Long term "high oncotype test" survivors
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Complementing the data from TAILORx, Genomic Health announced presentation of real-world clinical outcomes from a large cohort of patients in the Clalit registry. Over half of the 930 patients in the analysis were identified as low-risk and were treated with hormone therapy alone based on Recurrence Score results. A nearly six-year follow-up showed very high survival rates (99.8%) and low distant recurrence rates (0.5%) in this patient group.
Survival and recurrence rates in patients with high Recurrence Score results, most of whom received chemotherapy, were 96% and 4% respectively while for patients in the intermediate group survival and recurr.
DetailsThe Oxford Overview of adjuvant endocrine trials [1] indicates that 5 years of adjuvant tamoxifen reduces recurrence by 41% and deaths by 34% in women with oestrogen receptor (ER)-positive breast cancers. At 5 years, in all patients studied, the recurrence rate was 25.8% in controls but 13.9% on tamoxifen. There was a substantial 'carry over' effect of tamoxifen such that even after 15 years of follow up mortality was about 30% less in tamoxifen-treated patients. The effect of tamoxifen was greater in patients with ER-positive, PR-positive as compared with ER-positive PR-negative tumours. These data indicate a substantial effect of tamoxifen but it is clear that approximately half of patients are resistant to tamoxifen de novo (early relapses) or acquire resistance if we assume that women who relapsed later had an initial response to tamoxifen. The potential reasons for resistance include activated growth factor pathways overriding the inhibitory effects of the drug either via nuclear or membrane ER. Of ER-positive PR-negative tumours, 30% are HER1/2-positive, as compared with about 10% of ER-positive PR-positive tumours, and this difference may account for their lower activity of tamoxifen in PR-negative tumours. Modern aromatase inhibitors (AIs) are more effective in reducing relapse compared with tamoxifen whether AI treatment is initiated after surgery (ATAC and BIG1-98 trials) or after 2–3 years of tamoxi
and ARATA0 -
Preliminary results were released from the TAILORx trial validating low Oncotype scores not needing chemo. Higher scores are still being studied. But there is some good news from other studies that Genomic Health did announce regarding intermediate and high scores.
"Complementing the data from TAILORx, Genomic Health announced presentation of real-world clinical outcomes from a large cohort of patients in the Clalit registry. Over half of the 930 patients in the analysis were identified as low-risk and were treated with hormone therapy alone based on Recurrence Score results. A nearly six-year follow-up showed very high survival rates (99.8%) and low distant recurrence rates (0.5%) in this patient group.
Survival and recurrence rates in patients with high Recurrence Score results, most of whom received chemotherapy, were 96% and 4% respectively while for patients in the intermediate group survival and recurrence rates were 98.8% and 2.3% respectively."
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Well its a year later and how is everyone? I too am Luminal B and am now 3 yrs out.
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Hey Jojo,
Also ER+/PR-/Her2-. Rounding the corner and heading into 9 years with no problems.
TYG!
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"Survival and recurrence rates in patients with high Recurrence Score results, most of whom received chemotherapy, were 96% and 4%"
So is this actually saying the 6 year study only showed 4% recurrence in patients who had high oncotype scores and received chemo? I was told my risk of recurrence was somewhere around 15% with chemo and hormonal therapy. I would love to be able to see 4% instead.
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Hi Wildflower:
I believe the "Clalit Health Services" study referenced above was described in this abstract from the European Cancer Congress 2015, Abstract # 1963:
Abstract # 1963: http://www.europeancancercongress.org/Scientific-P...
"Results: 930 patients were evaluable with 5.9 years median follow-up. Median age, 61 (27–84) years; N0/Nmic (90%/10%); Grade I (15%), II (49%), III (18%), N/A (18%); histology, IDC (81%), lobular (12%), other (7%). Distribution of Recurrence Score risk groups (<18, 18–30, ≥31): low (52%), intermediate (39%), and high (10%), with chemotherapy (CT) use of 1%, 28%, and 85%, respectively. The number of patients with distant recurrence by risk group (low/intermediate/high): 8/479, 20/362, and 6/89. The 5-year KM estimates for distant recurrence rates by Recurrence Score group: low (0.5%; 95%CI: 0.2–1.9%), intermediate (2.3%; 95%CI: 1.2–4.6%), and high (4%; 95%CI: 1.3–12.2). 5-year KM estimates for breast cancer specific survival by Recurrence Score group: low (99.8%; 95%CI: 98.3–99.9%), intermediate (98.8%; 95%CI: 96.8–99.6%) and high (96.0% 95%CI: 87.8–98.7%)."
