Dr. Brittany Davidson, MD, a GYN oncologist, talks about oral chemotherapy, patient-centered research, and how patients feel when they’re going through cancer treatment.
Interview conducted by Ivanhoe Broadcast News in May 2022.
Why was oral chemotherapy an area that you and your colleagues wanted to study?
DAVIDSON: We have been fortunate in the realm of gynecologic oncology over the last 10 to 15 years that we have – our research has really made available some more orally available drugs for these patients. And when patients are in clinical trials for these drugs, there’s a lot of support. There’s clinical research coordinators and study team reaching out all the time and assessing their adherence, any challenges they have. They are very well supported, but we know that that’s not real life. That’s not how our patients in general interact with their disease and their treatment. We did this study for a few different reasons, one of which was to say, what is the patient experience like when they’re taking cancer directed therapies orally at home? We know that in other disease processes that adherence is challenging. We know that in hypertension and diabetes. We wanted to know if that was the case in cancer. And several of my partners said, well, it’s not going to be a problem. These patients have cancer. So of course, they’re going to take their treatment. But what we found was that, yes, some of our patients were able to do it well, but there were some patients that still had challenges. If we can understand what those challenges are, then we can help support our patients through that to maximize adherence and then ultimately maximize the benefits for their cancer. That was sort of the thought process going into this.
What did you find?
DAVIDSON: Our study was twofold. The first part was 100 patients and we surveyed them on their adherence. There are some validated survey tools that we used to really assess what their week looked like. We recognized that about 50% of patients took their doses of their drug like clockwork and didn’t miss a single dose in the last week. But, we found another 25% or so missed one dose in the past week. Then another 25% or so missed more than one dose. What we don’t know are the implications from a cancer perspective. This tells us that adherence is still a problem, cancer, or no cancer. Then the second part of the study was that we wanted to do some interviews of patients to really understand how they felt about orally available cancer treatments. That was interesting.
When someone misses one or two of their treatments, what’s the risk? What happens?
DAVIDSON: We don’t know. Even in big clinical trials, there historically has not been a lot of emphasis on adherence. So, we don’t know. Maybe it’s not a problem to miss one dose. But if that one dose becomes two doses or three doses, one could surmise that there’s probably going to be an oncologic consequence. We don’t know right yet.
What were some of the challenges?
DAVIDSON: One thing was interesting, because before we surveyed before we interviewed the patients, we interviewed my colleagues to say, “what do you think patients are going to say about their oral medications?” and “What is going to be the No. 1 barrier for them?” My colleague said across the board, it’s going to be financial. That these drugs are expensive and it’s going to be hard for them to get refills. They’re going to miss doses because they can’t get the drug on time. Things like that. That did not come up in patients. Some patients really loved the quality of life that having orally available drugs allows them potentially less frequent trips to the doctor’s appointment, certainly not having to sit in infusion rooms for hours at a time. That was a big benefit for patients. One thing that was interesting, though, was that patients talked about this transition of responsibility for treating their cancer. That on traditional chemotherapy they would come into the cancer center. A nurse would give them their I.V. infusion. The responsibility was sort of external. Now suddenly, their cancer outcomes were potentially reliant on how they were able to take the drug at home. Some of them felt very overwhelmed with that transfer of responsibility to themselves. That caused some anxiety.
Were there other findings that surprised you?
DAVIDSON: I think that was probably the biggest one. I think another thing was that some patients reported, that because for some instances orally available anticancer treatments allowed them to go longer in between doctor’s appointments, and they missed seeing their providers. They felt detached. They were used to seeing them every three to four weeks. For some maybe endocrine therapies we may be seeing them every three months. That was stressful to them. They liked coming in more frequently to get checked out and have that reassurance. We’re thinking about, how we can maintain lines of communication using telehealth and the electronic health record so that patients don’t feel disconnected when they’re taking orally available anticancer treatments.
Now that you have the information from your patients, what’s the next step? What do you do to try to address some of them?
DAVIDSON: I think the first step is recognizing that not every patient is adherent. You can’t just assume they’re taking the drug because you prescribed it or because you know that they filled it, right? Explicitly asking patients, “how are you doing with this medication?” and “On average, how many doses do you think you miss in a week?” Really setting the expectation that some patients struggle with it and that’s OK. We want to know if you struggle with it so that we can help you. I think the first step is recognizing that there is the potential for non-adherence. We must sometimes draw that out of patients or explicitly ask about that. Because, if a patient’s not taking their therapy, of course, we can’t expect it to work to shrink their cancer.
Could you estimate a cost? Are some covered by insurance?
