Question about the "intermediate range" on OncotypeDX

HealingDreams

I was unsure where to post this question. But, we've had four recent questions about the OncotypeDX test, so I thought I'd start here.

I saw my MO for the first time yesterday. Young and smart, he's also wise and won't make a recommendation about chemotherapy v. hormonal therapy for me until the OncotypeDX results come back in a week or two (June 1 - 8). As I've seen on these boards and been reminded, especially by NancyHB, our path reports can't predict what our scores will be.

If the results come back either high or low, the choice is obvious, So I asked the MO what he does about intermediate scores. He says he "splits the difference."

So I looked up what is intermediate and where the "difference would be split." Well, if you check the pages here on the OncotypeDX you learn that intermediate is considered between 18 and 31. But if you read to the end of article, the study that is investigating how to prescribe treatment for those in the intermediate range defines intermediate as 11 to 25.

Huge difference between 11 and 18. I have a lot of sympathy for p22nut5 trying to decide what to do with a score of 12. It would seem obvious if the intermediate range starts at 18, but at 11?

Does anyone have any insight into why the principal investigators decided to lower the range so dramatically for this large, significant study?

pupmom

Maybe to check whether the current guidelines are accurate? I hope they are, cause my Oncotype was 14 and I did not have chemo. However, I am not young and have a low Grade cancer. I think it was the appropriate decision.

wildrumara

I think that study you are referring to is the TailorX which lowered the scores specifically for the study......??  Correct me if I'm wrong, somone?

otter

wildrumara is correct.  The "official" categories are still 0-17 for "low risk," 18-30 for "intermediate risk," and 31+ for "high risk."  Remember, though:

1) Those categories are defined arbitrarily.  What one person considers "low risk" might be different from what another person thinks is "low risk" (etc.).  A score of "15" corresponds to a recurrence risk of 10%, which sounds pretty meager.  But, that's the risk of developing metastatic breast cancer ("distant recurrence") in the next 10 years.  Some people might not think a one-in-ten chance of mets is such a trivial thing.  OTOH, other women on these boards have not been convinced that a score in the "high risk" range was necessarily that high.

2) It seems like the difference between the categories is more significant than it really is.  Remember that the scale for the "Recurrence Score" is continuous.  For instance, a score of "29" is classified as "intermediate risk," while a score of "31" is in the "high risk" group (according to the official criteria).  But, that score of "29" corresponds to 19% chance of developing mets, while the "31" represents a 21% chance of distant recurrence.  Really, there's not much difference between 19% and 21%, even though the scores are in different risk groups.

Finally, as per the question about the TAILORx categories vs. the official categories:  I've been looking for a good answer for that question, ever since I found out my score was a whopping "26". Here's what I've located (note that it's a pdf file)... http://ecog.dfci.harvard.edu/general/gendocs/tailorx_comm_ed_script.pdf

The relevant section:  "Slide 13 -- Definition of Risk Groups for TAILORx"

++++++++Quote begins++++++++

1) It is important to point out that the definitions of low, intermediate or mid-range, and high risk have been modified for the TAILORx trial, and are different than the original definitions reported for the assay.

2) The definitions were modified in order to reduce the risk of under-treatment in the trial. In other words, an effort was made to minimize the risk that patients who are truly benefiting from chemotherapy would not receive it.

3) It is currently unclear at which Recurrence Score benefit from chemotherapy occurs. It is clear that chemotherapy is not likely to be beneficial if the Recurrence Score is less than 11. It is also clear that chemotherapy is very beneficial if the Recurrence Score is more than 25. The trial will determine whether there is any chemotherapy benefit if the Recurrence Score is 11-25, and if so, at what level this benefit can be detected.

4) For the low Recurrence Score group, the upper bound was reduced from 18 to 11. … This was done because at Recurrence Score of 10 or lower, there is a less than 5-10 percent chance of relapsing with hormonal therapy alone. This 5-10 percent threshold is typically used for recommending adjuvant chemotherapy. Therefore, women with a Recurrence Score of less than 11 will receive hormonal therapy alone.

5) For the high Recurrence Score group, the upper bound was reduced from 30 to 25. … A RS of 30 is associated with a 20 percent risk of recurrence. This group will receive chemotherapy in addition to hormonal therapy. Lowering the threshold to 25 will reduce the risk of under-treating this group.

6) Finally, the definition of the intermediate or mid-range group was adjusted from 18-30 down to a range of 11-25. This is called the Primary Study Group because it is in this group we are evaluating whether chemotherapy is beneficial. Changing this definition reduces the risk of under-treatment at the upper range of this mid-range group.

