Timing of Oncotype Test

Girl53
Girl53 Member Posts: 225

Ladies: It's been a while since I've been on board...Was waiting for weeks for genetic test results, which came back negative, thank goodness. Have sentinel node biopsy Thursday and am eager to get that done so can move on to next step of treatment planning (hoping for radiation and Tamoxifen with no chemo).

Question re: Oncotype test. According to what I've read, I'm a candidate for it (small, apparently early-stage BC). If I had excisional biopsy/lumpectomy two months ago and will have SNB Thursday, when will Oncotype test happen, if this is often used in cases like mine to determine if chemo needed? Do I have to request it (of the breast surgeon or medical onc)/why hasn't it been done already? Are there situations where treatment plan is made based on pathology report alone (very small, well-differentiated tumor)?

I'm primarily wondering because my BC is lobular, not ductal, and is negative for progesterone, putting it in the "Luminal B" category. Just want to make sure I am covering all bases.

Comments

  • BarredOwl
    BarredOwl Member Posts: 2,433
    edited November 2015

    Hi Girl53:

    Good news on the genetic testing.

    Yes, there are cases where the treatment plan is made on traditional factors alone (e.g., age, pathology). The NCCN guidelines vary in what they provide regarding the Oncotype (21-gene) test for invasive disease based on both the size of the tumor and the nodal status (which is outstanding in your case).

    I am not sure exactly how tumor much tissue is currently needed for the test, but that would be a threshold question. Once your SNB results are in, you can ask your medical oncologist about whether there is enough tumor tissue from the 2 mm ILC available for the test, and if so, whether you are formally eligible, what the NCCN guidelines provide about the test for tumors the same size and node status, whether they recommend it, or if not, why not (e.g., how well-validated is the test in patients like you).

    Hoping for negative nodes for you.

    BarredOwl


  • Girl53
    Girl53 Member Posts: 225
    edited November 2015

    Owl: Thanks for your reply...you are so knowledgeable and explain things clearly. Had SNB today...it went smoothly. Results in about a week. I asked BS re: Oncotype test, and she said for node-negative (assuming it's neg) tumor <5mm, it's not done, since chemo wouldn't be needed anyway (not because there isn't enough tissue to test). I hadn't seen or read this "cutoff" before. This gives whole new meaning to "size matters!"

    Did she perhaps mean that if tumor is that small AND has other favorable aspects listed on path report (no LVI, low mitotic rate, well differentiated, etc.), that Oncotype won't tell us anything we don't already know re: recurrence risk? Aren't there tumors less than 5mm whose profile would justify doing the test, and if so, what kind are they? With what I've read about prognostic significance of PR- status -- and with my rampant family history, LCIS, and decision for lumpectomy/rads over mastectomy, etc.-- I want to be sure all bases are covered.

    Should I ask my oncologist about Oncotype when I see him 11/30...or is BS saying that no one with a tumor of this size and apparent type would get the test?

  • MelissaDallas
    MelissaDallas Member Posts: 7,268
    edited November 2015

    From their website:

    Which patients are appropriate for the Oncotype DX assay?

    The Oncotype DX assay is clinically validated for newly diagnosed breast cancer patients who are either:

    • Stage I or II node-negative, estrogen-receptor-positive*
    • Postmenopausal, node-positive, hormone-receptor-positive
  • BarredOwl
    BarredOwl Member Posts: 2,433
    edited November 2015

    Hi Girl:

    Eligibility for the test is formally a little broader than what the guidelines provide about its usage.

    This is a live link for eligibility:

    http://breast-cancer.oncotypedx.com/en-US/Professi...

    Here are definitions of tumor size under the TNM staging system, which are mentioned below:

    T1mi: Tumor ≤ 1 mm in greatest dimension

    T1a: Tumor > 1 mm but ≤ 5 mm in greatest dimension

    T1b: Tumor > 5 mm but ≤ 10 mm in greatest dimension

    If we assume node-negative, then the National Comprehensive Cancer Center (NCCN) guidelines for Breast Cancer (Professional Version 1.2016) do not include the Oncotype DX (21-gene test) invasive disease in node-negative ductal or lobular invasive breast cancer that is hormone receptor-positive, and HER2-negative when the Tumor ≤0.5 cm or Micro-invasive. This is consistent with the comments from your surgeon.

    Regarding treatment of node-negative ductal or lobular invasive breast cancer that is hormone receptor-positive, and HER2-negative when the Tumor ≤0.5 cm or Micro-invasive, the NCCN guidelines say:

    "Consider adjuvant endocrine therapy (category 2B)"

    Thus, for these small tumors, under the guidelines chemotherapy is not included. The relevant discussion, which should still be correct says: "Small tumors (up to 0.5 cm in greatest diameter) that do not involve the lymph nodes are so favorable that adjuvant systemic therapy is of minimal incremental benefit and is not recommended as treatment of the invasive breast cancer."

    In general, there may be cases in which it may be appropriate to depart from what guidelines provide, or where a patient may prefer to do so. For example, a patient with a 0.5 mm tumor (node-negative, hormone-receptor positive, HER2-positive) with unfavorable features might request the test and/or chemotherapy. I do not know enough about it to know what constellation of features might direct such a decision.

    According to this 2013 paper on usage characteristics, it seems that at least in the past occasionally very small tumors were tested. (I don't know what drove that or if it was within guidelines or not at the time.)

    http://jop.ascopubs.org/content/9/4/182.full

    "RS use was greatest among patients with tumors on the borderline of chemotherapy choice, as dictated by guidelines. These include T1b, T1c, and T2 tumors. Use decreased in patients with very small (T1mic and T1a) and very large (T3) tumors, for whom decisions regarding chemotherapy were more likely to be based on size, given favorable pathology."

    As you know from your other threads, lobular cancer has distinct features, even though the NCCN guidelines do not seem to treat it differently. So please take the opportunity to raise all of your questions and concerns with the MO, who has the most relevant expertise in this area. If the test is considered, you may also wish to ask about how well-represented lobular patients were in the studies of the test.

    Glad the biopsy went smoothly. Will keep my fingers crossed.

    BarredOwl

    [By the way, you can access the NCCN Guidelines for Breast Cancer Professional Version at NCCN.org. Registration is free. The relevant chart ("BINV-6") is at page 18 of the .pdf document.]

  • Girl53
    Girl53 Member Posts: 225
    edited November 2015

    Ladies: Really appreciate your responses! Owl, detailed info you provided is so helpful. Thanks for reminding me re: lobular histology; I will be sure to ask MO about this. I think, all things considered, I'd choose to go ahead and have Oncotype test if MO is willing to consider.

    According to both of your suggestions, will visit Web sites and do some reading. Thanks again for taking time and care to respond so thoughtfully...it is appreciated.

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