Breast Cancer Index or Prosigna Assay?

Peregrinelady

Hopeful, I had a blood clot (after surgery) while on Tamoxifen so that is off the table for me. I may try brand name Arimidex, letrozole, or aromasin. I just feel like a change in meds might help with the resistance issue. The achiness since my month off is worse or I just didn’t realize how much I had gotten used to it. I felt so clear headed and energetic while off the drugs, but was too scared to stay off more than a month. Thanks for the link.

windingshores

So I gave the tip, for Breast Cancer Index, to print out the Biotheranostics paperwork and bring to the oncology appointment and they may be more amenable to order it.

Now, with the Prosigna Assay, things are a little different. I has already provided the paperwork to my MO, with contact info and website for Prosigna at Nanostrings. Here is the site with ordering info.

https://www.nanostring.com/diagnostics/prosigna/or...

The MD signed the paperwork but the assistant had no idea how to proceed and finally contacted me with several questions on my portal. Not sure why it was such a challenge. Granted she couldn't find my specimen, because one of my specimen blocks was still at Biotheranostics for the BCI (two months ago!) so I called them and asked them to send it back to pathology locally.

Then I called LabCorp, where the test would be done, because noone at my MO's office can figure this out. Labcorp said they would send a courier to pick up paperwork at the hospital and specimens at pathology (at a different hospital).

I called pathology at the hospital where I had my surgery and asked them to get a back up blocks of my specimen from storage. and told them Biotheranostics was returning the other one.

I called my hospital back and asked them to keep the paperwork and attach my pathology report.

Now I will wait for the specimens and contact all three, the MO at one hospital, pathology at another, and LabCorp so that the courier can do these pickups in the same day, probably next week.

LabCorp and Quest labs have the Prosigna kit and equipment. I had to call the main LabCorp number and they told me where the regional office is.

This took about two hours.

The pathology person said " You shouldn't be doing this, why isn't your doctor doing it?"

To be safe I also wrote a letter to pathology giving them permission to release my samples to the LabCorp courier.

I'm tired!

Peregrinelady

Omg, that made me tired just reading it. I didn’t even know that my oncologist had ordered the BCI. He did so after I just mentioned it during an appt. I did absolutely nothing. Do you think the issue is that the Prosigna is more recent or is it your drs. office? How long do they keep tumor samples?

windingshores

Prosigna is "decentralized" meaning, unlike BCI, the test is not done at the company that makes it (Nanostrings) but can be done at any lab that has the equipment to do the test, which so far is Quest and LabCorp- maybe others but those are the two.

The assistant at my oncology office had never done it and said it was a "challenge." I don't know why she thought it was a challenge, maybe because the block I requested was still at Biotheranostics after the BCI two months ago. The assistant just didn't seem to know how to proceed. I wanted the test, so I investigated and told her!

Peregrinelady

Good for you for pursuing this. Your info will help others interested in this test. Thanks, and keep us posted!

windingshores

I just had a long conversation with a rep at Biotheranostics, the company that does the Breast Cancer Index. I finally got someone who can explain the test. They have a new report format that does not assign risk category, only risk %, and simply a yes or no to whether there is benefit to continued endocrine therapy.

My risk of 5.7% is up to me to classify The old cut off was 5.1% for "low risk" so the old report has me as "high risk." My Oncotype had me at a 6% risk with a score of 8.

The results of the testing for hormonal treatment effectiveness IS binary, just a yes or no, no score or spectrum Fully 95% of women do not benefit, and only 3-5% DO benefit. The numbers at the bottom of the page with the graph (In my case 13%without therapy and 9% with) do not actually pertain to any particular client and have been removed from the new report because that part of the report is so confusing. High risk people who DO benefit have a risk reduction of 65%.

The first test, for risk of recurrence, includes cell proliferation, like the Oncotype (though some different markers). PLUS H/I (ratio of two genes) which interprets the estrogen signaling pathway. Think of this as how fast or slow the cars go, not how many cars. Estrogen scores from pathology (I was 95%) measure how many cars, not the speed.

The second test is H/I only without proliferation. As I wrote above, it is binary, just yes or no. The "no" people sit very close to the line where therapy actually could do harm. So this is like the chemo decision where chemo actually harms when it doesn't benefit.

It is possible that those of us with "no benefit" have not been benefiting in the first 5 years either, but BCI is only validated for years 5-10 for those who have already done 5 years of therapy and have no recurrence of disease.

So "Low benefit" really means "No benefit." "High benefit" people benefit substantially from continued meds so I guess that would help with motivation.

Some women opt to continue meds regardless for security even though it may not actually be helping. For people with high risk I think the low benefit score would be especially hard to accept.

There is a company rep in many areas that will talk to doctors.

