TAILORx Study

DR HUDIS: It’s sad to me that 20 to 30 percent of clinical investigators and practicing oncologists are uncomfortable with participating in TAILORx, according to responses in Figure 23. This study was written specifically to make sure that we were randomizing those cases in which we admit that we don’t know the answer. I’m supportive of the trial, and I’ve encouraged any number of people who have called me for advice to enroll on the trial as suggested by their doctors.

We use Oncotype DX for patients with node-negative, ER-positive breast cancer in a couple of situations. One is the patient who our team believes needs chemotherapy, but the patient is reluctant and we’re looking for a little more “ammo” to convince her. Another scenario is the patient with a small tumor — say, seven to nine millimeters, intermediate grade — for whom we typically might not recommend chemotherapy, based on guidelines, but we want to make certain we’re not missing a case where it would be beneficial.

In my practice, I don’t think utilization of Oncotype DX has changed the number of patients we treat with chemotherapy. Rather, it has affected to whom we administer chemotherapy. I think that for every case where we decide not to treat based on the Oncotype DX score, there's another one that convinces us to use chemotherapy.

MammaPrint Assay

DR HUDIS: Although I’m supportive of the MINDACT (Microarray In Node-negative Disease may Avoid Chemo-Therapy) trial, the MammaPrint assay behind it is of limited meaning for American physicians because it requires fresh-frozen tissue. In a research environment, that’s not so difficult, but a series of logistical challenges to that exists in the United States. I’ll describe them because I think it’s important to understand. First, most breast cancer is not treated at research centers, and second, most hospitals don’t bank fresh-frozen material.

They don’t have an infrastructure in place to freeze and save the tissue. Third, to get around that, you need to send the specimen off at the time of surgery, but you may later discover in some patients — for example, with node-positive disease — that you don’t want the test, so you need to be able to recall it.

Fourth, as I understand this, some pathologists are reluctant to send chunks of tissue away before they have a final and complete diagnosis because they have some medical/legal concerns. One concern is that a tiny bit of cancer will be lost in the fresh-frozen material that’s carved out at that initial diagnosis. In research, most databanks that are built with fresh-frozen material tend to be biased toward larger tumors, and they are in house, so the specimen still exists for the pathologist to retrieve if there is a medical/legal concern.

Although the MammaPrint assay is approved for use in the United States, the technology isn’t applicable to most American practices.

< previous • 1 • 2 • 3 • 4
Select Publications