Need a ONCO DX test but was started on letrozole before surgery

I'm glad that you're getting a second opinion. Or more. I had a very plain vanilla EP+, HER2- 5mm tumor removed. Clean margins. Sentinel node biopsy negative. And my surgeon was the head of breast cancer surgery at a top-ranked facility. The oncologist is affiliated with the same institution. But I still got a second opinion. Which, happily,,agreed with my oncologist's recommendations.

It just gave me less chance of later regretting that there was a better treatment path that I didn't bother to look into.

Thank you so much for the information. Your summation of the issue is well stated. The information you provided was my understanding but without some of the details. I am HER2 negative. The one thing I didn't know is the necessity for a 2mm piece of continuous tissue, which is why the one lab is telling my doctors there wasn't enough tissue to perform the test prior to aromatase inhibition therapy. I think I need to double-check that both labs evaluate two different sets of biopsies on 5 tumours total. I started on letrozole after both biopsies and 5 weeks prior to surgery for a double mastectomy and lymph dissection. All 4 lymph nodes were negative 🙂 It is unclear whether the doctors understood they were done at different facilities/labs. It also sounds like a specific order needs to be in place to ensure a large enough sample is biopsied for the purpose of this important test.

It seems I have no options regarding getting this test done in some form. I will not accept my Oncologist's plan to wait until possible metastasis. I plan to get 2nd and 3rd oncologist opinions if necessary. My other goal is to share this so as to prevent others from this catch-22. Although I am not looking to finger point and will not, I think the companies' reps doing the ONCOTYPE DX need to educate the surgical and medical oncologist as well as the doctors ordering the initial biopsy such as the obstetrician/gynaecologist. The latest studies are showing promising data on starting endocrine therapy prior to surgery in certain cases. Doctors need to understand these timing issues. I'm concerned and sad I may need to move forward without a clear prognosis, not what I expected. I thank you for your time and interest in this subject. I promise to post any further information I find. Wishing you all well on your BC journeys. Hugs, Randy

Hi Randy,
OK here's what I learned from talking to the Oncotype people (at Exact Sciences) today including the person I think of as 'the science guy because he's the person physicians call but helped me a lot when I was trying to understand what the OncotypeDX tested and its algorithm when I had a lumpectomy last October.

The OncotypeDX would be invalid if the client had already had aromatase inhibitors, radiation or chemo. So the letrazole would preclude valid results from an OncotypeDX test.

BUT, they do accept tissue for analysis from biopsies with the following caveats and maybe this gives you an option. The rep did note that some insurance companies won't cover biopsy genomic testing but that's a different issue.

1. The sample must be at least 2mm of 'continuous' tumor tissue. (Basically at least a 2mm clump of tumor tissue.)

2. The cancer must be estrogen positive. (It can be progesterone negative and, though you didn't mention HER2 status, they accept both HER2 positive and negative. [The most common tissue they receive though is from E+, P+, HER2- tumors.]

Also someone elsewhere on MC posted that the "risk of recurrence" number clients receive from an OncotypeDX test precludes the risk of spread from the original tumor. That is incorrect. The 'risk of recurrence within 9 years' applies to "anywhere in the body." But I think there's an assumption that surgery left clean margins. Some tissue submitted to Oncotype is rejected or sent back because misdiagnosed. Including samples from tumors labeled non-invasive which clearly show signs of invasive characteristics in the labs at Oncotype.

My OncotypeDX risk result was 3% (if I took aromatase inhibitors). Which translates to approx. 5.5% risk if I don't. I didn't have radiation. And the low OncotypeDX number ruled out chemo. So the test was very important in my decision(s). I post about these genomic tests so others can nudge their doctors into being conversant with the array and quality differentials of the tests available. Data is data and is all that we have to work with other than physicians' experience and our own knowledge and gut instinct about our own bodies.

I hope this is helpful for you and anyone else able to get this test done if they know about it aforehand.]

