Cancer Research and Clinical Trials

Dr. Vaughn: Welcome today, listeners.  We are going to talk about clinical trials, here in the Fredericksburg area.  This is something dear to me, because one of our missions was to incorporate clinical trials into our oncology care, here at HOAF.  I think it’s something that we’re able to bring these new, novel treatments that are changing the direction of oncology care. And it’s just great to have this opportunity to do it for our patients, here.  I am so honored today, though, to have both Rosemary and Judy here to get the perspective from a patient’s view about a clinical trial. And I want to welcome you both.

Rosemary: Thank you.

Dr. Vaughn:  If you wouldn’t mind, Rosemary, we’ll start with you.  But just a little background about the diagnosis and how you were referred to HOAF and how clinical trials became an option, or how it was brought up, as a treatment for you.

Rosemary: Well, in 2006, I was diagnosed with multiple myeloma.  And, at that time, it was recommended that I see Dr. Maurer.  And I did go to see him, and he gave me the diagnosis and treated me with Thalidomide and steroids, to start with.  That put it in remission, in six months. And then, he referred me down to Richmond, at VCU, and I had a bone marrow transplant.  After I came back from that, I did not want to take any medicine. So, he agreed with me, and we just went along with no medicines after that.  And I went 12 years without having another reoccurrence – recurrence. Yes.  

And when I came to see – I stayed with my bloodwork and everything.  I did all my checkups and everything. And when one of the factors in my blood was a little bit changed, I had an appointment with Dr. Maurer.  And I went in to see him, and he ran tests for several months, before he finally told me what it was, again. And I had a recurrence of multiple myeloma, again.  But that had been 12 years, so I was good. So, then, we went into – he recommended a clinical trial for me, which I was glad, because I did not want to have another bone marrow transplant.  I did not want to go through that again.  

So, we did the clinical trial, and I did KYPROLIS, and it was a success.  We had a whole year of treatment, and now, I’m in remission, again.  

Dr. Vaughn:  That’s a wonderful, remarkable length of time from one treatment to the next.  And, for those with multiple myeloma, as you were alluding to, just for those of – help understand myeloma, we follow a monoclonal protein.  So, it’s really based on a lot of blood work that can tell us if something has returned or not. Sounds like you had a long – we call it a remission-free interval there, for 12 years.

Rosemary: — I did.

Dr. Vaughn:  So, that’s quite remarkable, Rosemary.

Dr. Vaughn:  When you mentioned the, ‘word clinical’, the trial was brought up at your visit with Dr. Maurer, what were some of the feelings or thoughts or fears that came across your mind, with the word, ‘trial’?

Rosemary: It didn’t bother me at all, really.  I have full trust in Dr. Maurer, and I knew he would only recommend what was best for me.  He said it had been approved, already, but it was a trial, where I was going through twice a week with chemo, or once a week, to see how it affected different people.  So, I really didn’t have fears about it.

Dr. Vaughn:  That’s wonderful.  So, you were really comfortable with your — 

Rosemary: I was very comfortable.

Dr. Vaughn:  — relationship with Dr. Maurer, that — 

Rosemary: Right.

Dr. Vaughn:  — that he was giving you good information.

Rosemary: Right.

Dr. Vaughn:  Well, that’s excellent.  And I’m also honored, here, to be with Judy, who is a good friend of Rosemary’s, been a buttress of support through this.  Judy, how is it going through this, as the main support system, here? How did – were you in the room, that first visit with Dr. Maurer — 

Judy: Yes.

Dr. Vaughn:  — to talk, and — 

Judy: Yeah.  I — 

Dr. Vaughn:  — how did you experience this?

Judy: I liked him, the minute I met him, because he was just a very gentle but forthcoming man and put everything in layman’s terms, so we could understand it.  Never hesitated, if I asked questions, which I have a habit of doing, asking questions. And he answered everything and made us feel secure, and we were just ready to go.  And I feel, everybody that’s going through any of this, no matter what their cancer is, a support system is so important. The doctor’s top of the line, the patient’s most important, and if I could do nothing else, I just wanted her to know there was always somebody there.  

We laughed.  We smiled. We joked.  We talked to patients. And that part of it, to me, is just as healing as the medicine, laughter and support.  And I hope everybody realizes that. So, if you know somebody going through something, please, just be there for them.  Go out for lunch after it, take them to the stores, tell a joke, watch a movie. Doesn’t matter. Just as long as you’re together, and they know they have care.

Dr. Vaughn:  That’s wonderful.  It is such an important part, I think, having — 

Judy: It really – 

Rosemary: It is.

Dr. Vaughn:  — someone else to – it’s a long journey.  There’s a lot of ups and downs, and having someone there for you, it means a lot.

Judy: — really does.

Dr. Vaughn:  Particularly, when you were presented a clinical-trial option, I know, a lot of times, you have a few days to kind of mull it over.  You may have the, kind of, clinical-trial protocol to look over. Were there some questions you guys shared, together, about that? Or did you feel pretty comfortable — 

Rosemary: No.

Dr. Vaughn:  — just from the beginning?

Rosemary: I was comfortable from the beginning, and I think, so was Judy.

Judy: I was – I agreed, right away.

Rosemary: She just – yeah.  Mm-hmm. We both felt that it was good, and we were pleased with it. 

