Dcis with microinvasion genomic test

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Jessiei
Jessiei Member Posts: 6
edited November 2017 in DCIS (Ductal Carcinoma In Situ)

Hello. I have been diagnosed with Dcis with microinvasion and just had unilateral mx. Is there any one who had genomic testing done to assess risk of recurrence to determine whether radiation or chemo will be needed? I mentioned Oncotype Dx to my BS but she said it is only for invasive cancer. Can't they order this for the microinvasive component? Thank you

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  • Peregrinelady
    Peregrinelady Member Posts: 1,019
    edited November 2017
    Just guessing, but it could be that the micro invasion is not big enough of a sample to test. I had an additional 2 mm tumor and they didn't even test it for ER, PR, etc.
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  • Annette47
    Annette47 Member Posts: 957
    edited November 2017

    Yes, there is a minimum size (not sure what it is though) that the sample has to be for them to be able to test it. A micro-invasion would be by definition too small for that. Only my DCIS was tested for hormone receptors as I also had a micro-invasion that was too small for testing.

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  • brigid_TO
    brigid_TO Member Posts: 75
    edited November 2017

    Hi Jessiei Same here. I had a DCIS with microinvasion < 1mm that prevented the DCIS Oncotype and was too small of a sample for the Invasive Oncotype.

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  • MelissaDallas
    MelissaDallas Member Posts: 7,268
    edited November 2017

    As far as I understand, DCIS microinvasion is still treated as pure DCIS. No chemo, genomic testing, etc. It is not considered or treated as invasive cancer.

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  • BarredOwl
    BarredOwl Member Posts: 2,433
    edited November 2017

    There are two different Oncotype tests. They are used in completely distinct patient populations and for different purposes.


    (1) The DCIS test: For those with pure DCIS (pathologic Stage 0 disease, and no evidence of invasion) treated by breast conserving surgery to inform decisions about whether to add radiation to lumpectomy.

    - Patients treated with mastectomy are not eligible for the DCIS test.

    - Patients who have any invasive disease, no matter how small (e.g., T1mi or microinvasion), are currently not eligible for the test, because it has only been validated in patients with pure DCIS.


    (2) The Oncotype Test for Invasive disease: For certain patients with invasive breast cancer that is hormone receptor-positive (ER+ and/or PR+) and HER2-negative to inform decisions about whether to add chemotherapy to endocrine therapy

    - With very small tumors (e.g., 1 mm, 2 mm), there may not be adequate tissue to run the test.

    See below for more information.

    BarredOwl

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  • BarredOwl
    BarredOwl Member Posts: 2,433
    edited November 2017

    General Information - Oncotype - Invasive disease test versus DCIS test:

    Note that the tests for invasive disease and for DCIS differ in the number of test genes used, the tests are used in different patient populations (different "eligibility" requirements), for different purposes, and their recurrence risk categories are also different.


    OncotypeDX for INVASIVE Disease ("21-gene test"):

    This test is used in patients with invasive breast cancer that is hormone receptor-positive (ER+ and/or PR+), HER2-negative, regardless of type of surgery, to inform decision-making regarding chemotherapy (endocrine therapy alone or endocrine therapy plus chemotherapy).

    The Recurrence Score for invasive disease relies on the mRNA levels of 16 cancer-related genes and 5 reference or control genes from a sample of the tumor.

    The standard recurrence risk categories for the test for invasive disease are:

    - Low-risk (Recurrence Score < 18)

    - Intermediate-risk (Recurrence Score 18 to 30)

    - High-risk (Recurrence Score ≥ 31)

    For more information about the formal "eligibility" requirements from the commercial provider, see:

    http://www.oncotypeiq.com/en-US/breast-cancer/healthcare-professionals/oncotype-dx-breast-recurrence-score/is-your-patient-eligible

    Note that clinical consensus guidelines may differ from the above in some respects.

    Those interested in this test should ask their Medical Oncologist about it.


    OncotypeDX for DCIS ("12-gene test"):

    This test is used in patients determined by surgical pathology to have pure DCIS (no invasive disease present) and who were treated by local excision (also known as breast conserving therapy or lumpectomy) (with or without tamoxifen), to aid in decision-making regarding radiation therapy. Eligibility for the DCIS test does not require any particular receptor status.

    The Recurrence Score for DCIS relies on the mRNA levels 7 cancer-related genes and 5 reference genes (a subset of the genes used in the invasive test) from a sample of the tumor.

    The standard recurrence risk categories for the DCIS test are different, with "high risk" starting at a higher score:

    - Low-risk (DCIS Score < 39)

    - Intermediate-risk (DCIS Score 39–54)

    - High-risk (DCIS Score ≥ 55)

    Patients with pure DCIS treated by lumpectomy who are interested in this test should consult their Radiation Oncologist. Note that the DCIS test is less common, largely because it is not currently included in consensus guidelines for the treatment of breast cancer from NCCN (Version 3.2017).


    Here is some additional discussion about the DCIS test:

    The Oncotype test for DCIS:

    For those with pure DCIS in a breast treated by breast conserving surgery alone, the DCIS test generates a "Recurrence Score." Based on certain clinical trial data, individual Recurrence Scores have been correlated with certain average rates of ipsilateral recurrence at 10 years (any event (invasive or DCIS); and invasive only). This type of information is "prognostic"in nature (i.e., it speaks to recurrence risk).

    The "eligibility requirements" for the test for DCIS versus the test for invasive cancer are not the same.

