HER2 testing
I was diagnosed with high grade, multi-focal, ER/PR negative DCIS in March and had a bilateral mastectomy about three weeks ago. The sentinel lymph node and the other breast showed no cancer.
My oncological surgeon does not routinely test for HER2 on non-invasive cancer. Has anyone with a similar diagnosis/treatment had HER2 testing?
Comments
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My MO said that this was only done for invasive cancer, but maybe this varies by pathology lab?
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I think the same
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Thanks. That's reassuring. Lastar, you had nearly the exact same diagnosis as I did on the same day on the other side of the country.
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They don't do them for DCIS at the biggest cancer hospital in my region. They only did ER and PR because I begged.
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Some facilities do HER2 testing on DCIS, others don't. Whether they do or not, at this point the results don't change anything - if the testing is done, it's simply for the record. While it is well established that HER2+ invasive cancer is more aggressive, and while there is a special treatment for those who have HER2+ invasive cancer (Herceptin), the situation with DCIS is very different.
There is not yet any clear understanding of what it means to have HER2+ DCIS. A few studies have shown HER2+ DCIS to be more aggressive and more likely to evolve to become IDC, but a couple of studies have shown HER2+ DCIS to be less aggressive and most studies have found no difference between HER2+ DCIS and HER2- DCIS. The other thing that's confusing about HER2+ DCIS is the fact that approx. 40% (or possibly more) of DCIS is HER2+ whereas only about 20% of IDC (or possibly less) is HER2+. There is no understanding of why this is. Does the HER2 status change as DCIS evolves to become IDC? Or does a lower percentage of HER2+ DCIS evolve to become IDC?
What all that means is that it's dangerous to draw any conclusions about HER2+ DCIS. Many women whose DCIS is tested and who find that they are HER2+ get very worried because they know that HER2+ IDC is so aggressive and they assume the same is true for DCIS. This is a unfounded concern - at least for now. So while it may be useful to know the HER2 status of your DCIS for future reference in case there are new discoveries and new learning, at this point knowing your HER2 status is likely to only lead to concerns which may be unwarranted and which you can do nothing about.
To that point, as for what you can do if you have HER2+ DCIS, the answer today is "not much". Herceptin is not approved for DCIS. There are no differences in treatment (or prognosis) for those who have HER2+ DCIS vs. those who have HER2- DCIS. There are a couple of clinical trials underway for women with HER2+ DCIS but these are small trials with limited enrollment - not something that most women will be able to participate in.
And that's why many facilities don't do HER2 testing on DCIS.
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Thank you Beesie. That was very comforting/informative.
As many of my rants have stated, I had my surgery at MSK. My first biopsy, at a different hosptial, only gave me my ER results (+) and nothing about PR. After a second biopsy and then BMX at sloan, still no PR results and they did not do a HER2 test. Everytime I read into it, I find nothing that justifies it, but I still want to know.
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We went ahead and got the HER2 test done on my DCIS so we'd have the information should treatment evolve in the future. I was concerned my removed breast tissue would no longer be available for testing down the road. It was positive so I'll keep an eye on the research on treating DCIS with Herceptin.
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I wish I had know enough to insist that they do it. I "assumed" Memorial Sloan Kettering would do, at the very least, the PR test. I'm guessing its too late now that I've had my mastectomy?
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The PR testing is an interesting question. I had both ER and PR done at my original hospital, so that when I progressed to Memorial Sloan Kettering, the question had already been answered. I think that ER positive is the only information needed for hormonal treatments for DCIS, which is probably why MSK only does ER. Beesie, is it possible to have ER- and PR +? I know it can be the other way around. I had ER + and PR -, but my treatment recommendations would not differ from someone with ER and PR both positive. I also don't think it really says much about the aggressiveness of the DCIS when ER is positive and PR is negative.
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There have been scientific articles suggesting that it is possible to have ER-/PR+, but it is very very rare, and could possibly mean that the ER test did not pick up ER+ properly. There is a very small percent of women for whom the antibody stains are not correct, or the percentage of ER is just under the amount that would classify her as positive. The same is true for PR status. In *most* women ER and PR status go together. The tests for ER and PR are not perfect, this is especially true for small tumors. Because there are so few women with discordant (+/- or -/+) ER/PR status it is very difficult to assess how important this phenotype (genetic type) is ...