Although the study included 930 patients, only 10% had high risk RS ≥31 (or by my calculation ~93 pts). Chemotherapy use in that group was 85% (or by my calculation ~79 pts)*****. Rates are given as 5-year Kaplan Meyer estimates. Probably because the number of high risk patients was smaller, you can see that the confidence intervals in the high risk group are larger than for the low and intermediates.
BarredOwl
*****Edited to add: The actual number of "high risk" was 89 patients.
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BarredOwl - I'm not sure what all that stuff actually means. Does it mean that if a woman with a high onco score has only 4% chance of recurrence AFTER doing Chemo? I started this thread 8 years ago and didn't know anyone with an onco score as high as mine (52). I just visited my oncologist and she said "it's patient's like you that made me want to practice oncology for the past 30 years". She was not meaning that I'm a fantastic patient - she meant that what she does in medicine does help a lot of people survive long periods of time, even with mean cancerous tumors such as I had. I am 10 years clean and feel great. I love to encourage woman with the dreaded "high score" that I am still here and they can be survivors too. I never want to say that I'm free of this forever because breast cancer can come back 25 years later. It's just that I rarely think about it anymore and I'm am so grateful to my Lord for allowing me to live this long to see my children get married and have children of their own. PTL. But BarredOwl if you could explain in layman's terms what exactly all this information means, many of us reading this form would be very appreciative.
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BarredOwl,
Yes, it's still unclear to me, I don't even know what a confidence interval is
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Hi Wildflower:
I was just providing the underlying abstract further to Mamagrammy's information quoted from a press release above. Generally, when I see a statistic like that, I want to know more about the composition of the study population (node negative? node positive? other features?) and the size of the sub-group in which "4%" was reported. The features of the study population may limit the relevance of the study findings to particular patients. In addition, a smaller number of patients ("n") can undermine the statistical significance of a result.
For example, this overall study population (n = 930) was largely node negative (90%), and a small percentage (10%) were Nmic, so the study result would be most relevant to N0 patients, and perhaps Nmic (although the number of the latter were relatively small). As relevant to this thread, the "high risk" recurrence score sub-group was only 10% of the study population, so not very large. Also, in this regard, the confidence intervals or ranges are given in the original abstract.
Abstract # 1963: http://www.europeancancercongress.org/Scientific-P...
There seem to be different ways of looking at "confidence intervals". I am not a statistician, but my very crude layperson understanding of a "confidence interval" is that it is a statistical assessment of the likely accuracy of a measurement and wobble room around the value. One interpretation would be that there is a 95% probability that the value of interest (e.g., distant recurrence rate) lies within the interval or range (a to b).
So, I think that for the distant recurrence rate in the high risk group "(4%; 95%CI: 1.3–12.2)" measured as 4% in this population, the confidence interval ("CI") of 95% is a range from 1.3 to 12.2, possibly meaning 95% of the time, the rate would end up somewhere between 1.3% and 12.2%. So 4% is what they measured, but it could actually be higher or lower (between 1.3 and 12.2). If a full-length manuscript is ever published, it would contain more details.
While statistical measurements in populations are informative for the group as a whole, an individual patient either experiences something or does not.
BarredOwl
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Hi IOUgirl:
As noted by Mamagrammy above, the recent TailorX study publication only contained the results for a group of low risk patients with recurrence scores of 1 to 10. Those with scores 11 and above are still being followed.
However, at the time the TailorX result was published, a number of other abstracts were published from other studies, such as the one described in the press release, which appears to be the "Clalit Health Services" study described in this abstract from the European Cancer Congress 2015, Abstract # 1963:
Abstract # 1963: http://www.europeancancercongress.org/Scientific-P…
There is not a whole lot of information available from the abstract, although the dense format makes it very hard to read. I will recap it here, hopefully making it more understandable.
