NCCN Guidelines and adjuvant therapy

[jjames]

Post double masectomy i am getting oncologists opinions for adjuvant therapy since my original diagnosis of dcis at biopsy changed at surgery; the pathology report from surgery revealed a small 6mm tumor stage 1a grade 3 invasive bc Her2/neu positive and very weak positive for ER PR, so weak that one oncologist considered it negative when he ran the NCCN guidelines.

anyway, i seem to fall inbetween the No Adjuvant therapy and "consider adjuvant chemo therapy with trastuzumab", basically TCH. One oncologist says since the size is 6mm it is very small and not worth the harsh treatment to put my body through. Another oncologist said because of the aggressiveness of the her2 and the grade 3 tumor and my young age (45) she highly recommends adjuvent therapy.

I dont know what to do. the footnotes on the Guidelines seems to say they cant statistically prove benefit, but cant prove that it doesnt benefit and that there are risks in therapy that need to be wieghed against the unknown benefits.

One oncologist said i have up to a 25% of it recurring, but i cant find that information anywhere in any study. If i truly beleived the chances were that high i would go on the therapy.

Has anyone else had to make the decision on their own because they fell within the range where they cant prove benefits but can't unprove it either?

I'm totally lost right now.

[AlaskaAngel]

It is basically a question about you, and how you feel about it. Those for whom uncertainty is most difficult tend to opt for full treatment. My understanding is that MD Anderson favors treatment for the majority of that group with whatever long-term side effects and other illnesses are a risk due to treatment, in favor of adequately treating the tiny group that can benefit from it. The oncology community has differing opinions about it, in part because there is uncertainty about whether the addition of trastuzumab prevents recurrence or only delays it, and the question of how that applies if one does only trastuzumab and not the chemo. At this point doing trastuzumab alone for adjuvant treatment is in trials for those who are older than 70, and we don't know for sure what results there would be for doing trastuzumab alone as adjuvant treatment for those with a low or no tumor burden plus an intact immune system, as opposed to giving it with chemo to non-adjuvant patients whose immune system has been/is compromised.

Those who tend to want to do it whether it helps some or not will choose the recommendation to do it, and those who tend to want not to do it will choose the recommendation not to do it whether it helps some or not.

A.A.

[Jean]

JJames,
Sorry that you were dx and you are experiencing what many of us have had to go through. First of all you are in the group that early detection is a favorable marker. Now on the other hand we just don't have the concrete answers as to who will benefit the most. Here is what we do know. Her2 is aggressive, likes to travel and once out is a difficult enemy. I had a 6MM tumor like you. I had asked Dr. Salmon how many tumor cells in a 6MM tumor. Millions was the answer. therefore my thoughts were what are the odds of one getting away?
Also we now know saying a small 6MM tumor is not a threat is not a truth - it has to be taken as seriously as a 2CM tumor...since size is not the issue. While we have a greater chance of the smaller tumor not shedding as soon or as much...it still can happen. Remember there are millions of cancer cells even in a small tumor. It is like saying I am a tiny bit pregnant. Cancer is cancer...catching it early is a good advantage but there are many gals on our site who were dx. stage 1 and progressed onto stage 4...don't think you get stage 2, 3, once the cell is out and about and sets up shop in another part of the body you are stage 4.

Oncotype DX is a test to have the tumor tissue analyzed for recurrence but you are weakly ER positive and one must be ER positive for that test.
I had the test and my tumor came back with an extremely high recurrence.
There is no cut and dry answer on this decision. What we have learned is that a great majority of women who are DX Her2 have benefited from herceptin. We do not know who or why some women who are treated continue to progress. But the landscape of Her2 has changed (for the better) in the last decade. Prior to herceptin most dx. women were given a poor prognosis.

Read the recent trials and the benefits. Yes there is a dark side to treatment all meds have side effects. You will have to make a medical decision that answers your concerns. A few years ago you would not even have had the choice of treatment as early stage women were not offered treatment.
I had to fight to get treatment off label back in 2005. Do you know what your KI 67 level was from your pathology report.

Your tumor may have been tested for Ki-67, your pathology report will show a Ki-67 score. High scores—greater than 20%—mean that the cancer cells are growing and dividing at a rapid pace.

Higher-grade tumors typically have a higher Ki-67 score. However, there is no conclusive evidence that Ki-67 is associated with survival. Some studies have found that it is; others have found that it is not.

Some studies have suggested that there are certain estrogen receptor (ER)-positive tumors with a high Ki-67 score that may not respond as well to tamoxifen or an aromatase inhibitor. However, they do respond well to chemotherapy. Since you are boarder line ER receptor positive
portion of your cancer you may not fall into either group.

What most who are dx. (early stage 1) are most concerned about is recurrence - none of us know if we will recur. I was speaking with a wonderful lady the other day who was dx. 15 yrs. ago - of course she does not know if she was her2..back then they were not checking. But she had lumpectomy, rads, and done. She has no evidence of disease since.

