My Oncotype Test Was Got Refused

summerhappy

Hello folks, my oncotype test was got refused by califonia breast centre, they said I do not meet the criteria, what is that mean? I was diagnosed with DCIS with one lemphnote cancer of 0.6mm, should I be treated with chemo treatment?

Thank you in advance

Annette47

Are you sure your diagnosis is pure DCIS? Because that can't spread to the lymph nodes and you say you have a micromet in the lymph node. Oncotype isn't really done on DCIS as it is meant to determine whether the benefit of chemo for your tumor will outweigh the risks, and DCIS never requires chemo - chemo is meant to kill any stray cancer cells in the rest of your body before they can spread to other locations such as bones or organs. DCIS by it's very nature cannot leave the ducts so can't leave the breast and cause trouble. On an invasive tumor, many docs will not due it unless the tumor is over a certain size, and I'm not sure, but I believe node status affects eligibility as well, although the recommendations on that may be changing.

SelenaWolf

It is my understanding that some cancer centres have protocols stating that, once there is lymph node involvement, chemotherapy is a given and the OncoType test becomes moot.  I, also, understand that there is a great deal of debate and difference between cancer centres and that this may change.  Perhaps a second opinion would put your mind at ease?

SpecialK

I agree with Annette47 - if you have a positive lymph node than your diagnosis can't be pure DCIS, there would have to be an invasive component. There actually is a new Oncotype Dx test from Genomic for DCIS, here is the blurb form their website:

"The Oncotype DX breast cancer test for DCIS patients is the first clinically validated genomic assay to provide an individualized prediction of the 10-year risk of local recurrence (DCIS or invasive carcinoma) to help guide treatment decision-making in women with ductal carcinoma in situ treated by local excision, with or without tamoxifen."

Beesie

Just to add to what the others said, yes, with a positive lymph node, the diagnosis can't be pure DCIS. It might be that you have some DCIS along with some invasive cancer (IDC) - that's very common - but if that's the case, the diagnosis is considered to be IDC, not DCIS. The DCIS is the lesser condition and while it has to be removed, the staging and treatment is all based on the IDC, because the IDC is the more serious condition. Whatever you do for the IDC will be more than enough to address any DCIS that might also be there.

There are two different Oncotype tests, one for DCIS, which helps determine the need for radiation therapy after lumpectomy surgery, and one for invasive cancer, which helps determine the need for chemo. The invasive cancer Oncotype originally was given only to women who were node negative; treatment protocols indicated that anyone who had a positive node was going to get chemo. I know that sometimes this Oncotype test is now given even to women who have one or two positive nodes, but that's not always the case and I'm guessing that's what's happened here. As SelenaWolf suggested, a second opinion from another facility might be a good idea.

percy4

Just saw MO prior to treatment for small, low-grade DCIS (from biopsy).  I also asked that an oncotype test be included in my pathology testing when I have the lumpectomy, to help me decide about radiation after.  She also (nicely) refused, saying that although this test exists, it's not the standard.  Possibly RO can order it done on my specimen later, but not when pathology is first done.  I'm confused, too.  I'm just going to ask for it after; how else can I make my most informed choice about radiation?  Presume they can go back and test my specimen (is that what it's called?) for another thing after it's already been tested once.  True?  For how long is specimen from lumpectomy good for being re-tested, after originally done?

summerhappy

thanks for all reply. from my report it says DCIS with micro invasive, plus one node is positive. so my MO sent my things to California for Oncotype Dx, they got it refused, said I did not meet the criteria, I do not know what is their criteria, is this mean my case is lesser than normal cancer?

Annette47

I'm not sure how the positive node changes things (and I believe in some centers, such as the one I use, a tumor of only .6mm in the node would still be considered node negative), but I wasn't offered oncotype on my microinvasion because it smaller than the criteria they used (<5mm).

The thinking is, that the benefits of chemo with a tumor that size pretty much are automatically outweighed by the risks as the risk of spread is so small in that situation. Now as I said, you having a micro-met in your lymph node may change things, but then again, with it being that small they may still consider you node-negative, in which case the argument would still apply that your prognosis is good enough without chemo to make the risks of chemo not worth it.

And I'm not sure what you mean by "normal cancer" ... everyone's case is different, but if you mean your prognosis is better than someone with more advanced (i.e. larger tumors) then yes, that is most likely what is going on.

Beesie

summerhappy,

The microinvasion means that there is a tiny amount of invasive cancer present, along with the DCIS. I had a microinvasion too; that changed my diagnosis from being Stage 0 DCIS to Stage IA, DCIS-Mi. Although DCIS-Mi has "DCIS" in the name, it is actually the earliest invasive cancer diagnosis

DCIS cannot travel to the nodes but I was told was that with a microinvasion, I had about a 10% risk of having nodal involvement. My nodes were clear but it sounds as though you are in that 10% who's microinvasion has led to having a positive node. That changes your diagnosis and staging yet again. If the amount of cancer in the node is very tiny, what's call micromets, it would mean that you are Stage IB. But in most cases, having a positive node puts the staging at Stage IIA.

So even though the majority of your cancer may be DCIS and you may have only two very small areas of invasion - one in the breast and one in the nodes - that's a very different diagnosis than pure DCIS. It means that you would not qualify for the DCIS Oncotype test. You would be able to have the invasive cancer Oncotype test but as mentioned earlier, some facilities don't provide that test to anyone who is node positive.

Beesie

Annette, according to AJCC staging, "(a)n area of cancer spread that is smaller than 0.2 mm (or less than 200 cells) doesn't change the stage, but is recorded with abbreviations that reflect the way the cancer spread was detected. The abbreviation "i+" means that a small number of cancer cells (called isolated tumor cells) were seen in routine stains or when a special type of staining technique, called immunohistochemistry, was used."

