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Intermediate Oncotype Test - Dilemma!

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  • Rameson
    Rameson Member Posts: 5
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    IDC stage 1, 1.3cm, node negative, ER+, PR-, HER2-

  • kira1234
    kira1234 Member Posts: 754
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    Then your cancer will more likely benefit from chemo treatment. Mine was similar to yours and 7 years ago chemo was recommended but this time not because I have lobular.

  • chisandy
    chisandy Member Posts: 11,271
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    That article erroneously states that the “intermediate risk” group starts as low as 11—which not only contradicts Genomic Health’s own criteria of “low risk” being 0-17, but misstates the observations of the TailoRx study. The reason low-risk women with scores above 10 have yet to be reported on is because there are so many patients who fall into the 11-17 group, and the data is more slowly compiled and analyzed. It is ridiculous to characterize 11-25 as “intermediate risk” because there is a helluva difference between the higher and lower scores in that group. 0-10 is definitely a more homogeneous group—it’s pretty much a universal assumption that a score of 10 carries no practical higher recurrence risk than a score of 1-3. The true “intermediate” group is 18-25, and often those on the cusp (20-25) need a second test such as Prosigna or MammaPrint (both of which have only “high” or “low” risk results with no in-between) before they and their doctors can feel confident about how to proceed. The next group for which results are likely to be released is the higher bracket of “low risk,” 11-17. I would be extremely surprised if the study lumped them in with the 18-25 truly intermediate group, and if they concluded an 11 score is no riskier than a 25…or conversely, needs chemo just as much as a 25 (the latter at least acc. to conventional oncology theory).

  • kira1234
    kira1234 Member Posts: 754
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    Romeson another thing to consider is your pr- in choice of whether to use tamoxafin or one of the ALS. When I started doing some research after my reacurrance I discovered that apparently tamoxafin isn't as effective.

  • BarredOwl
    BarredOwl Member Posts: 261
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    Until a clinical trial or study is published with practice-changing results (which has not yet occurred as of this date, please confirm it with your Medical Oncologist), the Standard risk category ranges for the OncotypeDX test for invasive disease are and remain:

    RS = 0 to 17 ("Low Risk");

    RS = 18 to 30 ("Intermediate Risk"); and

    RS = 31 to 100 ("High Risk").

    ChiSandy:

    Regarding Prosigna or MammaPrint, your commment that "both of which have only "high" or "low" risk results with no in-between" may lead certain patients to suffer significant disappointment when they do not receive a clear signal from MammaPrint (due to falling in a "discordant" category) or receive an intermediate score from Prosigna (node-negative).

    Please see my post on the previous page regarding the MINDACT trial results and gray areas introduced by those results and that Prosigna appears to include an "intermediate" category for node-negative patients.

    https://community.breastcancer.org/forum/108/topics/853465?page=1#post_4940692

    image

    Patients should discuss with their medical oncologist the possible outcomes of any further testing and whether such further testing may or may not provide added clarity in their individual case. With MammaPrint, this should necessarily include a discussion of "clinical risk category."

    BarredOwl

  • voraciousreader
    voraciousreader Member Posts: 3,696
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    sandy...with respect to the contradiction with Genomic Health and the classification of Intermediate scores, the reason why the TailorX chose the different categories was due to ethical considerations. Not knowing EXACTLY where chemo would benefit, to be on the safe side, all participants with 25-30 Oncotype scores would be given chemo. Likewise those patients up to 11 Oncotype scores would NOT receive chemo. And then, the rest of the patients with scores between 11-25 would be randomized to either receive chemo or no chemo. The researchers conducting the trial could then HOPEFULLY see where EXACTLY the benefit of chemo begins for those patients in the original Intermediate score range created by Genomic Health, that is the 18-30 range.


    Now, my oncologist said that it might take many, many more years to conclusively know EXACTLY where the benefit of chemo score might be. Because ER +, HER2- tumors are less aggressive, he said there might not be a statistical significance between the groups for years to come. He also said that despite closing the trial, the patients might still be surveilled for years to come.


    That said, the possibility exists that those patients who were given the chemo in the upper score Intermediate range of 25-30 in the original Genomic Health range MIGHT NOT have benefited from chemo when compared to those in the study's randomized 11-25 range. Of course it is MORE likely that those in the 25-30 score range SHOULD benefit from chemo AND that those from scores of 18-25 MIGHT have a greater chance benefiting from chemo than those with scores between 11-18, but the fact is, the 2017 results MIGHT give us more info as to who might benefit from chemo and that would be a good thing.


