Targeting the Cure - DOCTalk Speaks With CTRC President

and CEO Dr. Karen K. Fields

• SAN ANTONIO

It’s the most dreaded and pernicious of killers, cancer. It challenges the otherwise healthiest of patients as well as the more resourceful of physicians AND RESEARCHERS.  One place where these resources have been concentrated, collected and effectively used is the non-profit Cancer Therapy & Research Center in San Antonio, a facility that served over a million cancer patient visits since its founding in 1974.

It is the site for primary research, Phase 1 clinical trials for drugs and other cancer treatments, drawing in patients from across the United States, and its cooperative project with the University of Texas Health Science Center at San Antonio—the San Antonio Cancer Institute—is awaiting renewal of its status as a National Cancer Institute Designated Cancer Center.

In charge of this enterprise since the beginning of the 2005 is Dr. Karen K. Fields, the CTRC’s president and chief executive officer.  One of the country’s leading oncologists and investigating researchers, she was a founding member of the Blood and Marrow Transplantation Program at H. Lee Moffitt Cancer Center and Research Institute in Florida.

We recently sat down with Dr. Fields at the center to discuss both its present and future.

DOCTalk: Tell us where you are from.

Dr. Karen K. Fields: I am originally from Northeastern Ohio. I did all my training in Ohio, and I went to medical school at Ohio State. I then did my fellowship down in Florida.

You were trained of course as an oncologist?

Yes, as a medical oncologist.

Where were you before you came to CTRC?

I was at the Moffitt Cancer Center in Florida as an attending physician for sixteen years before I came here; it’s the third-largest cancer center in the United States.

I came to Texas in January of 2005.

I hope you’re a Spurs fan by now?

My son was already a Spurs fan before we came. We love the Spurs; just after I got here, Tim Duncan had given a gift to our foundation to support screening for breast and prostate cancer. So, in my first week [here] I got to go down to a Spurs game to receive that gift.

I got here six months before my son did, so I forwarded him the picture of me standing with Tim Duncan. He thought that was really cool.

CTRC is a big facility. How many practicing oncologists do you have here?

Our medical staff is almost two hundred, but there are probably about fifty to sixty physicians who practice regularly.

Do you still see patients yourself?

Unfortunately, I haven’t since I’ve been here. I’ve [been] so busy doing a lot of other things.

One of the primary things that is pharmaceutical trials. Can you go through some of this history of that?

Well, we were actually the Institute for Drug Development, which was formed officially in 1991. And it was probably the first of it’s kind, the first center to be focused on Phase 1 drug development, as well as incorporating some of the pre-clinical elements.

When we say pre-clinical, we mean that a lot of testing still has to go on in the mouse model before it comes to humans. So, we take drug compounds from the first time they come out of the laboratory, look at many of them in the mouse model to see what the doses that we might expect in humans, the side the effects that we might expect, and what responses are that we might expect.

We then take them into the early developmental stages with humans, which are Phase 1 trials. What Phase 1 means is that it’s the first time it’s ever been tested in humans. We’ve been doing that since the early 1990s. We’re the biggest and the best in the country at looking at lots of compounds  – at any given moment we might be looking at 40 to 50 new compounds that aren’t yet FDA approved. We also test new combinations of known, FDA-approved drugs with new drugs, looking for new effects and side effects.

These drugs come to you from the large pharmaceutical companies?

They bring them to us because we are very good at what we do. We have wonderful staff—a highly trained nursing staff, a highly trained clinical research staff. We also attract high volumes of patients—one of the big challenges of any medical trial is that you have to put enough patients into the trial to meet a statistical endpoint.

In Phase 1 you need fewer patients because you’re just looking to see safety and side effects.

Is it fair to say that the majority of patients that you receive for these clinical trials are cases that other oncologists view as hopeless, that perhaps they could benefit from a drug trial?

Exactly. In the Phase 1 program, you are eligible for a Phase 1 trial if there are no standard therapies for you, or if you have failed other kinds of standard therapies. Basically, the patients don’t have a lot of therapeutic choices, and we offer those patients one last chance.

However, with some of our new drugs and the way drug development has been evolving over the last decade, we’re actually starting to understand the molecular causes of cancer. So, sometimes we can predict that this particular drug is going to work with lung cancer, or other types of cancer. So we can sometimes give them a drug we know has a higher probability of working, whereas before the drugs might have been general drugs that would kill cells in a less specific way, or bind to DNA to cause cells to die—they were given to all the patients, and we would look to see if any of those diseases responded.

The goal is that we will get more targeted, more specific about how drugs work on patients, and hopefully we won’t have to use the last-ditch approach as much. That’s our dream, that’s our hope. Now we have the tools – the Human Genome Project helped create the tools for us to be able to look at targets.

In general, patients who come to us really don’t have other treatment options. They understand that they are volunteering for a Phase 1 trial that may or may not see any success. They understand that they are helping us to decide what the best dose is, the safest dose, what the side effects are – and hopefully, they might be responding to that drug.

And the data goes back to the company that is developing the drug, and from there it goes to the FDA?