Dr. Vaughn:  So, right off the bat.

Rosemary: Right off the bat.

Dr. Vaughn:  You were ready to go.  

Rosemary: Yes, we were.

Dr. Vaughn:  — awesome.  What are – I guess, going through the trial — and I think clinical trials do offer some benefits that sometimes other patients who are not on trial may not have.  But going through this, what were some of the things that you noticed, Rosemary, that may have been different or really was a benefit to you?

Rosemary: Well, the clinical trial did pay, so [laughs] — 

Dr. Vaughn:  Right [laughs].  So [laughs] – that’s true.  They are kind of covered. That’s — 

Rosemary: — [laughs] so, that’s — 

Dr. Vaughn:  — yeah.  Financially, yeah.  That’s a good – yeah.

Rosemary: — I did get paid [crosstalk] which is good.

Dr. Vaughn:  That’s true.  

Rosemary: Which I know, some don’t.

Dr. Vaughn:  Right.  Right.

Rosemary: But it was well worth it.  I would’ve done it, without anything.  I just felt – I really did not have that many problems with the side effects, or anything like that.  I had shortness of breath, which was about the worst thing I had. But, other than that, it was good. It was good, and I was pleased with the way it went.

Dr. Vaughn:  That’s excellent.  I know from running these clinical trials, in the office, one of the, I think, the better things, at least from a patient’s point of view, is we’re very strict about side effects.  There’s a lot of follow-up, which is wonderful, because it keeps patients on track. We’re monitoring things very closely. And you also have the benefit of really having a specific research team and a pair of nurses who are aligned with you, that may not be aligned with other patients in the office that aren’t on trial.  Can you talk about your relationship with the clinical-trials team?

Rosemary: Well, the nurse was fabulous.  It was Brenda Murray, and she was just fabulous.  She was always there to answer questions and checked on me every time I came in.  And she was just fabulous. And the two nurses that we had, mostly, for the chemo part, was Katelynn and Ashley, I believe.

Judy: Mm-hmm.

Rosemary: And they were just as nice as could be and as wonderful as could be.  You couldn’t have asked for anybody nicer. They were great, and they never hesitated if you had a question.  And we heard them on the phone various times with patients calling in with a concern or worry, and they were fantastic.  You could just hear how they would allay their fears and say, ‘We will get back to you.’ They’re just – they were like, our girls, you know?  Yeah. They are. They’re just like our girls.

Judy: They were.  

Rosemary: I hated to – the clinical trial to end, because they did [laughs] –

Judy: We enjoyed them, so much.

Dr. Vaughn:  I have to remember this trial.  Did it end just because you ran out of time?  Is that why? 

Rosemary: — [laughs] 

Dr. Vaughn:  That’s not a bad way to end the clinical trial, if it just was a certain amount of time, and it’s over.

Rosemary: — yes.

Dr. Vaughn:  Well, that’s wonderful.  KYPROLIS is a medicine we use a lot, now, for myeloma.  So, it shows you how the – that some of these medicines that we may use, early, in these trials, become sort of a standard of care and sort of a changing of the landscape of treatments of a lot of different diseases.  So, that’s nice to see – and to allow our patients here in Fredericksburg to be offered that. It’s really the mission of clinical trials, here in Fredericksburg, for our practice.

Judy: Well, Rosemary’s such a sweet person.  The first thing she said about the trial was, ‘Well, if this just helps one more person, I’d do it, anyway.’  And she meant it, because she was through it, before. So, she wanted to help – if it just helped one more person, that’s a benefit.

Dr. Vaughn:  Gosh, that’s a great — 

Judy: Isn’t it?

Dr. Vaughn:  — unselfish point of view.  But that is – that is wonderful, and — 

Judy: That’s – that’s her.

Dr. Vaughn:  — just to help others, and that’s — 

Judy: Yes, absolutely.

Dr. Vaughn:  — that’s tremendous.  Well, what have you guys learned, from beginning the clinical trial, and now ending it?  Any advice you would give to someone else, maybe coming into our office, and Dr. Maurer, let’s say, brings up a clinical trial again, for something? How would you advise someone going through it?

Rosemary: I would tell them to do it.  I would tell them to do it. Yes.  Because he – he would only advise, I think, the best, and I just think that his advice is gold.

Dr. Vaughn:  Yeah.  That’s wonderful.  So, really, that trust with your doctor, here, was really critical in the decision making.

Judy: Yes.  Right.  And we recommend your practice, to anyone – 

Rosemary: Oh, yes.  Mm-hmm.

Judy: — that has cancer, that comes up and says, ‘I had a diagnosis.’  Or, ‘I need to go see the doctor.’ We tell ‘em.

Rosemary: I had a friend who was misdiagnosed by other physicians, four times, and met Dr. Maurer.  Right under control. He said, ‘We’re gonna take care of you. Don’t you worry.’

Dr. Vaughn:  Wow.

Rosemary: So, I was like, ‘Oh, my’ – because I met her, here.  Could not believe it. And she said, ‘He’s somethin’ else.’  And he’s working with another physician, for her benefit.

Dr. Vaughn:  Wow.  Mm-hmm.  Excellent.

Rosemary: And I said, ‘What more do you want, of a doctor?’  And he’s a cutie. [laughs] He is.

