Polite Explanations are Welcome....
Comments
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Trials involve getting patients to participate. If you design a trial and you can't accrue enough patients, then that's one of the reasons why it takes so long to get answers, if they can get an answer at all.
That's also why the sisters who choose to participate in trials are heroes.
Remember when trials are designed the doctors must not put women at additional risks when they create trials and must at a minimum offer them standard of care.
Ten years is a long time for everyone. But the reality is that there have been great discoveries found right here in the USA in the last decade, Herceptin, for example and that has made its way into clinical practice in the last decade. Zometa too for certain women is now prescribed.
Partial breast radiation is also being done.
I would say the researchers here are making great strides. -
Keeping the original question I asked in sight for discussion:
How long will it take for us to get a comparison of either ovarian ablation and trastuzumab alone (or possibly trastuzumab plus lapatinib) for premenopausal early stage HER2 positive bc patients, versus standard chemotherapy, in this country?
Trials require enough participants to be meaningful and if there aren't enough participants it can take longer or not be possible.
True. Over the last 10 years, many patients have been willing to do trastuzumab alone rather than with chemotherapy. So the reason for delay in running trials of trastuzumab (or trastuzumab and O/A for premenopausal HR+ patients) isn't due to lack of willing participants.
The sisters who chose to participate in clinical trials are heroes.
True, and the reason they are is because they are doing something that may have negative consequences, including worsening their condition.
Remember when trials are designed the doctors must not put women at additional risks when they create trials and must at a minimum offer them standard of care.
There is no way to know whether this is true or false. It is assumed that the standard of care provides that protection but there is no way to know. You are correct that is the rationale (or rationalization) that is used as the reason (or excuse) for not subjecting women to something that may have negative consequences, including worsening their condition. However, that is what women already are subjected to when they enter into clinical trials as volunteers. There is no way to know whether adding of the "standard of care" to new treatment will be what worsens the results..... results that might be better if the new treatment was given without the "standard of care".
But the reality is that there have been great discoveries found right here in the USA in the last decade, Herceptin, for example and that has made its way into clinical practice in the last decade. Zometa too for certain women is now prescribed.
Herceptin changed the picture for about 50% of HER2 positive patients. That is an improvement. But how much did it really help? Among that 50%, for some the drug works initially but then fails. We still don't yet know if for that 50% of the HER2 positive patients the Herceptin generally only delays recurrence or if it generally prevents it. While 50% do have some success with it, about 50% do not get that benefit. And only 18-20% of all breast cancer patients are HER2 positive. The other 80% to 82% have not benefitted from it (and 50% of that 18-20% do not benefit even though they are HER2 positive, so that makes the total number of breast cancer patients who do not benefit from trastuzumab around 90%). That means that the picture in the last 10 years of not studying the use of trastuzumab alone (or with O/A for some) has improved for 10% of breast cancer patients -- and we still don't know yet whether it prevents recurrence or only delays it. Any improvement is better than none and trastuzumab is one beginning, but not on the basis of rationalizing why we can't subject women to anything that doesn't include at a minimum the "standard of care". How can we know if the standard of care doesn't actually make the outcome worse when added to a new substance than it would if the new substance was offered alone (with an intact immune system)?
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Over the last 10 years, many patients have been willing to do trastuzumab alone rather than with chemotherapy. So the reason for delay in running trials of trastuzumab (or trastuzumab and O/A for premenopausal HR+ patients) isn't due to lack of willing participants. = FALSE
To fill the trial the participants have to be willing to do either treatment: chemo + H or H alone. Most are not willing to do either. There is a high likelyhood that those that don't want chemo won't agree to be randomized to the chemo + H arm. And those that want chemo are unlikely to agree to be randomized to the H only arm. The study must be randomized to be worthwhile because if you let patients/docs select which arm to be in than low risk patients would gravitate to the H only arm and the high risk patients would fill the chemo + H arm. Since the risk of the two arms would not be equal, the relative effect of each treatment would not be known.
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orange1,
That might be true if the only options those patients who would prefer not to do chemotherapy plus trastuzumab weren't left with at present is...... chemotherapy with trastuzumab.... (or, if HR+, possibly O/A, or tamoxifen, or aromatase inhibitor).