    Regarding Oncotype for DCIS, the eligibility requirements of the commercial provider are described here (my [edit] in brackets):

    "Eligibility" for DCIS test: http://www.oncotypeiq.com/en-US/breast-cancer/healthcare-professionals/oncotype-dx-breast-dcis-score/is-your-patient-eligible

    When indicated, the Oncotype test for DCIS is usually performed on surgical samples, after surgical pathology establishes pure DCIS in a breast treated with lumpectomy.

    Although the commercial provider suggests that the test can be done on core biopsy samples, if a later lumpectomy identifies the presence of invasion, then the test results will not be relied upon for decision-making about radiation. This is because the test has not been validated in patients with any invasive component. Thus, in most of the patients who receive the DCIS test, the test is performed on surgical samples from lumpectomy.

    A sample report from the DCIS test can be found here:

    Sample report for DCIS test: http://www.oncotypeiq.com/en-US/breast-cancer/healthcare-professionals/oncotype-dx-breast-dcis-score/interpreting-the-results


    The commercial "eligibility" requirements for the DCIS test are probably a broader statement than what occurs in practice in the clinic at this time. This may reflect in part the characteristics of the patient populations in which the DCIS test was evaluated (limitations in "clinical validation"), and that the DCIS test is not included in the National Comprehensive Cancer Network (NCCN) guidelines for Breast Cancer (Version 3.2017).

    The DCIS test may not be recommended to some patients with pure DCIS treated by lumpectomy:

    - This may reflect that the test is not included in consensus guidelines for DCIS.

    - In some cases of pure DCIS, the test may not be seen as sufficiently reliable if the pathology differs in significant ways from that of the patient populations in which the test has been studied (a question regarding the "scope of validation" of the test).

    - In some cases of pure DCIS, certain clinicopathologic features may weigh strongly in favor of radiation:

    The test is not a stand-alone test. It is used to provide prognostic information about recurrence risk without radiation, and its outputs should still be considered along with other clinicopathologic factors that affect personal risk profile. In certain cases, the other factors may easily dominate the calculus (making the test of no added value).

    The outputs of the test for DCIS currently do not provide a recommendation about radiation, and do not predict efficacy of radiation:

    "Of note, in contrast to the Oncotype DX 21-gene array and systemic therapy, the DCIS Score defines a risk of recurrence (prognostic) but conveys no information about the effectiveness of WBRT (predictive)."

    I am a layperson with no medical training, so all information above should be confirmed with your team. Anyone interested in the Oncotype test for DCIS should not hesitate to ask their Radiation Oncologist for current professional advice regarding eligibility and the potential utility of the test in view of their particular presentation and current clinical evidence.

    BarredOwl

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  • BarredOwl
    BarredOwl Member Posts: 2,433
    edited November 2017

    By the way, while DCIS plus node-negative (N0) microinvasive disease ("T1mi") is often treated similarly to pure DCIS, this is not always the case. Clinical consensus guidelines for breast cancer from the National Comprehensive Cancer Network (NCCN)(Version 3.2017) do include consideration of the option of chemotherapy plus trastuzumab for certain patients with HER2-positive, node-negative (N0), microinvasive disease.

    To ensure consideration by a professional with the appropriate expertise, patients with invasive breast cancer, including microinvasive disease ("T1mi" tumor less than or equal to 1 mm in greatest dimension), should consult a Medical Oncologist to obtain current advice in light of the specific facts of their case (including all relevant clinical and pathologic features (e.g., histology (e.g., ductal, other); ER status; PR status; HER2 status; tumor size; lymph node status, as well as grade, peritumoral lymphovascular invasion ("LVI") and multifocality)).

    Even those with pure DCIS (Stage 0) that is hormone receptor-positive (ER+ and/or PR+) should consult a Medical Oncologist regarding whether endocrine therapy (Tamoxifen or an Aromatase Inhibitor) may be right for them in light of their personal risk/benefit profile.

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  • Jessiei
    Jessiei Member Posts: 6
    edited November 2017

    Thanks everyone for their reply. It seems that in my case either test will not apply. Barred Owl, thanks for the comprehensive response. it looks like you had 1.5mm invasion, were you able to get Oncotype test? So is there no test that could apply to me like Mamaprint?

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  • BarredOwl
    BarredOwl Member Posts: 2,433
    edited November 2017

    Hi Jessiei:

    In my case, although the largest IDC was 1.5 mm (which is not microinvasive, but is "T1a" in terms of size), several histopathological tests were needed to confirm invasion, so there was insufficient tissue remaining for testing in my case (in fact, my complete ER, PR and HER2 status was unknown, so eligibility was also unclear).

    In general, under clinical consensus guidelines from NCCN (Version 2.2017), applicable to microinvasive ("T1mi" in terms of size) breast cancer, decisions about systemic treatments are made on the basis of clinical and pathologic factors alone, and prognostic multiparameter tests (e.g., Oncotype, MammaPrint) are not indicated/used. That said, in one usage study of the Oncotype test for invasive breast cancer, there were a handful of case with Oncotype testing of very small tumors, but again, such testing is not very common for a variety of reasons. For example, NCCN guidelines for breast cancer (Version 3.2017) do not include the Oncotype test for node-negative (N0), hormone receptor-positive, HER2-negative, ductal, lobular, metaplastic or mixed histology tumors that are Tumor ≤0.5 cm in size (including microinvasive). For patients with such tumors, the prognosis is generally relatively favorable, and in general, the systemic therapy "considered" would be endocrine therapy alone (e.g., Tamoxifen, an Aromatase Inhibitor). (Note that guidelines address the typical case, and there may be appropriate exceptions.)

    As for other tests, I have not researched the tissue requirements for all the various prognostic tests (e.g., MammaPrint, Prosigna, Endopredict). Please ask your Medical Oncologist to ensure you receive case-specific, expert advice.

    BarredOwl

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