Judy: She has to get that in. [laughs]

Dr. Vaughn:  [laughs] Oh, yeah.  

Rosemary: I can’t help it.  He’s lovely.

Judy: Yes.

Dr. Vaughn:  And you can go to our website, to look at his picture.  It’s on there.

Rosemary: [laughs]

Judy: [laughs]

Dr. Vaughn:  I thank you both for being here and sharing this with us.  It’s so helpful, I think —

Rosemary: No problem.

Dr. Vaughn:  — to hear it from a patient’s view, because, when I walk in, I know, medically, why it’s appropriate.  But I want to make sure the patients are comfortable, and coming from your perspective, how we can both meet together, to approve for clinical trial.

Rosemary: This – it’s true.  And people have to have trust.  Trust is very important, when you come here.  And I just feel, this – the whole atmosphere, in this building, just makes people feel at home and safe.  And they’re smiling, most of the time, just a few, but [laughs] – and it’s wonderful.

Dr. Vaughn:  Right.  Thank you.

Rosemary: It’s like the end result of a good recipe.  It’s just all the ingredients that you put into it, to get the result you need.  And then, they’ve proven this, and I’m so proud to be her friend, and that she’s here.  She’s been a good support for me. So – and not just bringing me to all my chemo sessions and doctor’s appointments.  I mean, she’s right there, if I need her, anytime. So, she’s been good. And I want people to remember that.

Dr. Vaughn:  Yeah.  That makes a huge difference.

Judy: Yes.  

Rosemary:  Remember the people that need you.  

Judy: Because I may need her, one day.  You never know.

Dr. Vaughn:  Well, thank you, ladies.  I appreciate it so much.

Rosemary: You’re very welcome.  Good luck with everything.

Judy: You’re welcome.

Dr. Vaughn:  Well, thank you. 

[Music playing]  We are here, now, with our research team at HOAF.  As I mentioned earlier, this is really something that’s been important to me, our Clinical Trials Team, our development, our continued growth.  And, just to give a little background, I think, for those listening, we started clinical trials here, in 2010. That was the first year we incorporated trials into a treatment plan for our patients.  At that time, we were aligned heavily with VCU, which was really good. They offered a lot of support for our office.  

And I was just reminded about a trial.  One of our earlier trials was a breast-cancer trial that we used Herceptin, but with another novel drug that was also a HER2 directed therapy.  And the trial – the goal was to have about 350 patients, nationwide, and we actually here accrued 10 patients, in a matter of 4 to 6 months. And the reason I bring this up is, I was at – this was in 2014, and I was at our main oncology meeting, global meeting.  American Society of Clinical Oncology has a big meeting in Chicago. And they brought this trial up as one of the landmark papers, at the conference, and showed such benefit of doing what we call dual HER2 therapy, which has now become standard of care.  

But it was so rewarding, I think, for me, to see 10 of our own patients in Fredericksburg, out of 350, on this trial, and the power and the importance, I think, of having a clinical-trials program as a backbone of what we do and how we can shift the needle on cancer therapy.  And this was a big movement that now is standard of care for all the patients coming in to see me, with HER2 breast cancer. We are doing this, now, as a standard of care. In 2014 – or 2012, when the trial was opened, we didn’t know. But with such positive results, it has now become the standard of care.  And I think it was just an eye-opening experience for me.  

And I think that is really the message in why we do what we do with clinical trials.  So, I’m so excited to talk about it with our team, here, Brenda, Susan, and Rebecca. I am going to open it up and allow you guys to introduce yourselves.  I will start over here, with Brenda. Little background on your story, when you started at HOAF, and why you wanted to get into the Research Department.

Brenda: Well, my name is Brenda Murray, and I have been with HOAF since 2010.  So, I’ve been here for nine years. It’s hard to believe. And I started as an infusion nurse, in the Infusion Center.  And then I became the Charge Nurse in the Infusion Center. And I was asked to go down to Research, to kind of help orient Susan, who was coming onboard.  So, she came onboard kind of at the same time I went down to Research. And I found out that I really liked it. It was a whole different piece of the picture, if you will.  And I decided to stay, and I’m really glad I did, because I really, really love what I do.

Susan: I’m Susan Ayre, and I am the Clinical Research Manager, but I’m also a nurse – research nurse.  I’ve been here at HOAF a little over three years, now, but I was in research for many years, before that, not in a community practice setting, but in a large teaching hospital.  And I loved research, back then, but I really love it, now. Being in the community setting is just a whole different atmosphere. You have so much more time with your patients. You can really connect, and things move very quickly in a community practice.  

We move trials through, very quickly, to open them, if it’s something that our patients need, which is – large institutions, they do the best they can.  But that’s one of the things I love about working here. I’m just really proud of our department, and I’m also proud to be a HOAF employee. It’s a great place.

Rebecca:  My name is Rebecca.  I’ve been at HOAF for two and a-half years, now.  I’m a little nervous to be here today, but I’m really excited that this is my first podcast.

Dr. Vaughn: So, Susan, I’ll direct this question to you.  What is the experience like for a patient coming through our office as a new patient, and the word ‘clinical trial’, is mentioned?  Where does the Research Team – where are they involved in helping that patient get on a clinical trial? How do you help break down some of the barriers, the fears, let’s say, that may come with the idea of a clinical trial?

