Q & A with Dr. Gabriel Hortobagyi, MD

July 6, 2016 at 11:41 pm Leave a comment

Gabriel-Hortobagyi

Dr. Gabriel Hortobagyi

In 2001, Dr. Gabriel Hortobagyi published an editorial in the Journal of Clinical Oncology that reviewed what was known at that time about treating breast cancer patients with very few metastatic sites. This limited metastases is called oligometastases. BCT spoke with Dr. Hortobagyi about what types of clinical trials are needed to move forward in this research area.

Q: How has research into oligometastases advanced over the past 15 years?

A: This is an uncommon situation, and the problem with uncommon situations is it takes a long time to do research. There’s been very little additional data since I wrote that piece. The reality remains that there is a small percentage of patients with metastases—somewhere around 5 percent—who have oligometastases and, of these, one in three or one in four could potentially be cured with systemic treatment plus surgery or radiation or both.

The data we have show that these patients tend to be younger, in good physical condition and have metastatic disease that can be removed surgically with clean margins in the lungs, liver, brain and maybe some soft tissue. It also seems that patents with hormone-negative tumors are more likely to be cured, which is probably because their tumors are more responsive to chemotherapy.

Q: Does this mean women should have more screening so that more women would be found with fewer metastases?

A: That’s the controversy. It is a huge question, whether we move away from having the guidelines that say no tests should be done regularly and women should just be alert to possible symptoms. Some of us believe that the studies on which those guidelines are based, which were done in the 1980s, need to be repeated with modern technology.

Q: Could this be done?

A: The problem is that it would take 10,000 to 15,000 patients followed for at least five years, and most likely 10 years. And it would cost between $40 and $100 million to demonstrate, or not, that closer monitoring and earlier diagnosis of metastases will identify a subset of patients who could be treated and never develop additional metastases.

Q: Is money the only obstacle?

A: No. There are other concerns. Because so few women develop oligometastases, the majority of the women in the trial would not experience any benefit. So, it is a complicated issue because whenever you deal with uncommon or rare events you face this situation.

Q: Do new technologies create new possibilities?

A: Right now, the tools we have aren’t at a point where we could do this kind of study. But let’s say in two to three years we have the perfect circulating DNA test and we can show that out of 100 patients we find 30 who have circulating DNA and no other abnormality and that all 30 develop metastatic disease—and none of the others do. Then we’d have something much more solid and something we can rely on. But we don’t have that today.

Also, having a test like that means we wouldn’t need such a large clinical trial. We’d only need to identify 200 patients who test positive on the circulating DNA test and then randomize them to treatment or no treatment and that would only cost maybe $3 million as opposed to 40 or 100 million.

Q: Are we getting closer to that type of test?

A: We’re doing research right now to develop this kind of circulating DNA test, with clinical trials at MD Anderson and through SWOG. (SWOG is a worldwide network of researchers that is part of the NCI’s National Clinical Trials Network.)

I know it’s frustrating for patients. It seems like, ‘why are these guys taking all their sweet time doing this when women are dying of breast cancer’ and I am acutely aware of this frustration. But, unfortunately, this is the way things work and it’s the reality of clinical trials. We need to develop solid preliminary data before we can move to more advanced trials. Most of the trials we complete are negative and they don’t move the field forward they just tell us things don’t work. But we still have to do them.

You can learn about trials open at MD Anderson here.

You can learn more about SWOG-sponsored trials here.

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Entry filed under: Metastatic breast cancer, Oligometastases. Tags: , , , , , .

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