average wait time for oncotype results

Am still waiting for my Oncotype results, pretty nervous, and hoping to hear something by end of work week. As stated elsewhere, my tumor was small -- 2mm -- low mitotic rate, well differentiated, no LVI, node negative. But PR-, which I know may put me in intermediate score territory. PatRN, I see you had chemo...was your regimen what is called "chemo lite?" Are you finished, and how did you tolerate it? Hope you're doing well.

Had a death in the family this week and am planning a funeral. Had cataract surgery Thursday, irritated eye and trying not to cry, but it's hard with grief and nerves waiting for Oncotype. Usually eat healthy and exercise, but with all the upset going on, am on my third batch of Tollhouse cookies in a week. Sometimes cookies and milk just do the trick.

Ladies: I am upset and so angry I could spit. I called Oncotype folks today to find out status of my test, which they said would be done today. The customer rep told me that, after all this waiting, there wasn' enough tissue to do the test! My oncologist's office had assured me -- when I asked more than once, to forestall exactly this scenario -- that a 2mm tissue sample wasn't a problem. (This is same MO's office that failed to send letter of medical necessity for my horrifically expensive multi-gene panel test, and my claim was denied). This MO is on "Best Doctors" list for my east-coast city.

Am expecting to talk to MO by phone tomorrow. What's the next step for most patients in this situation? Will he probably say that, since tissue sample too small to do test, that I probably don't need chemo anyway, and proceed with the radiation? He ordered the test because my very small tumor was PR - (all other factors pretty favorable...see signature line).

The string of mishaps and lapses that have come with my BC dx and treatment have been discouraging and could turn a girl very cynical. This is compassionate cancer care? Mostly, of course, I want to be sure that my treatment is effective. It has already been delayed, and I hope anxiety -- and not cancer spread danger -- is the worst consequence of that.

It's a good thing I still have some Toll House cookie dough!

It makes no sense what is going on at your MO office. They should have told you from the beginning that 2 mm was too small for an Oncotype. Something is wrong with whatever is going on.

Since it's not likely that you will get an answer today, I'd call again on Monday or Tuesday, due to MLK Day. Then go to the office in person. It may be time to switch doctors. Not something anyone really wants to do at this point.

I was under the impression that OncotypeDX was done only for T1N0 clear-margined ER+/HER2- IDC (and in some cases, DCIS). ALH is definitely not cancer--though it can raise the risk of developing breast cancer, which is why sometimes endocrine therapy is given after it's removed. Unlike DCIS, most doctors don't even consider LCIS to be cancer, despite the word “carcinoma." It's usually treated with periodic surveillance. I'm surprised they were running an OncotypeDX on ILC, even PR-, especially since your tumor was extremely small (0-2mm, smaller than a bell-pepper seed) and grade 1 is often considered so slow-growing as to be “indolent." Maybe they are trying to backtrack around the fact that it was never really ordered because it wasn't indicated, but for some reason they told you earlier they were ordering it?

Stella, sorry to hear they couldn’t get clean margins. My remarks were addressed to Girl53, whose ILC was extremely tiny and slow-growing and whose only other neoplasms were ADH (benign) and LCIS (acc. to Susan Love, not even considered a precancer)--therefore no need for OncotypeDX because the chance of needing chemo was so remote to begin with. (My BS and MO explained that they reserve Oncotype testing for “gray areas,” not for tumors for which chemo clearly is either indicated or not. Had my tumor remained <1cm as originally thought, the test wouldn’t have been ordered). I wasn’t aware that ILC in general doesn’t respond well to chemo--many women here with ILC did get chemo.

Hi girl53:

Above you said "they said not enough tissue" and in your last post you asked "Will I be on the hook to pay for the test, though no conclusive results obtained?"

Did they actually say they ran the test, or were you just surmising that because of the lag? It is formally possible that after a sample of the 2 mm ILC was received at GenomicHealth, it was accepted by some clerk, and was forwarded to the lab. Upon reaching the lab, it entered a queue and a professional examined it and determined the sample was insufficient in quantity and/or quality to perform the test. It is unclear when or if they informed your oncologist of this conclusion. The test may never have been run. Naively, I would think if the test was run, they would issue an official report describing the result, even if it failed in some manner.

I agree that the NCCN guidelines do not include the Oncotype test in cases like yours (Invasive lobular, hormone-receptor positive, HER2-negative, node negative (pN0), Tumor ≤ 0.5 cm. This is because in general, chemotherapy is not recommended in such cases. So in the minds of the committee members, the test is not needed to inform the chemotherapy decision.

