Stage 1, grade 1 and pre-menopausal
Comments
-
AA..... Here's an example of how Topol proposes new treatments will be discovered:
"Hi. I'm Dr. Eric Topol, Director of the Scripps Translational Science Institute and Editor-in-Chief of Medscape Genomic Medicine and theheart.org. In our series The Creative Destruction of Medicine, I'm trying to get into critical aspects of how we can Schumpeter or reboot the future of healthcare by leveraging the big innovations that are occurring in the digital world, including digital medicine.
But one of the things that has been missed along the way is that how we do clinical research will be radically affected as well. We have this big thing about evidence-based medicine and, of course, the sanctimonious randomized, placebo-controlled clinical trial. Well, that's great if one can do that, but often we're talking about needing thousands, if not tens of thousands, of patients for these types of clinical trials. And things are changing so fast with respect to medicine and, for example, genomically guided interventions that it's going to become increasingly difficult to justify these very large clinical trials.
For example, there was a drug trial for melanoma and the mutation of BRAF, which is the gene that is found in about 60% of people with malignant melanoma. When that trial was done, there was a placebo control, and there was a big ethical charge asking whether it is justifiable to have a body count. This was a matched drug for the biology underpinning metastatic melanoma, which is essentially a fatal condition within 1 year, and researchers were giving some individuals a placebo.
Would we even do that kind of trial in the future when we now have such elegant matching of the biological defect and the specific drug intervention? A remarkable example of a trial of the future was announced in May.[1] For this trial, the National Institutes of Health is working with [Banner Alzheimer's Institute] in Arizona, the University of Antioquia in Colombia, and Genentech to have a specific mutation studied in a large extended family living in the country of Colombia in South America. There is a family of 8000 individuals who have the so-called Paisa mutation, a presenilin gene mutation, which results in every member of this family developing dementia in their 40s.
Researchers will be testing a drug that binds amyloid, a monoclonal antibody, in just [300][1] family members. They're not following these patients out to the point of where they get dementia. Instead, they are using surrogate markers to see whether or not the process of developing Alzheimer's can be blocked using this drug. This is an exciting way in which we can study treatments that can potentially prevent Alzheimer's in a very well-demarcated, very restricted population with a genetic defect, and then branch out to a much broader population of people who are at risk for Alzheimer's. These are the types of trials of the future and, in fact, it would be great if we could get rid of the randomization and the placebo-controlled era going forward.
One of things that I've been trying to push is that we need a different position at the FDA. Now, we can find great efficacy, but the problem is that establishing safety often also requires thousands, or tens of thousands, of patients. That is not going to happen in the contrived clinical trial world. We need to get to the real world and into this digital world where we would have electronic surveillance of every single patient who is admitted and enrolled in a trial. Why can't we do that? Why can't we have conditional approval for a new drug or device or even a diagnostic test, and then monitor that very carefully. Then we can grant, if the data are supported, final approval.
I hope that we can finally get an innovative spirit, a whole new way of a conditional and then final approval in phases in the real world, rather than continuing in this contrived clinical trial environment. These are some things that can change in the rebooting or in the creative destruction, or reconstruction, of medicine going forward."
0 -
So basically, an example of how genomics could be beneficial to us in figuring out whether or not each of us could benefit from 10 years of Tamoxifen would be if perhaps the NIH was to approve a new Atlas study using genomics, where all the patients enrolled in the study would have the Oncotype DX test performed. Then, those patients could be tracked over time. When the study would close, then future patients could get a better idea if taking Tamoxifen for 10 years was better than taking it for 5 years based on their Oncotype DX score. Furthermore, because individual patients side effects could be digitally collected, we might know sooner, rather than later whether or not the risks and side effects outweigh the benefit of the treatment.
AA...I do understand that there are many untested treatments such as manipulations in diet and exercise. Again, those kinds of trials can be done using "smart" technology. We already have "smart" technology in the treatment of cardiac disease and diabetes. If you read Dr. Topol's book he explains how patients with those diseases can now monitor themselves. He even talks about a sensor that can be implanted in the body that can alert a patient in advance of a heart attack.