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I know they tested my DCIS routinely due to a Herceptin study w DCIS that the Univ of FL is involved in. Had my DCIS been Her2 + I would have received Herceptin x1yr as part of the study.
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a client of mine (wealthy/powerful women), who recommended me to Sloan, had DCIS grade 2 did chemo and herceptin. I never understood it. Just assumed she was extra cautious. I need to talk to her some more.
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Greenmonkey, my guess is that her diagnosis was DCIS + IDC. A lot of time when that happens, women focus on the "DCIS" and don't connect that they also have invasive cancer. Sometimes this happens if the preliminary diagnosis from a needle biopsy was DCIS only and then the cancer was upgraded after surgery to include invasive cancer. Often that happens when the diagnosis is largely DCIS with just a few millimeters of IDC; the assumption of many people when they see that is that the diagnosis is DCIS because that's what comprises the vast majority of the cancer. But with HER2+ invasive cancer, you only need to have a very small amount to move you over the bar to needing chemo and Herceptin.
I can't tell you how many times on this board I've seen situations like this. I try - as gently as I can - to suggest that the person saying this (that they had DCIS and had chemo) re-read their pathology report. Sometimes people are offended, sometimes not. I can only think of one case where eventually the person didn't come back and comfirm that they did in fact have invasive cancer along with the DCIS. In that one case, that might also have been true but they just didn't come back to say anything.
McCall, do you have more information on that trial? I know of two trials of Herceptin with DCIS - one had just one infusion of Herceptin, the other had two infusions. I'm not aware of any trials where a full year of Herceptin would be given if the diagnosis is pure DCIS so I'd be interested to learn more.
BL, thanks for that information about ER/PR status. I wasn't aware of that.
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Bessie, I don't have any details. At my appt when my BS gave me my bx results, she just mentioned that they were checking my Her2 status due to the study and that its not routinely tested w DCIS. They didn't have my results on that at that time, but she did say if it was (+), I'd get Herceptin monthly x 1 yr. She mentioned DCIS is routinely tested through UF because of the study. I didn't have my er/pr status at the time either, and when I found out later my Her2 was -, I didn't ask more questions. I am friends w the breast care coordinator and will see if I can get more details. I am not sure if this is a UF specific study or a national one.
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Beesie i also have noticed that people write the one diagnosis (DCIS) and omit the other diagnosis that they have for which they undergo chemo for.
Regarding HER2 and ER/PR testing our pathology dept routinely does is for tissue samples.
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Beesie is correct. If the DCIS is not invasive HER2 testing is not usually performed as it has little diagnostic value. Also, in our lab, if we look at a slide that is HER2 positive 50% or more of the nuclei must be positive before we report a HER2 test as amplified. anything under 50% is a grey area so far in the medical world.
Sandra
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McCall, I was really curious about the trial that you mentioned because it seems illogical to me to put someone with DCIS onto a year-long regimen of Herceptin. DCIS in the scheme of things is pretty low risk (~ 98% long-term survival rate, even considering invasive recurrences) whereas Herceptin is a heavy-duty drug with some very serious and potentially long-term side effects.
So I googled Univ. of FL and "Herception DCIS trial" to see what I could find. It appears that the trial they are participating in is NSABP B-43, which is the trial that I mentioned earlier in which patients get two infusions of Herceptin, in conjunction with their radiation treatments. Here's the Univ. of FL website with information about the trial: https://ufandshands.org/research-study/rtog-0974-nsabp-b-43-phase-iii-clinical-trial-comparing-trastuzumab-given
And here is more information about NSABP B-43:
That makes more sense to me.
If you do find out any more about the trial, or anything different than what I've found, please let us know!
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thank you Sandra and (again and again) thank you Beesie.
For me, knowledge is comforting. I understand that its not relevant because I had a BMX, but it makes sense that somewhere down the line, HER2 status will come into play with DCIS.
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GreenMonkey, I agree with you. Given the role that HER2 status plays in invasive cancer, it makes perfect sense that at some point down the line, HER2 status will also come into play with DCIS.
But here's the part that I can't figure out:
- 40% - 50% of all DCIS is HER2+.
- 20% or less of all cases of IDC are HER2+.
