Summary
Do pediatric patients with acute myeloid leukemia (AML) have to stay in the hospital after undergoing chemotherapy? Or, is it safe to send them home?
When a fellow physician posed these questions, Richard Aplenc, MD, PhD, MSCE, a physician-scientist within the Division of Oncology at Children's Hospital of Philadelphia (CHOP), recognized a gap in the literature. While current supportive care guidelines do recommend hospitalization after chemotherapy completion until neutrophil recovery, the data to support inpatient over outpatient management is limited.
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Original Article
Pediatric AML Management After Chemotherapy: Outpatient vs. Inpatient Care
Oncology Times
By Catlin Nalley
Do pediatric patients with acute myeloid leukemia (AML) have to stay in the hospital after undergoing chemotherapy? Or, is it safe to send them home?
When a fellow physician posed these questions, Richard Aplenc, MD, PhD, MSCE, a physician-scientist within the Division of Oncology at Children's Hospital of Philadelphia (CHOP), recognized a gap in the literature. While current supportive care guidelines do recommend hospitalization after chemotherapy completion until neutrophil recovery, the data to support inpatient over outpatient management is limited.
“To us, this seemed like a very important question for which there was inadequate information to guide the decision and the information that was available was not from the patient's perspective,” noted Aplenc, who is also Assistant Vice President and Chief Clinical Research Officer at the CHOP Research Institute.
Aplenc and his team launched a study in an effort to understand not only the medical consequences of inpatient and outpatient care, but also the patient perspective on these two approaches. Findings were recently presented at the 2019 ASH Annual Meeting (Abstract 379).
Three-Pronged Approach
In a sample of newly diagnosed AML patients (<19 years old), Aplenc and his team compared the clinical outcomes (Aim 1), patient experiences (Aim 2), and patient quality of life (QoL) (Aim 3) of the two strategies.
For Aim 1, researchers utilized retrospective, standardized chart abstraction for AML patients who received treatment between 2011 and 2019 at 17 centers in the U.S. “Patients were observed from their first course of chemotherapy through treatment completion, stem cell transplant, site transfer, relapse, or death,” the researchers outlined.
“The unit of analysis was chemotherapy courses, the primary exposure was inpatient versus outpatient management, and primary outcomes were bacteremia and time to next treatment course.”
To better understand the patient experience (Aim 2), patients and families at nine centers underwent interviews that were transcribed and analyzed using a conventional content analysis approach, according to study authors.
Lastly, Aim 3 involved prospective data from patients at 14 centers. “At the start of the chemotherapy, we would ask them about their quality of life,” Aplenc explained. “And then there QoL would be measured again after they recovered from the treatment course. This allowed us to compare how it changed depending on whether they were managed in or out of the hospital.”
This multifaceted approach is a strength of the study. “We have such rich data across so many aspects of the patient's and family’s experience that it allows us to understand this question of whether patients should be treated in or out of the hospital with a level of nuance that that wouldn't be possible otherwise,” Aplenc noted.
Key Findings
Each component of the study revealed important information regarding the management of AML following chemotherapy.
Aim 1, which included 573 patients (1,188 treatment courses), did not demonstrate a statistically significant difference in overall rates of bacteremia among patients receiving outpatient versus inpatient management (23.8% vs. 29.0%, RR 0.76, 95% CI: 0.56, 1.03; p=0.07).
“However, in every course that we analyze, there seems to be a protective effect and that effect was statistically significant in the last course,” Aplenc told Oncology Times. “We interpret that to mean that there's a very strong suggestion that being at home may be associated with less bloodstream infections and certainly outpatient management is not associated with more infections.”
In Aim 2, researchers performed 86 interviews in 57 families (39 inpatient, 18 outpatient). “Eighty-six percent of families receiving inpatient management expressed satisfaction and 85 percent receiving outpatient management expressed satisfaction,” researchers reported.
This was an interesting finding, Aplenc noted. “We thought one group would clearly be more satisfied than the other,” he said. “I think that means that the way the two options are presented really defines how people experience it.”
Study authors found that dissatisfaction with inpatient management stemmed from concerns for hospital-acquired infections and separation from families. In regards to outpatient care, dissatisfaction was driven by the stress of caring for their child safety at home.
“Patients/families also noted that the decision to receive inpatient or outpatient care should be made at the individual family level,” Aplenc said. “They emphasized that going home would not be appropriate for all cases.”
Aim 3 data showed that being at home was associated with better sleep and overall QoL, according to Aplenc. “While there was no statistically significant difference, there is a sense in the data that being at home may be easier for patients.”
However, there is one important exception. “Parents whose children were treated as outpatients reported a much higher level of stress around making mortgage payments,” Aplenc said. “For some reason, families of patients who are treated in the hospital found it significantly easier to meet their mortgage payments.”
“These clinical and patient-centered results suggest that outpatient management during neutropenia is a viable approach without excess risk for children with AML,” researchers concluded. “However, implementation studies are needed to identify patient/family characteristics that portend a positive experience with an outpatient strategy.”
Implications, Next Steps
This research provides real data to guide the decision-making process for pediatric AML patients, according to Aplenc.
“It gives us information with which to have a much more thoughtful and nuanced conversation with a family about which strategy is going to be best for them,” he explained. “Leukemia occurs in a patient who lives in a broader context and we want to personalize this particular decision about whether they stay in the hospital or go home.”
This study provides a plethora of data and opens the door for continued research on this topic. There are two avenues of study, according to Aplenc.
One is to dig deeper into the findings. “Why do families who are managed as outpatient have more trouble meeting their mortgage payments?” he explained. “Also, we don’t know yet whether patients who go home and have a bloodstream infection are sicker when they come to the hospital than those who are inpatients.”
The second area of study focuses on implementation. “Currently, about 80 percent of children with AML in the U.S. are treated as inpatients,” Aplenc said. “What would you need to do at a particular center to be able to send a certain set of your AML patients home safely and consistently? What are the changes you would need to make in the way you organize care to make that possible?”
This research has laid the foundation for ongoing study and offers a unique look at the patient experience. “It’s very meaningful for me and the rest of the research team to have the voices of both patients and families so much a part of this research,” Aplenc emphasized. “It is an important component of the study and offers a more comprehensive understanding of the patient experience.”
Catlin Nalley is a contributing writer.