Intermediate Oncotype Test - Dilemma!
Hi All (you very brave Gals and Guys),
New to posting here. Unfortunately not new to breast cancer. Had contralateral breast cancer diagnosed December 2016, mastectomy (no recon) in early January. My first breast cancer was nearly 20 years ago (right side). I was only 48 at the time, had mastectomy, chemo and tamox for 5 years and have apparently been fine.
I am now in my late 60's and this time the tumor was much smaller (6mm compared with 3cm in 1998) and this time lower grade (Grade 1 - in 1998 it was Grade 2). Both times I was node-negative.
Sooo....when I got my recent pathology result was VERY relieved since I was NOT looking forward to chemo again (I tolerated the tamox very well). I met with the oncologist who put my pathology data into the online Predict tool and said he didn't think I needed any further treatment.
I was happy to receive this news although I thought he might suggest an AI but he said he didn't think it necessary. I should mention the onco is quite experienced and has been working as a breast cancer onco for over 20 years in the major hospital centre in this part of Canada. Me (being me) had starting reading all that was new since 1998 in the field of breast cancer and had read about the Oncotype test that seemed to be quite widely done. I asked him about the test and he said that the province was paying for the test for early stage breast cancer where there was some question about how to proceed with adjuvant therapies - but he said that with my pathology report there seemed to be little question. However, I asked to have the test done (thinking that more information the better......). I was rather surprised (and perturbed) to receive the result of 25 (intermediate range) and will be meeting with the onco about this in several days.
In the last 48 hours I have been reading extensively about the oncotype test. There is a major study ongoing (Tailorx) looking at outcomes for intermediate oncotype scores with or without chemo (but that study excludes subjects with tumors less than 1 cm).
I searched and searched for the RSPC tool (which integrated the Oncotype score with pathology info) - but that is only available for physicians... So my questions for any who can offer any assistance here are:
- Have any of you been in a situation such as mine (very small cancer with intermediate Oncotype score)?
- Have any had experience with the RSPC Tool
- Do you have any information about decision making with intermediate oncotype score?
- What experience do any have in regard to how much "weight" oncologists are putting on the oncotype score?
Any other thoughts/comments are welcome as well!
Thank You
Comments
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nina, I don't really have answers to your questions, but did have a 21 onco score. My MO left it up to me as whether or not I wanted to do chemo. My tumor was larger than yours and a higher grade. It was also close to my chest wall. I have a family history, although there is no BRCA gene associated. So, I was aggressive in my treatment. I believe chemo is said to be more effective on the higher vs lower grade tumors...best of luck with your treatment plan!
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Hi ninaoctober:
I did not have the test, but I can comment on this question:
- Do you have any information about decision making with intermediate oncotype score?
Please be sure to discuss and confirm the following with your medical oncologist, to ensure receipt of accurate, complete, current, case-specific expert professional medical advice.
According to the GenomicHealth website, it is appropriate to consider a variety of additional clinical and pathologic factors with an intermediate Recurrence Score of 18 to 30 (scroll down to list of factors):
Genomic Health: http://intermediate.oncotypedx.com/en-US/Using-The-Intermediate-Recurrence-Score/Integrating-The-Intermediate-Recurrence-Score.aspx
With regard to the potential benefit of added chemotherapy, it is possible that there are differences within the intermediate range, such that chemotherapy benefit might differ by recurrence score or other factors. This is also discussed on the Genomic Health web site (scroll down):
Genomic Health: http://intermediate.oncotypedx.com/en-US/The-Recurrence-Score-Result/How-An-Intermediate-Recurrence-Score.aspx
In connection with the question of added chemotherapy, the standard intermediate range (18 to 30) is an area where a judgment call must be made in view of all relevant factors, as well as the personal risk tolerance of the patient.
In some cases (but not always), a second multiparmeter test might be ordered (e.g., MammaPrint plus BluePrint, Prosigna), if under applicable criteria (including "Clinical Risk" for MammaPrint) such further testing may provide additional information of value to decision-making. However, such secondary testing is not always recommended and appears to be less common outside of the United States.
