Anyone with very high Ki67, Grade 3, Low OncotypeDx, no chemo?
My sister is recovering from a bilateral mastectomy. Her initial biopsy indicated a Ki67 score of 70! She is ER+/PR+, node negative, and margins clear. Her tumor was described as aggressive and the cells were poorly differentiated. Size was 2cm.
Her IHC HER2 score from her preop biopsy was 2+ which was deemed borderline. Due to the borderline score, a FISH test was performed which returned a HER2 negative result.
Based on her high Ki67 score and high grade (3) determination, we expected a correspondingly high Oncotype Dx score and definite chemo. However, her Oncotype DX score came back with a recurrence score of 10. The oncologist seemed optimistic about the result but wanted to make sure it was accurate before discussing treatment next week.
Anyone else have very high Ki67 with a low Oncotype Dx and poorly differentiated grade 3 cells?
Based on several user posts I have read (of course none of which I have validated), it seems like some oncologists even recommend chemo based exclusively on tumor grade and Ki67 score without even ordering an Oncotype Dx test.
On the other hand, it appears that the current consensus is to only consider Oncotype Dx regardless of Grade or Ki67 score. Anyone know if this is true?
2:20 am and I'm fading fast...I'll add more info later.
1/25 some addit. info: My sister is 41yrs old. We were never given exact ER+/PR+ percentages but I'll try get them. Her oncologist said that Tamoxifen would definitely be part of her treatment.
Her oncologist is a very highly rated Breast Cancer specialist. Therefore, we have no immediate intention of requesting a second opinion...although I wouldn't completely rule this out.
After some additional research, it seems as if many oncologists follow NCCN guidelines for treatment. The NCCN recommends the Oncotype Dx test to determine which women with node-negative, hormone receptor positive, Her2 negative, will benefit from chemotherapy. The guide (pg 22) claims that a recurrence score of 18 or lower (for the above described group) means that chemo can be safely skipped, but hormone therapy must still be taken.
According to the chart on pg 67 of the NCCN Guidelines (linked below), women with breast tumors over 0.5cm, ER/PR+, HER2-, and node negative, with low oncotype (less than 18), only needed hormone therapy. Cancer grade does not even seem to be considered!
http://www.nccn.com/files/cancer-guidelines/breast/index.html#/72/zoomed
I've decided to list links to medical studies that contain info pertaining to topics covered in this thread. Perhaps these will be helpful to others with a similar diagnosis. Thanks to those people who pointed out many of these studies!
2011 Study (of 53 cases) that claims Ki-67 is a major but not sole determinant of Oncotype Dx recurrence score. The study showed a strong linear relationship between Ki-67 scores and Oncotype Dx scores. The second link provided is a graph of this linear relationship which is informative in light of my sister's scores. My sister's plot point would definitely be an outlier. The highest Ki67 score that has an oncotype around 10 is still below 30.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3241562/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3241562/figure/fig1/
The following 2011 study offers recommendations to standardize Ki67 analysis and reporting. A major problem cited that limits Ki67 clinical utility, is variability in the cutoffs that distinguish high, intermediate, and low Ki67 scores. This is not likely a factor for those like my sister with very high Ki67 scores. As far as chemotherapy is concerned, the study points to two other studies that claim Ki67 scoring is a predictor of adjuvant chemotherapy (Docetaxel) benefit. However, the paper also references a third study that found no predictive value in Ki67 scores as far as adjuvant chemotherapy is concerned.
http://jnci.oxfordjournals.org/content/103/22/1656.full
http://jco.ascopubs.org/content/27/17/2809.full
http://jco.ascopubs.org/content/27/8/1168.full
http://jnci.oxfordjournals.org/content/100/3/207.full
The following recent 2012 study discusses developments in Ki67 and other biomarkers for treatment decisions:
http://annonc.oxfordjournals.org/content/23/suppl_10/x219.full
The following Dec. 2010 press release references several studies regarding the Oncotype Dx test. One of the studies claims that "the Oncotype DX Recurrence Score used alone remains the recommended method to predict relative chemotherapy benefit in estrogen receptor-positive, node negative breast cancer". The same study claims that tumor size and grade were not a significant predictor of chemo benefit.
Prelim fidnings from a large study group referenced in the same press release reported a very weak correlation between central grade and Oncotype Dx Recurrence Score as well as between Ki-67 and the Oncotype Dx Recurrence Score. The findings note that "there were many patients with high grade and/or high Ki-67 and low Recurrence Score values. Neither tumor grade nor Ki-67 can predict the Recurrence Score status". It is worth noting that many of the studies referenced in this press release are funded by the company that owns Oncotype Dx.