Susan: Well, first of all, we sort of are one step ahead of the game.  We always know, before a patient comes in, that they have a diagnosis that might – they might benefit from a clinical trial.  So, we do let their doctor know, and we put an alert, so the doctor can start talking about it. Kind of see, is it something that they’re interested in, is it something they might not be interested in but are willing to hear a little bit more about?  And, if so, one of the members of the Research Team will go up and speak with them.  

And, no matter what the diagnosis, no matter what the trial, the first thing I always start with is, ‘A clinical trial is not a, “We have nothing else to offer you.  I’m so sorry.” It is just another choice. It’s another tool in your toolkit, that you can try for. It might be offering you a medication that you couldn’t get any other way.  And it might turn out that that was the best thing for you to take. It might not be better, but it’s giving you that opportunity. And I think that it’s important for people to know that no one is a guinea pig, and we’re not going to withhold any care that they would’ve gotten, if they weren’t on a trial.  So, that is always the first thing I tell them.  

If they are interested, we go over the trial, in some more detail.  I let their doctor know. And then, we schedule an appointment for them to come back, because, for every person that’s not sure about a trial, I – we also talk to people that want to sign on the dotted line, before you’re even done talking.  But we don’t want people to make rush decisions. So, we say, ‘Go home, think about it, and then come back. And if you’re still interested, we can get the process rolling.’  

But I – I always let people know, ‘Take time to think it over.  Talk to your family. Talk to your friends. Because you want to go – in 5 or 10 years, you want to look back and say, “That was the right choice for me.  I’m glad I did this. I’m glad I didn’t do this.” So, just take your time, and know that your doctor would not allow you to choose this option if he or she did not think it was in your best interest.  So, that’s usually the first thing I say to everyone, just to kind of alleviate a little bit of their fears. Because, in the not too distant history, clinical trials really got a bad reputation, so I just try to let them know, ‘It’s an option.  It’s not your last chance.’

Dr. Vaughn:  And most of the trials we are running, and they kind of – there are tiers to clinical trials.  Most of the ones we are running here are Phase II or Phase III trials, which the medication they were questioning, if it’s going to become a standard, has already been proven to be safe.  It’s just a question, ‘Is it better when added to, or by itself, than what is the sort of gold standard?’ So, that is what we are offering to our patients, here in Fredericksburg. I think one of the points you mentioned that was pretty critical was just being well informed.  

Just — we’re gracious to have a participant in a clinical trial and her friend, who’s been such a support for her, throughout this process.  But it’s important, I think, for a patient to understand, there’s so much information given to them, and you just touched on it, just making sure you give them an ample enough time to understand it, because it is a little bit of a different protocol.  Maybe a little more follow-up, a little more attention needed to the patient. Is that something, Brenda, you talk about with a patient, when you’re discussing the trial with them?

Brenda: We do a good job with that.  We want them to feel comfortable with their decision.  Another thing that we tell them is that, if they do sign an informed consent to be part of a clinical trial, it doesn’t mean that that informed consent is from that point forward.  That it’s an ongoing process, and that they do not have to participate, if they don’t want to, at any point during the clinical trial. So, just because they decide to do it, today, they might, in two months from now, say, ‘This is really not for me.’  And they don’t have to participate, anymore. So, it’s an ongoing thing, the informed consent. 

Dr. Vaughn:  And it appears to be something that there’s constant interaction, that our Research Team, and you being – your background of nursing, you’re constantly involved with these patients, almost as if you’re – kind of almost their direct nurse, to some degree.

Brenda: Very true.  They get very individualized treatment, because you are with them through the whole process.  First, you start off screening them, so that you can see if they are eligible for the clinical trial.  And you’re with them through that whole process. If they’re receiving treatment, you’re with them at every treatment.  If they are having side effects, you help them manage the side effects. And so, you spend a lot of time with these patients, and you really do get to know them and just kind of guide them through.  And I think it’s a nice thing for them, to feel that they have that guidance and that – through their treatments.

Dr. Vaughn:  And I think, Susan, you touched on this.  One of the exciting things, I think, about having clinical trials, here at HOAF, is that we can make decisions and tailor trials to our patient population.  I think that’s one of the real-life benefits of being a local community practice is, you may see a certain group of patients that you really want to fight for a trial for them.  How do we screen patients? How do we – you mentioned meetings. How does – how do we get together, as providers, as a group, and talk about potential trials, here at HOAF? 

Susan: On a smaller scale, we have weekly research meetings.  Our Research Department, with Dr. Vaughn, and, at times, with Dr. Whitehurst, who’s also involved in research.  And, on a larger scale, we have monthly meetings. We call them “All-Provider Meetings”. And I say, ‘Okay. Folks, these are the trials that we have, that are still open’, reminding them.  And then, also, ‘In the next month or two, these are the trials that will be open. In three to five months, these are the trials that I hope to open. And what do we not have that you want?  What patients are you seeing, that we don’t have a trial for them?’  

Sometimes, even if we’re seeing a lot of one diagnosis, there might not be any real movement in the research area, in that particular diagnosis.  But, where possible, we actively seek trials for the diagnosis of our population, of our community. What they need is what we open. I also like to have a trial for the really super-tough diagnosis, where we have treatment, but it isn’t fantastic.  It’s just the best we can offer. So, I’m always looking for treatments for those diagnoses. So – it’s always changing.  

