Lee Schwartzberg,MD: Targeted Therapies and Clinical Trials in the Community Setting
The Group Room sits down with Dr. Lee Schwartzberg, Medical Director of The West Clinic in Memphis, Tennessee at the 2012 Community Oncology Alliance (COA) Annual Meeting in Las Vegas. In this video, Dr. Schwartzberg discusses the revolution of personalized medicine and targeted therapies in cancer care, clinical trials in the community oncology setting and how important it is to treat the whole patient.
The Group Room interviews at the Community Oncology Alliance (COA) 2012 annual meeting in Las Vegas was made possible by the generous support of our members.
VIDEO TRANSCRIPT
Selma Schimmel, Founder & CEO, Vital Options International
This is Selma Schimmel for the Group Room at the Community Oncology Alliance meeting in Las Vegas, joined now by Doctor Lee Schwartzberg, Medical Director of the West Clinic in Memphis, TN, and I’m happy to welcome you back because the last time we did this it was the Group Room on the radio.
Lee Schwartzberg, MD, Medical Director, The West Clinic, Memphis, TN
Right, I’m very delighted to be back with you.
Selma Schimmel:
I am looking forward to a discussion today about targeted therapies and collaborative relationships involving clinical trials and what goes on between the community sector the academic sector, and how we bring these new compounds into the private practice.
Lee Schwartzberg, MD:
That’s a great question because this is a time of unprecedented change in cancer medicine, and that change is taking place both on the clinical level and the way we approach patients – really a fundamental way of approaching patients because we’re starting to understand the biology of cancer in a way that even ten years ago would have been thought of as science fiction. It’s very, very exciting for me personally, having been in this field for some time, to see the change starting to actually accelerate.
So the biology that we’ve learned from things like the human genome project and the understanding of the molecular biology of cancer cells is now tangibly becoming a part of clinical practice, slowly but steadily because our big road block continues to be the FDA and the regulatory process. But even given that we’re starting to understand that each of the cancers that we call a single disease is actually a group of related diseases but distinct.
So in breast cancer we now look at five or six different groups of patients, all of which looked the same under the microscope to the pathologist using the same technology that we done for the last century – in other words microscopes and defining patterns. But by looking molecularly we can target cancers to have a specific alterations that then are candidates for different drugs.
Selma Schimmel:
This whole field of molecular pathology is fascinating. I think there’s still some resistance with certain positions, surgeons, pathologists themselves who are learning this new technology about getting those tissue samples, and I really urge patients to consider logically that if the new compounds are based on your own biology that we have to look for genomic characteristics and the molecular characteristics of a tumor in order to most effectively choose a targeted therapy.
Lee Schwartzberg, MD:
We’re getting into this era of what’s called personalized medicine, and it truly will become personalized to the point that we’re going to have to know the entire genetic structure of us as individuals, our normal structure and what differs in the tumor. And it may get even more complicated because the primary tumor that’s removed, if it recurs five years later might look different. So we are definitely moving – I agree with you – to an area where we’re doing more biopsies.
Selma Schimmel:
When I had my ovarian cancer, and later developed a very small peritoneal legion they kept saying, ‘well you know it’s ovarian’ because under the microscope it looks the same, and then we sent it to the NCI and we sent it to a pathologist in Spain and they came back and said ‘no, no, no. It’s definitely ovarian’ and it was a creative pathologist who said ‘may we send this for molecular analysis?’
And pray tell, the physician who did the molecular analysis said ‘yes, there’s only one common mutation of the original ovarian. This is a denoval tumor, there’s no other common characteristics’ and the truth is it was peritoneal. But it didn’t change my treatment; it changed maybe a viewpoint, it changed my feelings, it changed the way my doctors viewed the tumor on a different level. The treatment was the same but it confirmed that indeed molecular pathology be identified by genome typing, and comparing it on a molecular level to the ovarian, and I wish patients could understand this because I think this is an area where patients can support their physicians and sort of own their pathology saying ‘no, I want further testing’.