    Interestingly, what you touched on with respect to newer genomic tests, with the advent of them, it is likely in the coming years that they will be way more accurate than the OncotypeDX test.


    As I write this, I am thinking about the latest breast cancer study that appeared last week in The New England Journal of Medicine that hasn't yet gotten the attention it deserves. The study suggests that small tumors found on routine population based screening mammograms MIGHT be so indolent that they might NOT pose a risk in an older woman's life. What the authors' suggest is it is those in between mammograms tumors that are worrisome. The ones that come out of nowhere and quickly grow large. They pose the idea, that is gaining strength, that there is overdiagnosis of tumors that might never be harmful in a patient's lifetime


    I know there is lots of controversy with mammography with respect to how many lives are actually saved by it, but I think researchers are on the trail that will one day soon, make mammography almost obsolete. Obsolete in the respect that there will be blood tests to find cancer AND blood tests that will tell us using genetics, who needs treatment and EXACTLY what kind of treatment a patient will need...

  • BarredOwl
    BarredOwl Member Posts: 261
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    To clarify, the investigational ranges of the TAILORx trial are:

    >> "Low risk" range: 0 to 10 (assigned to endocrine therapy alone);

    >> "Intermediate risk" range: 11 to 25 (randomized to receive either endocrine therapy alone or endocrine therapy plus chemotherapy);

    >> "High risk" range: 26 or higher (assigned to receive chemotherapy).

    The 5-year results for those scoring 0 to 10 were published here:

    >> http://www.nejm.org/doi/full/10.1056/NEJMoa1510764#t=article

    As noted above, we are still awaiting results from the randomized cohort scoring 11-25. The results for those scoring 0 to 10 do not speak to the question of whether any subset of those scoring 11 to 25 may or may not benefit from added chemotherapy.

    Until a clinical trial or study is published with practice-changing results (which has not yet occurred as of this date, please confirm it with your Medical Oncologist), the Standard risk category ranges for the OncotypeDX test for invasive disease are and remain:

    >> RS = 0 to 17 ("Low Risk");

    >> RS = 18 to 30 ("Intermediate Risk"); and

    >> RS = 31 to 100 ("High Risk").

    BarredOwl

    =================

    [EDIT: UPDATE: On June 3, 2018, the results of the TAILORx trial for certain patients with node-negative, hormone receptor-positive (ER+ and/or PR+), HER2-negative disease and a Recurrence Score from 11 to 25 (randomized to either endocrine therapy alone or endocrine therapy plus chemotherapy) were published here:

    Sparano (2018), "Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer"

    Main Page: https://www.nejm.org/doi/full/10.1056/NEJMoa1804710

    Free pdf: https://www.nejm.org/doi/pdf/10.1056/NEJMoa1804710

    Supplementary Appendix: https://www.nejm.org/doi/suppl/10.1056/NEJMoa1804710/suppl_file/nejmoa1804710_appendix.pdf

    Additional results pertaining to the non-randomized groups with Scores 0 to 10 or 26 to 100 are also reported.]

  • voraciousreader
    voraciousreader Member Posts: 3,696
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  • kira1234
    kira1234 Member Posts: 754
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    Good find voraciousreader I'm wondering if this is one of the reasons my oncologist chose not to have me do chemo and even suggested I could do without one of the ALS. My tumor was a local recurrence so no testing was ordered. I had a 24 oncotype score originally on a. 7mm tumor. Exactly the same size this time.

  • voraciousreader
    voraciousreader Member Posts: 3,696
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    kira...i just returned from the library and read the actual journal article. Amazing. Of course, Dr. Kopans, a radiologist will be coming along shortly to try to debunk the study. The study was undertaken to either give credit or renounce Dr. Welch's earlier controversial studies that claim there is serious overdiagnosis to breast cancer with respect to mammography. What this SEER meta-analysis found, suggests that Dr. Welch is correct. With "favorable" tumors, it is more likely they will be found by population based screening mammography and will be over treated.


    With a favorable tumor, grade 1, ER +, less than 2cm, the authors believed that those patients would do well with conservative treatment. They also mention with genomic testing becoming more routine, we will be able to better pinpoint those patients that could be spared aggressive treatment...and perhaps for older patients, little treatment or even watchful waiting....AND, they suggest, with the most indolent tumors, for older patients, there might not even be the need for treatment at all...