I apologize to AnniceMD for taking the discussion a little off track. But I think it is important to discuss the innovative ideas of Dr. Topol and his colleagues. I am frustrated that Atlas lacks the kind of data that I would like to have to make an informed decision about whether to continue taking Tamoxifen for many more years. With that said, the Atlas study still provides a wealth of information that is welcoming because it now gives many of us a choice.
0 -
If I understand correctly (a big IF here), then already known treatments and tests developed under the current system of developing and testing them (such as tamoxifen and Oncotype Dx) would be applied to patients over time to determine the most successful application of them to patients.
But when it comes to comparing the outcome of metabolic management methods to the outcome of the tamoxifen study you mention, to see which actually provides better results between the two types of treatment, that wouldn't be done. What I'm saying is that there needs to be a system that provides such comparisons to us.
Or are you saying that with smart technology, somehow the comparison could be made between the tamoxifen study and a metabolic management study using Oncotype Dx as the "ruler" for both?
0 -
Using "smart" technology will permit metabolic management and clinical studies to become easier. Right now it is difficult to do metabolic management studies because patients can't be thoroughly monitored. "Smart" technology will put into the hands of patients the ability to monitor their metabolism. So clinical trials CAN be designed EASILY and the data can be studied QUICKLY. For example....right now, as you know the DH has a very rare genetic metabolic muscular dystrophy. He is in a clinical trial which requires him to get blood analysis and urine analysis every three months. He is also required, from time to time to get on a treadmill, all hooked up to monitors and an IV and they measure all kinds of things that are going on in his body. It is expensive and time consuming and quite frankly exhausting! Imagine if you will for a moment if we created a clinical trial to look for metabolic "issues" in breast cancer survivors. Using the current technology and methods of analysis, it would be prohibitively time consuming and EXPENSIVE. However, "smart" technology and the method of clinical analysis that Dr. Topol describes will make a study like that CONCEIVABLE.
Now you ask...would the genomics tests be used as a "ruler"? Yes and no. Researchers will be able to acquire ALL the relevant clinical information about each patient and use that as a springboard to collecting more data and finding what works for each individual patient. So...getting back to the OncotypeDX test let's recall how we presently use that genomic test and what we can use it for in the future. Right now the test is used to determine whether or not the benefits outweighs the risk of chemo based on whether a person's OncotypeDX score is low or high. Unfortunately, as you know, for people in the dreaded "intermediate" range, we can't conclusively say whether chemo is warranted. Furthermore, the folks who created the OncotypeDX test used Tamoxifen as a measurement in creating their test. They know how well patients did on 5 years of Tamoxifen. Now, I'm proposing that the folks who make the OncotypeDX test conduct a new test. They should follow those patients who completed 5 years of Tamoxifen and begin comparing them to those who complete 10 years. Then, they could tell us EXACTLY who benefited more or less from the 10 years of Tamoxifen. So, with my OncotypeDX score of 15, I could not only tell how much or little benefit I could derive from chemo, but how much or little benefit I could derive from Tamoxifen taking it for 10 vs. 5 years. While that clinical trial unfolds, other researchers can begin using smart technology and create all kinds of other clinical trials and use the Oncotype DX test, or even newer genomic tests, to use as a benchmark when determining how effective what they are studying might be. So, let's make this simple. If a researcher wants to know if people who are overweight derive as much benefit from Tamoxifen as slender people....they could begin by looking at the Oncotype DX score and the patient's weight. Perhaps a person who has a BMI of 30 (obese) but has a "low" Oncotype DX score might benefit little or none at all at losing weight while taking Tamoxifen. Whereas they might find that that same overweight person might benefit from losing weight if they had a "high" Oncotype DX score. Then, using the data, I could figure out what I need to do...Thus, individualized medicine!
So, to answer your question:
"Or are you saying that with smart technology, somehow the comparison could be made between the tamoxifen study and a metabolic management study using Oncotype Dx as the "ruler" for both?"
The answer is "Yes!"
Now also understand, the researchers know from that Oncotype DX test patients who chose NOT to take Tamoxifen at all or for 5 years. Again, they can use that data to compare each cohort. We also know from the Atlas study that 40% of patients did not even complete the 5 years. So.... using technology WE CAN CONCEIVABLY DO ALL KINDS OF STUDIES COMPARING NUMEROUS TYPES OF GROUPS with genomics being the benchmark for discovery.