++++++++Quote ends+++++++++

The bottom line is that the categories were changed (cutoffs were lowered) for the TAILORx trial for ethical reasons.  The researchers dared not risk denying a woman the treatment she ordinarily have received, given the aggressiveness of her tumor.

BTW, my med onco recommended chemo for me in part on the basis of my score of 26. He pointed out that if I had enrolled in the TAILORx trial (which I declined to do), I would automatically be getting chemo with that score.

otter

HealingDreams

Thanks, otter. I thought I could probably count on you for the answer to this question. I am glad you researched it.

Have you made a decision about chemo? Why did you decide not to enroll in the study?

momof3boys

It is very interesting. My Oncotype score was 16. My MO's group uses "11" as the cutoff score to recommend chemo for "young" (im 43) otherwise healthy women. I did TC x 4, finished early March....

wildrumara

Frpm everything I've read on these threads throughout the last nine months, there are very few MOs that would recommend chemo for a score of 11.  Again, it's one of those differences in philosophies between doctors and institutions! 

NancyHB

I asked my MO and BS these same questions while waiting for the outcome of my Oncotype test.  They were both of the opinion that chemo would be recommended when a score falls into the intermediate range but that the choice was ultimately up to the patient.  My MO didn't feel comfortable "splitting the difference" because he felt that 25 (about mid-range) wasn't much different than 24...or 23...or 22...  I think they preferred to err on the side of caution, share all the associated information, and support their patients in the choices that are best for them.  As awful as it sounds, I was so grateful when my Onco score came back in a definitive range so that I didn't have to make that choice.  But I suspect that I would have opted for chemo if my score had been in the mid-range, too, just because I personally wanted to throw everything and the kitchen sink at this disease.  Of course, I had prayed for a score of 0 (would have been happy with 1), but was still shockingly surprised with 42.

mdg

My score was 18.  I had two opinions...one Med Onc said no chemo the other one thought I would benefit. I was 45 with a 4 year old son so I did the chemo.  I wanted to do everything I could to be here for my son.  I finished chemo last May.  I did TCx4.  I am glad I did it.  I used cold caps to keep my hair so after chemo I had hair and moved on. 

jenn333

My score was 14. I wanted to do everything I could do to be here for my daughter too but I didn't do chemo because my oncologist believed it wouldn't do anything for me with a very indolent, grade 1 cancer and the side effects were not justified. I agreed. I did do radiation even though I think that was probably overkill with a mastectomy though.



At the end of the day, if my cancer comes back I will not regret not doing chemo - I will be confident it would have come back regardless. If I had been grade 3 or had node involvement, different story. I would have had chemo regardless of my Oncotype score.



Jenn

HealingDreams

Thank you so much for your personal experiences related to this difficult decision.

Like Nancy HB, I'm hoping for a definitive response from the test, something not the extremely grey area of 11 to 25, that the TAILORx study is looking at. I'll let you know when I hear.

juneaubugg

I just got my #from BS and see MO tomorrow. Number is 22. Really uptight again.

HealingDreams

Let us know what your MO thinks and what you decide, juneaubugg. It's really hard being in the middle range.

My MO "splits the difference" on the 18 to 31 range, i.e. at 24-25, so probably would not recommend chemo for you, especially if you are post menopausal. Regardless of whether you are post-menopausal or not, it's a tough decision to make.

Get all of the information you need, and trust yourself to make the right decision.

I'll be thinking of you. 

Lee7

To add this discussion, there is also a trial now called RxPonder that is like the TailorX trial.  The RxPonder is looking at the Oncotype low and intermediate area for those that have 1-3 positive nodes to see where chemo is a benefit and where it is not.  

curveball

I signed up for the RXsponder trial, but when my score came back at 28, I became ineligible (the highest score that can participate is 25). I have my printout before me as I write. It shows rate of recurrence or death (in 5 years of followup) along the left side, and Oncotype score across the bottom. It's interesting to me that the lines for Tamoxifen only and Tamoxifen plus CAF-T chemo cross at about 19 whether you have 1-3 positive nodes or 4+ positive nodes. In other words, if your score is below the crossing point, your estimated disease-free-survival rate may actually be lower with chemo than without it. The chart also shows lines for 95% confidence, the area of uncertainty on each side of each line. Again interesting to me is that at scores somewhere around 32 or 33 the distance between the two corresponding treatment lines (i.e. between hormone only and hormone + chemo, for the same node status) exceeds the width of the area of uncertainty. Again, this happens at about the same score with any number of positive nodes. If I understand the meaning of the chart correctly, above the low thirties you can be very nearly certain there is a benefit to adding chemo to your treatment, at least if you use the same chemo regimen as the study did.

cookiegal

@jeauneaubug

I'm a 22 also.

