Are You Using the HER2/serum test?
 

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

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.

To avoid confusion here...
 

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.

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.

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.

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

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

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

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.

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.

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,

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.

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.

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.

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...

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.

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

HER2 serum test
 

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.

Latest Article on Herceptin and the Serum HER2 test.
 

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

Regards
Joe

Answers toQuestions about the Serum HER2 Test
 

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.

Thanks Joe, that is very informative. I will take the info to my doctor and see what he thinks...

What To Do???????????
 

My very excellent onc was immediately receptive to my request for the ELISA (?ELIZA?)HER2 serum bld test. It was done last Jan. I was normal. Forget the #. It was covered by my insurance company.

My new onc who is brilliant and highly informed/cutting edge, knew of the test but seemed to feel THERE ARE TOO MANY FALSE POSITIVES. He was concerned that he and I would be running tests and worrying unnecessarily were I to add regular serum bld tests to my ev 3 mnth panel of tests.

I know if I pushed, he would accede to my request, but now I am unsure. Same w/the hype about getting the ovarian cancer bld test. In that case, b/c of so many false positives, I go ev 6 mnths for transvaginal pelvic sonos, to assure myself that my ovaries are beautiful.

I must say that I have learned that hearing those words is the most joyfully complimentary pronouncement I have ever received. Also, 5 yrs back, I wound up w/the need for a hysteroscopy (in office) followed by a D&C, fibroidectomy, polypectomy, laparoscopy (in the outpatient clinic of the hospital) and then biopsy of course. These matters had to be checked out and all was well. I would not have found this is an ordinary GYN check I don't think, but even so wasn't scheduled for that for another 6 mnths.

It is all very bamboozling. Would really appreciate some concrete answers to the false positive issue. Anyone?????

Andi http://cdn-cf.aol.com/se/clip_art/gs...mals-butterfly

Of course I would love some concrete answers as I know that my doc will hold steady on that concern before signing off on it.

My oncologist is an ASCO fan. He never would do the tumor marker test and I wondered what they had been doing with all the blood they drew from my vein. Since they had not even been able to detect my recurrence during the 4 years after my first round of diagnosis and treatment, I really have no idea why I even bother to go to the hospital for 'routine' checks.

You can see I am not in a normal mind-set right at this moment. A lot of things have been happening lately that got me kind of 'mad'. And that three-letter-word has quite a few different definitions in the English dictionary. I do think 'upset' is different from crazy. But this whole breast cancer deal can really drive people 'over the edge' (can't find the definition in the dictionary, but my hubby told me it is similar to the word 'crazy'.)

Thanks to this board which allows us to 'vent'. It is the only place I can go when I need to restore my sanity.

Joe,

I have primary breast cancer Stage IIb ER- PR-. I tested for the serum her2 and tested 12.8/13.5 prior to starting delayed chemotherapy. I started Taxotere/Herceptin June 13th. At what point in the future would it make sense for me to utilize the serum her2 again?

'lizbeth

I would suggest every 3 months at the beginning of therapy.

Regards
Joe

Getting in sync with the Universe...
 

Hi Jackie,

I call that feeling you describe as STRESSED TO THE NINES. My dghtrs persist in telling me the expression is *dressed to the nines* -- but I know what I am talking about... http://cdn-cf.aol.com/se/smi/2b00001c91/06 It comes w/the territory. Then I collect myself and lie down, tune out and converse w/the Universe. In silence, of course. Sending loving energy...

Andi http://cdn-cf.aol.com/se/clip_art/gs...mals-butterfly

Joe,

I'm going to run up against the "Standard of Care" argument for not using the serum her2 unless I can come up with some research to show it is an effective tool for primary breast cancer. The doctor I need to convince thinks that Her2 ECD will be always be normal in primary breast cancer.

Any suggestions?

'lizbeth

Liz,

Show the following to your onc:

www.her2support.org/temp/serumher2.pdf


Regards
Joe

Jackie - if you are inclined to come to Austin for treatment (it might be just barely too far for you to travel...) I will happily give you my Onc's info. He is simply amazing. He is so thorough and we have found each of my 3 recurrences so far at their very earliest stages and have beaten them back each time. Let me know.

