Stage 1, grade 1 and pre-menopausal
Comments
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By and large I think much of what has been posted here by the originator and others is especially helpful and important in sharing information.
At the same time, I don't expect anyone to be perfect here just because they are especially knowledgeable from either previous formal education or personal experience, including myself. Legitimate disagreement is part of intelligent discussion. I don't think personal evaluations are helpful in educating each other about cancer.
I do think that when creating trials for early stage breast cancer patients, trial creators should make the effort to thoroughly evaluate the entire group of early stage breast cancer patients for inclusion, and not just by chance fail to do so. Given that the entire group presently in the trials is lacking adequate evidence to document their risk and that is the rationale for doing these trials, an arm for HER2's would have been no less valuable.
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These two groups referenced in our discussion ARE different groups; one is the standard practice recommended by the larger group of oncologists' consensus for the tiniest evidence of HER2 positivity, and one is the smaller group of some cancer centers and their recommendations for the tiniest evidence of HER2 positivity:
"Cancer centers that favor hitting even the tiniest evidence of early stage HER2 with chemotherapy"
versus
"According to the NCCN guidelines"
These two groups do differ in their recommendations for very tiny early stage HER2 positive cancer treatment.
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These two groups referenced in our discussion ARE different groups; one is the standard practice recommended by the larger group of oncologists' consensus for the tiniest evidence of HER2 positivity, and one is the smaller group of some cancer centers and their recommendations for the tiniest evidence of HER2 positivity:
"Cancer centers that favor hitting even the tiniest evidence of early stage HER2 with chemotherapy"
versus
"According to the NCCN guidelines"
These two groups do differ in their recommendations for very tiny early stage HER2 positive cancer treatment.
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A.A. You are missing the point. Simply put, researchers are not intentionally failing to include HER2 positive patients from clinical trials. Instead they are trying to protect from harming them. It's called First Do No Harm.
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That depends on just how one defines "do no harm". There is no reason to do the trials at all if one defines "do no harm" as "give chemotherapy to any breast cancer patients just in case", whether or not it is useful for most of them.
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First Do No Harm with respect designing a study that is ethical. Again, I will stress the example used of statins following the diagnosis of a heart attack. Statins are widely known to cause muscle issues and potentially deadly rhabdomylosis and yet when studies are designed to find better treatments for heart attack patients, an ethical study will NOT stop the use of a statin if a patient already had a heart attack and is currently being prescribed one, since it is the Standard of Care. Likewise, a patient who is diagnosed with a breast cancer that is larger than .5cm that is HER 2 positive and is less than 70 years of age will be given the choice of having chemo and Herceptin. To not offer both in a clinical trial would be outside of the Standard of Care and be unethical. Researchers cannot encourage the design of a study that suspends the Standard of Care. Doing so would create challenges to the oath of First Do No Harm.
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So, again, why do these trials at all for any early stage patients? Why not just continue the present standard of care for all of them?
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My ? is in what circumstances does the Standard of Care recommend giving chemo to Stage 1 BC patients?
Exactly, what are the characteristics that they use to
determine this protocol? Tumor size, Onco Scores, Her 2 +, node positive, type of aggressive tumor, ETC.???
And, how does it vary with different staging & grading within early stage breast cancer?
And, is "early stage BC" limited to Stage 1 only-- not Stage 2?
Thanks!
Violet0 -
A.A... You cannot pick and choose how to define First Do No Harm. There are legal and ethical implications of Standard of Care that is tied to First Do No Harm which researchers must carefully follow. Your "give chemo just in case" philosophy is hollow. If doctors truly believed that they were routinely obligated to give chemo "just in case" while knowing it would be more harmful and less beneficial to their patients, then today MORE patients would be receiving chemo. But thankfully that isn't the case. As you can see from this thread, many of these sisters here, including myself are NOT receiving chemo "JUST IN CASE." Rather thanks to the excellent design of the research that created the Oncotype DX score, fewer patients are being given chemo. And hopefully, when the preliminary results of the SOFT and TEXT trials are announced, then even fewer sisters will be told they need chemo.
First Do No Harm never meant we are going to have to treat many to save a few. With every passing year, studies have lead to discoveries that have lead to more beneficial treatments while doing less harm within an ethical and legal framework. And thank goodness we live in a developed society that respects these important concepts.0 -
Violet... Here in The United States, first and foremost Standard of Care is based on the NCCN Guidelines. There are additional guidelines created by ASCO and St. Gallens. You might wish to look all of them up. The NCCN guidelines breaks out the characteristics that you mention and creates Standards of Care by categories and levels of evidence.
With respect to heart attacks and statins, there are the NCEP guidelines here in The United States.0 -
A.A. The Standard of Care changes based on evidence presented in studies. Beginning in 2010 or 2011, the Oncotype DX test was finally incorporated in the NCCN guidelines.