Genetic Counseling
This is a completely separate question from the Oncotype testing of a tumor sample (because the Oncotype test looks at mRNA levels, not DNA).
At some point, you may also wish to inquire about a referral for genetic counseling to discuss the possibility of an inherited genetic predisposition to cancer. In addition to having asynchronous bilateral disease, it seems possible that you may have been age 50 or younger at the time of your first diagnosis in 1998. In this regard, our local National Comprehensive Cancer Network ("NCCN") Guidelines regarding "Genetic/Familial High-Risk Assessment: Breast and Ovarian" (Version 2.2017) set forth a long list of criteria that lead one to "[c]onsider referral to cancer genetics professional" (Chart BR/OV-1, pdf page 6). One current criterion is early-age-onset breast cancer (defined as age ≤50 y). Another criterion is "[t]wo breast cancer primaries [c] in a single individual." In the latter case, two breast cancer primaries "includes bilateral (contralateral) disease or two or more clearly separate ipsilateral primary tumors either diagnosed synchronously or asynchronously." Either of these two criteria (or others listed in the guideline) may trigger consideration of a referral. It is possible that the guidelines in your province in Canada may differ in some way. However, please do not hesitate to inquire with your medical oncologist whether you are a suitable candidate for referral to a genetic counselor.
A genetic counselor would collect a personal medical and family history, conduct a genetic / familial risk assessment, and provide advice about whether genetic testing of DNA from normal tissues (e.g., blood) is recommended in your case. If so, they will also make a recommendation about the scope of genetic testing (which genes), as well as the pros and cons of such testing. A patient may elect or decline such testing. Although you have already had left and right mastectomies, the identification of pathogenic mutations in certain genes (e.g., BRCA1, BRCA2, or other genes) would indicate an increased risk of breast, ovarian, and other types of cancers, and might lead to consideration of additional cancer screenings and/or prophylactic measures in the appropriate case (e.g., bilateral salpingo-oophorectomy (removal of ovaries and Fallopian tubes)). The results might also have implications for your family members (e.g., siblings, children).
Best,
BarredOwl
A copy of the National Comprehensive Cancer Network ("NCCN") Guidelines regarding "Genetic/Familial High-Risk Assessment: Breast and Ovarian" is available at no cost with free registration at this page:
This document is provided as background only, and is not a substitute for case-specific medical advice in this highly specialized area.
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Re: "There is a major study ongoing (Tailorx) looking at outcomes for intermediate oncotype scores with or without chemo (but that study excludes subjects with tumors less than 1 cm)."
That does not appear to be accurate. The TAILORx trial did include certain patients with tumors less than 1 centimeter, although these are less common than larger tumors. According to the recent TAILORx publication reporting interim 5-year results for those with Recurrence Scores of 0 to 10 (assigned to receive endocrine therapy alone), the following patients were included in the trial:
Sparano (2015), "Prospective Validation of a 21-Gene Expression Assay in Breast Cancer"
Main page: http://www.nejm.org/doi/full/10.1056/NEJMoa1510764#t=article
PDF version: http://www.nejm.org/doi/pdf/10.1056/NEJMoa1510764
"Study Patients
The study included women 18 to 75 years of age with axillary node–negative invasive breast cancer that was estrogen-receptor–positive or progesterone-receptor–positive (or both) and that did not overexpress HER2. Patients had to meet National Comprehensive Cancer Network guidelines for the recommendation of adjuvant chemotherapy,[21] including a primary tumor size of 1.1 to 5.0 cm in the greatest dimension for a tumor of any grade or a size of 0.6 to 1.0 cm in the greatest dimension for a tumor of intermediate or high histologic grade or nuclear grade (or both)."
In addition, Table 1 of Sparano indicated that 128 of 1626 (or 8%) of the patients with Recurrence Scores of 0 to 10 had tumors "<1.0 cm" in greatest dimension, and that 568 of 6883 (or 8%) of the patients with Recurrence Scores of 11–25 had tumors "<1.0 cm" in greatest dimension.
