Case 2: CPX-351 Treatment for AML With MRC


Naval G. Daver, MD:Dr McCloskey, if you see such a patient, what are the treatment options you’re thinking of? This is a 70-year-old man and who has a known diagnosis now of AML-MRC [acute myeloid leukemia with myelodysplasia-related changes].

James K. McCloskey II, MD:I think this is a patient who we would certainly easily identify as a high-risk patient. It’s an older patient who seems pretty fit, comes to us in adverse cytogenetic abnormalities, and has already received prior hypomethylator. This is a patient who certainly is at high risk from complications from his disease and requires a long conversation about the fact that this is high-risk disease and that even with all of the treatment options at our disposal, his prognosis is poor. What are their priorities? What is important to them from a quality-of-life standpoint? In general, for a patient who’s fit, who is eligible and interested in intensive chemotherapy, this is a patient who we would treat with Vyxeos. Again, when I sat down with that patient, my conversation with him would be that we really do have randomized phase III clinical data to support the use of this drug for this particular patient with AML arising from a prior hematologic malignancy like this.

Naval G. Daver, MD:Are you doing this routinely inpatient or outpatient to start the treatment? As you know, people do it differently; what has been your practice? Then also, Drs Gergis and Rizzieri, what do you do?

James K. McCloskey II, MD:I think we were very fortunate to be involved with the phase II and III clinical trials with Vyxeos, and in the phase III study we were actually very conservative. We treated all of our patients during induction and consolidation inpatient. The drug is a 90-minute infusion, as we’re going to talk about, on days 1, 3 and 5. It immediately raised the possibility that this could be delivered outpatient instead of a continuous IV [intravenous] infusion like we use in 7+3 [cytarabine/daunorubicin].

For us, like many of my colleagues, we’re fortunate to have a very large infusion center. We have a large transplant program, so we’re able to support our patients outpatient, and we actually had already piloted an early discharge program with 7+3 [cytarabine/daunorubicin]. Once the drug was commercially approved, we put in place a protocol to select the patients who might be eligible for outpatient induction. This included things like living in close proximity to the hospital, having a caregiver, not having certain other comorbidities, and then for us to hold a bed in the hospital that we often share with our transplant teams. We felt we could reliably bypass the [emergency department], and it has been feasible for us.

I would say that most of our patients are still treated inpatient, and that’s often their preference because patients are often quite taken aback with this new diagnosis and feel more comfortable being in the hospital. However, it is feasible with great caution and understanding that these patients require a lot of support while they’re outside the hospital.

Naval G. Daver, MD:What about you, Drs Gergis and Rizzieri?

Usama Gergis, MD, MBA:Just like Dr McCloskey mentioned, the initial induction chemotherapy, we’d prefer to be inpatient. After all, these patients have a 10% mortality in the first month or so. In the phase III clinical trials, half the patients received the drug in the consultation as an outpatient, so we follow this. My institution is in Manhattan. If this patient lives in the Upper East Side, with an infusion unit that we have open almost 16 hours a day, in the right patients, we can even do the induction. This patient is probably known to us, had this diagnosis, MDS [myelodysplastic syndrome], for a year and a half, so in a few patients, we have done the inductions in outpatient.

Naval G. Daver, MD:In a minority.

Usama Gergis, MD, MBA:In a minority, of course.

Naval G. Daver, MD:Right, in general, inpatient. Anything different, Dave?

David Alan Rizzieri, MD:I would echo that. I do think with our emerging understanding of the biology and the impact of the things supplementary to the diagnosis in chemotherapy that may impact outcome, I would expect more and more outpatient in the coming decade. As an example, number 1, what is the impact of exercise for the patient’s recovery and the impact on disease? That’s an emerging area of research that I think may be important. I think the outpatient setting is tougher for our patients. As we know, they have to get up every day and they’ve got to get back and forth to the center. That by itself is exercise, and so I think that’s important.

The other aspect is the impact in the microbiota of being outpatient versus inpatient. The emerging data on minimizing the protonations in the microbiota may be very important to both response and other toxicities. There may be a significant push in the future, as you understand those factors more, to do more outpatient, when feasible.

Transcript edited for clarity.

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