Lee Schwartzberg, MD:
That’s a very powerful story, and in the future it will go beyond that defining to actually, possibly in some cases – not all of them – making a difference in what the therapy is being chosen. And really what you’re talking about is increasing sensitivity of testing; it’s not as if one is good and one is bad.
Selma Schimmel:
They complement each other.
Lee Schwartzberg, MD:
They complement each other, and that’s where we need to move to.
Selma Schimmel:
When you talked about when we initially mentioned that we were going to talk about targeted therapies, tell me please, the impact now that many of these therapies are oral compounds. What is that ship like within practice?
Lee Schwartzberg, MD:
So that’s an interesting problem, an opportunity in practices for a number of reasons. We’re developing oral drugs – the number I heard is approximately one third of the drugs that are being developed for cancer now are oral agents, and of course the previous year was virtually all IVs, except for few older, legacy compounds.
Oral compounds bring a whole new host of challenges with them, and first and foremost is the question of adherence. When I give a drug to a patient in my office intravenously, I am very sure that either they got it or they didn’t by the time they leave the office, and then it’s a period of time – typically two or three weeks – till they get the next infusion. We don’t have the same issue with orals; it’s dependent on the patients taking their medications. Many, many studies, all kinds of pills over the years have shown that there’s very variable adherence, and it may be a little better in cancer because the stakes are a little higher but people don’t take their blood pressure medicine every day, or their diabetes medicine every day. And we don’t know how much adherence we need for them to work, and that’s the critical issue.
Selma Schimmel:
The compliance-slash-adherence issue is huge because – and this is of concern to me as an advocate working with patients realizing that if the drug has certain side effects, the patient might think ‘well you know what? I’ll skip it today’ or ‘I’ll take it later’ and we can’t afford for that because they own this and their responsibilities is falling on the patient very differently now than it used to.
Lee Schwartzberg, MD:
Right. It’s a huge responsibility on the patient, and one of the other areas which is partly patient and partly physician, partly unknown is the interactions – not only with drugs but with anything we eat. So just think about…things that are as simple as grapefruit juice can have a profound impact on whether or not a drug you’re taking is absorbed at the right amount or not at all or too much. So we now have to start monitoring everything you do every day with oral therapies – it’s very challenging.
Selma Schimmel:
Which also brings up the issue then of course of herbal components of people like to use supplements and vitamins.
Lee Schwartzberg, MD:
Right. All of those things can interact with oral medications. You know most drugs are metabolized through the liver through a particular pathway and those enzymes can be increased or decreased by any common foods, by herbal preparations, by many of the things you take at the health food store. So it becomes a real, in a sense, an informatics challenge to be able to have the whole list and know it, and parcel that dated to get it make sure the patient’s getting the right amount of medicine. Hopefully in the future we’ll be able to test in some way about what the right level is for these oral medications, which will make it a bit simpler. But we’re not quite there yet.
Selma Schimmel:
Let’s talk a bit about collaborative relationships at clinical trials.
Lee Schwartzberg, MD:
Community Oncology is changing; I’ve never seen more change than over the last couple of years, and the decades before that. We talked about the clinical piece of that which is wonderful on how we have many opportunities now for patients with new medications and new approaches. The delivery of care is changing and that’s an opportunity and a challenge as well. We see that in many ways.
First of all, clinical trials are the life blood of new medicines getting to patients to help them and beat cancer. The regulatory process is very onerous, and it’s getting more so with the current FDA administration in terms of the mandate to make things more even higher. That makes it more difficult to do clinical trials. In the community setting we’re geared to instant care to large number of patients, that’s the major focus of community oncology practices. I would say most, if not all, community oncologists want to participate in clinical trials but it’s difficult because it’s always a small segment of the practice, and it takes more time and more effort. So a number of groups have tried different ways to make the process more streamlined.