Unfortunately, the trial is on-going and we are still awaiting the results for the group of patients with scores of 11 to 25.
BarredOwl
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Hello Barred Owl,
Thank you for taking the time to respond. I had referred to the US NIH Clinical Trials page which states the inclusion criteria for the TailorX study:
Inclusion Criteria:
- Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment and meet the following criteria: ER and/or progesterone receptor (PR)-positive: Estrogen and/or progesterone receptor positive disease (as defined by local pathology laboratory)
- Negative axillary nodes: As assessed by a sentinel lymph node biopsy, an axillary dissection, or both, and as defined by the Sixth Edition of the American Joint Committee on Cancer (AJCC) staging criteria
- Tumor size 1.1-5.0 cm (or 5 mm-1.0 cm plus unfavorable histological features): Unfavorable features defined as intermediate or poor nuclear and/or histologic grade, or lymphovascular invasion
My tumor was graded as 1 (low grade)....thus I understand why my onco was not terribly interested in getting the oncotype done. Nonetheless I am very interested in the results of the Tailorx study in regard to the intermediate group. I suspect I am not alone in awaiting those results. There was huge publicity around the announcement of the results for those with low oncotype scores. I continue to look for publications online....it appears to me that the Oncotype company is certainly promoting the weight of their scoring system, while many oncos still rely upon the standard pathological findings (tumor size, nuclear grade, ER receptor, etc.). There should be a good way to marry the two pieces of information...........
I come about another interesting study in the New England Journal of Medecine which reports on a large study from Europe (evaluating Mammaprint which is more popular in Europe) which seemed relevant to my situation (if I were to assume I came out high risk on the Mammaprint). " 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer ".
Very interesting study in regard to examining situations where there is discordance (regarding risk of recurrence)...... between the pathology report and the genome report.........
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My oncotype was 26, and my MO said that I needed chemotherapy. I had a 1.2 cm tumor in my left breast, grade 2. The surgical pathology report also revealed DCIS in the left breast, which was also grade 2. I had a bilateral masectomy in February. According to the oncotype, my risk of distant recurrence within the next 10 year she was 17 percent with only 5 years of tamoxifen.
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Are they still only comparing use with tamoxifen? AI drugs are showing better statistics.
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Meow, all of the validating studies were done w/tamoxifen.
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Hhmnnn... I wonder why they don't include aromatase inhibitors in these studies? My oncotype was 22; the chart showed that the risk of distant recurrence within the next 10 years is 14 percent with 5 years of tamoxifen.... I am on Arimidex, so, I'm not sure how this percentage computes in relation to that..?
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While waiting for TailorX results, MD Anderson Cancer Center in Texas decided to retrospectively look at their own intermediate OncoDX patients (with and without chemo) and found this:
More patients with early-stage breast cancer may be able to avoid chemotherapy in the future
https://www.mdanderson.org/newsroom/2017/02/more-p...
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Nina,
As to your question about the RSPC tool, my MO used it (on Genomic Health's website) and my 10 year risk of distant recurrence went from 13% to 7% (when my age, tumor size, tumor cell grade and hormone therapy - AI instead of Tamox were taken into account). Although the RSPC tool has not been formally validated, it DID validate my MO's advice for me NOT to undergo chemo.
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Hi Nina -
my oncotype was 25 as well and I had 4 tumors all under 2cm with the largest 1.9cm. My MO was on the fence but ultimately decided against Chemo. I got a second opinion from Dana Faber in Boston and they also confirmed that Chemo would only better my chances of non-recurrence by only 2 or 3%. So we all decided against Chemo. I had however a mastectomy and radiation and am now on Tamoxifen.
All the best to you
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I personally would not base getting chemo on the oncodx statistic. My score was 34 and my instinct said no. I am fine over 5 years out.
If you believe chemo will be beneficial then do it. And yes AI drugs work differently then tamoxifen something to take in consideration. The statistic of recurrence is based on using tamoxifen so it is not accurate if you will be taking an AI.
