Concerns about trials, adjuvant Herceptin

[Lisa]

Friends,
I'm going to try and put into words what I've been feeling lately based on several posts. These are my thoughts alone and aren't intended to upset anyone. But they might.

Several women have asked about trials and/or getting Herceptin in an adjuvant setting. And some are very upset when they are turned down. Maybe I would be, too. While some are in recurrences, many of you are in relatively early stages of breast cancer and have not shown recurrences.

My concern is that there seems to be a belief among some that these trials and/or receiving Herceptin prior to or even during recurrence is a panacea. That they will prevent recurrence or stop its spread. For some, this may be true. But it's important to note that 1) trials are settings in which drugs and/or other treatments are tested. There is absolutely no certainty in their outcomes. In fact, I've spoken to at least one woman who's doctor switched her chemo since she didn't get in a trial, and that switch made all the difference.

2) While Herceptin has been a lifesaver for many of us with recurrence, there is absolutely no certainty that it will help prevent recurrence in early stage BC. Trials are underway and may/may not prove this to be so. Also, Herceptin is only effective in 1/4-1/3 of those who take it during recurrence.

And, of course, brain mets can occur regardless.

I suppose my point is that so far there is no way of predicting recurrence, even if a woman IS Her2 positive. Or if she takes Herceptin or not.

I continue to support the belief of a)find out all the facts about your disease, b)learn the stats involved and the treatment options available, and c)with a trusted doctor/medical team, choose your treatment and forget the stats. Fight the fight the best you can.

But don't spend too much energy on what MIGHT be, or what COULD occur. You are where you are. And fortunately there are a variety of treatments available today to make our fights good ones.

Love and healing light to all,

Lisa

[lauren]

With all due respect, I have to sort of disagree, or at least differ a bit. No, we do not know how the study will turn out. And no, herceptin is NOT a panacaea. However, I think that every woman out there with her2positive bc has a right to go out there and try to get herceptin now because so many women are getting it off study. It seems unfair to deprive it to women whose doctors do not want to think outside the box. MD Anderson discontinued the study and began to give EVERYone herceptin in the adjuvant setting (everyone with her2neu overexpression, that is), remember?

I think we have to pin our hopes on herceptin and grass roots the knowledge around that it is something we ALL should have access to.

[Joe]

To Lisa and Lauren,

I suspect that the preliminary results of the ongoing clinical trials will be announced at either SABCS in December or at ASCO next year. Until then I suggest that we all be patient.

I would like to remind all of you that we live in a very litigious society, with trial lawyers convincing their clients that there is a windfall to be made by suing drug companies and doctors.

Should a doctor give Herceptin to a Stage I, II or III bc patient and this patient later develops either an adverse reaction or cardiac damage. The doctor would have little defense in court as the FDA has approved Herceptin only for stage IV metastatic BC patients and Genentech explicitly states that in their prescribing instructions.

I personally know of physicians who pay over $140,000 per year in malpractice premiums, and its not only doctors, but pharmaceutical companies, hospitals, nurses and technicians who are targets of these lawsuits. AND who pays ??
WE ALL DO with higher medical premiums and medical costs.

I received an email in 2001 from a lawyer in Texas who wanted to initiate a class action suit against Genentech. This came the week that Chris' onc declared her to be cancer free. Needless to say, I'd rather have a healthy Chris than money.

Warmest regards
Joe

[Paul]

Dear Lisa,

I'm afraid that you have created a bit of firestorm on this one. I found your post a bit pessimistic on the stats and on the science. I found your stat that herceptin is only effective in 25% to 33% of the recurrence cases to be incorrect based on several studies. I can provide those studies to you if you wish.

Treatment decisions are very personal. Each woman has the right to "fight this battle" as she sees fit based upon a careful review of all available data and studies. In this regard, a compelling argument can be made for early use (i.e., prior to Stage IV) of herceptin based upon the M.D. Anderson and Dana-Farber neoadjuvant studies.

