Anyone with DCIS had the Oncotype test?

Infobabe

(I posted this on another thread but I think this is more appropriate.)It is available for DCIS since last December but few doctors are ordering it.  I don't know if they are unaware or if they have good reason, or they don't like to change.  Maybe they don't like their patients telling them what to do.I am running into a brick wall.  I asked my RO by phone.  His staff called back and said,"they don't do that for DCIS"  I asked her who "they" are.  She didn't know.I am not letting this one go. Has anyone had any success with this.  How did it change your treatment plan? 

BLinthedesert

Infobabe - the oncotype DCIS test is still in the research stage, it has not been validated.  The preliminary study that showed it was "useful" for DCIS was performed on stored samples from a clinical trial (meaning that is not what the tissues were collected for) and on 327 women (a relatively small sample size).  The Oncotype Dx test for invasive cancer is actually being used in a clinical trial right now, but it was tested on a much larger sample size.  I think many physicians are waiting to see data before they have patients use the test to direct treatment.

JamieB86

I did have the test, however, more DCIS was found after a re excision, so it really wasn't valid for decision making.  Keep asking so you will have all the information possible to  make the best decision for you.

Infobabe

JamieB86  

That is interesting.  How did this happen as there is resistance to give the test to DCIS.  Are you part of a trial?  Did you get the Oncotype score and what was it?  

I would think they would want new cases like us to be part of the data base.  I don't see why we were excluded in the first place and why having more information is a bad thing.

Anyway, thanks for responding. It is good to hear from those successful in obtaining the test.

BLinthedesert

Infobabe, I don't think there is resistance, it is just is has not been proven to work yet, so not all doctors are going to be ordering it routinely.  If you want to discuss the test with your doctor, the website http://www.oncotypedx.com/ has information for you to download.  

At the end of the day, I ended up making my decisions based on the evidence presented by my healthcare providers.  If I felt confident that the Oncotype test worked, then I might have asked to be provided the opportunity to use it, but since I am a cancer researcher myself, I am a little reluctant to use things like this until I am sure they have been adequately tested and validated.  However, I do know that others on this board, and their physicians, have used the test to decide treatment.  It is too early to tell if it has worked for them - since the eventual outcome (recurrence) is 5-10 years down the road.  I think, for DCIS, it is a little easier to gamble on this test, since for many of us, if we choose the "typical" path it is likely to be an "overtreatment"; a recurrence for many of us is still treatable and not a life-threatening situation.  That said, I don't want to go through this again anytime in the near future -- so I just chose the traditional path of lumpectomy + radiation. 

Good luck. 

JamieB86

My score was 37, but unfortunately, my DCIS was more wide spread than 1st thought.  I had called Genomic Health (866-662-6897) and they advised me what I would have to pay if my insurance denied payment.  I spoke with my doctor's office about it, and they sent my sample.  I didn't have any trouble with them cooperating at all.

Infobabe

 BLinthedesert

I think an out-of-hand dismissal of "we don't do that" to be resistance.   I would have till June 11 when 5 weeks of rads are scheduled to begin, to get this done.  

Say the score was a 10, that may mean 3 weeks of rads rather than 5 weeks that I am scheduled for.  Or it might mean I get an RX for 10mg of Tomoxifen rather than 20mg.

If I get a score of over 17 then I would be comfortable going the full treatment.  Don't forget, I am DCIS, Stage 0, grade 1, hormone + (they didn't do the HER test, another one they don't do for DCIS.)  Oh, and I am 76, and it is on my left side endangering lung and heart.

Why wouldn't I want all the diognostic tests possible. 

Infobabe

 JamieB86 

Interesting that your doctor cooperated.  A score of 37 would confirm traditional treatment.

Also, I like your dog.

JamieB86

Thanks Infobabe - he's as sweet as he is cute.

My doctor was AWESOME! I did end up with a UMX which was unexpected, but he tried to help me get as much info as possible so I would be comfortable with my treatment decisions.

Infobabe

JamieB86

Mastectomy has always been on the table for me too.  I know if there is any recurrence, I will go for it as I am not going through this again.  From everything I read, it is not such a traumatic experience.  It is more of a social issue. 

JamieB86

Once I made the decision to go with the UMX, it wasn't too terrible.  Getting to that point was tough though.  What I thought was going to be a little inconvience turned into a big major deal. But in the end, I didn't have a choice. Now I'm looking forward to my exchange/lift  in August.  I will be happy when this is a distant memory.

BLinthedesert

Infobabe, I am not saying that you would not want information, I am just letting you know why the test is not uniformly used - it has not been proven to be beneficial. Just think, if thousands of women use this test, before it is proven to provide any useful information, to direct their treatment, and all of them who choose no radiation/tamoxifin recur (worse yet, with invasive cancer) within the next 5 years - what do you think will happen?? who will be to blame?  the company?  the doctors?   I am not saying you shouldn't do it ... I just was trying to let you know WHY some doctors might be hesitant to push an unproven method.   I was not trying to make the choice for anyone -- I explained my case, as it is different from yours, and simply stated the facts as they are currently known.