- Numerous studies have concluded that HER2 status does not change (or only a very tiny percent changes) as cancer cells evolve from DCIS to IDC. So DCIS that is HER2+ becomes IDC that is HER2+. And DCIS that is HER2- becomes IDC that is HER2-.
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So if HER2+ DCIS is more aggressive, as many suspect, wouldn't that logically mean that a higher percentage of HER2+ DCIS cases would become IDC? But if that were true, it would have to mean that the percent of IDC that is HER2+ would be higher than 40% - 50%, the percent of DCIS that is HER2+. However we know that the percent of IDC that's HER2+ is lower, not higher, so how do we explain this? How can HER2+ DCIS be more aggressive, more likely to become IDC, if the data that we currently have is true? The math just doesn't work.
Am I missing something?
Perhaps what really happens is that HER2+ DCIS is actually less likely to become invasive (as a few studies have shown) but in those cases where HER2+ DCIS does become invasive, it is more aggressive than HER2- IDC. I don't know that this is the answer, but it doesn't appear to me that the obvious conclusion (that HER2+ DCIS is more aggressive, just because HER2+ IDC is more aggressive) holds true either. It's a mystery.
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It is not just HER2, it is the whole profile (ER/PR/HER2), HER2 "usually" goes along with ER and PR status (ER+/PR+/HER2+) and they do "well", however the mixed groups (ER-/PR-/HER2+, etc.) it is just too hard to say because they are so rare. The reason that HER2 is being examined for DCIS is that there is a targeted therapy for it (herceptin). Most IDC that is HER2+ will get herceptin in addition to standard chemo and radiation -- it is just one more treatment in the arsenal. By the way, depending on which antibody is used for HER2 (there are several tests, and a few different ways to measure it), HER2+ IDC is 20-30% - and since it is not tested in most DCIS, it is hard to say what the actual percentages are ... http://www.jcancer.org/v02p0232.htm
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good POINT BLinthedesert!!! (about most DCIS not tested for HER2 so hard to say what actual percentages are)
Beesie... I so appreciate the time you take to explain everything. Here is what I don't understand.. (please be patient with me)
"So if HER2+ DCIS is more aggressive, as many suspect, wouldn't that logically mean that a higher percentage of HER2+ DCIS cases would become IDC?"
I have been told that true DCIS is not capable of becoming invasive and yet they'll say that the cells have the ability to mutate and become invasive cancer cells if left untreated AND yet not all DCIS mutates into invasive. It's either misleading or I'm misinformed.
Also.. why is DCIS considered cancer and LCIS is only considered a precursor to cancer?
How do they test for HER2? (breast tissue? blood?)
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DCIS does not "turn" into anything, basically cancer cells are simply cells that are abnormal and grow really quickly (compared to surrounding cells) - DCIS is simply a type of cancer cell, and as these cells multiply and grow they can mutate even further and evolve to cells that are able to invade surrounding tissue, and eventually end up in the blood, through the lymph system. When/if these cells mutate even further is the key. So, if you have DCIS cells, they all have the propensity to mutate into the type of cells that invade outside of the ducts, grade 3 cells are multiplying more quickly than grade 1, so theoretically they can "mutate" sooner - but grade itself does not predict those that might invade.
LCIS is misnamed, it is abnormal cells, and having these abnormal cells gives a good "environment" for cancer cells to develop, but these abnormal cells themselves are not malignant.
HER2 is a protein that is expressed in cancer tissue, it is tested using special stains on the slides from breast cancer specimens (e.g., normal tissue would not stain, only cancereous tissue).
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The key about the percentages for HER2+ is that 75% of DCIS is ER+/PR+ of those 75%, somewhere around 40% are HER2+. HER2+ is usually associated with high proliferation - meaning the cells are in a good environment for growth, this is why many believe that even in DCIS high levels of HER2 positive cells could signal an agressive state. However, whether or not it is "worse" than ER-/PR-/HER+ or HER- in DCIS, is not clear.
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thank you BLinthedesert
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I am glad I read all this stuff because I was really confused as to why they did not test. They offered me the trial but with all my other meds we decided not to do it.
BLinthedesert - I think we have a similar diagnosis for sure.
