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Daniel George: Hi, I'm Dr. Dan George, professor of medicine and surgery and co-lead of the Duke Cancer Institute Center for Prostate Urologic Cancers. And I'm here today with two of my closest friends and colleagues on how we manage and operationalize PLUVICTO therapy here at Duke. And so I'm going to start with just the scenario of a patient, a patient that we've identified as a good candidate for PLUVICTO, and never mind the specific details at this point in time. How are we going to get that patient on treatment? How are we going to manage that patient on treatment and exactly whose role is it to do what? And that's really what we're going to cover today. So let me start with my first call. When I identify a patient who is going to get PLUVICTO, I reach out to our nurse navigator, our PA actually who coordinates this, Kristen Davis. And Kristen, when I send you a message, patient X is a good candidate for PLUVICTO, what do you do next?

Kristen Davis: Well, I of course look at the patient. I do look at their labs, to make sure no one's trying to sneak anything through, make sure that they have their scan. A lot of our patients have outside scans, so we'll need to get that pushed into Duke so that can be reviewed by our nuclear medicine team. And then I check for other comorbidities or make sure they've had chemo or if not, the reasoning behind that if they're not a good candidate. So once we have that in place, we have the scan at Duke, then I send that to the head of our PLUVICTO program in nuclear medicine so that he can review that scan and agree that that patient will be a good candidate for PLUVICTO.

If for some reason he does not agree with PLUVICTO, then we can have that discussion with the physician and move to the next plan. So once he agrees, then I compile all the clinical information and I send that to what's called our high impact committee. And that involves people from our insurance team who review insurance, obtain authorizations as needed, our reimbursement team, and then our medical necessity team. And so they are also reviewing the patient, covering NCCN guidelines. And once all that's been done, then I receive an approval notification for that patient and then we can move forward with scheduling.

Daniel George: So it sounds like a lot of internal steps, but I'm imagining that can go relatively quickly.

Kristen Davis: Sometimes it can and sometimes, depending on the patient's insurance company and how long it takes to get an authorization, that can be upwards of two weeks sometimes. So,-

Daniel George: So what's, I'm sorry, but what's the contact with the patient now? Are you calling the patient during this process and how do you kind of keep them informed of where we are in the process?

Kristen Davis: I do contact the patient, especially if there's a scan that we're waiting for, just so they know the process. I will typically talk to them as well once they're sitting with the high impact committee so that they understand. And then if a week's gone by and we haven't had an approval, I check in with the liaison through that committee and then update the patient. We're still waiting for insurance authorization or whatever the holdup might be.

Daniel George: Got it. So once that committee approves, once the insurance approves, then what happens next?

Kristen Davis: Then I talk to my cohort in nuclear medicine, the coordinator there, and we look at if the patient's had chemo, when do we need to schedule that? Because we typically give a four-week interval between chemo and the first PLUVICTO. So we want to make sure we cover that. We're looking at where the patient's coming from, when they need blood work, and when, of course, the first dose is available through the company, and then either that coordinator or I will contact the patient with that first treatment date.

Daniel George: Got it. So at that point, it's sort of depending on access with the company, when we can get that drug in.

Kristen Davis: Right.

Daniel George: And then some of the logistics in nuclear medicine.

Kristen Davis: Exactly.

Daniel George: So with me as well is Sarah Wood, a nurse practitioner who's been with our group for many years. Sarah, welcome.

Sarah Wood: Thank you.

Daniel George: So Sarah, when do you get involved in this process? Because for us at Duke, our APPs do the bulk of the management of the patients who are on PLUVICTO, and it's extremely helpful and leveraging for us on the physician side to have people we can trust to do that. So in that process that Kristen described, when do you come in, and what do you see as your roles in this process?

Sarah Wood: I usually start at day one. So when they're coming in to get their first treatment, I see them usually an hour or so before they're about to get their first treatment, double-check their labs, talk to them about how they're doing, assess them, and then just go over the teaching that's already been done by Kristen and is about to be done again in nuclear medicine, but it never hurts for them to hear it about four or five times. So I go through all of that again and get them ready, make sure they know how the process goes, where they're going to go, how they're going to get there, and remind them that they'll be getting labs in about three weeks and then the week before they get treatment again and they'll see me again before the next cycle of treatment.

Daniel George: Got it. Got it.

Sarah Wood: So usually, I see them on their treatment days.

Daniel George: And what are some of the top three or four things to educate the patients about? I know there's a lot you go through, but just to distill it down, what are the things they absolutely have to know about PLUVICTO on day one?

Sarah Wood: I think the radiation precautions are really important, that they're going to have to kind of stay away from people for about three days or at least keep their distance by about three feet. They need to drink plenty of fluids because it is cleared through the urinary system, so they need to drink plenty of fluids. They could get a dry mouth or dry eyes, so they need to watch out for that. And then potential toxicity with the bone marrow. So we'll be checking their CBC to see if there's any effect on that. I think those are the big four.

Daniel George: And then, as we're going through this process, we're treating patients every six weeks, so potentially only seeing them on an every six week basis. What are some of the symptoms and signs that you look for, for either the treatment working or maybe the disease progressing that might make you reassess the patient a bit early?

