Chapter 11: Research into Venous Thrombosis

Chapter 11: Research into Venous Thrombosis

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Description

Dr. Escalante explains that she is the Site Principle Investigator for a national study investigating how to treat blood clots in cancer patients. She explains why cancer patients develop clots and describes the results: the superiority of low molecular weight Heparin over Coumarin (Warfarin). Heparin is now standard of care and covered by insurance.

Identifier

EscalanteCP_01_20140603_C11

Publication Date

3-6-2014

City

Houston, Texas

Topics Covered

The Interview Subject's Story - The Researcher; The Researcher; Definitions, Explanations, Translations

Transcript

Tacey Ann Rosolowski, PhD:

All right. So we are ready to go. Okay. So we are officially recording now, and the time is 11:07, and this is March 14, if I’m remembering—

Carmen Escalante, MD:

May.

Tacey Ann Rosolowski, PhD:

May. May 14. (laughter) There we go. May 14, 2014, and I’m on the thirteenth floor of Pickens Tower in the Division of Internal Medicine, interviewing Dr. Carmen Escalante. This is our second session, so thank you for making time for me this morning.

Tacey Ann Rosolowski, PhD:

We kind of strategized a little bit beforehand, and we decided that you would finish up talking about your research this morning, and there’s your work on hypertension. So would you tell me how you got involved with that and what’s the character of the studies that you have worked on?

Carmen Escalante, MD:

Well, as part of general internal medicine, hypertension is a major focus for any general internist, but here, taking care of cancer patients with the use of these new class of drugs for cancer, one of the major side effects is hypertension.

Tacey Ann Rosolowski, PhD:

And what is the class of drugs?

Carmen Escalante, MD:

It’s the VEG-F.

Tacey Ann Rosolowski, PhD:

And that’s V-E-G—

Carmen Escalante, MD:

Dash F. I’m kind of blanking on the—

Tacey Ann Rosolowski, PhD:

I can look it up. (laughs)

Carmen Escalante, MD:

Vascular endothelium growth factor inhibitors. And TKIs or the tyrosine kinase inhibitors. And they commonly use these. There’s lots of new drugs coming out every day, especially in these classes, that seem to be effective in treating cancers, but the patients develop hypertension, and many times they can involve them needing more than one anti-hypertensive. Especially patients that already have hypertension seem to be even more susceptible than patients that come in normotensive, without hypertension.And when we first started seeing this, we got familiar with understanding that they may need three or four agents at times to control their blood pressure, and it’s very important so that they could continue to get the drug without, hopefully, either stopping or dose reduction. Of course, our main concern is so that they don’t precipitate other cardiovascular events such as stroke or heart attack, because the blood pressure can get really high.

Tacey Ann Rosolowski, PhD:

How high?

Carmen Escalante, MD:

Oh, it can get to what we call malignant hypertensive ranges, 240, 250. But what we generally do is the oncologists are familiar that before they start, they really need to make sure the blood pressure is in a normal range. Even that, though, with patients starting with normal blood pressure readings, they can get into really high blood pressures shortly, depending on the agent, within a week or sometimes several weeks, depending on the agent, and their blood pressure can get very high. And some are symptomatic and some are not, so you have to monitor it. Then we get them started on treatment. The question, interesting question is—and there’s some data now on that from the companies that have done trials before, looking at the blood pressure, but there was no data looking at once they stopped the drug, the blood pressure just doesn’t go back to normal. It takes a while. But there is nothing in the literature showing how long does it take, because many times there are three or four agents. And hypotension, or low blood pressure, can be just as bad as high blood pressure. So we have to carefully wean them off of many of these agents as they come off of them.We’re looking at some of the questions that we don’t know that will affect practice, like how long does it take for the blood pressure to get normal again? Are there agents that are more conducive to decreasing the blood pressure more effectively than others? There’s been some data to suggest that, but no real evidence. So, lots of interesting clinical questions about how we can better manage and better care for hypertension that commonly occurs while these patients are getting cancer treatment.

Tacey Ann Rosolowski, PhD:

Do you know, why is it that these classes of drugs actually raise the blood pressure to such degrees?