And we just open what we need, to best serve our community, which, again, like I was saying earlier, is really wonderful, because, when you’re a community practice, you can open a trial in six weeks.  If you’re a large, academic institution, it could take six months. And not because they don’t want to open it, but because it’s like a large corporation. Things move slowly. So, I think that is a huge benefit, and it’s very gratifying when you can see something that you need, find the trial, and open it, and it’s less than two months later.  It’s very gratifying, for the patients as well.

Dr. Vaughn:  Right.  Isn’t there one, and you can expand on this, isn’t there one called “Just in Time”?

Susan: It’s actually more than one trial, Dr. Vaughn.  It’s a whole system of opening trials. For example, a pancreatic trial, or maybe a lymphoma trial.  We don’t want to open it, because opening a trial, there’s a lot of what we call overhead. Even if you don’t have anyone on the trial, there’s still quite a bit of work that you have to do.  These trials, you’re screening. When you find a patient, it only takes 10 days to open the trial. You open it just in time for the patient. And that is very helpful, because it allows you to open a trial that – for a rare diagnosis, that maybe you only see one patient every two or three years.  So, we are involved in that, as well as your traditional pharmaceutical trials. 

Dr. Vaughn:  Right.  I think that’s just amazing to have that opportunity for — 

Susan: Mm-hmm, absolutely.

Dr. Vaughn:  — patients who, like you mentioned, may have a rare type of tumor, that we can have a trial for them, within a matter of 10 days.  I think one of the exciting things, also, by having trials in the area, is that we sort of are able to crosstalk amongst other specialties.  We have a lot of buy-in with our surgical oncologists, Dr. Blanchard, who’s our breast surgeon, and also Dr. Tim Sherwood, who’s our lung surgeon.  Right now, we’re working on trial with him, giving treatment before surgery.  

How does it work, as a community?  I know we are medical oncologists, but how does a research team reach out to the other surgeons and other providers in the area, to let them know about these exciting things we’re doing at HOAF?

Susan: So, I think we communicate with other areas, such as surgery and radiology and radiation oncology, at our weekly Tumor Boards.  And what a Tumor Board is, is where the medical oncologists — those are the people in charge of your drug regimen and your treatment regimen, and then, your radiation oncologists, if you’re getting radiation therapy, and then, the pathologists, who read the different slides of your blood and tissue, and the radiologists, who read all your images.  So, there’s lots of people there.  

Last week, at Tumor Board, I made a small presentation about a new lung trial we were opening, just because we want to make everyone aware.  Because, when Dr. Sherwood sees a new patient, and, again, this is something – it’s a neoadjuvant trial, meaning you get your treatment before surgery.  So, of course, you want the surgeon to know about that. So, we do presentations that way. We visit doctors’ offices, and we have very good relationships with the office staff, in the surgeon’s office, in the imaging, which is your CTs and your MRIs.  So, everybody’s always talking. Everybody’s always on the same page. 

Dr. Vaughn:  Mm-hmm.  How is the relationship within the office, amongst other employees, like maybe nurses – how do we make them aware of a patient on a trial?  How do we coordinate the care? Because it is a little more precise. There’s certain data points that need to be entered, that, on a patient off trial, you may not need to worry about.  How is the communication and the flow within the office?

Susan: All of our providers have teams.  So, if you have a patient that is going to be on a clinical trial, when they receive treatment, they are with that doctor’s nurses, to have their infusion, if that’s what their clinical trial is.  It’s – it would be in the infusion area, for that part. And so, what we do is start by going to team meetings and informing the teams of the patient that is gonna be on the clinical trial what’s going to be involved.  We also – our nurses have huddles, every morning. So, we would attend a huddle, and we would communicate what the trial is at that point.  

We build specific regimens for our clinical-trial patients, so that everything is laid out on their orders.  It’s identified very clearly within our medical records system that that patient is on a clinical trial. And then, of course, we are with that patient at their treatment, whether they are being seen on the exam side or being seen on the infusion side.  And we are there to coordinate that care. And then, if we had any changes in dosages or changes in any labs or special – sometimes, we have special labs that need to be drawn, we would provide anything special like that, in communication with the lab tubes to the nurses or to the MAs or to whoever’s involved in seeing that patient for the day.

Dr. Vaughn:  And what do most trials want, with special labs or special tissue?  I know, this comes up a lot. Patients ask that. What are they usually – what are they looking for? 

Susan: Well, every trial is different, and it depends on the phase of the trial, for exactly what labs or tissue would be required.  But, usually, the sponsor, if it’s a special lab that they want drawn, that they are going to test at their site, we call that a central lab.  So they would send us a kit that we would draw their labs. And we would – Rebecca is the one who handles that, and I’ll let her speak to what she does with that.  But we would send those labs off. Sometimes, tissue needs to be sent as well. And that is just different, with every trial.   

Dr. Vaughn:  So, it’s trial dependent.

Susan: It is trial dependent.

Dr. Vaughn:  I can say, in the movement in oncology, where we’re really looking at, I think, trying to identify, through either blood or through tissue, which is the biopsy that’s been done or the surgery that’s been done, with the cancer in it, we’re trying to find certain markers, we call them biomarkers, that may hopefully predict great responses.  So, the idea, going forward, it may be two years, maybe five years, that, through these trials, not only will it show a benefit, hopefully, to the overall group, but maybe you have a certain marker that really predicts a huge benefit.  

