The Oncotype for DCIS wasn’t really available when I was diagnosed, so I don’t know too much about it, but have you consulted with a radiation oncologist? This is their area of expertise and they could probably tell you whether they thought it would be worth resubmitting or not, and whether or not they would recommend radiation based on the path report (as opposed to Oncotype).

Hi Kristy-

It seems as if in your case they are confusing the regular Oncotype which is done on invasive cancer and is much better known with the one specifically for DCIS which hasn’t really seen widespread usage yet. Maybe print out some information from either here or the Oncotype website about the DCIS test to bring with you? They may not be up on the latest research yet, but from what I understand, they are pretty typical - it seems that very few people are being offered the Oncotype for DCIS at this time. I would see how responsive they are towards finding out about it before deciding if you should try to find a second opinion. There are standard treatments that have been around for years, but I would at least want them to be able to have a conversation about why they recommend what they do.

Hi KristyB, wanting to understand all of the treatment options and making the best choices for yourself are never overly dramatic. This test is relatively new and just because everyone isn't using it yet doesn't mean it isn't worth using. The following excerpt is from a 2011 announcement about the release of the oncotype test for DCIS.

"The Oncotype DX test uses genetic information in breast cancer tissue to predict the risk for recurrences. It is already marketed for use in invasive cancer, where it identifies women who might be able to forgo chemotherapy because of their low risk for recurrence. Now the test has been developed for use in DCIS, where it might help identify patients at low risk for recurrence who can be spared radiation therapy.

In the case of DCIS, the test only uses information from 12 genes; the other 9 genes in the 21-gene assay are not applicable to DCIS.

In a new study, the 9-gene assay predicted 10-year risk for local recurrence in patients with DCIS who were treated with lumpectomy alone, without radiation therapy.

Local recurrence was defined as either a new invasive breast cancer or the recurrence of DCIS in the same breast (ipsilateral breast event).

A DCIS recurrence risk score should help clinicians and patients decide about the need for radiation therapy, suggested the lead author of the study, Lawrence J. Solin, MD, chair of the Department of Radiation Oncology at the Albert Einstein Medical Center in Philadelphia, Pennsylvania."

Here is a population based study that you may want to print out for the radiation oncologist (if he'll consider this option for you).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC44911...

Getting a second opinion is always an option when you don't like the approach of your medical provider. Sometimes the second opinion is the same as the first, and that is useful information for you too. Good luck!

thanks! he's a sweetie to be sure. His name is Angus

that photo was taken during a summer float trip. A wet lab is a happy lab. 3 labs must mean you are surrounded by love all the time, lucky you!!!

General Information - Oncotype - Invasive disease versus DCIS test:

Note that the tests for invasive disease and for DCIS differ in the number of test genes used, they are used in different patient populations (different "eligibility" requirements), for different purposes, and their recurrence risk ranges are also different.

Because of these differences, if a person has invasive disease (e.g., IDC, ILC), then the test for invasive disease is used, and their Recurrence Score cannot be compared to DCIS scores.

Invasive Disease ("21-gene test"):

The Recurrence Score for invasive disease relies on the mRNA levels of 16 cancer-related genes and 5 reference or control genes from a sample of the tumor. It is used in patients with invasive disease that is hormone receptor-positive, HER2-negative, regardless of type of surgery, to inform decision-making regarding chemotherapy (endocrine therapy alone or endocrine therapy plus chemotherapy).

The standard recurrence risk categories for the test for invasive disease are:

Low-risk (Recurrence Score < 18)

Intermediate-risk (Recurrence Score 18 to 30)

High-risk (Recurrence Score ≥ 31)

DCIS ("12-gene test"):

The Recurrence Score for DCIS relies on the mRNA levels 7 cancer-related genes and 5 reference genes (a subset of the genes used in the invasive test) from a sample of the tumor. It is used in patients determined by surgical pathology to have pure DCIS (no invasive disease) and who were treated by local excision (also known as breast conserving therapy or lumpectomy) (with or without tamoxifen), to aid in decision-making regarding radiation therapy. Eligibility for the DCIS test does not require any particular receptor status.