So it's only if the nodal involvement is less tha 0.2mm or less than 200 cells that someone will still be considered to be node negative.

As for whether a larger area of nodal involvement moves someone up to Stage IB or Stage IIA (tumor size being another factor that can change the staging, of course), the break is 2mm: "If the area of cancer spread is at least 0.2 mm (or 200 cells), but still not larger than 2 mm, it is called a micrometastasis (one mm is about the size of the width of a grain of rice). Micrometastases are counted only if there aren't any larger areas of cancer spread."

So 2mm or less (but at least 0.2mm) is node positive but it keeps someone in Stage I however it's Stage IB instead of Stage IA, and anything larger than 2mm changes the stage to Stage IIA.

The American Joint Committee on Cancer (AJCC) TNM system

Annette47

Ahh ... thanks for the clarification. I had seen the 2mm threshold, but didn't realize it was for the difference between IB and IIA (and quite possibly had seen the .2mm in a discussion of micromets at a different point and missed the decimal point as I am on the threshold of needing reading glasses, but don't usually have them around )

I do know for sure though, that oncotype is often not used on tumors less than 5 mm, so that may be a factor in the OP's case as well.

She really should try to find out from the centre what the issue is and where she should go from there as the two possible reasons for not being offered the test come from very different directions.

pupmom

Oncotype DX can be done for post-menopausal individuals who have 3 or less positive nodes. You don't have to be node negative to get the test.

summerhappy

Thanks all. My Mo asked me to see RO next week for the next step - radiation treatment, I wonder whether I need to do chemo as well?

Annette47

Usually chemo is given before radiation, so I would think your MO would have discussed it with you already. DCIS with micro-invasions are not typically given chemo but I suppose the positive lymph node could change that. Why don't you call your MO and ask?

Compass75

Hi Everyone

New to the board and am so comforted by all the ongoing discussions.

I was diagnosed 8 Nov (IDC grade 2 , ER/PR +, CerbB2 -) and had my double mastectomy on the 14th. I went in to the operation with the hope that my nodes would be clear and that I would be able to preserve my nipple in my left breast which had the malignant tumor (1.7cm)

Unfortunately, at least one node was affected (my doc thinks that it is only one node due to preliminary testing during the surgery.) The full report comes out next week.

My surgeon says that because 1 node was affected, the oncotype dx test is ruled out (I'm 37). Another disappointment. I'm concerned/dreading chemo and am even considering not undergoing it. Based on all given reports, chemo raises my survival rate over 10 years from 87% to 93%. It feels ridiculous to not consider fighting this with all I can but with work, being a single mum with 3 kids and the side effects (short and long term) of chemo, I am hesitant about the 8 treatments my doc has suggested.

It has been a roller coaster week and I so wished I was recovering from surgery and not looking at another 7 months of treatments and feeling sick.

Am I completely ruled out for the test or should I be looking at the micromets when the results come out?

BLinthedesert

Oncotype test is for ER-positive, HER-2 negative patients.

The Oncotype DCIS test, theoretically is for both ER-positive and ER-negative patients.

percy4

Saw radiation oncologist today.  Told him I would like the oncotype test for DCIS.  He was young, with-it, and honest (in many other ways, too).  He said that the oncotype test for DCIS is insurance padding the bill.  Only effective in rare, genetic types, and not of value. I don't know.  Said I would pay for it to be added; he said a waste of money, though I could.  He has no vested interest in this, as he is paid the same from my HMO either way.  He was, also, though within my same HMO, the first person to say DCIS is not cancer; does not meet the criteria for it, though it can change.  He said 0 Grade isn't a grade, they grade cancer 1-4.  Did say they have to treat it as if it was, though.  Still, I feel validated.

percy4

Just spoke with Dr. Lagios's nurse on the phone, to see what he would need in the path report to get an accurate picture.  She said he feels the oncotype test for DCIS has problems associated with it, and he does not recommend it.  I found that helpful, as now I only have to argue to get one thing, the pre-treatment MRI. 

percy4

Sorry; realize now that your situation is different from mine; you were diagnosed with an IDC.  From what I've read, here, there shouldn't be any reason your oncotype test should be refused.  Your surgeon sounds absurd.  We put ourselves into the hands of these people, and it has become obvious to me, even at this early place, that one may need more than one opinion.  Sorry, sorry, sorry.  These people should take us into their hands, and their hearts, as if we were one of theirs.   Please insist about it.  As I've said before, it's hard enough to have something like this, and yet still have to argue for things.  Very best of luck, and DO NOT give up. - P.

wyo

okay I am reading this differently and maybe not getting the true picture.

The pathology specimen was sent to CA because Redwood City CA is where Genomic Health is located. I am wondering if possibly the reason they are rejecting the tissue for testing is if the wrong test was ordered based on your pathology/histology.

In my cynical self they are a for-profit entity and would certainly want to perform a test even if they said the patient had to pay for it out of pocket that makes me wonder why it could not be done.

as several have said its two different tests based on DCIS vs IDC- could they have requested the wrong one? I have also read that there are calculations that physicians can do based on a bunch of different variables that predict the recurrence risk with a very high level of accuracy (in the 90th percents if I recall correctly) when compared to Oncotype testing.

Compass- welcome to our "world" I believe as you get more information about your specific situation you will do the things that are right for you and not what anyone else says or does because that is only right for them. We all have opinions based on our own experiences but you are your most passionate patient advocate at the end of the day