TAILORX trial results Monday, September 28

Anonymous

Hi labelle, I too was a 11 Oncotype with isolated tumor cells in one sentinel node and was Stage 2 at 2.2 cm IDC. I still believe that the Oncotype is correct. It doesn't mean that you aren't going to 100% not be mets but it means that chemo will not help.

voraciousreader

Here is a taken from the above link from Sloan Kettering's Dr. Hudis:

"The results are a "confirmation" that the 21-gene assay, which has been used for about 10 years by clinicians, "can identify a cohort of patients who should be spared chemotherapy," writes Dr Hudis.

However, he adds, the TAILORx results are "both reassuring and frustrating."

Dr Hudis believes results from this and other prospective trials "cannot come soon enough," given the already "widespread adoption" of the assay by clinicians. But there is a problem, he says: the investigators changed the recurrence risk scoring scale for the study.

Dr Albain and her colleagues explain that because they wanted "to minimize the potential for undertreatment of the participants enrolled in our trial," they tightened the definitions of risk.

Thus, recurrence scores used in the TAILORx study are different than those generally applied in the widely used assay for low (≤10 vs <18), intermediate (11 to 25 vs 18 to 30), and high (≥26 vs ≥31) ranges.

Dr Hudis is worried about the changed low-risk definition. "For the many physicians already using the test, the gap between this cutoff point of 10 and the higher 'standard' cutoff point of 18 may be a concern."

And he anticipates trouble. "There will be two conflicting guides to their treatment that need to be reconciled: the cutoff point used in this trial and the previously available cutoff point that is associated with the commercial test," he explains.

But Dr Hudis suggests that the snafu is not overwhelming, in part, because it is likely that other multigene tests will also be proven to "provide a prediction of chemotherapy benefit."

Less expensive tests would be helpful, especially for global use, he says. The Oncotype DX is regularly cited as costing $4000."

voraciousreader

ahhhhhh....quote from the folks who designed the OncotypeDX score!

I was correct! There haven't been enough recurrences yet! AMEN!👏👏👏👏

https://www.genomeweb.com/molecular-diagnostics/ta...

"Without data on the ultimate outcomes of these patients, drawing a conclusion on what these discrepancies mean has been impossible. Unfortunately, the current analysis of TAILORx has not yet delivered the awaited outcomes data for the randomized intermediate RS subcohort that could help answer some of these questions.

Steve Shak, chief scientific officer of Genomic Health, told GenomeWeb that this is because there simply haven't yet been enough recurrences or other events in this subset to exclude or confirm a benefit from chemotherapy.

"The data monitoring committee advised that [the researchers] need to continue to follow those patients and that they will inform them when that [intermediate RS] analysis can be done," he said. "The understanding … is that it's taking longer because the event rates are low, which would be great news for patients."

123JustMe

From his lips to God's ears

jctreehugger

Voracious, I was just coming here to post that link because it gives us a little bit more info about the 11-25 RS folks. Good sign indeed.

voraciousreader

jc....they don't call me voraciousreader for nothing! That said, I am deliriously happy that other sisters like you have stepped up to the plate and are actively pursuing the evidence!

Tonight, instead of being disappointed that there hasn't been statistical significance data, I'm going to sleep well. This PROSPECTIVE study should usher in more tests like TAILORX. More and more genetic tests will make visual pathological tests unnecessary. Patients will be seeing more individualized treatment based on genomics. How truly amazing!

momand2kids

so

I am confused--I thought I was "intermediate at 26 or 27" but this has me at "high"????

did chemo-so I think I did the right thing, but was hoping for more clarity....sigh

thanks to all of you who keep posting this info for all of us....

momand2kids

so

I am confused--I thought I was "intermediate at 26 or 27" but this has me at "high"????

did chemo-so I think I did the right thing, but was hoping for more clarity....sigh

thanks to all of you who keep posting this info for all of us....

labelle

None of that has changed-26/27 is still considered intermediate for treatment plans.

