Should I have chemo and/or radiation? Onco score a 5.
I am 47 and have ER/PR+, HER2 negative, IDC (and DCIS ) on the right side. I had 3 spots, .5cm, 1.6cm and 1.7 cm all grade 2. Opted for bi-lateral, nipple-sparing mastectomy with immediate reconstruction. Final pathology showed LCIS on the left side but the 3 sentinel nodes were clear. One of the 2 sentinel nodes removed from the right side had micro metastasis. All genetic testing came back fine and Oncotype score was a 5. Docs say no real benefit to having chemo and also say no to radiation but they'd give it to me if I want it. Does anyone else have a similar experience? Anyone have a low onco score, not do chemo/radiation and god forbid have cancer recur?
Comments
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Hi Lurline, I had a 2.5 cm tumor, micromets in one sentinel node, and an Oncotype score of 12. My oncologist said no chemo, and I got 3 different opinions on radiation and all 3 said that it wasn't worth the risk. My cancer was on the left side so I am not sure if that contributed to those recommendations. I also had a mastectomy. I didn't really feel like I was fighting the chance of recurrence until I started taking the antihormonals, but since I was 100% ER + hopefully they carry enough of a punch. I am 2 years out and doing well, but everyone has to do what they think is the best choice at the time. Don't hesitate to get a 2nd opinion. Keep usposted!
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Oncotype of 5? You'd be nuts to do chemo. With a score that low it would probably confer little to no protection against recurrence and might even result in shorter overall survival (life expectancy until death from any & all causes). At 47, it's worth doing the anti-hormonals, though. (I'd think twice if you were in your 80s).
Note, though, that anti-hormonals and chemo are not interchangeable, as they kill different kinds of tumor cells via different mechanisms. Chemo kills cells that divide rapidly by poisoning them: not just aggressive cancer cells but also healthy mucosal membranes, hair follicles, bone marrow, nail beds, etc. (Collateral damage which does carry real risks, some of them permanent and serious).
But an Oncotype that low means any micromets would be too “indolent" to succumb to chemo, yet the rest of your rapidly-dividing normal cells would be damaged by chemo nonetheless. Anti-hormonals, OTOH, are designed to starve estrogen-dependent tumor cells of the fuel they need to survive and replicate. They have side effects too, but much milder than those of chemo (depending on whether you take a SERM like tamoxifen or an AI, they either reduce the estrogen in your body or block tumor cells' access to it, so their side effects are the same as those of aging; but unlike actual natural aging, many of them may be reversible after finishing treatment).
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lurline...what is your menopausal status? If you are premenopausal you might want to discuss the results of the SOFT and TEXT trials. There is much research regarding ovarian suppression in lieu of chemo. Furthermore, an even more recent study now suggests a small benefit of doing ovarian suppression with an aromatase inhibitor rather than tamoxifen for those of high and intermediate risk
http://ascopubs.org/doi/full/10.1200/jco.2015.64.3...
I suggest you register at the NCCN's website and read about the breast cancer treatment guidelines. As you are aware, with a very low oncotypedx score, the risks of chemo outweigh the benefits AND according to the TailorX study, those patients with OncotypeDX scores below 11, have extremely favorable outcomes without aggressive treatment.
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The risk estimates provided in your Oncotype test report are the risks observed in patients from a clinical trial who were assigned to receive (a) Tamoxifen Alone; or (b) Chemotherapy plus Tamoxifen. In other words, all patients received Tamoxifen at least. Therefore, you should receive a recommendation for some sort of endocrine therapy (e.g., Tamoxifen). Otherwise, your risks will be higher than shown in your report
Re VoraciousReader's comment about TAILORx, please note that with micromets in a lymph node, the findings of the TAILORx trial do NOT appear to be applicable to your particular case, because the TAILORx study population was node-negative ("N0").
Sparano (2015), TAILORx Trial in NODE-NEGATIVE ("N0)" patients:
http://www.nejm.org/doi/full/10.1056/NEJMoa1510764#t=article
"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 guide- lines for the recommendation of adjuvant chemo- therapy,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 great- est dimension for a tumor of intermediate or high histologic grade or nuclear grade (or both)."
There are other relevant studies which included pN1mi patients (ask your team).
BarredOwl
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I had an Oncotype score of 3 and micromets of .3mm and .7mm in the first sentinel node only. The other 7 were clear. My oncologist recommended rads to the breast and nodes including supraclavicular. I am also on Armiidex for at least 5 years. I had no problems with the radiation (at least so far) and the Arimidex has been a easy with no side effects. My Oncotype report gave me a lower 10 year survival if I had done chemo. Since I was grade 1 with a 3.3% Ki67 the chemo would have had little if any effect.
