Are You Using the HER2/serum test?

Joe · 08-22-2008, 08:34 AM

Siemens Healthcare Diagnostics is interested in hearing your experience and your thoughts about the Serum HER-2/neu Test. Have you used it to monitor your disease? If so, do you feel it has helped manage your disease? Was it offered to you by your doctor or did you request to be tested? Did you receive any positive or negative reaction from your doctor about the test? If you don't feel comfortable posting your comments on the forum, please free to send your comments to Joe and I and we will forward them to Siemens while keeping your identity anonymous. Siemens would like this information as feedback to understand how much awareness and utility there is among patients and physicians. Just a note, this is the same test developed by Oncogene Science (now a part of Siemens Healthcare Diagnostics). It was formerly distributed by Dako. Oncogene Science was formerly a part of Bayer Healthcare. Thank you

Regards
Joe and Christine

schoolteacher · 08-22-2008, 09:18 AM

Joe and Christine,

I requested the test after seeing yours or Christine's post on the board. Kate also told me to have the doctor do the test because her doctor could tell from the test when her cancer had returned.

My doctor did not know about the test, but he gladly did the test for me. I have had it done twice since my neoadjuvant chemo. I really wish I had had the test done when I was first diagnosed, so I would know how high my level really was.

When I asked the doctor about doing tumor markers in July, he said, "when I initially had my tumor marker test it was in the normal range 21, and he would rather use the HER2 test again."

I posted on the board the cost in Georgia. It is around $300.00 dollars and less if your insurance company has a deal with the lab. The doctor was amazed at how low the cost is. When I first asked him, "he figured it would be between $1500.00 or $1000.00 dollars before he checked with the billing office." I feel that this is reasonable for this test. If others start taking the test maybe the price will drop even more.

If there is anyway I can help with responding to this I will.

Amelia

P.S. I have asked the doctor to see about me taking a vaccine for my Her2 once I finish my Herceptin in February. I did have some BC in my L4, but when I had a scan in April it was gone. Has Christine ever taken one of these vaccines? Does she still take Herceptin? If she does, how often does she take it? I am half way through my treatment, and I want to know what my next step should be.

I would glady receive any info your might have concerning these questions.

AlaskaAngel · 08-22-2008, 10:42 AM

Joe,

Because there are so many here who may not know about this test, is it still true that it is not used for early stage bc patients, but primarily for patients with mets?

A.A.

kk1 · 08-22-2008, 01:34 PM

Hi Joe;

1. For the last 3 yrs I have been getting the CTC test done generally every 12 weeks.

2. I made the first request to my Dr. 3 yrs ago just after it was approved and he was very positive about it at that time. He now uses this test routinely to monitor his patients.

3. Yes it has made a difference in how we treat my disease and my Dr. has stated that he has found it very useful with his other patients, although it is not a replacement for scans or other markers but is another useful tool in the box.

Lori R · 08-22-2008, 02:31 PM

I asked my Dr. about the test and was told that it was not a "standard". I assumed that the test must be extremely costly and possibly not reliable.

Based upon this thread I am going to demand that we run the test. It appears my assumption was incorrect on both fronts; cost and reliability.

I do receive scans on a 3 to 6 month basis so I am confident that I am being monitored appropriately. I just feel that I am missing out on another tool that could help us tell what this mysterious monster is up to.

Joan M · 08-22-2008, 05:09 PM

Joe and Christine,

Several months ago I asked my onc about using the Siemens HER2 serum test for metastatic HER2+ breast cancer.

First, my onc was puzzled as to why I would want yet another marker since I already use CA27-29 and CA15-3.

I would have still requested it anyway, but she said it was not available in-house (that is, where I get Herceptin, which is a hospital) and not available through any of the outside labs they use.

Would there be any other way for me to get the test?

Joan

Brenda_D · 08-23-2008, 10:12 AM

Is this just for metastatic bc? I was not offered this test.

Chelee · 08-23-2008, 01:28 PM

I asked for this at my cancer center and it looked like I caught my onc off guard. She looked puzzled? Then she thought a second and said "we don't use that here". (To this day I'm not sure she even had a clue as to what is was?)