In other words, what you are guessing is that patients who would like to do trastuzumab alone would generally not choose to do standard therapy if they can't have trastuzumab alone, so they will do either some other therapy or no therapy at all.
I see many posts from those who go to oncs to do trastuzumab alone. Some get it, some don't, and those who don't sometimes to go more oncs until they do get it alone, or else they end up on standard chemotherapy, or if they are HR+ they do hormonal therapy only.
If your philosophy were true, then the trastuzumab trials would never have filled because those patients were interested in getting trastuzumab..... and all they could get if they couldn't get the trastuzumab would be.... standard therapy.
Or am I not getting what you are saying....?
A.A.
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Hello, AA!
It is interesting, I know the ethics around these studies is pretty strong: you don't get people into study groups to try out new protocol unless there is no established effective protocol in place for sure. That said, I've met two women whose doctors determined they were not healthy enough for chemo, yet they felt they needed it. Seems to me there is some population that could be corraled for these types of studies.
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Orange1...Your point is EXACTLY the point that I'm trying to make to AlaskaAngel! In order to get questions answered you have to have patients (or as AlaskaAngel refers to them, consumers), who are WILLING to participate in a clinical trial. The HIGHER the risk of recurrence, the MORE conservative the trial must be to attract WILLING participants. The MORE risk involved, the LESS likely that a patient will participate. So, researchers are very CAREFUL when they design trials. That's one of the reasons WHY it takes so long to design a trial and impliment it. If a trial fails to accrue the appropriate number of patients, AND PATIENTS, (like you mention) ARE NOT RANDOMIZED PROPERLY then the results will NOT be statistically significant when the trial is completed, if or when it IS completed....5 and/or ten years down the road.
And the last time I checked...the SOFT trial is ALMOST completed and we should be knowing the results shortly:
Everytime I post information regarding the SOFT trial, AlaskaAngel seems to breeze over it. This trial speaks to the heart of comparing ovarian suppression/ablation to chemotherapy for early stage ER+ sisters. The trial was begun in 2003 (and I assume it was designed and planned several years before that) and the results should be known some time in 2014-15. Interesting to note that the time frame for this IMPORTANT study...from inception to completion is approximately 15 years, assuming it was planned in the year 2000. The researchers should be applauded for the design of the study because they met their quota of accruing 3000 patients.
And when AlaskaAngel asks:
"Any improvement is better than none and trastuzumab is one beginning, but not on the basis of rationalizing why we can't subject women to anything that doesn't include at a minimum the "standard of care". How can we know if the standard of care doesn't actually make the outcome worse when added to a new substance than it would if the new substance was offered alone (with an intact immune system)?"
In light of what we know about designing trials and the ability to accrue patients for those studies, it appears that researchers walk a fine line between being able to conduct trials that will lead to discoveries while also making it worthwhile for patients to risk participating in the trial.
One more example....regarding risk....The ONLY trial right now comparing Herceptin ALONE (without) chemotherapy involves patients OVER 70 and the trial ONLY is looking to accrue 300 patients. One can see that this trial is EXTREMELY conservative. Despite being a conservative study, the question remains whether or not it will even meet its quota of 300 patients. And even if its completed, it will be a stretch to conclude that the information obtained from the study can be applied to women younger than 70. Why was this study conducted rather than one that would include younger sisters? BECAUSE IT INVOLVES MORE RISK and the likelihood of finding enough YOUNGER patients willing to participate would be difficult. I am not saying it would be impossible. I'm saying it would be difficult. And then you would have to worry about accruing the appropriate number of participants and then having the results fall short of being statistically significant.
Blame all the researchers here in this country for dragging their feet at finding appropriate non toxic treatments....but when you RATIONALLY look at the reasons WHY it takes so long for new discoveries to occur, one realizes there must be a BALANCE between the needs for the researchers to find out VS the ability to find WILLING patients to participate. And with more aggressive tumors and younger women, it would be difficult at best to design and implement a study that does NOT offer chemo.