By the way, if you get radiation, then I think you get radiation ... the Oncotype test is not going to give you information on dosage of radiation - have you heard this lower dose (e.g., 3 weeks) option from your RO?  I have never heard of that before.  

As it stands, based on the current clinical trial in invasive cancer, and the literature, they are hoping to use the test to decide for and against radiation (I have not seen one paper that talks about lower dose based on lower recurrence score) and/or tamoxifen.  They will not be using the test to decide radiation and/or tamoxifen dose -- the test just is not designed for that level of detail.  

Infobabe

 BLinthedesert

The RO said a 3 week period or a 5 week period.   I don't know if the 3 week would be a stronger "dose" or not.  These questions come up but I cannot ask them until the apointment.

redsox

I am very optimistic that the Oncotype Score for DCIS will lead to the first really good methods for identifying which patients can benefit most from radiation therapy and which may be able to skip it.  But it is still early.  The test got FDA approval within the past year.  The first study supporting it was reported in December at the San Antonio Breast Cancer Symposium.  It is important to have more studies to validate it and to look at other patient groups.  At this point doctors may be reluctant to order the test for various reasons, including 1) they are waiting for more confirmatory studies before being willing to rely on it or 2) the patient would not have met the eligibility requirements for the one study reported so they do not believe the results would make a difference in treatment.

At this point, unfortunately, the Oncotype DCIS Score is more useful if you get a high score -- you should have radiation.  If you get a low score, it is one more piece of information but it is not so clear if you should rely on that to skip radiation. 

The underlying study that was reported was intended to define a very favorable group within DCIS.  If you would not have met the eligibility requirements (I had a lot of favorable features but would not have been eligible for the study), it is probably not good to rely on it. 

If I were just diagnosed now, I would want this test but it might well just make the decision making more confusing than ever.

As far as 3 week vs. 5 week radiation therapy (maybe with some boosts after either), there have been no results to indicate that the Oncotype DCIS Score matters in that decision.  The 3 week plan uses higher dose per fraction but a lower total dose because the time period is shorter.  It should be ~bioequivalent in terms of the effect on the cancer.  The shorter, more intense regimen has been used for a long time in Canada so there is a considerable amount of data showing that it works as well for some groups of patients.  If your doctor thinks it is an acceptable option for your situation, that should not depend on the Oncotype test.

Infobabe

Thanks  redsox for that reply.  

I have already printed out that San Antonio press release that you posted on another site.  Maybe it would be insulting to send a copy to my RO.

I would not depend on the result, I would just like to know.  A question I do have is though it would show the gene makeup of my DCIS, another type like IDC could develop but the whole breast radiation would have prevented that by knocking out baby cells.  But I suppose it could develop with or without radiation.

 I will probably end up with the 5 weeks.  I just think there is a better way on the horizon. 

BLinthedesert

Hi redsox, where have you read that the FDA has approved this test?  last June I was at a conference sponsored by NCI and I was under the impression the FDA has not yet even approved the Oncotype test for invasive cancer (and the studies are much more compelling than the 327 samples from the Oncotype DCIS study) - pending results from the TailorDx trial.  Could you PM me the link regarding the FDA?  

Thank you!!!  (this is more for my scientific interest, not related to my diagnosis or treatment )

Lagata1276

I learned about the Oncotype test on this website right before I went to see my BS for my follow up after my lumpectomy. When I asked about it, the nurse said they do not do that test for DCIS. Then we heard much discussion in the hallway about the test and the BS came in and said they would order it. Well, my score came back high, 54. Then I have my first appointment with my MO and told her I had the test. She said after looking at my records, it was basically a waste of $5k as my comedonecrosis indicated I would need radiation anyhow. Oh well, that's my experience.

Infobabe

Thanks for that,  Lagata1276

I think I could form my own database. 

There are eligibility standards and it would appear to me that you would not qualify.  I would like to know what those standards are. 

BLinthedesert

http://www.oncotypedx.com/en-US/Breast/HealthcareProfessionalsDCIS/FAQ#2

Why would you not qualify?  The only requirement is that you had a lumpectomy.

Good luck with your decision infobabe, I know this is a stressful time.  I like the 3 week option (especially if it means lower dose of radiation) ... kind of the best of both worlds  

Infobabe

BLinthedesert 

Thanks for that.  I feel that I am on an expres train and am not the one making the decisions.

voraciousreader

Please see my post on the other thread that you started infobabe...

Infobabe

I did see it  voraciousreader

As far as standard of care goes, that is what I think I am getting.  It is the one size fits all that disturbs me.  I don't relish rads.  Have you read the experiences of women currently going through it?

I have my simulation appt. June 11. So I should be done with it about the middle to end of July. 

voraciousreader

Infobabe... You need to have an informed discussion with your doctor outlining precisely what is standard of care and what else is experimental and you want to know what all clinical trials are out there. There is nothing wrong with standard of care as long as you have made an informed choice. If you feel that your doctor is NOT informing you properly, well that's a different issue.