So, hopefully, we get smarter on selecting certain treatments.  And I think that’s what a lot of these trials try to figure out, with either – through the bloodwork or through biopsy specimens and when they say – when they are sending it off for analysis.  So, Rebecca, I know, with a clinical trial – or I know at least I’m signing a lot of stuff, a lot of data. I know you hit me up for a lot of signatures. But there is so much information, and that’s what’s so great, is the data that we’re collecting for our patients and, hopefully, to show, again, that there’s such benefit on a trial.  But it’s so much information and data. How do you keep it all together? 

Rebecca: Well, all of us do our work with high integrity.  We have great outcomes and, because my data is on time, we are recognized for it.  They see that. And, honestly, because data accelerates the significance in new therapies to patients the better the data, the faster it’ll happen.

Susan: What Brenda and I do with a patient is the clinical side.  That is only half the picture, because it doesn’t matter what we do, if the data is not entered correctly and not entered quickly, they will not use the information.  So, in the end, it doesn’t matter how hard we work, or how willing the participant is, it’s up to Rebecca to make sure everything gets entered the way it needs to be. Her role is of utmost importance, because she is the only way the study knows what we’ve done.

Rebecca: Thank you, Susan.  It really is so much easier for me to just do the job than to actually describe it.  Thank you.

Susan: You’re welcome.  You do it very well.

Rebecca: Thank you.  I enjoy it.

Dr. Vaughn:  Well, I think that’s a testament to our Research Team.  And we can talk about this, a little bit. I think we’ve been approached by a lot of pharmaceutical companies, because of how accurate our data is, how timely it is, our general patient population, how excited they are to be trial participants.  So – and this is open to anyone to jump in, here, but I think it’s something that we’ve really, each year, kind of built on the success. And we obviously want to keep the needle moving. I’m just really thrilled with where we are and the future, too.  But talk about how we’ve been able to kind of build these relationships with major pharmaceutical companies.

Susan: I think, if you can do a good job for a large pharmaceutical company, Eli Lilly, Genentech, Merck, Bristol-Myers Squibb, all of the big names that we see on TV, advertising different medications, I think if you can do a really good job once, they know you’re serious.  And they will come back to you. So, we’ve really just – all of us, all three of us, just given our all, and done the very best we can do. And I think you can’t fake enthusiasm, and I think all of us love what we do.  

And that’s been commented on by some pharma companies, that they can tell that we really care about our patients and that we love what we do.  That’s what they want. They want investment. They want personal investment by everyone involved with their trial. And I think that’s what – when they meet us, and they give us our first trial, they know that’s what they’re getting, here, when they use HOAF as a site.  So, I think, really, the way we get these trials, to just keep doing a good job and keep enrolling the right patients, because not everyone is right for a clinical trial.  

So, choosing trials that are appropriate and working with patients that are both appropriate for the trial, would like to do it, and it might benefit them.  So, I think just doing a job well is what gets you more trials. And also, we have a lot of pharmaceutical reps that come here, and we ask to speak to, there’s something called their MSL, which is their Medical Science Liaison.  And that’s usually a PhD pharmacist, and they know about all the drugs that are in development, and they are the ones that really have their finger on what trials are coming.  

So, we tell them what our need is.  Maybe we need some more trials for lung cancer, or we need more trials for bladder cancer.  And they’ll say, ‘Okay. Well, we have a drug.’ So, they put us on the short list, and then, perseverance is a good thing.  I keep calling and emailing. And then, it just goes from there.

Dr. Vaughn:  It’s a reminder for me.  I love those interactions we have, with these Medical Science Liaisons, because it really brings you back to college and even high school, when I wanted to get into medicine.  I get back into my kind of nerd science behavior, and it’s really cool to get back to the amazing drugs they’re developing and how we can take it ‘from the bench’, we call it, to the bedside.  And you can see it in motion, here at the office. And it’s such an exciting thing to be a part of.  

What are – and we can go around, here, and talk about a little bit of this, but what are some of the exciting trials?  We can name a few, but what are some of the exciting trials we either have opened – for a listening audience to hear this, but have opened, or about to open, within the next one to two months?

Brenda: I’ll talk about the ones that I’m coordinator on.  Right now, I have a lung trial open that is a neoadjuvant lung trial, and it was a drug that we use here, often, but in a different way.  So, they’re testing this drug used up front, with chemotherapy, before surgery. So, that’s the neoadjuvant part of the trial. And then, after surgery, then, they come back, and they can receive more treatment if their choice is that they receive more treatment.  So, that is – it’s been a very interesting trial that we’ve been very excited about. And — 

Dr. Vaughn:  If I could interject, real quick, that is – what’s exciting, that’s an immunotherapy trial —

Brenda: — it is.

Dr. Vaughn:  — in conjunction with chemotherapy.

Brenda: Yes.  I was just gonna say that [crosstalk] [laughs]

Dr. Vaughn:  Oh, I’m sorry.  No, I – no. I didn’t want to steal your thunder, Brenda.  