They changed the parameters for this study only-at least that is my understanding-divided participants into low/med/high, not based upon existing models, but upon how they wanted to set up the study/place the dividing lines. As a result of this study treatment guidelines may indeed change someday but as of now that has not happened.

voraciousreader

mom...calm down!!!!! The takeaway message is that you still are an intermediate and I am still a low AND WHAT TAILORX HAS FOUND SO FAR IS THAT FOR SCORES OF 11-25...THERE HAVE BEEN FEW RECURRENCES....FOR THE PURPOSE OF THE TEST, THEY RANDOMIZED THE GROUP AND GAVE HALF OF THEM CHEMO AND IT HASN'T SHOWN YET IF CHEMO HELPED....YET! AND FOR THE REST OF THOSE IN THE INTERMEDIATE ZONE (25-30) THEY GAVE ALL OF THOSE SISTERS CHEMO....SOOOOOOOOO..until 2017 we are going to see how all of the 11-30 intermediate scores fare....but for now we all can sleep a tiny bit better! This is all good news!!!!

39andhip

I'm glad I had this board to remind me that these results just came out! I had an Oncotype DX of 13, and was sort of sad to see myself moved into the 'intermediate risk' category for this study, as well as the category for which they did not have definitive results. Nonetheless, the important takeaway message for me is that this test does indeed have strong predictive value. There won't ever be a definitive way to dictate individual medical treatment; there's always going to be gray areas, and additional results are just going to move those gray areas around. Heck, I got DVT after hip surgery, when there was supposedly only a 1% of this happening, and I still put faith in statistics.

P.S. @voraciousreader - please don't yell at me. I GET that I am still 'low risk.'

voraciousreader

39....you have just started your journey and all I will say is that, I scored a 15 and was told chemo would not benefit me. I put faith in the test and here I am over 5 years later ....doing well! I am so glad the Oncotype DX test was developed and thrilled that the TailorX trial was commenced. Going forward, it is wonderful to know that we are moving away from one size fits all treatment.

39andhip

It's interesting... somehow my Oncotype DX got sort of overlooked during the whole hoopla of my initial diagnosis/surgery, and I didn't even have the results when I was shopping around for MOs. So I never really had a lengthy discussion about it with a doctor. When I looked up the TAILORx results today, I have to admit the numbers they used to define their groups confused me a little, which is why I found this thread. Thanks to all who contributed in clarifying this.

My understanding is that this is a retrospective/prospective study - meaning the Oncotype DX assay was developed based on the genetic characteristics of tumors that recurred/didn't recur within a certain time frame, so researchers already had confidence in the data. The latest results confirm this confidence.

Anonymous

I am so enjoying this discussion concerning Oncotype. I was diagnosed in 2007 and no one on this website knew much about the test. My doc is a research guy and he was part of the study for the test. I did a tremendous amount of reading on the test and with my 11 decided not to do chemo. Now when I talk with the doc and his staff they admit that many doctors encourage chemo because they make money out of it. Just as we have seen on the news recently. Disgusting but true.

voraciousreader

aug...while I would agree with you that there are still some doctors still offering chemo because they profit from it, IMHO, nowadays, because of advances in digital technology, it would be more difficult to do that. Today, there is a better way to find all kinds of doctors, in all kinds of specialties, that are practicing outside of the norm. Today we have multiple databases that are discovering the bad apples.

That said, if you read Otis Brawley,MD's terrific book, HOW WE DO HARM, you will read about how some patients will beg for chemo despite it being unnecessary. He describes a patient who went doctor shopping until she finally found a physician that would give her chemo. So there is some blame on the patients' behalf as well.

