Dr. won't do Her2 serum test

Emelie B · 03-21-2010, 07:57 AM

I was just wondering if anyone else had an onc that won't do Her2 serum testing. He says that he does not think they are reliable. I was hoping to include it in my regular management of my mets.
Any ideas as to why he would say this?

Rich66 · 03-21-2010, 09:45 AM

Although I love the idea of it, the clinical utility has been contentious. My sense of it is that, like tumor markers, may be relevant to some but not to others. I suspect big numerical swings are more reliably indicative. I believe there is someone on this board who is maintaining stage IV by reintroducing Herceptin when her serum her2 goes up.
Have you had a serum circulating tumor cell (Veridex etc) test?
Also..if you haven't had a biopsy since the primary, might give you some leverage in getting the serum her2 test or a new biopsy. The onc should be comfortable with the idea that pathology of mets can be different from the primary. For example, if a new biopsy showed ER+ mets, a new avenue of treatment would open up. The mets may have switched to using estrogen due to previous her2 therapy. If getting a biopsy is an option, you could also push for a chemosensitivity test...though you may have to pay for that.

Barbara H. · 03-21-2010, 11:40 AM

The last time I checked, the oncologists at the Dana Farber do not do this test. I haven't been too concerned about this test since tumor markers are reliable for me.
Barbara H.

vlcarr · 03-21-2010, 01:39 PM

My onc, nor the hospital where I'm being treated, do either of these. Basically, if I have a pain, etc more than 2 weeks then tests are ordered. They do blood work but not tumor markers.

They say that are not reliable. I did some research and it does appear they are not an indicator of recurrence but part of me wishes they would do them but I just have to let it go......

Emelie B · 03-21-2010, 02:05 PM

Thank you for your responses. Rich, I was wondering if we should have done biopsy before we started treatment. He was inclined to not to it, as he feels fairly certain I am still Pr/Er-. Don't know how he comes to that conclusion though. I will definitely bring it up on Thurs.
I don't feel quit so bad knowing that other places aren't using it.
Thanks again for all your help.
Emelie

Rich66 · 03-21-2010, 02:36 PM

Seems there is a lot more, and growing, support for the CTC test. Again...larger swings may be more indicative. But you won't know unless you have results to compare. Could be one of a number of factors that gives a heads up. Even if lacking in nuance, the serum her2 could also be helpful if number was extreme.
Regarding biopsy, even different locations within the same tumor can give slightly different results. More stringent guidelines for processing time of paraffin slides have recently been suggested as important to results. Methinks too many variables make a 4 year old pathology less relevant, and perhaps misleading.
Treatments themselves seem to change the tumor behavior/pathology. Might be wise to make sure insurance issues aren't clouding diagnostic choices.

Mary Anne in TX · 03-21-2010, 02:44 PM

I did the CTC test and had a 0! Celebrated and still NED!
I'm now at appts. every 4 months. I'm believing..... ma

Joe · 03-26-2010, 06:08 PM

EBCC: HER2 Levels May Predict Breast Cancer Response

By Charles Bankhead, Staff Writer, MedPage Today
Published: March 25, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and

Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

BARCELONA -- Monitoring HER2 levels during neoadjuvant breast cancer therapy may improve early identification of patients likely to benefit from trastuzumab (Herceptin), a prospective clinical trial suggests.

Elevated baseline levels of HER2 and a decline of at least 20% during treatment significantly increased the likelihood of pathologic complete response. In multivariate analysis, the 20% decline in HER2 levels remain statistically significant.
"Results of this study demonstrate that prechemotherapy serum HER2 levels as well as a decrease in serum levels to be a significant predictor of response to neoadjuvant chemotherapy for breast cancer," Isabell Witzel, MD, of the Medical University of Hamburg-Eppendorf in Hamburg, Germany, reported here at the European Breast Cancer Conference.
"Monitoring serum HER2 levels in the presence of trastuzumab treatment might be a promising adjunct to clinical evaluation during neoadjuvant chemotherapy in HER2-positive patients."
The neoadjuvant setting offers an opportunity to optimize treatment strategies for patients with nonmetastatic breast cancer. In patients with HER2-positive breast cancer, the extracellular domain of HER2 is shed into the serum, creating potential for a biological role of HER2 during treatment with trastuzumab, Witzel said.
To examine the association between serum HER2 levels and pathologic response, investigators used a commercially available assay to measure HER2 levels before and after neoadjuvant therapy in 90 patients with HER2-positive beast tumors and 85 patients with HER2-negative tumors. All patients with HER2-positive tumors received trastuzumab in addition to chemotherapy.
Pathologic complete response was defined as no microscopic evidence of invasive residual tumor cells in all resected specimens of the breast and lymph nodes. Neoadjuvant therapy led to pathologic complete response in 44 (49%) of HER2-positive patients compared with 12 (14%) HER2-negative patients (P<0.001).
Pretreatment median serum HER2 values were 7.7 ng/mL in the HER2-negative patients and 14.9 ng/mL in the HER2-positive group.
Receiver operating characteristic curve analysis identified 10 ng/mL as the optimal cutpoint for discriminating between HER2-positive and negative tumors, resulting in a sensitivity of 72%, specificity of 85%, positive predictive value of 85%, and negative predictive value of 73%.
Comparing baseline HER2 values and pathologic complete response, the investigators found that a baseline value >15 ng/mL was significantly associated with pathologic complete response (P=0.045). An even stronger association emerged from an analysis of the decline in serum HER2 levels in response to treatment (P=0.02).
In multivariate analysis, a decrease of >20% tripled the likelihood of pathologic complete response (OR 3.2, 95% CI 1.13 to 9.55, P=0.029).