Comments
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Geezer, Was your sister very strongly ER+ and PR+? This may have pushed the Oncotype lower. Since there is such a discrepancy, maybe she could ask for a pathology test of a different slice of the tumor, by either a different pathologist or different lab. I've read that Ki67 results can be unreliable and grades aren't cut in stone. This is where I feel the Oncotype is really important, to verify the pathology report.
So good of you to help your sister in this difficult time.
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Geezer,
My Ki67 was 96, grade 3, stage 1, 1.1 cm. I am triple negative, poorly differentiated cancer. I am having taxotere/cytoxan every 3 weeks x 4, a month off then 30 radiation treatments. Because I had a lumpectomy I am having chemo for any microscopic cells that got away.
Sheryl
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Geezer...I answered your PM with the additional information you requested along with even more information.....Hope ALL the information I provided helps.
Regarding a concensus....I don't think there is a concensus among physicians. Instead, I think all the information gathered regarding the pathology of the tumor is important towards making decisions. The Oncotype DX test is simply one tool of many when deciding what course of treatment is right for each patient. Likewise, the health of the patient is also part of the equation as well as age.
As I mentioned in my PM, her case is NOT straightforward and it might be a good idea for a second pathologist to review her tumor AND perhaps her case should be presented to a tumor board.
Please read the PM I sent you answering your questions. I went into greater detail in the PM.
Good luck! Your sister is very lucky to have you for a brother.
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http://jnci.oxfordjournals.org/content/early/2011/09/29/jnci.djr393.full
http://jnci.oxfordjournals.org/content/103/22/1656
Here's some additional information regarding the reliability of the KI-67 test.
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I'm sure you already know this, but another, non-scientific factor to consider is your sister's age and her menopausal status (pre or post). Simply, the younger she is, the more life she has ahead of her, but that also leaves a lot of time for the cancer to return. That is something to think about in addition, IMO.
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It certainly seems counter intuitive that she would have a low oncotype score. If after review, the oncotype still comes back that way, I would have a long discussion with the onc about why that would happen and what he thinks about it. To put a positive spin on it, information is power and if there really would be no benefit to doing chemo for your sister, it would be very good to know that and not take the chance on side effects from chemo. On the other hand, the oncotype is not the be all and end all, and perhaps given the other risk factors, she may opt for chemo even with the low oncotype. At least this is a good surprise, I think the low oncotype score indicates she has a low chance of recurrence, which is very good news. Good luck with all your decisions and treatments.
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Geezer - I know of 1 very small study that looked at low oncotype scores and the Ki67. I have posted the link below. Please keep in mind that this study was very small only 32 patients but it raises an interesting conversation for your sister to have with her oncologist. Best wishes to your sister as she navigates through the desicion making process.
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Thanks for the responses. I have updated my original post with some additional info about my sister- Doxie, we were never given the exact ER+/PR+ percentages.
Voraciousreader - thanks for your PM. I decided to include all links relating to the topic in my original thread. However, the post is now pretty large, clearly stage 3 (I know, not funny!). Regardless, it seems like a good idea to keep links to all studies in the original post.
Toomuch- can you repost that link as it does not appear complete?
So far, it appears that the Oncotype Dx score does indeed trump all other indicators that predict the benefit of adjuvant chemotherapy (that is for people who are PR/ER+, node neg, HER2 neg).
It would still be great to hear from anyone with Grade 3, very high Ki67, and low Oncotype.
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HI there, I am similar. Had a 2.1 tumor, poorly differentiated, grade 3, ER, PR+ something like 95 and 65 I recall. Her2+1, KI was considered high. My Onco score came back as 11. Since I was young, offered chemo by 1 onco, 2 others felt I'd be fine without it , and were comfy I'd benefit most from AI's - but due to young age, offered. So we sound similar. I'm now2 years out and doing fine. I worry sometimes about skipping chemo, buy remind myself, I have first lne therapy available to me again god forbid I should get a recurrence.
Its scary I know, I suggest a couple of Onco consults and see what they recommend. Good luck and PM with any questions.
B
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Sorry about that. The link below should work:
http://ijs.sagepub.com/content/17/4/303.full.pdf
If not you can use google scholar to find the article. "Complimentary Value of the Ki-67 Proliferation Index to the Oncotype Diagnosis Recurrence Score" published in the International Journal of Surgical Pathology in 2009.