Carmen Escalante, MD:

Yeah. It’s the path of physiology of how it acts on the blood vessels and the constriction and related to then causing subsequent hypertension. So that pathway, there’s multiple thoughts about how it occurs. There’s at least three different thoughts about the exact path of physiology that attributes to the hypertension, and some of it also may be help in addressing the tumor, and the constriction of blood vessels to the tumor may be what’s effective in improving the oncologic situation. But on the other hand, it can cause hypertension and other cardiovascular side effects. So it’s trying to balance these things so that we can appropriately treat the blood pressure and continue them on effective therapy without having any significant mortality or morbidity from the cardiovascular side effects.So, you know, but there are a lot of new agents, because this group of drugs seems to be very effective for some cancers. So there are a lot of new agents coming out and some cause more hypertension than others, and they have varying timeframes until the hypertension shows up and they have looks like probably varying time ranges at the end result of coming off of the drug, and other interesting questions about how many agents, antihypertensive agents may be needed, whether certain agents may be more effective in treating the hypertension and questions related to those aspects. So that’s what we’re looking at, and we have a few studies going on.We’re also looking at the kidney side effects. Proteinuria, which is protein in the urine, and acute kidney disease, which means that with the kidney failure, kidney function, because these drugs also cause this side effect, and these also can be linked to hypertension. So initially, we’re doing some data mining to look at some of the patients that have already received these to get an idea of what’s going on. Hopefully, we can then design prospective trials so that we can see what we might be able to do better.

Tacey Ann Rosolowski, PhD:

I was going to ask you how you’re getting the information. I was wondering if maybe you were partnering with other clinical trials to examine for these side effects.

Carmen Escalante, MD:

You know, we’re working with some of the oncologists from the groups that used these. For example, Bevacizymab is used in GI oncology, so we have a collaborator working with us from the GI group, and then the renal cell carcinoma is commonly treated with these TKIs, and we have a collaborator from that group that we’re working with closely. But many times some patients are given these off trial, because they are FDA-approved, many of them, the older ones are FDA-approved for treatment, so they may or may not be on a clinical trial.

Tacey Ann Rosolowski, PhD:

Right.

Carmen Escalante, MD:

So there was a lot of searches through the pharmacy database, then collection. Because our record system is not completely electronic, so we can’t mine the electronic health record because it’s limited. So some of this, we can get some of the information from different data pools, but some we have to go into the charts and pull records. And hopefully that’ll change as we get into the new EPIC health record, but now it takes a lot of work to pull some of these. Some of these, you know, if they do have the data from clinical trial and they’re willing to share it, we can get some of the data from that record, but we also use the pharmacy database, we use the lab database, we use the institutional repository, another dataset, to pull different things, to help save some time.

Tacey Ann Rosolowski, PhD:

Right, right. You know, it’s funny, because when I first started hearing about the electronic medical records, I mean, I think ordinary folks just think, “Oh, yeah, I go to the doctor, and that means that my physician is going to type [unclear] into something,” or the physician’s assistant. You never think about the fact that actually that’s just the tip of the iceberg and this is a repository for very fundamental information to be studied.

Carmen Escalante, MD:

Right. And with the ClinicStation we have now, you can’t query it, so you can’t pull out things, you know, about what was all the blood pressure readings at the visits. So some of that we have to go in and pull it out. We can get cancer diagnosis, the lab variables, some of those kind of things from different databases. But some of the things, even basic things like vital signs, you can’t just pull that out of the system we have now. Now, I understand with the new system, we’ll be able to do that. But so now you have to—it’s very labor-intensive. You have to go in and pull out the blood pressure reading, and, thankfully, they’re in there now, and the date and lots of hand labor. (laughs)

Tacey Ann Rosolowski, PhD:

Right. I’m seeing work for a lot of fellows and graduate students. (laughs)

Carmen Escalante, MD:

Yes. Money, takes a lot of cost to do all that, huge costs.

Tacey Ann Rosolowski, PhD:

Huge amounts of time, yes. [unclear].

Carmen Escalante, MD:

You know, effort, to just put all this stuff together.

Tacey Ann Rosolowski, PhD:

Right. Interesting. Interesting.

Carmen Escalante, MD:

So we’ll be presenting some of our work at the multi-institutional—it’s called MASCC, Multi-Association of Supportive Care in Cancer, in Miami in June. It was accepted for an oral presentation. And I think we presented some at different venues before. But this is important for physicians managing hypertension in the community that may not see these patients as commonly as we do and may need education on how to look for these patients and treat these patients and understanding that this is a common side effect of these kind of drugs. So we’ve also provided some educational venues and trying to get some funding for CME that we can do online that people could access to learn more about this toxicity.

Tacey Ann Rosolowski, PhD:

Is there anything else that you—any other significant research at that you wanted to cover?

Carmen Escalante, MD:

I think we’ve already talked about the fatigue and the thrombosis, and this would be the three big areas, yeah.

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