In my case, where I was at low risk of recurrence, I was happy to do O/S, at my medical oncologist's recommendation, rather than chemotherapy. Before agreeing however, I was asked to consider joining the SOFT trial, but refused because I did NOT want to be randomized and then possibly undergo chemotherapy. However, if I had a more aggressive tumor and was asked to participate in different clinical trial, I doubt I would participate in a trial if chemo wasn't included...and on most days, I consider myself pretty brave....However......
The real heroes? All of our sisters participating in clinical trials! They are truly the bravest!
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VR,
I do hear what you are saying and am listening. I'm not as sure as you are that there are in reality so few willing participants, and in part the "lack" of willing participants might be due to the influence of their oncs against participation, like the onc I had. I specifically told my onc numerous times I was interested in participating in a clinical trial if at all possible. My onc knew (although never told me and absolutely should have done so) that I was HER2 positive and that there was one trial I would have been eligible for. It wasn't as if oncs who treated bc patients didn't know about the trastuzumab trials at that time (unless he was deaf, dumb and blind). Again, part of what still doesn't make sense to me at all is that this onc is considered highly professional by not only peers but by support staff as well. Go figure. I've never understood the why's behind that lack of professionalism with me, other than that I was too polite and too trusting because I believed my onc was professional when he actually was NOT.
The total failure to provide guidance with the issue of chemopause as one aspect alone was disgustingly unprofessional. So my direct experience, being different from yours 10 years later, is not something to discount by any means as if it doesn't still happen frequently. I am currently seeing consistent posting by patients who underwent treatment saying that medical providers are still very unprofessionally avoiding dealing with that topic prior to choice of treatment by the patient. My experience and impression about oncs and medical providers is not quite as extreme or unusual as you may believe it is.
You can wave the flag as much as you want to about trial participants, as I am in total agreement with you about that.
In terms of the various trials you mentioned, the question arises as to just how the 6 trials that were noted in my original post managed to get willing participants and be completed over 10 years ago in other countries, as compared to the trials you mentioned. Perhaps the scientists in other countries got things going much, much sooner than those in our country?
A.A.
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"Again, part of what still doesn't make sense to me at all is that this onc is considered highly professional by not only peers but by support staff as well. Go figure. I've never understood the why's behind that lack of professionalism with me, other than that I was too polite and too trusting because I believed my onc was professional when he actually was NOT.
The total failure to provide guidance with the issue of chemopause as one aspect alone was disgustingly unprofessional."That's exactly why we were curious to hear the outcome of your complaint against your doctor. If all you say is true, then he's not professional, not competent, and should he held liable for his malpractice!
Why not appropriately direct your (justified) anger and frustration about how poorly you were treated by this one doctor? You've said you did take action against him, but for whatever reason you don't care to share the outcome. Yet you continue to insist that medical provider incompetence is a common and widespread issue. We get it that you were treated badly, and it's a terrible shame. Why do you refuse to believe that most of us were treated by our doctors with respect and professionalism?
Why not offer your suggestions on taking action against the specific doctors you think are guilty of malpractice or whatever? Share your experience with filing an official complaint, the grievance process, or whatever process you went through - wouldn't that be more helpful than continuing to merely express your dissatisfaction and holding a grudge? Seriously.
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http://annonc.oxfordjournals.org/content/early/2008/03/05/annonc.mdn037.full
AlaskaAngel...Read the above link. Twice. Three times. Read it as many times as you like and you will see how over the years the medical community ATTEMPTED to answer the important question of whether or not chemotherapy can be deferred. Also note that this journal article was written in 2008 BEFORE the widespread use of the OncotypeDX test.
Just a point of information, the PERCHE trial stats are as follows:
Patients accrual
Start date: June 2004
Closure date: December 2006
Target nr. of
patients: 1750
Final accrual: 29Reason for closure: low
accrualI can't imagine that there are THAT MANY oncologists who REFUSED to permit their patients to participate in the trial, OR NEGLECTED to tell them ABOUT the trial.