On the node positive chart, it looks like the "chemo benefit" kicks in at 20.5. Yeah it would be good to be there.

My onc was fine with no chemo for node positive up to 20...but I declined it.

Lee7

So my RS with the positive node is 20....  Talk about being in the gray area! Would I benefit from chemo or would it just hurt me?  I also had to consider the time that had elasped in my case. I would have been starting chemo almost 4 months after the biopsy and lumpectomy. What I really wish is that I could've started the AI right after surgery. I did start it at the same time as rads.  Hopefully I got some benefit out of that.

juneaubugg

Cookiegal: love the name... I think im going to opt out too. My MO hasn't pushed either way. In fact she's driving me a bit nuts! I have clear nodes and margins and I just don't think I can handle this too. I've had enough. My exchange is still a little over 3 months out.



I see my BS for the first time since surgery Thursday.

Hortense

My score is 20 and I have 2 out of 2 nodes positive. I spoke with oncologists at two top hospitals in NYC and both felt that as I was on the low end of intermediate I would benefit from chemo, so I just completed four treatments of T/C two weeks ago. I will be starting radiation next month.

Like mdg, I used cold caps. I have kept most of my hair.

juneaubugg

How did you arrange for the cold caps. Did you order a kit and they bring the ice too!? I'm so confused. I'm supposed to start Monday in north jersey.

Chris13

My score was 6 (CI 4-8) and reported to me as 8, maybe because of the one positive node. Oncotype not entirely correlated with node positive so far.

 My MO recommended chemo. I expressed surprise and she suggested taking my case to her tumor board. They recommended testing my second tumor (ILC, both 1.6). Waited for results and found out they sent wrong sample , so again waiting for results.

So a low score is not necessarily a no chemo call from the MO. I'm 65, too young for automatic AI, too old for automatic chemo, she told me--plus had one postive node. 

edwards750

My ONC decided the Oncotype test would determine my treatment plan. I had Stage 2, Grade 1 BC. One positive micromet in the SN. Had they not split the tissue they would not have known about the micromet but they did and my BS immediately said it would get me chemo. Devastated of course but luckily its the ONC who makes the call. I had the ONC test done and my score came back 11. It is true a low score does not mean you dont get chemo but it is an overriding factor that you wont. I also had a non aggressive cancer and a small tumor. I think even though there are conflicting reports and decisions made by a BS and ONC the final say is made by your ONC. We were all inundated with information at the time of DX and when it was time for a treatment decision because the fact is it is our decision. I had 33 RADS treatments. They were a piece of cake compared to chemo. The techs were great and the procedure took less than 10 minutes. I had SEs like fatigue and burning but overall it was not bad. I am on Arimidex and am blessed that I dont have the debilitating SEs from the drug. Of course we all are going to be forever looking over our shoulders because once you are DX with the C word your life is never the same. How could it be? I have read a lot of stories from women who are over 10 year survivors and some of those women had Stage IV which is remarkable. I have also read accountings from ladies who had low ONC scores the cancer came back. Researchers are at a loss as to why that happens or even why some of us get BC to begin with. We would all love to chill and not fixate of what ails us but that is virtually impossible to do. I try to focus on other things and not dwell on an ache or pain but rest assured if it is a pain that does not go away and I didnt have prior to my DX I am going to consult with my ONC. I prefer to be the perpetual optimist. Had all of us not had our annual mammograms we might not be posting on this board. I was blindsided but relieved that BC is no longer the death sentence. With absolute certainty I would change doctors if you dont feel comfortable with your dr; he/she is your lifeline. Had my dr been too ambivalent I would have looked elsewhere. There are a number of drs to choose from. I found mine from advice from a friend who had BC. He is one of the two best in town but also a charm school dropout. He so needs to work on his bedside manner. Still at the end of the day it is our life and our decision. Just make it and dont look back.

Jazzygirl

Hi ladies- I have been on a couple of these discussion groups since November and now found this new thread about the OncType Dx test. I had a small invasive areas on the left, DCIS on the right and had a lumpectomy on both sides. Now going through internal radiation (left just completed last week, right to be done in February).