0 -
VR,
I'm interested, but I agree that this is taking up the OP's thread and it probably would be better to start a new thread for the discussion of Topol's ideas. I appreciate the food for thought.
A.A.
0 -
Great post, VR. I appreciate the thoughts and information shared. Interesting that Topol is with Scripps. Scripps Institute in Florida requested breast tissue from my BMX and I gave it to them. I had no idea that he was the Director, I'm now very interested in taking a look at his book.
0 -
bhlri - I'm in a very similar boat. 35 at diagnoses. BRCA negative. ER/PR+, HER2-, Grade 1, mitotic 1, Stage 2 (2.5cm tumor, plus 3 other smaller tumors). My ki67 was 1% and my oncotype came back at 5%. I didn't do chemo or radiation and just am on tamoxifen (plus had BMX. Breast surgeon recommended that to help prevent recurrence as my Mom also had BC). I'm actually seeing my MO today (and praying all goes well). They felt chemo would give me less than 1% difference. Let me know what oncotype score you get!
0 -
I was reading the early posts on this thread, which raised some other interesting questions, and thought I'd add a few additional brief comments in answer to the OP about differences in age and menopausal status for dx and treatment.
1. Ten years ago, as a perimenopausal 50+ year old with lots of estrogen at dx I enjoyed a full life, including being in excellent physical shape, taking pleasure in sexuality, etc. I completed chemo and rads exhausted but in general in the same state. My oncologist never in any way indicated that there might be any loss of any type in my condition due to treatment. Within just 2 weeks of starting tamoxifen, my sex life was OVER, both mentally and physically, and at present I consider myself as genderless as any 3-year-old but with the body of a 62-year-old prematurely aged to about 70.
2. At time of diagnosis I'd had a subtotal hysterectomy previously so I asked my oncologist whether doing an oophorectomy plus tamoxifen would be comparable to doing chemotherapy plus tamoxifen. Although I did not know it, a study completed at that time had demonstrated that they would be comparable. He either was not familiar with the study or else was biased, and never told me they might be comparable and actively denied that they were. The study was done before the use of taxanes for bc, which may or may not make some difference. However, when I asked him about whether I should consider a taxane (a newer drug at the time), he said specifically that it was not useful for HR+ and was primarily used for HR- patients.
Those comments are intended to provide some response to your original posts.
A.A.
0 -
Hi everyone,
Well, I'm also pre-menopausal (35 y), stage 1 grade 1, negative nodes, but unfortunately I have LVI and I'm having a hard time choosing if I should go on chemo or not.
I have a stage Ia, grade 1, ductal invasive tumor ( 1.3 cm, SLN -, RE+ 100%, RP+ 100%, HER2-, Ki67 < 15%, BRCA1-, BRCA2 -) but there was LVI (lymphovascular invasion) documented in the initial biopsy and after, in the tumor analysis, the report showed: ...focal angioinvasion...No mets were found (bone CT, lungs XR, etc.) and negative nodes.
I had a lumpectomy in 15 January with clear margins (>=0.5 cm) and did 2 IVF (with FSH+letrozol) cycles after, to preserve fertility, as I have no kids yet.
I consulted 3 private reputable oncologists, they all said a very big NO to chemo, my surgeon also says NO to chemo. The treatment they all recomend is Radio and (at least) 5 years of Tamoxifen + 2,5 years of Goserelin (ovarian ablation). None of them did care much about LVI, only one talked about it and only to say that it's a bad factor, together with my age, but all other factors are good, so, NO chemo for sure. They were secure and didn't show any kind of doubt. For them, chemo risks were higher than benefits (in my case). All oncs were from different hospitals and also discussed my case in the hospital tumor board (so, 3 different boards) before give me their final opinion. I was ready to accept I was not goint into chemo and I was happy with that (but suspicious about LVI).
After that, I had to go to another doctor (surgeon), in a public hospital, to start hormonal therapy (it’s not supported by my health insurance) and I found he has a strong different opinion, he thinks LVI and young age are very bad factors and I should go on chemo. I couldn’t believe it. I had already forgot about chemo. I’m not sure I can deal with it now. But what if he is right?
I can't do Oncotype DX or MammaPrint, it's extremely expensive where I live, health insurence doesn't cover it and unfortunately I'm unemployed and don't have the money to pay for it (I'm still anger about it).