The abstract text describes results from a study of 930 patients. It is a real-world study of the use of the Oncotype DX test for invasive disease, in which the standard recurrence score ranges (<18, 18–30, ≥31) were used in clinical decision-making in patients in Israel between December 2004 and December 2010.
Study patients had N0 or Nmic disease and received Oncotype DX testing from 12/2004 to 12/2010.
It is important to note that it was not a randomized study. Thus, patients were free to choose chemotherapy or decline chemotherapy, regardless of their recurrence score. For example, 85% of those with a high recurrence score received chemotherapy.
The patients were treated at Clalit Health Services (CHS), the largest HMO in Israel, presumably according to local standards of care. I do not know how closely these compare with those in the US.
930 patients were evaluable with 5.9 years median follow-up. The characteristics of these 930 patients are listed below. The distribution of tumor sizes and stages were not provided.
Median age, 61 years (Age range 27–84 years);
Node Status:
N0 = 90%
Nmic = 10%
Grade:
I (15%)
II (49%)
III (18%)
Not available (18%)
Histology:
IDC (81%)
Lobular (12%)
Other (7%)
Distribution of Recurrence Score risk groups (<18, 18–30, ≥31):
Low risk (<18): 52%
Intermediate risk (18–30): 39%
High risk (≥31): 10% (n = 89)
Chemotherapy (CT) use:
Low risk: 1%
Intermediate risk: 28%
High risk: 85% received chemotherapy
Number of distant recurrences by risk group (raw numbers):
Low risk: 8/479
Intermediate risk: 20/362
High risk: 6/89 (six distant recurrences among 89 patients with a high risk recurrence score)
5-year Kaplan-Meyer (KM) estimates for distant recurrence rates:
Low risk: 0.5% (95% Confidence Interval: 0.2% – 1.9%)
Intermediate risk: 2.3% (95% Confidence Interval: 1.2% – 4.6%)
High risk: 4% (95% Confidence Interval: 1.3% – 12.2%)
5-year Kaplan-Meyer estimates for breast cancer specific survival by Recurrence Score group:
Low risk: 99.8% (95% Confidence Interval: 98.3% – 99.9%)
Intermediate risk: 98.8% (95% Confidence Interval: 96.8% – 99.6%)
High risk: 96.0% (95% Confidence Interval: 87.8% – 98.7%)
All patients should have received endocrine therapy. However, no information is given regarding actual number of patients receiving endocrine therapy, the particular therapies, or their adherence to it.
The authors observe that chemotherapy use was generally consistent with recurrence score. Indeed, only 1% of low risk score patients received chemotherapy, while 85% of high risk score patients received it.
The authors also state that "the outcome data are consistent with previously reported prospective-retrospective studies for this assay," which provides some confirmation that the test works in accordance with the current understanding. (Prior studies had conducted the test on archived tissue from a limited number of very old clinical trials and then looked at outcomes from those older studies.) They also emphasized the low distant recurrence rate in the low risk cohort.
With 5.9 years median follow-up, there were 6 distant recurrences among 89 patients with a high risk recurrence score (with 85% receiving chemotherapy, and probably endocrine therapy).
Keep in mind that 15% of patients with high risk recurrence scores did not receive chemotherapy. Their particular scores are not given, yet they appear to be included in the outcome data.
As I mentioned above, only 10% or 89 patients had a high risk recurrence score (≥31). Given the small number with high risk recurrence scores, there is quite a bit of wobble room around the measured values for high risk (see 95% confidence intervals). The value determined for distant recurrence rate was 4% (confidence interval 1.3 % to 12.2%). The value determined for breast cancer specific survival was 96.0% (confidence interval: 87.8 – 98.7%). The numbers are encouraging, but they are based on a small number of patients.
While statistical measurements in populations are informative for the group as a whole, an individual patient either experiences something or does not.
Abstracts are preliminary in nature, and additional results may be published from this or other studies. Apparently, at the meeting, additional results were presented (for up to 2900 patients), but I have not seen published materials on the full 2900 patients.
