MammaPrint

yes I had the blue and target print also. I will see my doctor on Wenesday, I guess chemo for me. I still don't underestad going from 90% to 0,06 ( the mammaprint score) I am so freaking out !!!

Konakona, it is really scary. To think that you might not have gotten the treatment that you needed...now you have more information to use in your decision. What was the BluePrint result? Hopefully you're able to sleep tonight.

JuniperCat Never asked you, did you have an Oncotype test first, or go straight to the MammaPrint?

My heart goes out to you both. I remember the anxiety of this point in my treatment decision. Breathe!!

the blue pint result is Luminal type +0,354

thanks so much

Hi JuniperCat:

You said: "The MammaPrint Risk Assessment value is -0.030 which places the patient in the HIGH risk category."

Three questions/requests:

(1) Was your test was "MammaPrint FFPE" or "MammaPrint" (used with stored fresh-frozen samples)?

(2) Does the word "Borderline" appear anywhere in your test results?

(3) Please confirm the value is negative 0.030 and not negative 0.30.

BarredOwl

Hi JuniperCat, as BarredOwl suggested, I would get a copy of your MammaPrint and ALL your test results for your personal records. (American Cancer Society has a packet called the Personal Health Manager you can call and request for keeping everything together. It's so helpful)

If your MO isn't comfortable going through the results, speak with your BS, whom you trust. If you still have questions, I'd call the customer service line at Agendia and they can help you interpret the results, as the value is so low.

Konakona, sorry about the bad score and the weird ER number. Hopefully your MO can explain the discrepancy between the biopsy and the Mammaprint. Many seem to get through chemo okay, if that is your choice after you learn more.

JuniperCat, all of these critical decisions are so stressful I'm waiting on my Oncotype right now. Good luck at your rad appt.

BarcelonaGirl, I would also be interested in any other information you find out about the Mammaprint test.

Konakona:

The following tests are part of a test suite (set of three tests) offered by Agendia:

(1) "MammaPrint" (different versions rely on tumor tissue prepared in different manners)

(a) "Mammaprint" (done with fresh frozen tumor tissue); OR

(b) "MammaPrint FFPE" (done with Formalin-Fixed Paraffin-Embedded tissue)

(2) "BluePrint" (for molecular subtype);

(3) "TargetPrint" (re how active the ER, PR and HER2 genes are);

I believe that tests (1), (2) and (3) have different test outputs with different meanings.

Please ask for copies of the the results of each test, so you can independently confirm the actual results obtained (actual score, classification as high risk or low risk, etc.) and see exactly what the report states about them.

Please ask your MO for an explanation of the report and the meaning of each test result. Ask which of the test results can inform your decision about chemotherapy (together with all other relevant pathologic and clinical features, such as age, co-morbidities, etc.), what the MO recommends about chemotherapy, and what factors support the recommendation.

Please ask about the meaning of the immunohistochemical (IHC) results from your pathology reports (percent ER and percent PR determined by biopsy and from later surgical pathology) with respect to endocrine therapy. Ask how the "TargetPrint" classifications of "negative" or "positive" for ER and PR might further inform your decision about endocrine therapy, what the MO recommends about endocrine therapy, and what factors support that recommendation.

BarredOwl

Hi JuniperCat:

It appears that the test was "MammaPrint FFPE", and the MammaPrint FFPE Index (MPI) is minus (-) 0.030.

Please let me know if my understanding is not correct.

Here is a link to a sample report for "MammaPrint FFPE" tests given in "the Americas":

http://www.agendia.com/media/24Feb15_MP-High-Risk....

This sample report applicable to the United States includes the language:

* * * "If a FFPE sample's MammaPrint Index (MPI) falls within a pre-defined area around the classification cut-off between -0.0575 and +0.0575, the classification accuracy is less than 90%. See MammaPrint Physician's Brochure found on www.agendia.com for more information." * * *

The quoted passage describes a "Borderline Range" around zero applicable to MammaPrint FFPE tests only. Note that the "Borderline Range" applicable to "MammaPrint" using fresh frozen tissue is DIFFERENT, and the applicable ranges should be indicated on each person's test report.

According to the report you posted, the test result of minus (-) 0.030 is classified as "High Risk". At the same time, this number appears to fall between -0.0575 and zero, which I think is considered to be a region close to the classification threshold of zero, where the "classification accuracy" of output as "high" or "low" risk potentially falls below the overall analytical accuracy of the test of 90% ("the classification accuracy is less than 90%"). I do not know how such results would be viewed by a clinician.

(1) Can you please confirm your location in the United States?

(2) Can you please check to see if the exact language quoted above between asterisks (* * *) appears on your report?

If your test result is indeed a "borderline" result, consultation with a Medical Oncologist who is familiar with the test would seem to be required to properly understand the meaning of such a test result and interpret it, towards helping you understand how to view this result along with your other test results (Oncotype) and your unique clinico-pathologic features.

