Oncotype DX results are in...

Dara, 4 1/2 weeks seems awfully long for oncotype results. I was told it would take 2 weeks, but it ended up only taking one week. This was a year ago. The BRCA results took a lot longer. I think it was around 8 weeks before I got my results

I was told my results over the phone from my BS, and my MO. I think it's good that you've inquired about this,because mistakes are made, even in the best facilities.

My score was 11 five years ago. I had IDC, Grade 1 and have been taking Tamoxifen. My last ONC visit is next month. I'm wondering what the reasons are for lowering the scores other than random group surveys. According to my Oncotype results I have an 8% chance of recurrence.

A lot of factors go into determining whether chemo is the treatment of choice. Had the scores been lowered back when I was tested I would still not have opted for chemo because I didn't have an aggressive BC.

My BS told me I had a wimpy cancer whatever that really means. I did have 33 rounds of Rads which was a walk in the park compared to chemo.

There is a radiologist in our support group at church. We meet every other month. Great group of ladies who try to help others who are DX with BC. We have lost one lady who had aggressive BC from the getgo and a litany of medical issues like diabetes and lung problems. The radiologist probably feels like she is at a press conference when she comes to our meetings because we inundate her with questions. She said the Oncotype test is a good barometer of your BC and oncologists are relying on it more and more to determine treatment.

Recently one of the ladies who has ILC found out her cancer has metasized to her hips. She was stunned and so were we. Her tumor markers were up so her ONC did scans and found lesions scattered all over her hips. They had planned to do Rads but given they were not confined to one area opted for the chemo drug for life. Idk if she had the Oncotype test or not.

We all know there are no guarantees. We all make the best choices for ourselves based on what we know and what we can tolerate. After all we all should have a decent quality of life regardless.

Diane

Dr called last night with my results... onco 20. He laid out all the data, options, survival rates, etc. Doing chemo will only give me an added 2%-3% advantage 5 years out. Knowing what the chemo could possibly do long term, I'm really pretty sure I will pass on the chemo, especially since I'm on the low end of intermediate. Already made my consult appt with rads.

Moondust thanks for your reply.  According to the oncotype score I am now ER negative at 5.9 the cutoff for positive is 6.5, and PR positive with a score a 5.7. the cutoff for positive is 5.5.  I have heard the new "cutoff" is 25 although not officially stated, and I do worry about being closer to a triple negative and tamoxifen not being as effective.  MO recommended TC x4 for me as well.  I would have to take time off work though, as I work with the elderly.  Right now I'm on a rollercoaster and have changed my mind day to day.  Still have a few days to decided.  Will take your points in to account.

Thanks again,

Brandi

DaraB-  I've just seen a few women mention it on here, moondust, in the post above me being one of them. Don't think it's official though.

DaraB:

I've posted elsewhere and often on the standard ranges versus the test ranges of the TAILORx study in node-negative ("N0") patients.

The standard ranges have not been changed. Because the TAILORx trial is on-going, the standard ranges are still in effect (RS low <18; intermediate 18 to 30; high ≥31).

For the purposes of the TAILORx trial, because patients deemed intermediate risk would be assigned at random to receive either endocrine therapy alone or chemotherapy plus endocrine therapy, to minimize the potential for undertreatment, the definitions of low, intermediate, and high risk were slightly revised as compared with the standard ranges in use in clinical practice [citations omitted]. In my layperson's understanding, the revised ranges selected for the purposes of the trial are "investigational" until demonstrated otherwise:

http://www.nejm.org/doi/full/10.1056/NEJMoa1510764...

"To minimize the potential for undertreatment of the participants enrolled in our trial, the recurrence-score ranges used in our study differed from those that were originally defined as low (≤10 in our study vs. <18 in the original definition), intermediate (11 to 25 vs. 18 to 30), and high (≥26 vs. ≥31). The recurrence-score strata derived for the trial were based on prior studies that indicated that the risk of recurrence of breast cancer at a distant site at 10 years after diagnosis and a 5-year course of tamoxifen could be as high as 10% among patients with a score of 11 (point estimate, 7%; 95% confidence interval [CI], 5 to 10) and up to 20% among those with a score of 25 (point estimate, 16%; 95% CI, 13 to 20), indicating a risk that was substantial enough for a recommendation of adjuvant chemotherapy in patients with a score of 11 or higher."

No results from the TAILORx trial for the groups scoring either 11 to 25 or 26 and above have been published as of this date, because the trial is on-going. Therefore, we are still awaiting TAILORx trial results for its "intermediate" and "high" risk groups, and the standard ranges are still in effect (<18; 18 to 30; ≥31).

Nevertheless, patients with a Recurrence Score ("RS") of 26 to 30 should not hesitate to discuss the rationale for the TAILORx trial design with their Medical Oncologists to understand whether and how it should be viewed in the context of their individual situation, as it reflects considerations of the magnitude of recurrence risk associated with particular RSs on the high end of the standard intermediate range. The best anyone can do is to make an informed decision based on the evidence available at the time, in consultation with their medical oncologist.

BarredOwl

Hi Dara:

I just expanded the last paragraph of my post a tad.