Incredible information. Thank you for taking that step. I obviously had enough biopsy tissues (2 tumors) to get an ONCOTYPE pre surgery as the oncologist would have begun chemo before surgery to reduce excessive surgical harm to axillary nodes ( shrinking or clearing).

For a 3% recurrence risk with AI … what would an Oncotyoe score look like?

Hi Randy,
OK here's what I learned from talking to the Oncotype people (at Exact Sciences) today including the person I think of as 'the science guy because he's the person physicians call but helped me a lot when I was trying to understand what the OncotypeDX tested and its algorithm when I had a lumpectomy last October.

The OncotypeDX would be invalid if the client had already had aromatase inhibitors, radiation or chemo. So the letrazole would preclude valid results from an OncotypeDX test.

BUT, they do accept tissue for analysis from biopsies with the following caveats and maybe this gives you an option. The rep did note that some insurance companies won't cover biopsy genomic testing but that's a different issue.

1. The sample must be at least 2mm of 'continuous' tumor tissue. (Basically at least a 2mm clump of tumor tissue.)

2. The cancer must be estrogen positive. (It can be progesterone negative and, though you didn't mention HER2 status, they accept both HER2 positive and negative. [The most common tissue they receive though is from E+, P+, HER2- tumors.]

Also someone elsewhere on MC posted that the "risk of recurrence" number clients receive from an OncotypeDX test precludes the risk of spread from the original tumor. That is incorrect. The 'risk of recurrence within 9 years' applies to "anywhere in the body." But I think there's an assumption that surgery left clean margins. Some tissue submitted to Oncotype is rejected or sent back because misdiagnosed. Including samples from tumors labeled non-invasive which clearly show signs of invasive characteristics in the labs at Oncotype.

My OncotypeDX risk result was 3% (if I took aromatase inhibitors). Which translates to approx. 5.5% risk if I don't. I didn't have radiation. And the low OncotypeDX number ruled out chemo. So the test was very important in my decision(s). I post about these genomic tests so others can nudge their doctors into being conversant with the array and quality differentials of the tests available. Data is data and is all that we have to work with other than physicians' experience and our own knowledge and gut instinct about our own bodies.

I hope this is helpful for you and anyone else able to get this test done if they know about it aforehand.]

Wow, I don't know how to thank you Callallo. I would be most grateful for any information you receive. I am a few weeks post-surgery and still recovering with pain, emotional stress and fatigue. I am finding all of this overwhelming. I have my loved ones encouraging me to let this go. I do not think they understand the importance of this for my future.

I just spoke with a customer service representative at Oncotype and he didn't know if the letrozole would rule out the OncotypeDX test. And my 'science guy' contact there was off today. I'll try to get an answer tomorrow as I have a few questions of my own. [I want to find out if I can get the exact lab results from my test not just the 'final results which was, thankfully, very good.]

Thank you so much for your reply and great suggestions. To clarify, I was told that taking the letrozole prior to biopsies would invalidate much of histological and genetic testing. Onco type testing was never brought up until after surgery. I was then told it wouldn't be accurate or have much meaning since the surgical pathology tissue was exposed to letrozole. All biopsy tissues and surgical tissues are saved for 10 years by the receiving labs. I am trying to find out if all the different types of testing an Oncotype DX does and see if any of them may be valid with the available tissue. My multiple biopsies with 2 different labs are "not enough tissue" for this test so I am told. My plan now: Awaiting ONCOTYPE DX company to contact me, 2nd opinion from another oncologist, I will contact both labs that hold my biopsy tissues, determine how much each have and if combining them may be enough for part or all of the ONCOTYPE DX testing. Again, I appreciate your interest and time put into this.

The order for the Oncotype DX must have been ordered to be done during your biopsy. Enough tissue would have taken the test at that time. This is the point at which I fell through the care net. Thank you and best wishes 🙂

I’m not sure what my two biopsies were called technically, procedure wise, but my two Oncotypes were based on the biopsies and I had results before surgery.

My experience was a needle biopsy followed by the injection of a clip to identify during mastectomy.