Brenda: That’s okay.  But it – but that is a good point, because it’s really an exciting time to be involved in cancer research.  Because there’s all of these drugs that are – we’re seeing, in these clinical trials, that are the immunotherapy drugs.  And those drugs are given with the hope that they will stimulate a person’s immune system, to help them fight the cancer.  So, we are seeing very exciting things, in that area. So, that’s one very exciting trial we have going on right now.  

We just finished a trial on multiple myeloma.  I know one of our patients was here, earlier, speaking with you.  And we had two patients on that trial, and that was just looking at different dosages and different schedules of giving the same drug and comparing how the patient tolerates the two.  And it was just done in a community setting, that trial.  

We have another trial that is going to be opening, that is a neoadjuvant lung trial as well.  This trial is looking at neoadjuvant treatment, and then surgery, and then, adjuvant treatment, after the surgery.  So, they will get chemotherapy – or treatment on both ends, depending on which arm they get.  

Oh, I also am the coordinator on a breast cancer trial that is looking at weight loss and the role that weight loss plays in the recurrence of cancer in early breast cancer.  So, we have quite a few women on that trial.

Dr. Vaughn:  That’s more of a survivorship trial, right?

Brenda: Yes.  It’s more — 

Dr. Vaughn:  That’s a question, which is — 

Brenda: — there is no treatment involved in the trial.

Dr. Vaughn:  — right.  And some of our – I think, sometimes, we just think of trials’ being aimed at a, medicine A verse B does what?  But a lot of the stuff we’re also interested in is, how can we educate patients after their treatment? I’ll mention this trial with weight loss, or exercise, how it impacts quality of life, daily function, and these important things for survivors.  So, that trial you alluded to was a – is a breast-cancer survivorship trial. And what are the endpoints of that trial, Brenda?

Brenda: They’re hoping – they’re either randomized to a weight-loss arm that has a coach, and they receive all kinds of health information, or an arm that received just health information, alone.  And they’re hoping that a person would lose five percent of their body weight, I believe, is what they’re looking at, and then how that – their recurrence rate, based on their weight loss, of breast cancer.  So, that’s an interesting trial.  

And then, I have one more that is a metastatic lung trial.  And that is looking at a new drug, in combination with an immunotherapy drug, in the metastatic lung setting.  So, the Stage IV, later stage, lung patients. 

Dr. Vaughn:  Right.  So, that’s a great kind of breadth of what we – I’m just taking the lung cancer kind of window, here, because you’re looking at – almost a trial before surgery.  We also have a trial, asking – not only before, but then, after surgery. And then, also, one that has Stage IV cancer. So, you’re almost at a patient coming in, at least kind of fits all the criteria, for lung cancer trial enrollment.

Brenda: Yes.

Dr. Vaughn:  Now, that – as Susan mentioned, sometimes, though, trials are very picky about who can enroll or not, but at least, think you’ve done a great job laying out kind of a landscape, where everyone with lung cancer would almost – would meet a trial opportunity.

Brenda: Yes.  We have a lot of lung cancer patients, and that was really our goal, was to be able to have trials to offer in different settings of that diagnosis.  So, it’s exciting.

Dr. Vaughn:  Maybe it’s coming down the pipeline very soon, but don’t we have some exciting breast cancer trials, about to start?

Brenda: Yes.  You were just talking about how there’s something for early-stage lung cancer, and then, after surgery, and metastatic.  Well, breast cancer, my goal was to have something early stage, late stage, HER2 positive, hormone-receptor positive, and triple negative.  That would be something for everyone, and it’s – it is in the works. We’re going to have something for everyone. Very soon, in the next, I’d say about six weeks, we’re going to have two trials opening.  Both of them are the neoadjuvant, which, again, is before surgery. One is for women who have already gone through menopause, and the other is for either women who have gone through menopause or not yet gone through menopause.  And they’re both immunotherapy trials.  

And then, another trial that we have opening, probably a little bit later than that, two or three months, is for something called triple-negative breast cancer.  And that’s for Stage IV triple-negative breast cancer. And probably in the next three weeks, we will have a HER2-positive breast cancer study opening. So, we’ve got about four to five trials opening, I’m hoping, before the end of the year.  And, as I said earlier, always looking for any other diagnosis. 

Dr. Vaughn:  So, remind me again, how we keep all that together, because that’s juggling a lot of different trials.  How do we select, or how do we know who would fit? Because we hate to miss the opportunity for a patient.  I know we talked about multidisciplinary tumor conferences, which we – recently, I was bringing this up with our breast-cancer surgeon.  But not only that, patients that may be already in our office, you mentioned maybe some that already have advanced breast cancer, how do you guys keep it all together?  That’s a lot to juggle.

Susan: Well, I think we’re all very fortunate to have something called an EMR, which is an electronic medical record system.  So, everything is digital. And then, there’s another layer on top of that, that we have, called Onco Trials. And it really helps us screen.  So, the way it works is, if you have a diagnosis, let’s say, breast cancer, and it’s hormone-receptor positive, Onco Trials can see that, and they’ll – when I come in, in the morning, or Brenda comes in, it’ll say, ‘These are the patients coming in today, for whom we may have a trial.  Take a look at them.’ And we don’t just wait till that day. We look, usually, about a week ahead of time. And, as I said, earlier, we let the doctors know that we might have a trial.  