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having refused to participate in the study, due to the fact that it would have necessitated changing radiologists and delaying the begining of radiation - I have always been curious about that connection. it is my understanding that in HER2+ IDC herceptin infusions don't usually start til after radiation is completed? a major part of the study seems to be the impact of herceptin provided during radiation. Your thoughts on that aspect?
cut and pasted from the study description:
OBJECTIVES:
Primary
- To determine the value of radiotherapy with vs without trastuzumab (Herceptin®) in preventing subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral ductal carcinoma in situ (DCIS) in women with HER2-positive DCIS resected by lumpectomy.
Secondary
- To determine the value of these regimens in prolonging invasive or DCIS disease-free survival.
- To determine the value of these regimens in increasing invasive or DCIS recurrence-free interval.
- To determine the value of these regimens in improving regional or distant recurrence.
- To determine the value of these regimens in improving the incidence of contralateral invasive or DCIS breast cancer.
- To determine the value of these regimens in improving overall survival.
- To explore the effect of trastuzumab on ovarian function.
- To determine if the benefit of trastuzumab added to radiotherapy will be significantly higher in cMYC-amplified tumors than in the cMYC nonamplified subset.
- To determine if the benefit of trastuzumab added to radiotherapy will be less in tumors with mutations in the PI3 kinase gene than in tumors without PI3 kinase gene mutations.
OUTLINE: Patients are stratified according to menopausal status (pre- vs post-), plan for hormonal therapy (yes vs no), and nuclear grade (low or intermediate vs high). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo standard whole breast irradiation (WBI) over 5-6 weeks.
- Arm II: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in arm I.
Tumor tissue samples are analyzed for mRNA and DNA copy numbers of HER2, cMYC, and other candidate predictive genes; PI3K gene mutation status; other candidate predictors of trastuzumab response; and candidate prognostic markers of ductal carcinoma in situ.
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Hi Jelson, I don't think that herceptin "needs" to be given at the same time - unlike chemotherapy, it doesn't cause any immediate systemic stress, so it *can* be given at the same time (chemo and radiation is rarely given at the same time because it just causes too much stress on your whole system). It has been given after radiation for IDC, although I have seen some protocols that have it during radiation as well, I don't think it matters. Many times, clinical trial designs are written so that treatment is given consistantly, just to reduce the variation that could potentially occur if everyone recieved the treatment at different times in the course of their treatment.
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Jelson, I think the dilemma for the researchers is that normally Herceptin is given in conjunction with chemo. But DCIS patients don't get chemo.
The other dilemma is that for patients with invasive cancer, the primary goal of both Herceptin and chemo is a reduction in the rate of distant recurrences, i.e. mets. These treatments also provide benefit in terms of reducing local (in the breast) recurrence rates but the biggest threat and concern about HER2+ invasive cancer is the risk of mets. DCIS patients for the most part don't face the risk of mets; when we talk about 'recurrence' for a DCIS patient, it's local recurrence only. Rads is used to reduce the risk of local recurrence. So I'm guessing this is why Herceptin has been tied to rads for DCIS patients.
Re the earlier discussion and the percent of DCIS that is HER2+, while it's true that not all DCIS is tested for HER2 status, that doesn't mean that doctors and researchers don't have a very good handle on this. There have been dozens of studies that have looked at HER2 status in DCIS, and in each of those studies, obviously HER2 status would have been determined for any participating DCIS patients. There appears to be quite a bit of consistency in the findings, so it seems to me that we do have reliable data on this.
Although we don't have any clear answers about HER2+ DCIS, in digging through the research it's interesting to see how long this has been studied:
From 1992: Overexpression of HER-2/neu and its relationship with other prognostic factors change during the progression of in situ to invasive breast cancer. This study found that 56% of DCIS was HER2+ vs. only 15% of IDC.
From 2002: HER-2/neu Gene Amplification in Ductal Carcinoma In Situ of the Breast This is one of the studies that has actually found an inverse relationship between HER2+ DCIS and the risk of invasiveness. "HER-2/neu gene amplification was less common in DCIS associated with invasive breast cancer (cases) than DCIS alone (controls)... We found that HER-2/neu gene amplification was inversely associated with the risk of invasive progression in DCIS patients, even though it correlated with high-grade lesions in both cases (DCIS-associated invasive cancer) and controls (DCIS alone). The inverse risk association was independent of pathologic and quantitative image-analyzed morphometric (z score) nuclear grade."