The standard recurrence risk categories for the DCIS test are different, with "high risk" starting at a higher score:

Low-risk (DCIS Score < 39)

Intermediate-risk (DCIS Score 39–54)

High-risk (DCIS Score ≥ 55)

The Oncotype test for DCIS:

For those with pure DCIS (in one breast) treated by breast conserving surgery alone, the DCIS test generates a "Recurrence Score." Based on certain trial data, individual Recurrence Scores have been correlated with certain average rates of ipsilateral recurrence at 10 years (any event (invasive or DCIS); and invasive only). This type of information is "prognostic" in nature (i.e., it speaks to recurrence risk).

The "eligibility requirements" for the test for DCIS versus the test for invasive cancer are not the same.

Regarding Oncotype for DCIS, the eligibility requirements of the commercial provider are described here (my [edit] in brackets):

"Eligibility" for DCIS test: http://breast-cancer.oncotypedx.com/en-US/Professional-DCIS/WhatIsTheOncotypeDXBreastCancerTest/WhichPatients

- For women with ductal carcinoma in situ treated by local excision [also known as breast conserving therapy or lumpectomy], with or without tamoxifen.

A sample report from the DCIS test can be found here:

Sample report for DCIS test: http://breast-cancer.oncotypedx.com/en-US/Professional-DCIS/Ordering/ReadingReports

When indicated, the Oncotype test for DCIS is usually performed on surgical samples, after surgical pathology establishes pure DCIS in a breast treated with lumpectomy.

The above is probably a broader statement than what occurs in practice in the clinic at this time. This may reflect in part the characteristics of the patient populations in which the DCIS test was evaluated (limitations in "clinical validation"), and that the DCIS test is not included in the National Comprehensive Cancer Network (NCCN) guidelines for Breast Cancer (Version 2.2016).

The DCIS test may not be recommended to some patients:

- This may reflect that the test is not included in consensus guidelines for DCIS.

- In some cases of pure DCIS, the test may not be seen as sufficiently reliable if the pathology differs in significant ways from that of the patient populations in which the test has been studied (a question regarding the "scope of validation" of the test).

- In some cases of pure DCIS, certain clinicopathologic features may weigh strongly in favor of radiation:

The test is not a stand-alone test. It is used to provide prognostic information about recurrence risk without radiation, and its outputs should still be considered along with other clinicopathologic factors that affect personal risk profile. In certain cases, the other factors may easily dominate the calculus (making the test of no added value).

The outputs of the test for DCIS currently do not provide a recommendation about radiation, and do not predict efficacy of radiation:

"Of note, in contrast to the Oncotype DX 21-gene array and systemic therapy, the DCIS Score defines a risk of recurrence (prognostic) but conveys no information about the effectiveness of WBRT (predictive)."

I am a layperson with no medical training, so all information above should be confirmed with your team. Anyone interested in the Oncotype test for DCIS should not hesitate to ask their Radiation Oncologist for current professional advice regarding eligibility and the potential utility of the test in view of their particular presentation and current clinical evidence.

BarredOwl

The following are for background information only. If any post or document influences you, be sure to discuss your thinking with your team, to ensure accurate understanding, applicability, and the receipt of current, case-specific expert advice.