Althought the M.D. Anderson study results involved a very small sample, the neoadjuvant use of herceptin + chemo prior to surgery produced stunning results. A cross-link to the M.D. Anderson study results is provided below. Following neoadjuvant therapy in the M.D. Anderson study, 67% of patients treated with Herceptin®/chemotherapy, compared to only 25% of patients treated with chemotherapy alone, had no detectable cancer. This study strongly suggests that sooner may be better in that herceptin may be even more effective with the low tumor burden present in early breast cancer. When a prestigious research institution such as M.D. Anderson makes neoadjuvant herceptin/chemo treatment of HER-2 positive breast cancer the standard of its care --one should sit up and take note at a minimum.

C'mon and join the optimist club -- with current and developmental drugs like herceptin, lapatinib, herstatin, omnitarg, and various vaccines, the future is bright.

Paul

[Vicki]

It is wise of you bring this up and help to put things in balance. I am new to this group and when I first started reading all the posts, I found myself feeling "deprived" and worried that I had not had the chance for Herceptin. For a while I even became overly preoccupied (my husband said obsessed) by it.I have certainly learned a lot from reading what's on this site and think it's the best I have come accross. I am enormously impressed by the likes of Paul for such wonderful scientific contributions and the numerous women who model such courage and provide much needed support. Your cautionary comments are equally valid contributions.

Vicki

PS. I am doing great at 22 months... no signs of recurrence despite my horrid prognosis 2 years ago. It's a comfort to me knowing that there is still Herceptin if I do have a recurrence.

[Vicki]

....with current and developmental drugs like herceptin, lapatinib, herstatin, omnitarg, and various vaccines, the future is bright.

It sure is.What a wonderful sentence....one I will carry in my head.

Thanks,
Vicki

PS I tried the link for pre-op Herceptin and didn't get very far. Any suggestions?

[Leslie]

When I was diagnosed, I had 13/15 lymph nodes positive. The grim stats for this factor alone was that I had less than a 10% chance to survive. My onc suggested the BCIRG6 trial because it would give me a 2/3 chance to get Herceptin. I randomized into the standard treatment arm - ACT. I was pretty devasatated because everything I had read told me that standard ACT was not very effective against HER2. I asked my onc if he would give me Herceptin off label. At first he said "No, we respect the randomization". Then I appealed to him with the grim statistics that were out there for me. He said he would look into it. After very careful consideration, he decided to give it to me off label. I had a really tough time because I felt in my heart that I should stay in the trial and contribute to the research, but I also wanted the best chance to survive. My will to survive won out. I have since found out that my onc is now giving Herceptin off label to those with more than 10 lymph nodes positive. He is extremely ethical and professional, he is also very stubborn. He will tell you there is no evidence that Herceptin will help until the trial results are in. But, I know he would not have considered giving it to me off label if he did not believe it would help me.
To those who have been in the trials and contributed to the research, I for one am very grateful.

[Kitty]

Couldn't have said it any better myself. Thanks Lisa!

[Kitty]

What a change this support group has made in the past two years. It was here where I "lurked" after being given a pretty grim prognosis 2 years ago. In addition to relentlessly researching everything remotely related to her2 so that I could be informed, involved and in charge of my life and disease, I always ended up coming back to this site. Two years ago there were many brave women who regularly posted and were stage IV survivors. The postings took on more of a sharing of experiences and what worked, rather than complaints of not getting their way. Maybe that was my perception, but it is because of these women that I found the peace and strength to battle this disease. I was very deeply disappointed that I did not get the Herceptin arm of the clinical trial. I also had the knowledge it would be there if I needed it, and a progression of the disease did not mean a death sentence. When my cancer progressed, I was not scared...I was ready to fight it and have done so successfully. I guess it's that half-empty or half-full way of looking at things. Two years ago, things seemed half-full...today the posts seem half-empty. I still to this day get goosebumps every time I think of Barbara & Ginger & Christine. Maybe that's what Lisa was trying to say.....It's hard to find inspiration and hope when the focus is on what people are not getting rather than ALL the great successes we are seeing.
Just a thought...
Kitty

[Joe]