Inquiry with Agendia by the Medical Oncologist may also be very helpful in the case of a "borderline" result.

I can provide a little more information about this and the test if you like, but it would still be essential to consult with an expert Medical Oncologist to confirm any such information as I am only a layperson, and I have not received any MammaPrint testing or associated expert medical advice.

I am a layperson, with no medical training. There may be errors of fact in the information above and/or errors in my understanding. All information above should be verified with an Medical Oncologist to ensure accurate, current case-specific expert professional advice.

BarredOwl

Hi JuniperCat:

Thank you for your message.

I do not know under what circumstances doctors request BluePrint and TargetPrint tests, or whether the results might further inform decision-making in your case or not. An MO with relevant experience might be able to advise you on that question. From my Feb 7, 2016 02:19PM post to Konakona above, you can see that I am not sure exactly how the results of BluePrint or TargetPrint are used by clinicians, hence the form of the questions.

Does your report contain the word "Borderline" anywhere? Please read all print, including small print.

Please also look for signs that you have all pages of the report (e.g., page 1/1).

I am uncomfortable suggesting that the result is actually a "Borderline" result, unless it is clear on the face of your report, either by use of the word "Borderline" or a statement regarding an applicable range around zero (e.g., "between -0.0575 and +0.0575") that encompasses your MPI score from MammaPrint FFPE.

Regarding MammaPrint FFPE, the Agendia website includes a link to a Physician's Brochure for MammaPrintFFPE at this page (under the heading "Specimen Collection and Transportation Kit Ordering"):

http://www.agendia.com/healthcare-professionals/br...

Physician's Brochure MammaPrint FFPE (United States): http://www.agendia.com/media/M-USA-056-V2_MP-FFPE-...

The Physician's Brochure states: "When a sample is considered to be "borderline", it is clearly indicated on the MammaPrint FFPE analysis report."

The above I why I think there needs to be some indicia, before one can conclude the result is "borderline".

Let me know what you find.

BarredOwl

Hi JuniperCat:

Contacting Agendia may be helpful.

From Agendia's information cited above, it should be clear from the content of the report if a result is deemed "borderline". That does not seem to be the case from what you describe.

Thus, despite the relatively low MPI, it seems possible that it is not "borderline" at all. I feel that I have added to your confusion by raising this question when it may not be applicable at all, and I apologize for that.

Some information from Agendia indicates that a sample with a first MPI falling in the applicable borderline range near zero is re-tested prior to final risk classification:

"Samples that lie within the borderline region and that are close to the threshold are more likely to switch classes with repeated analyses. In a diagnostic setting these samples will be performed in duplicate in order to obtain better outcome accuracy. A borderline sample will be re-tested from RNA onwards going through the following steps a second time: synthesis, amplification, labeling, hybridization, and scanning and XPrint analysis. After two QC-passed results are generated for a borderline sample, the MammaPrint® Index of both results will be averaged, and the final risk classification will be made according to the mean value."

Please confirm that your test result IS NOT borderline, despite falling "between -0.0575 and zero".

Ask if your sample was re-tested. If it was re-tested, ask for an explanation of what the final result means. Ask whether it means that the final risk classification (of minus (-) 0.030) as "high risk" (resulting from re-testing and averaging of scores) has >90% chance of being correctly classified.

Btw, if a result is not borderline, then it is my understanding that the 5-year and 10-year "Distant Recurrence Probability without Treatment" are High Risk Population Averages (with some possible "wobble room" as indicated by the "CI" or confidence interval). The distant recurrence probabilities are not an individualized risk assessment. You may also wish to confirm this.

Again, all information above should be confirmed with your MO.

BarredOwl

Hi JuniperCat,

I was speaking with a pathologist today and he explained the results in the following way: there is a statistical significant difference between high and low risk. If you fall into the classification cutoff, it is not considered to be a "grey area", but is still statistically significant. Thus if you repeated the testing on the tumor, 9 times out of 10 the results would be the same...and they repeat the test to insure that accuracy. He said think about the Grand Canyon, and you're on the west side. You may be close to the bottom, but the east side is far away, and there clearly are two sides. Same as your results.

Not sure why you didn't have a BluePrint test, but some doctors don't order all of the options. Since you already had the Oncotype, perhaps your doctor felt just the MammaPrint was needed. (They only ordered the MP on me and our numbers were comparable.) The BluePrint is helpful in identifying the molecular subtype be it, Luminial A, Luminial B, Basal (Triple Neg) or Her2. This along with clinical factors provide more information on what type of treatment would benefit your tumor.

I definitely encourage you to call Agendia to ask more questions, however. In order for you to move forward, you need to feel confident about your decision. Wishing you peace of mind!