I'm A Perfect "6"

[Christine]

I just received the report from the HER2/neu ELISA Serum Test. My result was a resounding 6 ng/mL. Anything under 15 ng/mL is considered to be normal as everyone has HER2/neu cells to some extent. This test is an early indicator on progression, so my oncologist will be testing me every 3 months. 6 will be considered my baseline.

This test is currently FDA approved only for Stage IV metastatic bc patients but like Herceptin can be prescribed "off label" for other HER2 patients.

Hugs and well wishes,
Christine

[Esther]

Christine, is this test more sensitive than the CA 27-29?

Is this going to be advocated as another tool in addition to or instead of the CA 27-29?

[Christine]

Hi Esther,

This test is only for women who are HER2+ and as it is fairly new, it would be in addition to other tests. It is sensitive for us HER2 gals only.

If you are interested, Dr. Dennis Slamon is currently running an extensive clinical trial to determine its accuracy. You may want to contact the Jonnson Cancer Center for further info.

Hugs and well wishes,
Christine

[Kaye]

Christine--thanks for sharing. I had some ?'s. Are you on Herceptin now? What would it mean if someone who had been Her2+ and had a year of Herceptin but was off it--tested less than 15? If they also had a metastasis but had a score of <15, would that mean that they were no longer eligible for Herceptin?

[Christine]

Kaye,
I have been treated with Herceptin since August of 1999. This test currently should be used with other standard tests that measure progression although that may change in the future as more data is collected.

Less than 15 means that you are currently considered to be in remission.

A score higher than 15 means that you should be treated with Herceptin if you are currently not taking it. If you are currently taking Herceptin and your score is above 15, your onc should consider changing your treatment by using alternative combinations with or without Herceptin.

Below is an abstract which was presented at the 2004 SABCS meeting. More data may come out of ASCO this week.

Hugs
Christine


[6001] Clinical utility of circulating HER-2/neu in monitoring and prediction of progression-free survival in metastatic breast cancer patients undergoing trastuzumab-based therapy.

Esteva FJ, Cheli C, Fritsche HA, Fornier M, Slamon DJ, Thiel RP, Luftner D, Ghani F.. UT M. D. Anderson Cancer Center, Houston, TX; Bayer Healthcare, Tarrytown, NY; Memorial Sloan-Kettering Cancer Center, New York, NY; University of California Los Angeles, Los Angeles, CA; Thiel Consultants, Oxford, CT; Humboldt-Universitat, Berlin, Germany

The objective of this study was to determine the clinical utility of serum HER-2/neu in monitoring metastatic breast cancer patients undergoing trastuzumab-based therapy and to compare these results to those obtained using CA15-3. Additionally, we sought to determine whether early changes in serum HER-2/neu levels could be a predictor of progression-free survival (PFS). Patients and Methods: Patient sera were obtained retrospectively from 103 patients with HER-2/neu overexpressing metastatic breast cancer who were scheduled to be treated with trastuzumab, with or without additional therapies. Serum samples were taken prior to initiation of trastuzumab-based therapy, and at the time of clinical assessment over a 12-20 month period. Samples were tested using Bayer HER-2/neu and CA 15-3 ELISA assays.

Results: Concordance with clinical status in monitoring patients undergoing trastuzumab-based treatment using HER-2/neu and CA15-3 as single tests were 0.793 and 0.627, respectively and when the tests were used in combination concordance increased to 0.829. Baseline HER-2/neu levels were not predictive of PFS (p=0.12). However, progression-free- survival was significantly different in patients with >75% of baseline levels of HER-2/neu as compared to those with < 75% of baseline levels at 2-4 weeks after the start of therapy. The median PFS for those patients whose HER-2/neu value was less than 75% of baseline was 587 days. In the cohort with > 75% of baseline the median PFS was 260 days (p=0.035).