Best wishes to you on the additional tests and your decision-making.

BarredOwl

By the way, regarding the actual published results of TAILORx, they included results only from those with Recurrence Scores of 0 to 10 (all node-negative ("N0"), who were assigned to receive endocrine therapy alone.

Another prospective study (WGS Plan investigated and reported on those with Recurrence Scores of 0 to 11. I've discussed that study and its very different design elsewhere:

https://community.breastcancer.org/forum/69/topics/842601?page=1#post_4680091

https://community.breastcancer.org/forum/69/topics/842601?page=2#post_4691611

BarredOwl

Barred, Here's a question for you.. (with obvious we're not doc disclaimers) They tested my biopsy, not my tumor for ER/PR.. so the numbers at my tagline are based on the IHC biopsy numbers. However, the OncotypeDX shows widely different percentages (me thinks).. but I can't figure out how to actually translate the Onco numbers into percentages. I've done some google digging and most say the IHC is more accurate. I asked my doc about the disparity and she blew off the oncotype numbers saying the IHC numbers were more important.

Here's my numbers:

IHC (from Biopsy)_OncotypeDX (from section)

ER= 95% _______8.8 Positive (in the positive range it lands about here on the scale l__________Y______________________l - certainly doesn't look 95% to me.

PR= 5% ________6.6 Positive (in the positive range it lands about here on the scale l_______Y_________________________l - looks more than 5% to me.

So I'm now growing concerned that maybe I'm much less ER+ than I thought, which would mean that Oncotype score of 20 and Ki-67 of 30-35% is saying chemo is warranted moreso than I thought. I figured I'd just double down on the estogen blockers if the mammoprint is high, but if the ER is lower, then maybe I should reconsider the chemo. If the damn IHC was done on the tumor rather than the biopsy, I would feel better too.

I'm going to add to my thought here... looks like the Oncotype score for ER and PR is all over the map for the Percentages given by IHC. Apparently they match for Positive V. Negative around 95% of the time, and in the 5% that don't match, the Oncotype is usually the one that's wrong. If you look here... it shows that a lot of women had even LOWER oncotype scores and were still considered high ER+ by the IHC. Makes me feel helluva better to know that I shouldn't look at the Oncotype Score as a percentage of my ER. PLEASE someone correct me if I'm off base here. If I have a lower ER, I will do the damn Chemo. I'm banking on the high ER+ level that my doc told me to use.

http://www.nature.com/modpathol/journal/v25/n6/full/modpathol2011219a.html

Hi Lisey:

From the sample node-negative (N0) report on-line, single-gene ER scores greater than or equal to 6.5 units are considered positive by the Oncotype qRT-PCR method, and an ER score of 8.8 seems well within the positive range:

▼ (around 8.8)

As you know, the experimentally defined cut-off for positivity is different for each gene. The PR cut-off shown on the node-negative (N0) report is 5.5, and single-gene PR scores greater than or equal to 5.5 units are considered positive by the method:

▼ (around 6.6)

I note that according to the Discussion of the 2012 paper you just cited, they used biopsy samples for IHC and surgical samples for qRT-PCR:

http://www.nature.com/modpathol/journal/v25/n6/full/modpathol2011219a.html

"In our study, initial immunohistochemistry was performed on core biopsies, whereas resection specimens were used for the RT-PCR assay. Studies suggest high concordance between qualitative ER expression in core biopsies versus resection specimens.(24) However, there may be some variation in the level of expression between the two,(24) and this may have contributed to some initial discordance and less than perfect correlation coefficients."

The Discussion notes a similarly high level of concordance between qRT-PCR and IHC found by Badve et al., but notes a difference (see bold):

"In a similar study but using tissue microarray and different antibody clones, Badve et al (23) (in concert with Genomic Health) compared central immunohistochemistry for ER and PR with oncotype DX^® qRT-pCR assay on 776 cases. For ER, the concordance between central immunohistochemistry and central RT-PCR was 93%. For PR, the concordance between central immunohistochemistry and central RT-PCR was 90%. In this study immunohistochemistry ER-negative cases that were RT-PCR positive were more common than immunohistochemistry ER-positive cases that were RT-PCR negative (unlike our study). However, in regards to PR, immunohistochemistry PR-negative cases that were RT-PCR positive were less common than immunohistochemistry PR-positive cases that were RT-PCR negative (similar to our study). The reasons for the difference between Badve et al study and our study include immunohistochemistry analysis on very small samples (ie tissue microarray), and possibly using less optimally fixed tissue and less sensitive antibodies by Badve et al. (23)"

This is Reference 23, Badve et al. (2008), in case you are interested:

http://jco.ascopubs.org/content/26/15/2473.full.pdf

BarredOwl

MFALABELLA, ask your doctor if you should have hormone therapy. I thought ilc responds better to that than chemo. Radiation sounds like a given but I would ask what benefit there is to chemo for your situation.

Ilc is not as common.

lisey...in her signature ( below her comment) MF tells us that she is Grade2.

Lisey, what is your mitosis number? I'm trying to find information re the numbers but am not seeing much other than the formulary.