I took anastrozole and exemestane total for 4 years. No recurrence. Chemo may lessen your risk but it is not a cure, recurrence can still happen.
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Hi ninaoctober, thanks for posting this.
I am in a similar situation: Stage 1A; post menopause; 8mm tumor; ER +; oncotype 19. I too saw that the medical community is waiting for this TailorX study, which my oncologist confirmed. She was very clear that she had no statistical evidence that the chemo would help because the benefits were at most a 4% reduction in risk, which was within the margin of error.
I have four weeks to make my decision. I'm seeking second and third opinions. But, I don't have any wisdom or new information yet.
I so appreciate everyone's input.
Sending everyone love and appreciation.
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hi Ninaoctober. Thank you for sharing your story. i am kind of in the same boat but this is my first dx this year. I am a 25 for the Oncotype test too!!! Ugh!! So perturbing and disappointing!! According to the stats they supplied on the Oncotype test, i would only benefit from chemo ONLY 4%!! That does not seem worth it to me at all! And just like someone else mentioned, it's not a cure. I am in a total cunundrum.
I will be reading everyone's replies. I am so thankful for this sight!
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getting the Mammaprint test seems logical. Likewise, have your case presented to the hospital's tumor board...
And, yes! What is most fascinating about these genetic tests is that they are now trumping tumor characterestics with respect to clinical treatment decisions. Since being included in the NCCN's 2011 bresst cancer treatment guidelines, the more subsequent research has certainly proven interesting. It is quite interesting to note that there are a small percentage of tumors with favorable characterestics but have high OncotypeDX scores, while some with less favorable characteristics have low scores. That fact underscores the need for genetic tests that can help guide treatment decisions. Likewise, the Anderson study is interesting too. For many patients, breast cancer is becoming a highly treatable disease with better individualized treatment.
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My Oncotype score was 27 and I decided against chemo.
I was told that there was no way to know with any certainty if the benefits to chemo would outweigh the risks. The possible life long side effects of chemo concerned me and I didn't want to put my body through all of that unless I knew there would be a benefit.
My MO supported my decision, so I moved forward to radiation and am now on Tamoxifen. Since I was young at my diagnosis, (41), my MO has decided to keep me on Tamoxifen for 10 years as opposed to 5.
It's a tough decision to make, with a lot of wrestling back and forth.....but in the end, you need to make the decision you feel is best for you. I have no regrets over my decision.
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The MD Anderson press release includes some important comments from the lead author:
"The study has a number of limitations, said Barcenas. Due to a relatively short follow-up and the few number of outcome events, the researchers feel that the benefit of chemotherapy cannot be ruled out yet in this group of patients.
While not practice changing, the findings do give Barcenas more information when discussing the benefits of chemotherapy in early-stage breast cancer patients, should their RS score be 11-25."
Unfortunately, the full-length research article is behind a paywall:
Barcenas (2017): http://onlinelibrary.wiley.com/doi/10.1002/cncr.30618/full
1424 patients were studied, using the investigational risk ranges from the TAILORx trial:
RS = 0 to 10 (297 patients; 21%): 1.7% of these received chemotherapy;
RS = 11 to 25 (894 patients; 63%): 15% of these received chemotherapy;
RS > 25 (233 patients;16%): 73.4% of patients of these received chemotherapy.
Note: Standard risk ranges for the OncotypeDX test for invasive disease are 0 to 17 ("Low Risk"); 18 to 30 ("Intermediate Risk"); and 31 to 100 ("High Risk").
The MD Anderson study was a retrospective study based on clinical usage, so it appears that decision-making about chemotherapy was at the discretion of patients and their physicians.
The second group with Recurrence Scores of 11 to 25 included both patients with Recurrence Scores of 11 to 17 (i.e., in the standard "Low Risk" range) and patients with Recurrence Scores of 18 to 25 (i.e., in the standard "Intermediate Risk" range). My layperson impression is that the inclusion of those with scores of 11 to 17 could conceivably contribute to certain favorable findings, as well as potentially limit the potential benefit of added chemotherapy, seen in the 11 to 25 group as a whole (or say, perhaps, in a subgroup scoring 18 to 25).
