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gdpawel · 10-28-2013, 08:53 AM

John L. Marshall, M.D.
Medscape Oncology

I have been focused these past few months on the concept of molecular profiling. For the cost of a CT scan, you can send your patient's tumor for a deep sequence, a next-generation sequencing. You can do proteins and get a lot of data from your patient's tumor. Then you get back a report that has 80 pages in it, and you are flipping through this thing with lists and lists and lists of different molecular targets, some of which surface up to the first page. And then a recommendation is made, or at least a suggestion is made, to you about how to treat the patient.

Has this been useful for you yet? There are times when it really is compelling. You get one of these reports back and you think, "Maybe I should use this" or "Maybe I should follow it." In our world, we are mostly using these kinds of reports to try to help us pick which phase 1 trial a patient should go into, not whether to give oxaliplatin or irinotecan. And which tumor are you sending? Are you sending something from right now or are you sending something from years ago that you have in the basement in the pathology department? There are so many variables.

And, of course, patients are hearing about personalized medicine. It is obviously a very attractive subject. They want us to do these tests. They want us to interpret these tests. Are you qualified to interpret these tests? I'm not, and I'm a pretty smart guy who is focused on these things a lot, but I'm not sure that I am qualified to take one of these reports and make a clinician recommendation. I wonder if we are going to ultimately need something called a molecular oncologist or a pathway specialist -- someone who can take these reports and try to make some sense out of them.

There are so many things up in the air with these, and I am wondering if this is still research or if it is now a practice. Should we be incorporating this more and more or is it still only under a research umbrella? That question has been plaguing me, so this year our symposium here at Georgetown University, to which we invite folks from all walks of life to come and talk about this, will be focused on molecular profiling. We have representation from the US Food and Drug Administration and from the Centers for Medicare & Medicaid Services. Should Medicare pay for a drug that the profile says is the right drug to give to that patient but is not on the National Comprehensive Cancer Network pathway? We have private payers coming. We have bioethicists for privacy and the management of these data. We have good folks from the pharmaceutical industry, oncologists, patients, and patient advocates all getting together on December 6-7, here in Washington, DC, to really drill down on the subject and see where we are in terms of the interface between research and practice.

I think we are right there and that we will bust through this over the course of the next few years. We need some guidance. We are going to need to discuss this openly among ourselves. What are the best ways to do this? Should we be looking at genes? Should we be looking at proteins? They don't always agree. Should we be looking at circulating factors such as microRNA? What really defines key targeted actionable items in our patients? Of course, there are a bunch of different assays out there and a bunch of different times that you could biopsy your patient and do the analysis. The next time you decide to order one of those things, be sure about what you are going to do with it. Are you going to make a clinical treatment when you get that result back? Are you doing it just to appease the patient and learn as we go? Are you doing it for research? Are you doing it for practice? If you know the answers to those questions, I think it will help once that big report comes back to your desk and you have to figure out how to make a therapeutic decision.

Come to our meeting, Fighting a Smarter War Against Cancer 2013: A Three-Part Symposium, on December 6-7 in Washington, DC.

https://secure.alumni.georgetown.edu...form_id=159447

Citation: Dazed and Confused About Molecular Data? Medscape. Oct 23, 2013.

10-28-2013, 08:53 AM	#7
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	Dazed and Confused About Molecular Data? John L. Marshall, M.D. Medscape Oncology I have been focused these past few months on the concept of molecular profiling. For the cost of a CT scan, you can send your patient's tumor for a deep sequence, a next-generation sequencing. You can do proteins and get a lot of data from your patient's tumor. Then you get back a report that has 80 pages in it, and you are flipping through this thing with lists and lists and lists of different molecular targets, some of which surface up to the first page. And then a recommendation is made, or at least a suggestion is made, to you about how to treat the patient. Has this been useful for you yet? There are times when it really is compelling. You get one of these reports back and you think, "Maybe I should use this" or "Maybe I should follow it." In our world, we are mostly using these kinds of reports to try to help us pick which phase 1 trial a patient should go into, not whether to give oxaliplatin or irinotecan. And which tumor are you sending? Are you sending something from right now or are you sending something from years ago that you have in the basement in the pathology department? There are so many variables. And, of course, patients are hearing about personalized medicine. It is obviously a very attractive subject. They want us to do these tests. They want us to interpret these tests. Are you qualified to interpret these tests? I'm not, and I'm a pretty smart guy who is focused on these things a lot, but I'm not sure that I am qualified to take one of these reports and make a clinician recommendation. I wonder if we are going to ultimately need something called a molecular oncologist or a pathway specialist -- someone who can take these reports and try to make some sense out of them. There are so many things up in the air with these, and I am wondering if this is still research or if it is now a practice. Should we be incorporating this more and more or is it still only under a research umbrella? That question has been plaguing me, so this year our symposium here at Georgetown University, to which we invite folks from all walks of life to come and talk about this, will be focused on molecular profiling. We have representation from the US Food and Drug Administration and from the Centers for Medicare & Medicaid Services. Should Medicare pay for a drug that the profile says is the right drug to give to that patient but is not on the National Comprehensive Cancer Network pathway? We have private payers coming. We have bioethicists for privacy and the management of these data. We have good folks from the pharmaceutical industry, oncologists, patients, and patient advocates all getting together on December 6-7, here in Washington, DC, to really drill down on the subject and see where we are in terms of the interface between research and practice. I think we are right there and that we will bust through this over the course of the next few years. We need some guidance. We are going to need to discuss this openly among ourselves. What are the best ways to do this? Should we be looking at genes? Should we be looking at proteins? They don't always agree. Should we be looking at circulating factors such as microRNA? What really defines key targeted actionable items in our patients? Of course, there are a bunch of different assays out there and a bunch of different times that you could biopsy your patient and do the analysis. The next time you decide to order one of those things, be sure about what you are going to do with it. Are you going to make a clinical treatment when you get that result back? Are you doing it just to appease the patient and learn as we go? Are you doing it for research? Are you doing it for practice? If you know the answers to those questions, I think it will help once that big report comes back to your desk and you have to figure out how to make a therapeutic decision. Come to our meeting, Fighting a Smarter War Against Cancer 2013: A Three-Part Symposium, on December 6-7 in Washington, DC. https://secure.alumni.georgetown.edu...form_id=159447 Citation: Dazed and Confused About Molecular Data? Medscape. Oct 23, 2013.