Response from Dr. Carney re: Bayer serum test

As I've mentioned, I e-mailed Dr. Carney at Bayer re: the Her2 serum test. He generously answered me and I think some of you might benefit from his response.

Dr. Carney,

I just watched your presentation of "Clinical Utility of Monitoring Serum Her-2new Oncoprotein Level. It was a wonderful description of Her2 and its role in women with breast cancer. I was left, however, with one big question.

How can this serum test benefit me and women like me?

I had original BC detected in 1999 (at age 41). We knew then that I had positive Her2-neu status. But with no metastasis or positive nodes, of course, Herceptin was not an option. I proceeded with chemo and mastectomy.

Then in Sept. 03, I had metastasis indicated in liver and bones. A FISH test of the liver tumor determined I was Her-2+++. Months of treatment with Navelbine, Herceptin and Zometa shrunk the vast majority of the liver tumor and reduced the bone mets. However, several months later mets were indicated in my brain, for which I had WBR. Following that 21 day treatment, my next scan (in 3 months) showed mets still decreasing in the bone, stabilization in the liver and new mets in the stomach-area lymph nodes. Since Sept. 04, I have been on a regime of Taxol, Herceptin and Zometa.

My last 2 PET scans showed new mets in the liver. The last scan showed stabilization of those mets.

So, my question:

The only benefit I see to taking the serum test would be to tell me whether my disease is truly stable (with less than 15 ng/ml) or if I can expect further destabilization and a shorter life. Since there are currently no treatments other than Herceptin, how could this test benefit me? I have no desire to know if I can expect to die in the upcoming months.

I am active in a web site devoted to educating and supporting Her2+ women. Your response will be shared ( if you permit) with women around the world.

Thank you for taking the time to respond.

Sincerely,

Lisa Lowe
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Hi Lisa. Thank you for your response. The HER-2/neu test is meant to help
oncologists in their management and monitoring of patients with metastatic
breast cancer disease and in particular patients with HER-2 positive breast
cancer. As you know HER-2 positive cancers are known to be aggressive and like estrogen receptors, knowing the HER-2 status can be important. We believe and hope that monitoring the serum HER-2 in the metastatic setting will help avoid FISH type tests having to be done on a liver biopsy. Most likely the alternative to a liver biopsy and FISH test was the serum HER-2/neu test but not having the specifics I can't really comment. I think you will agree, a blood test is far less invasive than a liver biopsy.

Our intent is to have the serum test used to determine if the breast cancer
is responding to or not responding to treatment. As you know, it is important to understand if the breast cancer is progressing, because physicians have many tools available to them to help treat patients. The sooner it can be determined that a breast cancer is progressing the sooner the physician can seek alternative solutions. So instead of thinking that an increasing serum of HER-2/neu is just a bad sign, think of it as information to help physicians do the very best they can for their patients.
The other thing you should know is that most if not all physicians use serum based tests in oncology as one of the many tools to monitor and manage their patients but won't treat patients based on a stable , increasing or decreasing serum HER-2/neu value alone but will use it in conjunction with other clinical information for treatment.

As i said in my earlier email Glaxo SmithKline like many Pharmaceutical
companies are also developing anti-HER-2/neu therapies which will provide
patients and physicians alternatives to Herceptin in the near future.. It is
always positive to have alternatives. We believe that the serum HER-2/neu test will continue to be explored as a Biomarker for patients with HER-2 positive disease in patients with breast cancer and hopefully one day will be widely used to track HER-2/neu positive disease and be used to manage anti-HER-2/neu therapies.
I started HER-2/neu studies in breast cancer in 1986 and although we still have a long way to go, we have come a long way in breast cancer research.

I wish you all the best for your future. It sounds from your description below that you have received excellent care and your team of physicians and nurses are dedicated to doing their best to help you.

I hope this email is informative and also that you understand that as
researchers/scientists and physicians , we still have many challenges in cancer research and that folks like you are part of helping the medical community find better treatments.