Whenever a drug goes to the FDA it has to go though Phase 1, then through Phase 2 and Phase 3. With Phase 1 we decide the dose, the schedule that it is given, and determine the expected side effects. We put patients with any kind of cancer on the Phase I trial, and perhaps we see that it is responsive in lung cancer. Then in Phase 2, we look at lung cancer patients and see if that was a real effect. And then there’s Phase 3, where we’ve determined that yes, we did see an effect in a percentage that was not by chance, and then we compare it to the best standard therapy out there.

We do a Phase 3 study in by enrolling patients for one therapy or another chosen at random, because we need to eliminate the element of chance telling us that the drug is working, rather than doctors that are very good at picking patients most likely to respond. Then, if there is a real effect, it can be approved by the FDA.

You said you have about fifty trials going on at any given time?

In the Phase 1 area. We have other trials going on in Phase 2 and so on.

How many breakouts do you have, the drugs that are real successes and have gone out into the marketplace today, helping patients?

Since the IDD was opened in 1991, there have been fifteen drugs that have made it to market. I know that doesn’t sound like a lot, but when you consider that maybe one in one hundred drugs might make it to market—this institution has had the largest number of drugs that have actually made it to market. And right now there are a couple of other ones in the Phase 3 area awaiting – hopefully – FDA approval.

We have about one a year that makes it out, including one just a couple of weeks ago.

And these drugs run the gamut of all types of cancer therapies?

When we start out, we are just looking at the drugs purely from the standpoint of how you administer it, what’s the safe dosage, what the side effects are, and we start to identify what it might be used for. The last drug we got FDA-approved was for renal cancer. We’ve done a lot of work with drugs for lung, colon and G.I.

There’s a new drug that we’re investigating right now that hopefully we’ll see some activity for lymphomas; we reported that activity last spring in the American Society of Clinical Oncology. That drug is currently undergoing more testing. We haven’t worked as much with leukemia and lymphomas due to the patient volume and population that we see. But we look for activity in any patient that comes through our door for a drug that might be candidate—that might put us down that path of success.

What’s your relationship with the University of Texas Health Science Center?

Well, I came in a year-and-a-half ago, and one of the first people I met was Dr. Cigarroa. He and I have a very similar vision for what we hope both our centers can bring to San Antonio and this region, which is high quality cancer care and research.

We also share another mission, which is educating the next generation.

We’ve had a thirty-year relationship with the Health Science Center. Since the Cancer CenterCTRC opened, faculty from Health Science Center has practiced here. And we also have had private doctors practicing over the years. So, it’s always been a very unique blend of academic and private doctors from the community.

Dr. Cigarroa and I spent a lot of time together deciding what our vision was, and how we would accomplish that. We face some challenges, and one of them will be renewing our NCI designation.

Our joint partnership is the San Antonio Cancer Institute. We both bring dollars and revenue to the table to support SACI. And that’s where the NCI designation actually sits – we’re the outpatient arm, and a lot of the other faculty and basic science comes from across the street. It’s really a way to bring the best of both centers to the table, and we’ve turned out to be the vehicle for critical care delivery with both academic physicians and private physicians.

We spent a lot of time looking at those challenges, and we both agreed that we wanted to be an NCI-designated cancer center. So, we jointly recruited Dr. Tyler Curiel, who is one of the finest clinical scientists in oncology today. He is a very well-funded investigator, who has brought unique research to the Cancer Center. But mostly we brought him in because he is a great person for integrating the two institutions together and getting the best out of both worlds.

Does this facility have inpatients?

No inpatients. Our patients get admitted over at UHS, at Methodist and at CHRISTUS Santa Rosa…

But not all your patients are in clinical trials, correct? You also have patients come in for normal cancer treatments?

Yes, exactly. Patients get regular, standard cancer therapies here as well.

In the national percentages, putting ten to fifteen percent of your patients into clinical trials for an academic center is high – in your private practice, you usually see two or three percent.

We put a lot of patients in trials, but that still means the majority are getting high-quality standard therapies. We do chemo and radiation here. We have an outpatient surgery center as well.

When I pick up a newspaper like the Wall Street Journal, one of the things I read is that cancer is a very expensive business – you read about a new drug treatment and what it costs, and you think, “if the cancer doesn’t kill me, those bills are going to.” What do you tell the average person about there about that?

Unfortunately, taking care of cancer is a very expensive proposition. Chemotherapy and radiation therapy are very expensive to deliver, as well as the surgeries that patients need. So, all those numbers you see are real numbers about how much it costs to provide cancer care.

On the other side of the coin, this year for the first time since the United States started keeping data on outcomes, we actually started to see that we are decreasing the mortality rate of cancer. Now that we have more therapies and more tools—including screening patients and being able to treat them earlier, when they are more curable—the investments we are making are actively translating into improving life—the length of life, the quality of life, as well as decreasing the chances you will die if you are diagnosed with cancer.

Our society is going to need to decide if they want to make those investments, and obviously, we have made those investments – we do think that trying to cure patients up-front is a good investment.

