Factors (comorbidities, social factors) can largely affect the success of therapies in daily practice, despite findings observed in clinical trials.
John Bossaer, PharmD, BCOP,Professor, East Tennessee St. University Bill Gatton College of Pharmacy, Johnson City, Tennessee met with Pharmacy Times in Phoenix, Arizona at the Hematology/Oncology Pharmacy Association (HOPA) Annual Conference 2023 to discuss updates on treatment regimens for solid tumor malignancies and the possible burden of interpreting clinical data, and more.
PT Staff: Solid tumor malignancies are historically difficult to treat—where does the current literature stand?
John Bossaer, PharmD, BCOP: We've made, I think, quite a bit of improvements in recent years in treating solid tumors with the emergence of immune checkpoint inhibitors (ICIs) in lung cancer, melanoma, and I think some of the really exciting data recently is in mismatch repair deficient, or microsatellite, unstable gastrointestinal (GI) malignancies, where potentially some of these cancers may rely less on surgery and more on drug. So we are making some improvements there. And like I said, in non-small cell lung cancer and melanoma, even in metastatic disease, we're seeing 5-year survival rates that we wouldn't have dreamed of, you know, 10 to 15 years ago.
PT Staff: What process should oncology pharmacists take to interpret clinical data most effectively?
John Bossaer, PharmD, BCOP: Interpreting clinical trial data is a burdensome task for the novice clinician. And like any skill, the more you do it, the better that you get. So that would be step 1 and I would encourage people just to engage more in critiquing clinical trial data, it also takes a really good understanding of the disease states. A really common potential flaw in many clinical trial publications is a control arm that isn't exactly a standard of care control arm and that can skew the results and make an average experimental arm look better than it than it really is. Because it's showing that improvement compared to something that may be substandard. And that, again, speaks to really understanding the disease state, it's been studied better.
PT Staff: How can pharmacists safely/strategically implement this data into a care plan?
John Bossaer, PharmD, BCOP: Well, you know, most practices, the next step was going to be if it's a brand-new regimen, or new drug is building an order set, or, you know, care plan into the electronic health record (HER). I think it's always helpful to go back and look at the methods and see of the study, whether it's in the FDA label, or in the Methods section, or even the supplementary appendix of the publication, to see: what were the criteria for dose adjustment? What were the exclusion criteria? That sort of stuff is alerted to prescribers. Patients with heart failure may be excluded from a certain study [but it] doesn't mean they can't be on that that regimen—but it is something that should be evaluated before that rolls out to that patient.
PT Staff: Is toxicity profile enough of a reason for the pharmacist to not recommend undergoing a certain treatment for solid tumor malignancy?
John Bossaer, PharmD, BCOP: We’re playing with some toxic drugs here in oncology. And of course, we're not going to give them to people that are healthy, we're going to give them to folks who have cancer. I think everyone's pretty aware of that. So, you know, if you're giving cisplatin or carboplatin, you have a good reason to do it and you're treating with curative intent most likely. I think that where the pharmacist’s role comes in when evaluating toxicity is trying to identify patients who are at a greater risk of toxicity due to organ dysfunction with their kidneys, their liver, drug-drug interactions, or even age and other comorbidities that might overlap with the drugs toxicity. So a good example would be a patient with diabetic peripheral neuropathy, who's going to receive a chemotherapy regimen that has drugs that can cause peripheral neuropathy as well, that would be an issue or flagged or raised to the patients treated physician.
PT Staff: How can a pharmacist identify the best appropriate treatment for an individual when considering particular toxicities and their unique circumstance?
John Bossaer, PharmD, BCOP: Well, that, you know, that speaks to really the 1 of the main roles of the pharmacist is making sure the drugs are used correctly. And in some malignancies, the only drugs that we have, they have a side effect profile. Not every anti-cancer drug or anti-cancer regimen works for all other malignancies. So I talked about this with trainees a lot. It's, you know, the, the novice learner thinks I need to know the drug of choice for this or the chemotherapy regimen, a choice for this. And then everything else is inferior to that the second line a second line for a reason. And that is true, but it's also worth knowing how much more inferior the second-best regimen is because sometimes that gap is very wide. And it's really a detriment to the patient to take that step down in therapy, perhaps to avoid a side effect. But sometimes, the second line is almost as good as the top recommended regimen. It's just maybe a little bit less effective or maybe it's more costly, or maybe it's got a different toxicity profile. And it could just be more burdensome to administer as well. This is not an oncology specific thing but it's like taking a twice a day drug for blood pressure versus a once-a-day drug. You don't always prefer the one today drug because it's easier. But if that once-a-day drug causes a side effect that this person is prone to that there's not necessarily a problem doing the twice a day drug if that's better for the patient.
PT Staff: How do social and economic factors (i.e. income, race, geography) impact the success of new therapies in a clinical trial vs. daily life?
John Bossaer, PharmD, BCOP: Oh, yeah, so the social, you know the patient’s social status is incredibly important. It's the first thing, like on rounds in the hospital, that our physicians will ask when they walk into a room and the patient's there by themselves. You know, one of the first things I ask is, “Do you live by yourself? Do you have someone who can help drive you back and forth to appointments?”
It's a huge barrier where I practice in northeast Tennessee, [which] is a bit of a rural area. So, for example, if we have somebody with a lymphoma, or leukemia, and we want to refer them to chimeric antigen receptor (CAR T) or for an allogeneic bone marrow transplant, they got to drive for hours, usually, to get to our referral center. And some patients have the ability to do that with social support and financially, and some don't. And that directly impacts the quality of care that they can receive, because they're so much of the best care that we offer. In this country, oncology is siloed. In the ivory tower academic medical centers, that's where we get a lot of this great research, but it is challenging for patients who don't have the financial means and the social support to travel to get that top quality care.
PT Staff: What is needed to overcome these barriers to treatment?
John Bossaer, PharmD, BCOP: Well, if I had the answer that question, we'd probably see some changes. I think for 1, it would take really a societal change. I think, right now, if you have a newly diagnosed cancer and there's a drug that's approved, an oral tyrosine kinase inhibitor (TKI) that costs 20 grand a month, usually we can get those things paid for with insurance and patient system programs. It's really hard sometimes to get a health care center to pay for a hotel for 2 nights. So a patient can come into town to be evaluated for CAR T or bone marrow transplant, only to pay maybe a couple 100 bucks to have someone drive them back and forth from appointments so that they can get care and be monitored so that we know that treatment is safe and that they're still in position to tolerate it going forward. So a lot of it is relatively simple stuff, but we don't have an infrastructure and a payment model to help patients with getting to appointments and helping to remind them how to take their medications. In our health care model, that stuff is not valued financially, whereas a new drug is valued financially because it gets paid for.