Oncotype test for DCIS post-surgery radiation decisions

Beesie

Big news.  There was an announcement today at the San Antonio conference that the clinical trial using the Oncotype test to determine if radiation is needed after DCIS surgery was successful - and as a result the Oncotype test will be made available to doctors for this use as of December 28th.

The study, presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium, met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score goes beyond traditional clinical and pathologic measures to predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast....

The study demonstrated that 75% of patients have a low DCIS Score as pre-specified in the study and may be able to forego radiation therapy. DCIS breast cancer patients with a low DCIS Score had a low 12% likelihood of a local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast, and an even lower 5% likelihood of developing a new invasive breast cancer. Conversely, the study demonstrated that patients with high DCIS Score had a 27% likelihood of local recurrence, of which approximately half was likely to develop a new invasive breast cancer. The DCIS Score also demonstrated consistent association with local recurrence across subgroups regardless of lesion size, grade, surgical margins, or menopausal status. 

http://ca.finance.yahoo.com/news/genomic-health-announces-positive-study-233000822.html 

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I saw this story reported on the NBC news tonight and I was really disappointed in the way that DCIS and these results were positioned.  They referred to DCIS as being a "pre-cancerous condition" and although they explained that the Oncotype could be used to determine who needs radiation, the way that it came across it sounded as though no treatment at all (including surgery) is needed for low risk cases.  

NBC Video Segment on Oncotype use for DCIS 

Not sure if this link to the video will work; if it doesn't, you can go to the NBC Nightly News website, then to 'Health' and 'Women's Health'. The video is at the top of the list. 

Edited several times to try to fix the link - it keeps going to the next video.  Hopefully I got it right but maybe not! 

digger

Very, very exciting news!

miricurt538

I thought I had pretty well made my mind up about treatment for my DCIS, er/pr+, stage 0, grade2 dx, but this makes me more confused.  Have an appointment with onc day after tomorrow so I will see what she says.  I see a lot of women on here who have the Oncotype DX test and go on to have chemo and I see no need of doing it if I went on to have radiation anyway.  $4,000.00 isn't cheap.  Even if one's insurance pays, the more they spend, the less they will allow on all charges.

pcollins

Thanks so much Beesie, you are a true font of knowledge.  I plan on taking this information to my BS visit tomorrow.  Also have a doc friend who attends these annual San Antonio conferences and plan on asking him how this will improve our treatment going forward. 

cinnamonsmiles

I get so irritated with people who call it pre-cancerous. The better term is pre-invasive. I just had my ovaries out last week, so I am a bit touchy  (bitchy). It is like an oxy-moron. Why would you give radiation for pre-cancer? Just doesn't make sense.

I am also afraid that women and health professionals will look at this and apply it generally across the board, rather than a case by case basis. And for those who do have low grade DCIS, will this study make it harder for women to get radiation paid for by the money hungry insurance companies who want to cut back payment for more and more services???

As I go back and read again, I see something about not even needing surgery??? Did I read this right? When I found out I had DCIS, I wanted the cancer out. I realize some are on the fence about this, but I would think that is a minority from what I see on the boards. I thought it was out of the question to leave any cancer in my body if there was/is a chance to take it out, I wouldnt't want to leave it in to grow and get bigger.

agada

I was excited by the news as well.  Does this mean those of us who have high family cancer histories and who had bilateral mastectomies can have this test done as well? I was not happy with the way the report was presented, too cavalier for my tastes, and not very detailed.  I think I am seeing a trend in papers, etc.  where DCIS is concerened.  No one wants to call it cancer anymore (until they get it) and want to take a wait and see attitude in case something does turn up positive for cancer.  That is criminal in my opinion.

Agada

lisa-e

Thanks for posting the links, Beesie.   I think this is major, wonderful news! 

 I think one of the worst things about a DCIS diagnosis is the the fact that the treatment (surgery, radiation and tamoxifen) is the same for an early stage invasive cancer.   Hopefully this will begin to change now.

 

dancetrancer

Hey Beesie,

What's your opinion on applying the results of this study to those of us who have had a BMX and are contemplating radiation?

Also, this statement perplexes me:

The addition of radiation therapy for DCIS has been shown in clinical trials to reduce local recurrence risk, but has not been shown to prolong survival. 