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A.A... Why do these trials??? You answered the question yourself! BECAUSE RESEARCHERS AND CLINICIANS SUSPECT THEY ARE OVERTREATING ER positive HER 2 negative PATIENTS WITH CHEMO.
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Vor:
Thanks...0 -
Violet 1,
There are also two different versions of the NCCN guidelines. One is minimal and is the "patient" version. The other is supposed to be for providers, but many breast cancer patients use the more technical version as well.
What VR is saying is that once a therapy is recommended by NCCN guidelines, trials can be designed to ADD other treatments to see if they help even more (or do more damage), but the basic treatments that are recommended must be given to all patients in the trial.
Therefore, even though the preponderance of evidence was never documented that chemo in addition to trastuzumab is useful for early stage HER2 patients, the "standard of care" is to give chemo regardless, since that was the original NCCN authorized treatment offered to HER2 patients before trastuzumab was ever created. It means that the standard of care cannot be changed whether or not it is in reality more useful or more harmful for these patients. It is okay to offer trastuzumab in addition to chemo as the standard of care, but early stage HER2 patients are stuck with chemo as part of the standard of care whether or not it is harmful or helpful to them "just in case" some unknown number of them "might" be benefitting from the addition of chemo to trastuzumab. That NCCN philosophy of do no harm even though we don't know whether we are doing harm and we do know chemotherapy has many disadvantages is what VR and the NCCN so proudly believe is "ethical". It is what VR and the NCCN are glad is in place. It protects providers from having to determine who is hurt by chemo and who is helped by it.
Stage 1 and stage 2 are early stage bc.
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VR, I do understand your point.
"The standard of care changes based on evidence presented in studies. Beginning in 2010 or 2011 the Oncotype Dx test was finally incorporated in the NCCN guidelines."
The result is that early stage HER2 patients are excluded from all of the above possibilities and given lip service, including in terms of the celebrated Oncotype Dx.
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No. A.A. Those guidelines are in place to protect all of us. You might not like them, but they have saved many lives AND have helped push through studies that have led to changes in the Standard of Care that we should all be grateful for.
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Okay...but if that's the deal for trials...what about a doc. In private practice outside of clinical trials? Can't he/she recommend outside of the guidelines/ SOC? Right? They do it sometimes or sometimes patients refuse 1 treatment but want the other part recommended but NOT the
recommended COMBO, let's say...Can a doc. administer
that only then? OR would
some docs refuse to treat the
patient...depending upon the
situation?
Violet
Just trying to get this straight...0 -
Thanks for the patience with outlining why the NCCN guidelines are considered ethical, even though they are failing to BE ethical for the patients who are not allowed to participate in studies to provide proof of what works and what does not.
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A.A. HER 2 positive patients getting lip service? A.A., I am really sorry that you continue with such banter...Why not write to the chairperson of the NCCN and ask for answers to your questions? Be sure to mention that you believe HER2 positive patients are not being studied properly and being endangered due to poorly designed studies AND lack of studies. Be sure to let us know what the chairperson has to say.
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Violet 1,
That too gets complicated. For example, when the trastuzumab trials were completed, they were considered to be successful, and that was a surprise to most oncologists at the time. It was such a surprise that many of them were caught with their pants down, so to speak. They stumbled around for over a year trying to come up with "ethical" NCCN guidelines for who should receive the trastuzumab.
Those of us who had just completed treatment with chemotherapy at the time of the trial end were left hanging for over a year. At first, these confused experts recommended giving it to patients who were 6 months or less out from treatment only. By 6 months later that changed to including only patients who were a year or less out from treatment.
That was clearly idiotic, since it was well known to everyone that in pure fact, the first TWO to THREE years out from treatment is the period of highest risk for HER2 patients. DUH. Get your boots on. (THAT was the "ethical" NCCN decision at the time.... that we should trust and respect SO highly.)
The NCCN guidelines may work for many cancer patients. But they seriously fail early stage HER2 bc patients who are HR+ because they are not based on any foundation except a blind belief in the need for chemotherapy "because that is the way it always has been done".
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Violet 1,
During the period of confusion about who should get trastuzumab and who shouldn't, oncs were free to prescribe trastuzumab without chemotherapy to early stage bc patients and many did so, particularly those who were in private practice and able to use more common sense than those who were locked into confused organization practices. After the medicare rules for who could have it were defined, for better or worse the insurers tended to go along with those rules. The rules required chemo plus trastuzumab, since that was what had been given in the trials.
