Beyond Clinical Trials: Mastering Patient Care for Lutetium-PSMA-617 Therapy - Michael Morris

May 2, 2022

Alicia Morgans speaks with Michael Morris about the practical considerations for the clinical utilization of Lutetium-PSMA-617 outside of a clinical trial setting. Dr. Morris emphasizes the necessity of a well-coordinated, multidisciplinary approach to patient care, ensuring each team member understands their role in the process, from handling patient safety checks to maintaining communication with the patient. He explains the importance of having clear, pre-arranged workflows and regular meetings to effectively manage the increasing number of patients requesting this therapy. Dr. Morris also highlights the significance of establishing appropriate relationships and having a 'playbook' to deal with the influx of patient inquiries about Lutetium, many of which may be better suited to other treatments or research programs. The discussion underscores the crucial role of meticulous planning, coordination, and consistent communication in providing effective and safe patient care.


Michael Morris, MD, Prostate Cancer Section Head, GU Oncology, Memorial Sloan Kettering Cancer Center, New York, NY

Alicia Morgans, MD, MPH, Genitourinary Medical Oncologist, Medical Director of Survivorship Program at Dana-Farber Cancer Institute, Boston, Massachusetts

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Alicia Morgans: Hi, I'm thrilled to join you today from APCCC 2022 in Lugano, Switzerland, where I have the opportunity to speak with Dr. Michael Morris, who's a professor of medicine at Memorial Sloan Kettering, as well as being the prostate cancer section head. Thank you so much for being here with me today.

Michael Morris: Thank you, Alicia, for having me.

Alicia Morgans: I appreciate you because, for many reasons, but one of those, is that you have extensive experience with Lutetium-PSMA-617, and how to really get that to patients, not just through a clinical trial. And so, the real clinical utilization of this drug can be different than it is when we coordinate things through a trial. How would you describe your process at Memorial, and what should we consider as we're kind of ramping up the use of this drug?

Michael Morris: Well, I think most patients are going to either self-identify, or be identified by their medical oncologist, as being a candidates for this treatment. And the greatest challenge about Lutetium and other radioligand therapies is really then, how to keep the patient safe and the process efficient, as you navigate that patient through the process of getting a treatment that's either going to be delivered by nuclear medicine or radiation oncology, depending on the center. And having those relationships in place before the patient walks through the door, so that it's not the patient who is testing those relationships. And then figuring out ahead of time, who's going to assume responsibility for what aspect of the patient's care over the course of the patient's treatments? And what's really important is that that be as tightly integrated as any other shared care model with patients with any other department or service.

So knowing, for example, what the patient flow will be through whose clinic. Who will do the safety checks on the patient, in terms of counts, there are post-treatment counts? Who's going to maintain the patient, in terms of their other medical issues, be those, the whole variety of supportive care issues that the patient might need? Because remember that these patients generally will have pretty advanced disease. Who's going to do the follow-up? Who's going to do the receiving of the phone calls if the patient has questions? All of that needs to be worked out ahead of time, so that when those first patients walk through the door, everybody knows what they're doing. Those relationships between, not just physicians but apps, nurses, supports and administrative staff, everybody knows where the flow will go.

Because remember, it's not the doctor that the patient's going to be talking to when they call the next week with a question. The support staff and the administrative staff needs to know as well. Where does that question get directed to? Who's the right department? So those relationships and those workflows should really be sorted out ahead of time.

And then I think, that it's quite useful to have regularly scheduled, either weekly or even more, meetings between the medical oncologists and their staff, and the nuclear medicine folks and their staff, to run through the list of patients who are either being treated that week, or who are in follow up, so that everybody gets tracked. And it really is a multidisciplinary care team that's been created around radioligand therapy.

Alicia Morgans: I think those are some great points. I remember when we first started using Lutetium at Northwestern, for example. We had to figure out, who puts in some fluid and anti-medic orders? Which is not something that's typical of the nuclear medicine team, but they may be used to double-checking a CBC that we order through medical oncology, and we're looking at too, but they also want to do a double check. So this is important for patient safety. And also, as you said, when patients call in, who do they reach on the end of that phone, or who gets the message that they send through their patient portal? Maybe if it's related to, what are my restrictions, in terms of potential radioactivity, and engaging closely with others for the next few days? Talk to this person. Maybe if it's related to nausea or fatigue, they talk to this team. And how do we communicate that to the patient?