I am just a layperson, so the above is my understanding only. Anyone making a decision and considering these results should print out the abstract from the link and discuss it, as well as the current state of clinical research, with their oncologist to ensure relevance to their presentation and consideration of current clinical study data.
BarredOwl
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My ability to understand oncology and study data has grown enormously since my diagnosis. Frankly, this is information I would have preferred to have never learned.
BarredOwl - I always appreciate your informed posts. I'm having a difficult time reconciling some of the numbers from various studies. The research you're citing leads me to believe the recurrence rates are not terribly high compared with studies that show significantly higher systemic recurrence rates. Does any of this make sense to you?
Wildflower - I too have a higher recurrence risk than what the study suggests. It makes me think my tumor was far more aggressive than anyone revealed to me. I just don't know.
IOUgirl - Good for you. I love to see women doing well many years out. I look forward to the day this looks like a blip on the radar.
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Hi WarriorWoman:
I'm still learning. Some very general things that lead to discrepancies between studies are differences in sizes and characteristics of the study population, differences in the particular endpoint(s) used (distant recurrence was used here, as some view it as most relevant to the particular benefit of chemotherapy), time-frame (5-year rates here), and/or the type of intervention. But it could be that the studies of the Oncotype test are really geared toward determining if the test is working well for the purpose of deciding the chemotherapy question. They contain hormone-responsive patients of a variety of different stages, most of whom will receive endocrine therapy. Then, of those receiving chemotherapy (and some did not), they likely receive a variety of chemotherapy regimens. The outcome numbers would likely differ from those assessing outcome by specific stages or the benefit of a specific treatment regimen, for example.
BarredOwl
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Thanks BarredOwl. I like the numbers for this study. I like any study that gives me a better chance.
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Further to my recent description of Abstract #1963 from the European Cancer Congress 2015, this group has published another abstract at SABCS 2015 with additional results from the Clalit Health Services study based on 1594 patients. The numbers are a little different when the larger group is considered.
Chemotherapy use in the high risk group was 89%.
The 5-year Kaplan-Meyer estimate for distant recurrence rate was 6.9% (95% Confidence Interval: 3.7-12.9).
The 5-year KM estimate for breast cancer specific survival was 90.6% (95% Confidence Interval: 84.5-94.4%) for the high Recurrence Score group.
Please consult the original for more information.
Abstract No. P5-08-02: "Real-life analysis evaluating 1594 N0/Nmic breast cancer patients for whom treatment decisions incorporated the 21-gene recurrence score result: 5-year KM estimate for breast cancer specific survival with recurrence score results ≤30 is >98%"
http://www.abstracts2view.com/sabcs15/view.php?nu=...
BarredOwl
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Thank you for sharing. I fell into that dreaded intermediate group and, while I try to never second-guess my decisions, these numbers were reassuring -distant recurrence rate for intermediate 5.6% with chemotherapy and 5.3% without. After a second opinion at the NCI designated research center in my state, I decided to pass on the chemotherapy. I know that we make the best decisions we can with the information we have at the time but if these numbers had been different for the intermediate range, it would be hard not to feel I should have gone with the first doctor's recommendations.
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Barred Owl,
Thanks so much for pointing out the SABC abstract. I had missed it, and it's good to see an update on DFS by RS. The big push for AIs came only after this study, so maybe those will push down that 5-year KM estimate a bit.
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I love this thread and thank you to all of the contributors!
JoJo - I am 4 years out from surgery (chemo followed) and my Oncoscore 39. Luminal B.
IOUgirl and other longterm survivors that have posted...I very much appreciate your posts!
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my pathology report mentioned nothing about luminal a or b ?? How or what determines this? I unfortunately did not have the oncotype test. Do all grade 3 generally have very high oncotype scores and does node positive, Lvi increase the score?
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Doing OK at 4 years oncodx was 34, I chose no chemo just AIs
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Good for you Meow13! My score was 27 and I did not do chemo either, (one MO recommended, MO at NCI research center did not), and am five years out doing fine. Wasn't an easy decision but once I made it, I've done my best to not look back.