If radiation doesn't prolong survival, what is the point?  I know there is something basic here I'm missing, but someone needs to spell it out to me.  

Moderators

Thanks for posting this Beesie!

 

The Mods 

redsox

Dancetrancer wrote:

If radiation doesn't prolong survival, what is the point?  I know there is something basic here I'm missing, but someone needs to spell it out to me.

Clinical trials for DCIS (and early stage invasive breast cancer) use local recurrence as the primary endpoint.  They usually report survival as a secondary endpoint but they do not have the statistical power to detect differences in survival even if survival differences existed.

I'll try to find an old thread on this topic and bump it.

RetiredLibby

Thanks for posting Beesie.  I saw this on NBC Nightly last night and e-mailed my onc.  Even though the ship has sailed for me (the breasts have sailed?!), I asked her if there was any applicability to my current situation.

Dancetrancer, I just wanted to add a personal perspective to the rads/not rads/recurrence discussion.  I was dx at 49 in 2007 with 1 cm (more or less) of DCIS solid form, Grade 3 w/comedonecrosis.  I had a lumpectomy and a re-excision (not really a dirty margin but too long to explain here) with greater than 1 cm margins on all sides.  I had 28 regular and 8 boosts of radiation.  I started tamoxifen on 12/1/2007, a week after rads ended.  On June 24 of this year, I was dx with a recurrence (at my annual mammogram) same breast.  Pathology was 1.5 cm of DCIS Gr 2/3 with necrosis, solid and cribiform.  Both were ER+ >90%; first was PR+ >90%, second was PR+ <5%.  I had a bmx w/immed DIEP recon.  Ditched the tamox, and of course no rads because I played that card in 2007.l

I DO NOT regret having rads or taking tamoxifen.  I would do it over again in a heartbeat, although with the new application of the Oncotype test I might have moved up my mastectomy to the first time.  While I did recur, it was still pure DCIS.  While I don't know (and don't think there is any way to prove) that the rads and tamoxifen kept me on the DCIS side of the 50% DCIS/50% IDC recurrence rate, I can't rule out their benefits.  I am sure there are plenty of women who had my pathology and did what I did and unfortunately recurred on the IDC side of the divide.  But I am confident I did what I could to prevent a recurrence and I'm satisfied with my decisions.  (And, BTW, since I am still pre-meno, I'm having an oophorectomy next spring after my Stage II recon surgery.) 

Good luck to you.

L

bgail84

 Miricurt538 --The company that does the DX test has a very generous allowance. If your income is $80,000 you can get the test for nothing. They will send you a form to apply and are very generous. Please don't let the cost stop anyone from getting the test. Talk to your BS and get the information from him.  Blessed Be!

Beesie

Dancetrancer, as someone who had a mastectomy, I immediately thought of the same question as you.  Can the Oncotype also be used to predict recurrence risk for those who have a mastectomy for DCIS, particularly if they have close margins?

It seems reasonable to think that if the Oncotype provides a better assessment of recurrence risk than the factors that we've been using up to now (size of tumor, grade/aggressiveness of tumor, margin size) for those who've had a lumpectomy for DCIS, then the same should apply for those who've had a mastectomy.  

I'm past treatment so it's not something that is going to affect me but if I were still at that stage it's definitely something I would ask my oncologist about. 

dancetrancer

Thanks Beesie...I'm DEFINITELY asking about this!  

Deirdre1

Beesie you are always on the front lines with new information! I had missed this so I very much appreciate the info.  I am, like you. beyond treatment (5 years in January) BUT I have cousins and sister's and friends who might need this information so I try to stay up to date..  You truly are amazing - 5+ years later and you are still here brining us cutting edge information!    Thanks so much!  Take care, Deirdre

dancetrancer

Seriously, thank you Beesie.  I just emailed my doc and am anxiously awaiting to find out if they will run this test for me or not (when it's available).  Fingers crossed! 

jyg

To those who have had mastectomy or BMX and the question of radiation still exists, this test certainly should be discussed with your oncologist.

However, the study was conducted with women who had lumpectomy with or without tamoxifen. I do not think outcomes can be generalized to those of us who have had mastectomy. I would bet such a study is underway. Although the risk of recurrence after mastectomy is low, this test could be a better predictor than the USC/Van Nuys Index.