I note that the TAILORx trial protocol suggests that the planned analysis includes certain outcomes by small increments in Recurrence Score within the 11 to 25 group (who were randomized to receive endocrine therapy alone OR endocrine therapy plus chemotherapy) to probe whether a subset within the 11 to 25 cohort may benefit from added chemotherapy. The results from this trial cannot come fast enough.
It is not really possible to evaluate the implications of a full-length paper from a press release or abstract. Those with pending treatment decisions interested in these findings should be certain to discuss them with their Medical Oncologist, to ensure proper weight is given to its findings.
BarredOwl
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Don't forget to read the relevant article on BCO's own website: http://community.breastcancer.org/blog/what-my-pat...
EXCERPT: (emphasis mine)
"...many women are asking about the intermediate risk group in this study — women with Recurrence Scores of 11 to 25. What do the results suggest? Can these women skip chemo, too?
Unfortunately, this information isn't available yet and wasn't included in the Sept. 28 paper.
Dr. Steve Shak, chief scientific officer of Genomic Health, the company that makes the Oncotype DX test, said in an online interview that this is because there haven't been enough recurrences or other events in this group of women to make a decision about the benefits of chemotherapy.
While the low number of recurrences in the intermediate risk group may sound promising, I'm telling my patients that the study is not finished yet and I will still use the standard values to determine risk. The women with intermediate risk scores are still being followed, so much could change before the next analysis is published.
Until the next TAILORx analysis is published, I plan to continue to consider a number of factors in addition to the Oncotype DX test results for my patients when making decisions about chemotherapy, including:
- age
- the size and stage of the cancer
- hormone receptor protein levels and HER-2 status
- the grade of the cancer
- any other health conditions the patient has
- the patient's personal preferences
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If you want a clearer picture about your risk, I would suggest asking about MammaPrint+BluePrint (which also classifies whether your tumor is Luminal A vs.
or Prosigna. Both of these tests have no “intermediate risk" category—just “high" or “low." One woman on this board with an ODX of 20 came back “high risk" on Prosigna and got chemo; the other, with an ODX of 23, came back “low risk, Luminal A" on MammaPrint+BluePrint and skipped chemo.In your case, I think you should read between the lines of what your MO is saying in recommending against chemo and perhaps even endocrine therapy: your age. At 68, you would likely have a much tougher time than you did at 48 with chemo (including comorbidities that may have arisen in those intervening years). As to the endocrine therapy, we who are way past menopause tend to either experience fewer SEs from AIs or don't notice them as much because of all the aging we've already done. And an AI, if taken now, would probably be more effective than the Tamoxifen you took 20 years ago (when AIs were used mainly as third-generation fertility drugs or by male bodybuilders to suppress the estrogens that could cause gynecomastia in steroid users and interfere with extreme muscle development). Perhaps your MO is supposing that you might not want to afflict your golden years with AI side effects…but you might not get them anyway.
Another thing an OncotypeDX test does not take into account is how aggressive a particular tumor would be in a younger vs. an older woman. It does not test the patient at all—only a ground-up piece of her tumor, regardless of where and in whom it grew. In a woman of 68, a tumor with an ODX score of 25 would likely be more “indolent" (slow-growing) than would a tumor scoring 18 in a premenopausal woman. Consider your quality of life, as well as your life expectancy regardless of cancer. If you are destined to make it into your 80s (as we both statistically are), how would you like to live those years? Which would you consider less endurable—side effects (which might be mild) or worry (which might be unfounded)? I stopped worrying—it is what it is. I've already lived longer than three out of four of my grandparents and half my aunts & uncles. (Not to mention eight of my friends). I still have a very long bucket list, and I'd prefer to be in a condition to enjoy as much of its items as I can to the fullest even if I never get to complete it. (I can't see myself skydiving or cruising to Antarctica at 90).
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I just have to say that I really enjoy reading your posts, Sandy! You have a gift of writing and explaining things in a way that I can understand. So thanks for being here! In fact, so many of you have helped me immensely already. What a great resource you all are!