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Thinking positive:
I don't know if all grade 3's have high Oncoscores, but most "high" Oncoscores are grade 3. Genomics use to have graphs /statistics about this on their web site.
Luminal B is not usually reported on pathology. It is a subtype of ER+ BC. Roughly, luminal B is ER+, PR-, Her2-, Ki67 > 12%. Not everyone gets their Ki67 % reported on their pathology because most pathologists feel it is hard to precisely, or even accurately, measure. Oncoscore considers Ki67 and hormone factors and since these factors are less favorable in Luminal B than Luminal A, it follows Luminal B will get higher Oncotype scores.
As far as the more nuanced differences between A and B, I think that is the stuff of medical journal articles. Once I was deep into that stuff, even considering Metformin to prevent recurrence due to Luminal B being more affected by Insulin like growth factor, but then I found things contrary to this. Survival statistics are sometimes differentiated between A and B.
I research less, maybe not at all, these days, and my memory for precise facts less reliable. I may be off a percent here and there.
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Quinncat, thanks for the response.. it seems that the further along I get from my final chemo (which was 13 months ago, the more worried I become. I thought it was supposed to go the other way, that as time goes on, you worry less?? My Ki67 was 28% but I was ER+ and PR+ Her2-. I read so many different things and I know I should just move on and not worry, but it really is difficult. It doesn't make me depressed or not able to function, just that I worry about Stage 4.
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ThinkingPositive - I am the queen of worry, so I get it. It does get better and occasionally a day, or may be even two in a row, goes by and I haven't thought of cancer. From all my reading, I do believe I'm in my own personal risk timeframe (year 3-5, being 4 years plus from surgery), but even given that, I worry less. After 5 years, my risk is the same as a luminal A, but I still know that isnt zero.
I was PR+ too, but IHC 5% and Oncotype showed similar. That was enough (or not enough 🙃) to still qualify as luminal B per my MO
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I had grade 3, ER 90%, PR 90%, KI-67 10%, one positive node (1 cm), LVI and my oncotype score was 19. I'm not sure if I'm luminal A or B though - seems like every study I read has a different definition.
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Boys62 - luminal A, unless definitionhas changed lately.
Someone asked if LVI part of the oncoscore calculation -NO
The test, for sure ER+, Her2-. Not sure about a node, but might allow 1 node or micromet, or whatever still qualifies one as Stage 1. Chemo burned my brain out.
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Boys62, your pathology is very similar to mine, but I was Stage 2A. My Ki67 was 27%. Had node positive that was 8mm, tumor was mix of DCIS and IDC... 1.1mm. Had LVI that was present as well I assume you did chemo? Based on what my MO said, my oncotype would come back probably high, so he was recommending chemo. I went ahead and did the chemo.
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ThinkingPositive - I just found this little factoid about luminal B. Seems to agree with what I think I knew at one point in this process:
"Luminal B is higher risk but the risk drops to something similar to Luminal A after 5 years. Half of recurrences occur in the first 5 years and the 2-3 year mark is a time of higher incidence."
And perhaps, since I am 4 years out, I started worrying less this last year, though it hasn't gone away, by any means, it's just less
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thinking positive- yes, I did AC-T chemo. My MO agreed to order the oncotype test (I was just curious about what my score was) but told me no matter what the score was she was recommending chemo based on all of my other factors - grade 3, positive node, tumor size, LVI and I'm young (late 30's).
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Boys62- I did TC. MO gave me two choices but would not tell me which one to do. I picked TC due to heart problems act could cause and since I have extremely high blood pressure I chose tc. So you never ended up having the oncotype test either? If you did whst was your score? Did your MO give you any percentages? Mine didn't really didn't answer questions to my satisfaction but I felt I didn't have time to get second opinion and felt I was at a pretty goodso I stayed.
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my score was a 19 which is a 12% chance of recurrence in 5 years with or without chemo per the report. Even though oncotype didn't show any benefit to adding chemo my MO thought it would get a few percentage points. I never considered not doing chemo - I'm a young mom and needed to do everything I could. I also did not get a 2nd opinion. Now I'm doing zoladex shots, taking femara, twice a year Prolia shots and hoping for the best
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