    We are still far away from figuring out who can forgo treatment and who would benefit from the smallest amount if treatment, but studies like this build on the philosophy that for many of us, breast cancer is a very treatable disease and....for the older sisters, there might come a day that a breast cancer treatment can be safely avoided...now wouldn't that be something?


    Perhaps the savings of avoiding rigorous treatment might free up money toward finding a cure for aggressive breast cancers....now that is something worth pondering....


    And Kira, based on what I read today, you have a GREAT team! I wish you and all our sisters well

  • voraciousreader
    voraciousreader Member Posts: 3,696
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    btw... here his Dr. Kopan's most recent reply to Dr. Welch's October, 2016 NEJM article...


    https://www.sbi-online.org/Portals/0/pdfs/Response...



    With regard to Dr. Kopan's last suggestion that Dr. Welch have Dartmouth fund a study whereby half the subjects get mammograms and half, not get them is simply unethical. Furthermore, outside of the United States, in other developed countries, many women are not getting annual mammograms beginning at age 40. With average breast cancer risks, they are invited to be screened at age 50, every two years until age 75.


    So, this study that appears in the June 8th, NEJM, is a welcome trend that should make many of us more comfortabke about our screening and our treatment choices...

  • kira1234
    kira1234 Member Posts: 754
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    I agree to fund a study like that is unethical. In my case both of my breast cancers were found through my yearly mammagram. This time almost missed. Thank goodness she took a second look.

  • voraciousreader
    voraciousreader Member Posts: 3,696
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    kira...mine was missed by both annual mammography AND sonogram. A diagnostic sonogram confirmed mine.



  • kira1234
    kira1234 Member Posts: 754
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    voraciousreader that is why all should be required. At least in my experience a sonogram wasn't even offered unless something was seen with the mammagram. This year was the first time I've had the 3d mammagram. I'm guessing it might have been seen with it last year it

  • ATXgirl
    ATXgirl Member Posts: 2
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    I am in stage 1, with invasive ductal carcinoma. My oncotype score came back at 27. Do you think I should do more research on this? My oncologist is recommending chemo.

  • moth
    moth Member Posts: 3,293
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    Alysse - how old are you?

    Is your tumor strongly hormone receptor positive? What grade is it?

  • voraciousreader
    voraciousreader Member Posts: 3,696
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    This is an old thread....recently, the TailorX study concluded that most early stage ER + HER2 - patients can forgo chemo. However, patients like yourself with an OncotypeDX score of 27 WILL benefit from chemo. That is why your oncologist is making the recommendation. Until a few months ago, those patients with intermediate scores were in a grey area. No more. Please note the following and read up on the TailorX study.


    “According to the authors, the new findings suggest that chemotherapy may be avoided in about 70 percent of women with HR-positive, HER2-negative, node-negative breast cancer:

    • older than 50 and with a recurrence score of 11–25 (45 percent)
    • any age with a recurrence score of 0–10 (16 percent)
    • 50 years old or younger with a recurrence score of 11–15 (8 percent)

    The findings suggest that chemotherapy may be considered for the remaining 30 percent of women with HR-positive, HER2-negative, node-negative breast cancer:

    • any age with a recurrence score of 26–100 (17 percent)”

  • ATXgirl
    ATXgirl Member Posts: 2
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    27 years old. It is estrogen+ and progesterone+

    Grade 2.

    I am scared, but my oncologist has told me that I will be fine. I believe I am in good hands. My oncologist travels around the world to give talks on cancer and has published extensively on cancer research, specifically on breast cancer.

  • voraciousreader
    voraciousreader Member Posts: 3,696
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    atx....you are in great hands. And, you have great prognostics. Once I trusted my oncologist, and we formulated a treatment plan, I felt much better and you will too! I wish you well

  • sissy60
    sissy60 Member Posts: 11
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    hi there ,

    First posting....😳

    I’m in UK. I was diagnosed in November and had surgery in December. I’m 60. Results came back great. Very clear margins, no lymph node and was told stage 1 ( was a grade 2).

    I understood I’d be only having radiotherapy and hormone treatment after pathology results. I wish I hadn’t done Oncotype. She wasn’t even going to do it but I asked. It came back as 30. Totally shellshocked as my nurse said it was very unlikely to come back high with my results. It’s the upper score of intermediate. Taking it all into consideration do I really need to consider chemo now at my age which I fear will cause worse damage and the stats show less benefit to older women. Should I do a retest?

