Evaluating Clinical Pathways in mBC Treatment

Ryan Haumschild, PharmD, MS, MBA: As we talk about different treatment approaches for patients and organizations, we talked about this a little bit earlier, you have community oncologists who really aren’t experts in breast cancer. You have some specialists who all they do is breast cancer [and] precision medicine. A lot of times, organizations will develop clinical pathways. We know that there [are] some that are out there, like the Dana-Farber [Cancer Institute] clinical pathways and others. Clinical pathways are a great way to create standardization and approaches, but you still need to get more specific in terms of patient-centered care, right? Because not every patient is the same within a clinical pathway. We see it rolled out through a lot of large community oncology practices, some large academic and NCI [National Cancer Institute]-designated comprehensive cancer centers. Dr DiMarco, if you could, maybe compare the benefits and even limitations of using clinical pathways vs traditional treatment approaches in the management of metastatic breast cancer, considering the factors of treatment response, some of the toxicities, and even some of the cost-effectiveness [factors] that are taken into consideration?

Rose DiMarco, PharmD, BCPS, BCOP: Absolutely. You’re 100% right. Pathways are excellent for standardization. They are a dream for getting evidence-based decision-making right at the physician fingertips, but they are only as good as they’re built. Depending on if you make your own pathways or you’re outsourcing them, sometimes you don’t have any input on what goes into those pathways. Luckily, for the most part they are based on NCCN [National Comprehensive Cancer Network] guidelines and available data. But if you make your own, you can tweak them to add in some cost-effectiveness or cost-savings initiatives, quality initiatives, whatever your institution is trying to prioritize. But another piece of that, which is harder to fix, is that if the physician isn’t staging appropriately or if they’re not documenting that stage appropriately, then the pathways aren’t going to lead you to the right decision. That is so crucial. At least for us, our pathways are integrated into our EHR [electronic health record], they feed in through our treatment plans for IV medications—but for oral medications that doesn’t exist. We have built some out to see how that would work, but I’d be interested to hear what it’s like at your institutions. But I don’t think that user ability is there for the oral treatment plans the way it is for IV, and that’s really impacted the way we use pathways for the oral treatments. In a dream world, it would flow seamlessly, and people could input the comorbidities, the patient’s social status, and all of those things into the pathways to get a decision. But ultimately it still needs to be a person looking at a patient and figuring out what the best drug is for them. But I would love to see how you guys are doing it at your institutions because it’s a huge struggle for me.

Ryan Haumschild, PharmD, MS, MBA: If you want to chime in.

Heather Moore, CPP, PharmD, BCOP: Yeah, we actually don’t use pathways…more so because of the concern [that] you’re just skipping over some of the personalized components. What we found is that we prefer when we’re seeing patients, when they’re in clinic, that we’re making that decision based off of their disease but also the patient who is in front of you. [Making sure you’re] thinking about things like comorbidities, lab values, other medications they may be on, or their own personal preference in terms of goals of their care. We actually do not utilize pathways at our main campus.

Ryan Haumschild, PharmD, MS, MBA: We actually have started utilizing them to build them out within our EMR [electronic medical records]. We’ve started with IV therapies, and we have transitioned to orals. There [are] definitely limitations that we have to work through, but it’s a huge project of ours because so many times we look at the IV components and sometimes someone could be mismatching orals that aren’t appropriate. We don’t have that rigor and structure to it because it is being sent through the prescription phase. Or maybe there are certain lab values left off, or even as we’re targeting things like ESR1 [estrogen receptor gene] or other mutations. Now we’ve built it out together, and we’re starting to build that infrastructure both for the orals and the IVs. I’ve seen huge improvement with it. But a lot of it, you must have really great engagement with the digital team to make sure that things are flowing appropriately because there’s nothing more frustrating than when a provider tries to initiate an oral plan and it doesn’t work the same way as an IV, and then they give up altogether.

Rose DiMarco, PharmD, BCPS, BCOP: Yes, I’m sweating thinking about that.

Ryan Haumschild, PharmD, MS, MBA: Well, it’s interesting, and there are so many different new agents coming in in this area. [With] HR+/HER2- metastatic breast cancer, there’s a lot coming, especially new targeted therapies. Dr Moore, you hit on this elacestrant targeting ESR1 for certain patients. If you could, how will the impact of the treatment landscape continue to evolve, and what will be the impact or how will these be used in combination with CDK4/6 [cyclin-dependent kinase 4 and 6] inhibitors?

Heather Moore, CPP, PharmD, BCOP: Yeah, that’s a really great question, which we could talk about all day. But in short, our goal is that we’re using more targeted therapy. We’re hitting on the PAM [PI3K/AKT/mTOR] pathway, the utilization of PI3K inhibitors. ESR1 degraders; capivasertib will likely be approved at the end of the year; thinking about an AKT [protein kinase B] inhibitor. It’s really having more of an individualized focused therapy for patients. Just like we added CDK4/6 inhibitors to endocrine therapy, I anticipate that some of these [ongoing] clinical trials…[will soon result out]. But thinking about combination, thinking about oral SERDs [selective estrogen receptor degraders] in combination with CDK4/6 inhibition. As some of these agents roll out, I anticipate that we’ll look at combinations of these therapies. And I’m always going to bring this up because we’re pharmacists: When we’re thinking about that, [we need to be] thinking about toxicity management. It seems to me that as these drugs continue to get approved, the toxicity profiles associated with them become more complex. It really does absolutely require the intervention of clinical pharmacists within that setting. It’s being mindful of the toxicity profile, but also thinking about it from a financial standpoint. When you think about the cost of elacestrant and the cost of CDK4/6 inhibition, that’s almost $40,000 a month for those 2 agents. How do we realistically implement that? That’s where going back to studies like the SONIA trial [NCT03425838], when do we need to do that? When are we doing more harm than good? You want to make sure—going back to efficacy, are we seeing the overall survival? Are we seeing the progression-free survival? We want to make sure that when we’re adding these other agents in, from a toxicity profile and efficacy standpoint and financial toxicity, does it make sense to do that? But I am encouraged. It’s awesome that as we continue, we have more treatment options for these patients. When we think about something that otherwise was just endocrine therapy or chemotherapy, we now have targeted agents. We’re looking at antibody-drug conjugates before we’re going to chemotherapy. Chemotherapy just keeps getting kicked down the line. That’s helpful from a treatment standpoint for patients, just giving them those additional options.

Ryan Haumschild, PharmD, MS, MBA: It’s an exciting time with additional options that are still available, and hopefully this provides great hope to our patients, better outcomes, and longer durations of treatment.

Transcript is AI generated and edited for clarity and readability.