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In my post above, I noted:
"In some cases (but not always), a second multiparmeter test might be ordered (e.g., MammaPrint plus BluePrint, Prosigna), if under applicable criteria (including "Clinical Risk" for MammaPrint) such further testing may provide additional information of value to decision-making. However, such secondary testing is not always recommended and appears to be less common outside of the United States."
Patients who do receive such secondary testing may or may not receive a clear signal.
MammaPrint: Is it black and white?
Please confirm the following with a professional. MammaPrint may have a "binary" output (High Risk or Low Risk), but as a result of the design of the MINDACT trial and the available 5-year results pertaining to "discordant" groups, the test appears appears to yield less clear information in many patients.
Results from the MINDACT trial with 5 years of follow-up were recently published (Cardoso (2016)). This is a highly detailed and technical publication, so I refer others to the original. The documents can be accessed here:
Cardoso (2016):
Main Page: http://www.nejm.org/doi/full/10.1056/NEJMoa1602253
PDF version (Free): http://www.nejm.org/doi/pdf/10.1056/NEJMoa1602253
Supplementary Appendix (Free): http://www.nejm.org/doi/suppl/10.1056/NEJMoa1602253/suppl_file/nejmoa1602253_appendix.pdf
Hunter perspective (2016) (Free): http://www.nejm.org/doi/pdf/10.1056/NEJMp1608282
Hudis editorial (2016): http://www.nejm.org/doi/pdf/10.1056/NEJMe1607947
(Available for purchase)
The MINDACT trial design incorporated two risk classifications. It used a Clinical Risk Classification (using a MODIFIED version of Adjuvant! Online) to assign clinical risk as either "Clinical Low Risk" or "Clinical High Risk". It used a Genomic Risk Classification (using the MammaPrint test result) to assign genomic risk as "Genomic Low Risk" or "Genomic High Risk".
This yielded four different study groups (MP = MammaPrint):
(a) Clinical Low / Genomic MP Low
(b) Clinical High / Genomic MP Low ("discordant")
(c) Clinical Low / Genomic MP High ("discordant")
(d) Clinical High / Genomic MP High
The group that is Low Risk by both criteria (Group (a)) and the group that is High Risk by both criteria (Group (d)) are "concordant" (same: Low Low or High High).
The two groups that have different clinical and genomic risks (one Low and one High) are "discordant" (Groups (b) and (c)).
Part of the study looked at whether directing chemotherapy decisions on the basis of genomic risk or on the basis of clinical risk led to any difference in distant recurrences in the "discordant" groups. In certain groups, the test was not found to give a very clear signal regarding the potential benefit of added chemotherapy, (although due to differences in risk tolerance, patients may have differing views on this). The study had some limitations. For example, the study was not adequately powered to demonstrate the statistical significance of some differences between groups for all endpoints. (A medical oncologist should be able to explain possible caveats arising from these limitations.) In any event, the clarity of the information provided by the test and the medical advice received in light of same, will likely differ according to these groupings.
Prosigna: Some cases appear to yield an "Intermediate" result
Please confirm it with a professional, but it appears the Prosigna test may in some situations provide an "Intermediate" risk output. The following screen shot is taken from the Package Insert, which seems to suggest that test outputs differ by Risk Category, and that the test yields "Low, Intermediate, High" outputs in the node-negative setting.
http://prosigna.com/wp-content/uploads/2016/09/LBL_C02223_06_Package-Insert-Prosigna-Assay-US.pdf
Of course, patients should never hesitate to inquire with their medical oncologist about such additional testing.
BarredOwl
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Wow! Wonderful discussions have been happening with this topic. Let me give you an update on my situation. I saw my onco on March 20th to discuss my Oncotype score of 25. He was rather surprised and in a dilemma. Apparently at the medical centre where I am , they have just recently started ordering oncotype testing for early stage breast cancer and had not encountered many (or perhaps any) discordant situations (low genomic profile, moderate oncotype). My research (I printed off all the relevant articles - most of which have been referred to in the discussions above) and introduced my onco to the RSPC Calculator Tool which, as a physician, he was able to access.