I still to this day get goosebumps every time I think of Barbara & Ginger & Christine. There are many other long term survivors. Phylicia Bowman whose inspiring story is on our "Stories" page was the first woman given Herceptin in 1998 in Washington DC. There are many other long term survivors who have simply gotten on with their lives and simply do not visit BC support boards. Others such as Ginger Empey speaks on behalf of the Jonson Cancer Center in LA. and of course Christine envisioned and created this web site as a way of paying back the considerable support that she received from others when she was dx'ed with recurrance.
I agree that the culture on this web site has evolved. I hope it is for the good. We are always looking for new ideas. If you have any suggestions, please email us.
The one thing that we have to always keep in mind is that we are all in this together. Even the husbands, sons, children, parents, and friends of bc patients are deeply involved on this site.
I firmly believe that in the end, We Will Conquer This Beast'
Warmest Regards
Joe

[Kaye]

Lisa, I understand your concerns. However, I disagree with your stance at this point in terms of what info. we now have re. Herceptin. I agree with much of what Paul wrote below.
I am not sure where to start first in what I would like to say. I have lots of thoughts flooding me mind re. this.
First, though, I want to say that trials should continue. At the same time, Herceptin could still be made available to others off-trial. After all that is what has been done with aids medications. The results of doing that has allowed a great many to survive.
Considering the implications of Her2+ on ones' prognosis, I strongly feel that the same standards should be adopted for use of Herceptin for those who are Her2+ The problems in doing that, appear to be factors regarding cost and facilities. In regard to the former--if the cost of aids medications can be dropped significantly, why can't that be done for Herceptin? If fast track approval can be given to potentially life saving medications for aids--why can't that be done for breast and other cancers?
There is so much inconsistency in the treatment of breast cancer, it is quite confusing to understand. Why are some allowed to have Herceptin for more than one year?
I am convinced that everything is being done to delay diagnosis of metastases--why--the cost of treatment since I was Her2+ What they (HMO) has done in terms of imaging studies--inconsistent reports, wrong or I should say less than optimal and changing imaging procedures so that comparisons can't be done is outrageous.
Now, as far as progression of cancer with Herceptin--that may be but it could still be allowing extension of that person's life. One example---colleague who had stem cell transplant for lymphoma. He had been on the monoclonal antibody Rituxin. Two months after stem cell transplant the cancer was back. He was given a prognosis of 2 weeks to 2 months. That was 27 months ago. However, during this time he remained on Rituxin. He also did some alternatives. He currently has something in his sternum but the liver lesions are no longer visible.
Cancer treatments can work for some but not all of ones' cancer cells. Who is to say that Herceptin can't remain effective enough to help keep the cancer under control. I am guessing it can but how would all who could benefit get it? Where would they receive treatment? Who would pay for the cost for all? Under present conditions, it isn't feasible or possible. Those who are lucky enough to have the 'right' dr's and the 'right' insurances are getting it.
I met a gal last year who was told she would get a year of Herceptin through her HMO. She switched to a PPO but kept same dr. As soon as she did that she was told she could have Herceptin the rest of her life.
I recently saw 2 top breast cancer dr's--one a research psychologist the other a breast surgeon. The oncologist turned out to be horrible--he was a bully--who baited me/us telling us to tell him where the cancer was. We asked him to review reports because of all the inconsistencies. He refused to even discuss--and said we had to have confirmation of metastases in writing or he wasn't interested. The breast surgeon said basically the same--although he eventually admitted that give the circumstances of my situation, he was also sure that I had some metastatic process going on.
This type of treatment is an outrage. However, dr's can get away with it because the NCI has not yet changed its standards to coincide with latest research. Standards are based on theory that early treatment of mets does not extend survival. That's B.S. Why bother treating in the first place. However, some health care providers have taken that even further and do everything imaginable to delay diagnosis of metastases.
I don't think anything is going to be done until enough of those involved understand the process. It isn't easy and they--insurers don't want that to happen. At least not yet. They think in terms of cost-effectiveness, not positive outcome.
Jumping off my soapbox here...hoping that things will soon improve...

[vicki p]

I have been on herceptin for three years..
I am taking also taking cisplatin..
I am very near remission..
I will continue to take herceptin for the rest of my life..
Vicki P