You had a bad experience. There are probably some women who, like you were NOT told about alternatives. But if the problem is as bad as you THINK it is...then explain to me why they developed the OncotypeDX test and why we have the TailorX trial? I will tell you why we have both? So that ultimately MORE women can defer chemotherapy. Last year, the OncotypeDX test was even written into the NCCN guidelines. Are you going to argue with me that women aren't being told about the OncotypeDX test....here in the UNITED STATES where it was developed? With each passing year since its development, more and more women from all over the world are now clammering to get the test!
You might be LISTENING to what I'm saying, but it is apparent to me that you are not UNDERSTANDING what is being said. Look at the PERCHE trial....It took 2 1/2 years to get 29 women from AROUND THE WORLD to agree to be randomized in the trial. That boils down to 1 woman each month, from around the world, that was WILLING TO TAKE THE RISK. Bless those 29 women for being brave.
I understand what you're saying. You are carrying the torch for the women who like you are not given a full understanding of their treatment choices. I get that. But mainstream medicine IS embracing NOT using chemotherapy wherever possible. And when the TailorX trial is completed in 2015, hopefully even more women will be able to defer chemotherapy.
So AA, this obsession that you have which resulted from your relationship with your doctor, has led you down a path that simply defies reason. Read the journal article. Or better yet...have a good friend of yours read it with you and see if they come to the same conclusion that you have. It's time for to either change your perspective or just move on.
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Like you and those offering the trials, I am glad the trials are in progress for O/A.
However, I do wonder about the wisdom of including tamoxifen for the studies. As we know, HER2 positive cancers are somewhat more aggressive, like HR negative cancers are. Interestingly, studies indicate that about 1/3 of HER2 positives who happen to have a high AIB1 level and who use tamoxifen have worse outcomes, which I would think could very well affect the outcome of the trial somewhat. In addition, recent study information indicated that most HR- patients also happen to have a high AIB1 level, so if they too were given tamoxifen as part of the studies being done to compare OA + tamoxifen to chemotherapy as being patients with less positive but still somewhat HR+, that may provide very poor information about whether or not OA in itself is of value in comparison to chemotherapy.
Again, I want to emphasize that insisting that OA "has to be tested against chemotherapy" fails to recognize that there are patients who economically or practically or by preference will not do chemotherapy in the meantime, good oncs or bad oncs, so they need to be offered OA if they stand any possible chance of benefit from it. I'd hate to see the numbers added up against OA simply because the patients who have a high AIB1 level who are in the trial end up with poor outcomes due to the tamoxifen and not due to OA.
I am not asking you to "change your perspective" or to "move on", as I think differences of opinion are quite important in understanding the total picture. Neither you nor I will ever be perfect.
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That was a really interesting and informative post and link VR. Many thanks for all of your effort.
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Unfortunately for all of us, there is a benefit/risk issue that is difficult to measure and that gets more or less tossed aside when using a therapy as "standard therapy" that does not help in the majority of cases, and is does not offer predictable results for any given individual.
If chemotherapy matched the patient's cancer in the majority of cases AND if it did no harm in the process, it would be a different matter.
A.A.
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I was not offered an Onco test as I have previously stated. I had to fight to get it. I researched it on my own. Had I not I would be doing chemo right now, which I do not need with a 22 score.
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Actually, I think 22 is on the fence? Am I wrong? I seem to remember seeing women who said that they were around this number, so were up in the air about whether or not to do chemo. Agonizing decision, I imagine.
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The score was 22 but the reoccurance rate was 14 and is considered low risk.
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AA... You are missing the point. In order to accrue enough participants into a trial, you have to carefully evaluate how much risk you want to take. If the PERCHE trial had been successful in its design, then it would have accrued the necessary number of patients. And I hope you noted that most of these breast cancer studies are global.
So, are you going to let go of your perception of judging American researchers and doctors against European researchers and doctors?
Are you going to concede that studies take a long time from inception to completion? Are you going to STOP changing subjects when you don't answer direct questions? And are you ever going to get off of the topic of how your doctor mismanaged your treatment and are now left with this OBSESSIVE belief that you must speak on behalf of sisters who you stubbornly believe, are too many like yourself, who have been screwed by the established medical community? I will concede that even 1 screwed patient is too many. But will you EVER concede that the great majority of researchers and doctors are doing a terrific job?
