I think Oncotype DX is a SCAM!!

peppopat
peppopat Member Posts: 90
edited July 2018 in Waiting for Test Results

..and I'm not  just saying  this because it would appear I'm upset with the score they  gave  me.---a miserable 28.   Bear  in mind  I already had three pathology  reports  spead out  over 8  months. The last report had me down as a 3  on the Notthingham scale  which is the best score one can have. This  was the sample  Genomic Health  used for  their findings.

 I  called Oncotype this  morning and told them  that the 4-page report I received  yesterday was total crap,  It left  me with more  questions than  answers.   

 #1,  they  treat a micromet  node  the same as no  node involvement

#2  The  report tells  me that I  am  PR- negative. A  little under the  threshold  for positive.   All  my  other pathology  reports  had  me down as positive. 

#3  My  previous pathology report had me  down as 99% ER  positive  but  this report  only had  me down as a  little over  the threshold  as  being positive.

#4  Size  and grade of tumor  are NOT  at all  figured in to  their calcs.  

 They  would not break down the results  of  the 21-gene testing. When  I asked  them  if they could at least  give  me my  Ki-67  score  they  told me I  cannot have access to  that  and neither  can  the doctor.  MY preivious  Ki-67  was a zero  on my invasive portion of tubular cancer.

 I am now  very  suspicious of this  service  and I  think it's  a rip-off.   I say it's just another Medicaid fraud  scam  that's  ongoing  and  quite a gold-mine  at  $4K  a pop.   Would you like to  see what a  4-page report looks  like  that  costs  $4000? You're  gonna laugh!!   

  The  calcs  have  already  been done  for a score  of  28 that  breaks  downs to  a  19%  chance  of  recurrence.   You  will  see that  radiation does not  factor into  the chance  of recurrence,  only  Tamoxifen and Chemo.    My  19% recurrence  is  with Tamox only.  If  I  do chemo  GH  says  I  can  cut off  another 4%-BIG DEAL!!!

 It also seemed to me like the reliability of the oncotype test was not based on a large number of patients and as far as I know the study has not been duplicated. These are two standard medical benchmarks which I am not sure that this test has met yet. This could be why my .-2mm SMALL tubular cancer, which is LOW grade got a relatively high score.

Update  9/19/2011:

It  was  explained to  me  that having  tubular  within  a  medium range  score  does happen, maybe about 20%  and  they also told me  that  they  have even seen  one in  the  high  range. 

another newsflash 9/21/2011:

It's come  to  my  attention that  Oncotype  hands  out poorer scores  to  women with  PR-  status.  Odd  thing  is,   3 labs  say  I'm  positive  for PR, not  much  but 25%  is  enough,  is  it  not?  Only  Oncotype  has  me  down  as negative, sightly  neg, that  is.  Now  how  can  I  make  an informed decision???

Abnormal MRI: Mar'09, Dx: Aug,'10 DCIS w,Grade 2 w/ comedo necrosis, ER+99%/PR25%+ HER2+, lumpectomy w/SLND 4/20/2011, Tubular ITC confirmed, HER2 status confirmed as NEGATIVE, 1/3 node positive for micromet
Diagnosis: 4/20/2011, <1cm, Stage IIa, Grade 1, 1/3 nodes, ER+/PR+, HER2-

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  • PLJ
    PLJ Member Posts: 373
    edited March 2012
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  • voraciousreader
    voraciousreader Member Posts: 7,496
    edited September 2011

    You raise some interesting questions. I had questions too when I received my Oncotype DX score for my rare mucinous breast cancer. As you are probably aware, the NCCN 2011 treatment guidelines recommend the OncotypeDX test for most ER+ HER2- breast cancers,but they do NOT make the recommendation, as yet, for tubular and mucinous. One reason is that the test is NOT as strongly validated for our types of BC and because of the mostly favorable characteristics of the rare breast cancers. While a score in the high 20's for a tubular breast cancer seems rather high, remember there are outliers and obviously you are one of them. I think that with the rare favorable histology sub-types we also have protective genes as well that aren't accounted for in the OncotypeDX test. As you probably know, women who are node positive with tubular bc still have an excellent prognosis.





    Good luck and thoughts and prayers to you.

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  • coraleliz
    coraleliz Member Posts: 1,523
    edited September 2011

    I doubt it's a "medicaid" scam because Medicaid probably won't cover it(or maybe just in some states). As for you being considered node negative because of a micromet, node positive means >2mm in all staging & just about every study I've read. You're not the only BC person here on the boards that doesn't like this & thinks it should be different. So, if you consider yourself node positive, does your chance of reoccurence go up when you use the node positive graph? Is there even a graph for tubular BC?