Everything I read about LVI says it is a very bad prognostic factor, survival rates are less and that pushes me to the agressive chemo side. On the other hand, the oncs say chemo doesn’t kill cancer cells that grow slowly (like mine), so why take the risk to do chemo (leukemia, chemo brains, etc..) and even weaken my imune system? But if that is true, then everyone with positive nodes and a tumor with grade 1 and low Ki67 wouldn't go on chemo, but that's not what happen's, and also, looking at the Ki67 marker (cell proliferation) should be enough to everyone decide on chemo, everyone with a low ki67 marker would not go into chemo, independently of other factors, and there wouldn't be any need to do Oncotype DX. But again, that's not what happens, so, something must be wrong in this thinking.."slow growth tumor -> no chemo" rigth?
I'm suposed to start adjuvant treatments in the next days and I don’t know what to decide. I can’t even sleep anymore. It looks like I’m playing poker with my life...
Does anyone here have this kind of tumor, with LVI? What did you do? And is there anyone with a low Ki that went on chemo? Is there anykind of other argument to go on chemo with a Ki67 < 15% ?
I didn't even had the time to think about how is going to be to be menopausal with 35 y, and the effects of hormonal therapy. Oncs also didn't told me nothing really bad about that (besides bone weaken and Zoladex needle being very large)...but I've read some of your posts and it doesn't look good..but well...one problem at a time...
0 -
Ataena... Sorry to hear about your diagnosis. I can't speak to your indecisiveness with regard to doing chemo. You seem to understand all the pros and cons with respect to having a Stage 1, Grade 1, premenopausal BC ... but with LVI. I would ask that your case be presented to the tumor board at your local hospital for a recommendation. Regarding ovarian suppression, many of us have done it. Some with fewer issues than others. If you do choose o/s... keep in mind that the side effects, if you do get them, can be minimized. All treatments have risks and benefits. Ultimately, we all find peace with our decisions. I wish you well finding yours!
0 -
Hi, I don't have lvi but I did have only a .6mm micromet in one node,which put me in a funny grey area like you. I got a second opinion last night about my chemo. The onc said that he would also have given me a short course of chemo, but had my ki67 been lower (it's 18%) for example, 14, I would not have warranted chemo. He said chemo works less well with grade 1 cancers but if I had grade 2 they might give me a taxane as well as Ac.
I hope that helps you. He offered me the taxane if I want it but the risks outweigh the benefits for me, so I've decided against it.
All the best with your decision
Xx kk0 -
atanea Welcome to these boards, sorry that you have to be here.
Although I did not have LVI or affected nodes, I want to tell you of my experience. I am receiving oncology care in Budapest, where I live, and also in the United States, where I am from, and will share with you the differences that I see. I understand that the standard of care is pretty much the same everywhere, however from discussions with my oncologists in Budapest and in Florida, European oncologists are much more likely to recommend a course of treatment for lower stage and grade cancers that does not include chemo. European oncology treatment for pre-men low stagers and grade 1 ER+ is more likely to include ovarian suppression and Tamoxifen, rather than chemo. So an equal diagnosis in the States might receive chemo, whereas in Europe it may not be recommended. This may be why you are reading about a similar diagnosis to yours, receiving chemo, and alternately an adamant response from your 3 opinions on no chemo. Is the decision for chemo a better choice? That's the million dollar question, and is an answer that only you can provide.
Hope that this helps to clarify some of the disparity that you might be reading about. The decision making process is so difficult. Once a treatment plan is in place, you will feel so much better. Your early stage diagnosis with grade 1 is a good prognosis. And by the way, I'm needle phobic and the Zoladex injections are not that bad!
I wish you the very best, let us know how you're doing.
0 -
Atanea,
The doctor who recommends chemo for you is a surgeon and generally I would listen to the oncologists. The European guidelines (http://annonc.oxfordjournals.org/content/22/suppl_6/vi12.long) state that chemo is not recommended for early stage unless you are unresponsive to endocrine therapy or are HER2+. One of the authors of the report is Dr. Fatima Cardoso who is head of the Breast Cancer Unit at Champalimaud Cancer Center in Lisbon.
0 -
Hi,
Thanks for the answers.
