Teri Manolio: So, next, we're hearing from Sandra Swain
and Bill Pao -- I think you're doing a duet -- from the Society for Clinical Oncology.
Sandra Swain: Right.
So thank you very much.
And I'd really like to thank Gene Passamani, particularly, for organizing this.
And when we had the discussions, he said the main goal was about education in this area.
And I think already I -- we're all educated about what each of us are doing, and I think
you've achieved one great goal.
And from what I see and what I hear, we all have a lot of similar issues that we're working
with.
So if we can do, as some of us suggested, work together on the guidelines -- and it's
interesting hearing this discussion about guidelines and the heated remarks.
At our board meetings, probably that causes more discussion than anything else.
So it's clear that, you know, all of us need to do more work in that area and figure that
out.
So it -- cancer, I think, is a little different as a specialty than some of the other diseases
in that 5 to 10 percent are, at least, as we know now, are caused by mutations in specific
genes.
But most of the cancers are caused by somatic mutations of genes.
So most oncologists, certainly, you know, deal with it on a daily basis and do learn
about it in their fellowships and in their training.
And I really especially liked what Tom Nasca said, that it's going to be changed in the
future.
It's going to be part of the fabric of what everyone knows, and I think that that's critically
important.
It'll be -- I like what he said a lot, that it's going to be the pathophysiology or part
of the pathophysiology for everyone.
So just -- and I think that, Bruce, you already showed this example, but I'm going to show
it again -- the example, the big [inaudible] from the lab to the clinic is imatinib.
And it -- the Philadelphia chromosome was discovered in 1960, so that's almost 50 years
ago now, in chronic myeloid leukemia.
And just to show you a little bit of genetics -- you said genetics were important, but they're
interesting anyway -- it's a translocation where the BCR-ABL fuse cancer gene is formed
and becomes an abnormal growth of white cells, or CML.
And the treatment that was discovered was imatinib, approximately 30-some, 30 to 40
years after the Philadelphia chromosome was discovered.
And it caused a lot of excitement.
FDA approval and accelerated approval in 2001, and even a TIME Magazine cover, as you sure
-- I'm sure all are familiar with, calling it the magic bullet.
So it's really been the poster child for targeted therapy for cancer treatment that we've all
heard about.
And later on, it was also found that it affected other genes, c-kit, and is used for other
diseases like GIST.
So I just show you this as an example.
For us in our field, it took 50 years now to have a treatment for GIST.
And it's changing a lot.
We have the ALK gene in lung cancer; that took about four years to go from the laboratory
to the clinic.
So it -- the rapid dissemination of this information from the laboratory to the clinic is really
happening, fortunately, because, you know, our patients can't wait this long anymore
to find the cures for them.
So there -- I think that you all are probably familiar with all of this is the major challenges
in completing the cancer molecular map or sequencing the exomes, or -- and we can change
-- I misspelled that it should be, I guess, H-O-L-E, genomes?
[laughter]
Thank you, Debra.
So in differentiating between what the driver and passenger mutations are because there
are thousands of mutations, and we need to really sort out what's what and what's important
because the tumors are very unstable and they do change over time.
So even if you biopsy it one time, it may be different later on.
You do have a lot of mutations.
Integrating these data across platforms, and then finding solutions when you have multiple
testing of all this massive amount of data.
So how do we get from the research to the clinic?
You've got the multiple targets in these tumors.
You -- they, as I said, they continue to mutate.
They don't always tell you how the cancer's going to act.
The genomic discovery has been very, very rapid.
I mean, tons and tons of information has already been said, but the therapeutic agents really
have not kept up with that.
So are we going to be able to deliver?
And I think that's one of the reasons for this meeting, too, and the meetings you've
had, the last three or so meetings, is to try to sort that out.
Quality diagnostics; Debra commented on that already.
At the community level, as you probably know, about 85 percent of patients with cancer are
treated in the community.
I think that that's a really important point to remember, and we're all talking about embedding
geneticists.
It can't happen for 85 percent of people in the community as a person, cannot do that.
I mean, that's just not going be physically possible, so we have to find other ways to
get our message and the education to the community.
And then how do we help the general oncologists really keep up with the massive amounts of
information?
And I think what's really important is that the paradigm is changing from being at the
bedside and saying, you know, "What's your differential diagnosis, Doctor, for these
10 things for this patient?"
I mean, people can look it up now, and that's okay.
It's all right to look it up.
You know, we have -- our fellows are all in there with their smartphone.
They're looking everything up.
I mean, that's okay because the information's accurate.
There's good evidence.
So we need to incorporate those kind of things into how we work.