Good Luck>>>>>>>>>>>>>>>>>>>>>>>>>>>>>.walt

Lisa,

What does Opra say?

"You go girl!!"

I think the response was great...but back to a question I asked earlier when the serum test was first announced, "will this replace FISH?"

It's sounding more and moree like it.

Take care and the best to you and Mel,
Love,
Al

[StephN]

Question relating to Al's comment that a serum test could replace FISH.

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?

Some more details, but to me they are important if I am considering using this test to tell me about the type of HER2 and not just the activity level.

Going off-track just a bit, I was just wondering: how many of you have had ONLY the IHC test done, but NOT the FISH test? I was never given the FISH test, just because my path dept believes that any "3" indicated on the IHC test is almost automatically a positive in the FISH test (on the high end of the score range). I cannot help but wonder, what kind of FISH score I would have, had I had been analyzed for the FISH test.... How important can the FISH score be, if the IHC proved to be 3 initially?? BTW, the IHC test scores come in as: 1, 2, 3; is that right?

As I understand it, the Bayer Serum is not intended to replace the FISH test, but will reinforce HER2 status as determined by either the FISH or IHC test.

It is just what Dr. Carney states, a monitoring tool that can be used in conjunction with tumor markers and pet scans. It may in the future give an early indication if your current protocol is working or not.

Jojo, there is no reason to be retested using the FISH test. Christine's HER2 status was determined using the IHC test in 1999 only because that was the only test available at that time.

If like Lisa said, you click the arrow in the grey box on the Test page, there is an extremely good description of the differences between the FISH and IHC test and why there is no correlation between the results. They measure different components of the cancer cell.

Warmest Regards
Joe

[Lolly]

I also had only the IHC test when I was diagnosed in 1999. I tested at 3+ positive.

<3,
Lolly

I recall reading a study once comparing IHC and FISH. I think that I read a 3 on the IHC has a 100% correlation to a positive score on FISH.
Al

We tend to dance around the issue of FISH vs IHC, hoping that those of us who only had the IHC have a correct reading. What I personally see from my reading is that

1. The IHC is a less expensive test than the FISH. The comparison in base price that I saw was $5 for the IHC and $50 for the FISH (this price was a couple of years ago). It is now standard for all those diagnosed with bc in the U.S. to be tested by one or the other. If they get it wrong either way it can cost a lot...

2. Scientists were shocked to learn that IHC's done in facilities where the test was less frequently done resulted in incorrect results in around 18% to 23% of the cases. The FISH was much more accurate, so they got pickier about which test they would use as the basis for clinical trials. They did feel that results from 6 labs that were central facilities did the IHC often enough that those results were credible enough that they were willing to accept the those IHCs.

3. The pathologists themselves were concerned about the difference, and now I understand that labs that do the test less often can be (or are?) subject to regular comparison with the FISH, and this is improving accuracy.

4. Before starting patients on courses of expensive drugs like Herceptin, some oncs are having those with IHC's done again by FISH so that everybody isn't wasting time and effort and money.

A.A.

[MGordon]

Just a quick 2 cents worth - if it's really woth that much ;-)

It is my understanding that Onc's will continue to use FISH and/or IHC testing for tissue samples. The goal of the serum test is to continue to measure HER2 by blood samples and therefore reduce any follow-on biopsy surgery requirements. The FISH and IHC require tissue sample and the serum requires blood work.

If an Onc can monitor continued HER2 status throughtout treatment without invasive biopsy so much the better. Now an Onc can monitor status more often and use this metric as "part of his/her toolbox" to monitor the efficiency of current treatment and/or consider additional treatment as well. As this deisease repsonds to treatment, HER2 status can change. If the change can be monitored via blood test vs. biopsy halleljuah!

Once again - my take - and I am by no means an expert of a doctor!
Mel (spouse of Lisa)

For we who have not previously had herceptin could the bayer test be of some use. I know we have taled 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?

Hi All,

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?

Susan

I've e-mailed Dr. Carney with your questions. I'll let you know his response.

Love and light,

Lisa