We have set up, for example, a clinical trial group called ACORN which offloads the research administrative burden from the practice so the contracting, the budgeting, the project management, the financial piece of that is done by a third party rather than having to focus that at the practice where it’s a very small part and very different than the rest of practice.
Practices then can focus on what they do, which is take care of patients, identify patients for clinical trials, place them on clinical trials, monitor them, and deliver excellent care. So that’s one approach, and there are a number of networks around the country that are both private networks and then of course the public networks, the Cooperative Group Mechanism, which the government has acknowledged very recently was not working optimally or even efficiently. So right now we’re in the middle of a transition period, we’re all of the cooperative groups that are administered by National Cancer Institute are being re-tooled, consolidated together.
Unfortunately, one of the big problems with the cooperative groups is the funding doesn’t come close to meeting the funding needs of the practice or an academic center for that matter in terms of providing that clinical trial care so we still have a difficulty of who’s going to pay for this. If society says that clinical trials are important we need to increase the budgets from the public side. On the private side Big Farm has understood that and their budgets cover the costs of the clinical trial piece.
The reason that’s important is that we used to use the revenues that came from drug purchase in the community setting to pay for unfunded mandates like clinical trials; that funding no longer exists. There is no margin to do things like that and to do other important patient-centered aspects like give nutritional advice – there needs to be a funding mechanism for that. And nowhere has that been more critical than in clinical trials.
So I have groups that I know about that have gotten out of doing clinical trials – good, respected community oncology practices who say they just simply can’t afford to support the effort anymore because there is no longer any margin from any other activities that will support that.
Selma Schimmel:
You see opportunities that could enhance collaboration between community based practices and the academic sector?
Lee Schwartzberg, MD:
Absolutely. Collaborations between community practices and other larger institutions are accelerating now, not only in the clinical trial sector but also in the administrative sector, just the delivery of care. Many community practices are aligning with academic medical centers, with larger networks, or with community hospitals. Bigger is better in that sense so if you have a structure there is some kind of scale and that definitely plays to the clinical trial endeavor as well. So if the structure’s already there, regardless of how you access it through one of these multiple mechanisms it will help the practice from having to recreate the entire structure, which they simply can’t afford anymore.
Selma Schimmel:
As a closing thought, Dr. Schwartzberg, you might want to say something to your colleagues.
Lee Schwartzberg, MD:
I’d like to say something, actually, to the trainees, since our group has recently taken on a fellowship obligation and it’s been interesting to talk directly to the trainees. I think this is a challenging time for community oncology; things are changing, but I think I speak for my colleagues who have been doing this for a long time that there’s nothing that is more gratifying than to take care of people with cancer, and to help them with their journey as best we can whether it’s to cure or to help them live as long and good a life as possible. It’s only getting better, and I think that’s true, no matter where you are on your career continuum, but particularly for those who are just starting their path in oncology.
Selma Schimmel:
I’m glad you had a chance to say that and also in closing I’d like to acknowledge about my time of learning about you and working with you that you have a very unique approach with patients, and also I believe you’ve got a huge investment in supportive care and quality of life for patients, and maybe now you want to give one closing thought to the patients who are viewing you.
Lee Schwartzberg, MD:
I can tell you from my perspective, all the advances in cancer on the therapeutic side would absolutely have not been possible without developing supportive care, and to me, the idea that we’ve now come around to speaking about patients and to cares, of course what we should always be doing and what we always have tried to do. The patient is at the center of this, and I’ve always viewed this as a partnership between the provider and how the team of people that help care for the patients, and the patient, to try and find the best path because there is no one right way and we define the way that it both enhances quality of life and quantity of life.
Selma Schimmel:
Thank you, Dr. Lee Schwartzberg, Medical Director of the West Clinic in Memphis, TN, and a pioneering force in community medical practices.
Lee Schwartzberg, MD:
Thank you so much for having me.
Selma Schimmel:
Pleasure.
END OF VIDEO