One of the important things is the targeted therapies we’re talking about. Can we get more specific in our therapies over the next few years, so that we can apply the best therapy to the best patient under the right circumstances?

 If you come in with lung cancer, we’re going to take the two best drugs, and maybe add radiation and surgery to that, and we are going to give it to you. But not every patient responds. So, if we can develop the tools to say, ‘That patient will respond to that therapy, and these patients will respond to these therapies,’ we’re going to get more targeted and more individualized, and we’ll be able to use some of the more expensive therapies in a more effective, rational way.

I’ll give you an example. Early-stage breast cancer, meaning it’s still a small tumor confined to your breast—we know that most of those women are going to be offered chemotherapy if it’s a certain size, or if it has certain features. About eighty to ninety percent of women might already be cured with just radiation and/or surgery alone, but we have to give chemotherapy to almost every one of those patients if we follow what we call the general prognostic indicators. The bottom line is, most of those patients did not need the therapy so that we could get a ten percent improvement in survival for the other patients. And that also means that there is a small group that is just not going to benefit at all, because their cancer is going to come back regardless.

An exciting tool has been developed that has come to market in the last couple of years. They studied many, many patients and decided that profile meant that this group of patients didn’t need chemotherapy. So, they got anti-hormonal therapies – less expensive, fewer side effects. So, we became more targeted and we didn’t give chemotherapy to that group anymore. Before we would have thought they benefited because we gave them chemotherapy, but now we know they benefited from hormonal therapy, and we can identify it up-front. That’s the promise of targeted therapies; it’s a way to decrease expense, it’s a way to decrease morbidity and the side effects that come from chemotherapy. That’s just one small success story and applies to a small group of women with breast cancer.  We need to figure out how to do that for all women with breast cancer, for all people with lung cancer and so on.

Do you treat children?

We do adolescents here, and we’re starting to do more of them since we developed that sarcoma clinic downstairs with Dr. Ron Williams running that. Sarcomas of the bone are pretty common diseases in pedes and adolescents – though it’s easier for us to see pedes down at the Children’s Hospital.

We also do all the pediatric radiation for the city, because we have the biggest radiation program, and we have the resources—kids who have radiation need anesthesia to stay still in the machine. So we have the pediatric nurses and infrastructure and stuff like that.

Being a healthcare provider, you have to be affected by the same issues that affect everyone else – Medicare and Medicaid reimbursements.

Well, being here in Texas, we face these things even more acutely, as you know. Texas has the highest uninsured population in the entire nation. Read the “Code Red” report …

Yes, we sat down with Dr. Shine.

Also understand, we are not getting all of our patients who could be eligible for Medicaid. That is a huge challenge.

Being a tertiary care center – we are the place to come for clinical trials that might not be eligible. We end up seeing the more complex patients.

Unlike a hospital, where they might see a broken ankle that might cost $5,000 to treat – we’re talking cancer. That’s going to be a lot more than $5,000.

Yes, we’re talking about hundreds of thousands of dollars. It’s very, very difficult.

Medicaid reimbursements are a little bit less than Medicare, and we have to account for the impending cuts in our budget for next year. It’s going to have a huge impact on our revenues.

Where does your patient mix come from?

Most of our patients come from the six-county area, and we also see patients from all the way down from Laredo to Austin. And because of our Phase 1 unit, we also see patients from all over the United States – if you want to be in this part of a trial, we are the only one that has that. So we have always had a large part of the patient population come from outside of the city.

What are your goals?

My hope is that we really get to the level of being a comprehensive cancer center. For both of our institutions, it means continued funding from the NCI, to build our tools and infrastructure, and it also means the prestige of being an NCI-designated cancer center. It means more opportunities in being regarded as a center of excellence, more opportunities to provide care, and in competing among insurers as a preferred place of care. And it also helps us recruit the best and the brightest – the people we want to recruit either come from an NCI-designated cancer center, or our competition for them is an NCI-designated cancer center.

In a perfect world, when will you receive that designation?

Well, we had been NCI designated already, but we will know in October of ‘07, and we will see how we fare with our competition. When you go up for that designation, the NCI puts you in front of your peers, to critically assess your science and see if it’s worth funding. We only have so many dollars to go around and be competitive, so it’s a very important goal of us.

I also want to see us be more cohesive in inpatient care. We need a designated inpatient facility, and I don’t know what the timetable on that is – it’s expensive and more of a long-range goal.

Our ultimate goal is to stop cancer early. Finding cancer early is the best way to cure it; it costs the least to treat it. If we interact with all healthcare providers who are focused on a healthy community, we’re going to decrease the morbidity of cancer as well. So one of our wishes is to develop some center or relationship with the Health Science Center and other members of the community in order to really focus on a healthy community. We have great partners and great people to collaborate with.

What do you tell people when they ask the question, “When are we going to cure cancer?”

I always say, “We’ve cured enough mice; we have to start working on humans.” I think that taking all the resources that we have and actually asking questions that—in the end—apply to patients, and doing these clinical trials—I mean, the more people we put on clinical trials, the sooner we are going to find those answers. • DT