I will concede there are sisters who are not properly advised by their physicians. But you have taken your personal experience way too far. -
Circles... A 22 is an intermediate risk according to the Oncotype score. Hopefully with the TailorX study, we will know with more certainty if sisters with that score can defer chemo.
While the NCCN guidelines have just recommended using the Oncotype score, remember it is just one measure in helping decide chemo or not. And many doctors still are not embracing it until they know more clinically. Furthermore, until TailorX is completed, we will have a lot of sisters in that intermediate score area where the test really doesn't add much to helping make a decision. -
AA... Maybe I missed something when I took Statistics in college... Exactly what do you mean by predictable results for any given individual????!!! Do you understand Statistics at all???!!! I will take it a step further.... Have you ever invested money??? After some investment house tells you how great they did the last year, they then remind investors that past performance is no guarantee of future earnings.
Despite looking at one's treatment benefits VS risks... There are never any guarantees.
What are you talking about???!!! -
VR, I really enjoy many of your posts. Maybe it's time to take a breather on this one?
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Thanks for posting info with the global studies, VR, and for correcting me on that point.
Neither of us have anything but limited experience to use to judge whether most of the time patients are given biased guidance or the best guidance possible without bias. I do think that medical providers are no more or less prone than any other field of endeavor to being misled themselves when involved with very expensive costs for their product to patients, for substances and services that do not have any garanteed outcome and so few exact measureable performance criteria.
A.A.
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AA... I have still made more concessions. So it is time for YOU to concede further. You rail often about why studies take so long. Will you concede that it takes a long time to do a study and follow up? And that 10 or 15 years for a global study isn't such a long time? I realize 10 or 15 years IS RELATIVELY a long time when you realize sisters lives are at stake. But do you understand the necessity of the long length of trials?
And, let's set the record straight about bias. Bias is a given in ANY study. That's why every effort is made to reduce bias. Will you concede that when researchers design studies they look for ways to reduce bias? If you truly believe that every study has inherent bias that can't be mitigated, then it seems to me that researchers should just stop doing research.
And once more, it's time to concede that if you want to answer the most compelling medical questions, most times it will be difficult to design a study that doesn't put sisters in an unenviable position.
So again, I will reiterate that the sisters who choose to participate in clinical trials are our heroes.
Instead of constantly reminding us about your lack of proper care, can you at least applaud THOSE brave sisters? I know you mentioned that you would have liked to participate in a trial.. But I never heard you once applaud those sisters who had FAITH in their doctors and researchers and chose to participate. Would you concede that those sisters are our heroes and a testament to the hard work that the researchers are doing? -
I started reading this thread because I found it in a search and wanted to know more and to hear experiences, focused on what if my daughter needs an alternative to chemo someday. Thank you both for the links.
Then I found I was reading pages of this thread to figure out what you two - AA and VR - need from each other. I'm lost and going elsewhere for more info, but just can't understand anything anymore, except my empathy for your feelings.
AlaskaAngel - I know your frustration, having been poorly guided and falling between the cracks on what my alternaative options could have been, as seen by the medical community. I have been on my own for some reason, scraping it together. And your beliefs are probably as jaded and wary as mine, especially since you were not given an option that could have changed your entire treatment and perhaps your life now. I know I know, am there now.
Voraciousreader wrote "I wish everyone would take a moment to remember that and remember all of the sisters who sign up for clinical trials, because without them, milestones would NOT occur."
And I say yes, that is so honest and true, they are needed. Not just the trials, but everyone who has undergone any treatment and shares their experience and health changes, they all guide us now in our choices, every step of the way to healing.
But, the intensity?
VR wrote some time back.... "So I will NOT peace out, or refrain from posting as long as AA continues this POLITE discussion."
So, I hope to run into both of you on other forums, under better circumstances. We're in this together, let's all remember to breathe.
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I'd bet a million bucks if AA had done OA instead of chemo, she would be on here complaining about the side effects of that. Time it move on AA, you are probably alive now 10 years after the event because you were given chemo. You can't change the past.