My oncologist said no.....he did not feel it was reliable enough. I brought him the info provided here - we will see if it helps. I am particularly interested since blood tests (cancer counts) do not work on me.

I had the test run after my liver resection surgery in April and it came back in normal (6) range. I asked my onc to run it on me, and he did so, but said it was old technology. I wish I had that test run before my lumpectomy and/or chemo so I would have something to compare it to, but you live and learn.
You may also want to check out this new HER2 test. I had my liver tumor tested there and it showed up negative for her2 proteins..... HERMARKASSAY.COM.

Joe, Question...is it possible to go and have the original tumor tested to get a baseline Serum her2 reading (had not had neoadjuvant treatment)?
Thank you,Marcia

I would be interested in the same question Marcia asked about having our orignal tumor tested with the Her2 serum test? Does anyone know if that is at all possible to get a baseline done that way?

Chelee

her2/serum test
 

early stage testing... from one who has been there...
 

To date there is no indication whatsoever that the serum her2 test would benefit early stage her2+ patients breast cancer patients. If the level was normal, this would not contraindicate a need for aggressive chemotherapy, herceptin and adjuvant treatment, as shedding of her2 into the serum at levels of concern may not occur in early disease process. If positive her2 serum tests results occur in early stage her2 bc, there would be no change in the aggressive treatment that would normally be offered to early stage her2+ treatment. Therefore, there really is no Routine need to test her2 serum level in women who are diagnosed with early stage her2+ BREAST CANCER.
From an RN who has studied this issue.
PS. Years ago, I had my serum level tested for her2 prior to adjuvant Herceptin. The result was
negative but in no way did that alter my decision to recieve Herceptin.

Questions about CTC test
 

Questions about CTC test:

From RCJ11,

The CTC test was taken 1 week after she began weekly Herceptin & Abraxane infusions. The test showed NO ctc's. She will be given another test 4 weeks after beginning treatment & I will report results.

Can anyone explain this CTC test result so quickly after beginning new treatment when PET scan 1 week earlier showed significant progression? Is the test unreliable or unable to pick-up certain kinds of circulating cells? Please reply with any experiences having similar results or possible explanations.

Following is Kathleen's history copied from other posts I have made on this site:
http://her2support.org/vbulletin/ima...ser_online.gif http://her2support.org/vbulletin/ima...ons/report.gif http://her2support.org/vbulletin/ima...c/progress.gif

Ixabepilone & Tykerb
Success with this combination after only 3 treatments. My wife, Kathleen, is 58 yrs old, original breast cancer 7 years ago, removed left breast, standard chemo & radiation. Followed for 6 yrs with Herceptin when treatment discontinued. 9 months later her cancer returned with 3 lymph nodes involved and a mass above her heart. Treated with Tykerb & Xeloda for 9 cycles with terrible side effects & progression of disease. PET scan disclosed 8 lymph nodes involved, growth of mass above heart, & small mass in plura space below left lung. Discontinued Xeloda and began infusions of Ixabepilone every 3 weeks and continued daily Tykerb. After 3 infusions cancer is undetectable on PET scan. Will continue infusions for at least 2 more cycles & thereafter the plan is to continue daily Tykerb and monitor cancer. Consider this treatment!

Next post:
My wife, Kathleen, was NED for 6 years maintained on Herceptin only. 6 months after she ceased the Herceptin infusions her cancer returned with multiple mets. She was removed from Herceptin because of fear of heart damage. In hindsight we should not have made that decision. We can't prove that the herceptin was still effective when she stopped taking it, but why take the chance especially when new research indicates that long term use of Herceptin does not increase risk of heart damage.

For information on Kathleen's treatment since the cancer returned see thread under "Ixabepilone & Tykerb. While the result of her treatment with ixabepilone & tykerb was favorable at 1st, her cancer returned while taking only Tykerb as a maintenance drug. She is now back on Herceptin & Abraxane but only for the past 2 weeks ( weekly infusions) so too early to know the effects. Our prayer is that the Herceptin is still effective for her.

http://her2support.org/vbulletin/ima...ser_online.gif http://her2support.org/vbulletin/ima...ons/report.gif