The result was that if patients could not afford to pay for the trastuzumab on their own, they then either had to do without treatment or stuff in the chemo plus the trastuzumab. Most patients could not afford the $70,000 to $100,000 trastuzumab payment. So that forced patients into doing chemo plus trastuzumab in order to get the trastuzumab at all.
Does that sound medically necessary and ethical?
At present, the way for early stage HER2 bc patients to get trastuzumab without chemotherapy is to refuse chemotherapy; that allows the provider to hold the position that even if the patient doesn't receive chemotherapy, there is a strong possibility they will at least stand to possibly benefit from the trastuzumab. And so they are still being "ethical" because they have offered chemotherapy plus trastuzumab to the patient.
Deluxe lip service.
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A.A. You have mentioned time and time again how you were personally scorned by the medical establishment back when you were first diagnosed and Herceptin was discovered. As I have told you REPEATEDLY, you have every right to feel frustrated by the medical establishment and they do owe you an apology. However, your continued scorn and contempt at the researchers and clinicians today is unwarranted. It appears that you just might like to prefer throwing out the baby with the bath water. Your crusade is over zealous. In every field of medicine researchers and clinicians will often find themselves in quandaries along the way, but eventually they make peace with what evidence there is and stumble forward.
No doubt you have suffered and continue to suffer from the side effects from chemo. But you made your decision to do the chemo based on the best evidence at the time when you were diagnosed. You haven't recurred despite not being offered Herceptin when it was finally available. Could you be alive today thanks to the chemo and chemo alone? I really wonder why you are so jaded when you are more than 10 years out from being diagnosed.0 -
I will look at the Guidelines/ Professional version. ..;)
***I just did NOT KNOW /realize that some BC patients that are Stage 1 (a) grade 1, with no node involvement, Her 2-, could be recommended chemo...
So...I'm guessing it's because of a high Onco score?
I'm confused...sigh. Too tired to read about this tonight...0 -
Violet... Yes! There are Stage 1 (a) Grade1 patients who have high Oncotype DX scores and are recommended chemo. And then there are so many of us here on this thread who are anxiously waiting for the SOFT and TEXT trials preliminary results to see if doing O/S offers us a reasonable alternative to chemo. When the SOFT and TEXT trials were initiated, the Oncotype DX test did not exist. Presently, there are still many Stage 1, Grade 1 sisters not getting the Oncotype DX test. Likewise, there are some getting the Oncotype DX test and finding out they have dreaded intermediate scores. The ongoing TailorX trial is trying to help get more info to determine if many more sisters can move safely out of the intermediate zone, that is, know with more precision whether or not the benefit of chemo will or will not outweigh the risks.
A.A. is angry at researchers for not unveiling similar trials for HER 2 positive sisters and is equally angry at how researchers and clinicians treated patients like herself a dozen years ago. But what she fails to appreciate is that we can't go back and correct those mistakes nor can we go forward with HER 2 positive trials that might put patients at a higher risk of recurrence. Nor can trials be created, which takes lots of money to design, where it is likely to NOT accrue enough patients ( like PERCHE) and then have to disband the study leaving us with no new evidence.0 -
Violet, medical research is messy. Could we do a better job? Yes. And with every medical controversy that is exposed, think of the Vioxx debacle, the powers that be in medicine, especially the medical ethicists, attempt to improve their methods.
Reading a best seller book on President Garfield, we now look back and wonder why American physicians were slow to accept the British Standard of Care of antiseptics. Today it is believed that Garfield could have survived had the concept of antiseptics been accepted here sooner.
Similarly, ovarian suppression has been used more regularly in Europe for decades. Only now are we anxiously looking forward to the results of SOFT and TEXT so we will know one way or another if for many ER positive, HER 2 negative patients, if O/S is a good alternative to chemo.
Without a doubt, it is a given that mistakes routinely occur in medicine. But many are made on the side of being cautious and that is because of ETHICS.0 -
I probably shouldn't jump in, but I've been reading the recent discussion and wanted to mention that in the 8 years since I was diagnosed, I've seen a lot of changes in the NCCN Guidelines as new research has come out.
Violet, to your comment, "I just did NOT KNOW /realize that some BC patients that are Stage 1 (a) grade 1, with no node involvement, Her 2-, could be recommended chemo..." the fact is that back 8 years ago (and in fact much more recently than that), chemo was recommended to ER+/PR+/HER2- Stage I women based on the size of the tumor. If I remember correctly, the guidelines said that for those who had an invasive tumor that was greater than 0.5cm - 1cm in size, chemo could be 'considered' and for whose who had tumors larger than 1cm, chemo was 'recommended'. So prior to the availability and testing of the Oncotype test, a lot of Stage I women were prescribed chemo - including many (probably most) with grade 1 tumors that were larger than 1cm in size. The Oncotype test represents great progress in that now it's better understood that many Stage I women don't benefit enough from chemo to make it worthwhile for them to be exposed to the risks and side effects.