Using this tool my risk of recurrence went from about 16% down to about 7%. After using the tool both my onco and I were quite comfortable with NOT doing chemo (whew.....) but I suggested that it might be wise to do an AI. So about 4 weeks ago I started on Arimedex and have not noticed any side effects except for insomnia (more than usual....) and perhaps more anxiety (and edginess) than usual. However, those symptoms could be caused by other factors perhaps. But certainly no SEs that seem intolerable and I think that I feel better doing something.....at least for now.
Moral of my story - do your research - there are studies (quite recent ones) that look at these discordant situations around early stage breast cancer and tools available that incorporate a variety of factors to help you look at your risk factors.
Twenty years ago, I did not hesitate about chemo - I was 48 - had a 3cm tumor, albeit node negative - had two small kids - in fact I sought chemo out.
However, now with much small tumor size and lower tumor grade - I really didn't think I should have chemo even with the oncotype 25. However, I'm glad I did the oncotype even though it left me in turmoil (once again) for about 10 days.... after doing the research I thought perhaps I should do an AI - which hopefully will be the right decision.
Thank you all for your wonderful caring sharing of knowledge and experiences and let's "keep talking amongst ourselves" (to borrow a line from SNL's Linda Richman)
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Just some more information: Initially my onco used the calculator tool PREDICT (available online and apparently widely used - although it does not integrate any of the genome marker tests).
Articles that I found helpful in addition to those cited above are:
Paik et al: Gene Expression and Benefit of Chemotherapy in Women With Node-Negative, Estrogen Receptor–Positive Breast CancerJournal of Clinical Oncology 24, no. 23 (August 2006) 3726-3734.
Tang, Gong et. al Gene Expression and Benefit of Chemotherapy in Women with Node-Negative, Estrogen Receptor-Positive Cancer J Clin Oncol, 2016
Tang et. al: Risk of Recurrence and Chemotherapy Benefit for Patients With Node-Negative, Estrogen Receptor–Positive Breast Cancer: Recurrence Score Alone and Integrated With Pathologic and Clinical Factors Journal of Clinical Oncology 29, no. 33 (November 2011) 4365-4372.
Stemmer SM, Steiner M, Rizel S, Ben-Baruch N, Soussan-Gutman L, Geffen DB, et al. 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%. Presented at San Antonio Breast Cancer Symposium (SABCS), Dec 8–12, 2015, San Antonio, TX.
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Hi NinaOctober:
Thank you for the update.
Is there an error in the second citation you provided above? When I google the title of the second article you listed, I come up with Paik (2006) not Tang (2016). Paik (2006) is particularly important, because it is one of the two validation studies featured in the graphs in the node-negative (N0) Oncotype report.
I believe these are the links for the four articles you intended to cite:
Node-Negative (N0) Validation Studies Featured in Node-Negative Reports:
Paik (2004), "A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer"
http://www.nejm.org/doi/full/10.1056/NEJMoa041588#t=article
Free pdf available for download. Figure 4 is the source of the data presented in the first graph of the node-negative report.
Paik (2006), "Gene Expression and Benefit of Chemotherapy in Women With Node-Negative, Estrogen Receptor–Positive Breast Cancer"
http://jco.ascopubs.org/content/24/23/3726.full.pdf
Free pdf available for download. Data from Figures 3 and 4 is presented in the second section of the node-negative report.
Selected additional publications:
Tang (2011), "Risk of Recurrence and Chemotherapy Benefit for Patients With Node-Negative, Estrogen Receptor–Positive Breast Cancer: Recurrence Score Alone and Integrated With Pathologic and Clinical Factors"
http://ascopubs.org/doi/pdf/10.1200/JCO.2011.35.3714
Free pdf available for download.
Stemmer (2015), "Abstract 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://cancerres.aacrjournals.org/content/76/4_Supplement/P5-08-02
Note: 10% of patients in this study had N1mi (Nmic) disease.