Remember this is a genetic test and thus a red flag for anyone trying to get health insurance. The "pre-existing" portion of health reform does not include all adults until 2014, assuming the law does not get changed. Not that this would impact my decision to get tested if it could have changed my treatment decision, but it is something everyone should be aware of before any genetic testing.

cycle-path

Here's another article about today's announcement: 

http://prescriptions.blogs.nytimes.com/2011/12/06/new-breast-cancer-test-may-help-curtail-treatments/ 

Edited to add: Having now read the entire press release, I'm not sure I'm overwhelmed with optimism over this news. The press release says:

"After breast-conserving surgery for DCIS, local recurrences of DCIS or a new invasive breast cancer occur in 20-25% of patients at 10 years, on average, with surgery alone." 

But -- 

"DCIS breast cancer patients with a low DCIS Score had a low 12% likelihood of a local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast, and an even lower 5% likelihood of developing a new invasive breast cancer."

So, let's say I was one of those with a low DCIS score. I used to think my likelihood of a recurrence was 20-25% without rads, but now I learn it's only 12%, which is smaller but not tiny. My question, then, is -- if I still got rads (knowing my risk was only 12%) would I reduce my odds even more, maybe to 6%?

If so, is this study really just giving us more accurate odds, rather than whether or not we "should" get rads? 

dancetrancer

Cycle-path, yes, I think it is giving us more accurate odds.  That information allows each individual to make a better decision about rads, based upon their own personal risk tolerance, weighing those odds against the risks associated with tx by radiation.   

stac

Beesie,  Thank you for alerting us all to this new information...and they say information/knowledge is power.  Well at least when I am informed I can make better choices.

Cycle-path, I just noticed your bio mentions that you had IORT and the website you listed had very helpful information for me.  I am considering that now as an option because I found out last night that the surgeon did not get it all from my first lumpectomy last Friday (i.e. I do not have clear margins). So, now I need to go back again for surgery.  I thought this might be a chance for me to explore the possibility of IORT afterall, but I'd have to go to another surgeon/hospital that has such equipment, which I am fine with.  This probably isn't the best place to chat about such things, but I would like to talk with you more - online is ok, but I'm new to all of this so let me know if you are open to that and how best to proceed and if you are available to touching base in some way.

Thanks again to all for sharing your journeys and the information you are finding along the way to help those of us who are newly diagnosed.  It is a great help.

cycle-path

stac, I'll send you a PM.

Natters

Oh boy, I wish we could get our hands on the presentation, instead of having to rely on the news reports. If I understand this study correctly, they took a group of women with DCIS who were already at low-risk for recurrence (and who only got lumps as a result of that lower risk, rather than all the bells and whistles of rads + hormonals) and tested their tissues then checked to see who had a recurrence down the line. And the test confirmed that 75% of this low-risk women were indeed low-risk and never needed rads or anything else?



I'm not sure what this adds for women who are higher risk, above and beyond the VNPI? I wonder if they have tested or plan to test tissue from women who were higher risks, and who had MX for DCIS....



Nat

dancetrancer

Natters, this isn't the actual presentation, but it does offer more details: http://www.medscape.com/viewarticle/754967Study Details

This study is a retrospective analysis that used data from the 670-patient Eastern Cooperative Oncology Group E5194 study, which compared outcomes in DCIS patients treated with surgery alone with those in patients treated with surgery plus radiation. About a third of the patients also received tamoxifen.

The study revealed the 10-year risk for a subset of 327 patients with DCIS treated with surgical excision (negative margins of at least 3 mm) alone. The patients had low- or intermediate-grade DCIS (2.5 cm or less) or high-grade DCIS (1 cm or less).

The assay was performed with quantitative reverse-transcription polymerase chain reaction, using tumor specimens from the patients. A new, prespecified DCIS score was designed to predict recurrence using an gene-expression algorithm featuring 12 of the genes in the 21-gene Oncotype DX breast cancer assay.

The primary objective of the study was to determine whether there was a significant association between the risk for an ipsilateral breast event and the continuous DCIS score in Cox models.