Here on the discussion board, I have seen such cases! I recall a sister who came here looking for "support." With an OncotypeDX score of 11, she went doctor shopping to find a physician who would give her chemo. Sloan Kettering was among the places she went. EVERY SINGLE DOCTOR TOLD HER NO CHEMO. As she traveled from place to place, some sisters told her to keep traveling. I, on the other hand, told her how lucky she was to get there opinions including one from Sloan Kettering and that she should accept their opinions. After suggesting if she still was emotionally uncomfortable with the decisions of the PHYSICIANS, she should seek counseling, I WAS PILLORIZED BY SOME SISTERS. So.....there were, and still are, some sisters who will not take no for an answer AND, a handful of sisters whose way of showing "support" is to fuel another sister's worry.

Aug...you have touched a nerve with me because I have seen too many sisters here disparage too many doctors. Make no mistake, I am not naive. There are some nefarious physicians and researchers. But I think we need to quantify our beliefs and statements.

That said, the whole idea of creating the genomic ONCOTYPEDX test AND the TAILORX trial, was, so that many, many, many more patients could be spared chemo. Is offering chemo a money making proposition? Yes! But so is angioplasty and soooo many other treatments! Consequently, we must be very careful when we are making treatment decisions and not let our prejudices stand in the way while making informed decisions.

labelle

Hopefully the Tailorx results will help those with low oncotype scores who have been told they don't need chemo to rest easier and curtail the desire to doctor shop for chemo (I've seen this on here as well) and will also stop some doctors from recommending chemo to those with low scores with reasoning like "your oncotype score is low, but you are so young you should have chemo anyway." We see and hear this and I always wonder how, if the genetic profile of the tumor shows it won't respond to chemo, the age of the patient can make chemo work better?TailorX results while not complete, are certainly validating the fact that many women w BC can definitely safely skip chemo and all the side effects associated with it and that oncotype testing is as accurate as we've been told it to be.

Anonymous

Dear Voraciousreader and everyone, I love this discussion and love everyone getting to share their thoughts. I am repeating what my doctor stated about other doctors and I certainly hope it strikes a cord with everyone. I believe that there are good doctors and bad but every doctor makes a living through their practice. Look at doctors who offer reconstruction but 'forget' to inform the woman that they will need an exchange every xx years. I personally went to a plastic surgeon who just simply left out that fact. I think that we all we be informed consumers whether it be medicine, cars or iphones.

39andhip

I agree wholeheartedly with voraciousreader that patients are often as much at 'fault' as doctors, especially in this era of patient-driven treatment. Just look at all the ads for pharmaceuticals on TV - those are directed toward patients, so the patients will push their doctors to prescribe something for them. When I went for a consult with an MO, he went on and on explaining to me why he didn't think I would benefit from chemo and I finally told him I didn't need convincing. He seemed surprised and relieved and said that so many patients he saw wanted chemo that he always had to give a thorough explanation of the risks and benefits. (I wrote about it here: http://39andhip.blogspot.com/2015/06/consultation-...) I've also seen the same thing here... Someone actually said to me and another woman trying to decide on chemo/no chemo that there are two types of cancer patients - those who fight and those who just lay down and die, and she chose chemo because she is a fighter. I think it's sad that choosing not to do chemo when there are little data to suggest that the benefits would outweigh the risks is perceived as some by 'laying down and dying.'

That said, there are many doctors out there who offer treatments based on money, just like in every other institution that needs money to operate. My husband works in medical sales, which is, of course, profit-driven. At the same time, this need for profit has resulted in the development of amazing drugs and devices that save lives. Two sides to everything! Thank goodness we have the Internet so that we can be informed consumers - not just of medicine, but iPhones, too.

Thanks for the lively discussion!

Anonymous

Again, I love the discussion!

voraciousreader

yes....labelle! The TailorX trial should give confidence to both patients and physicians alike! I really believe that the documenting of treatment and outcomes in the digital age will benefit sisters to come. This is all great news!

grammakathy

This type of discussion is reassuring to me. There are others out there who question their doctors and do independent research and then make a decision based on what they learn. There are people who get scared and follow the directions of the first person/doctor they talk to. In my opinion, each choice needs to be made by the individual involved after understanding all the risks for each action. And understanding that doctors are people too, without magic wands or the ability to foresee the future.

voraciousreader

gramma....yep!