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  • bevin
    bevin Member Posts: 1,902
    edited September 2011

    HI Poppepat,

    This is very interesting. I had never thought about the fact the onco type has not been validated by other reseachers; I was concerned about the newness of  the Onco type  when relying on it for my tx decisions but never thought about the population size or the fact the test has never been duplicated.

    I do understand its in the NCCN guidelines now, but I was always thinking that with the possible new move to national health care they wanted a new way to eliminate giving chemo  or offering chemo to some patients since it is so costly, hence why it was adopted so quickly.

    You raise some valid points here.

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  • elimar86861
    elimar86861 Member Posts: 7,416
    edited September 2011

    I believe the test assumes the patient has had either Mx or Lumpectomy + Rads prior to testing.

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  • voraciousreader
    voraciousreader Member Posts: 7,496
    edited September 2011

    BTW... The test WAS validated, but not in the traditional sense of a randomized trial. Basically, they identified the 21 genes that they thought were important including some controlled genes and they then compared those 300 samples with the samples of thousands of women retrospectively who they knew the outcomes of, via Kaiser and developed the score.

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  • peppopat
    peppopat Member Posts: 90
    edited September 2011
    coraleliz wrote:

    I doubt it's a "medicaid" scam because Medicaid probably won't cover it(or maybe just in some states).

      They  most  certainly  do.  In  fact,

     *****welcome to Florida---Medicaid fraud  capital of the US.where their motto is, "take our money, we're in a hurry"******

      I have an HMO thru  medicaid  that  would not approve  the Oncotype because  I  was node positive-even  just  a little   so  Medicaid  eagerly picked up  the whole cost  and I didn't even have to ask them. Oncotype took  care of all  the authorization work,  so  go  figure!!!

     So, if you consider yourself node positive, does your chance of reoccurence go up when you use the node positive graph?

     It  was  negligible

     Is there even a graph for tubular BC?

    Absolutely  not, no  special subtypes are ever  figured  into  their  equation because there's no substantial  amount  of  test subjects

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  • JimDeb86
    JimDeb86 Member Posts: 2
    edited September 2011

    Hi. I was node positive too and my in refused, but the dr office went ahead with it and I don't have anything to pay. It saved me from chemo.

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  • voraciousreader
    voraciousreader Member Posts: 7,496
    edited September 2011

    One more thing. The folks who make the Oncotype Dx test are including data for the special subtypes. You can google it. From time to time I try to copy the table that gives the mean scores for the special subtypes, but I can't get it to copy. The median score for tubular is 15.2 according to the lead investigator, Dr. Baehner.

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  • Kay_G
    Kay_G Member Posts: 3,345
    edited September 2011

    Am I wrong, I thought a 3 on the Nottingham scale was the worst score you could get?  I thought it corresponded to a grade 3 turmor?

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  • voraciousreader
    voraciousreader Member Posts: 7,496
    edited September 2011

    Nottingham3,4,5 is low grade, 6,7 is intermediate and 8 and nine are high grade.

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  • sheila888
    sheila888 Member Posts: 25,634
    edited September 2011

    3,4,5= Grade 1

    6,7=    Grade 2

    8, 9 =   Grade 3

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  • Kay_G
    Kay_G Member Posts: 3,345
    edited September 2011

    Oh, okay, I had a score of 6, but they called that a grade 2 on the surgery pathology report.  Sorry, I was confused.

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  • sheila888
    sheila888 Member Posts: 25,634
    edited September 2011

    kay..I got confused too. Mine was 7.

    Why do you have Grade 3 under your DX?

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  • Kay_G
    Kay_G Member Posts: 3,345
    edited September 2011

    On the pathology from my biopsy, it said grade 3.  I had neoadjuvant chemo and on the pathology from the surgery, it said grade 2.  I wonder which is correct?  I had a large tumor before chemo and I think I read that you would probably have samples of all grades in a large tumor.  So I am really not sure about it.  I will ask the onc what she thinks when I see her.  She's supposed to go over the surgery pathology with me.

    Thanks for letting me know I wasn't the only one who got confused.  Sometimes I wonder about me.  LOL

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  • sheila888
    sheila888 Member Posts: 25,634
    edited September 2011

    kay..I just noticed you are also Triple+ there is only handful of us.

    I don't think the size of the tumor relates to the grade again I might be wrong.Innocent

    Nice talking to you.