So we have a leadership development program, and I think Debra mentioned it, too, that
you also have one in pathology.
And we started this several years ago; and unfortunately, Dr. Nagowski [spelled phonetically],
who was supposed to be sitting here from Mayo Clinic was -- Rochester -- was not able to
get out because of the weather, and so he wasn't able to be here.
But he is one of our trainees in our leadership development program.
And they chose as this area of genomics and genetics and what resources that our membership
of about 30,000 members need, he did a small focused -- not really survey, but they interviewed
people -- community medical oncologists, academic medical oncologists, people in the leadership,
surgical oncologists, and pathologists -- to try to determine what was needed for education
in this area.
And they just came up with the same things that everyone else has said here.
There's overwhelming amount of data.
It's coming very quickly.
And I really like what -- I can't remember what her name was -- said that, you know,
we have just have to assume it's going to be there because it's there.
Patients are coming in with their genetic data now.
They want to know, "Doctor, what do I do with this information?"
So there's no standard resources available, and we can use the path reports and drug/device
reps to tell us what to do, but [inaudible] doesn't seem to be the right thing to do.
So they came up with these recommendations that they're simple, searchable, clinically
relevant, updated, user friendly, patient friendly.
Things should be available.
Not a laundry list.
It should be in the guideline format.
Again, guideline, what is a guideline?
We do also have vigorous discussions about this because, in oncology, we have the NCCN
Guidelines, which are consensus-based.
And those guidelines, only 6 percent are really on Level 1 Evidence.
And that's not because they're not -- they didn't find the evidence or they didn't look
it up.
It's because that's what exists.
You can't have Level 1 Evidence on absolutely everything, the hundreds of decisions we as
practitioners make every day when we're treating our patients.
So they came up with a [inaudible] was going to be most effective was a website, and they
wanted to be able to find it quickly, bookmark it, use it -- or a mobile device application.
And then decision support tools embedded in the EMR, which has already been mentioned
already today.
So what is ASCO doing -- I'm trying to answer all the questions that Gene handed out to
us -- in education and training?
We have ACGME program requirements for medical oncology, which we've been active in working
with ACGME for.
And these are just -- I'm not going to read the whole thing, but I think it kind of goes
with what you would expect -- the things that people should know -- and that's -- was effective
on July 1, 2012.
We have an ASCO Self-Evaluation Program, which includes chapters in molecular biology and
biologic therapy.
And at our annual meeting, because I felt like this -- this was actually even before,
Gene, you contacted me -- felt like it was such an important topic because of what I
see in my patients coming to me with, you know, 23andMe or whatever they're, you know,
coming to you with this data or wanting to get their cancer gene looked at by Foundation
Medicine.
So I felt like it's overwhelming for people in practice to figure this out.
So I organized -- and William Pao is one of the co-chairs -- for our annual meeting in
June, a course for "Genetics and Genomics for the Practicing Clinician," and it'll be
one and a half days.
And these -- we had these last year.
We just started doing these last year, these kind of pre-annual meeting courses.
Very, very successful, and they were basically oversold.
I mean, people really wanted to come to them.
And it will be CME, as everything that we do pretty much in ASCO is CME.
So the main thing that I was really interested in -- and I put practicing clinicians on the
steering committee -- is it's got to be something that's -- when a practicing clinician goes
home to their community, they have some tools to work with or they understand what they
don't have and what they need.
So I'm really looking forward to that, and it's interesting that a lot of you all are
doing similar things.
So I think it would be great if we can do the -- put all the stuff on the website that
Dr. Green mentioned and learn from each other on that.
We have several 75-minute educational sessions at our annual meeting on lung cancer, for
example, on "Bridging Science and Clinical Practice: How to Use Molecular Markers in
Brain Cancer," and then "Barriers in Expanding Access to Genomic Information."
We have what we call ASCO University.
And this is, again, all based digitally.
It's eLearning center; it hosts online, digital, and app-based educational products.
We also have tumor boards, and I know some people, at least in the oncology field, are
now having these multidisciplinary genomic tumor boards, and that might be something
that we will do, you know, in ASCO University, too.
I know at least two or three centers are doing that now.
We have CME-accredited courses: The Cancer Genetics Review, Molecular Oncology, and Genetic
Testing in Oncology.
And then getting into guideline development process.
We have chosen as a society to be evidence based and we -- because we are evidence based,
we only have about 23 guidelines.
When you're evidence based, you have to review all the literature.
It takes forever.
It takes two years.
You go back and forth about "Is this really evidence?
Is at that really evidence?"