Michael Morris: And that's going to really vary site by site, in terms of how that model will work. There are some nuclear medicine department, in which the dictum will be, the patient is still the medical oncologist's to manage, and we are here. We're very well defined, well delineated role of treatment delivery. And there are other nuclear medicine departments that are going to say, "We will assume control of the patient for the period of time that they're on this therapy." And then, there are all the gradations between.
And I think, that the key is that, there's not going to be a one size fits all for guidance to all centers, but the rule of thumb that applies to everybody is, work those things out, and develop an ongoing relationship, where you're really now a multidisciplinary team.

Alicia Morgans: I think that's a great comment. And to also circle back to one of your other comments about multidisciplinary care. You mentioned maybe a weekly meeting to continue follow up. I think scheduling is that six-week intervals, which is a little different than we do for other things. So having that weekly meeting kind of keeps us all on track, with something that may not be as normal for us.

But the other thing that we have to do, potentially as multidisciplinary teams, is identify patients. Because there are many patients who are interested in this therapy. They don't always meet the criteria by the label. And they may not meet criteria by safety, if they're very heavily pretreated, or just have advanced disease.

Michael Morris: Yeah.

Alicia Morgans: Do you and your team sit together too to help decide patients that might be moving forward with Lutetium? Because with the large numbers, and sometimes the requests that are not always the right requests, it can be complicated.

Michael Morris: Absolutely. And it really, it works much better whether it's from an appropriate use or a safety issue, for everybody to be marching in time with each other. You'll have patients who will want Lutetium for an inappropriate use, or if not inappropriate, at least unlabeled. And it's good to have everybody on the same page when you're messaging to the patient, no, we're not going to do this.

By the same token, there're going to be patients for whose counts might be nattering. Remember that there is around a 10% grade three or four hem tox associated with this. So decisions about, should we re-dose? If so, should we reduce dose? Should we delay treatment? Should we keep going? Should we stop? Should the goals of care be changed? Everybody has to be on the same page. And although treatment is only at once every six weeks, let's say you're treated between, let's say, three patients per week. Well by week two of opening your program at your center, you'll have six patients to follow, and then nine, and then 12. And the numbers will balloon, and you have to have a regularly scheduled meeting. Even if the treatment is only every six weeks, the cadre of patients who are going to be followed just gets larger and larger. And at some point, of course, will reach some plateau, but you have to have some regularly scheduled method of communication around that.

Alicia Morgans: I agree. And the safety issue with the cytopenias is one that I think we do need to keep a close eye on, just because these patients, some of them have been so heavily pretreated, and their marrow can be full of cancer as well. So lots of things to keep an eye on.

So what advice would you have, other than really working things out in advance, and then using this multidisciplinary approach? Are there other thoughts that you would lend to people, things you wish you had known as you were trying to set up your program that you can share?

Michael Morris: I think that there's a huge amount of patient enthusiasm right now. And we've gotten so many calls for Lutetium, for patients who see this as a new and exciting therapy, and think that it's for them. Everything from patients who have localized disease to a biochemically relapsed patients. The key is to be able to... There's so many patients calling about this therapy, you may end up saying no five times for every yes.

The key is to also, as a team, recognize that those patients may be completely appropriate for other research programs, or may have concerns about existing standards of care that need to be addressed. And I think that it's very useful for everybody to understand what the answers are to those patients. You don't want those patients to be lost to follow up. You don't want them not to go onto appropriate clinical trials. You don't want them to be denying themselves potentially curative standards of care because it's not Lutetium. So having a playbook for everybody on the team is very important. Many of those calls won't go to the oncologist, they'll go to the nursing staff, the administrative staff, the research staff. I think that's really important to have every member of the team prepared to deal with those circumstances and eventualities beforehand.

Alicia Morgans: I think that's great advice. I think the number one message here is, be prepared, work together in a very structured and coordinated fashion. So, thank you. Very practical tips.

Michael Morris: Thank you. And don't forget the diagnostic component.

Alicia Morgans: Yes.

Michael Morris: Somebody's got to read those scans. The patient has to get a PSMA scan. If you're not in a center that does PSMA scans, then those relationships with local radiology centers need to be developed as well. Somebody has to assess that scan in terms of eligibility. So there's the whole diagnostic piece that can't be forgotten.

Alicia Morgans: So coordination, coordination, coordination.

Michael Morris: Yes. But ultimately, it's well worth it. It's a good therapy. And I think that it's, anytime you get to work as a team in a much more consolidated way, that's generally professionally more satisfying, and ultimately, better and safer for patients.

Alicia Morgans: I could not agree more. It is actually just, it's fun-

Michael Morris: Yeah.

Alicia Morgans: ... to work together.

Michael Morris: Absolutely.

Alicia Morgans: And to do the right thing for patients. So thank you so much for sharing your expertise. We appreciate your time.

Michael Morris: Thank you, Alicia.