Herceptin for HER2+++'s who have never had it

[AlaskaAngel]

The recent Herceptin trial outcomes certainly raised more questions. What I want to understand is why there is lots of open discussion about how those at early stages who have never been treated can benefit, and there is lots of discussion about how those with mets can benefit, but so far there is dark, repressive silence from oncologists about this question:

"What approach is being taken in regard to establishing better clinical data about how the use of Herceptin affects those who have had chemo without Herceptin and who are currently NED?"

To me if the results of the clinical trials for Herceptin use for early bc clearly indicate a significantly lower recurrence rate, then logically those HER2++'s who are still alive and who have never had Herceptin are going to continue having a significantly higher recurrence rate. So why is there not discussion about clinical trials for those who have been treated but have not received Herceptin?

I know that one concern is cardiac toxicity. I know that there are lifetime limits on the amount of Adriamycin one can have, and also that some people who are HER2+++ and who have a low ejection fraction may not be able to tolerate more chemo-in-combination-with-Herceptin.

But what about the possibility of a clinical trial giving one combined dose, or 2 combined, dose-dense doses to those who have a good ejection fraction/MUGA or echo to see if early stage bc survivors who are NED end up reducing their recurrence rate?

(I do know it probably means losing hair again. I still ask.)

I have to also be very honest here about other aspects of being HER2/neu that are part of the breast cancer picture as a whole that we all are part of. A major aspect of the current HER2/neu confusion is unfortunately due to the lack of open discussion about HER2/neu all along with many of those who have breast cancer.

I am not raising rabble here. I am just asking that those who know the most about oncology try harder to avoid continuing to make that mistake.
It is up to oncologists to see our questions not as something to avoid answering, but as an opportunity for maintaining (or restoring) trust with HER2+++ patients who went through the nastiness of Adriamcyin without Herceptin at the advice of their oncologists; patients whose cancers were not even tested to find out whether they are HER2+++; patients who were never told what their HER2 status is or even why it could be important to know.

If oncologists truly don't know whether Herceptin is beneficial to those who have already completed chemotherapy without it, or how much benefit it would have for us, then at a bare minimum they should at least communicate with us about what they are actively doing about that to get better answers for us.

(I would like to at least know they don't just assume--or even worse, hope--that we are all dead, which is what their silence is saying to me.)

Respectfully,

AlaskaAngel

[*_Scott_*]

It's understandable that people who didn't combine their chemo with Herceptin feel like they missed the boat, but they can still receive single agent Herceptin for say a year and still benefit. It's the nature of the disease that there is always going to be improvements over the therapy you received, which is a good thing. Why don't the oncologists bring everyone back and give them Herceptin plus chemo to try and gain the synergistic effect of the combination? Your first shot is your best shot while the cancer cells are still naive to chemotherapy, they become resistant to chemo if you don't get them all the first time. So, they could bring you back and pump you full of toxic chemo and Herceptin at considerable risk to your quality of life and expense with a small chance of cleaning up all of the residual disease. In the not so distant past, (the 90's) more chemo was better with high dose chemotherapy and multiple regimens of drugs, and they found patients really fared no better than those who had a single regimen of moderate dose chemotherapy. So I think Herceptin must be in the mix with a Taxane for first line adjuvant treatment, as it shouldn't be combined with AC. I do think Herceptin may turn out to be beneficial as a long term treatment option as we see with the hormonal therapy beyond 12 mos., say 2 to 5 years. Only problem is the cost and inconvenience of having regular infusions. I don't think the side effect profile is really much more risk than say Tamoxifen with blood clots and endometrial cancer or the A.I.'s with osteoporosis and joint pains as long as heart function is continually monitored. We'll see when more data matures if the benefits continue beyond one year.

[Montana]

I was not offered Herceptin...onc said I wouldn't quality???? This was LAST WEEK!
Stage 1, Grade 3, Her2+++, DCIS and IDC; had 2 lumpy, A/C X 4 and 33 rads. Now on AI.
I guess I have to wait for recurrence???

[Montana]

Should have added that I was 0/14 nodes and less than 1 cm

[Janet/FL]

Montana writes:
I was not offered Herceptin...onc said I wouldn't quality???? This was LAST WEEK!
Stage 1, Grade 3, Her2+++, DCIS and IDC; had 2 lumpy, A/C X 4 and 33 rads. Now on AI.
I guess I have to wait for recurrence???
tumor less than 1 cm 0 nodes positive.

