The Truth about Cancer

One clearly could make a very persuasive argument that it has less to do with ethics than it does to do with the fact that the number of metastatic HER2 positive bc patients to be treated with chemo (when they are not excluded for this or that reason) is tiny compared to the number of early stage bc patients who are advised to do chemo -- a pool that is becoming larger and larger all the time by including earlier and earlier stage patients.

But why consider the facts....

kayb,

The result here is that physicians either blindly follow the standard recommendations and use them as an excuse for not applying ethics more logically and pragmatically, OR they use different ethics and more discretion about recommending chemo in the first place.

VR, yes. SOFT and TEXT are being done to find out whether or not fewer patients benefit from chemo as opposed to OA.

EXCEPT, of course, for any patients who happen to be early stage HER2 positive patients, since they were banned from finding out the SAME INFORMATION.

EDITED: From the response to my question, it appears that the standardization, definition and application of ethics is in question.

That may be why some doctors think for themselves a bit more than others.

Thank you both.

So, ETHICALLY, then, it is considered "dandy" to run a trial where some patients forgo the proven effective treatment (OA plus tamoxifen) in favor of another therapy (OA, with exemestane)?"

"Both trials were designed to compare the aromatase inhibitor (AI) exemestane with tamoxifen in premenopausal women with early breast cancer who also received ovarian suppression. The joint analysis involved 4690 patients.

http://www.ncbi.nlm.nih.gov/pubmed/24095609

Because there were fewer events than expected in both trials, the two studies were combined. Because one of the requirements was that subjects be of low risk of recurrence, my understanding is that the majority of women in the study had not had chemo prior to enrollment. Recall that the study's main goal was to determine if adding o/s was beneficial to either an ai or tamoxifen. My oncologist was not impressed that we will see any major news coming out of the preliminary results. He believes that since most of these patients were at low risk of relapse in the first place....we will NOT be seeing statistically significant SURVIVAL statistics before the next decade. The good news coming out of these two studies is that it confirms that clinicians are confidently using LESS chemo on certain cohorts, contrary to what AA believes. Ann and again, HER 2 POSITIVE PATIENTS WERE NOT invited to participate for the simple fact that thbbeir risk of relapse was too great to be included in. A study that didn't offer chemo and Herceptin.

VR:
"My oncologist was not impressed that we will see any major news coming out of the preliminary results. He believes that since most of these patients were at low risk of relapse in the first place."

Which is exactly my point. Ethically they have never determined that very early stage HER2 positive bc IS in fact at "higher risk", since those patients were left out of the trials in the first place.

kay....that is correct. And for those who had a higher risk and had chemo....they would now have the choice of continuing adjuvant endocrine therapy with more options! And those who deferred chemo because of their low risk would also have more options!

Lower than what? Patients who are never allowed to be compared by trial?

Is risk level not subject to definition by trial? Guilty without ever going to trial?

June,

You wrote: "Bottom line is if a doc wants to treat a cancer patient other than std care...its illegal."

That is simply not so. However, if the doc disregards standard of care and instead of accepted treatment gives you bubblegum and foot massage and then you die, your loved ones can sue and will probably win a large settlement. Also, if the behavior is egregious enough, the doc could lose his license.

So, docs to protect themselves against lawsuits will use SoC, unless there is some strong medical reason not to or the patient refuses XYZ treatment.

Kay....AA is very familiar with the study that you refer to. In fact, Dancetrancer's thread, which I referred to earlier, specifically mentions that retrospective study! The frustrating point for Dancetrancer and sisters like her who have tumors 1 cm or smaller and test positive for HER 2, is that there are no clinical trials to join that are less aggressive in nature BECAUSE their tumors are documented to be of higher risk of recurrence. Most of the treatment recommendations for them and especially for those with HER 2 positive tumors under .5 cm comes from retrospective analysis. AND...if you read the NCCN guidelines carefully.....chemo and Herceptin are NOT even recommended for those .5 cm or smaller tumors. Reading further, it is a point of frustration for patients and clinicians alike because of the little documentation that does exist. And that is what fuel's AA's pathological obsession! She wants clinical trials that are trying to document less aggressive treatments for many cohorts of patients to include subjects,who by nature of their HER 2 Positive tumors are at high risk of recurrence!

You can tell her from now and forever that it would be unethical to allow such patients to be invited to join such studies, THAT IS, UNTIL WE LEARN MORE FROM THE CURRENT SMALL STUDY OF the over 70 cohort that are currently being investigated.....but she will NOT be appeased! Her retort will always be that giving them chemo exposes them to all kinds of other risks!

And those progressive European researchers....many studies nowadays are global. So there are fewer distinctions between how patients are treated in developed countries. That said, cultural differences do exist. One of our rare breast cancer researchers at Sloan Kettering is European. When she arrived in NY three years ago the first thing that SHOCKED her was the abundance of pharmacies in Manhattan. Without exaggeration, you can't walk more than a few blocks in midtown without passing a CVS, Walgreen's, Rite Aid or Duane Reade. She thought it was rather insane to see so many pharmacies and so many shelves filled with so many medical products.

In summation...AA understands most of these important points. She has seen the studies and knows their limitations. She is entitled to her own opinions. However, I will repeat what esteemed US Senator Daniel Patrick Moynihan once said and that is...."Everyone is entitled to their own opinions, but not their own facts.". AA chooses to ignore facts. HER 2 POSITIVE IS WIDELY REGARDED AS A POTENTIAL BEAST. Retrospective analysis supports that opinion. It is a fact that ethical consideration must be paramount in the design of clinical trials. Therefore, risks and benefits of a potential therapy must be carefully weighed before a study can be deemed ethical. Without ethics, our "safety net" would be missing. AA believes that that exposing HER 2 positive patients to chemo without "documentation" is unethical and dangerous. She is entitled to that opinion. However, based on all of the facts that we have to date, it would be unethical to conduct a trial and give AA the documentation that she desires.

AA says, "Keep in mind that the group of patients we are referring to are early stage bc patients, and the preference by non-patients is to continue to avoid at all costs the compassionate investigation into whether or not the VAST MAJORITY of those early stage bc patients would be much better treated with trastuzumab used ALONE, while they limit that use to those over the age of 70 because most HER2 patients are conveniently told they are considered hopelessly recurrent without chemo."

You certainly know how to make things up as we go along! The cost is NOT what is keeping investigators from investigating. It's due to ETHICS. Again, you are entitled to your opinion. But...you are NOT entitled to your own facts. And it most certainly is NOT about "convenience." The more you spew your opinions, the less credibility you have AA. And your default mode is always that people like myself who AREN'T HER2 positive or HAVEN'T received chemo have no place in this discussion. I beg your pardon. I think people like myself who have experienced a cancer diagnosis, have every right to be concerned about how clinical trials are designed and ultimately be concerned about standard of care. And if you have proof that that "non-patients is to continue to avoid at all costs the compassionate investigation"....then let's see it! In all the years that I've been reading what you have written, I find that statement to be the most offensive.

A gap? Perhaps it is you AA that should enlighten yourself about ethics and then maybe there will be a bridge to fill that gap. The compassionate and practical search is not blinded by our reliance on "one interpretation of ethics." It is blindness on your behalf of the meaning of ethics that sadly keeps you in the dark.

AA, my tumor was HER-, although they had to do extra testing to be sure of that. This doesn't change anything I said in this thread. As far as chemo, you can see from my tag what chemos I had. I did not have pcr, but my tumor shrank from somewhere above 5cm to something less than 1. I had significant tumor shrinkage after the 2 ndchemo and felt better overall by then as well. The cancer had been wearing me down for years, as far as I can tell.