Conclusion: Serum HER-2/neu testing is clinically valuable in monitoring metastatic breast cancer patients undergoing trastuzumab-based treatment, and provides additional value over the commonly used CA 15-3 test. Futhermore, the percentage of baseline HER-2/neu levels in the early weeks after the start of therapy may be an early predictor of progression-free-survival.



Date: Saturday, December 11, 2004 07:00 AM
Session Info: Poster Session: Detection/Diagnosis: Circulating Markers (7:00 AM-9:00 AM)

[*_joy_*]

Thanks Christine. I am bring this info to my doctor today. And congrats on the '6'. You are such an inspiration!
Love, Joy

[Lisa]

Christine,

Did you also test your CA15-3?

Why did your doc recommend this test?

Love and light,

Lisa

[Guest]

Thanks for the info, Christine--but I still have a question. Yes, my score is now <15. But, so is yours and you are still taking Herceptin???
Last October I had the CTC and my score was 4. A score >2 is considered significant.
I did have a year of Herceptin. I have been told that I had bone marrow mets to all the vertebrae in my thoracic spine. I have been told there are other signs of bone mets. I have 30 to 40 enlarged retroperitoneal nodes--matted together. I had PET scans that showed uptake in the submandibulara gland that was recently removed.
At the time of my dx I had advanced b.c.--3 types of very aggressive b.c. I had a lesion in my liver (still there) that has never been biopsied. I had several enlarged retroperitoneal nodes (which have increased). I was Her2+ (+3), had 9 of 12 positive nodes (although first CT scan said there appeared to be remaining positive nodes that were matted together (the ones removed were not matted together). I had extracapusular spread and extensive lymphovascular invasion.
So, my question is based on the above why should I not be given Herceptin at this time with a score of 12? Does that mean I am in remission and would no longer benefit? At the same time you report that your score is now 6. Does that mean you are in remission? If so, wondering how one can justify long-term use of Herceptin for some and not all?

[Kaye]

Thanks for the info, Christine--but I still have a question. Yes, my score is now <15. But, so is yours and you are still taking Herceptin???
Last October I had the CTC and my score was 4. A score >2 is considered significant.
I did have a year of Herceptin. I have been told that I had bone marrow mets to all the vertebrae in my thoracic spine. I have been told there are other signs of bone mets. I have 30 to 40 enlarged retroperitoneal nodes--matted together. I had PET scans that showed uptake in the submandibulara gland that was recently removed.
At the time of my dx I had advanced b.c.--3 types of very aggressive b.c. I had a lesion in my liver (still there) that has never been biopsied. I had several enlarged retroperitoneal nodes (which have increased). I was Her2+ (+3), had 9 of 12 positive nodes (although first CT scan said there appeared to be remaining positive nodes that were matted together (the ones removed were not matted together). I had extracapusular spread and extensive lymphovascular invasion.
So, my question is based on the above why should I not be given Herceptin at this time with a score of 12? Does that mean I am in remission and would no longer benefit? At the same time you report that your score is now 6. Does that mean you are in remission? If so, wondering how one can justify long-term use of Herceptin for some and not all?

[imported_Joe]

To Lisa and Kaye,

Lisa,
This test is in addition to my regular blood tests and tumor markers. It just gives my onc another indicator with which to monitor my treatment.

Actually, I volunteered to take this test. I had read a press release about it several years ago and just last November decided to investigate it more thouroughly. The company sent me several pieces of literature which I gave to my onc and she realized the value of it in monitoring my progress. The 6 is just a baseline that she will compare to subsequent tests.

CA15-3 is primarily to measure bone mets.

Kaye,
I am not aware of any Stage IV HER2+ bc patients who have discontinued Herceptin while still in remission as the general agreement among researchers is that the HER2 gene would restart if the treatment is withdrawn. Besides, who would take a chance? In my case, I have absolutely no side effects, a great quality of life, while continuing my therapy.
From what you are stating, you should be able to qualify for Herceptin. When were you last restaged?