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It is important to note that breast cancer tumors are not homogenous - the sample sent for Oncotype Dx is not the same sample that was sent for routine pathology that returned the Ki67 and grade result. Different area of the same tumor have even returned differing hormonal status. I think most oncologists take each piece of information into consideration when making a decision for or against chemo, including age, overall health, and the ability of the patient to move forward with or without chemo as a safety net.
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I could be your sister. My tumor 2.1cm grade 3 highly differenciated cells and high Ki67. I've just turned 40. My pathologist couldn't believe my oncotype score of 10 so my oncologist is looking into it. I was wondering if there was any way the oncotype could be wrong?
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I think I know who your sister is. She's the prettier, better loved, more popular sibling.
But I'll give the brains to you. Thanks for helping me work through this. I need all the input I can get. Love you Geezer. And any input would be much appreciated. -
Hello Geezer,
I am in a similiar situation.
I am 42 and was diagnosed in November with IDC. Tumor was 1.5cm, grade 3 and a nottingham score of 8. (I am considered stage 1c) I had a unilateral masectomy of my right breast. No lymph node involvement. I am highly ER/PR positive (100%/95%) and her2-. Ki67 was not done on my tumor however since receiving the pathalogy report after the surgery everything pointed to having chemo since the tumor was considered aggressive and my age. That was until my oncotype test score came in this past Thursday. I received a RS of 16 which gave me a 10% chance of reccurence. My oncologist is recommending no chemo but to start Tamoxifen (for 5 years) due to the low score. However he also stated that my situation is uncommon. He said he expected the score to come back in the intermediate range.
He said this is great news however I am worried. Ultimately it is my decision. He will give me chemo if I want it. He states chemo will only reduce my 10% risk of recurrence by 2-3%. I am worried that the doc should be taking the grade and age into more consideration then he is. He reassured me that the oncotype tests 21 genes and looks at the tumor in better detail. Is it worth it to have chemo and the possible side effects later? Or take the chance that I am not doing enough now to eliminate cells that could have moved beyond the breast. I am going to seek a 2nd opinion. I am San Diego and have one of the top oncologist but need another opinion.
I just dont know what to do at this point. Trying to research all I can. Please let me know if you have any or get any additional information. -
Hbsandwalk.. Ask that your case be presented to the tumor board. Also, since you are highly ER positive and I assume premenopausal, ask about the SOFT trial and whether or not you are a candidate for ovarian suppression in lieu of the chemo. Good luck. I wish you well.
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Voraciousreader-
Yes, I am premenopausal
Thank you. I've made notes regarding your recommendations.
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Were you able to get the percentages of her ER/PR? Have you asked to have her Oncotype Dx re-run? Have you looked at the other genomic test, MammaPrint? Second opinions in this business are ok—even your specialist would be all right if you told him you needed a second opinion. What a nice brother.
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Here's the update...
Although Genomic health did not do a retest with a new block, they did confirm their confidence in the original RS score. However, my sister's oncologist told her that there is discordance between the grade assessment of her pathologist and that of Genomic Health's pathologist. I don't know the exact details but it appears that the tumor sample assessed by Genomic Health did not have the same high grade very aggressive characteristics of the original pathology specimen. In addition, it is my understanding that my sister's pathologist has re-examined the tumor resection tissue and confirmed the grade 3 very aggressive classification. It is also worth noting that the oncologist has backed up this determination and reinforced her total confidence in the pathologist. She is now recommending chemotherapy regardless of any Oncotype re-test. In her opinion, the aggressive nature of the tumor and my sister's age make chemotherapy (and later Tamoxifen) the best course of action. While this may seem like disappointing news, in retrospect we are really very lucky that the Oncotype score was questioned in the first place. The worst case scenario would have been to decline chemo based purely on the Oncotype score when significant benefit from chemo was likely.
As mentioned previously, my sister's oncologist is very experienced and highly recommended (including from people in the medical community). This is the reason that we do not intend to get a second opinion or request a Tumor Board hearing. I still have a few general questions about the relative importance of clinicopathological factors verse genomic factors in coming up with a chemo recommendation....however, I'm confident that we're selecting the best treatment option. Even though groups like the NCCN appear to lean towards the Oncotype score, it is also apparent that clinicopathological factors should still be considered - especially in unusual cases (high grade and aggressive tumors) like that of my sister. This is also the reason that we won't request any other tests like Mammaprint.