Validation Studies for Oncotype test for DCIS:

Rakovitch (2015): http://link.springer.com/article/10.1007/s10549-015-3464-6/fulltext.html

[pdf copy available for free - button at upper right]

[Supplementary Materials also available at right]

Solin (2013): https://academic.oup.com/jnci/article-abstract/105/10/701/946478/A-Multigene-Expression-Assay-to-Predict-Local?redirectedFrom=fulltext

Commentary:

Leonard (2016): http://ascopubs.org/doi/full/10.1200/JCO.2016.69.8332

Berg (2013): https://academic.oup.com/jnci/article/105/10/680/949147/Resolving-the-Ductal-Carcinoma-In-Situ-Treatment

Duggal (2013): https://academic.oup.com/jnci/article/105/10/681/949250/A-Multigene-Expression-Assay-to-Predict-Local

[EDIT: Added comment re Supplementary Materials for Rakovitch]

Thank you all for responding!!! I wish I would have found this community/form when I was first diagnosed. Update from this afternoon: the nurse from my my medical oncologist called and confirmed what I thought was going to happen. The oncotype test requested was for DCIS and yes it will help to decide radiation treatment. My doctor even said he expects a low grade on my test. The nurse was unaware. I an so glad I had her ask!!

All of my doctoring thus far has been out of town as we have not lived in our present city long enough to get a good primary care doctor. The radiation office that my doctor sent all my records to is in the town I live in. They are the ones telling me that the oncotype test wouldn't help in deciding treatment. Now I am so thankful that I doctored back home!!! I continue to post my journey thru this!! Again thanks to all that responded!!

Btw, how did everyone get the info at the bottom of their messages? I know some of it...but it appears some of it is very detailed

Hi Anib:

Re your statement: ". The Oncotype research I have found only definitively states that Chemotherapy is not indicated with a low score."

You are confusing the Oncotype test for invasive disease (aids in chemotherapy decision) with the Oncotype test for DCIS (aids in radiation therapy decision with breast conserving surgery).

I explained the difference in detail in my Jan 27, 2017 post farther up in this thread. I included links to the validation studies of the DCIS test, and links to the test provider's web site.

I also included some reasons why the DCIS test may not be relied upon in some cases. You may wish to ask your Radiation Oncologist to explain the reasons he sees the test result as "irrelevant" in your case. For example, is it because the biopsy sample was not representative of the tumor as a whole, because of concerns about validation, or because certain clinicopathologic features (e.g., large size, etc.) strongly support treatment, and/or some other reason?

Obviously, if a person's pathology report indicated that any invasive disease was present (e.g., microinvasion), then the person would not be "eligible" for the DCIS test (and any prior DCIS test result would be disregarded with respect to the question of radiation, because such patients were excluded from the validation studies.

BarredOwl

Hi BCAE:

The below applies to the Oncotype test for DCIS in those with pure DCIS who receive breast conserving treatment.

Re your question, why isn't that on the website? There is a physician portal, and I do not know what additional information, material or guidance (if any) may be found there.

However, the two main validation studies (Solin (2013) and Rakovitch (2015)) are featured on the website, and the information you are citing is from Rakovitch (2015). Expert familiarity with both of these validation studies, the features of the disease in the study populations and the results for the group as a whole or for certain sub-groups, is required for the appropriate use, interpretation, and application of the test results by Radiation Oncologists.

The DCIS test outputs are not the sole deciding factor regarding radiation therapy, but are used to provide some insight into local recurrence risks without radiation. The test outputs should be considered along with other clinicopathologic factors that could affect personal recurrence risk profile. Multifocal disease may be one such factor.

In this regard, I agree with your understanding that sub-group analysis in Rakovitch (2015) indicated that in this study, individuals with multifocal DCIS as defined and as tested in the manner used in the trial, experienced a higher risk of local recurrence ("LR") compared to those without multifocal disease.

If you wish to confirm that active consideration was given to potential issues raised by multifocal disease in connection with the advice you received regarding radiation therapy, as well as how it was considered, then please discuss this with your Radiation Oncologist. As part of this, you may wish to request an explanation of: Rakovitch's findings regarding multifocal disease; the potential implications of multifocal disease on the recurrence risk estimates provided in your DCIS test report; and what is known about the reliability of estimates obtained from testing multiple foci.

BarredOwl