BarredOwl
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This is a useful article regarding the test, early study publications, and the rationale for the TAILORx trial design:
Sparano and Paik (2008): "Development of the 21-Gene Assay and Its Application in Clinical Practice and Clinical Trials"
http://ascopubs.org/doi/pdf/10.1200/JCO.2007.15.1068
For those with node-negative (N0) disease and a Recurrence Score of 0 to 10, the TAILORx trial publication cited earlier in the thread reporting interim 5-year results for those with Recurrence Scores of 0 to 10 (assigned to receive endocrine therapy alone) is noteworthy:
Sparano (2015), "Prospective Validation of a 21-Gene Expression Assay in Breast Cancer"
Main page: http://www.nejm.org/doi/full/10.1056/NEJMoa1510764#t=article
PDF version: http://www.nejm.org/doi/pdf/10.1056/NEJMoa1510764
In other threads, some members inquired about the use of an Aromatase Inhibitor instead of Tamoxifen. Although the Oncotype reports currently feature "validation" studies in which Tamoxifen was used, this reflects historical and practical considerations of clinical trial design. In current practice, the use of OncotypeDX Recurrence Score information does not restrict choice of endocrine therapy.
For example, a later Oncotype "validation" study was conducted in patients who had received 5-years of the aromatase inhibitor Anastrozole. This study used samples and 9-yr recurrence rates from the tamoxifen arm and the anastrozole arm of the ATAC trial, in node-negative and node-positive postmenopausal women with localized breast cancer.
Dowsett (2010), "Prediction of Risk of Distant Recurrence Using the 21-Gene Recurrence Score in Node-Negative and Node-Positive Postmenopausal Patients With Breast Cancer Treated With Anastrozole or Tamoxifen: A TransATAC Study"
http://jco.ascopubs.org/content/28/11/1829.full.pdf
I note that the TAILORx protocol permitted choice of endocrine therapy. For example, Sparano (2015) notes:
"In the low-risk cohort of 1626 patients [scoring 0 to 10], endocrine therapy included an aromatase inhibitor in 963 patients (59%), tamoxifen in 560 (34%), sequential tamoxifen followed by aromatase-inhibitor therapy in 13 (1%), ovarian-function suppression in 44 (3%), or other or unknown therapy in 46 (3%)."
There are hundreds of articles and abstracts available regarding the test in the node-negative and node-positive settings. If a publication influences your thinking in any way, it is essential to confirm your understanding, as well as currency and applicability to your case, with your Medical Oncologist.
BarredOwl
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Hello Barred Owl
Thank you for the links to all those relevant articles. When I try to put links on my posts the forum will not publish my posts. ...
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Hi ninaoctober:
I think there is a restriction on including links until after a certain number of posts (to discourage spam), and you may only have just reached the threshold.
You may already know this, but once you qualify to insert a link, then to ensure your links are operational, it is best to use the "Link" tool located above the text entry field where various formatting and insert options can be found (Bold, Italic, Strikeout, List bullets, etc).
The fourth option from the far right is the Link tool (line inside of rounded brackets).
Copy the link; Click on the Link tool (-); Select Insert Link; Paste link into the URL field, and click insert.
BarredOwl
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Looks like December (or later) before we get TAILOR X results for Intermediate OncotypeDX. Study ends in December - results probably not announced until later than that.
https://breastcancer-news.com/2017/02/24/early-sta...
QUOTE FROM 2/24/17 ARTICLE REGARDING TAILOR X STUDY: "The Phase 3 study, which began in 2006 and involves almost 11,250 patients throughout the U.S., Europe, Canada and elsewhere, is expected to finish in December."
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I have read many similar articles indicating people with an intermediate oncotype dx score can safely skip chemo. My frustration is the intermediate scores in the relevant TAILORX study ranges from 19 to 25. Would appreciate your thinking on how would the outcome of this study help people with higher intermediate score 26 to 30? Thank you
Rameson
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Romeson may I ask if you have lobular breast cancer or idc? It's a huge difference for chemo treatment
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