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I note that with radiation therapy, different clinical guidelines apply to those with invasive breast cancer treated by mastectomy versus those treated with lumpectomy.
To the extent that there is some exercise of clinical judgment, a second opinion can be helpful.
BarredOwl
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barred...not to split hairs....But the origional poster qualified for the OncotypeDX test and scored a 5. We don't know if the OP's team considered her node negative when they requested the test. However,, I am assuming that the OP was not participating in the RXPonder trial because a patient would need to have cancer in 1-3 nodes, so that leads me to assume that her team and the Genomics folks consider her node negative. That said, there is debate whether micromets are clinically "node positive." Also making the water even more murky is Sparano's lack of mentioning which side of the debate micromets fall into. Not all node negatives are alike...so I don't think it is clear that we can conclude that TailorX's preliminary data isn't relevent. IMHO, i think she and her team need to discuss its findings
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Hi all - thank you so much for your replies! So I did get three opinions from med oncs at MGH, Dana Farber and BIDMC and radiology at MGH and BIDMC. They all agreed no chemo based on Onco score. However, there were some screw-ups along the way that make me perhaps overly skeptical regarding everything. For one of my biopsies they marked the wrong breast with a big YES and after I pointed out that they had marked the wrong one - they didn't actually biopsy the cancerous spot - they missed it by 1cm and I had to go back in for an MRI guided biopsy. Also, during that same biopsy, the nurse dragged a garbage can across the room and then almost applied the sterile dressing to my biopsy site without changing her gloves until I gave her a horrified look. When I went to have the radioactive die injected the night before my surgery - the nuclear lab never got the memo that I was having a double mastectomy and had only drawn up one radioactive needle. The Onco lab performed their initial testing on the wrong tumor - the 1.7cm tumor had mucinous features which makes it less aggressive than the 1.6cm and .5 cm that didn't have mucinous features. The micro mets in my node didn't have mucinous features so they likely would have come from the 1.6cm non-mucinous, more aggressive tumor. However, the Onco Lab tested the 1.7cm tumor at first and somewhere along the way realized they should have been testing the 1.6cm tumor. By the time I got the results, it was 4 weeks and 2 days after my surgery. Then they sent over the node negative reports and graphs (my doc said that with micro mets, I had to be considered node positive) and my doctor had to call to get them to send over the node positive info. My concern with these studies is that the sample size is so small - especially for the node positive results. The node positive graphs for low Onco scores even shows a higher recurrence rate for Tamoxifen plus chemo than it does for Tamoxifen alone which my doc said was probably a statistical anomaly. Making me think - well how reliable is this? Finally, I don't really fit the profile for any of the studies as I'm "young" (47), pre-menopausal, have micro mets in one node and have a low onco score. So it's really a lot of extrapolation to me. Thrilled that I don't need chemo but just kind of looking for reassurance I guess.
They were more on the fence about radiation, but in the end both docs said they are typically very conservative, but in this case would tend to say no but would give it if I wanted it.... I also will be taking Tamoxifen - starting it this weekend. Thanks again for all of the insight everyone!
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lurline...i am confused. So, according to the reports, you are node negative, but because of the micromets, your doctor considers you node positive? Regardless, you have opinions from leading hospitals and they all seem to agree despite the discordent results. In sum, for most of us, there is little black and white when making treatment decisions. We all do what each of us is comfortable doing
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No according to my docs I have to be considered node positive because of the micro metastasis. However, the Onco lab initially sent over reports showing results from node negative studies. Then my doc requested the reports for the node positive studies because she said I am considered node positive. Onco score is still a 5 in both cases - it just changes which study results and graphs they send over. SWOG 8814 for node positive and NSABP B-20 and NSABP B-14 for node negative . In my case with an Onco score of 5 - the recurrence rate for node negative with Tamoxifen only is 5% and for node positive with Tamoxifen only is 8%. In either case - both show no benefit to chemo - but again, I don't fit squarely into any of these studies.
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Yes - I know - probably overthinking it, but as I said, just looking for some reassurance.
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thank you for the clarification.
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC43812...
Page 13 gives an interesting point about the debate if micromets should be considered node negative or positive...and this retrospective study tries to flesh out if there is importance. Very interesting, Lurline, that the Difference was small and still the risks of chemo outweighed the benefits in both cases
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Thank you! I'll check that out. Actually node negative graphs showed tamoxifen and tamoxifen plus chemo to both be approx. 5% recurrence rate. Maybe .5% higher recurrence without chemo. Node positive showed 8% recurrence with just tamoxifen and about 12 % recurrence rate with tamoxifen plus chemo (that's what my doc said was probably a statistical anomaly - Chemo might not help you but shouldn't make recurrence rate higher.)
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Vorcaciousreader - yes very interesting.