Another recent change is just the fact that now there is a Stage IA. Until a couple of years ago, there was only 'Stage I' with no "A" or "B". Any nodal involvement, even micromets, automatically moved the patient to Stage II (or higher if there were more nodes affected) - and that possibly meant more treatment. But research showed that women who have micromets with invasive tumors that are 2cm or smaller in size have a long-term prognosis that is more similar to that of women who are Stage I with no nodal involvement, vs. those who are Stage II with more nodal involvement. That led to a decision to shift those with micromets down to Stage I, and the splitting of Stage I into IA and IB so that the women with micromets could continue to be monitored and tracked separately.
Those are just two examples - both relevant to this discussion - of the many changes that I've seen made in the 8 years since I was diagnosed. The NCCN Guidelines are a dynamic ever-changing document. As new research comes in, often there is first a notation and reference without an actual change in guidelines, but then as the research is firmed up and/or confirmed, the guidelines are changed. So when people complain that no progress is being made and that breast cancer treatments haven't changed for years, I shake my head because I've seen so many changes.
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And Violet, I would be remiss if I didn't throw into the mix the following study:
http://www.nsabp.pitt.edu/B-47.asp
"To determine whether the addition of trastuzumab to chemotherapy (TC or AC→WP) improves invasive disease-free survival (IDFS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed."
Notice when reading the study that in order to do the study they are selecting VERY carefully patients who are technically at a lower risk of recurrence than are patients with HER 2 Positive characterisitcs.
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Thanks for chiming in Beesie, your observations are very insightful.
The research that points to less aggressive treatment for a deadly disease needs to be watertight and so the changes in clinical practice often take much longer because of the very point VR has raised about first doing no harm.
The problem with studies fine tuning/ reducing treatment for HER2 positive patients is that this group historically have experienced the worst survival outcomes overall. Herceptin and aggressive chemo regimens improving outcomes in HER2+ women have contributed to the recent significant improvement in long term survival. This group is therefore possibly the most tricky group to study effects of less aggressive treatment (while ensuring that survival is not compromised). If only research was easy.0 -
Geez...head spinning but I AM learning soooo much from you ALL...Thank you for taking the TIME to help explain things to me that will help me WHEN I read further on my OWN.
My Sugical Onc. who did my BMX did NOT automatically order the Onco Dx test for me because I was such low grade/stage on BOTH SIDES -had Syncronous Bilateral BC.
I get that.
But, being the curious and have-to-KNOW type of person that I AM, once I HEARD ABOUT the Onco DX Type test--I was clueless until I heard about it on THIS SITE...;), I chatted up my Onc & told him I wanted it which he said was fine.
I just happened to be going to my 2nd opinion Onc. a few days after that and asked HER about it & she was happy to order it & thought it prudent. ..:). She had recently gone to some big conference where a patient with my exact Stage 1a status had come back with an UNexpected HIGH Onco score. The Medical Team involved were in a quandry as WHAT TO DO/RECOMMEND to this woman...chemo or not, etc.
So...even though she said it's uncommon to happen, it CAN happen--I know you all already know this. My point is that she was willing to request thw test for me which I know is very $$$. My insurance covered it on BOTH BREASTS/TUMORS...YAY!
SO. MY scores are: 6 & 13
Pretty low, but I guess I STILL would've liked both to be 6's...;)
Other Take Away:
ASK TO BE TESTED IF YOUR ONC HASN'T ORDERED IT FOR YOU...:)
VIOLET0 -
In the last 10 years, progress for early stage HER2 positive and HR positive patients has been next to nil because they have been denied the chance to apply any such alternatives as ovarian ablation plus trastuzumab WITHOUT chemo, with the option of use of an AI.
A more genuine scientific process is not biased in favor of ANY single treatment (such as chemotherapy) when given in conjunction with other treatments; scientific principles demand that each treatment administered be considered to be a factor in itself. The NCCN does not adhere to that high standard. All the excuses in behalf of NCCN or medical practitioners for their failure to follow that simple scientific principle year after year are only excuses, not reasons.
The changes that have been made during that time have only been to increase the number of HER2 positive HR positive patients who are exposed to chemotherapy, even though that group is known to be least likely as a group to recur within the first 10 years, and even though it is known that chemotherapy at time of diagnosis is not very useful after the first 5 years.
I'm doing fine personally. As I too have clearly indicated, it is remotely possible that chemotherapy may have done the trick for me. HOWEVER, it is very unlikely because HR positives tend to recur for the most part after the first decade of remission, and because chemotherapy given at time of diagnosis is not helpful after the first 5 years or so. Progress for this group has been nil in the last decade.
A.A.
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