Onco type numbers to change.

I was low...but now I'm intermediate I guess. Still would have skipped chemo I think.

While there has been some talk by some people that the numbers associated with the different ranges will change, this info is not coming from Genomic Health. Rather, different studies have used the Oncotype scores in their own groupings, assigning a lower range than the Oncotype does.

The Oncotype was validated and incorporated intro use with it's currently published ranges and until Genomic Health announces otherwise, I'm not going to worry about a reordering of the ranges.

Hi, Fe Princess - I can see where you're coming from and I'm terribly sorry if I sounded accusatory or something; that was certainly not my intention. It's more the lack of clarity that annoys me.

I had not seen that link on their site but have read the recent studies. I think all of this muddies the waters for a whole lot of people (unnecessarily). Frankly, I wish Genomic would flat out address the issue for both the lay and medical audience!

I'm confused. Did some of the 12-25 group not get chemo? I see where 94% of the 12-25 group that received hormone therapy and chemotherapy had a 5 year DFS. I don't see where the study gave a 5 year DFS for those in the 12-25 group that received only hormone therapy? Did I miss something?

Yes, I have read the WGS PlanB paper and abstract and the TailorX study. As of this date, it is my understanding that the standard ranges have not been changed by either of these studies.

Based on the published studies validating OncotypeDX for invasive disease, the standard ranges are: <18, 18–30, ≥31:

Low Risk: RS = 0 to 17 (<18)

Intermediate Risk: RS = 18 to 30 (18-30)

High Risk: RS = 31 to 100 (≥ 31)

TailorX:

(1) This trial includes node-negative patients only.

(2) "Low risk" for the purposes of this study was defined as Recurrence Score ("RS") of 0 to 10.

(3) Patients with a score of 0 to 10 were assigned to receive endocrine therapy alone, and did very well, per the published results:

TailorX (2015) NEJM: http://www.nejm.org/doi/full/10.1056/NEJMoa1510764...

(4) The results from the 2015 publication did not alter standard ranges, but showed that the test is particularly robust for those scoring 0 to 10 in this node-negative study population, and provides added confidence for reliance upon endocrine therapy alone in this group:

"The study included women 18 to 75 years of age with axillary node–negative invasive breast cancer that was estrogen-receptor–positive or pro- gesterone-receptor–positive (or both) and that did not overexpress HER2. Patients had to meet National Comprehensive Cancer Network guidelines for the recommendation of adjuvant chemo- therapy, including a primary tumor size of 1.1 to 5.0 cm in the greatest dimension for a tumor of any grade or a size of 0.6 to 1.0 cm in the greatest dimension for a tumor of intermediate or high histologic grade or nuclear grade (or both)."

(5) Patients with a mid-range score of 11 to 25 were randomly assigned to receive either (a) chemotherapy plus endocrine therapy or (b) endocrine therapy alone. This part of the study is on-going.

(6) Those with a score of 26 or higher were assigned to receive chemotherapy plus endocrine therapy. This part of the study is on-going.

(7) Because the TailorX trial is on-going for those with RS of 11 to 25 and those with RS of 26 or higher, at this time it is not known whether or how the results will impact ranges in clinical practice.

West German Study Group Phase III PlanB Trial ("WGS Plan B");

(1) This study included node-negative AND node-positive patients (pN0 and pN1). (Compare: TailorX is node-negative only)

(2) "Low risk" for the purposes of this study was defined as RS of 0 to 11. (Compare: TailorX was 0 to 10)

(3) The study design and objectives are different from TailorX. All patients with RS = 12 or above received chemotherapy ("CT"). Specifically, they were randomized to receive one of two different chemotherapy regimens under comparison:

(a) anthracycline-containing (four cycles of epirubicin/cyclophosphamide followed by four cycles of docetaxel every 3 weeks); OR

(b) anthracycline-free (six cycles of docetaxel/cyclophosphamide every 3 weeks)

(4) Three-year data has been reported in a full-length peer-reviewed publication:

Gluz (2016): http://jco.ascopubs.org/content/early/2016/02/24/J...

(5) Five-year data has been reported in an abstract:

EBCC10 Abstract: http://www.ecco-org.eu/Events/EBCC10/Abstract-sear...

(6) The results for those scoring 0 to 11 were generally consistent with those of TailorX (0 to 10, all node-negative), although the WGS study is smaller, and included pN0 and pN1 patients.

(7) Because all patients scoring 12 or above received chemotherapy, the five-year data for these cohorts does not speak to the question of who may forego chemotherapy. Neither the paper nor the abstract above appear to report the results of the chemotherapy regimen comparison in any cohort.

BarredOwl

BarredOwl,

Thanx for your research and comprehensive feedback on this and ALL of the posts you provide.

I'm delighted that there is research (taylorX) on foregoing the chemo when in that dreaded gray area. My Oncodx score is 28 and I declined the chemo, higher than the study #'s but at least there is ongoing research for intermediate dx score. I'm so looking forward to the final results.

Do you think they will research scores of 26-30? Or would that be unethical?

thanx again, Maureen

Barred Owl,

Thank you very much for your VERY well-worded summary of OncotypeDX confirmation studies. I have started typing replies to posts that expressed concern at "changed" OncotypeDX ranges but always deleted them because I just couldn't find the exact words to capture the subtleties of these emotionally-charged findings for those of us with early stage BC. You succinctly laid out what's been confirmed and what is still being considered. And don't forget, Oncotype DX scores are based on a presumption of 5 years treatment with Tamoxofen. In reality, many BC patients systemically address BC recurrence with AI's instead of Tamox.