As far as the Oncotype Dx test is concerned, it is worrying that tissue sampling is not a fail-safe process and that intratumor heterogeneity is a real factor that everyone should consider.
Still haven't got exact ER/PR scores.
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Geezer...glad to hear that your sister has a treatment plan that she's comfortable with. Regarding intratumor heterogeneity, as SpecialK mentioned before on this thread...we've been following for the last year, the work of Dr. Charles Swanton. When his research was published, it gave many of us pause.
For those of you unfamiliar with Dr. Swanton's research, here's a link that is easy to read and understand (I hope).
I'm not sure why the most aggressive parts of your sister's tumor wasn't sent to Genomics. I recall when I was diagnosed that my niece, who is an oncologist, told me that when pathology reviews a tumor, they slice it up and try to find the most aggressive part of the tumor and that's the part that they look at and also send to Genomics. I've never been quite sure what exactly the pathologists look for when they first look at a tumor that helps them decide which part is the most aggressive. Likewise, we've had quite a few sisters tell us that when their tumors were sent to other pathology labs, the results contradicted the first pathology report. The bottom line is....the treatment plan is only as good as the pathology report. I know with my "rare" type of breast cancer, the pathology report is paramount. Because of it's rarity, it is common for SEVERAL pathologists to sign off on the report, because most pathologists don't have experience at looking at many mucinous breast tumors.
The second thing that I find interesting regarding your sister's case is why she had the Oncotype DX test in the first place. I understand that the NCCN guidelines began recommending the test in 2011. However, it is simply one tool of many that a patient and their oncologist use to decide what treatment is best. As you recall, many of us said that the age of the patient and tumor grade is also an important component of that decision. While it is unusual for a Grade 3 tumor to have a low Oncotype DX score and it DOES occur, I don't know whether or not I would have even agreed to the Oncotype DX test had I been premenopausal and had a Grade 3 tumor. I was premenopausal with a Grade 1 tumor when I was diagnosed. I agreed to the Oncotype DX test to CONFIRM that I didn't need chemo. Had I had a Grade 3 tumor, I probably would have passed on the test and insisted on chemotherapy because of my premenopausal status and the Grade 3. I don't want to open up a can of words with saying what I would have done. Everyone needs to choose a treatment plan that is right for themselves using the best available evidence at the time of diagnosis. There is no right or wrong choice.
I'm curious to know whether or not other tissue samples of your sister's tumor are being sent to the folks that make the Oncotype DX test. I am interested in knowing whether or not there is more to this story.
Nonetheless, thanks for keeping us updated and I wish your sister well with active treatment.
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I know for me, the oncologist had recommended the Oncotype test because I was stage 1 and no lymph node involvement. I didn't question it (being grade 3) at the time because it seemed to be part of the series of testing that was done when they determined my staging and that I was er/pr positive and her2-.
When I initially had the biopsy the tumor was considered a grade 2 but after the surgery it was changed to a grade 3. I was told that there was an area of my tumor that had cells that were poorly differentiated - therefore my tumor was categorized as a grade 3. I also have wondered if the most aggressive slice of my tumor was sent to Genomics - it would make sense that it would but you have to wonder. I will ask this question.
I am curious if women who are a grade 3 with a low Oncotype RS have high ER/PR positive tumors therefore being on Tamoxifen for 5 years is the key in controlling estrogen - the very thing that is feeding the tumor. But is it the right thing to do skipping chemo when you are a grade 3? Very difficult decision.
I am going to get a 2nd opinion to day and a 3rd tomorrow.
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VR: The oncologist told my sister that even if we go ahead with a re-test and it comes back low, she'll still recommend chemo. Therefore, we do not plan on requesting a re-test.
I'm interested to find out if there is any solid evidence that those with high grade tumors (but still node negative, HER2-, and ER/PR+) should skip the Oncotype test? Based on the forum posts I've read, it is apparent that some people with Grade 3 tumors and low Oncotype scores have received a no chemo recommendation. Your original link to the Oncotype press release references a study that suggests no significant correlation between age and RS or between grade and RS. The study included patients with high grade tumors and low oncotype scores. The press release also claims that RS score alone is the best indicator of chemo benefit. Based on these studies, it is undertandable that some oncologists may not recommend chemo for some people with Grade 3 tumors and low oncotype scores. Are these studies accurate?....I have no idea! Perhaps the TailorRx results will resolve this question.