123JustMe

Interesting Q&A from John Hopkins:

Have you heard anything about when the results for the 11-25 RS group will be released? Should people in my situation be concerned? Thanks for all you do.
Replied JHU's Breast Center Reply
9/30/2015 probably at the san Antonio breast cancer conference in dec. your score was quite low. women don't do chemo for a score of 11. don't fret.

JohnSmith

I'm not surprised by this early data, but I do have questions everyone should be asking.

To recap, for the low-risk cohort, results showed that at 5 years:
1. distant relapse-free survival = 99.3%
- I assume 0.7% experienced metastasis, correct? What was unique about this group?

2. invasive disease free survival = 93.8%
- This refers to the group that experienced local / regional recurrence, correct?
Would I be brushing with broad strokes to assume this relapse group had a higher percentage of the lumpectomies and the surgeons didn't get "clean margins"? I clearly understand that the mastectomy cohort has no greater overall survival benefit, so I don't want to start a debate about which is better.

3. overall survival = 98%
- What was unique about this 2% that didn't survive? What % died from something other than BC?
- What was the subtype? IDC, ILC, etc.
- What were the genomic characteristics of these tumors?
- Have they done extensive genetic and molecular tests?
- Was this 2% truly "node negative, ER+, HER2-"? Can an independent lab re-test to verify?
- What was the average age of the 2%? Given the notion that age (preM vs. postM) is an independent factor that determines OS, as elucidated in this recent research called "The molecular landscape of premenopausal breast cancer" which essentially says the estrogen receptor behaves differently between the preM vs. postM cohort and specifically that preM tumors may respond less favorably to hormone therapy.
- Finally, what was the analysis of the cancer stem cells? Could they isolate them and if so, what was unique about them?

These questions should be applied to all three groups, but at the very least, I hope the researchers are doing a deep investigation about this 2%.
It would be a crime if they weren't.

voraciousreader

john..you can rest assured that EVERYTHING is being looked at! What I find interesting is that this study comes on the heels of the recent DCIS study. Labs all over the world will be tackling the results of both and will be looking for morsels that require understanding.

39andhip

@JohnSmith - re. #1 and #2, I thought this part was sort of confusing - but admittedly, I haven't read the results carefully. I think the 93.8% included deaths from other causes.

From the article:

"Recurrence events were uncommon regardless of histologic grade and were not significantly affected by younger age at diagnosis. In fact, in this low-risk population, the rate of recurrence events at 5 years was far exceeded by the rates of second primary breast cancers, other second primary-cancer events, and deaths from other causes, which resulted in a rate of invasive disease–free survival that was nearly 5 percentage points lower than the rate of freedom from recurrence (93.8% vs. 98.7%)."

voraciousreader

39...you are correct!

And the important part was that younger women did, in fact, DO BETTER THAN EXPECTED!

voraciousreader

I just want to mention...having visited the Sloan Kettering Rare Breast Cancer, these last few years, I want all of you to know that the researchers continue to surprise themselves with respect to their accelerated pace of discovery. They made me extremely aware of how they and other labs around the world have discovered and learned more about breast cancer in these last few years than they had in the last decade.

Looking ahead to the next few years, this latest study makes me very hopeful

123JustMe

Wondering how tamoxifen resistance plays into this?

http://www.breast-cancer-research.com/content/7/s1/s19/abstract

upsidedown42

This paper gives me some more confidence in the oncotype test.....just crossing my fingers that my test results come back low! Oh waiting is the worst! But I am grateful that this was published now for my own understanding and piece of mind.

When I was diagnosed (on 7/31/15), the nurse navigator told me that my experience would be completely different from my mom's experience with breast cancer. I kind of scoffed...I mean my mom was diagnosed in 1996 (passed away in 2003), not the stone age. How much has medicine changed? Well, the further I get in this journey the more I think this is true. My oncologist told me that if I were diagnosed 10 years ago, chemo would probably be a sure thing. I really find this advancement amazing.

Just my rambling for the day!