Heidihill one of the oncs to were I went to look for a opinion was at Champalimaud Cancer Center in Lisbon, and is at Fatima Cardoso team, and yes, she is against chemo with my kind of tumor. Champalimaud Cancer Center in Lisbon is also the only place in Portugal that provide the Mammaprint test, unfortunately, it's not covered by private health insurance and it's also not made in public hospitals (I supose because it's expensive) and that is truly stupid, as it may send a lot of people to chemo that might not need it (and that's even more expensive).
Meanwhile, the decision was made! But, well...not by me...the oncs that work in the same hospital of the surgeon that want's me on chemo don't agree all with him and they told me today they decided together against chemo. Their decision is final and my opinion it's now irrelevant to them. So, I have know 4 oncs from 4 different clinics that don't want me on chemo, so even if I want chemo, they will denie it to me.
As strange as this may look, I'm relieved, I never trust docs 100% and always like to have a word in final decisions, but I just didn't feel ready to take this decision on my one.
Well, starting radio today and Tamoxifen and Zoladex in the next days.
0 -
Ataena...There's nothing "strange" about how you felt about making the decision! Looking back, I realize now 3 things. The first thing I realized months AFTER I made my decision was that I was given TERRIFIC information from my team of physicians. I received three medical oncologist opinions and there were only slight differences in their opinions. However, I realized much later that, point #2, all of the information that was given to me was relevant and the most accurate information available at the time. And finally, the third point I realized, which, by the way, came MUCH LATER, was that despite being a very knowledgeable individual, in the beginning, this cancer journey was unchartered territory for me and there was NO WAY I could comprehend the amount of information I truly needed to know to make an informed decision. I realized the help from my team, who had years of experience, trumped any amount of information that I was able to comprehend. So, the most important thing that I learned from all three points was that my greatest strength was, and continues to be, my ability to choose physicians whom I trust and ALLOW them to decide for me what is in my best interest. I also want to point out that having cancer often gives one what we think is the luxury of time to make an informed decision. Prior to my breast cancer diagnosis, I had TWO life-saving emergency operations. Last summer, the DH had a life-saving emergency operation as well. In a matter of minutes, when each of us were diagnosed, then shipped off to the operating room, we had absolutely NO TIME WHAT SO EVER to make a decision. When faced with life-saving emergency surgery, it puts into perspective how vulnerable we are and how sometimes our greatest strength is manifested when we simply LET GO AND LET OTHERS DECIDE FOR US.
I have always felt that we've been placed in the hands of extraordinary physicians and researchers. The decision to enter into the hands of these people is often the hardest decision. However, once that decision is made, what comes afterwards is easier. And, I want to point out that the surgeons who saved our lives...we NEVER met until AFTER the surgery! We were "lucky" to have chosen great physicians who knew us and then THEY put us into EXTRAORDINARY HANDS. I feel blessed!
I think once you complete active treatment you will begin your "new normal" and find comfort in your decisions....
I wish you well!
0 -
atanea - happy for you that you have found some relief and can move on to your treatment phase. I, too, sought several opinions, getting different recommendations, and found it to be a very stressful time. I started tamoxifen and zoladex in January. I know everyone's experience is different, but the SE's have been manageable so far. I've had 2 zoladex injections and have not noticed the needle. My nurse numbs the area with Lidocain, and in fact, I didn't even feel the 2nd injection I had last week. I will be thinking positive thoughts for you as you start this phase of your journey!
0 -
Although the word "cancer" is highly charged, after a decade of listening to people dealing with it and dealing with providers, my general impression is that a larger number of practitioners themselves in the medical profession itself seem to believe or understand that the medical "machine" has oversold chemotherapy as the treatment of choice. There is more awareness of how desperate the urge can be to choose that therapy, versus how reliable it actually is in successfully treating the problem, and also in comparison to the additional serious medical issues involved with the administration of chemotherapy and its support drugs. This is most true in terms of those who are least likely to benefit.
I think they themselves are beginning to realize and accept that there is a cutoff point where that patient group actually does better by a significant margin through the use of other medical approaches.
The problem is that it is hard for a patient in crisis to truly know that. We are used to thinking that "the worse the medicine is, the greater the chance we will get better", which simply doesn't hold true enough for early stage bc.
