Nurses Adapt to New Hematology Advances and Approvals in Leukemia Treatment

Stephanie Jackson, DNP, MSN, RN, AOCNP, BMTCN

Treatments options for various histologies of leukemia are expanding with FDA approvals for drugs such as the combination of ivosidenib (Tibsovo)/azacitidine and the chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel (Tecartus).^1,2

“I’m excited about seeing many of my patients living much longer and being able to have treatments like CAR T, we’ve done a few of the [allogeneic CAR T-cell therapy] alloCAR T treatments here [at UCLA as well],” Stephanie Jackson, DNP, MSN, RN, AOCNP, BMTCN, said.

Jackson, a certified oncology and bone marrow transplant clinical nurse specialist and unit director at UCLA Medical Center, recently participated in the 6th Annual School of Nursing Oncology Meeting by presented on advances in the treatment of leukemia. In an interview with Oncology Nursing News® she discussed the role of nurses in delivering and educating patients on these pivotal approvals.

The FDA recently approved ivosidenib/azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with IDH1 mutations. Have you used this in your practice? What should nurses be aware of regarding the regimen?

Yes, we are using this in our practice here at UCLA. The 2 biggest [adverse] effects [AEs] that nurses should be aware of when [treating] patients are differentiation syndrome and QT prolongation. With differentiation syndrome, even though this is an oral agent, it is one of the major AEs of this therapy and can be seen anywhere from 1 day to 3 months after starting treatment. Patients [may] start to have fevers [and], once they have count recovery, they start to have congestion in the chest that could be indicative of differentiation syndrome. It’s important that steroids are started in a timely manner.

QT prolongation is something that nurses should be aware of and if, for any reason, the patient starts [reporting] chest pain [or] palpitations, that should be taken seriously; it may be indicative of needing to stop the treatment. Nurses need to have keen assessment skills and take anything the patient or family may verbalize very seriously so that it can be treated in a timely manner.

The FDA also approved brexucabtagene autoleucel for relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) in 2021. Please comment on this approval and discuss where the field of CAR T-cell therapy is moving for patents with leukemia.

This was a second-generation CAR T [product] that was approved as a result of [data from the] ZUMA-2 trial [NCT02601313], in which 74 patients were enrolled…and 85% had an overall response, and 59% had complete remission. [Brexucabtagene autoleucel] was approved at an accelerated rate for patients who either have relapsed or refractory mantle cell lymphoma or CD19-positive B-ALL.

When you look into the literature, I see CAR T-cell therapy going toward alloCAR T. Right now, there’s only a few centers that offer CAR T. It takes 3 to 4 weeks to manufacture the cells once they’re collected from the patient, and there’s not many patients who may be eligible for this therapy. Another thing to think about is the current way that we offer CAR T. It’s very expensive, over $1 million [per] treatment. This is very dissatisfying for us as providers, when we know that patients may be eligible, but [must ask] are they eligible to get to the centers that offer CAR T and able to afford the expense of it even when it is covered by insurance? It’s a huge strain on the patient as well as the family, so we are now going to be moving to alloCAR T.

There are 3 alloCAR T trials open. [The product] will already be manufactured, [there] will be less of a wait time for patients, and it’ll be something that more centers will offer if it’s FDA approved.

For patients with chronic lymphocytic leukemia (CLL), the treatment paradigm has expanded beyond continuous treatment with BTK inhibitors with the addition of the time-limited regimen of venetoclax (Venclexta) plus obinutuzumab (Gazyva) and there are numerous other therapies under exploration. What factors are important to consider when choosing a treatment approach for this patient population?

Patients with CLL are usually between [age] 50 and 70 [years] and sometimes even older when they [receive a] diagnosis. [Therefore,] one of the 4 things we need to be mindful of is the patient's other comorbidities—heart disease, liver disease, kidney disease—and how that can impact treatment? The other piece we need to think about is drug adherence because many of these drugs are oral agents. We assume when sending patients home to take oral treatments, that they’re compliant. But, oftentimes, once they begin to have AEs, they’re no longer taking [the agents] and these are drugs that need to be taken at the prescribed time every day, or this disease starts to replicate.

The other piece is now we’re in the era of monoclonal antibodies and many of these monoclonal antibodies, [such as] obinutuzumab [Gazyva], have a risk for anaphylaxis—especially with first infusion. This requires the family to transport patients to medical centers, where sometimes they’re staying 4 to 5 hours for treatment. It’s important to consider [the physical and nonphysical] AEs when thinking about the best treatment for the patient beyond the prognostic factors and biomarkers.

Another piece to think about is if [the therapy is administered in the] inpatient [setting] or is this a treatment that can be safely administered in the outpatient setting? Those are all factors that we need to think about, as well as the family support; I am a huge proponent that even though we may be treating the patient in front of us, we’re also treating that family connected to them. If it will be a strain on that family to transport this patient back and forth, [this] may be a patient who we need to have admitted into the inpatient setting, so that we can have eyes on that patient for 24 hours and not put the burden on the family to bring them to the outpatient setting and be the eyes and ears for us at home. [Family] may not be able to be aware or report the AEs that the patient may have once they leave the medical center [as well].

How is prognostic marker testing playing a role in treatment decisions? What is the nurse’s role in biomarker testing?

I’ve been in this [field] over 2 decades and the world of solid oncology has seen this for many years, but hematology hasn’t.

[Yet,] over the [past 10 years, we’ve seen so many improvements with hematology therapy, Philadelphia [chromosome] AOL FLT3, IDH1, JAK2, these [are] biomarkers that we look at to determine the best treatment for patients. Historically, if you had AML, you got [one] treatment, if you had ALL you got [another] treatment. But now with these biomarkers, we can be more prescriptive in finding the best treatment because we’re targeting the genetic mutation that’s driving the cancer. It’s important for nurses to know the biomarker we’re [targeting for] a particular cancer with and be aware of the AEs [of the associated treated], so that we can report any AEs the patient may have and educate the patient.

Nurses are there 12 hours with patients and when our medical team rounds, they’re there sometimes 5 to 10 minutes unless they need to educate the patient more on their disease or if the family has questions. It’s important that nurses are familiar with these new FDA approved drugs so that they can reinforce why we are giving this treatment, and not just the historic 7 + 3—7 days of cytarabine and 3 days of daunorubicin. Now, we’ve added FLT3-[targeting] drugs, midostaurin [Rydapt], these are all of the advances we’re seeing in the field of hematology, and it’s important that nurses are practicing to the top of their licensure, getting themselves certified so they can be aware of why we are doing this treatment vs another treatment.

What are you most excited about in the field of leukemia?

It is an exciting time. I think about patients I treated when I first came into this field who died. [Individuals] went through so many treatments and these patients had so much hope, whether they were young or even elderly. Now to see drugs that are being approved for [patients] 75 years [with] newly diagnosed [disease] that are tolerable [is inspiring].

It takes a nurse who is knowledgeable of the drugs, knows the AEs, and who are partnering with the interdisciplinary team to make sure that we can get these patients through this treatment. It’s exciting to see where the field of hematology is going.

References

1. FDA approves ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia. FDA. Updated August 1, 2022. Accessed August 6, 2022. bit.ly/3zHl9Wr
2. Tecartus (brexucabtagene autoleucel). FDA. Updated April 13, 2022. Accessed August 7, 2022. bit.ly/3QsLnTq