Like many, my Onco score was intermediate - 20. I consulted two MO's and both advised against chemo. Especially when considering all other factors (tumor grade, patient age, AI vs. Tamoxofen, etc). OncotypeDX, although an excellent predictive tool, should be one of several factors in our chemo/no chemo decisions.

Also, just FYI - please direct your MO's to the Genomics Health website. There is calculator on the website that (presumably) uses the database of OncoDX patient scores and allows the MO to enter other factors (such as patient age, size of tumor and AI instead of Tamox.) This gives another 'predictor' of distant metastasis. It is a presumptive tool because results have not been clinically validated. It simply uses metadata to create a useful measure as part of overall discussion and decision-making. This tool can only be accessed by the medical practitioner who registers with the website - not patients.

Edited to add Oncotype website info about this tool:

RSPC (Recurrence Score-Pathology-Clinical) Calculator

RSPC may help physicians understand how integrating clinical and pathological factors with the Oncotype DX Breast Cancer Recurrence Score result can enhance the understanding of the score.

• Input:
  • Oncotype DX Breast Cancer Assay Recurrence Score
  • Patient age
  • Tumor size
  • Tumor grade
  • Planned adjuvant hormonal therapy (tamoxifen or aromatase inhibitor)
• Output:
  • Integrated assessment of the risk of distant recurrence for node negative, ER positive invasive disease
  • Option to produce a numerical or a graphical printout

Good luck and big (((((hugs))))) to all who are on this journey together. Thank God for the 'Inter-web'.

fe, I hope you don't mind me jumping in. Yes, the onco score risk/benefit is based on the patient receiving Tamoxifen as hormonal therapy.

Fe, that's an interesting question. Personally I never considered not taking Tamoxifen so it is a moot point for me. I have an 8% chance of recurrence. My Oncotype score was 11.

I have a friend whose daughter is in her 40s with BC and she refused Tamoxifen because she didn't want to be thrown into menopause. Her call, her life. Frankly I was scared not to. I'm older than she is but I still would have made the same decision.

When you decide just don't second guess yourself or look back and wonder what if...

Diane

Fe ,

If you don"t take Tamox, your Oncotype SCORE would not change, but your risk of distant recurrence would. Your Onco score reflects the characteristics of your tumor based on 21 genes in the tumor. Once that score is determined, then Genomics Health uses it to predict your RISK OF DISTANT RECURRENCE, assuming you use Tamoxofen. This prediction has been certified through clinical testing. I am not aware of this test offering "risk of distant recurrence" if Tamox. is not used.

I presume and hope you will consider your oncologist's advice when deciding whether or not to take Tamox. It is very effective in reducing risk of recurrence.

Hi Fe_Princess:

Was your oophorectomy a bilateral oophorectomy? If so, you would have the additional option of an aromatase inhibitor:

Post-menopausal (this includes patients whose ovaries have been removed by oophorectomy)

(a) Tamoxifen; or

(b) Aromatase inhibitor

Under the guidelines in the United States from NCCN, typically, endocrine therapy is also prescribed to post-menopausal women, including those who have received an oophorectomy. This is because tissues other than the ovary can make estrogen (e.g., adipose (fat) tissue). With bilateral oophorectomy, you would be considered post-menopausal, but under the NCCN guidelines such patients are still offered tamoxifen (to block the action of estrogen) or an aromatase inhibitor (to block the production of estrogen from other tissues).

To obtain current, case-specific, expert medical professional advice, please arrange an appointment with a Medical Oncologist to review your medical history, the meaning of your Recurrence Score (by OncotypeDX test for invasive disease), potential endocrine therapy options, and their associated risk / benefit in light of your estimated risk of local and distant recurrence, menopausal status, and overall health and presentation.

BarredOwl

Hi Farmerlucy:

It sounds like he was talking about increased risk, not a change in score. In your post, you said "doubling your oncotype score if you don't do HT". I think you meant to say (roughly) "doubling your risk"?

However, without knowing exactly how it was determined and associated assumptions (4% with endocrine therapy, 7% without), it is difficult to extrapolate to another materially different situation, and I would recommend people seek case-specific expert advice and personalized risk assessments from their providers.

BarredOwl

Thanks BarredOwl for breaking it down for us. In my case, my whole decision of whether to skip chemo or not was based on my oncotype score. If I was in the gray area (>18) I would have done it or at least asked for the Mammaprint test. Having a positive node (very small, but positive none the less) puts me in a very grey area that is being studied by RxPonder. Most oncologists feel that RxPonder is going to match up with current Oncotype guidelines but of course they can't just assume. I feel great about the decisions I made and I honestly don't think about my cancer until I do some research here.

I was told risk doubles without hormonal therapy.  So if your Oncotype is 11 and your risk is 8% with Tamox, for instance, then it would be 16% without.

When the Oncotype was developed, they used Tamoxifen as the medication that would lower risk. Aromatase inhibitors apparently are a little better at that but the Genomic Health graphs and info don't use them.