TAILORX trial results Monday, September 28

123JustMe

It will be interesting to see what the TailorRx study says on Monday!

SoCalGrl

I can hardly wait for these results. I'm an Oncotype 22 and my score made me elect to have chemo. I'm halfway through chemo treatments and I'm wondering if these results will affect my plan of action at all.

C'mon Monday!

voraciousreader

bosum....I wish to clarify what you said because there is a lot of misunderstanding with respect to "lowering." And with respect to the OncotypeDX " accuracy."

Let me begin by addressing the accuracy point. The OncotypeDX score is quite accurate. It is so accurate that in 2011, the NCCN breast cancer guidelines began recommending its use.

Sooooo....one might ask if it is so accurate, why then do they create the TailorX study? The study was created because too many people fell into the dreaded intermediate zone.

Sooooo....then one might ask...why the heck did they lower the intermediate score from 18 down to 11 for the test?

Simple answer was that they wanted to see the EXACT point where chemo's benefits outweigh it's risks....sooooo.....come Monday when the data is released, we might see a trend that the patients who got scores of 25 or 26 benefited, while people between 11 and 24 didn't benefit. The idea of the test was to get as many people out of that dreaded intermediate score as possible. Including people with low scores, 11-18 and randomizing into getting chemo or not, might reinforce the accuracy of the OncotypeDX test and"prove" the lack of need for chemo for people with low scores.

That said....my concern is that there won't be enough recurrences to make the data statistically significant. Furthermore, these results are merely preliminary. The trial will continue to collect data until December 2017. So, we should all keep our fingers crossed that at some point we will see statistical significance.....or shall I dare say....that perhaps in a year or two we will have an even better genomic test that can give us more precise answers as to who needs chemo.....

voraciousreader

bosum.....the reason for the TailorX trial was to try to get as many people out of that dreaded intermediate zone. The OncotypeDX was deemed reliable and was duplicated before it's formal approval.

Owl published an upcoming trial's abstract for the European conference regarding another study that ties into TailorX. I can't wait to see the details because the news seems very encouraging for patients with OncotypeDX scores below 25. Here is the link...

http://www.europeancancercongress.org/Scientific-P...

Again, I pray that TailorX's results are statistically significant!

Sloan15

bosumblues - I'm like you. As long as I don't have any lasting SE from the chemo, then I'll be fine that I'm doing it "just in case." I'm not BRCA pos, but my mom's ovarian cancer was sooo aggressive, my ki67 was high, and the doc said there are genetic markers that we just don't know enough about or haven't even discovered yet that I opted for chemo, too. Like anything, I don't want to regret my choices. I'm glad the TailoRx is coming out so new people to this circus don't have to guess.

Sloan15

BosumBlues - I thought my doc ordered the test, but he ordered some other onco test. It gave him good info, but i wanted the oncotest. I changed MO's, and since it was nearing the end of the window period for my chemo, my 2nd and 3rd opinion docs said, "You are estimated to be in the dreaded intermediate range. It is your choice. Would you have any regrets if you didn't do chemo and the cancer recurred?" I picked chemo for me. The McGee equation and Adjuvant Online estimated 17-25 ish for my oncotest scores. Pending the prelim results of the TayloRx study, I'm going to ask my MO on Monday to still do the oncotest. With another study that came out of that European Conference saying that the genetics of tumors at the beginning sometimes change the cancer later on, I think knowing more genetic info so you can have targeted therapy is going to be the future of treating cancers. What was your oncotest score?

PoohBear-61

Hummmm ...this is what is out so far ....hope there is more than this to come soon for the MID -Range Gals between 11 and 25 !!!

vorasiousreader..ill wait for your interpretation and feedback...maybe you have more info ??? .

"These results, also presented at the 2015 European Cancer Congress (ECC2015, abstract #5BA) today, which involve the group of 1,626 patients with a Recurrence Score between 0 and 10, demonstrated that 99.3 percent of node-negative, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative patients who met accepted guidelines for recommending chemotherapy in addition to hormonal therapy, had no distant recurrence at five years after treatment with hormonal therapy alone. Outcomes were excellent irrespective of patient age at diagnosis, tumor size, and tumor grade".

"Further follow-up of the trial is ongoing to determine whether chemotherapy may also be effectively spared in patients who have a mid-range Recurrence Score between 11 and 25."