DAVIDSON: It’s so variable depending upon which drug we’re prescribing, depending upon the insurance coverage that some patients have. For some of these newer drugs, while insurance may not cover it or their out-of-pocket may be very high, there may be drug assistance programs through the pharmaceutical industry. It’s very, very variable. But I can, anecdotally, I have a patient who was going to start an oral PARP inhibitor last week and it was going to be covered by her insurance, but she had to first pay a $3,000 initial deductible. Then it would decrease over time. However, that’s a big chunk of change to lay out there. That is one of the challenges with getting initial access to these medications is cost. However, that does not seem to be at least a patient-identified issue for them.
Are you able to speak to Deborah’s case a little bit? She’s a survivor of not just one, but two cancers that were not related.
DAVIDSON: Not related. Correct. She is a patient who has a low-grade ovarian cancer, and low-grade ovarian cancers traditionally do not exhibit the same sort of chemo sensitivity that some of the higher-grade garden variety ovarian cancers exhibit. During the initial courses of her treatment, she did have chemotherapy. So, she had experienced the long infusions, the back and forth. Then, when her cancer unfortunately recurred again, we had this new data in her particular kind of cancer that demonstrated some efficacy. We sat down together, and I said, “We have this new option. Let’s talk about why you may or may not want to give it a try.” After this, we talked about risks and benefits and what was important to her, and she ultimately decided to give it a go. She’s been on it for quite some time. There have been some bumps in the roadside effect wise. But for the most part, she’s done beautifully. If COVID hadn’t happened, I would expect that she would be traveling and ballroom dancing and living her life and going to the theater. Overall, her quality of life has been very good on these oral agents.
The oral agents are something that are that new for ovarian cancer, do you know the name of her particular?
DAVIDSON: Yes, she’s on a drug called trametinib. Even when I was a fellow, and I graduated fellowship in 2016, these drugs were not available. Even in the last five to six years now, there’s now randomized clinical trial data that demonstrates efficacy of this drug, the trametinib, in low grade ovarian cancers. This is a relatively new opportunity for these patients like Deborah with its own set of side effects and toxicities but for the right patient could potentially be not only an efficacious cancer treatment strategy, but also one that can provide them with an improved quality of life.
This is a recurrence?
DAVIDSON: This is a recurrence.
Is it a low grade?
DAVIDSON: That’s a great question. Her ovarian cancer markers, the CA-125 are coming down. GYN in cancers in general when they’re first diagnosed are given a cancer stage. When they come back, we don’t restage them. We just tell patients that they’re recurrent. She has a recurrent ovarian cancer. The other part of cancer that’s important is sometimes the grade. When we think about ovarian cancers, we dichotomize them into two groups. There’s low grade, which is what Deborah has, and then there’s high grade cancers. Those ovarian cancers are what people think about when they think about ovarian cancers. That they have very low five-year survival rates, high, high burden of symptoms and are potentially deadly. Low grade ovarian cancers, again, which is the cancer Deborah has, are much more known for this sort of longer indolent course. Women live longer with the disease. Because they’re not quite as biologically aggressive, that’s why they are not as chemo sensitive. That’s why targeted therapies like this trametinib can be really helpful. What we’re learning about them and there’s even a clinical trial right now to understand if there is even a role for chemotherapy, or do we just more targeted therapies?
Does this signal a new thought in how you treat these cancers?
DAVIDSON: Yes. With increasing knowledge of the biology of the cancer and what pathways are broken, we can better identify, or we can better match the cancer treatment to the patient and their particular cancer instead of chemotherapies, which are cell agnostic. They hit all the cells in the body. As we learn more about the molecular issues with cancer, we are hoping that we can better target our drugs to the cancer not only to improve cancer outcomes, but hopefully also to minimize side effects.
In your study, were those patients just ovarian cancer patients?
DAVIDSON: They were not. Any gynecologic cancer that was on an oral cancer strategy. We had some patients on oral endocrine therapies, this trametinib, another big cohort was a class of drugs called PARP inhibitors, which were first FDA approved in 2014. It is still less than a decade since we’ve had our first FDA approval for those.
What are the next steps from this research?
DAVIDSON: The next steps from this research for me are how we implement the assessment of adherence into our clinical practice, No. 1, and being thoughtful that it’s not a one size fits all. Just because we have one patient who is great at working her cancer treatment doses at home into her daily life, that that may not be the same for each patient we encounter. We won’t know if we don’t ask. To me, that is the most important thing. The other piece of the puzzle is we don’t know yet does it matter if you miss one dose versus four doses in a week? We don’t know if that’s going to have an outcome on cancer survival rates. I think that would be hard to study. Just because it’s hard doesn’t mean it’s not worthwhile. To me, that is the next step of this.
Anything I didn’t ask you that you want people to know?
DAVIDSON: I think it would just be to communicate with your physicians. If you are on these medications or considering these medications. reach out to your doctor and ask these questions or let us know if you’re having trouble fitting these pills into your lifestyle, missing pills. We want to know about this. We want to be able to intervene on your behalf to make it easier, because we have the same goal. To help women live longer and better with their gynecologic cancers.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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