    Sheila

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  • Kay_G
    Kay_G Member Posts: 3,345
    edited September 2011

    No, size doesn't relate to grade, but just read that different areas of the tumor will not all necessarily be the same grade, or ER/PR status or Her2 status either.  Not sure where I read that.  Nice talking to you too, my fellow triple +.  Glad to see it's been over 6 years since diagnosis for you.  Wishing you many more!

    Kay

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  • dixiebell
    dixiebell Member Posts: 280
    edited September 2011

    I hope your wrong. Just an FYI Here is a new study for node positive pts.  

    RxPONDER Trial (SWOG S1007)

    Opened in January 2011, the RxPONDER Trial (Rx for Positive Node, Endocrine Responsive Breast Cancer) will reveal whether chemotherapy benefits patients with node positive breast cancer who have low to intermediate Oncotype DX® Recurrence Score® result. The trial also seeks to determine whether there is an optimal Recurrence Score cutpoint for these patients, above which chemotherapy should be recommended.

    The trial is being conducted by SWOG with the participation of all the major National Cancer Institute-funded cooperative groups in the United States.

    Researchers plan to enroll 4,000 women with Recurrence Score results of 25 or less who have early stage, hormone receptor-positive, HER2-negative breast cancer that has been found to involve one to three lymph nodes. They expect to screen over 9,000 breast cancer patients to identify 4,000 with Recurrence Score results in this range. The use of Oncotype DX in patients with node-positive breast cancer has been validated in several studies including a previous SWOG led-study, SWOG 8814, ECOG 2197 and TransATAC. The test has been available for use by physicians in clinical practice for node-positive disease since 2008, and it has been reimbursed selectively in the U.S. for this patient population.

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  • marzipan2020
    marzipan2020 Member Posts: 2
    edited September 2011

    Hi!

    i lost my old sigin in but read your post and wanted to chime in.  Ever since my diagnosis i have read up on as much about breast cancer as possible.  I attended a recent talk by a breast only pathologist who said that tubular tumors were a "great" subtype to have because they are, according to the pathologist, very slow growing and never metastasize. 

     the doctor also said that they are very tricky to diagnosis because the only thing that looks different about tubular versus a ductal tumor is that the tubules have more rounded edges in one but not the other [i dont remember which] and that a a pathologist that doesn't see a lot of breast cancer cases can easily mistake a diagnosis.  i hate to say it but if you are node positive i would think of double checking if this is a truly tubular tumor.  the oncotype maybe wrong but a high score, pr negative and a node positive? something doesnt add up.

    theres only a handful of places i would really rely on at this point -- essentially the major cancer centers like mayo clinic, md anderson in tx or sloan kettering in NY to make sure your tumor is reviewed by a professional who's seen lots of breast tumors ervryday rather than a handful a couple of times a week some local hospital pathologists

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  • peppopat
    peppopat Member Posts: 90
    edited September 2011

    hello Marzipan,

    Thanks for your  input.  I  absolutely, positively agree  that tubular  can often be  missed, not  the other way  around.   I've  had 2 labs tell  me  that  I  met  the threshold  for tubular  and  one of  the labs  was  the  AFIP   BUT  they  were testing a  very  degraded  sample  from August  2010. When  I finally got some REAL good  samples  harvested from my  lupectomy in Apr 2011  they  also  came  back  as  tubular. THis  was conclusion by a  local lab,  though.   I  plan on getting one  more "2nd  opinion" by  the AFIP,  again, since  I am  already  in their  system.   I  went  to  the  AFIP  because I understood  they were the  best  out  there.  

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  • marzipan2020
    marzipan2020 Member Posts: 2
    edited September 2011

    great to hear!

    i found this article as well, you mentioned you were on the threshold for tubular correct? the study looks at people wuth different levels i guess of tubular tumors and how they faired.  the ones with almost 100% pure tubular did fine but you notice that there is a higher chance for mets the less "pure" the tumor is.  even at 70% patient start to have issues: 

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1345032/pdf/annsurg00216-0022.pdf

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  • peppopat
    peppopat Member Posts: 90
    edited September 2011

    Maybe  I  should  correct  myself when I used  the  threshold.  I used  that  term because  I  was just  trying indicate  that  i  did  fall  into  tubular  category---70%  or greater. By  how much?  I  don't know.  It was  not  indcated  on  either  of  the  two  reports.  That will  be  something I  should insist on in my  final  decision  making  next  month  when  I  ask  the  AFIP  to  take  look  at  the newer  samples.   I  think a  big  reason  as  to why  my  tubular  portion had micro  met  to  the  node  is  because  I  waited  two  years  before  having  the  surgery. I am  not  surprised  at all.  Had  I  done  it  when I  was  SUPPOSED to,  I  wouldn't be  in  this  mess. PCP  didn't tell  me  results  of an abnormal MRI  1  1/2   years  earlier. Found  out  biopsy  was  recommended but kept  secret  from me.  

