BreastCancerUpdate.com - Surgeons 1

Tracks 1-10

Track 1	Introduction
Track 2	Clinical use of the Oncotype DX assay
Track 3	Impact of the Oncotype DX assay on clinical decision-making
Track 4	Clinical trials of bevacizumab for breast cancer
Track 5	Side effects of bevacizumab
Track 6	Incorporation of bevacizumab into adjuvant clinical trials

Track 7	Fulvestrant: A “pure” estrogen receptor antagonist
Track 8	Using a loading dose of fulvestrant
Track 9	Combining fulvestrant with biologic and/or hormonal therapies
Track 10	Clinical trial of delayed adjuvant fulvestrant

Select Excerpts from the Interview

Track 2

DR LOVE: What are your thoughts about the Oncotype DX assay?

DR HUDIS: A high recurrence score clearly identifies a subset of patients who are very likely to benefit when chemotherapy is added to hormone therapy. At the same time, it’s important to emphasize that for those patients who have intermediate and low recurrence scores, the confidence intervals are somewhat wide. Therefore, one cannot exclude the possibility of a chemotherapy benefit, even in patients with low or intermediate recurrence scores, based on the available data (Paik 2004; [4.1]).

From my perspective, you use the test in the clinical context where it will help you make a decision. For example, in a 32-year-old patient who is worried about fertility and is committed to five years of tamoxifen and says, “You really need to convince me to receive chemotherapy,” I see a role for the test. As the patient is already on the “no” side of that equation, if she has a low or intermediate recurrence score, I may not change her mind.

If she has a high recurrence score, I have evidence to say, “You don’t want chemotherapy, but you’re in the subset of patients in whom we have pretty good evidence with a tight confidence interval that you’ll benefit from it.” I do not perform this test on every patient; you need to know what you will do with the results.

DR LOVE: A presentation of the data showed that the patients with a high recurrence score derived a dramatic benefit from chemotherapy, avoiding about 75 percent of recurrence, and it was an older type of chemotherapy that we no longer use.

DR HUDIS: That’s exactly right, it was CMF or MF, and it was a really impressive result. At the same time, I have to point out that it was consistent with other data we’ve recently seen using lower-technology approaches. At the 2004 San Antonio Breast Cancer Symposium, Kathy Albain presented the retrospective analysis of SWOG-8814, evaluating tamoxifen alone or with CAF in patients with exclusively node-positive, ER-positive disease (Albain 2004).

In that study, in general, adding chemotherapy to tamoxifen showed a benefit. When they went back and looked at a centrally performed estrogen receptor analysis, they showed the benefit of chemotherapy was in the patients with low or intermediate ER-positive disease, not so much in the patients with strongly ER-positive disease (Albain 2004). That may all be consistent.

The blanket statement that chemotherapy is ineffective in patients with ER-positive disease is clearly untrue. The Oncotype DX assay, among other technologies, may be one of the better ways to separate the wheat from the chaff.

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