    I’m shattered it’s the worst day since diagnosis as I was feeling lucky. I know my doc will say do chemo as she is very science based but these percentages are not always the absolute gospel are they. I’m seriously considering doing radiotherapy and hormone but leaving chemo out for now.

    Has anyone else done this ... we are individuals and I feel instinctively chemo will do more harm than good in my case. When I looked on other sites it says stage 1 with clear margins etc is rarely treated with chemo.

    I’m utterly devastated. Worst day since diagnosis. Is there anything else I should know?

    Please help as I’m so anxious. Thank you.

  • keepthefaith
    keepthefaith Member Posts: 856
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    sissy60, when I was DX'd at age 58, 5 yrs ago, my onco-score was 21. I'm not sure today that I would do chemo after the tailorx results came out,....but, I did and am doing fine. I pretty much told my onc that I would not do AC+T and when I was on my last infusion, I had her reduce the dose, bc I was having a slight allergic reaction to the Taxotere. I did 4 doses of TC. You may want to ask for a Mamma-print test and it may sway your decision one way or the other. If you have no other other health issues, I would suggest looking into chemo, at least. It's a hard decision, regardless. I took Tamoxifen for 2.5 yrs instead of the 5 that was recommended. You could always get a second opinion. Ask a lot of questions until you feel comfortable making an informed decision. My MO told me I am her chemo poster-child. Very few SE's and those were pretty mild. Everyone isn't as fortunate, but so far, I feel as though I made the right decision for me. Be your own advocate! Best wishes:)

  • moderators
    moderators Posts: 7,982
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    Welcome to our community, Sissy60! We know it's a tough blow, but we're all here to support you through whatever course of action you decide is best for you!

    The Mods

  • savinggrace
    savinggrace Member Posts: 21
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    I too am facing this dilemma. My Oncotype score is 20 and I am in my 40's. I am wondering how many have chosen to have chosen chemo in similar situation? What has swayed your decision, one way or the other?

  • voraciousreader
    voraciousreader Member Posts: 3,696
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    recent study, TailorX, now suggests that for those patients less than age 50, with OncotypeDX scores 16 and above, there is some benefit of doing chemo.

  • simonerc
    simonerc Member Posts: 154
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    Hi voraciousreader!

    I missed that part of the TailorX study. Was that in the major study that was realeased in 2018 or was it in subsequent data? I was 51 years old and oncotype 19. As I read the study and was also advised by my MO, it excluded me from chemo. Can you point me to the data so I can discuss with my MO?

    Thanks so much!


  • simonerc
    simonerc Member Posts: 154
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    image

  • simonerc
    simonerc Member Posts: 154
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    So sorry voraciousreader. It just dawned on me that it just looks like you made a type o. Just saw the post you were responding to above! Sorry! Had a momentary panic

  • voraciousreader
    voraciousreader Member Posts: 3,696
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    https://www.cancer.gov/news-events/press-releases/2018/tailorx-breast-cancer-chemotherapy

    • June 3, 2018



    “According to the authors, the new findings suggest that chemotherapy may be avoided in about 70 percent of women with HR-positive, HER2-negative, node-negative breast cancer:

    • older than 50 and with a recurrence score of 11–25 (45 percent)
    • any age with a recurrence score of 0–10 (16 percent)
    • 50 years old or younger with a recurrence score of 11–15 (8 percent)

    The findings suggest that chemotherapy may be considered for the remaining 30 percent of women with HR-positive, HER2-negative, node-negative breast cancer:

    • any age with a recurrence score of 26–100 (17 percent)
    • 50 years old or younger with a recurrence score of 16–25 (14 percent)
  • simonerc
    simonerc Member Posts: 154
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    Thanks so much, voraciousreader! You may want to edit your post above. I think you typed 59, instead of 50:-)

  • wallycat
    wallycat Member Posts: 1,255
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    Results for the TailorX were not available when I was making my decision, so went blindly with this statement from my breast surgeon: If you get less than a 4% benefit with chemo, skip it. More than that, do it. There was (don't recall the sign in or the site anymore) a webpage where you could plug in your stats, then with the assumption you would do tamoxifen (since arimidix, femara, etc. were not widely used then) it would spit out your risk/benefit. Mine was just at 3% and decided to forgo chemo. I was 49 at dx and my onco score was 20.

    According to the TailorX results, I should have done chemo. I've asked my onco if I should go back and do it and she said no.