"Advances in surgical and analytical techniques have resulted in increased frequency of diagnosis of pN1mi disease, but there is still a debate about its prognostic significance. Several studies have found no significant difference in overall and/or disease-free survival between patients with micrometastasis and those with node-negative disease [18,19,20], suggesting that the treatment of micrometastatic disease should be the same as node-negative disease. The distribution of Recurrence Score results observed in the current study is similar to the distribution seen in node-negative patients, providing support for the thesis that these patient groups are similar at the level of breast cancer gene expression. Other studies provide evidence that micrometastasic disease does indeed confer a worse prognosis [21,22] and that adjuvant therapy may improve disease-free survival [23]. If micrometastatic breast cancer behaves like node-positive disease, it may still be possible to eliminate chemotherapy in a lower risk group without worsening outcomes through the use of the Recurrence Score result [24].
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HapB - well I don't really want to throw anyone under the bus so I will preface this by saying that even through all of the screw-ups I would still have my surgery at this hospital. I have complete faith in the excellence of my surgeons and seemed to have a much easier recovery post-op compared to others. It is a teaching a hospital and a lot of the mistakes happened with residents not attendings and none of them were attributed to my actual surgeons. My surgery was at MGH and my "2nd opinion" was at DF - but as you mentioned - they are all part of Partners and I didn't feel like it was a 2nd opinion per se. It was more like - yeah what MGH said.
I will say that through this process I met some amazing people along the way and I met some not so great people including one of the admins that I'm pretty sure was the devil herself ; )
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Re: "Also making the water even more murky is Sparano's lack of mentioning which side of the debate micromets fall into."
TAILORx Study Population is "Node-negative":
My layperson understanding regarding the types of patients included in TAILORx (i.e., "node-negative" or "N0") was also based on my consultation of the clinical trial protocol published by NEJM. The inclusion criteria for TAILORx provide:
Elsewhere it states: "Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment and meet the following criteria . . "
In contrast to the various "N0" nodal statuses listed in the protocol, axillary micromets are considered "pN1mi" disease and do not appear to meet the listed inclusion criteria for TAILORx.
Five-year results for those with Recurrence Scores of 0 to 10 assigned to receive endocrine therapy alone have been published. Patients should consult with a medical oncologist regarding this publication to ensure accurate understanding of the findings and to confirm applicability to their specific case.
RxPONDER Study Population - Protocol Amendment:
Unfortunately for the pN1mi subset, per Mittendorf, writing in 2014, "A recent amendment to the protocol now requires that patients have macrometastases in their lymph nodes and excludes patients who only have pN1mi disease." See also, the current clinical trial entry:
RxPONDER: https://clinicaltrials.gov/ct2/show/record/NCT01272037
- "Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph nodes dissection (ALND); patients must have at least one, but no more than three known positive lymph nodes (pN1a, pN1b or pN1c); patients with micrometastases as the only nodal involvement (pN1mi) are not eligible; patients with positive sentinel node are not required to undergo full axillary lymph node dissection; this is at the discretion of the treating physician; axillary node evaluation is to be performed per the standard of care at each institution"
(Those who might be interested in joining this trial should confirm the above with their team.)
It is hoped that a significant number of pN1mi patients were accrued in RxPONDER before the protocol amendment.
As with node-negative disease, pN1mi disease (which is formally classified as "node-positive" disease by pathologists) may not be monolithic with respect to risk profile or the potential benefit of chemotherapy. However, the question of whether the Oncotype Recurrence Score can reliably identify Stage IB (pT1 N1mi M0) patients with more favorable prognoses ("prognostic" ability) or reliably identify those who may or may not benefit from added chemotherapy ("predictive" ability) turns on the scope and strength of clinical validation of the test in relevant patient populations. Therefore, I said, "There are other relevant studies which included pN1mi patients (ask your team)." Perhaps my suggested follow-up question was phrased too narrowly, but one would hope that in response, an MO would direct the person to the most important studies applicable to their particular situation.
Patients should always confirm any outside information with their team to ensure applicability and receipt of accurate, current, case-specific expert professional medical advice.
BarredOwl
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HapB - 3rd doc agreed with MGH and DF.
BarredOwl - MOs all said there weren't really any studies done on pre-menopausal, pN1mi women.
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Lurline...i have a rare cancer that "usually" affects post menopausal women. Whatever research there is, is not strongly validated for pre or post menopausal women...so, like your situation, you really need to depend on a team that you trust. What I have learned from my journey...nothing is straight forward. Looking thru a rear view lens, there is nothing I would have done differently. I found with cancer, there just is so many variables and no one size fits all. At the end of the day, you can crunch all of the literature and only hope you made the best choice with whatever evidence there is. That said, with an OncotypeDX score of 5, you should plan on doing very, very well!
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