However, the guidelines do not actually recommend against doing the test. (Not included, versus recommend against.) You may have indicated that if you had a high Recurrence Score (RS) you would consider chemotherapy, and your MO may have been interested in what the RS would show (you said he mentioned PR-negative).

The amount of sample and quality required to run the test is a different question. The actual minimum amount of tissue needed to run the test is not clear to me, so please keep us posted about what you learn. Here is what I could find from documents:

I found this 2013 paper on usage characteristics. It is a retrospective study, subject to accuracy of records. Six patients with T1mic tumors were tested (see Table 1, With Recurrence Score, 1mic, n = 6):

http://jop.ascopubs.org/content/9/4/182.full

"T1mic" size does not appear to be defined in the paper. Patients were diagnosed between January 2008 and June 2009. The current 7th Ed. (2009) AJCC definition for "T1mi" is: Tumor ≤ 1 mm in greatest dimension.

The Oncotype website includes information about sample submission here:

http://breast-cancer.oncotypedx.com/en-US/Professi...

Go to the very bottom of the page and click on "Breast Cancer Pathology Guidelines" to access a pdf. Then, see page 1, first Section "SELECTING THE MOST REPRESENTATIVE BREAST OR COLON TUMOUR BLOCK", Item

"D. For breast carcinoma submissions, microinvasive carcinomas (one or more foci < 0.1 cm) are not acceptable samples."

I would infer from this that the Oncotype test for invasive disease can theoretically be run with 1 mm or more of suitably prepared tumor tissue. (In fact, 1 mm is deemed microinvasive by AJCC, but whatever). The document also includes instructions for the submission of "tumor blocks" and "unstained slides".

Presumably, part of the 2 mm ILC was already sliced up and used for IHC staining to determine ER, PR, HER2, and maybe other things. I suppose your institution would prepare a sample submission from remaining suitable tissue blocks or slides (??). Perhaps when it reached the testing department, the professional determined that the sample could not be tested and rejected it (maybe because there was less than 0.1 cm of suitable tumor block or unstained slides in the submission??).

Again, please let us know if you receive more concrete information.

BarredOwl

Hi Girl53:

I agree re your second to last paragraph re obtaining affirmative, case-specific, expert professional advice. If the test could not be done at all, cannot be completed properly, or failed to generate an RS for whatever technical reason, then you want advice based on clinicopathologic features alone, so you can start treatment.

I will pepper you with questions now.

Re: "He did say they were checking to see if any more tissue is available to be sent to them." Even if possible, could it be done an expedited basis or might it introduce more delay? What if it still fails to generate an RS?

Do you, the MO, and RO think it is worth waiting for a possible RS? Back to what ChiSandy was getting at, I think many patients with your stats and Tumor ≤ 0.5 cm decide without benefit of the test. Having waited so long for the test, you kind of want it, but I guess it would not seem unreasonable if you and your team just threw your hands up and went forward without it.

Because the guidelines don't include Oncotype for invasive disease in the specific situation, if an Oncotype RS was generated, I might inquire about how robust the Oncotype test is seen to be in the T1a subset (e.g., based on how well-represented such patients were in all of the various validation studies used to establish the prognostic and predictive value test, or if not well-represented, can one properly extrapolate from the studies). I don't know the answers to these questions.

T1a Tumor > 1 mm but ≤ 5 mm in greatest dimension

For example, considering just one study, the recent TailorX study, the "inclusion criteria" required that patients had to qualify for chemotherapy under NCCN guidelines (quotes taken from the purchased pdf document):

http://www.nejm.org/doi/full/10.1056/NEJMoa1510764...

"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 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 greatest dimension for a tumor of intermediate or high histologic grade or nuclear grade (or both)."

"The current prospectively conducted study supports the use of the 21-gene assay to spare the use of chemotherapy in patients who otherwise would be recommended to receive it on the basis of clinicopathologic features."

My layperson's read of this, and I could be wrong, is that in this particular study, in node-negative, estrogen-receptor–positive or progesterone-receptor–positive (or both) and that did not overexpress HER2, there were no T1mi or T1a size tumors. They have layered on an added limitation regarding grade.

TailorX trial goal and design considerations are at play also. They are looking into who can likely be "spared" chemotherapy, so they chose patients in whom chemotherapy would be considered as an option (± adjuvant chemotherapy) in the usual case under clinical practice guidelines.

Sending positive vibes.

BarredOwl

So you already started radiation? And you don't need chemo for a grade 3 tumor? Mine is a grade 2 and my radiologist just said she thinks I'll need chemo. She is sending me to chemo dr