Among the 327 patients, 46 had an ipsilateral breast event, which was either an ipsilateral local recurrence of DCIS (n = 20) or invasive cancer (n = 26). Median follow-up was 8.8 years. The 10-year ipsilateral breast event rates were 15.4% for low/intermediate-grade DCIS and 15.1% for high-grade DCIS (determined by central pathology review); for an invasive ipsilateral breast event, the 10-year rates were 5.6% and 9.8%, respectively

The continuous DCIS score over the study period was significantly associated with an ipsilateral breast event (hazard ratio [HR], 2.34 per 50 units; 95% confidence interval [CI], 1.15 to 4.59; P = .02) when adjusted for tamoxifen use, and with invasive ipsilateral breast event (HR, 3.73; 95% CI, 1.34 to 9.82; P = .01).

Features associated with an ipsilateral breast event in multivariate models included menopausal status (HR, 0.49; 95% CI, 0.27 to 0.90; P = .02), tumor size (HR, 1.52 per 5 mm; 95% CI, 1.11 to 2.01; P = .01), and continuous DCIS score (HR, 2.41; 95% CI, 1.15 to 4.89; P = .02).

The results also indicated that 75% of the 327 patients had a "low" DCIS score, which was prespecified in the study.

The patients with a low DCIS score had a 12% likelihood of a local recurrence in the study, and a 5% likelihood of developing a new invasive breast cancer. These are the patients who are the best candidates to forgo radiation, said Dr. Solin.

The study also showed that patients with a high DCIS score had a 27% likelihood of local recurrence.

redsox

The official presentation is this afternoon at 4:30 (CST).  More information is likely to be available after that occurs.

http://sabcs.org/ProgramSchedule/Day3.asp

It looks like a big improvement over clinical and pathological factors such as those used in VNPI.  Let's hope so.

Natters

thank you, dancetrancer - that answered one of my questions, about the inclusion of any women with high-grade DCIS. The 15% rate of breast events in those women is close enough to the 20% suggested by my MO, considering that it probably included a lot of post-menopausal women. So I guess I'm not putting myself through all this for nothing. 

I still think that a 12% chance of local recurrence may be too high for some women. And I still would love to see those women scored using the age-graded VNPI and see if the categories differ at all. Because it's really cheap and easy to calculate the VNPI, so I wouldn't pay 4 grand for this new test if it didn't provide any different information. I see they controlled for menopausal status in their analyses, and that is a proxy for age. And they also controlled for margins and tumor size, so it sounds like they're still using some of the pathological and clinical information, but saying this test adds to the prediction, above and beyond age, margins and tumor size. I'd still like to see how different the classifications are using both metrics. 

redsox, it'll be good to get all the details! 

 

dancetrancer

And thanks for your analysis, Natters! 

Moderators

Read what BCO has to say about this latest news!

SABCS: Gene Test Predicts DCIS Recurrence Risk
December 7, 2011
The OncotypeDx test can help doctors decide if women diagnosed with DCIS need radiation therapy. Read more...

Emaline

I don't know how to pose this question....okay many of us have had MX, does this mean it does not apply to us?  I mean even with MX, you can have recurrence, so wouldn't this mean it is still applicable for us who have had MX?  Or it isn't applicable because they can't do the test once the breast is gone?  Wouldn't our pathology reports and all still be on file?  When I went for my second opinion, I was given a shoe box (well it wasn't exactly a shoe box but the size of it) filled with all my slides from my biopsy.  How long do they keep those?  Or it isn't pertinent?

dancetrancer

I think it should apply to MX, b/c they are looking at the genetic factors associated with recurrence, which would show how aggressive the DCIS is, irrespective of grade, margins, lesion size, or menopausal status.  If you have a more aggressive DCIS per the oncotype score, then you should be more concerned if your MX margins are small.  It would be one additional factor, a strong one IMO, to consider.  However, I may be viewing this too simplistically. 

Unfortunately, my RO locally here has refused to order the test for me.  She says it doesn't apply b/c it was done on lumpectomy patients, and also says I already have the other risk factors (small margins, comedo, Gr 2, under 45)  that make me high risk, so it wouldn't change her recommendation, since she doesn't think my score would come back low.  I'm waiting to see if my RO at another facility agrees with her or not.   

ZTeam

Dancetrancer, 

My RO said essentially the same thing, that it wouldn't change my treatment plan. Interestingly, she doesn't recommend radiation whereas I think your RO does?

I hope my MO is more agreeable to the test.

 Lisa 

dancetrancer

Correct.  I guess our RO's think they have all the information they need to make their recommendations.  I can't help but wonder if they would feel differently if it were their bodies?