The woman I spoke with is sending me a copy of the new revised report, patient and doctor pamphlets and also directed me to their revised website with more patient information. They will be doing more direct to comsumer marketing with a campaign entitled "Not Another Minute."

Their patient services rep, who answers phone and emails, is mainly about billing. I had to be a little assertive to get info on the test as a consumer. I ended up with a marketing person who was excellent and is also an 11 year breast cancer survivor.

Peregrinelady

Wow, thanks for sharing all this information. Obviously, it makes me even more determined to continue on the meds despite the side effects since I am one of the few with high benefit. I will point out that this test is for node negative people and that it states on my report that all people with positive nodes are considered high risk. I do believe that my micromets contributed to my high score, although I am not sure that information is included. I don’t think my oncologist knew that this test is only for node negative patients. Thanks so much for insisting on getting some answers, Windingshores.

windingshores

The Prosigna procedure is impossible to figure out. My Oncologist filled out the enrollment and preauthorization paperwork but never sent it anywhere. I had also given her the website where the MD can click on "Order here."

I spend 4 hours at the major cancer center yesterday trying to get a requisition or Rx for LabCorp, who perform the test. The hospital order from didn't have an account number for LabCorp so no go.

Meanwhile I had driven papers over to pathology across the city, because the LabCorp courier wanted everything in one place.

Today I contacted the "chat" on Nanostrings, the maker of the Prosigna and found out that a company names Veracyte has purchased Nanostring! And gave me their number. The person on the phone is talking with senior management to tell me what to do.

My specimens, enrollment form and MD order sit at pathology waiting and I have copies of the paperwork. Geez!

windingshores

Got a nice call from a VP at Veracyte. He doesn't know what to do either. He may give me the names of clinicians who could do the LabCorp order for me. But if that is the way to go, my PCP might do it. Not sure.

windingshores

The saga continues. The VP at Veracyte has an assistant who calls me every two days. They contacted Integrated Oncology, the LabCorp specialty test lab, and a representative from IO actually WENT to the cancer center and physically brought a requisition form and HELPED them fill it out with the right account number and other info. This was the culmination of many phone calls (by me) with Prosigna, Nanostring, Veracyte, the cancer center, and the pathology lab. The main obstacle this whole time has been getting the proper form (from where? noone knew) and also getting the cancer center to fill it out with their LabCorp account number (oncologist denied they had an account at all).

Today I went to finish up the requisition form which was left for me at the cancer center. But then I did not know what to do about getting it to Integrated Oncology. Did regular LabCorp labs do the test? Should pathology Fed ex or call a courier, or do I call the courier? Etc. I faxed the requisition form and called LabCorp, Integrated Oncology and left a message with the IO rep who had visiting the cancer center.

Finally the rep called me back because noone at LabCorp knew what to do. Turns out the specimens and paperwork need to go to Raleigh NC. Specimens, insurance card copy, pathology report. The rep offered to call pathology (I was on the phone with them at the same time) and arranged for the courier so I didn't have to do anything else.

Throughout, I heard, why are you, the patient, doing this? Some higher ups have been extremely nice and helpful and I think this is all just part of a transition since the company has been purchased. And they say it has never been this difficult so most likely the problem is my cancer center. The VP went so far as to pretend to be a patient trying to get this test and called Nanostring. Very impressed with all the help and concern.

I would encourage anyone to consider this test once they get it all straightened out. My specimens are now on the way to NC!

Peregrinelady

Wow, what a runaround. I hope you get results soon!

windingshores

Hi everyone. It seems like a distant memory that my main health concern was breast cancer testing.

I did just get my Prosigna results: Intermediate with a score of 47, total range 1-100, and my risk of distant recurrence would be about 9%. I expected info on Luminal A or B but the report didn't have any.

Oncotype Dx score was 8 with risk of 6% on meds, 12% not on meds.

Breast Cancer Index score 5.6 ("high" but they have now eliminated categories) with risk of distant recurrence 5.7% and no benefit to extended hormonal therapy.

If Femara was still helpful, then Oncotype and Prosigna match up, with close % without meds.

The BCI is really the outlier, both with lower risk w/out meds and it says extended meds aren't helpful.

I have stopped my Femara and am working on bones. I am considering another year or two of Femara at some point, whether months or two years as suggested by my doc.

In my view, with grade 2 or grade 3 (depending on hospital), LVI, ki67% of 20, the Prosigna risk seems to make the most sense. The high ER and PR would still seem to argue for hormonal treatment, but BCI explained that with hormonal responsiveness, they don't count the cars on the highway, they assess how fast they are going.

Were these tests helpful? Not sure .Certainly interesting!

Peregrinelady

From my limited knowledge and just reading your post, it looks like you are right in the middle. Not really high nor low risk. I think your plan of taking a year or two off then going back on Femara is a good one. Thanks for sharing!

windingshores

Good luck to you!