From my experience here, there is no one size fits all approach. The guidelines are merely a starting point for discussion. And by all means, it can't hurt to get several opinions. But make no mistake about it... Standard of Care DOES NOT mean, one size fits all. Speak to your doctor and explain your concerns and.... Also explain your concerns regarding his or her staff.

voraciousreader

I had six weeks of rads and did well. These boards are very skewed because patients will post when the have issues. Rest assured there are many, many women like me! And I had the left side as well.

Infobabe

 voraciousreader 

So you did have the Oncotype.  You scored 15 but went ahead with rads.  Did the Oncotype test have any bearing on your decisions?

I assume you did have a lumpectomy. 

redsox

BLinthedesert-

The Oncotype DX for DCIS test went on the market the end of December with the needed approval.  It comes under "devices" not "drugs".  It is a laboratory test, it is not invasive, and it is not providing treatment.  They just have to show good laboratory practice, good manufacturing practice, reproducibility of results in different labs, some benefit in some set of patients, ....  The FDA is not giving blessing to what it is used for or how the results are used; they leave the burden of weighing those questions on the individual doctor. 

redsox

Infobabe wrote:

Thanks  redsox for that reply. 

I have already printed out that San Antonio press release that you posted on another site.  Maybe it would be insulting to send a copy to my RO.

That press release is still the best description of the study I have found.  I think it would be good to take it to your doctor and discuss it.  S/he might say that you should have radiation therapy regardless of what the Oncotype DCIS Score might be, but the doctor should be able to explain the reasoning to your satisfaction.

BLinthedesert

redsox - That is what my understanding from the biomarker conference last year (I am a statistician and most of my research is around genomic biomarkers).  It is not a FDA approved test, it is a commercially available test - hence why it is not necessarily showing up as standard practice.  This is a common problem for all of the currently available "prediction" tools, none of them have been validated prospectively.  Furthermore, most of them have been developed on very small sample sizes, and sometimes very hetergeneous groups of patients. While I am very hopeful for the Van Neys Prognostic Index and Oncotype tests -- so far, the only randomized trial (the gold standard in terms of proof) that examined lumpectomy with and without radiation was stopped because of unacceptably high recurrence rates in the patients randomized to lumpectomy only.  While I am sure there are many of us that could avoid radiation, it just is not clear, yet, who "we" are!  Personally, I was willing to take on a high level of risk of recurrence (20%) to forgo radiation - but when the risk ended up being potentially higher than that,  I was not as comfortable. 

infobabe - YOU are making the final decision (you can opt out of treatment), but it does feel so much like we are not in control sometimes.  At the end of the day, you need to feel completely comfortable with your "team" of advisors, and your decision ... and you have a right to base that decision on whatever set of data you desire!   

BLinthedesert

voraciousreader - you must have just finished rads?  I am glad you had an easy time -- I am keeping my fingers crossed for good experience with mine too - and I will post under the "had rads and did well" section after I am finished 

redsox

BLinthedesert --

There have been four prospective randomized trials that have compared lumpectomy + radiation therapy vs. lumpectomy alone for DCIS.  Summarized in this paper:

http://jncimono.oxfordjournals.org/content/2010/41/187.full

they consistently show that radiation reduces the rate of local recurrence (overall and invasive only) by about 50%.  A more recent update of one of the key trials was published in:

http://jnci.oxfordjournals.org/content/103/6/478.full.pdf+html

What level of risk we or our doctors are willing to accept is a key point that is often obscured.  I was not willing to accept 20% when there was a treatment option (mastectomy) that could reduce the risk to 1-2%.  Even though I very much wanted to avoid mastectomy I wanted a risk closer to 10%.  One of my AH HA moments came while watching the NIH State of the Science on DCIS video.  One speaker said in passing, "I think 15% would be too high for most patients and doctors" while the next speaker said (not in response but in his own presentation) "I think 20% would be a reasonable risk." Then I realized that much of the disagreement when looking at data really reflected unspoken assumptions about acceptable levels of risk.

It is good to have someone with experience in genomic studies here to remind us not to get overly excited about applying promising results while the research still has a lot to accomplish.

voraciousreader

Infobabe... I did Not have DCIS. I had mucinous breast cancer and was a candidate for the Oncotype DX test because it was an ER + Invasive BC.



The Oncotype DX test has no relevance to whether or not one needs radiation when they are diagnosed with invasive cancer. The reason why I had radiation was because it was Standard of Care for lumpectomy for my age category. As I mentioned to you earlier, I was offered brachytherapy, but I declined. Instead, I chose to have six weeks of whole breast radiation after reviewing all the data. I completed radiation exactly two years ago and I am fine. I had no issues, with the exception of slight fatigue. I kept up my usual schedule which includes 3 mile walks each day. I did need an additional half hour of rest each day, but shortly after finishing my six weeks, I was fine.





Regarding damaging my left lung and heart, I was told that the machines used today are more precise and that it reduces the chances of long term damage.





Are there women who have issues? Absolutely. But the vast majority of women do well.



I wish everyone well here with their active therapy.