For patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), induction therapy often requires patients to remain hospitalized until blood cell count recovery, typically resulting in prolonged hospitalization stays, increased health resource use, and increased costs. According to results from a study published in JAMA Oncology, outpatient management of these patients is a cost-effective approach – cutting daily costs by more than $2,000 – but early discharge carries with it a higher risk for certain complications.
Jennifer E. Vaughn, MD, from Fred Hutchinson Cancer Research Center in Seattle, Washington, and colleagues conducted a nonrandomized, phase II, single-center study at the University of Washington Medical Center to compare the safety, resource use, infections, and costs associated with inpatient versus outpatient chemotherapy in AML and MDS patients.
From January 1, 2011, through July 31, 2014, the investigators enrolled 136 patients who received induction chemotherapy into the study. Those who met the designated medical and logistic criteria for early discharge following completion of induction chemotherapy (including ECOG performance status of 0-1 with adequate organ function and no active bleeding, agreeable to close outpatient follow-up, securing a reliable caregiver, and residency within 60 minutes of the outpatient clinic) were selected for the outpatient management cohort. Twenty-nine patients who met the medical criteria but not the logistic criteria, served as inpatient controls.
Patients remained on protocol until blood count recovery, additional chemotherapy was administered, or they hit the maximum of 45 days. The outpatient cohort was released from the hospital following chemotherapy and received supportive care in an outpatient setting until blood cell count recovery. If readmitted, early discharge was again possible if all of the medical and logistic criteria were met.
Patients in the outpatient cohort had a median 21-day recovery period (range = 2-45 days), while patients in the inpatient cohort had a median 16-day recovery period (range = 3-42 days).
Dr. Vaughn and colleagues analyzed differences in the following measures:
- Early mortality
- Resource utilization, including intensive care unit (ICU) days, transfusions per study day, and use of intravenous (IV) antibiotics per study day
- Number of infections
- Total and inpatient charges per study day, which were compared with inpatient and outpatient participants
During the 43 months of study follow-up, four of the 107 outpatient participants died within 30 days of enrollment, while no patients in the inpatient cohort died (p=0.58). Also, nine patients in the outpatient cohort (8%) required ICU-level care, compared with none in the inpatient cohort (p=0.20).
Focusing on resource use, the researchers indicated no differences in the median number of daily transfused red blood cell units (0.27 for the outpatient group vs. 0.29 for the inpatient group; p=0.55) or transfused platelet units (0.26 vs. 0.29 for the inpatient group; p=0.31).
The outpatient cohort did have more positive blood cultures compared with the inpatient group: 35 percent (n=37) versus 14 percent (n=4; p=0.04), though the outpatient group had fewer IV antibiotic days per study day compared with the inpatient group (0.48 vs. 0.71, respectively; p=0.01).
Overall daily health-care charges among the two patient groups were significantly different; those in the outpatient program had median daily costs of $3,840 compared with $5,852 for the inpatient cohort (p<0.001). “Daily charges among early-discharge patients were significantly lower than for inpatients (median = $3,840 vs. $5,852; p<0.001) despite increased charges per inpatient day when readmitted (median = $7,405 vs. $5,852; p<0.001),” the researchers reported.
“Early discharge following intensive AML or MDS chemotherapy can reduce costs and use of IV antibiotics,” the researchers concluded, “but attention should be paid to complications that may occur in the outpatient setting.” The single-center design is a limitation of this study, and the safety signals concerning, though, and the results will need to be confirmed at additional centers before this can be considered an acceptable, standard approach to treatment.
Vaughn JE, Othus M, Powell MA, et al. Resource utilization and safety of outpatient management following intensive induction or salvage chemotherapy for acute myeloid leukemia or myelodysplastic syndrome: a nonrandomized clinical comparative analysis. JAMA Oncol. 2015 September 10. [Epub ahead of print]