Urgent - HER2 Serum Test by Bayer

[Christine]

We need feedback prior to our trip to ASCO. There, we will be meeting with Dr. Carney. We would like your viewpoint on the value of this test and/or your doctors.

Hugs
Christine

[heblaj01]

Christine,
A question related to the sensitivity of the test.
Could you find out how early in the progression of HER2 cancer does the Bayer test show a usefull change ? (I assume when the measured level goes above 15ng/ml or is it otherwise?).
In other words will tumors be already be large enough to be detectable by other means (physical examination, scans, etc..) or before that stage?

Besides the big advantage of being non invasive does the test appear to be more sensitive than the FISH & IHC tests done on biopsies?
Thanks in advance.

[Lolly]

Christine,
Here are the results so far on my Bayer HER2 Serum test:

03/28/06 - 12.7
04/25/06 - 11.5
05/24/06 - 6.8 :)

Am currently on 2 weekly Herceptin with continuous low-dose Xeloda. Have been on Herceptin/+or- chemo since 2001 for systemic disease in lymph system. Initial tumor marker analysis was with CEA, but levels were no longer elevated at third recurrence in Oct.2005. First HER-2/neu Serum test was performed (and Navelbine stopped) one month after starting Xeloda.





<3 Lolly

[Cathya]

Christine;

The doctor in Toronto from Dako was in California and apparently brought them the completed application for the Canadian Gov't. I would love it if you could ask if this has been submitted yet. Dako has agreed to bring the test into Canada even on a research basis but can't until it is registered with the government and there is a lab which will agree to do the tests. So far they have not agreed to do so for Canadians. Could you ask about that as well? Thanks

Cathy

[Cathya]

Christine;

My onc has agreed to have me use this test and we're just waiting.

Cathy

[jhandley]

Please ask them about getting this test into Australia. Gina swears by this test as an indication of mets. It is also supposed to indicate mets many months before detectable by other means...so if your value was low and you went off herceptin you could go back on it when your numbers started to rise.

Jackie

[DeborahNC]

Can you ask how one can convince one's onc to give the test? My onc just waves away any suggestion of it.

[Cathya]

Yes, onc's don't seem to like...or rather trust these tests. Although my onc agreed to the test he did comment that the FDA is still hesitant because they only approved it for metatastic disease not early disease. He said results from all these markers give false negatives and positives and cause a lot of stress. However, if we can get it he will use it. So lets work on that.

Cathy

[Julie2]

I am getting this done every 2 months. I got the orders from my primary physician. But my oncologist doesn't trust this at all. she wants me to stop it.

Julie

[LovingDaughter]

Could someone please explain what this test is? I haven't heard about it until now.

[Cathya]

There is a string Bayer Serum Test - Dr. Walter Carney (http://www.her2support.com/vbulletin/showthread.php?t=22881)Go to this near the top of the her2group forum.

Cathy

[jsattaw]

My onc is unsure of the test as well -- similar to the Oncogene DX test in that they don't really know the prognostic value and how it "fits in" with other tests they do. Plus, I still believe they're biased to wait for symptoms to appear and then proceed with treatment.

I did provide the disk that was distributed in San Antonio to my onc and he said he would review it. Since I don't have mets, it's not approved for me and I haven't pushed to have the testing. I have not had a chance to ask whether he has ordered the tests for Stage IV patients.

I'm looking forward to seeing some results from ASCO.

Jill

[chrisy]

I have asked both of my oncs - my regular one and my second opinion doc at UCSF. Neither of them think this would be worthwhile and one poo poo'd it as only being recommended by the people who sell it. Clearly, there are people on this board who have found it useful - Gina comes to mind. However, the medical/oncology community clearly is not "on board" with the value of this test.

I don't know if others are also encountering this resistance - my oncs don't really rely on tumor markers, either - so what did I expect!

Thanks - and good luck at ASCO! I look forward to your posts on this.

[kristen]

Hi Christine,
I am on he BRCIG study and they take my blood for this test I assume, they don't mention it by name, but say they are testing it for HER2. I don't know if Bayer has a hand in this or not and if they are trying to find out if this test works on non met patients who have taken Herceptin for the year following chemo?
As a study participant, I do not get the results of these tests so I don't know any numbers and since it's labeled only for mets, I can't talk my onc into this one.
It would be intereting to know if they are involved with this and are trying to get it labeled for non met patients?

I also wonder, and maybe this is my chemo brain, I haven't watched the presentation since it first came out, but if they are finding out that 50% of met patients are HER2 somehow it has switched from original dx, I don't know why that is not a huge selling feature for them? Couldn't they just run this test rather then do some invasive testing to find out if a new tumor is HER2? Wouldn't the numbers correlate that a tumor would be HER2? Just an uneducated question? and it could be chemo/menopausal brain talking here. Sorry if it is....I am glad you are all going and representing us at ASCO. I am looking forward to seeing what will be posted from the meeting. Thank you all for everything that you do here. Safe Travels.

