BCI, Oncotype DX and IHC4 Face Off

Is the BCI available for anyone?  Is anybody getting retested?  Since I am no longer doing any treatments and starting year 7, I don't know if I should investigate this further...

10 years of an AI makes me squeemish...quality of life and later in life side effects.  Another post indicated that a good % of BC patients will die from cardiovascular disease...and AIs already have a black box warning (I believe...??) about additional heart issues.

Happy to hear discussions on this....

Hospitals keep your tissue for many years.  Depending on what research is saying at the end of the next 4 years, I may ask for a BCI test on my tissue as I approach the end of my 5 yrs on AI.  My oncotype score was a little higher than yours and I'd like as much info as possible as to whether to continue with these serious estrogen depleting drugs.  Maybe ins will even pay for this additional test in the future.  

The link above is bad. The original article from clinicaloncology.com was “archived”,
so I’ve copied / pasted the info below.

ISSUE: APRIL 2013 | VOLUME: 08:04

Face off between: BCI, Oncotype DX and IHC4 - BCI maintains prognostic performance
into late recurrence time period

San Antonio - The Breast Cancer
Index (BCI, bioTheranostics) outperforms the Oncotype DX Recurrence Score (RS;
Genomic Health) and the immunohistochemical (IHC)4 in accurately predicting
breast cancer recurrence risk five to 10 years after a disease-free period,
according to the TransATAC (Arimidex, Tamoxifen, Alone or in Combination)
study, presented by Dennis Sgroi, MD, the director of Breast Pathology at
Massachusetts General Hospital in Boston, at the San Antonio Breast Cancer
Symposium (abstract S1-9).

The ATAC trial 10-year follow-up
data demonstrated that late disease recurrence is a hallmark of estrogen
receptor (ER)-positive breast cancer, with greater than 50% of recurrences
occurring after five years of adjuvant tamoxifen or anastrozole therapy.
TransATAC collected tumor blocks for biomarker assessment. Previous analyses
have shown that RS and IHC4 (ER, progesterone receptor, HER2 and Ki67)
predict overall recurrence risk in the TransATAC cohort, beyond the Clinical
Treatment Score (CTS), an algorithm consisting of nodal status, tumor size and
grade, age and treatment.

In the new TransATAC study,
researchers evaluated whether BCI adds prognostic information to clinical
variables in predicting distant recurrence in ER-positive, lymph node–negative
patients with primary breast cancer. The test stratifies patients into three
risk groups and combines two independently developed biomarkers: HOXB13:IL17BR
gene expression ratio, which is both prognostic and predictive for extended
adjuvant hormone therapy, and the molecular grade index, a set of cell
cycle–related genes that predicts distant recurrence beyond tumor grade. The
study cohort included 665 primary tumor samples.

At 10 years of follow-up, BCI
distinguished three risk groups with a 10-year rate of distant recurrence of
4.2% in the low-risk group, 18.3% in intermediate-risk patients and 30% in the
high-risk group. “In analyzing the comparative prognostic performance over the
same time frame [0 to 10 years], one sees that BCI, IHC4 and the recurrence
score demonstrate highly significant prognostic performance,” said Dr. Sgroi.
“BCI and IHC4 provided equivalent prognostic information and both biomarkers
provide greater prognostic information than the recurrence score.”

Dr. Sgroi said recurrence
information is valuable in two time frames. The early recurrence time frame is
at diagnosis, when one is considering using adjuvant hormone therapy alone or
in combination with other systemic therapy. The late recurrence time frame is
at five years postdiagnosis, when one is considering extending adjuvant therapy
for patients who are disease-free after five years of hormonal therapy.

BCI identified two early recurrence
risk groups. The first group, 83% of the cohort, consisted of BCI low- and
intermediate-risk patients who had an average five-year rate of distant
recurrence of less than 4%. The second group consisted of BCI high-risk
patients with a five-year rate of distant recurrence of 18.1%.