123JustMe

I hope more info will be forthcoming as well!

katcar0001

And I hope that "ongoing" does not mean years!

katcar0001

Here is this: "Women with high Recurrence Score results (greater than or equal to 31) and intermediate Recurrence Score results (between 18 and 30) had a 4 percent and 2.3 percent risk of distant recurrence, respectively, after five years of follow-up. The selection of patients for chemotherapy treatment was consistent with the Recurrence Score results as recommended in treatment guidelines."

Edited to add that this was from the Genomic Health press release and quoted from another study, "In an analysis of medical records of 930 patients across four medical centers within Clalit Health Services, the largest Health Maintenance Organization in Israel, Oncotype DX was used to identify patients for treatment with hormonal therapy alone or with hormonal therapy plus chemotherapy (abstract #1963)."

Anonymous

On the national news this morning, they gave info from Vienna that states the low scores had a 1.3% recurrence. I cannot find this on the European Cancer website. Can anyone else find this?

jctreehugger

Here is a link to the Sparano abstract on the TAILORx study results and the online New England Journal of Medicine study. It only addresses the Recurrence scores <10, with the good news of very low recurrence for women with those scores. I am disappointed that they didn't report anything for us intermediate score women. I would have loved to even see the recurrence numbers.

https://www.europeancancercongress.org/Scientific-...

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

And a helpful editorial on the study

http://www.nejm.org/doi/full/10.1056/NEJMe1512092

The NEJM articles are open access.

Here are two abstracts 1937 and 1963 that are slightly more relevant for intermediate RS folks like me.

https://www.europeancancercongress.org/Scientific-...

https://www.europeancancercongress.org/Scientific-...

123JustMe

jctreehugger,

Can I ask what your Oncotype score was?

jctreehugger

Hi Sue - my score was 20. I am a new poster and trying to figure out how to fill out my signature!

voraciousreader

My take on why they haven't published the 11-25 Score results is probably like my gut feeling was telling me was because they need to study this group longer.....perhaps not meeting statistical significance at this time....

The accompanying New England Journal editorial mentioned the frustration that still exists for those patients with scores between 11 and 25....

I guess we will have to wait a bit for those results....

Now what is truly important that this study has established....and this info is HUGE....is that irrespective of age and traditional staging factors....if a person got a score below 11, they did not need chemo at all!! That means, the genetic test is EXTREMELY accurate! Now, we need to know the rest of the story....

So, stay tuned to late 2017 or early 2018...

My gut is telling me, you will still see exceptional numbers for patients who will be able to forgo chemo....

SoCalGrl

Good news for <10 onco scores, but I was really hoping for more info on the intermediate scores.

I'm a 22 Oncotype and am halfway through chemo.

123JustMe

JCtreehugger,

Thanks! The signature line is under the settings tab....I had a hard time finding it also

123JustMe

As for the study....frustrating because I'm not sure where that leaves me with a score of 15

MsPharoah

I was anxiously awaiting this news....but the news was a big DOH! for me. No chemo for 10 and under....double DOH! They could have announced that on a Friday when no one was paying attention, in my opinion.

It does help the younger women with high grade cancer make a no chemo decision, but I'm not sure those were the largest number of people in a "gray area".

MsP

labelle

Not as much info coming out of this study as many of us had hoped for today, but what has been released is very positive IMO, showing the oncotype testing to be quite accurate. I guess it is not too surprising that they want to study those in the 11-25 range a bit longer, but the info released so far shows oncotype testing and the advice many of us received based on our scores to be sound. Thanks for sharing.

123JustMe

Labelle,

Would you mind posting your Oncotype score?

jctreehugger

I am with you voracious reader, maybe the recurrence is also fairly low for the intermediate group such that they can't yet see a difference between the chemo and no chemo groups in the intermediate RS folks (similar to the Paik et al 2006 retrospective study in JCO). I am hoping they would have spoken out if the results were really clear for intermediate folks (10-25) about not taking chemo. But of course that is a guess without any more information!

I'm just glad to be able to talk about these results with you all. I was up late last night reading the abstracts and emerging news stories from Vienaa, trying to wrap my brain around all this stuff.