So, this screening software really has allowed us to screen literally every patient that walks through the front door.  It makes it much more accurate. We don’t feel like we’re missing patients, that there’s anyone that we haven’t screened, because I believe everybody should have the opportunity for a trial.

Dr. Vaughn:  Right.  That’s wonderful, because I was worried that, oh, my gosh, we may have missed an opportunity.  But it’s great to have technology work on our behalf, here, to capture everyone. Not that, I mean, there are other reasons why a patient may not be able to enroll in a trial, but at least we didn’t miss the opportunity to present that as a treatment option.  I think, as a provider, that’s something I always think I’d like to have, kind of a menu of options for patients. And a clinical trial is always one of the ones I talk about, if it’s available.  

Can you guys talk about the changes that you have seen, in the clinical trials, in our Research Department, here at HOAF, over the last few years?

Susan: Well, the physical space is greatly different.  There was a remodel, and an area has been designated, Research Office, and all of us can sit together.  Because, as you probably have concluded by now, we work very closely. And all of our research binders and notes and papers are with us, and we have a new, very impressive lab.  And a section of that lab is dedicated to research, so we can process our specimen. We have an area dedicated to store some of our research items, and I think that’s a testament to how the practice, as a whole, is really invested in research, in the traditional sense of investment, but also as a treatment, as yet another option for their patients.  And I think that just says it all.

Dr. Vaughn:  And that leads me into a question, is that, if you were to kind of map out the future of the Research Department, here at HOAF, kind of forward thinking, what are you looking at, next year, two years, five years?  Are we going to be, at our office in Stafford, for patients, offering trials at Stafford? Are we going to have two or three more Clinical Research Assistants? Trials for all tumor types? What do you guys think?

Susan: I would love to have research out of the Stafford office, because it would greatly benefit our patients who work up north.  So, I think that would be fabulous. And also, I think that we’re going to be offering trials in a different way, in the future, because we are getting involved with a new trial that is just a blood draw, and it will test for different biomarkers that Dr. Vaughn was talking about.  So, we might have 30 trials that we open, based on biomarkers. Research is so dynamic, I don’t know what it’s going to look like for us, in two or three years, but I know it’s going to be bigger.

Dr. Vaughn:  It’s going to change.  And it is — 

Susan: Sure.

Dr. Vaughn:  — it really is kind of the foundation for everything that kind of develops through research, and it’s going to keep changing, quickly.

Susan: And we are also very happy to announce that we’re bringing on another research nurse, Tammy, and she’ll be starting with us in the next couple of weeks, because we are opening these trials.  And we hope to accrue quite a few patients to them. I think that just shows our growth. And if we do a podcast next year, I’d like to introduce two more nurses. 

Brenda: And Tammy was an infusion nurse and then took a position as our oral oncolytic nurse and is now coming to Research.  So, she’s been with HOAF for many years as well.

Susan: Bringing great experience.

Dr. Vaughn:  Yes, a little diversity.  We do have a lot – which Tammy is bringing, a little bit of the oral oncolytic side.  We do have a lot of trials with oral oncolytics, so she’s bringing that expertise to the Research Team.  It’s also exciting, I think, rewarding, for me, you all have different kinds of backgrounds, in different areas of the practice.  And it’s exciting to see you guys grow and develop wonderful, new traits here. It’s research driven. 

Brenda: I think we complement one another, and we work well as a team.

Rebecca: Mm-hmm.  Yeah. We do.

Dr. Vaughn:  That’s kind of what I was going to finish up with.  How do you all get along? Seem like you do okay.

Brenda: I think we just like each other.

Rebecca: Yeah.

Susan: And we like what we do. 

Brenda: Yeah.  And we’re very good about, if Susan’s on vacation, and she – I may be the coordinator on some trials, but if I’m on vacation, she knows enough about my trials to be able to take care of any patients of mine that are coming in for the day, and vice versa.  And that’s just kind of how we run our department, is that we – if Rebecca’s not here, and blood needs to be processed, we can process blood. And so, we all can help each other out, if somebody’s not here, and it’s really – we have a good system.

Susan: We’re all in it for the patient.  I think that’s it.

Dr. Vaughn:  And patients see that.  I mean, it’s – having patients on trials and with you guys involved, there’s that camaraderie that they experience and feel.  So — 

Susan: Today — we have a patient going for surgery tomorrow.  And today, we all got on the phone, and we called her and wished her good luck tomorrow.  She was really happy we did that, I think.

Dr. Vaughn:  That’s wonderful.  And that’s one of the, as we talked about earlier, I think one of the benefits of being on trial, there’s a little bit of a special relationship that you may not get, if you’re off trial.

Susan: Mm-hmm.  I think so, too.

Dr. Vaughn:  Well, thank you, everyone.  As I mentioned earlier, this is something that is really dear to me, the Research Team and our Clinical Trials Department.  I think we’re going to continue to grow and excel and, as I mentioned, push the needle forward, for our patients at HOAF. So, thank you, all.  

Susan: Thank you.Brenda: Thank you.

Thanks for listening to Cancer Shop Talk: Behind the Diagnosis.  If you enjoy our show and want to know more, check out HOAFredericksburg.com; or leave us a review on iTunes.  Join us next month when we go behind the role of nutrition in cancer care.