My score of 6 indicates that my HER2 levels are in the normal range and that there is no cancer activity as determined by this test. It is Herceptin that keeps me at this level. Presently the FDA has approved Herceptin only for stage IV metastatic bc patients. Things may change this week by several announcements that will be made at ASCO.

Hugs
Christine

[Kaye]

I believe that I am doing as well as I am ONLY because of Herceptin in combination with everything else I have been doing--including AC, radiation, 2 Taxol and 2 Taxotere with a year of Herceptin followed by Arimidex (starting with the 5th month of Herceptin), then a complete hysterectomy with Salpingo--oopherectomy. After that I began Doxycycline and low dose Celebrex, doubling the Celebrex after one month to 200 mg/twice/day. The following month I had osteoporosis-prevention dose of Zometa (after that my steadily rising alkaline phosphatase level stabilized and then slowly came down to what it was at time of dx. In addition to the CEelebrex and Doxycycline (50 mg/twice/day) I then started Lovastatin about 6 mos. later. During the interin I was dx'd with either a mass or synovial cyst in my lower back--which resulted in severe pain. I had my 2nd infusion of Zometa (after 6 mos--for osteoporosis prevention supposedly) and then started taking Lovastatin about 6 weeks after that. I still was in alotof pain. 6 weeks after I started the Lovastatin I doubled the Celebrex to 400 mg/twice a day--and lo and behold, the extreme lower back as well as the sciatic pain went away. There is no question in my mind from all that I have learned about b.c., including the variations about the types of bc I have--3 different aggressive types--that I was stage IV from the start. In fact, the UCLA oncologist I saw for a 2nd opinion implied that. After all my first CT scan showed several enlarged retroperitoneal nodes (3rd most common area for metastases for lobular). It also showed remaining lymph nodes (12 were removed; 9 were positive--not matted together) that WERE matted together. A recent CT scan now shows 30 to 40 retroperitoneal nodes that appeared to be matted together as well. I also have liver lesions--never tested--but that is another story. Last October I had the CTC Circulation Tumor Cell test. Results were "4." Anything >2 is considered significant.
I had asked about taking Herceptin for more than a year while still on it. I was told by Dr. Pegram at UCLA---only one year. Later, I learned that another patient who was treated at UCLA through an HMO was going to get one year of herceptin. However, she decided to increase insurance coverage from an HMO to a PPO and was told by that same doctor that she would be allowed Herceptin for the rest of her life.

It's sad that one often cannot get an honest evaluation--even if they are willing to pay out-of-pocket for it. Your insurance rules everything--at least in much of California. My husband and I recently attended a breast cancer symposium for medical professionals at the City of Hope. One dr. commented while answering a question about monitoring breast cancer with a PET scan indicated that use of that or what was done for monitoring depended on the patient's insurance. The audience responded with a nervous-sounding laugh. It almost seems that HMO insurances are on par with medicare these days--or not far above it.

So--now that there is Herceptin which CAN prolong the lives of those with Her2+ breast cancer, are those of us who can benefit from it, going to be allowed to have it? Or is everything going to be done to delay diagnosis until it is too late??? I have had first class experience with this type of manipulation from the start. My progesterone status was not tested because there was no standard protocol to treat--that's what I was told. Delay of local recurrence is also suggested--again because my treating facility does not treat (with newer forms of focused radiation).

What can be done to insure that those who can benefit are going to be allowed to have Herceptin? I sure hope that there aren't going to be articles such as the one I posted that states that there is no cost benefit. What does it matter to Genentech--if the shift for Herceptin use will be for adjuvent use---as long as they can still profit?

Please excuse the negative tone of this post. I hope that its impact can result in a positive effect for those who may receive some benefit by being able to get it in a timely manner.

[Kaye]

I forgot to mention that 3 months after I stopped Herceptin my alkaline phosphatase level made its highest increase in 1 month--went up 20 pts--and was just a couple of points from being abnormal. I did alternatives at that point--what I mean by alternativies--not tested for b.c. control efficacy, per se at that time (Doxycycline, Celebrex, and Zometa)...