Weigh the positive and negative - do so with knowledge and not fear -

Read different studies and then make a decision.

http://www.youtube.com/watch?v=AbUbdOnsfao

http://www.asco.org/ascov2/Press+Center/Latest+New
s+Releases/Women+with+Small+HER2-Positive+Breast+Cancers+Have+Significantly+Greater +Risk+of+Recurrence,+Metastasis+and+May+Benefit+fr om+Adjuvant+Trastuzumab+Therapy

http://www.cancer.org/Cancer/BreastC...ating-by-stage


Warmest Regards,
Jean

[jjames]

I was not tested for the KI 67. I think I am getting a clearer picture of the benefits - it seems to cut the recurrance rate in half? What I'm maybe not understanding are the long-term risks. I guess we can put up with anything if its temporary and think it will save our lives,thus a few months of chemo and a year of herceptin.
I'm wondering what the long-term side effects are of both chemo and herceptin - when in reality I may be over-treating myself.
I have read the studies on the benefits of treatment for early stage her2 cancers, but the medical reasons for not having treatment is "risk and toxcities" and im having a hard time finding more information on that part.

I am 46 and grade 3 so for those reasons one oncologies wants to give me adjunctive therapy for the 6mm tumor.

Scary thought going from a stage 1 to a stage IV and thinking of all those cells that potentially could have seperated. But dont the "clear margins" mean something in that regard?

Thanks for your support!

[Jean]

jjames,
Understand the concerns of side effects...I am 7 yrs out and so far all is going great in my life. I am still taking AI for my high estrogen positive part of my bc. While there are women who are having some nasty side effects - I am doing well.

There are many layers to this disease. First of all if we are lucky we age. With age comes an entire host of issues that are natural.

The group of us early stagers who have been treated will be able to offer more answers in the next 10 yrs. We have seen the last decade of trials and studies which strongly shows improvement and survival has increased with Herceptin.
Will Herceptin be given without chemo in the near future? No one can answer that.
As research discovers more information on genes, DNA, enzymes, etc. and their role
in bc.

It is an individual decision when faced with early stage dx. For me it was easy choice. Understanding the nature of Her2 I wanted to be treated. Yes you can have clean margins...no node involvement...and yet still a rogue cell can lay dormant
and then venture out...

There are so many articles to pull on the site to read about small tumors and treatment...read as much as you can endure and then sit with your family and review. At the end of the day you will have to make the best choice for you.
All I can add is recurrence rate has dropped since treatment of early stage with herceptin (with chemo) now there are a few gals who have had treatment of herceptin alone....ask your onc. if they would be willing to treat without the chemo.

Keep us posted.
Best Wishes,
Jean

[Jean]

jjames,
Lani posted three wonderful videos on another post.

I have pasted the link below.

http://youtu.be/WSXrDap-O9M

Please take a moment to view as it will offer a positive lift without all the fear of treatment issues. We all realize this disease is nasty and we have to consider the risks and then balance that with what we consider to be vital to our life.

Dr. Slamon is the Dr. I flew out to see for help in my early days of dx.
He is wise, calming and an attentive medical researcher. He cuts to the chase with a no nonsense approach. He told me I more than likely saved my life by pushing ahead (at the time of my dx.) all dr. were going with the standard trt. for early stage Her2 gals. No chemo/or/herceptin. Now as I said earlier some gals were able to have their dr. just give herceptin but my insurance would not cover the treatment unless we followed the trial of TCH.
When I saw Dr. Slamon back then he told me he had just concluded the trials results of TCH and strongly urged me to have treatment. There was not a doubt in his mind. He was not as strongly concerned about the side effect that could be or maybe involved - he was more worried about HER2.
Now I did have higher KI 67 levels and I am strongly ER+ but as he clearly stated to me any women with Her2 should be treated. You can imagine my response as a patient fighting to have treatment and here this genius researcher dr. is agreeing that my dr's in NY had missed the boat. They were behind him in the newest cutting edge research, (following standard of care). Most dr.
will not venture out of that area. (understandable ) but my mind was on saving myself and turning over every stone of informatio and then making a medical decision that I would be comfortable living with.

Again, you must make the best medical decision for you based on knowledge
of the good, the bad and the ugly...but not on the fear of the unknown.
We do know what this Her2 disease can do.