[janet/FL]

Two of my oncs and one research nurse poo pooed the idea of the test and would not order it, period. My third onc did say he would order it if I wanted it and would pay for it but as a stage one--there doesn't seem to be any reason for it. At least I can't figure out when I should ask for it. My current onc is for not testing until symptoms present saying it makes no difference in long term out come. I will need to find facts to dispute this if I want tests following the end of Herceptin in August.
Janet

[Helen]

I am having a problem convincing my onc to give me this test too. I gave him a copy of the CD. I am stage IV. He said he will not use this type of test in his practice because it is not part of a clinical trial. How do I convince him? He is the only oncologist in the city where I live. If I change, the other nearest one is 30 miles away and I am not even sure if he also uses this test.

Helen

[kat in the delta]

Christine,
Tell Dr. Carney that I gave my Onc the website last week, but it would help if HE would contact MY ONC personally. I will get my onc's address/ fax and send it to you privately. I don't know how many ONCs. have even heard about it. Like another person said, I don't think most oncs. like to have TESTS done on us--BUT I DO !!!! My son's French friend Chloe teaches tennis to a lady who has returned to Switzerland for treatments. Chloe is getting in touch with her to see if she knows about the test. Is it available in other countries ?? ((Chloe has graduated from U of MS with a BS degree in Marketing and returning to France to be certified in tennis.{job possibility?))

[kat in the delta]

Christine,
Is there a CD on the Bayer Serum HER2 test you could send to us so we could give it to our ONCs?? I want to take the test. Could the local Hospital get the test ?? I know most dept. heads as my husband and another (of my 3) son are 2 of them. Please e-mail site, if so. Kat in the Delta

[StephN]

Hey Chris -
I am back from abroad and hope this my reply will get to you in time.

I had this test in February and had a good result of around 9, as I recall without looking it up.

When I first asked my med onc to order this test after San Antonio conference of 2004 he was not interested. This year he was - and he attends all these conferences so is "up" on new tests.

If I suspect any cancer activity I am sure he will order the test again.

Hope the word is getting out on this one and that the research will delve a little deeper into the question of possible use for early stagers.

[Barbara H.]

Hi Christine,
My oncologist won't order it for me and I printed out the information from Joe for him. I don't think anyone at the Dana Farber is using it. Do you know why? Tumor markers are reliable for me and my onlcolgoist uses them. I hope that more information will be available at the meeting. He will be there but I understand it is a huge conference.
Thanks,
Barbara H.

[Christine]

Thank you all for your many responses. I have been asked by the Bayer/Dako to participate in a discussion at ASCO. I will do my best to get more information and answers for your questions. In my own case, I will continue to take this test every 2 – 3 months, even if I am presently diagnosed as NED (No Evidence of Disease). I feel it is essential by any means to get the earliest possible indications from all tests available that works for you! I have been tested five times over the past ten months. Results are always around 8. Slight changes are normal as long as it does not go up steadily over 15. To me, this would mean it is time to get CAT or MRI scans of my body to rule out any progression. This test could alert us to get scanned. I don't have any reason to think I have more tumors except my brain is always under surveillance. Thank God I can continue to be free of all tumors.

Hugs,
Christine

[kk1]

Christine;

My Onc at UM Sylvestor routinely uses both the Her2 serum and now the CTC tests. I get them about every 10-12 weeks. So far everything has been within expected ranges. If we were to see a rise then we would do scans more frequently. While they remain low I get scans and Brain MRI only every 6-7 months.

My Onc. mentioned last week that he has found the tests extremely useful in many of his patients.

kk1

[Lisa]

Christine,

Like many others, my onc sees no value in it. I'm on continuous chemo (currently Xeloda) plus Herceptin and Zometa. He says, and I must agree, what is the real value of this test at this point. I'm already on Herceptin and to date there's no substitution, say if the test were high.

Love and light,

Lisa

[StephN]

Lisa -
When we met with the team that has created and tested this test last Dec. in San Antonio, there were a few answers. But the concensus was that the best use of this test was to monitor stage IV patients who are beginning a new treatment to see if the number goes up or down at two weeks into that cycle, and continue the blood test to monitor success or failure of that or a new treatment. Dr. Julie Gralow mentioned starting a trial using the blood test in just this way.

The other recommended use of the test was as a way to monitor stage IV patients who are NED or close to NED. A rise in HER2 cells can indicate increasing tumor activity well in advance of the other tumor markers or detection of tumors by various scan methods.

In your case, it would be a good idea to see what Dr. Carney thinks about using this test. I would still think it could be useful as a way to monitor success of your treatment.

[heblaj01]

Christine,

Could you find out if a low reading the test could potentially help to discover that, while Herceptin is making HER-2 tumours regress, other HER-2 negative lesions are progressing (or not regressing) by comparing with other non selective existing markers?
If so, this would allow the onc to add other treatments to Herceptin at an oppotune time.

[Cathya]

Christine;

Is there any information to answer the questions posed on this thread. I am still trying very hard to get this test in Canada. Thanks

Cathy

[Cathya]

Christine;

I have just gotten off the phone from my contact at Dako Canada and he tells me that all of the documentation for the Canadian government has been given to Bayer Oncogene and they are the ones who are delaying this test being available in Canada. They want more publicity or whatever......it's really a catch 22 to me as my onc has written up the prescription for it but we can't get it so he won't be after it for others..... We also need a lab but the Dako guy said that if the lab here is set up Elissa (spelling? I think he means other of their tests..?) they should be able to do the test. So.....what response did you get from them and can you put any pressure on them for the Canadians on the site?

Cathy