A.A.
0 -
atanea I'm glad that you are finding some relief in the decision, it does get easier with time. It sounds like you have a great team of oncologists, and can put trust in their expertise in making the recommendations that they have. Best to you in your journey - let us know how you're doing.
0 -
Atanea, i am glad you have a plan now. The decision making time is so hard especially when you can't access all tests and there are additional factors such as LVI. I feel you have the right plan. You have a low grade tumour and so chemo will not be such a panacea because it is most effective on aggressive high grade tumours. Sure your LVi puts you at a slitly higher risk of recurrence in the long term so using zoladex and tamoxifen are critical to protect you. I believe by the time you have completed 5 years of tamoxifen that there will be published data from trials underway at the moment that will show that longer treatment with tamoxifen will be more effective at preventing late recurrence for early stage ER+ BC, particularly those with any adverse prognostic factors. The improved survival resulting from treatment with 5 years of tamoxifen is maintained even 10 years after this treatment finishes! So dont forget the importance of the treatments you have been offered!
0 -
My MO was at a workshop that I was at last week (Cancer Transitions) and he is definitely on the 10 year tamoxifen plan. So, I am sure when I see him next month that's what he will be telling me. I am OK with it.
0 -
Hi All,
I have posted here but not for awhile and I absolutely believe that VR and Annice... and others are amazing with their knowledge. We are so fortunate.
I met with Kevin Fox. MD at U Penn today and he reviewed my case.
Stage 1, grade 1, 3.8 mm tumor, onco score of 1, family history, and tami failure. I had been considering ovary removal and or lupron shots if need be. Dr. Fox recommended continual 6 month visits to my surgeon. He did say his recommendation is based upon my particular situation and is personalized to me. So basically my data is 98.5 not to reoccur with out tami and 99% if taking tami not to re-occur.
Thought I would share. Happy News for me.
regards to all
CR
0 -
Happy dance time!!!!
0 -
Chocolate rocks, you have enviable stats!!
Celebration time
0 -
VR and Annice,
Thank you so much. I appreciate it. What I thought was really interesting was Dr. Fox pointing out that re-occurance in the skin and scar area does occur because there is no way to eliminate all the breast tissue. The importance of the 6 month follow ups..... I am still here hoping to continue to learn and support all.
thanks
CR
0 -
After a mastectomy, if the cancer returns in the skin, doesn't that automatically make us stage 3? I'm trying to decide between rads and skin saving mx, and that in itself might be a pro for rads.
Thanks if anyone knows the answer
Xx kk0 -
Kiwi,
I don't know the answer, but I would like to know. Last week at the doctor's (see last week) we discussed that re-occurance to the skin sometimes occurs but its not stage 4. I wish I had asked what stage is it? I was told not to skip my every 6 months appointments with the breast cancer surgeon (I wont). I was told that the problem is that they cannot remove 100% of the breast tissue. Originally, my surgeon had me do a mri in my home town, but they don't do one step reconstruction where I live and they do a bad job. So - if he wants me to do another MRI at some point I wiil do it where he is (3 hours away). The MRI is suppose to be a good post masectomy tool... Hope this helps.
Cr
0 -
Hi guys,
Breast/skin recurrence is usually classed as a local recurrence or new primary so it is totally different to distant mets. It does not mean stage 3 or 4. It would be treated based stats associated with the recurrent lesion I.e. the treatment may be surgery/hormoneTx/ chemo/rads. You can still be "cured" after treatment for local recurrence.
Skin or other site recurrence at a distant site away from the breast is classed as stage 4.0 -
Ah, I was getting confused with inflammatory breast cancer and a skin recurrence, I think.
Xx holly0 -
Thank you for all the great information here! I am 53 and pre-menopausal. I had a BMX (rt.-bc; left-prophylactic) last week for DCIS (7cm) and IDC (
Of course, I have a million questions! But mainly, I'm wondering what tx to expect.
I'm so glad to have found this site!0 -
Welcome BeHereNow. Sorry that you're joining us, but this is a wonderfully supportive site with lots of good information. Hope that you are healing nicely and feeling good post-BMX. What treatments have been recommended for you so far? Some of the treatments for ER/PR+ pre-menopausal patients include Tamoxifen, and ovarian suppression.
0