    Has  anyone with a  Dx  of  TC gotten  their  actual  percentages  and,  if  so, what  lab did  you  use?  I  have  duly  noted mayo clinic, md anderson in tx or sloan kettering in NY  as  being  very  good.

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  • Denise2730
    Denise2730 Member Posts: 648
    edited September 2011

    You guys seem much more educated than I am on pathology reports. My report says "Invasive mammary carcinoma with mixed ductal and lobular features, Nottingham grade ll of lll."

    Is that good or bad? I fired my current oncologist so I have nobody to really dicipher this for me.

    Denise

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  • D4Hope
    D4Hope Member Posts: 352
    edited September 2011

    I was diagnosed ER and PR postive cancer from my biopsy. When I had surgery and got my path report back. It read that I had a High er and pr positive tumor and a her2- status.

    My onco score came back as a 20 high er pr postive tumor which was a grade 3 My Onco test was consistent with my biopsy and path reports. So for me I was glad to have had it done.

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  • voraciousreader
    voraciousreader Member Posts: 7,496
    edited September 2011

    Chiluvr... You have an average growing tumor that contains two types of cancer. Your tumor is ER + which means you will be a candidate for endocrine therapy ( tamoxifen or an AI). Since your tumor is ER positive you can request the Oncotpe DX test to see if you will benefit from chemo. The test will also give you and your doctor a better idea of how aggressive your tumor is. But based on what you have identified, you have a very average tumor with lots of good treatments available. Good luck. Thoughts and prayers to you.

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  • peppopat
    peppopat Member Posts: 90
    edited September 2011

    Now  i've  seen  everything.   ONcotype  is  nothing but  smoking  mirrors.

    People  here  like DHhope  and jimdeb   have   a  GRADE  3,  one   with  ONCO  score  of  20 and  the other  not  given, but  low

    and  I,  on  the other  hand:

     have a grade  1 with  an onco score of  28

    Does  that  make  sense  in anyone   other than  Genomic  health's  "world"?  Sure  doesn't   for me  and if  GH  has  their  way  about  it  they  would  have everyone believe  that  grade  1, ,2  or 3  makes  no  difference.  1  node  +, no  problem.  In  the real pathology world we  all  know  that  that's just  factually incorrect!!!

    Sorry  I  have  impossible  time  believing  ANY  grade  three  should  not have  chemo or  that  any  grade  1  need  chemo just  because  GH has  screwy  point  system  that nobody  can  explain,  understand, or  compare it to.

    The  only benefit  I  have  taken  away  from having a Oncotype done  was to learn  how  borderline PR+/-  might  require  a  different,  more diligent course of  treatment,   a treatment not including  chemo but  rather  less less toxic tactics like diet, exercise, supplements, and hormonal therapy,  thank you  very  little!!!

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  • Kay_G
    Kay_G Member Posts: 3,345
    edited September 2011

    Peppopat, I agree with you.  I don't understand that either.  Also, why are only ER+ cancers given an oncotype?  All triple negatives should get chemo?  I know they say Herceptin works better if used with chemo, so I can see why ER-, Her2+ wouldn't get an oncotype.

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  • voraciousreader
    voraciousreader Member Posts: 7,496
    edited September 2011

    Kay ... The OncotypeDx test was designed to determine which ER + tumors could defer chemo. Oncologists realized before the test was designed that they were over treating many women. ER tumors usually would respond well to endocrine therapy. But they weren't sure which women with ER+ tumors also had less aggressive tumors that might not benefit from chemo. That is why they developed the test. And one day when more genetic testing is discovered, the present way of describing tumors will become obsolete. And we will have a better system at determining treatment plans.

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  • Kay_G
    Kay_G Member Posts: 3,345
    edited September 2011

    I realize that.  What I don't understand is why aren't they interested in over treating triple negative cancers.  Is that because they think all triple negative cancers should have chemo?

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  • voraciousreader
    voraciousreader Member Posts: 7,496
    edited September 2011

    Triple negative do not get the opportunity to use endocrine therapy(tamoxifen). So chemo is usually their only arsenal.Endocrine therapy can only benefit tumors that are estrogen fueled.

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