BCI identified two late recurrence
risk groups. The first, 61% of the cohort, consisted of BCI low-risk patients
who had a five-year rate of distant recurrence of 3.5%. The second group
consisted of intermediate-/high-risk patients who had an average rate of
distant recurrence of 13.5%. BCI was a significant prognostic factor beyond CTS
for prediction of late distant recurrences.

“In the early recurrence time frame, all three
biomarkers demonstrate highly significant prognostic performance in a
multivariate analysis adjusted for the Clinical Treatment Score,” said Dr.
Sgroi. “However, when we compared the performance in the late recurrence time
frame. … BCI demonstrates sustained prognostic performance in a multivariate
analysis, whereas IHC4 and the RS lose their prognostic ability.”

A patient with an intermediate BCI
score will do well in the first five years with adjuvant hormone therapy, Dr.
Sgroi said, but should be considered for extended adjuvant therapy at that
point.

Mathew Goetz, MD, a medical
oncologist and an associate professor of oncology and pharmacology at Mayo
Clinic in Rochester, Minn., said the three tests provide different information,
with BCI providing “better information in years 5 through 10.” He said the test
has been validated in multiple data sets, including the MA.17 trial. From a
clinician standpoint, he continued, the lymph node–negative, ER-positive patients
are the ones in whom clinicians are least likely to use extended adjuvant
hormone therapy, and identifying a high-risk subset in this group in years five
through 10 is novel.

“I would consider using this test in
lymph node–negative, ER-positive patients that have completed five years of
tamoxifen,” said Dr. Goetz. He pointed out, however, that many community
oncologists are using aromatase inhibitors earlier on, and studies have not
defined the benefit of extending aromatase inhibitor therapy in this group. “If
we have additional data demonstrating that 10 versus five years of aromatase
inhibitors is beneficial, this will really extend the potential ability of this
test at that point,” he said.

BCI provides a quantitative assessment of the likelihood of distant recurrence in patients diagnosed with ER+ node-negative breast cancer, and prediction of likelihood of benefit from extended (>5 year) endocrine therapy in patients who are recurrence-free after an initial 5 years of adjuvant endocrine therapy. 

This test was developed and its performance characteristics determined by San Diego, CA based bioTheranostics. 

lt has not been cleared or approved by the FDA, so I doubt many are ordering these tests, nor is insurance paying for it. That may change in the future

Meow13...haven't posted in awhile, but I am curious what you might have discovered about BCI since our dx and time frames very very similar. My oncoscore 39, probably due to Ki67 of 60%. ER+ PR- 1.4 cm. chemo then exemestane since 8/12 (dx 11/11). IHC had estrogen at 90% but Oncotype had it middling.

Meow,

What % was your ER, PR and Ki67? In my IHC results, I had very high ER + and very low PR+ (often considered negative) along with very high Ki67, which put me at 30 on my Onco score. I also was HER+1 which edged it up a bit also, though wasn't high enough treatment.

Of course there are other genes that impact scores, also strong, intermediate, and week staining. If you don't have your IHC information, you can request it.

Meow-so sorry to hear of your sister's bad news. I am brca2+ and am wondering if you are too?

Doxie, I never got a Ki67 but my er was 95% and pr less than 10%. HER+2.

Doxie- I never paid attention to the her2 test because I didn't qualify for herceptin, but they did do the FISH test due to ambiguity in my results. You have me wondering, was I actually partially (<<struggling for correct word) her2 positive? My Ki67 60% and my oncoscore 39. Progesterone close to zero. IHC showed ER+ 90%, but Oncotype had ERmiddling. Ah, I remember the Her component was low on Oncotype, but my memory fading on that part. Was that even on the Oncotype results?

Quinn, it was my half sister in law no physical relation. But being her 2 +2 no herceptin was recommended. So far I feel good on a break from exemestane. I am 4 years out and pray to God my NED continues. I was a complete coward on chemo. I had IBS so bad in my late 20s and couldn't chance going thru it again. Felt good these past 4 years.