From 2009: 14-3-3z Cooperates with ErbB2 to Promote Ductal Carcinoma In Situ Progression to Invasive Breast Cancer by Inducing Epithelial-Mesenchymal Transition "ErbB2, a metastasis-promoting oncoprotein, is overexpressed in 25% of invasive/metastatic breast cancers, but in 50%–60% of noninvasive ductal carcinomas in situ (DCIS). It has been puzzling how a subset of ErbB2-overexpressing DCIS develops into invasive breast cancer (IBC). We found that co-overexpression of 14-3-3z in ErbB2-overexpressing DCIS conferred a higher risk of progression to IBC. ErbB2 and 14-3-3z overexpression, respectively, increased cell migration and decreased cell adhesion, two prerequisites of tumor cell invasion. 14-3-3z overexpression reduced cell adhesion by activating the TGF-b/Smads pathway that led to ZFHX1B/SIP-1 upregulation, E-cadherin loss, and epithelial-mesenchymal transition. Importantly, patients whose breast tumors overexpressed both ErbB2 and 14-3-3z had higher rates of metastatic recurrence and death than those whose tumors overexpressed only one."
I could pull up about a dozen more, but instead here is an article from 2011 that isn't a single research study, but summarizes much of the research to-date: Biological Markers in DCIS and Risk of Breast Recurrence: A Systematic Review What I find most interesting is how much the results vary across the studies; this points out to me that it's dangerous to hang your hat on the results of just a single study. "Besides the steroid receptors, ER and PR, HER2 is one of the most extensively studied biological markers in DCIS. Studies have found HER2 to be of prognostic significance in invasive cancer; however, its importance in DCIS has yet to be elucidated. Among the 36 studies in our review that examined HER2 expression rate in DCIS, the mean expression rate was 40.1% (range: 9-67%, Table 6)...
Several studies investigated the relationship between HER2 and other biological markers. A few studies showed HER2 to be inversely correlated with ER and PR expression. One study showed HER2 to be positively associated with p53 expression. A few studies showed HER2 overexpression to be negatively associated with Bcl-2 expression. The majority of the studies in our comprehensive review showed HER2 overexpression to be positively and significantly correlated with high nuclear grade. However, one study did not show a significant association between HER2 overexpression and grade. One study showed HER2 overexpression to be significantly correlated with proliferative activity. In the same study, HER2 overexpression was significantly associated with p21 status.
We identified 15 (2,365 total patients) studies that evaluated the relationship between HER2 expression and local recurrence in DCIS. Eleven of these studies revealed no significant correlation between HER2 and disease recurrence...."
All very interesting. And no real answers yet.
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The early studies, 1992 - 2002 used a much older HER2 diagnostic. One problem, about all of these studies, is that the populations that use are studied are very heterogeneous in how they measure pathologic variables, surgical parameters, and most important, the technologies that they use to measure these other markers. The technology changes nearly daily. 15 years ago I was analyzing studies based on large (16,000) gene sets, now we measure 100,000 SNPs (smaller gene fragments), proteins, and even very tiny pieces of RNA (called microRNA) on a regular basis. However, the platforms that we use to measure these change all the time - as does our understanding of the biologic mechanisms of all kinds of cancers. As we move forward into personalize medicine we don't look at the organ system of the cancer (e.g., colon, breast, etc.), but are instead looking at the different protein and genes that are expressed in all cancers, regardless of what part of the body they are from (e.g., HER2 and the TGF-b mentioned above) -- for example, HER2 is over-expressed in many cancers, and Herceptin is being used to treat stomach and other cancers, in addition to breast. This is the reason that newer (and better) ways to measure these proteins/genes are changing so rapidly. And, that is why it is important to evaluate these proteins for all cancers. The biologic pathways for cancers are an integrated, and complicated, process.
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HER2 testing is so frustrating. We cannot call a HER2 positive in pure DCIS if it is in the ducts only. We have to wait until it spreads outside of a duct. I am angry that more research is not being done for HER2 testing and other "weird" looking cancer discoveries. The blanket statement of more research needs to be done just does not cut it. Sorry for the rant.
Sandra
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