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As a forum specifically provided for those who are interested in alternative therapies, the questions asked were trying to answer why, 10 years after trials demonstrated that OA + tamoxifen were equally effective as the chemotherapy at that time (still in use today) and 6 years after trastuzumab became commonly available, there still were no trials being done to find out if OA for hormonal patients plus trastuzumab was equally effective to the common chemotherapy regimens now plus trastuzumab.
The answer is that global trials are in progress, ten years later, with the results to be provided eventually. For those who are recommended to have chemotherapy and refuse, some oncs will provide trastuzumab alone. By standard (NCCN) guidelines, O/A is offered for very limited patient circumstances until trial results become available.
AlaskaAngel
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Essa,
I realized not very far into the discussion that many times others posted indicating they didn't understand why anyone might choose O/A or O/S over standard chemotherapy treatment.
Some were also of the belief that they were fully menopausal 1 year after absence of menstruation began, which is often not true for those who complete chemotherapy since some do have delayed return of menstruation even after a year with no menstruation following chemotherapy.
This is an alternative forum, and I wondered why so many were participating in the discussion who did not seem to think O/A would be a good option for anyone as long as chemotherapy was available instead.
Even though the results of the trial for determining its value in relation to the very limited value of chemotherapy are not yet available 10 years later, I thought that those who felt no patients would want O/A or O/S if chemotherapy were available might acknowledge that some patients do consider it preferable, sometimes simply for practical reasons and sometimes because they do not want chemotherapy. I thought perhaps some who prefer chemotherapy and wanted to continue to indicate they still did not understand why anyone would choose O/S or O/A might possibly need additional explanation to encourage their compassion for those in circumstances where chemo might be recommended but simply is not a true option. So perhaps that effort seeking their compassion for women who prefer O/A or O/S also prolonged the discussion.
The discussion was prolonged in part because of many personal attacks rather than rational discussion and in part because of the extensive amount of time involved in the comparison with chemotherapies more commonly used now. Many trials report out preliminary results much, much sooner. I have not seen any information in this discussion to indicate why that is not the case with this particular comparison, especially given the relatively minimal success with the continuing use of chemotherapy as the "standard recommended therapy".
Best to you and your family,
A.A.
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oh.. i get it. polite means dissing big medicine and all that without thinking.. bejunkers.. why didn't that occur to me earlier.
I'd have this forum renamed. Diss big medicine. You'd find more supporters and less discussion, I think, that is what you want. Why pretend to be 'polite'..? I'm serious.
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You are welcome to start a thread supporting standard therapy in the standard therapy forums, Apple.
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AA said:
As a forum specifically provided for those who are interested in alternative therapies, the questions asked were trying to answer why, 10 years after trials demonstrated that OA + tamoxifen were equally effective as the chemotherapy at that time (still in use today) and 6 years after trastuzumab became commonly available, there still were no trials being done to find out if OA for hormonal patients plus trastuzumab was equally effective to the common chemotherapy regimens now plus trastuzumab.
I believe bolded text is untrue, especially in Her2+ cancer. Can you provide evidence.
Also, you stated previously that tamoxifen doesn't always work so well for Her2+ cancer so I don't understand why you think tamox + OA would beat chemo for a fast growing cancer like Her2+ (not to mention half of Her2+ cancer is HR-, and those that are HR+ are often only weakly to moderately so, thus eliminating or limiting the utility of hormonal therapy - benefit is proportional to the degree of HR+itivity.
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Apple's statement speaks to the heart of this discussion. There are many of us choosing alternative therapy while still respecting established medicine. Just because you believe you were wronged by one physician, doesn't mean everyone should be suspicious of most researchers and physicians.
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Another point (although I don't know why I bother)
It is true, that overall (large population of women) tamoxifen is not as effective in Her2+ cancer as in Her2-. However in many women it is very effective (as demonstrated in the large herceptin trials) and overall has a beneficial effect.
Many people believe (because they are told by their docs) that an AI may be more effective in Her2+ cancer. But I haven't seen any evidence to support this - exploratory analysis (non-statistically valid looks at data to help guide future trials) have not shown this.
Bottom line: Less effective tamox in Her2+ patients DOES NOT EQUAL other hormonal therapies are better.
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