Moderators

jctreehugger, welcome to our BCO community and thank you for posting this information. Indeed, it is frustrating that it doesn't include other Oncotype scores! We will take a look and see if we can find additional information on this. We never meant to imply that the members should reach out to them, rather that we should consider doing such. Our apologies for the lack of clarity.

Also, on a different note, if you need assistance filling out your signature, please let us know.

NOTE: Treatments and diagnoses marked as public are displayed to other users on your profile page and are included in your Discussion Board post signature. Also, you can add something additional by going to My Profile: Settings.

keepthefaith

I think I read that the results for the intermediate scores are supposed to be out in 2016 or 2017...

When I asked my MO how much benefit she thought I would get with chemo, she told me 50% (of 13%, I guess); being a 21 onco-score, I guess that is probably not true. Luckily, I have fared the chemo well. I am glad to see the onco-score is a good indication of recurrence, regardless. I think I still would have worried about a stray cell wandering around, had I not done chemo. We are fortunate to have such advanced research to help us with these hard decisions. Thanks to anyone who has participated in the trials to get us where we are today!

Anonymous

The only thing is even if the recurrence/mets rate is 1.3%. It's still 1.3% and if you are the 1.3% you still die.

123JustMe

True Aug242007,

If you are in the 1.3% recurrence group your rate of recurrence goes from 1.3% to 100%......

labelle

123, my oncotype score was 11 and even w one positive node, doctors at two different BC centers said no chemo for me, based on the oncotype score. They seem to put a lot of faith in that number, so I'm glad to see results that seem to show their faith is justified.

While a low recurrence rate is not a zero rate, treatment with chemo, while it can cure, can also be deadly. Our doctors seem to try to sort out for whom the benefits of chemo might outweigh its risks. The oncotype test scores seem to be a pretty good/accurate tool for them to use-at least that is what the data seems to support.

123JustMe

Thanks Labelle!

Hotrodmommy

I'm feeling very confused about my score of 12 believing that I fell in the low range, it now looks like I'm in that GRAY area Errrr!!  So does this mean they have completely reconfigured the numbers for low, intermediate, and high ranges from what they have been??? That's more surprising to me then the results. This still is very positive news, and glad to see that Oncotype DX testing is reliable. Just feel more confused and discouraged. 

voraciousreader

Since there is soooo much misunderstanding, I'm reposting what I wrote earlier.

Below is what I wrote and I hope it clarifies the misunderstandings.

Furthermore....the results seem to confirm my thought that the "intermediate" group's score has not yet been validated. I put "intermediate" in quotes for a reason....see below.....those of us with score of 11-18 are STILL low scores....but they are trying to validate at what point chemo is needed, so the low 11-18 scores were included in TAILORX

I feel comforted with respect to today's announcement. It seems to really validate the OncotypeDX test... And that it is even more accurate than traditional categorizations for invasive BC.

I'm beyond the five years since diagnosis with a 15 score and I did not do chemo. So far, so good. I think in two years, my prediction is that many, many more BC patients will get out of the dreaded intermediate score zone and will ultimately not need chemo!

....I wish to clarify what you said because there is a lot of misunderstanding with respect to "lowering." And with respect to the OncotypeDX " accuracy."

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Let me begin by addressing the accuracy point. The OncotypeDX score is quite accurate. It is so accurate that in 2011, the NCCN breast cancer guidelines began recommending its use.

Sooooo....one might ask if it is so accurate, why then do they create the TailorX study? The study was created because too many people fell into the dreaded intermediate zone.

Sooooo....then one might ask...why the heck did they lower the intermediate score from 18 down to 11 for the test?

Simple answer was that they wanted to see the EXACT point where chemo's benefits outweigh it's risks....sooooo.....come Monday when the data is released, we might see a trend that the patients who got scores of 25 or 26 benefited, while people between 11 and 24 didn't benefit. The idea of the test was to get as many people out of that dreaded intermediate score as possible. Including people with low scores, 11-18 and randomizing into getting chemo or not, might reinforce the accuracy of the OncotypeDX test and"prove" the lack of need for chemo for people with low scores.

That said....my concern is that there won't be enough recurrences to make the data statistically significant. Furthermore, these results are merely preliminary. The trial will continue to collect data until December 2017. So, we should all keep our fingers crossed that at some point we will see statistical significance.....or shall I dare say....that perhaps in a year or two we will have an even better genomic test that can give us more precise answers as to who needs chemo.....