They're very, you know, very non-nimble documents.
But we have done it, and I think people really appreciate those and do use them.
However, you -- we just can't do it for everything.
So that's been our struggle, too, is to how to go forward with guidance or guidelines,
and how to incorporate that into our practice.
So we have a formal consensus development process used when there's insufficient evidence;
so we haven't done a lot of that.
And now the whole goal would be to focus on evidence that informs a clinical utility of
the genomic assay results.
So we -- as Debra already mentioned, we have collaborations with CAP for the HER-2 testing
and the ER testing, which I think have been very successful and very important because,
as oncologists, we work extremely closely with our pathologists as colleagues, so to
show to the community that we're working together, I think, was very critical, and to have the
expertise both there sitting there at the same time; and then also, more recently, the
Association for Molecular Pathology with the Colorectal Cancer Markers Guideline.
So the policy on the release of the joint guidelines is that there's concurrent posting,
publication of joint guidelines on respective websites or journals, coordination with sister
societies about press releases.
All these things are really important because everybody puts a lot of effort into this.
So we really want to make sure that, you know, we get along, and we do these appropriately
for all the different societies that we work with.
So, next, I want -- I'm very excited to talk to you about this because I've heard a lot
of people really wanting what I'm going to talk about now.
And our board, a couple of years ago, had similar discussions to what we're hearing
in here today.
And as a practicing oncologist, care is fragmented all over the place.
I get a lot of patients for second, third, fourth opinion.
They could have had their path reported at one place, their -- everything's everywhere.
It's just kind of scattered.
Then you give an opinion.
They -- it's in your EHR, and it's really problematic to kind of get that information
everywhere, plus you don't have outcomes.
Only 3 percent of our patients in oncology that have cancer go on clinical trials.
Three percent.
So 97 percent of the patient's information for treatment that I give or other people
give is lost.
We have no outcomes.
We have no -- the data is totally lost.
So you're talking about with genomic data having a problem; we have a problem with clinical
data, and that we're not utilizing it to the fullest extent.
So based on the Institute of Medicine's rapid-learning system ideas which they have put forth over
the last few years -- and they've put out several documents on this -- we decided to
take on a very ambitious project, the rapid-learning system, which we have called "Cancer Link."
And what we will do and what we've done -- it's, actually, the prototype has been very successful
-- we were concerned that there would be many hurdles.
One, just getting people to give us the information because it's, you know, it's data on patients.
It's not anonymized data, initially.
And we have now decided to do a breast cancer prototype in the last few months, and we have
gotten clinical records on 130,000 breast cancer patients.
So this is like the biggest amount of data, clinical data, that is available anywhere.
Worked through all the issues of the different electronic records and, actually, right now
30,000 of those records are dumped into, you know, one network system.
The whole idea is that there'll be a central knowledge base.
As shown here, you have data that's going to come in -- patient data, then you have
provider data, also research data, and all of these things will be able to generate knowledge.
So there's several aspects of this Cancer Link.
One is this it will help the physician right there at the point of service.
And I don't have all the slides to show you, you know, what we've done if the prototype,
but at the point of service, embedded in that are our guidelines and our quality oncology
practice initiative, which is something we've worked on for several years, so physicians
can look and see if they, for example, give Herceptin for patients who have HER-2 positive
or negative disease, which is the wrong thing to do.
So they -- that will pop up and say you shouldn't do that.
Or give tamoxifen to a patient who's had a DVT in the past.
It'll pop up and say the guidelines say, "No, you shouldn't do that."
And so far, it's actually working, as I said, in 30,000 patients.
We have another 100,000 to put in there, and this is just the prototype.
A lot of what's been done is using open source computer software.
So it's an expensive project, so we'll see, you know, how that goes in the future and
the ability to do it, but we're very excited about it.
Everyone was concerned about whether we could do it, but it really -- it looks like we're
definitely going to be able to, and be able to do a lot of the things you all said.
Embed; you can embed the genetic recommendations and the guidelines that you have, and it will
be helpful for physicians.
So our next step for ASCO are the recommendations to ASCO from the leadership development program
that I mentioned to you about what they're going to recommend that we do.
Incorporate the genomics into our Rapid-Learning System or our Cancer Link plans.
Discussions with other societies, not just pathologists, but I hear a lot of people here
are doing similar things, and I would be really delighted to talk to anyone about this.
And involvement and follow-up, certainly from today's meeting.
So I wanted to -- I was going to give a couple minutes of my time to William Pao because
I think what he's done is really pretty remarkable already in helping generate information for
practicing oncologists.
So he's going to talk for a few minutes about that.