I also brought this up to my 2nd opinion onc at the "COH" and was told again that this is not used. Since I'm a stage III'er with positive nodes I would love to have a baseline test ran and do this on a semi regular schedule. Especially since I know how well it worked for our sweet Kate and several other woman I know of. I think its a great tool that should be used. I plan on bringing this subject up again at my next appt.

Chelee

Melissa · 08-24-2008, 06:23 AM

Hi,
I asked my onc about the test and of course he had to find out what it was. He did give me the test but had me sign that I would pay for it if insurance didn't. Insurance did pay and now he thinks it's a better test, rather than the more expensive scans. It's about 300.00. My reading is 8, should be less than 15. He did say it was usually used for mets but said it would be good to catch any new mets early. Although he said it would not catch for brain mets, I'm looking into this. For me the blood test is less stressful than the scans. I have had two but at my three year mark I may have it once a year.

kk1 · 08-24-2008, 07:11 AM

Hi just want to make 2 comments:

To mellissa: Please do not let your Dr. think it is a replacement for scans. I can speak from experience, twice now I have had a recurrence to my liver with a CTC of 5. So if the met is small or a regrowth of a dormant met you may not have cancer cells circulating yet. What the test in my case did tell us was that we could treat the met in a more localized fashion and not jump right into a systemic difficult treatment. There is an excellent tutorial here on how to use the test results. http://www.clinicaloptions.com/Oncol...r%20Cells.aspx

To Joan: my hospital does not do the test either because only Quest labs is licensed by Seimens to do the test. The hospital just draws th blood in a special tube that they order thru Seimens and then ship it to Quest for analysis. Many of the Drs. at my center must be using this test as the nurses always have the tubes on hand in CTU.

Melissa · 08-24-2008, 02:08 PM

Thanks KK1. My onc actually wants me to have a scan once a year, a pet scan, but this test really makes me nervous so he said we could watch the numbers. At the three mark I will decide if I want another pet scan. But he did say we should do the serum with scan. Most bc survivors I know say their doctors do not scan unless there are symptoms. In these situations maybe the serm test would be better than nothing.
Thanks again,

Lee · 08-26-2008, 10:32 AM

My oncologist has been running this test every 3 months on me, and we just recently decided to use the results of this test to determine whether or not to run scans (as opposed to doing the scans ever 3-4 months, as we have been). I've been NED for 2.5 years and I am comfortable with using these test results as a trigger for doing more testing if the number should rise. I brought this test to his attention about 2 yrs ago, and he now uses it regularly on a number of his metastatic patients. His experience has been that an increase in the serum Her2 is a very good indicator of disease progression.

We will still do scans occasionally (every 6-8 months) and I have a brain MRI every 6 months, but we will no longer do them as often as we were. I'm very glad for that!

KK1 - this test is not the same as a CTC test. It tests the amount of Her2 in your blood, not circulating tumor cells. Just thought I'd point that out.

StephN · 08-26-2008, 11:09 AM

Hi everyone -
I have had this test three times in the past couple of years. My number has been stable and well within normal range.

My med onc knew about the test, so had no trouble with ordring it when I asked. I have it on an annual basis now. Don't think I have had it since it switched to Siemens.

Not sure how many of her other patients have this assay, but I am sure there are some as she does have a number of HER2 positive stage 4 patients.

Quest has a lab location in my city, so no probem with getting the test run. They have labs in major cities so there must be one near Joan.

P.S. I have had both my "old" insurance and Medicare pay for this test. No problems with that.

hutchibk · 08-26-2008, 01:00 PM

My doc is not ready to start using it as he says it is not ready for prime time... not convinced that standards have been determined yet, and is not sure what the results would yield us, or how they would benefit us.

hutchibk · 08-26-2008, 01:10 PM

questions for Siemens:

Does medicare readily pay for the test?
Is private insurance on board to pay for it?
How often does it need to be run?
How dependable are the results?
Are there ever false results?
What does a doctor do with the results?
How is it different than tumor markers?
How has it been received by ASCO?

I am not dissing it as I am 100% behind development of more diagnostic tools!! I just know that I don't know any of these answers and I know that my doc has a skeptical eye before he jumps on a new train, so these answers would really be helpful...