Tumor grading is subjective, so obviously not all Grade 3 tumors are the same. The deciding factor for my sister was the pathologist's insistence that the tumor was extremely aggressive and very poorly differentiated. It is my feeling that if the pathologist didn't emphasize the unusual characteristics of the tumor, the Oncotype score would have prevailed and a no chemo recommendation would have been made (even with the grade 3 classification). Please note that this is ONLY my feeling and I have no evidence to confirm it. I'm pretty sure that there are also oncologists who would do as you seem to suggest...recommend chemo for all grade 3 tumors. Again, perhaps the TailorRx study will shed more light.
You're correct that the pathologist should have sent the most representative tissue sample to Genomics and I assume that this was done.
I did previously read the article you noted about intra-tumor heterogeneity. However, a distinction should be made between pathological heterogeneity and genomic heterogeneity. The former would be an example of tumor heterogeneity that may result in variable tumor grading. On the other hand, genomic heterogeneity which is the subject of Dr. Swanton's research, deals with DNA mutation. From my understanding, there is no way to visually assess this type of heterogeneity in the same way as one would assess variable intra-tumor grading (under a microscope), because sequencing is required.
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Geezer... Perhaps TailorX might give us more insight. Until then, there seems to be quite a dilemma especially for outliers. Genomics stands by their test and claim that traditional tumor characteristics, nor age can predict Oncotype DX scores. Once again, I wish your sister well. You seem like a terrific brother! I wish you well too!
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Thanks VR, I'm sure she'll get through it fine! Any idea when the TailorX results are coming out?
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TailorX results are scheduled for 2015.
I am anxiously waiting for preliminary SOFT trial results as well. My understanding is that later this year we will have information. It will probably be announced at the 2013 San Antonio Breast Cancer Symposium. -
I just want to say that of course Genomics stands by their test: remember they are a for profit corporation.!
Until something supercedes it, they will stand by it and sell it as the gold standard, to use a phrase. And one day, something will no doubt supercede it. But it's the state of the art thing now.
I don't know if ever I posted this, but I had posted when my oncotype test originally "failed". I was so upset about that. But now, secretly, I am GLAD. My MO was completely on board with my doing chemo for my small grade 3 cancer. Had I received a 'good' score, it would have been a tough fight and frankly, I am with you VR, I wouldn't have wanted to forgo it (being grade 3).
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hbsandwalk,
I was wondering if you got your 2nd or 3rd opinion. Do you have to do chemo? What was your oncotype and ki67 scores?
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new2bc-
No, I am still trying to determine if I need chemo.
My second opinion said no chemo. My 3rd opinion (Dr. John Link - he specializes in breast cancer only. he is also the author of the book: The Breast Cancer Survival Manual) said he was concerned as it is uncommon for the Oncotype test to come back low with a high grade tumor.
My Oncotype score was 16. I had a 1.5 cm - grade 3 tumor (nottingham score 8). I had a right breast masectomy (with reconstruction on December 21, 2012)
He is running my Ki67 (it wasn't done originally) and also ordered the Mammaprint test to be done on my tumor. I should have my results back next week. Based on these test results we will decide if chemo is the next best option. I will update when I get the results.
In the meantime, I've started taking hormonal therapy (tamoxifen).
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http://www.biomedcentral.com/1471-2407/11/486
May be of interest....
Ki67, chemotherapy response, and prognosis in breast cancer patients receiving neoadjuvant treatment
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ugh now I am nervous because I am waiting on me Oncotype DX score and my tumor was grade 3. I still had hope I would get a low score until I read this post. Now I am so scared I will have to get chemo....
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Come on Jessica there is no perfect 100% guaranteed infallible test or the company that conducts them either and to suggest that Genomics refused to budge on their findings because they are a for profit company is blatantly unfair. They had a difference of opinion; that doesn't make them the bad guy because they are a for profit company. Good grief. My BS was surprised when my Path report came back that showed a micromet in my SN...very surprised but my Oncologist ordered the Oncotype test for me because she was ambivalent about my treatment. I was Stage 2, Grade l IDC. The test came back with a low score and a non-aggressive cancer but from what I have read and heard had I had a Grade 3 tumor I probably would have had chemo. Your age makes a difference too and I am sure Oncologists consider a lot of factors before recommending treatment. I for one am glad there was an option for me because had there not been an Oncotype test my treatment would have been chemo plus the test affords my Oncologist and me more information about my specific tumor. Diane
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