**************************************

Hello
Montana, when were you diagnosed and treated?

I am very similar-- same size tumor but grade 2 --am ER/PR-, but I did not do the A/C as was recommended. I figured then--lumpectomy 12/07/04--why do A/C without herceptin. (33 rads).
I still feel that way and I have bugged my oncologist about it. His nurse agrees with me and that it is politics and money that keeps herceptin from us. I see my oncologist Tuesday and will ask again. Trouble is, I don't know if I want to go through A/C now even if herceptin would be offered. With about an 80% chance of having no reoccurance, it is hard to decide to put my mind and body through so much. But I have the flu now, and it does scare me that maybe this is my body unable to fight cancer, too. So, will report back what my oncologist says.

I was reading a poll on another list. Most of the people reporting in are either A or O blood type. Almost no B or AB's. I am an A. I wonder what this means?
Janet/FL

[AlaskaAngel]

What makes the most sense to me is that there should be full, open discussion about how to deal with the HER2+++'s who are currently NED and have never had Herceptin -- whether or not it is "too late" to combine it with Adriamycin. And if anyone at all can find that kind of discussion happening anywhere and can refer to me to it, that would help.

Naturally, since the oncologists are professionals in this area and I am not, I had thought that once they sat down together and looked at the newest information, there would be some effort made to help us to understand that they haven't forgotten about us entirely -- since "whoever it is" that hasn't received Herceptin as first-line treatment is in the group who is at significantly higher risk for recurrence.

The only info out there at present that I have been able to find is anecdotal, from those who have seen their oncologist (many are on a schedule and haven't seen one yet, and it often takes months to book an appointment). I think this is VERY unhealthy.

Scott, in terms of considering various options for Herceptin, how do they know without having offered a clinical trial for people who have already had one chemo regimen, how Herceptin-with-chemo compares to putting those people on Herceptin indefinitely? Consdering the ongoing costs, as well as any cumulative effect of Herceptin anyway on those who have already had Adriamycin?

I know Herceptin doesn't work for all HER2+++'s, also.

Wouldn't some open discussion of options for those HER2+++'s who are NED make better sense in terms of building better mutual understanding for all of us?

A.A.

[*_jeff_*]

Dear Alaska Angel,

I've been following your posts here and on some level there is nothing I want to say other than: you're right. This is nuts that no one (except you and a few others in cyberspace) is talking about this.

But on the other hand, I think that's how it is going to be. We're in the middle of a huge paradigm shift--generally towards targeted therapies and more particularly towards using herceptin for early stage her2+ breast cancer. There will be follow up trials that come out of the recent adjuvant trials but I don't think any of them will address your questions. They will have to do with figuring out who gets most benefit (through the subset analyses of the current and maturing data, the monitoring of various markers like PTEN and so on) from adjuvant herceptin. There might even be follow up trials to figure out if 6 months is enough.

The reason I don't think your questions will get addressed is that there's no percentage in it. There is this incredibly painful dilemma you've outlined, and it is relevant to thousands of women, but it won't stay relevant. There's not an ever expanding market who will be treated according to the results of the kind of trial you want to see.

So I don't have any advice. Just deep sympathy for this incredible frustration you feel....

Best,
Jeff

[Bevie]

Hi Alaska Angel, I too have been following your posts here with intrest because I am in the same boat with you. I just wanted to let you know what my Onc. told me a couple of weeks ago, I went to him complaining of neck a shoulder pain that I have been having since Feb. he ran some blood test and sent me for a bone scan and he said IF it was bone mets he would put me on Heceptin with Taxol or Taxatore right away because I only had A/C without a Taxane when first dx 4 1/2 yrs ago. He also said if I was newly dx HER2+ that I would of gotton the Herceptin now. I am happy to say the bone scan was neg. for mets it showed arthritis in my neck and lower spine, I asked if the arthritis is being caused by the Arimidex I have been on for the past 3 yrs. of course he said no not from the Arimidex..... me I'm not so sure of that. I am also wondering how they can tell the diffrence between bone mets and arthritis on a bone scan?

[*_Scott_*]

A.A.,

I guess they don't know if a second round of chemo with Herceptin is any better than Herceptin alone without doing a trial. Unfortunately I wouldn't expect them to run a trial specifically for this group of patients like yourself because it is a relatively small number of patients in this predicament. They would just use the Herceptin-Taxane combination on the new patients(Adriamycin shouldn't be combined with Herceptin for heart risks).