Sheila · 08-27-2008, 04:27 AM

Like Brenda, My oncologist and the others in Chicago where I go are not ready to offer this yet...too many undetermines ....and not enough information.

maouno · 08-31-2008, 11:24 AM

how is this serum test be done? Is it painful and is much blood drawn? Is it also for nodes neg people?

09-06-2008, 12:08 PM

My number has been on the cusp (15), and even above (16), for the two years since I was diagnosed. So far I am fine. I was friendly with Kate and her number was always well below mine and we began taking herceptin at the same time. Please don't think that a normal number means all is fine or an above normal number indicates you have a problem. This test is one tool of many, and it is not reliable, or used, as a diagnostic tool, nor is it advertised by its maker as such. Some of us have higher HER2 in our blood than others, even without cancer.

Joe · 09-06-2008, 12:38 PM

Dr, Carney of Siemens Diagnostics kindly sent me the latest research findings on the Serum HER2 test.

Regards
Joe

Joe · 09-07-2008, 09:47 PM

1. The serum HER-2/neu test was cleared in 2000 by the FDA for the management and monitoring of women with metastatic breast cancer, however, it should be noted that many clinical research studies have shown that women with early breast cancer can also have elevated ( greater than 15 ng/ml) serum HER-2/neu levels

2. The test has been standardized, is highly reproducible and is manufactured under Good Manufacturing Practices (GMP).

3. In addition to Quest, Lab Corp, ARUP and Pathway DX ( all reference labs) all offer the test. Siemens does not license any one reference lab to offer the test

4.The Siemens serum HER-2/neu test is the exact test sold by Bayer Dx and Oncogene Science. Both Bayer Dx and Oncogene Science were acquired by Siemens.

5.Siemens is the only manufacturer of this test. It is known as an Oncoprotein test and is not a traditional tumor marker like CA 15-3.

6. The serum HER-2/neu test is a simple blood test and it specifically measures the levels of the HER-2 protein released by the cell into the blood.

7.. Normal breast cells release the HER-2 protein into the blood. The normal level is less than 15 ng/ml. Patients should considered any number less than 15 ng/ml as normal and it doesn’t matter if the patient is 8,10, 12, or 14.

8.The blood test is very simple and the test needs very little blood to measure the amount of the HER-2 protein in the blood.

9.Increasing levels of the HER-2/neu protein in the blood reflects tumor progression while decreasing levels reflect response of the tumor to therapy.

10.Medicare and some insurances pay for the test.

11.Increasing levels may be the signal to do scans.

The serum HER-2/neu test is an additional tool for managing breast cancer patients and should always be used in conjunction with other diagnostic tools

Some women that are said to be negative for a HER-2 by tissue testing (IHC or FISH) can have elevated serum HER-2 levels at the time of metastatic breast cancer. Women with elevated levels and a negative tissue test should have their original tumor re-tested by IHC or FISH or a biopsy of a metastatic tumor to check the HER-2/neu status.

More education is needed to inform breast cancer oncologists, so they will know that the test is available, is standardized, is FDA cleared and is reliable

Serum HER-2/neu levels will fluctuate depending on the behavior of the tumor in response or lack of response to therapies.

The test should be done on all women with metastatic breast cancer and repeated 3 or 4 times a year. The test is dynamic and changes with growth of the tumor or the shrinking of the tumor. The test is a real time test and will help physicians manage patients with HER-2 positive tumors since increasing levels reflect cancer progression while decreasing levels reflect the response of the tumor to treatment. The serum HER-2 level reflects the behavior of the tumor and is independent of the therapy type

ASCO does not endorse the use of any tumor markers or the HER-2/neu oncoprotein, however, in the Jan 2007 issue of the Journal of Clinical Oncology guidelines were published which provided a substantial summary of the serum HER-2/neu data indicating the importance of the test.

There is a substantial amount of data and information published on the serum HER-2/neu test which patients should offer to their oncologist to read. Physicians are incredibly busy and need help from advocates to stay current.

HER-2/neu positive patients can be either lymph node negative or lymph node positive. They are independent factors.