[Joan M]

I've been skeptical about the new wave of tumor profiling in breast cancer, and I'm still uncertain what to think about it. The question seems to be about clinical relevancy.

Last year, several posts on the board discussed specific labs and how a tumor profile could perhaps help us determine which chemo drug would work best. As a result, during a Q&A at a local meeting I asked a top breast cancer onc at Sloan Kettering, and he said it was all "fraud." I was shocked, as I didn't expect that kind of an answer. I thought I would get the scoop, and was disappointed at his choice of a such a strong, finite word. But that word clearly conveyed his thoughts on the topic.

The point is that we often have more data than what we know what to do with. Yet these services perhaps make up feel that getting our tumors gene sequenced today is the answer. More to the point, and something that often escapes us, many of these assays are not clinically relevant at this time: That is, they don't translate from the bench to the clinic. So are we raising our hopes and at the same time wasting our time and money? Are these assays just another way for labs to make additional money by giving us information that cannot yet be fruitful? And what about future assays that actually might be relevant?

At SABCS I picked up a flyer from City of Hope's Clinical Molecular Diagnostic Laboratory. It reads: Coming soon ... Next-Gen Sequencing Panels. The photocopied sheet of white paper then listed the panels, the individual genes, and the cost of the assay:

*Onco-44-gene panel, $1,875
*Cancer-30-gene panel, $3,250
*Breast-17-gene panel, $2,350 (ATM, AXIN2, BAP1, BARD1, BRIP1, CDH1, CHEK2, MRE11A, NBN, PALB2, PTEN, RAD50, RAD51C, RAD51D, STK11, TP53, XRCC2)
*Ovarian-22-gene panel, $2,350
*Colorectal-19-gene panel, $2,350
*Cancer-428-gene panel, $3,950

Besides relevancy, another important word is diagnostics. Put simply, for breast cancer: ER/PR, HER2. Assays show us which breast cancer subtype we have and therefore which supplemental treatments work best. That is, a specific diagnostic test corresponds with specific drugs. Further, Oncotype DX is another clinically relevant assay that helps patients and oncs make informed decisions about treatment. The 21-gene assay and its recurrence score is a way for oncs to determine whether or not adding chemo to endocrine therapy would likely be beneficial (except of course for the patients who fall in the middle of the scale, and perhaps the results of the TAILORx trial will eventually result in tweaking that assay or developing a second-generation Oncotype DX).

As a breast cancer advocate, these are the types of questions that I try to remember to ask myself before I get caught up in the hype. Next-gen sequencing is not new, but lately it's become much cheaper than previously. And right now, I don't know where it's going. But I'm optimistic that the seeming quagmire of such sequencing results will some day be the antithesis to the Pandora's Box of cancer that it seems to have opened and help us to beat cancer.

Love
Joan