Went to see my breast surgeon today for a post check on the radiation and got my OncTypeDx results for both sides. I fell in the intermediate range (although I was not given the exact numbers and will call back for those) and was told that I now might need chemo. It has been off the table with a very early stage bc and dcis with low grade, but now with the intermediate chance of it coming back, new information that may suggest more treatment. And just when I thought I was seeing the light at the end of the tunnel (which now feels like that train coming back at me!)

I am going to be seeing two MO's to discuss this- one at my out of state radiation center I will go back to next month and the one here. My breast surgeon says there is no clear answer about chemo with an intermediate score, and she mentioned the Taylor X study but that it won't have info for another two years to help with some of the stats for women to make decisions. So my hope is between the two MO reviews, I will have enough to make a decision about the pros and cons of doing or not doing chemo.

More to follow!

Rockym

Jazzygirl, I can tell you from my own experience I would have done anything to NOT have had to do chemo.  Looking at your stats, it seems that you have had all the treatment that usually goes with IDC, DCIS and no nodes.  The big question would be perhaps your age and how do you feel in your gut.  Chemo is very powerful and for some it can cause permanent damage and leave you worse off.  I'm not saying don't do it, but I am saying it's important to look at the benefits versus the harm.

Jazzygirl

Hi Rockym- thanks for your note. I always said I would do surgery and a bit of radiation but no chemo. My breast surgeon knows I am not oriented to do chemo unless there is a for sure reason to. I think your advice about understanding the pros and cons is important. I am already researching things so I am prepared for my two MO apts, which won't be for awhile yet. Just been processing the "new information" today.

I am age 52 so the doctors say I am "young" and may live another 30 plus years so they have tailored much of my care around what they think is best with respect to that. My guess is my age will be a factor with this too. One thing I am learning is much of the standard care was always designed in mind for older women who got cancer in their 60s or later. Now they are rethinking a lot of things knowing women will have to live with the longer term side effects for 20 or more years. So far, I have done well through the surgery and the 1st side of internal rad.

My sister also has bc at the same time as me (she got diagnosed 2 months before me) and just came off chemo in November. She has an HER2+ cancer so they did chemo to start, but have heard the effects from her and she tells me some of the things that now seem permanent like numbness in her toes. I have heard from other women on this site about cateracts from chemo. These things make me think to not go there. 

Appreciate your feedback!

Rockym

Jazzygirl, have you had the BRCA test (since your sister had cancer too)?  Have you looked at cancermath.net?  You can plug in your stats and see how much of a percentage difference (regarding recurrence and death) one or another treatment makes.  Also, if you have some specific questions, Lilly (a 2x survivor and RN) at Johns Hopkins answers individual questions on their website at:

http://www.hopkinsbreastcenter.org/services/ask_expert/

I asked many questions before treatment and she was great.  She gave me better answers then my MO at the time.  I ended up sending my pathology slides to them for a second opinion.  That helped a lot with my decision.  By the way, I was a 22 Oncotype too.

pupmom

Chris, why are you too young for an automatic Al? I got Aromasin immediately after surgery. I was age 63 at the time.

Jazzygirl

Rockym- yes, I had the BRACA test and it was negative. We have no history of bc in our family, but when we both came up with it at the same time and also some other reasons, I had the test done.

Thanks for the Hopkins and cancermath.net links, going to look into that too!

curveball

@chris, did you ever get the results back from Oncotype on your 2nd tumor?

I have the same question as yorkiemom, why no AI? Menopause isn't a chronological age, it's a hormonal status. There is a blood test that can tell you definitely whether you are menopausal. I asked my gyn for the test--my status was uncertain because I'd been using a Mirena IUD for some years, which suppressed my period. Originally my onc was going to prescribe tamoxifen for 2 years, followed by an AI, on the assumption that if I hadn't gone through menopause yet, the tamoxifen would probably trigger it. Later on, after getting the test results that show I am definitely post-menopausal, and the raising of a possible clotting issue (still awaiting further investigation), he switched to starting me on an AI as soon as I finished chemo, which was two days before my 57th birthday.

Lee7

curveball, yorkiemom, the way I read chris's comment was she's 65 and that is too young for an automatic AI...meaning, they wouldn't just skip chemo and put her directly on the AI because of her age.  I would think after chemo, then they would follow with the AI.   I am surprise though that her MO was recommending chemo with the low score, unless her MO still always recommends chemo when a node is positive no matter what.

pupmom

Ok, Lee, that makes sense. I thought the onc prescribed Tamox rather than an Al because s/he didn't know if she was post-menopausal. There are few, if any, women who are not post-menopausal at 65. I never got chemo so haven't had that conversation.