Wishing you all the best.
Jean

[roz123]

jjames
you may want to go to bco.org. Under the her2 section there is an entire thread dedicated to her2 tumors under 5mm (or close as in your case). This may help you make a decision
I completely agree with Jean - her2 is sneaky and aggressive and does not behave like other bc.
as for the side effects of chemo, they are totally doable as you can see from all the women on this site who are many years out and living happy, healthy lives after treatment. Yes there are some long term side effects like chemo brain/fog and neuropathy but they are manageable
from my understanding TCH is less cardio-toxic then the alternative of ACT-H if the heart issue is of concern for you. Herceptin works best with chemo that's why most docs won't prescribe it seperately
As for oncotype score on her2, my onc said they do not do them b/c her2 guarantees chemo and oncotypes are done to determine the benefit of chemo - which is clear in her 2 cases

I would urge you to do the chemo/herceptin even for a 6mm tumor

[NanaJoni]

Jjames - I do understand your fears of long term effects of cancer treatments because I have several: some lung damage from radiation, anemia from the chemo, pulmonary emboli from multiple surgeries. But I have to say (and I stole this from another survivor) my favorite long-term side effect of chemo is being alive. For me personally, and I am considerably older than you, I felt a need to throw everything I could find at the cancer in the beginning. I was grade three, HER2+++ and had a second tumor that was triple negative. I followed my oncs recommendations and went with the TCH followed by radiation. Even with the things I'll be dealing with long term, my fear of recurrence is much less now. Bottom line still is - you have to do what's right for you and no one else. You need to feel comfortable and at peace. Wishing you the best as you move forward.

[1rarebird]

JJ et.al., it seems to me the discussion in this thread is centered on how aggressive should one be who is diagnosed with a small stage 1 tumor that is Her2+ and high grade. I am not a woman, but I suspect that my doctors three years ago next month would have given me the same advice had I been female. They told me then to fight my early stage Her2+, ER+, zero nodes, clear margins breast cancer with every treatment available then. I clearly understood that they were telling me not miss the opportunity I only had then to succeed in defeating the cancer. I followed their advice and suffered a year of side effects from the regimen noted in my signature line below. But I am feeling much better now as I close in on my 3-year anniversary, even though the tamoxifen is particularly no fun for a man. I am grateful for the chance I had back then to do what I could, and if I am lucky I will never have to look back and second-guess myself for not trying to kill off the beast with every weapon I could find. I hope you will be as lucky too.--bird

[Jean]

NanaJoni,
But I have to say (and I stole this from another survivor) my favorite long-term side effect of chemo is being alive.


Love it...great quote!!!

Jean

[caya]

I LOVE that quote Jean - "my favourite long-term side effect of chemo is being alive."

I'll mention that one to my onc. when I see him in July.

all the best
caya

[Jean]

Haha Caya,
Wish I could say it was my quote..NanaJoni shared it on the previous post!!!

But I think we should all keep it posted somewhere where we can see it each day...and say it like a mantra.

jean

[jjames]

Thanks all for your replies and i like that quote about favorite side effect. What i am struggling with is the heart toxicity issues potentially irreversable with herceptin. I have been searching around on the net to get the cardiologists point of view on oncologists treating her2 cancer patients with llower and lower chances of recurrence, such as those with smaller tumor sizes. The are the ones who have to deal with that side effect and they all agree the heart takes a major hit from herceptin....they seem to think the risk is higher than from what my oncologist is telling me...i think i would be more upset with my decision of accepting treatment and irreversably damaging my heart, than with not accepting treatment knowing i have a chance of the cancer returning. I am truly struggling with the heart toxicity issue.

[NanaJoni]

Jean - someone else may have already mentioned this, but your drs (onc) will closely monitor your LVEF (left ventricular ejection fraction) by doing an echocardiogram every 3 months. This is a standard protocol for Herceptin. If the number (which is reported in a percent) drops below 50% they'll stop the Herceptin and usually the LVEF recovers within a few months. or even quicker. Mine stayed around 55%-60% while I was on Herceptin and is now back up to 70% which isn't bad for my age and general health.
I really understand your fear that you'll make a decision that you may regret. I hit a terribly low point when I found out that my decision to have radiation resulted in permanent lung damage. It took a lot of tears and some tough talks with a counselor to get past the anger and fear. After the past year, I now feel that it was the right decision at the time and I don't regret it. Regret is an emotion I can't afford anymore - it only adds stress which makes us susceptible to more complications. I felt like I was on a rollercoaster for over a year but like all wild rides, it ended in a nice safe level place.

[Jean]

jjames,
As NanaJoni said, a patient is tested during treatment and monitored for obvious signs of heart stress related issues. Before you start treatment you usually have a muga test to have a baseline.

Updated results on the drug's cardiac risk over time have also resulted in a risk profile that should help determine which patients might want to steer clear of Herceptin. For instance, women who were older, used hypertensive medications and had a low normal baseline left ventricular ejection-fraction were more likely to develop heart failure while taking the drug.

This latest study, reported at the American Society for Clinical Oncology meeting in Chicago, found that after five years, the incidence of heart failure was 3.8 percent. With an additional two years of follow-up for a cumulative five years, the incidence of heart failure in the available group numbers was essentially unchanged. There was a substantial recovery in cardiac function in all three groups who had clinically relevant declines in heart function.

I have to wonder out of the percent of 3.8 women how many had a previous risk, how many had A/C chemo with the herceptin (that is no longer done)

Kind Regards,
Jean