
questions.
walt

Lisa, I really appreciate your contact with Dr. Carney. His answers have me alittle confused, though. (Maybe it's just my chemo brain!) In his reply to StepN he says "The FISH test in only performed on the primary breast tumor," and "So the FISH test and IHC tell us the HER2/neu staus of the original breast cancer. Later in life when the HER2/neu breast cancer has spread to other parts of the body (metastatic breaast cancer) the FISH tests and IHC aren't used". Since my original breast cancer occurred 20 years ago, and the second (a stage IV to my spine) occured 14 years ago,I doubt that either test was given in either case. Now that I have the second stage IV 14 years later in my lungs, the FISH test was given and the HER2/neu status was discovered. I asked my onc about the Bayer serum HER2/neu test and he had never heard of it. It sounds like I need to have the serum test, but I need to understand all this better than I do right now. I seriously doubt that my original 2 cancers were HER2/neu because I recovered so well from them. It's my understanding that the HER2 status is a very aggressive, fast-acting cancer, and herceptin is what stops or at least slows it down. If they were HER2, how did I survive without herceptin? Can you see my confusion? If someone can clarify things a little for me I would greatly appreciate it! Thanks so much! Tricia

[MGordon]

Tricia -

I'll hope to shed a little light on your confusion. Please remember, I am not a doctor and I will be relaying my understanding - I do not mean to speak for Dr. Carney. I also talk alot, so try to be patient with me! ;-)

The FISH and/or IHC test is a tissue based test. That means a surgeon has to perform a biopsy to take the tissue to run these tests against. Usually the primary cancer is sampled from a biopsy or removed during the lumpectomy and one of these tests (among many others) is run using the tissue from the tumor which determines the HER2 status, as well as several other important markers (diplodomy comes to mind).

Generally, as a course of treatment is performed there is no follow-on biopsy - and in many cases there is nothing left to biopsy - so the only tissue available is from the original biopsy or lumpectomy. In the cases where the disease metastisizes there may be another biopsy. In Lisa's case, she recurred to the liver, bones and brain. A liver biopsy was performed, and since there was "new" tissue available from this biopsy, the onc's could run a new series of FISH and/or IHC tests for issues like HER2 status.

The Bayer-Serum test is a diagnostic tool that the doc's can run via blood samples instead of biopsy. By looking for specific markers in the blood (I am going to refer you to the wonderful slide show that Dr. Carney put together and is listed in previous posts) based on his research showing how HER2 is shed into the blood stream. If an onc really wanted to, they could now test a patients HER2 status with every blood test and not require additional biopsies to determine a change in HER2 status. I do not believe that the Bayer-Serum test will replace the FISH/IHC tests performed on tissue samples, but will enhance monitoring and detection without the requirement of additional tissue removal.

The goal is to be able to more closely monitor any change in status without requiring any invasive surgery - because even a biopsy is invasive. If your course of treatment has been anything like Lisa's - blood draw needles are seen every week! And although some of us might dislike needles, they sure beat invasive biopsy and/or surgery.

I would tend to agree with you that FISH and IHC were not performed on your original tumor. I cannot say with all certainty, but at least the general acceptance and availability of these tests is not over 20 years old. Just curious here, with your lung recurrance, did you have a biopsy recently or did the onc test your 14 year old lung tumor sample? Most tumors are frozen and kept over a long period of time.

Regardless, I would agree with your understanding that HER2 status makes for an agressive, fast-acting cancer. And yes, Herceptin is currently the best course of treatment to slow down this aggressiveness. As far as how you survived without it - because you are who you are.

I believe that people and faith and attitude defeat cancer and drugs like Herceptin are only a tool to help. I would guess that you are a strong woman and your attitude rocks! Thank God for drugs like Herceptin and Drs. like Dr. Black and Dr. Love and Dr. Moran (he's our Onc)- and of course Dr. Slamon. But the real heroes in the battle are you and those like you (and of course my Lisa!).

I really hope this helped at least a little...

Love and Light
Mel (Spouse of Lisa)

Thanks! For myself I may check the Bayer site for trials using this test to monitor early stage DC.

Mel and Lisa, Thankyou so much for your enlightenment and encouragement. It really helps! I am quite sure that the only tissue used for the FISH test was the current mets. I will ask my onc if they tested the tissue 14 years ago, but I doubt it, although it is the same onc and it's possible he had the last tissue from then. I will share your information with him and see if I can get him to explore the Bayer serum test. So far the lung mets have not grown or changed in a year, but I just had a bone scan because of something suspicious in the T11 vertebra. The cancer 14 years ago was in T9 and T10. The notes on the last MRI about 14 years ago states "healed metastatic breast cancer". I love it! I'll let you all know the results of this one when I get them. Thanks again! This board has been a God-send to me, and I mean that literally! Tricia

Lisa,

Thank you so much forwarding our questions to Dr. Carney. His answer reinforced what my oncologist had to say this week when we discussed the use of the serum test for me. I did a preliminary search on the Bayer site to try to find the clinical trial measuring serum HER-2/neu in the adjuvant setting but have not come up with anything yet. I will continue to search for it.

Your help in obtaining this information for us was anything but "inept"! You must have written that about yourself on a low day. I hope you can see that now. You are much appreciated here. Thanks again.

Susan

[StephN]

Lisa -
Thanks so much for forwarding our "puzzlements" to Dr. Carney. One can tell by his answers that he is very clear on what he feels this test is good for. I was just wanting that clear thinking in a little more detail.

I am printing out this thread for future reference and to use to explain to others I run across about what all these tests do and when they are best done.

Would be interesting to see if Dr. Carney feels that this test is better than any tumor marker so far in use. I know other blood screenings are in development as I am in a study tracking K-19 (keratin 19) that is getting some results that will be out in the next 6 months or so.

Hi all! Thought I should let you know I asked to have this serum test for her2 to get my results. I also wanted to get my Onc involved in doing the her2 serum testing on the other her2 bc patients. My resuts were what I expected . In a Normal range of 0-15 , my result was 6. oVER 15 INDICATED PROGRESSION. Three mos later it remained the same. I contimue on herceptin every 3 wks and have remained NED. I would encourage your Oncologists to give you the her2 serum test as recomended to monitor pts progress. Also Quest/Lab Corp has the assay test and charge < $200??? ;my Insuance covered it.
As you continue on chemo this can prvide additional info on tx remission or progression.

Hope you will put this test on your list to ask the Onc on your next visit.

Your help is needed in order to get this targeted blood test on its way to help monitor our her2 bc disease.

HUGS, Christine