Sarah Wood: Well, if they're having increased pain, sometimes that's a good thing. Sometimes that's a bad thing. So it kind of depends. Is that accompanied by more weight loss? Is their appetite improving or is it decreasing? What's going on there? Because that would matter. Just in general, how their ECOG status is doing, how their performance status is doing, how they're getting around in their day-to-day life, if that's improving or not improving. I mean, what their PSA is doing is sometimes helpful. It's not always helpful. Sometimes it rises through the first couple of cycles and then drops. So you can't count on that completely; you have to look at the whole picture. And then we do scan after cycle three before cycle four to get more information as well. And then Kristen is also checking in with them in between cycles to see how things are going.

Daniel George: And Kristen, you talk to patients in between cycles, so that week three labs, when they're getting checked. What do you counsel them around that? Because I imagine that we do see some cytopenias in that setting. And what are the things that you're looking for and what are sort of the flags to say, "I got to alert the physician here before the next cycle because we might not be able to give that next cycle?" I guess the week three and the week five labs.

Kristen Davis: Right. So, I mean, I think it's a lot of what Sarah said too. I do call them just to review their labs mainly if there are some concerns, their white count is down, their hemoglobin or their platelets are questionable. But I'm also asking about pain, about if they're getting off the couch, those kinds of side effects that we may or may not see. And if the cytopenias are significant enough where I'm concerned that treating them in three more weeks is probably not a good idea, then I will communicate with the provider team. We can always, and we have rechecked counts a week later, especially looking at those platelets, which can go down pretty fast once they start decreasing.

So, we have flexibility, of course, with monitoring them more closely. And I just explain to them really upfront and then reinforce that when I'm talking to them during treatment cycles, that we expect to see these changes and that's why we monitor you closely. So it's not that we might not be able to treat you ever again, but maybe when we recount or recheck, we're still not ready at your scheduled six-week dose and we're pushing that out to eight weeks or 12 weeks. And so just educating the patient that the treatment is still working, but it's taking a toll on your body and or your bone marrow, and we just need to reassess so that the long-term goal is to get you all those doses if we can and if we know that it's working for you.

Daniel George: And I think that second point is so critical. I mean, I think just to end on patient expectations, I mean, I think it's really the physician's job upfront to really set those expectations because there's a lot of hope out there and appropriately so for the benefits associated with PLUVICTO. But like any medicine, it doesn't work in everybody. And I think it's really important for patients to understand that as much as we hope this is going to benefit them, we don't know that until we treat them. And as they go through treatment, and Sarah pointed out, PSAs may rise and then fall, but they may rise and they may rise and they may continue to rise and symptoms may worsen. And making sure patients understand that is really critical.

Kristen Davis: Yes.

Daniel George: Kristen, we've had more than one call together around patients that do need to transition to supportive care.

Kristen Davis: Right.

Daniel George: And those are really hard conversations, but they're especially hard if the patients are not prepared. At this stage, where patients have really exhausted a number of other therapies, it's really critical. And just how do you reinforce those expectations? And then when things aren't going well, Kristen, and you are referring a patient back to the provider for that kind of goals of care discussion, how do you frame that for people without kind of going through all of it?

Kristen Davis: So, I just try to let them know that this is what I'm seeing with their blood work, these are my concerns. And because Dr. George knows you so well, I think it's important at this time that we have you see him, talk to him, and make sure that we're still on the right path. And while we don't know everything by labs, we order those scans, and instead of doing it between three and four cycles, we might need to do it after the second cycle to really help us know if we need to continue or if we don't. So, I just try to reassure them that they have this whole team thinking about them and at each point, we're reassessing, are we doing the right thing? And I think they understand that.

Daniel George: I think that's great messaging. I mean, I think it's really important that we as physicians have the back of our staff, that when they do identify somebody with real concerns, that we can support that timely and compassionately because those are conversations ultimately, I think, that's done by the physician with the relationship, but we really rely on Kristen and Sarah to help us identify those transition points. So, okay, Kristen, one other question now regarding patient education. What's the most unusual question you've gotten so far from patients about to receive PLUVICTO?

Kristen Davis: Well, a very common question that I had to look into when it was first asked is, what about my pet? So many people have their dogs that they sit with, sleep with, they want to be around, and so what can they do with them? And of course, we don't have data on animals, but we have just equated them to the size of a child. And so we recommend, as much as you can, maybe try to separate. Jumping on the lap, a hug, of course, those brief interactions are perfectly fine and probably important for their mental health, but maybe not sleeping right next to them, just if they're very concerned about their safety.

Daniel George: Ferberize the dog; that's going to be harder than it sounds, I'm afraid. But that's a great question. Thanks so much. Thank you guys so much for what you do. Honestly, we've treated hundreds of patients here at Duke. There's no way we would have that kind of volume and management without your experience and your commitment. I hope other groups out there can find people like this to work with. It really does take a team, and there are other members of this team, including nuclear medicine, pharmacy, palliative care, and others, who are involved. It's really important to recognize the sort of multidisciplinary field that we're in here, but these two roles are really critical to the successful and scalable use of PLUVICTO in your practice. Well, thank you so much, Kristen and Sarah, for your time. I really appreciate you joining us today. And on behalf of UroToday, thank you very much.

Kristen Davis: Thank you.

Sarah Wood: Thank you.