Joe · 03-26-2010, 06:26 PM

Citation: European Journal of Cancer Supplements Volume 8, No.3, March 2010, page 115

H. Makino1, K. Kuninaka1, C. Yoshida1, H. Hashidate2, M. Siotani3

1Niigata City General Hospital, Breast Oncology, Niigata, Japan
2Niigata City General Hospital, Pathology, Niigata, Japan
3Niigata City General Hospital, Radiology, Niigata, Japan

Background: Tumor markers can be an easier modality to detect cancer metastasis compared with diagnostic imaging, and its decrease or increase is often correlated with effectiveness of treatment.
Patients and Methods: Serum human epidermal growth factor receptor 2 extracellular domain (HER2-ECD) levels were reviewed in 56 breast cancer patients with metastasis and 21 patients who underwent preoperative systemic therapy (19: chemotherapy, 2: endocrine therapy). Patients were stratified into 2 groups, those with HER2-positive (group I) and negative (group II) breast cancer.
Results: In patients with metastatic disease, median serum HER2-ECD level was 14.6 ng/ml (group I) vs 12.9 ng/ml (group II, p = 0.14). furthermore, HER2-ECD levels were assessed in 17 patients at the detection of metastasis. In those, HER2-ECD was significantly higher in patients of group I (median: 17.2 ng/ml) than group II (12.2 ng/ml, p = 0.03), and proportion of patients with raised HER2-ECD (>15.3 ng/ml) was 75% (group I) vs 23% (group II, P = 0.099). In patients who undergoing preoperative treatment, median HER2-ECD level was 12.8 ng/ml (group I) vs 9.5 ng/ml (group II, p = 0.28). Proportion of patients with raised HER2-ECD was significantly higher in group I (60%) than in group II (0%, p = 0.008). In those patients, HER2-ECD levels decreased following chemotherapy, and were observed to be less than 15.3 ng/ml in patients who achieved pathological complete response. In 11 patients (85.7%) out of 14 who were evaluated both HER2-ECD levels and imaging diagnosis following systemic therapy, HER2-ECD was successfully associated with tumor response.
Conclusion: Serum HER2-ECD levels were observed to be raised in 75% of HER2-positive breast cancer patients at the time of detection of metastases, and well associated with tumor response in 85.7% of patients.

Becky · 03-27-2010, 06:15 AM

http://www.medpagetoday.com/MeetingCoverage/EBCC/19229

Emelie - an article from the European breast cancer symposium. May help your cause for the Her2 Serum test.

Hug to you

Joe · 03-27-2010, 07:51 AM

You can also print out the entire study:

EBCC HER2 Study

This is the authors preliminary draft. Highlighted green text indicate references.

Regards
Joe

Emelie B · 03-29-2010, 07:27 AM

Thank you for the info. I have printed the study and will be sharing with him on Thurs.
I sometimes get the feeling that he does not want me to question him. He is there to "take care" of me.
Boy did he get the wrong patient!
Thank you again to everyone for being so supportive.
Emelie

Chelee · 03-31-2010, 11:55 AM

Hi Emelie, I asked about having this test several times and my onc's answer was always, "It's not prime time yet". Maybe that's why your onc isn't so quick to use it yet? I also asked a 2nd opinion onc up at the City of Hope about using this test and was told they don't use it either. Just wanted to let you know it's not only your place that doesn't want to use it yet.

Joe has posted some great ammo to show your onc so that alone might change his mind. So good luck and let us know what he says after he reads it.

Chelee

undecided8 · 11-10-2010, 07:16 AM

I just watched a video and have been researching this serum her 2 blood test. I mentioned this to my Onc. yesterday and he said he does not do this test and most Oncs'. don't either because it's useless and just another laboratory trying to make money off of cancer patients??? Anyone know if this is a real test or a scam??

StephN · 11-10-2010, 10:58 AM

Hi -
This is a legitimate test and NOT a scam. The founder of this site uses it as do several others here, including me. My oncologist is internationally known, as is her research. She had no problem using it in my case.

There may be some parts of the country where the test is harder to process, but in these days of fast delivery that should not be a barrier.

We use the results of the HER2 serum as part of my overall surveillance. It seems to follow the results of my scans. The blood test is MUCH cheaper than any scans!