If you really feel strongly about getting the combination now you should push for it with your oncologist or find an oncologist that will. This is your life you're dealing with here, if you really feel your not getting the treatment you deserve, fight for it. Sometimes I feel like the oncologists aren't being straight with us or are taking the safe route by offering standard care. I go at it with the oncologists all the time, I don't care how well respected in the field they may be. Get a second or third opinion, we currently consult with three oncologists.

Good luck,

Scott

[AlaskaAngel]

To answer your question, Bevie, on bone scans, normally I try to use the radiologists website but for some reason it isn't working. Bone scans just identify areas of abnormality, either "hot" or "cold" spots, and then if there is something seen you may end up getting other tests to tell what is causing the hot or cold spots. Here's some discussion about them:

http://www.breastcancer.org/testing_xray.html

As for the HER2/no herceptin question, I'm not so sure the group of people affected actually is relatively small unless we are looking at it in terms of the 20-25% of all bc that is considered to be HER2 positive... (by the way, Joe, since many were never tested at all for HER2, does that percentage include the estimated percentage of survivors who were never tested?). However, I agree that with time it won't be growing (especially if we end up dying off...!) And that brings to mind another question -- Does anyone have any estimate of percent of HER2+++'s DO end up with mets in their lifetime? Or even what percentage of all mets are HER2+++'s?

As remarkable as it might sound, I have never heard the word "HER2" from my oncologist since I was diagnosed in 2002. I especially appreciate the advice about utilizing more than one oncologist's opinion whether or not he is considered highly qualified, as I agree with that after 3 years of trying to find ways to deal more effectively with the one I have.

Thanks,

A.A.

[*_mts_*]

I am in the same boat when it comes to the onc's delivery of info. After reading so much about Herceptin, I find I know more about it than my oncologist. Scary thought! I do have 2 oncs that I work with. I was dx'd Stage 1, yet multifocal. Opted for lumpectomy and dose dense AC + T and rads. I feel confident but still keep the port in case I can get Herceptin. At this point, the insurance company is reviewing my case. If they do not pay, I don't know what I will have to sell; (my home? my kids?). It costs approx $76,000 a year for Herceptin for people who did not qualify for trial. I have a sister that lives in Chile and Herceptin is considerably cheaper there!
Bottom line- $$$!!!
Once our subgroup is deemed qualified for use of Herceptin, then the ins carriers will need to add us to their costs. A price they are not willing to pay right now.

mts

[AlaskaAngel]

It may not be not so much genuine ignorance, but a "if they don't ask, don't tell" policy... but I have to move on to something better, and thanks for the encouragement.

I know Herceptin is expensive, and I still think it would be beneficial to the insurance companies too if some clinical trials for this group got off the ground.

Another question for us is, is something like Cellsearch reliable enough for early stage bc that it would be covered for periodic testing, instead of us and our oncs prophylactically putting us on Herceptin?

Or would it make more sense for those of us who are HER2+++ to be among the first to routinely receive the gene identification test to see if we are in the high-risk category, and if we are, then to routinely be given Herceptin prophylactically?

A.A.

[MarianneWa]

My question re. the Hecpetin trials is: for those who DID have a recurrance, how soon was it, and WHERE was the recurrance? As Herceptin doesn't cross the BBB, then I'd be concerned that a recurrance after Herceptin would be more likely to be in the brain, which has fewer treatment options then say bones, liver.

I haven't seen any details about the people in these trials who did recurr. Why not? I didn't have Herceptin back in 2002 with my initial treatment, but would maybe consider it now if there was strong favorable evidence, but it seems that it really has to be taken with taxol, and I hated Taxol! What to do, what to do??

Marianne

[*_Bevie_*]

In the Dr. Perez interview on medscape today:

Medscape: How should clinicians approach patients with HER2-positive disease who have completed adjuvant therapy without trastuzumab?

Dr. Perez: This is something we are looking at. Based on the natural history of breast cancer, where we see the disease-free survival curves continue to decrease, this therapy is going to have to be considered for women who have completed chemotherapy. I don't think those women will derive as great a benefit as those who are treated with trastuzumab combined with chemotherapy, but it should be considered for these patients -- ideally, we should conduct a trial to quantitatively assess whether there is a meaningful benefit in this situation.

[AlaskaAngel]

Spot on! At last, some meaningful consideration of possible options... Thanks, Bevie - A.A.